WO2015170956A1 - Pharmaceutical vial bottle having two openings - Google Patents

Pharmaceutical vial bottle having two openings Download PDF

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Publication number
WO2015170956A1
WO2015170956A1 PCT/MX2015/000071 MX2015000071W WO2015170956A1 WO 2015170956 A1 WO2015170956 A1 WO 2015170956A1 MX 2015000071 W MX2015000071 W MX 2015000071W WO 2015170956 A1 WO2015170956 A1 WO 2015170956A1
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WO
WIPO (PCT)
Prior art keywords
vial
further characterized
vial bottle
pharmaceutical
opening
Prior art date
Application number
PCT/MX2015/000071
Other languages
Spanish (es)
French (fr)
Inventor
Rodolfo VILLALÓN ROJAS
Original Assignee
Villalón Rojas Rodolfo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Villalón Rojas Rodolfo filed Critical Villalón Rojas Rodolfo
Publication of WO2015170956A1 publication Critical patent/WO2015170956A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material

Definitions

  • This invention relates to a pharmaceutical vial containing two openings, for atomization, of pharmaceutical compositions and bioproducts in humans, which need to be reconstituted or diluted before being used.
  • nasal dosage forms of drug delivery systems include four groups: " ⁇ liquids, which include: nasal instillation catheters, nasal drops, single dose containers, and manually copsible containers (squeezed bottles).
  • measured dose nasal inhalers base their operation on the use of one or more different vehicles or carriers.
  • measured dose nasal inhalers that use pressurized propellant as a vehicle or carrier and nasal spray inhalers based on an aqueous vehicle or carrier.
  • ⁇ a container container that has a unique opening.
  • - a carrier or aqueous vehicle.
  • - a pharmaceutical composition, ie active ingredient and excipients.
  • - a dosing valve that firmly fitted to the single opening, closes the container and administers the doses of its compositions.
  • an actuator which generally although without imitations to this, in action coordinated with the booster valve, administers the doses.
  • this actuator has its own protective cover.
  • Some nasal spray actuators have very sophisticated actuation systems, with insurance to prevent late performance and boxes with operating levers. Notwithstanding this sophistication, its container container, is a pharmaceutical vial made of glass, with a totally conventional external structure that has a unique opening.
  • Veramyst® product in the United States of America or Avamyys2A® in Mexico, Fluticasone Furoato which has such an actuator.
  • Verarnyst® and Avamyys2A® are registered trademarks of the GSK plc corporation and / or its subsidiaries.
  • Nasal sprayers that administer liquid or aqueous compositions, either in solution or suspension generally use pharmaceutical grade vial vials or containers very similar to each other in their general external structure and always have a unique opening.
  • the vial is made of various materials, such as pharmaceutical grade glass in its various classes and colors. There is also the possibility of having various coatings such as silicones or other polymers to improve the insulation and resistance characteristics of these pharmaceutical glass containers. Also, the pharmaceutical grade vial can be manufactured in different pharmaceutical grade polymers. Examples of these polymers are polyethene or PE, polyethiyerephthalate or PET, low density polyethylene and the copolymer of cyclic olefin or cycloolefin, all of them pharmaceutical grade.
  • the current pharmaceutical compositions of intranasa ⁇ administration are basically of two types: pressurized and not pressurized. Pressurized ones use oropelent as a carrier vehicle, which generates a pressurized aerosol. The non-pressurized ones, currently include, but are not limited to, all aqueous compositions and dry powders. Pressurized compositions.
  • compositions for administration by the intranasai route in pressurized aerosol, by using pressurized propellant are generally packaged, but not limited to, in metal alloy cans, capable of withstanding the pressure of the oropelent without problems. Its dosage is carried out with a measured dose valve and its actuator; The dosing valve is firmly secured to the single opening of the metal can.
  • the can assembly, dosing valve and actuator are known in the global pharmaceutical industry as nasal pressurized aerosols, which is a translation of the English "presurized nasal aerosols". In this case, it is pressurized aerosols of measured dose for intranasa ⁇ use.
  • Non-pressurized compositions are:
  • compositions in dry powders which require specific attachments to be administered and liquid compositions or aqueous that use atomizing valves as their base to be administered by means of nasal sprayers.
  • compositions that use nasal sprays have to be aqueous or liquid, either in solution or in suspension to be dispensed by their metered dose atomizing valves and also because, they use the current vial vials that have a single opening.
  • the two-opening vial bottles and a single container chamber useful for the atomization of drugs that need to be reconstituted or diluted, prior to their application according to the present invention differ significantly from the device described in U.SA, No. 4,607,671; Said device consists of a single opening vial that requires a second container for the reconstitution process.
  • the device claimed by this US patent, number 4,607,671 is the device itself and not the vial.
  • the reason for the present invention claims ownership exclusively over the two-opening vial with a single container chamber.
  • all possible reconstitution devices are simple vial bottle caps made of resilient, crimped material. by its metal caps, on which this invention makes no claim claims.
  • Figure 1 is a representation of a longitudinal section of the pharmaceutical vial having two openings, where they are: main opening (1); lip of the main opening (2); neck of the main opening (3); body shoulder (4); secondary opening perpendicular to the vertical axis of the vial (5); lip of the secondary opening (6); secondary opening neck (7); body container (8); floor or bottom (9); wall (10); single container chamber (11).
  • Figure 2 is a representation of an average longitudinal section of the pharmaceutical vial having two openings, the main floor-opening vertical axis (11) is illustrated; and the central axis of the secondary opening (12). In this mode, the position at 90 * of the central axis of the secondary opening (5) is shown, relative to the main floor-opening vertical axis.
  • Other structures already numbered and described in Figure 1 respect their numerical order.
  • Figure 3 is a representation of an average longitudinal section of the pharmaceutical vial having two openings, the main floor-opening vertical axis (11) is illustrated; in another embodiment, the secondary opening (51) and its central axis (121) are at an angle less than 46 ° with respect to the main floor-opening vertical axis; the lip of the secondary opening of this modality (61); neck of the secondary opening of this modality (71).
  • Figure 4 is a representation of a longitudinal sectional front view of the pharmaceutical vial having two openings, in this embodiment, both openings have threads, where they are: main opening (1); main opening thread (13); neck of the main opening (3); body shoulder (4); secondary opening (5) perpendicular to the main floor-opening vertical axis (11); secondary opening thread (14); secondary opening neck (7); container of the vial vial body (8); bottom or floor of vial vial (9); and single container chamber (10).
  • Figure 5 is a representation of a longitudinal section of the vial having two openings, in another embodiment whose main opening has a lip, while its secondary opening has a thread, and where they are: main opening (1); lip of the main opening (2); neck of the main opening (3); body shoulder (4); secondary opening (5), perpendicular to the vertical axis of the vial (11); secondary opening thread (14) secondary opening neck (7); central axis of the secondary opening (12); body container (8); floor or bottom (9); and single container chamber (10).
  • Figure 6 illustrates the exterior representation of the vial that has two openings and both openings have a lip. This mode has the cylindrical outer body container (81); and its shoulder of the body has a slightly rounded outer shape (41). The other structures are numbered according to the previous figures.
  • Figure 7 illustrates the exterior representation of the vial that has two openings, of the main opening (1), has a thread (13); the shoulder of the body is slightly rounded (41) and (at secondary opening (5) it has lip (6); this modality has the cylindrical outer body container (81).
  • the other structures are numbered according to the previous figures .
  • Figure 8 illustrates the outer representation of the vial that has two openings and whose outer shape of the body container is composed of two flat side faces and two concave faces (82); the main opening (1) has a lip (2); and the secondary opening (5) also has a lip (6); The outer shape of the shoulder of the body is composed of four well-defined faces (42).
  • Figure 9 is a representation showing three views A) posterior, B) lateral and C) superior, of a vial with two openings.
  • the primary opening (1) has a lip and neck;
  • the secondary opening (5) also has its own lip and neck. It has the shoulder of the body formed by four well-defined faces (42); and its body container (82) has four faces, two of them prismatic sides and concave front and back sides. It is the reverse side that communicates with the secondary opening.
  • Figure 10 is a representation of the vial of two openings and other components separately from a first nasal spray mode.
  • the two-opening vial has a lip in both openings and a cylindrical outer body container (15), in the main opening (1) the following are integrated: the metered dose atomizing valve (17), its actuator ( 18) and plug (19); In the secondary opening (5), they are integrated: a cap for a vial made of resilient material (20) and its metal bushing (21) for crimping.
  • Figure 11 is a representation of the vial of two openings and other components separately from a second embodiment of nasal spray.
  • the pharmaceutical vial of two openings whose container of the body has an outer shape composed of concave front and back faces and two prismatic side faces (16), this two-opening vial has lip in both openings .
  • the route of intranasal administration of drugs offers two great therapeutic possibilities: the first possibility is to be a direct route for local, topical or in situ treatments, whose target organs are the irrtranasal mucous membranes and rhinosinusates, using minimal doses for it.
  • the second possibility is to be an access route for systymic drugs, with target tissues and organs, very different from the nasal mucosa or nasal cavity.
  • a topical treatment is one that is applied to the skin or mucous membranes to achieve a therapeutic effect.” In this case, the application of the drug is directly on the nasal mucosa.
  • the objective of the present invention is to provide the pharmaceutical industry with a vial containing two openings, which not only packages and administers pharmaceutical compositions that use the intranasal route, but also has the ability to reconstitute or dilute , pharmaceutical compositions and bioproducts inside, maintaining the integrity of both the atomizer and the pharmaceutical composition itself, ensuring the integrity of the container-content system.
  • These reconstitution or dilution capabilities generate real possibilities of creating new and very diverse pharmaceutical and bioproduct compositions.
  • the present invention as a vial of pharmaceutical quality and bioproducts maintains the existence of an essentially piano floor or bottom (9), as well as a well-defined shoulder of the body (4), (41 ⁇ and (42).
  • the shoulder of the body is also a well defined part in the pharmaceutical vial and bioproduct motif of the present invention, it is a transition structure that joins the body container with the main opening. Its exterior shape can be varied, starting from the perfect flat, rounded, as well as the integrated by several flat, convex or concave faces and combinations thereof.
  • Each of the two openings of the present invention have their own neck, that is to say in this vial, the neck of the main opening (3) and the neck of the secondary opening (7).
  • each of the two openings of the present invention has its own outer distal edge, which allows incorporating attachments for closure, closure and passage, as well as for administration in measured doses .
  • This outer distal edge has two options: - is a lip (2) and (6).
  • the lip allows to its opening in question, the crimping or coupling of additional elements such as: a metered dose atomizing valve, or a vial vial cap, firmly crimped with its metal cap.
  • additional elements such as: a metered dose atomizing valve, or a vial vial cap, firmly crimped with its metal cap.
  • the lip is a regular exterior prominence, of perfect central outer shape, located in the distal part, of one or both openings of the vial of the present invention, is easily distinguishable, at the end of the neck of its corresponding opening.
  • One embodiment of the present invention is that it has, has its two lip openings ( Figures 1, 2 and 3).
  • each of the two openings has a thread, instead of having a lip ( Figure 4).
  • Another modality has one of the two threaded openings, while another opening has a lip ( Figure 5).
  • the thread (13) and (14) is also an outer prominence around the opening, but now its shape is ia of a single helical thread and not of perfect cylindrical.
  • this thread in the openings of the present invention allows him to fix other elements by screwing, such as, the metered dose atomizing valves and threaded metal caps, which when screwed by turning Threads of the vial of the present invention close their openings in the pharmaceutical plant.
  • the incorporation of a second useful and practical opening does not modify at all the single container chamber of the conventional vial. That is, the present invention It maintains the existence of a single container chamber (10) and at no time, for any reason, or under any procedure, more than one container chamber is generated inside the present vial containing two openings.
  • the single container chamber is the entire interior space within the wall of the two-opening vial which is the subject of the present invention.
  • This interior space includes, of course, the spaces within the necks of each of the openings and of course within the entire interior of the container and shoulder of the body.
  • the single container chamber communicates with each other to both openings of the vial of the present invention.
  • the body container begins where the shoulder of the body ends to the essentially piano floor or bottom. It can have perfect cylindrical exterior shape; oval; cubic, trapezoid, with flat, convex or concave faces and combinations thereof.
  • the wall of the container of the body in its outer part is the most common site in the industry, for the pharmaceutical labeling of the vial vials motive of the present invention.
  • its measurement parameter is its outer perimeter. This is measured on the outside of the body container, immediately below or above the secondary opening. If there are differences between both measures, the official data will be the major measure between the two.
  • the vial of motif of the present invention measures in its outer perimeter of the body container of 50 to 130 millimeters.
  • the main opening (1) is physically located in the shoulder of the body, in a completely opposite position to the floor or bottom that is essentially flat of the vial vial motive of the present invention. This physical position of the main opening totally opposite to the flat floor or floor, creates the existence of a vertical axis floor-main opening (11).
  • the main opening of the vial of two openings has several functions:
  • the measurement parameter of the main opening is its outer diameter.
  • the outer diameter of the main opening is measured, from the outside of its lip or, where appropriate, from the outside of its thread.
  • the outer diameter of the main opening of the pharmaceutical pharmaceutical vial of the present invention measures from 12 to 21 millimeters.
  • the measuring parameter of this lip will be its height.
  • the height of the lip of the main opening is measured from its outer part, from the distal part of the opening, to where this uniform edge ends to join its respective neck.
  • the height of the lip of the main opening is measured on the outside of the lip, following the direction of the main floor-opening vertical axis, in the present invention it measures from 3 to 6 millimeters.
  • the main opening always has its own neck, which is referred to in the present invention as the neck of the main opening (3).
  • This neck of the main opening is cylindrical and its measurement parameters are two:
  • the outer diameter of the neck of the main opening can be measured at any point of the neck, where there is no interference from the lip or the thread, since being a cylindrical structure its measurement is uniform.
  • the outer diameter of the neck of the main opening measures 8 to 17 millimeters.
  • the length of the neck of the main opening may not be uniform, since in certain modalities of a vial with two irregularly shaped shoulder openings, or by optional presence of the thread, the length measurement of the neck of the main opening would not always be the same, so when there is more than one length measurement of the neck of the main opening, its official measurement will be the largest of these, from the shoulder of the body to the lip without including the latter, or up to the limit of the main opening, despite the presence of the thread.
  • the neck length of the main opening measures from 3 to 20 millimeters.
  • the secondary opening (5) of the vial subject of the present invention is located on the wall of the body container (8), with its central axis of the secondary opening (12) in a transverse position of 30 ° to 90 ° degrees to the main vertical axis of the main cover (11), (figures 2 and 3).
  • the measurement parameter of the secondary opening is also its outer diameter.
  • the outer diameter of the secondary opening is measured from the outside of its Sage or, where appropriate, from the outside of its thread.
  • the outer diameter of the secondary opening of the pharmaceutical vial vial of the present invention measures from 12 to 21 millimeters.
  • the measurement parameter of this lip will be its height.
  • the height of the lip of the secondary opening is measured from its outer part, from the distal part of its opening, to where this uniform edge ends to join the body container.
  • the height of the lip of the secondary opening is measured on the outside of the lip, following the direction of the central axis of the secondary opening, in the present invention it measures from 3 to 6 millimeters.
  • the secondary opening always has a propk> neck, which is referred to in the present invention as a neck of the secondary opening (7).
  • This pendulum of the secondary opening is cylindrical and its measurement parameters are two:
  • the outer diameter of the neck of the main opening can be measured at any point of the same, since in the case of a cylindrical structure its measurement is uniform.
  • the outer diameter of the secondary opening collet measures 8 to 17 millimeters.
  • the length of the neck of the secondary opening may not be uniform, since in certain modalities of a vial with two openings the cylindrical shape of the container of the body with a concave or irregular outer shape, or thread, the measure of the length of the secondary opening cave would not always be the same. In this way, when there is more than one length measurement of the neck of the secondary opening, its official measurement will be the greater of these, from the container of the body to the lip without including the latter, or to the limit of the secondary opening , despite the presence of thread.
  • the length of the main opening hole measures from 3 to 20 millimeters.
  • the secondary opening incorporated into the pharmaceutical vial has several functions, since it is not only capable of allowing the entry of pharmaceutical compositions and solid, semi-solid bioproducts, in gei, but also adapts with the closing and passage means, to enter a pharmaceutically acceptable reconstituting agent to the single container chamber, to reconstitute or dilute said pharmaceutical or bioproduct compositions before being administered.
  • this secondary opening allows its entry into the single container chamber, as well as its dilution before being administrable.
  • the existence of the secondary opening allows a second access to collect an additional attachment, for example a needle syringe.
  • the secondary opening allows the reconstituting agent or diluent to be introduced into the single container chamber, where it will come into contact with the pharmaceutical composition packaged therein.
  • the secondary opening has its own elements of the corresponding closure and passage means screwed, screwed.
  • the elements of the closure and passage means for the process of reconstitution or dilution of the ingredients of the pharmaceutical compositions are of two types; the combination of a vial bottle cap made of resilient material (20), with a metal bushing (21) or a metal cap for crimping or screwing in the secondary opening; and the combination of a shut-off valve "luer" type, for use with a syringe without a needle, with its metal cap or metal cap for crimping or screwed into the secondary opening.
  • the present invention employs as a means of closure and passage, the combination of a vial vial cap, made of resilient material and its metal cap or metal cap, crimped or screwed into the secondary opening, to perform reconstitution or dilution of the pharmaceutical compositions.
  • the body of the two-opening vial has structures similar to those of the single-opening vial, that is, a body with an essentially piano and well-defined floor or bottom, shoulder of the body with a well-defined exterior shape, which joins the container of the body with the neck of the main opening.
  • the container of the body (8), (81 ⁇ and (82), of the vial viai of the present invention begins where the shoulder of the body ends, to the floor or flat bottom. have a very diverse exterior shape that goes from (to a perfect cylindrical shape and the ovaf, passing through the shape formed by conical, concave or concave faces and any combination thereof.
  • tota ⁇ aitura measures 35 to 66 millimeters. This total height is measured, following the vertical axis of the main floor-opening, from the floor or bottom, to the distal limit of the main opening.
  • the pharmaceutical vial that has two openings that are the subject of the present invention can be manufactured using the following materials always with pharmaceutical quality: glass, polytethiene, low density polyethylene, polyether phosphate, polypropylene , polyvinyl chloride or pvc, the cyclic olefin or cycloolefin copolymer, as well as any other material known in the state of the art.
  • the pharmaceutical grade materials very useful in the manufacture of the vial vials motive of the present invention can be clear or transparent, as well as amber coffer in its very different shades.
  • the vial bottles that have two motive openings of the present invention, adapt to the techniques and machinery known in the state of the art.
  • the expert in the field will recognize that the entry of pharmaceutical compositions and solid, semi-solid, gel or liquid bioproducts, into the interior of the vial vials motive of the present invention, is carried out with the techniques, areas, conditions and machinery, common in the state of the art.
  • the vial bottles, which have two openings that are the subject of the present invention are adapted as metered dose dispensers, with the incorporation of a metered dose atomizing valve (17), with its actuator (18) and cap (19) (figures 10 and 11), to atomize the pharmaceutical or bioproduct composition, after being reconstituted or diluted.
  • the vial bottles that have two motif openings of the present invention also comprise: a vial stopper (20), made of resilient material crimped by its metal cap (21) (figures 10 and 11), or screwed with a metal cap threaded to (at secondary opening; and a pharmaceutical or bioproduct composition in solid, semi-solid, gel or liquid state, which needs to be reconstituted or digested to be administrated and then atomized.
  • a vial stopper (20) made of resilient material crimped by its metal cap (21) (figures 10 and 11), or screwed with a metal cap threaded to (at secondary opening; and a pharmaceutical or bioproduct composition in solid, semi-solid, gel or liquid state, which needs to be reconstituted or digested to be administrated and then atomized.
  • the present invention snaps, collects or screws tightly in its main opening, metered dose atomizing valves, which comprise valves of wide range of doses, although without any limitation in this, administer 50 to 140 microliters per actuation and have measures comprised of 13 at 21 mm.
  • metered dose atomizing valves which comprise valves of wide range of doses, although without any limitation in this, administer 50 to 140 microliters per actuation and have measures comprised of 13 at 21 mm.
  • Their actuators and the caps for these actuators correspond in size to their respective atomizing valves.
  • the two-way vial flask of the present invention is very own and adapts with the machinery and routine tools, for placement and crimping or coupling or screwed on, atomizing valves that are firmly fixed to the main opening. Once the valve is fixed, it can receive its actuator and plug; also with machinery and routine tools, the actuators are fixed to them, guiding the bases of the actuators on the pistils of the valves. The caps of the actuators are placed at the end of this stage on the pistils of their respective actuators.
  • the two-way vial which is the subject of the present invention is very own and is adapted with routine machinery and tools, for placing the caps made of resilient material in the secondary opening. Once the plug made of resilient material is placed, also with machinery and routine tools, this plug is crimped or screwed to the secondary opening by metal bushings or by threaded metal caps.
  • the present invention is very own and adapts to firmly hook the lip, or screw the thread of the secondary opening, vial caps made of resilient material placed in it, using metal caps or threaded metal caps.
  • the caps for vial and metal caps or threaded metal caps correspond to measures ranging from 13 to 20 mm.
  • the vial vial cap made of resilient material, placed and crimped or screwed with its metal cap or threaded metal cap, to the secondary opening of the present invention comprises one of butyl, chlorobutyl, bromobutyl, Isoprene, rubber, silicone, cyclobutyl / isoprene or butyl / polytetrafiuoroethiene, as well as four other material described in the prior art.
  • the vial of pharmaceutical use of two openings is totally suitable and proper to: enter its single container chamber, reconstitute or dilute and atomize, pharmaceutical compositions and solid, semi-solid, gel and liquid bioproducts that require the reconstitution of its ingredients , before being administered. Also to close their openings with their respective attachments, after entering the composition into the single container chamber.
  • Said compositions include one or more active principles in solid, semi-solid and gel, or liquid physical state, to be reconstituted or diluted before being administered.
  • the innovation of the present invention allows this novel bottle via its main opening to have a metered dose atomizer valve firmly crimped, coupled or screwed, thus closing it by integrating its respective actuator and cap, while its secondary opening, it can have, at the same time, the elements of the closing and passage means, which consists of the combination of a vial vial cap made of pharmaceutically acceptable resilient material and metal alloy cap or a threaded metal cap that locks it or screws it tightly.
  • compositions so packaged, reconstituted or diluted before being administered.
  • pharmaceutical or bioproduct compositions that comprise active ingredients of low pharmaceutical stability and that require refrigeration during their useful life, it is important to note that the reconstituted or diluted pharmaceutical compositions administered in the vial vials of the present invention are totally compatible with refrigeration, since none of the elements of the vial of the present invention are opposed to it.
  • compositions that need to be reconstituted or diluted before being used include one or more active ingredients as well as other different ingredients and / or pharmaceutically acceptable excipients.
  • active ingredients include one or more active ingredients as well as other different ingredients and / or pharmaceutically acceptable excipients.
  • other ingredients other than the active ingredients may include solubilizing, tonicity, suspending, pH regulating, gelling, absorption enhancers, preservatives, antioxidants, humectants and surfactants widely described in the international pharmacopoeia.
  • the vial via the motive of the present invention is very own and is adapted to the entry of solid, semi-solid or gel, or liquid pharmaceutical compositions that need to be reconstituted or diluted before administrable, as well as the closure of their main opening with its atomizing valve with actuator and cap and when closing its secondary opening with the elements of the closing and passage means, in sterile areas, with normal atmosphere conditions, without the use of non-oxidizing or nitrogen enriched atmosphere, Argon, or any other non-oxidizing inert or noble element or gas. Under conditions of normal working atmosphere, in one area the entry of the composition into the single container chamber and the closure of the openings of the sterile vial is carried out with the sequence that includes:
  • the corresponding pharmaceutical or bioproduct composition is introduced in solid, semi-solid, gel, or liquid state, to its single container chamber:
  • the vial of the present invention passes into its final packaging and is incorporated into it: the sterile pharmaceutically acceptable liquid reconstituent or diluent, packaged in its own vial containing a single opening and which is closed by a vial vial cap made of resilient material, crimped with a metal cap; Also added in this final carton, a syringe with needle both sterile and an instruction manual.
  • the vial of the present invention spends its entire shelf life packed in this way.
  • the present invention is understood as the solution or suspension required by the pharmaceutical compositions, which, due to their initial solid, semi-solid or gel physical state, always require it, before they can be administered by means of metered dose sprays.
  • Dilution is understood in the present invention, to the depletion of the concentration, required by the pharmaceutical and bioproduct compositions, which, due to their initial liquid physical state, so they need, before they can be administered by means of measured dose sprays,
  • the vial of the present invention is adapted to reconstitute and dilute the pharmaceutical and bioproduct compositions entered in its single container chamber and when its two openings were already closed with its atomizing valve with actuator and cap and the closing and passage means, first , when a pharmaceutically acceptable reconstituent or diluent is introduced through the secondary opening, which is the specific part of the vial, of the present invention, adapted for this purpose.
  • the pharmaceutically acceptable reconstituting agent or diluent is taken out of its own container in the amount necessary for that purpose.
  • the safety seal of the metal cap or metal cap is removed, on the cap for vial vial stuck or screwed into the secondary opening of the vial of the present invention and introduces the reconstituting agent or diluent contained in the syringe, in the amount necessary to the single container chamber.
  • the pharmaceutical or bioproduct composition within the single container chamber has contact with the reconstituting agent or diluent.
  • the vial of the present invention with its contents, is vigorously shaken manually to achieve adequate reconstitution or dilution of the pharmaceutical or bioproduct composition, so that from this point the composition is administrable and its atomization is possible.
  • any pharmaceutically acceptable agent is understood as capable of achieving the necessary solution or suspension, so that solid, semi-solid or gel pharmaceutical or bioproduct compositions can be administered by measured dose sprays.
  • any pharmaceutically acceptable agent is understood as capable of achieving a reduction in the necessary concentration, so that the pharmaceutical or bioproduct compositions in the initial liquid state reach their final and complete aqueous phase, for that can be administered in a better way, atomized in measured doses.
  • the metered dose atomizing valve used by the atomizers that are incorporated into the vial vials that are the subject of the present invention, consists of an attachment that operates correctly until the pharmaceutical composition is properly reconstituted or diluted.
  • pharmaceutically acceptable reconstituting agents or diluents include sterile injectable water and optionally include other excipients, such as:
  • the pharmaceutical vial and btoproducts motive of the present invention spends its entire shelf life in its final carton.
  • This vial then allows the reconstitution or dilution of the pharmaceutical or bioproduct composition that has been in its single container chamber in a solid, semi-solid, gel or liquid state, so that it is first admirable and then atomized manually.
  • the method for reconstitution or dilution and atomization with the vial vial of the present invention, of pharmaceutical compositions and of solid, semi-solid, gel or liquid bioproducts, which thus k> require before being administrable is further characterized because it comprises: first, providing the vial vial motive of the present invention with all its attachments and content, provided in the final carton; fill with the sterile needle syringe both and provided in the final carton, with the necessary amount of the pharmaceutically acceptable reconstituting agent or diluent and also provided in the final carton; then, remove the safety seal from the casquiiio or metal cover crimped or screwed to its secondary opening; then introduce the reconstituting agent or diluent inside, to that it comes into direct contact with the pharmaceutical or bioproduct composition in (a single container chamber; subsequently, shake the vial with all its attachments and vigorously containing, to obtain with this, a pharmaceutical or bioproduct composition, which is from this point administrate, inside the single container chamber, and finally, manually
  • the pharmaceutical and bioproduct compositions which were solid, semi-solid, gel or liquid, are administrable from this point and their Atomization is now possible.
  • the vial vial motive of the present invention is adapted with the metered dose atomizing valve in coordination with its actuator, as well as with the manipulation of the user for the atomization, of the pharmaceutical compositions and of already administrable bioproducts, that is to say after these They were reconstituted or diluted.
  • the atomization can be carried out at any time, holding the vial vial motive of the present invention, with all its attachments hooked, coupled or screwed and its pharmaceutical or bioproduct composition already administered inside the container chamber unique, as follows:
  • the atomization is carried out directly with the manipulation of the user, atomizing measured doses of 50 to 140 micro-meters for each action, manageable intranasally.

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Abstract

The invention relates to vial bottles for pharmaceutical purposes and for bioproducts, having two openings. The two openings permit the bottling, as well as the reconstitution or dilution and the administering in metered doses of pharmaceutical compositions and bioproducts that can be administered intranasally. These pharmaceutical compositions or bioproducts require the ingredients thereof to be reconstituted or diluted prior to use. The invention is based on the general structure of pharmaceutical vial bottles with one opening, but with the innovative addition of a second opening. In this way, the vial bottle for pharmaceutical purposes and for bioproducts having two openings can include: a metered-dose spray valve interlocked, coupled or screwed in the main opening together with the valve actuator, said valve administering metered doses of pharmaceutical compositions and bioproducts; as well as accessories interlocked or screwed in the secondary opening, said accessories permitting the reconstitution or dilution of the pharmaceutical composition or bioproduct housed in the container, prior to use.

Description

FRASCO VIAL FARMACÉUTICO CON POS ABERTURAS  PHARMACEUTICAL ROAD FLASK WITH POS OPENINGS
CAMPO DE LA INVENCIÓN FIELD OF THE INVENTION
Esta invención se refiere a un frasco vial farmacéutico que posee dos aberturas, para ta atomización, de composiciones farmacéuticas y de bioproductos en humanos, que requieren ser reconstituidas o diluidas antes de ser usadas. This invention relates to a pharmaceutical vial containing two openings, for atomization, of pharmaceutical compositions and bioproducts in humans, which need to be reconstituted or diluted before being used.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
Hoy día ios fármacos modernos, cuentan con diversas vías ó rutas de administración en humanos. Son ejemplos de vías de administración comunes para composiciones de fármacos: las vías "enteral, parenteral, inhalada, transdérmíca y la tópica' (Rau's respiratory care Pharmacology 2012. Gardenhire, Douglas S.. 8a. edición, Elsevier, p.13). En la vía de administración tópica, "los fármacos pueden ser aplicados directamente a la piel o a las membranas mucosas para producir un efecto local* (Gardenhire, p.14). Bajo este concepto de vía de administración tópica, ía ruta íntranasal, administra fármacos directamente en ía mucosa nasal Por la propia estructura anatómica de las narinas o fosas nasales, ía administración directa de fármacos sobre su mucosa requiere sistemas específicos de administración. Today, modern drugs have different routes or routes of administration in humans. Examples of common routes of administration for drug compositions are the 'enteral, parenteral, inhaled, transdermal and topical' routes (Rau's respiratory care Pharmacology 2012. Gardenhire, Douglas S .. 8th edition, Elsevier, p.13). In the route of topical administration, "the drugs can be applied directly to the skin or mucous membranes to produce a local effect * (Gardenhire, p.14). Under this concept of topical route of administration, the intranasal route, administers drugs directly in the nasal mucosa Due to the anatomical structure of the nostrils or nostrils, the direct administration of drugs on their mucosa requires specific systems of administration.
En Nasal and pulmonar/ drug delivering systems. 2012. Satapara, Rahul y otros. 2012. Lambert. página 32, se menciona que las formas de dosificación nasal de los sistemas de administración de fármacos incluye cuatro grupos: "~ líquidos, que incluyen a: los catéteres de instilación nasal, las gotas nasales, tos contenedores de dosis única y a ios envases manualmente coíapsibies (squeezed bottles). In Nasal and pulmonary / drug delivering systems. 2012. Satapara, Rahul and others. 2012. Lambert. On page 32, it is mentioned that nasal dosage forms of drug delivery systems include four groups: "~ liquids, which include: nasal instillation catheters, nasal drops, single dose containers, and manually copsible containers (squeezed bottles).
- sólidos, que incluyen a ínsufladores, a inhaladores de los polvos secos en monodosís y a los inhaladores de polvos secos en multidosis. - solids, including insufflators, single dose dry powder inhalers and multi-dose dry powder inhalers.
- semisóíidos como gel nasal. - Semisóíidos like nasal gel.
~ inhaladores de dosis medidas, basados en oropélente o en atomizadores." ~ metered dose inhalers, based on oropélente or atomizers. "
Estos últimos, tos inhaladores nasales de dosis medidas, basan su funcionamiento en el uso de uno o más vehículos o portadores diferentes. Existen los inhaladores nasales de dosis medidas que usan propelente presurizado como vehículo o portador e inhaladores atomizadores nasales (nasal sprays) basados en un vehículo o portador acuoso. The latter, measured dose nasal inhalers, base their operation on the use of one or more different vehicles or carriers. There are measured dose nasal inhalers that use pressurized propellant as a vehicle or carrier and nasal spray inhalers based on an aqueous vehicle or carrier.
Los actuales atomizadores nasales contienen y administran composiciones farmacéuticas en forma líquida o acuosa, es decir, se utilizan tanto en soluciones como en suspensiones. Estos atomizadores nasales que contienen y administran composiciones farmacéuticas en forma líquida, frecuentemente cuentan con 5 partes fundamentales: Current nasal sprayers contain and administer pharmaceutical compositions in liquid or aqueous form, that is, they are used in both solutions and suspensions. These nasal sprayers that contain and administer pharmaceutical compositions in liquid form often have 5 fundamental parts:
~ un envase contenedor que posee una abertura única. - un portador o vehículo acuoso. ~ a container container that has a unique opening. - a carrier or aqueous vehicle.
- una composición farmacéutica, es decir principio activo y excipientes. - una válvula dosífícadora que firmemente acopiada a la abertura única, cierra ei envase contenedor y administra ias dosis de sus composiciones. - a pharmaceutical composition, ie active ingredient and excipients. - a dosing valve that firmly fitted to the single opening, closes the container and administers the doses of its compositions.
~ un actuador, que generalmente aunque sin ¡imitaciones a esto, en acción coordinada con la válvula dostficadora, administran las dosis. Generalmente éste actuador tiene su propia tapa protectora. ~ an actuator, which generally although without imitations to this, in action coordinated with the booster valve, administers the doses. Generally this actuator has its own protective cover.
Algunos actuadores de atomizadores nasales, cuentan con sistemas de actuación muy sofisticados, con seguros para prevenir la actuación fuera de tiempo y cajas con palancas de actuación. No obstante esta sofisticación, su envase contenedor, es un frasco viaí farmacéutico fabricado en vidrio, de estructura general extema totalmente convencional y que posee una abertura única. Es ejemplo, el producto Veramyst® en Estados Unidos de America ó Avamyys2A® en México, Fluticasona Furoato, que cuenta con un actuador de este tipo. Verarnyst® y Avamyys2A® son marcas registradas de la corporación GSK plc y/o sus subsidiarias. Los atomizadores nasales que administran composiciones líquidas o acuosas, ya sea en solución o suspensión, usan generalmente frascos viales de calidad farmacéutica ó envases muy semejantes entre sí en su estructura externa general y siempre poseen una abertura única. Some nasal spray actuators have very sophisticated actuation systems, with insurance to prevent late performance and boxes with operating levers. Notwithstanding this sophistication, its container container, is a pharmaceutical vial made of glass, with a totally conventional external structure that has a unique opening. For example, the Veramyst® product in the United States of America or Avamyys2A® in Mexico, Fluticasone Furoato, which has such an actuator. Verarnyst® and Avamyys2A® are registered trademarks of the GSK plc corporation and / or its subsidiaries. Nasal sprayers that administer liquid or aqueous compositions, either in solution or suspension, generally use pharmaceutical grade vial vials or containers very similar to each other in their general external structure and always have a unique opening.
El frasco vial se fabrica de diversos materiales, como es el vidrio de calidad farmacéutica en sus diversas clases y colores. Existe también la posibilidad de contar con diversos recubrimientos como los siliconados o de otros polímeros para mejorar las características de aislamiento y resistencia de estos contenedores de vidrio farmacéutico. Asimismo, el frasco viaí de calidad farmacéutica, se puede fabricar en diferentes polímeros de calidad farmacéutica. Son ejemplos de estos polímeros: el polietiieno o PE, el polietiientereftaiato o PET, eí polietíleno de baja densidad y el copollrnero de olefína cíclica o cicloolefina, todos ellos de calidad farmacéutica. Las actuales composiciones farmacéuticas de administración intranasaí, son básicamente de dos tipos: presurizadas y no presurízadas. Las presurizadas utilizan oropelente como vehículo portador, que genera un aerosol presurízado. Las no presurizadas, incluyen actualmente aunque sin limitación a esto, a todas las composiciones acuosas y a los polvos secos. Composiciones presurizadas. The vial is made of various materials, such as pharmaceutical grade glass in its various classes and colors. There is also the possibility of having various coatings such as silicones or other polymers to improve the insulation and resistance characteristics of these pharmaceutical glass containers. Also, the pharmaceutical grade vial can be manufactured in different pharmaceutical grade polymers. Examples of these polymers are polyethene or PE, polyethiyerephthalate or PET, low density polyethylene and the copolymer of cyclic olefin or cycloolefin, all of them pharmaceutical grade. The current pharmaceutical compositions of intranasaí administration, are basically of two types: pressurized and not pressurized. Pressurized ones use oropelent as a carrier vehicle, which generates a pressurized aerosol. The non-pressurized ones, currently include, but are not limited to, all aqueous compositions and dry powders. Pressurized compositions.
Las composiciones farmacéuticas para administración por la ruta intranasaí en aerosol presurízado, por usar propetente presurízado, son generalmente empacadas aunque sin limitación a esto, en latas de aleaciones metálicas, capaces de resistir sin problemas, la presión del oropelente. Su dosificación se realiza con una válvula de dosis medidas y su actuador; la válvula dosíficadora está firmemente asegurada a la abertura única de la lata metálica. Al conjunto de la lata, válvula dosíficadora y actuador, se les conoce en la industria farmacéutica mundial como aerosoles presurizados nasales, que es traducción del Inglés "presurized nasal aerosols". En este caso, se trata de aerosoles presurizados de dosis medida para uso intranasaí.  Pharmaceutical compositions for administration by the intranasai route in pressurized aerosol, by using pressurized propellant, are generally packaged, but not limited to, in metal alloy cans, capable of withstanding the pressure of the oropelent without problems. Its dosage is carried out with a measured dose valve and its actuator; The dosing valve is firmly secured to the single opening of the metal can. The can assembly, dosing valve and actuator, are known in the global pharmaceutical industry as nasal pressurized aerosols, which is a translation of the English "presurized nasal aerosols". In this case, it is pressurized aerosols of measured dose for intranasaí use.
Composiciones no presurizadas:  Non-pressurized compositions:
Éstas comprenden a las composiciones en polvos seco, que requieren aditamentos especíales para ser administradas y las composiciones líquidas o acuosas que usan válvulas atomizadores como su base para ser administradas por medio de atomizadores nasales. These comprise compositions in dry powders, which require specific attachments to be administered and liquid compositions or aqueous that use atomizing valves as their base to be administered by means of nasal sprayers.
Las composiciones farmacéuticas que usan ios atomizadores nasales tienen que ser acuosas o líquidas, ya sea en solución o en suspensión para ser dispensadas por sus válvulas atomizadoras de dosis medidas y también porque, usan los actuales frascos viales que poseen una abertura única.  Pharmaceutical compositions that use nasal sprays have to be aqueous or liquid, either in solution or in suspension to be dispensed by their metered dose atomizing valves and also because, they use the current vial vials that have a single opening.
La razón para lo anterior es que, usando los actuales frascos viales de una abertura única, no es posible el envasado y ¡a administración de composiciones farmacéuticas para la vía íntranasal de formas físicas sólidas, ya sea en polvo, granulo, o bien en forma de cristales o liofilizados en polvos finos, que requieran su reconstitución antes de ser usadas. Asimismo al usar frascos viales de una abertura única, no es posible el envasado y la administración de composiciones líquidas que requieran ser diluidas antes de ser usadas. The reason for the above is that, using the current single-opening vial vials, it is not possible to package and administer pharmaceutical compositions for the intranasal route of solid physical forms, either in powder, granule, or in form of crystals or lyophilized in fine powders, which require reconstitution before being used. Also when using single-opening vial bottles, it is not possible to package and administer liquid compositions that need to be diluted before being used.
Los frascos viales de dos aberturas y una cámara contenedora única útil para la atomización de fármacos que requieren ser reconstituidos o diluidos, antes de su aplicación motivo de la presente invención, difieren significativamente deí dispositivo descrito en la patente U.SA, número 4,607,671 ; dicho dispositivo consiste de un frasco vial de una sola abertura y que requiere de un segundo contenedor para el proceso de reconstitución. Además, el dispositivo reclamado por esta patente U.S.A., número 4,607,671 es el dispositivo en sí mismo y no el frasco vial. El motivo de la presente invención reclama propiedad exclusivamente sobre el frasco vial de dos aberturas con una cámara contenedora única. En la presente invención, todos tos posibles dispositivos para reconstitución son simples tapones para frasco vial fabricados de material resiliente, engargolados por sus casquíllos metálicos, sobre tos que esta invención no hace ningún reclamo reivindicatorio. The two-opening vial bottles and a single container chamber useful for the atomization of drugs that need to be reconstituted or diluted, prior to their application according to the present invention, differ significantly from the device described in U.SA, No. 4,607,671; Said device consists of a single opening vial that requires a second container for the reconstitution process. In addition, the device claimed by this US patent, number 4,607,671 is the device itself and not the vial. The reason for the present invention claims ownership exclusively over the two-opening vial with a single container chamber. In the present invention, all possible reconstitution devices are simple vial bottle caps made of resilient, crimped material. by its metal caps, on which this invention makes no claim claims.
Actualmente existen en eí mercado sistemas de reconstitución para frascos viales que poseen una abertura única y que usan válvulas atomtzadoras, mediante la utilización de un adaptador de espiga para vial, que permite la reconstitución en el interior, separando eí interior del frasco vial en dos cámaras contenedoras del frasco vial en cuestión, como la descrita en la patente Ü.S.A., número 6,269,976. En la patente U.S.A., número 4,607,671 se divulga un dispositivo de reconstitución de fármacos en un frasco vial con un líquido en una segunda cámara. Currently there are on the market reconstitution systems for vial bottles that have a unique opening and that use atomizing valves, by using a spigot adapter for vial, which allows reconstitution inside, separating the interior of the vial in two chambers Containers of the vial in question, as described in the Ü.SA patent, number 6,269,976. In U.S. Patent No. 4,607,671 a drug reconstitution device is disclosed in a vial with a liquid in a second chamber.
BREVE DESCRIPCIÓN DE LOS DIBUJOS DE ESTA INVENCIÓN BRIEF DESCRIPTION OF THE DRAWINGS OF THIS INVENTION
La figura 1 es una representación de un corte longitudinal del frasco vial farmacéutico que posee dos aberturas, en donde son: abertura principal (1); labio de la abertura principal (2); cuello de la abertura principal (3); hombro del cuerpo (4); abertura secundaria perpendicular al eje vertical del frasco vial (5); labio de la abertura secundaria (6); cuello de ía abertura secundaria (7); contenedor del cuerpo (8); piso o fondo (9); pared (10); cámara contenedora única (11). Figure 1 is a representation of a longitudinal section of the pharmaceutical vial having two openings, where they are: main opening (1); lip of the main opening (2); neck of the main opening (3); body shoulder (4); secondary opening perpendicular to the vertical axis of the vial (5); lip of the secondary opening (6); secondary opening neck (7); body container (8); floor or bottom (9); wall (10); single container chamber (11).
La figura 2 es una representación de un corte longitudinal medio del frasco vial farmacéutico que posee dos aberturas, se ilustran el eje vertical piso-abertura principal (11); y el eje central de la abertura secundaria (12). En esta modalidad se ilustra la posición a 90* del eje central de la abertura secundaria (5), respecto al eje vertical piso-abertura principal. Otras estructuras ya numeradas y descritas en la figura 1 , respetan su orden numérico. La figura 3 es una representación de un corte longitudinal medio del frasco vial farmacéutico que posee dos aberturas, se ilustra el eje vertical piso-abertura principal (11); en otra modalidad, la abertura secundaria (51) y su eje central (121 ) están a un ángulo menor de 46° respecto al eje vertical piso-abertura principal; el labio de la abertura secundaria de esta modalidad (61 ); cuello de la abertura secundaria de esta modalidad (71). Figure 2 is a representation of an average longitudinal section of the pharmaceutical vial having two openings, the main floor-opening vertical axis (11) is illustrated; and the central axis of the secondary opening (12). In this mode, the position at 90 * of the central axis of the secondary opening (5) is shown, relative to the main floor-opening vertical axis. Other structures already numbered and described in Figure 1 respect their numerical order. Figure 3 is a representation of an average longitudinal section of the pharmaceutical vial having two openings, the main floor-opening vertical axis (11) is illustrated; in another embodiment, the secondary opening (51) and its central axis (121) are at an angle less than 46 ° with respect to the main floor-opening vertical axis; the lip of the secondary opening of this modality (61); neck of the secondary opening of this modality (71).
La figura 4 es una representación de un corte longitudinal medio vista frontal del frasco vial farmacéutico que posee dos aberturas, en esta modalidad, ambas aberturas tienen rosca, en donde son: abertura principal (1); rosca de la abertura principal (13); cuello de la abertura principal (3); hombro del cuerpo (4); abertura secundaria (5) perpendicular ai eje vertical piso-abertura principal (11); rosca de la abertura secundaria (14); cuello de la abertura secundaria (7); contenedor del cuerpo del frasco vial (8); fondo o piso del frasco vial (9); y cámara contenedora única (10). La figura 5 es una representación de un corte longitudinal del frasco vial que tiene dos aberturas, en otra modalidad cuya abertura principal tiene labio, mientras su abertura secundaria tiene rosca, y en donde son: abertura principal (1 ); labio de la abertura principal (2); cuello de la abertura principal (3); hombro del cuerpo (4); abertura secundaria (5), perpendicular al eje vertical del frasco vial (11); rosca de la abertura secundaria (14) cuello de la abertura secundaria (7); eje central de la abertura secundaria (12); contenedor del cuerpo (8); piso o fondo (9); y cámara contenedora única (10). ta figura 6 ilustra la representación exterior def frasco víaí que tiene dos aberturas y ambas aberturas tienen labio. Ésta modalidad tiene el contenedor del cuerpo de forma exterior cilindrica (81 ); y su hombro del cuerpo tiene forma exterior ligeramente redondeada (41 ). Las otras estructuras son numeradas de acuerdo a las figuras anteriores. Figure 4 is a representation of a longitudinal sectional front view of the pharmaceutical vial having two openings, in this embodiment, both openings have threads, where they are: main opening (1); main opening thread (13); neck of the main opening (3); body shoulder (4); secondary opening (5) perpendicular to the main floor-opening vertical axis (11); secondary opening thread (14); secondary opening neck (7); container of the vial vial body (8); bottom or floor of vial vial (9); and single container chamber (10). Figure 5 is a representation of a longitudinal section of the vial having two openings, in another embodiment whose main opening has a lip, while its secondary opening has a thread, and where they are: main opening (1); lip of the main opening (2); neck of the main opening (3); body shoulder (4); secondary opening (5), perpendicular to the vertical axis of the vial (11); secondary opening thread (14) secondary opening neck (7); central axis of the secondary opening (12); body container (8); floor or bottom (9); and single container chamber (10). Figure 6 illustrates the exterior representation of the vial that has two openings and both openings have a lip. This mode has the cylindrical outer body container (81); and its shoulder of the body has a slightly rounded outer shape (41). The other structures are numbered according to the previous figures.
La figura 7 ilustra la representación exterior del frasco vial que tiene dos aberturas, de la abertura principal (1), tiene rosca (13); el hombro del cuerpo es ligeramente redondeado (41 ) y (a abertura secundaria (5) tiene labio (6); esta modalidad tiene el contenedor del cuerpo de forma exterior cilindrica (81 ). Las otras estructuras son numeradas de acuerdo a ias figuras anteriores. Figure 7 illustrates the exterior representation of the vial that has two openings, of the main opening (1), has a thread (13); the shoulder of the body is slightly rounded (41) and (at secondary opening (5) it has lip (6); this modality has the cylindrical outer body container (81). The other structures are numbered according to the previous figures .
La figura 8 ilustra la representación exterior del frasco víal que tiene dos aberturas y cuya forma exterior del contenedor del cuerpo está compuesta de dos caras laterales planas y dos caras cóncavas (82); la abertura principal (1 ), tiene labio (2); y la abertura secundaria (5) también tiene labio (6); la forma exterior del hombro del cuerpo está compuesta por cuatro caras bien definidas (42). Figure 8 illustrates the outer representation of the vial that has two openings and whose outer shape of the body container is composed of two flat side faces and two concave faces (82); the main opening (1) has a lip (2); and the secondary opening (5) also has a lip (6); The outer shape of the shoulder of the body is composed of four well-defined faces (42).
La figura 9, es una representación que muestra tres vistas A) posterior, B) lateral y C) superior, de un frasco vial con dos aberturas. La abertura primaria (1 ) tiene labio y cuello; la abertura secundaria (5) también tiene labio y cuello propios. Tiene el hombro del cuerpo formado por cuatro caras bien definidas (42); y su contenedor del cuerpo (82) tiene cuatro caras dos de ellas laterales prismáticas y cara anversa y reversa cóncavas. Es la cara reversa la que se comunica con la abertura secundaria. Figura 10, es una representación del frasco vial de dos aberturas y otros componentes por separado de una primera modalidad de atomizador nasal. En esta modalidad, el frasco vial de dos aberturas tiene labio en ambas aberturas y contenedor dei cuerpo de forma exterior cilindrica (15), en la abertura principal (1 ) se integran: la válvula atomizadora de dosis medidas (17), su actuador (18) y tapón (19); en fa abertura secundaria (5), se integran: un tapón para frasco vial fabricado de material resiliente (20) y su caequillo metálico (21) para engargolar. Figure 9 is a representation showing three views A) posterior, B) lateral and C) superior, of a vial with two openings. The primary opening (1) has a lip and neck; The secondary opening (5) also has its own lip and neck. It has the shoulder of the body formed by four well-defined faces (42); and its body container (82) has four faces, two of them prismatic sides and concave front and back sides. It is the reverse side that communicates with the secondary opening. Figure 10 is a representation of the vial of two openings and other components separately from a first nasal spray mode. In this mode, the two-opening vial has a lip in both openings and a cylindrical outer body container (15), in the main opening (1) the following are integrated: the metered dose atomizing valve (17), its actuator ( 18) and plug (19); In the secondary opening (5), they are integrated: a cap for a vial made of resilient material (20) and its metal bushing (21) for crimping.
La figura 11, es una representación del frasco víal de dos aberturas y otros componentes por separado de una segunda modalidad de atomizador nasal. En esta modalidad, que utiliza como componente, el frasco vial farmacéutico de dos aberturas cuyo contenedor dei cuerpo tiene forma exterior compuesta por caras anversa y reversa cóncavas y dos caras laterales prismáticas (16), este frasco vial de dos aberturas tiene labio en ambas aberturas. En la abertura principal (1 ) se integran: la válvula atomizadora de dosis medidas (17), su actuador (18) y tapón (19); en la abertura secundaria (5), se integran: un tapón para frasco vial fabricado de material resiliente (20) y su casquillo metálico (21 ) para engargolar. Figure 11 is a representation of the vial of two openings and other components separately from a second embodiment of nasal spray. In this modality, which uses as a component, the pharmaceutical vial of two openings whose container of the body has an outer shape composed of concave front and back faces and two prismatic side faces (16), this two-opening vial has lip in both openings . In the main opening (1) are integrated: the metered dose atomizing valve (17), its actuator (18) and plug (19); in the secondary opening (5), there are integrated: a vial bottle cap made of resilient material (20) and its metal bushing (21) for crimping.
DESCRIPCIÓN DE LA INVENCIÓN DESCRIPTION OF THE INVENTION
Algunos de los más importantes objetivos de la terapéutica moderna referentes a la eficacia y seguridad, pueden ser alcanzados a través de la utilización de ía ruta de administración intranasal de diversos fármacos. Esto es porque la ruta de administración intranasal de fármacos, ofrece dos grandes posibilidades terapéuticas: la primera posibilidad, es ser una ruta directa para tratamientos locales, tópicos o in situ, cuyos órganos blanco son las mucosas irrtranasales y rinosinusates, utilizando dosis mínimas para ello. La segunda posibilidad, es ía de ser ruta de acceso para fármacos sístémícos, con tejidos y órganos diana, muy diferentes a la mucosa nasal ó a la cavidad nasal. Gardenhíre, D. S. et ai. páginas 12-14, señala que "un tratamiento tópico, es aquel que se aplica en la piel ó en las membranas mucosas para lograr un efecto terapéutico". En este caso, la aplicación del fármaco es directamente sobre la mucosa nasal. Some of the most important objectives of modern therapeutics concerning efficacy and safety can be achieved through the use of the intranasal route of administration of various drugs. This is because the route of intranasal administration of drugs offers two great therapeutic possibilities: the first possibility is to be a direct route for local, topical or in situ treatments, whose target organs are the irrtranasal mucous membranes and rhinosinusates, using minimal doses for it. The second possibility is to be an access route for systymic drugs, with target tissues and organs, very different from the nasal mucosa or nasal cavity. Gardenhíre, DS et ai. pages 12-14, notes that "a topical treatment is one that is applied to the skin or mucous membranes to achieve a therapeutic effect." In this case, the application of the drug is directly on the nasal mucosa.
En el artículo Nasa! and pulmonary drug deitvering systems. 2012, Satapara, Rahul y otros. 2012. Lambert página 4, se menciona "el amplio interés en la ruta intranasal para propósitos terapéuticos, más allá de la mera administración tópica de fármacos nasales, surge de las características anatómicas y fisiológicas particulares de la cavidad nasal, las cuales potencialmente brindan una rápida absorción sistémica y pronto inicio de acción". In the article Nasa! and pulmonary drug deitvering systems. 2012, Satapara, Rahul and others. 2012. Lambert page 4, mentions "the broad interest in the intranasal route for therapeutic purposes, beyond the mere topical administration of nasal drugs, arises from the particular anatomical and physiological characteristics of the nasal cavity, which potentially provide rapid systemic absorption and early onset of action. "
Por lo tanto el objetivo de la presente invención, es proveer a la industria farmacéutica de un frasco vial que posee dos aberturas, que no solamente envase y administre composiciones farmacéuticas que usan la ruta intranasal, sino que adicionalmente, posee la capacidad de reconstituir o diluir, composiciones farmacéuticas y de bioproductos en su interior, manteniendo la integridad tanto del atomizador, como de la propia composición farmacéutica, asegurando la integridad del sistema envase-contenido. Estas capacidades de reconstitución o de dilución, generan posibilidades reales de creación de nuevas y muy diversas composiciones farmacéuticas y de bioproductos. La presente invención como frasco vial de caíídad farmacéutica y de bioproductos, mantiene la existencia de un piso o fondo esencialmente piano (9), así como de un hombro dei cuerpo bien definido (4), (41 } y (42). Therefore, the objective of the present invention is to provide the pharmaceutical industry with a vial containing two openings, which not only packages and administers pharmaceutical compositions that use the intranasal route, but also has the ability to reconstitute or dilute , pharmaceutical compositions and bioproducts inside, maintaining the integrity of both the atomizer and the pharmaceutical composition itself, ensuring the integrity of the container-content system. These reconstitution or dilution capabilities generate real possibilities of creating new and very diverse pharmaceutical and bioproduct compositions. The present invention as a vial of pharmaceutical quality and bioproducts, maintains the existence of an essentially piano floor or bottom (9), as well as a well-defined shoulder of the body (4), (41} and (42).
Es el piso o fondo esencialmente piano io que le confiere la posibilidad al frasco vial que posee dos aberturas, de mantenerse erguido en la mesa o el estante, así como de ser fácilmente manejable en la mano del usuario. It is the essentially piano floor or floor that gives the possibility to the vial that has two openings, to remain upright on the table or shelf, as well as to be easily manageable in the user's hand.
El hombro del cuerpo es también una parte bien definida en el frasco vial farmacéutico y de bioproductos motivo de la presente invención, es una estructura de transición que une al contenedor del cuerpo con el cueíío de ía abertura principal. Su forma exterior puede ser variada, partiendo desde la plana perfecta, redondeada, así como la integrada por varias caras planas, convexas o concavas y combinaciones de las mismas. The shoulder of the body is also a well defined part in the pharmaceutical vial and bioproduct motif of the present invention, it is a transition structure that joins the body container with the main opening. Its exterior shape can be varied, starting from the perfect flat, rounded, as well as the integrated by several flat, convex or concave faces and combinations thereof.
Cada una de las dos aberturas de la presente invención tienen cuello propio, es decir existen en este frasco vial, el cuello de la abertura principal (3) y el cuello de la abertura secundaria (7). Each of the two openings of the present invention have their own neck, that is to say in this vial, the neck of the main opening (3) and the neck of the secondary opening (7).
El experto en el área reconocerá, que el cuello de cada una de las dos aberturas permite un espacio libre para que en la planta farmacéutica, la maquinaria de colocación, acoplado, engargolado o enroscado, puedan operar sobre éste frasco vial, sin golpear, ni rozar eí hombro ni el contenedor del cuerpo de este frasco vial, Cada una de las dos aberturas de la presente invención cuenta con su propio borde distal exterior, que permiten, incorporar aditamentos para cierre, cierre y paso, así como para administración en dosis medida. Este borde distal exterior tiene dos opciones: - es un labio (2) y (6). The expert in the area will recognize that the neck of each of the two openings allows a free space so that in the pharmaceutical plant, the machinery of placement, coupled, hooked or screwed, can operate on this vial, without hitting, or rubbing the shoulder or the container of the body of this vial, Each of the two openings of the present invention has its own outer distal edge, which allows incorporating attachments for closure, closure and passage, as well as for administration in measured doses . This outer distal edge has two options: - is a lip (2) and (6).
- es una rosca (13) y (14).  - is a thread (13) and (14).
El labio le permite a su abertura en cuestión, el engargolado o acoplado de elementos adicionales como son: una válvula atomizadora de dosis medidas, o bien un tapón para frasco vial, firmemente engargolado con su casquiilo metálico. El labio es una prominencia exterior regular, de forma exterior c&ndrica perfecta, localizada en la parte distal, de una o de ambas aberturas del frasco vial de ¡a presente invención, es distinguible fácilmente, al final del cuello de su abertura correspondiente.  The lip allows to its opening in question, the crimping or coupling of additional elements such as: a metered dose atomizing valve, or a vial vial cap, firmly crimped with its metal cap. The lip is a regular exterior prominence, of perfect central outer shape, located in the distal part, of one or both openings of the vial of the present invention, is easily distinguishable, at the end of the neck of its corresponding opening.
Una modalidad de la presente invención es que tiene, tiene sus dos aberturas con labio (figuras 1 , 2 y 3). En otra modalidad de la presente invención, cada una de las dos aberturas tiene rosca, en lugar de tener labio (figura 4). Otra modalidad tiene una de las dos aberturas con rosca, mientras que otra abertura tiene labio (figura 5). la rosca (13) y (14) es también una prominencia exterior alrededor de la abertura, pero ahora su forma es ia de un hilo único helicoidal y no de cilindrico perfecto. One embodiment of the present invention is that it has, has its two lip openings (Figures 1, 2 and 3). In another embodiment of the present invention, each of the two openings has a thread, instead of having a lip (Figure 4). Another modality has one of the two threaded openings, while another opening has a lip (Figure 5). the thread (13) and (14) is also an outer prominence around the opening, but now its shape is ia of a single helical thread and not of perfect cylindrical.
El experto en la materia reconocerá que esta rosca en las aberturas de ia presente invención, le permite la fijación de otros elementos por enroscado, tales como pueden ser, las válvulas atomizadores de dosis medidas y tapas metálicas roscadas, que al enroscarse por giros a las roscas del frasco vial de ia presente invención, cierran sus aberturas en la planta farmacéutica.  The person skilled in the art will recognize that this thread in the openings of the present invention allows him to fix other elements by screwing, such as, the metered dose atomizing valves and threaded metal caps, which when screwed by turning Threads of the vial of the present invention close their openings in the pharmaceutical plant.
Es importante destacar que en ia presente invención, la incorporación de una segunda abertura útil y práctica no modifica en lo absoluto a la cámara contenedora única del frasco vial convencional. Es decir, la presente invención mantiene la existencia de una cámara contenedora única (10) y en ningún momento, por ningún motivo, ni bajo ningún procedimiento, se genera más de una cámara contenedora en el interior del presente frasco vial que posee dos aberturas. It is important to note that in the present invention, the incorporation of a second useful and practical opening does not modify at all the single container chamber of the conventional vial. That is, the present invention It maintains the existence of a single container chamber (10) and at no time, for any reason, or under any procedure, more than one container chamber is generated inside the present vial containing two openings.
La cámara contenedora única es todo el espacio interior dentro de la pared del frasco vial de dos aberturas motivo de la presente invención. Este espacio interior incluye por supuesto, a los espacios dentro de los cuellos de cada una de las aberturas y desde luego dentro de la totalidad interior del contenedor y hombro dei cuerpo. La cámara contenedora única, comunica entre sí a ambas aberturas del frasco vial del la presente invención. The single container chamber is the entire interior space within the wall of the two-opening vial which is the subject of the present invention. This interior space includes, of course, the spaces within the necks of each of the openings and of course within the entire interior of the container and shoulder of the body. The single container chamber communicates with each other to both openings of the vial of the present invention.
El experto en la materia reconocerá que de toda ésta cámara contenedora única, la industria utiliza como envase aunque sin limitación alguna en esto, al espacio exclusivo dentro del contenedor del cuerpo (8), (81 ) y (82), que es la parte del frasco vial con mayor volumen contenedor. Aunque sin limitación alguna en esto, no se usan como contenedor, los espacios en el interior de los cuellos de los frascos viales.  The person skilled in the art will recognize that of all this single container chamber, the industry uses as a container, although without any limitation in this, the exclusive space inside the container of the body (8), (81) and (82), which is the part of the vial with the largest container volume. Although without any limitation in this, the spaces inside the necks of the vial are not used as a container.
El contenedor del cuerpo comienza donde termina el hombro dei cuerpo hasta el piso o fondo esencialmente piano. Puede tener forma exterior cilindrica perfecta; oval; cúbica, trapezoide, con caras planas, convexas o cóncavas y combinaciones de las mismas.  The body container begins where the shoulder of the body ends to the essentially piano floor or bottom. It can have perfect cylindrical exterior shape; oval; cubic, trapezoid, with flat, convex or concave faces and combinations thereof.
El experto en la materia reconocerá que ia pared del contenedor del cuerpo en su parte exterior, aunque sin limitación alguna en esto, es el sitio más común en la industria, para el etiquetado farmacéutico de los frascos viales motivo de ia presente invención. Dada la muy variada forma exterior posible de¡ contenedor del cuerpo en eí frasco vial de dos aberturas de esta invención, su parámetro de medición es su perímetro exterior. Este se mide en la parte exterior del contenedor del cuerpo, inmediatamente abajo o arriba de la abertura secundaria. De existir diferencias entre ambas medidas, ei dato oficial será la medida mayor entre ambas. The person skilled in the art will recognize that the wall of the container of the body in its outer part, although without any limitation in this, is the most common site in the industry, for the pharmaceutical labeling of the vial vials motive of the present invention. Given the very varied possible exterior shape of the body container in the two-opening vial of this invention, its measurement parameter is its outer perimeter. This is measured on the outside of the body container, immediately below or above the secondary opening. If there are differences between both measures, the official data will be the major measure between the two.
El frasco vial de motivo de ía presente invención, mide en su perímetro exterior del contenedor del cuerpo de 50 a 130 milímetros.  The vial of motif of the present invention, measures in its outer perimeter of the body container of 50 to 130 millimeters.
En el frasco vial farmacéutico que tiene una abertura única, su denominación y ubicación física es muy obvia y sencilla, sin embargo en la presente invención ai existir al mismo tiempo dos aberturas prácticas y operativas, se hace necesario denominar y ubicar físicamente a cada una de ellas en este nuevo frasco vial. La abertura principal (1 ) se ubica físicamente en el hombro del cuerpo, en posición completamente opuesta al piso o fondo que es esencialmente plano del frasco vial motivo de la presente invención. Esta posición física de la abertura principal totalmente opuesta al piso o fondo plano, genera ía existencia de un eje vertical piso-abertura principal (11 ).  In the pharmaceutical vial that has a unique opening, its designation and physical location is very obvious and simple, however in the present invention there are two practical and operational openings at the same time, it is necessary to physically name and locate each of them in this new vial. The main opening (1) is physically located in the shoulder of the body, in a completely opposite position to the floor or bottom that is essentially flat of the vial vial motive of the present invention. This physical position of the main opening totally opposite to the flat floor or floor, creates the existence of a vertical axis floor-main opening (11).
La abertura principal del frasco vial de dos aberturas, tiene varias funciones:  The main opening of the vial of two openings has several functions:
- es la vía de ingreso acceso de la composición farmacéutica o de bioproducto hacia la cámara contenedora única, antes de contar con cualquier aditamento adicional engargolado, acoplado o roscado en esta.  - it is the access route of the pharmaceutical or bioproduct composition into the single container chamber, before having any additional attachment attached, coupled or threaded therein.
- es la abertura a través de la cual, se realiza la atomización en dosis medidas de la composición farmacéutica o de bioproducto, después de haber sido reconstituida o diluida. El parámetro de medida de la abertura principal es su diámetro exterior. El diámetro exterior de la abertura principal se mide, desde eí exterior de su labio o en su caso, desde el exterior de su rosca. El diámetro exterior de la abertura principal del frasco víal farmacéutico motivo de la presente invención mide de 12 a 21 milímetros. - it is the opening through which the measured dose atomization of the pharmaceutical or bioproduct composition is performed, after being reconstituted or diluted. The measurement parameter of the main opening is its outer diameter. The outer diameter of the main opening is measured, from the outside of its lip or, where appropriate, from the outside of its thread. The outer diameter of the main opening of the pharmaceutical pharmaceutical vial of the present invention measures from 12 to 21 millimeters.
Sí ía abertura principal tiene labio (2), es decir que no tiene rosca (13), ei parámetro de medición de este labio será su altura. La aftura del labio de la abertura principal se mide por su parte exterior, desde la parte distal de ¡a abertura, hasta donde este borde uniforme termina para unirse a su respectivo cuello.  If the main opening has a lip (2), that is, it does not have a thread (13), the measuring parameter of this lip will be its height. The height of the lip of the main opening is measured from its outer part, from the distal part of the opening, to where this uniform edge ends to join its respective neck.
La altura del labio de la abertura principal se mide sobre la parte exterior del labio, siguiendo la dirección del eje vertical piso-abertura principal, en la presente invención mide de 3 a 6 milímetros.  The height of the lip of the main opening is measured on the outside of the lip, following the direction of the main floor-opening vertical axis, in the present invention it measures from 3 to 6 millimeters.
La abertura principal tiene siempre cuello propio, que es denominado en la presente invención como cuello de la abertura principal (3). Este cuello de ia abertura principal es de forma exterior cilindrica y sus parámetros de medición son dos:  The main opening always has its own neck, which is referred to in the present invention as the neck of the main opening (3). This neck of the main opening is cylindrical and its measurement parameters are two:
~ el diámetro exterior del cuello de la abertura principal.  ~ the outer diameter of the neck of the main opening.
- el largo del cuello de la abertura principal.  - the length of the neck of the main opening.
Ei diámetro exterior del cuello de la abertura principal se puede medir en cualquier punto del mismo, donde no exista interferencia del labio o bien de la rosca, ya que al tratarse de una estructura de forma cilindrica su medida es uniforme. The outer diameter of the neck of the main opening can be measured at any point of the neck, where there is no interference from the lip or the thread, since being a cylindrical structure its measurement is uniform.
En el frasco vial farmacéutico motivo de la presente invención, el diámetro exterior del cuello de la abertura principal mide de 8 a 17 milímetros- Por otro lado, ei largo del cuello de ia abertura principal puede no ser uniforme, ya que en ciertas modalidades de frasco vial con dos aberturas con hombro del cuerpo con forma exterior irregular, o bien por presencia opcional de la rosca, la medida del largo del cuello de la abertura principal no siempre sería la misma, De este modo cuando existan más de una medida de largo del cuello de la abertura principal, su medida oficial será la mayor de éstas, desde el hombro del cuerpo hasta el labio sin incluir a este último, o bien hasta el límite de la abertura principal, no obstante ia presencia de la rosca. In the pharmaceutical vial which is the subject of the present invention, the outer diameter of the neck of the main opening measures 8 to 17 millimeters. On the other hand, the length of the neck of the main opening may not be uniform, since in certain modalities of a vial with two irregularly shaped shoulder openings, or by optional presence of the thread, the length measurement of the neck of the main opening would not always be the same, so when there is more than one length measurement of the neck of the main opening, its official measurement will be the largest of these, from the shoulder of the body to the lip without including the latter, or up to the limit of the main opening, despite the presence of the thread.
En el frasco vial farmacéutico motivo de la presente invención, el largo del cuello de la abertura principal mide de 3 a 20 milímetros.  In the pharmaceutical vial which is the subject of the present invention, the neck length of the main opening measures from 3 to 20 millimeters.
La abertura secundaria (5) del frasco vial motivo de la presente invención, se ubica sobre la pared del contenedor del cuerpo (8), con su eje central de la abertura secundaria (12) en posición transversal de 30° a 90° grados respecto al eje vertical písosabertura principal (11 ), (figuras 2 y 3).  The secondary opening (5) of the vial subject of the present invention, is located on the wall of the body container (8), with its central axis of the secondary opening (12) in a transverse position of 30 ° to 90 ° degrees to the main vertical axis of the main cover (11), (figures 2 and 3).
El parámetro de medida de la abertura secundaria es también su diámetro exterior. El diámetro exterior de la abertura secundaria se mide desde el exterior de su Sabio o en su caso desde el exterior de su rosca. El diámetro exterior de la abertura secundaria del frasco viaí farmacéutico motivo de la presente invención mide de 12 a 21 milímetros. The measurement parameter of the secondary opening is also its outer diameter. The outer diameter of the secondary opening is measured from the outside of its Sage or, where appropriate, from the outside of its thread. The outer diameter of the secondary opening of the pharmaceutical vial vial of the present invention measures from 12 to 21 millimeters.
Sí la abertura secundaría tiene labio (6), es decir no tiene rosca (14), el parámetro de medición de este labio será su altura. La altura del labio de la abertura secundaria se mide por su parte exterior, desde la parte distal de su abertura, hasta donde este borde uniforme termina para unirse ai contenedor del cuerpo. La altura del labio de la abertura secundaria se mkte sobre la parte exterior del labio, siguiendo la dirección del eje central de la abertura secundaria, en ía presente invención mide de 3 a 6 milímetros. If the secondary opening has a lip (6), that is, it does not have a thread (14), the measurement parameter of this lip will be its height. The height of the lip of the secondary opening is measured from its outer part, from the distal part of its opening, to where this uniform edge ends to join the body container. The height of the lip of the secondary opening is measured on the outside of the lip, following the direction of the central axis of the secondary opening, in the present invention it measures from 3 to 6 millimeters.
La abertura secundaria tiene siempre cuello propk>, que es denominado en ia presente invención como cuello de fa abertura secundaria (7). Este cuelfo de la abertura secundaria es de forma exterior cilindrica y sus parámetros de medición son dos:  The secondary opening always has a propk> neck, which is referred to in the present invention as a neck of the secondary opening (7). This pendulum of the secondary opening is cylindrical and its measurement parameters are two:
- el diámetro exterior del cuello de la abertura secundaria.  - the outer diameter of the neck of the secondary opening.
- el largo del cuello de la abertura secundaria.  - the length of the neck of the secondary opening.
El diámetro exterior del cuello de la abertura principal se puede medir en cualquier punto del mismo, ya que ai tratarse de una estructura de forma cilindrica su medida es uniforme. The outer diameter of the neck of the main opening can be measured at any point of the same, since in the case of a cylindrical structure its measurement is uniform.
En el frasco vial farmacéutico motivo de la presente invención, el diámetro exterior del cuelío de la abertura secundaria mide de 8 a 17 milímetros  In the pharmaceutical vial which is the subject of the present invention, the outer diameter of the secondary opening collet measures 8 to 17 millimeters.
Por otro lado, el largo del cuello de ia abertura secundaria puede no ser uniforme, ya que en ciertas modalidades de frasco vial con dos aberturas la forma cilindrica del contenedor del cuerpo con forma exterior cóncava o irregular, o bien rosca, ia medida del largo del cueilo de ía abertura secundaria no siempre sería la misma. De este modo cuando existan más de una medida de largo del cuello de la abertura secundaria, su medida oficial será ia mayor de éstas, desde el contenedor dei cuerpo hasta el labio sin incluir a este último, o bien hasta el límite de la abertura secundaria, no obstante la presencia de rosca. On the other hand, the length of the neck of the secondary opening may not be uniform, since in certain modalities of a vial with two openings the cylindrical shape of the container of the body with a concave or irregular outer shape, or thread, the measure of the length of the secondary opening cave would not always be the same. In this way, when there is more than one length measurement of the neck of the secondary opening, its official measurement will be the greater of these, from the container of the body to the lip without including the latter, or to the limit of the secondary opening , despite the presence of thread.
En el frasco vial farmacéutico motivo de ía presente invención, el largo del cueilo de la abertura principal mide de 3 a 20 milímetros. La abertura secundaria incorporada al frasco vial farmacéutico tiene diversas funciones, ya que no solo es capaz de permitir el ingreso de composiciones farmacéuticas y de bioproductos sólidas, semisólidas, en geí, sino también se adapta con el medio de cierre y paso, para ingresar un agente reconstituyente farmacéuticamente aceptable hasta ia cámara contenedora única, para reconstituir o diluir dichas composiciones farmacéuticas o de bioproducto antes de ser administrabas. In the pharmaceutical vial which is the subject of the present invention, the length of the main opening hole measures from 3 to 20 millimeters. The secondary opening incorporated into the pharmaceutical vial has several functions, since it is not only capable of allowing the entry of pharmaceutical compositions and solid, semi-solid bioproducts, in gei, but also adapts with the closing and passage means, to enter a pharmaceutically acceptable reconstituting agent to the single container chamber, to reconstitute or dilute said pharmaceutical or bioproduct compositions before being administered.
En el caso de las composiciones farmacéuticas o de bioproductos líquidas, esta abertura secundaria, permite su ingreso hasta la cámara contenedora única, así como también, su dilución antes de ser administrables.  In the case of pharmaceutical compositions or liquid bioproducts, this secondary opening allows its entry into the single container chamber, as well as its dilution before being administrable.
La existencia de la abertura secundaria, permite un segundo acceso para acopiar un aditamento adicional, por ejemplo una jeringa con aguja. Es así que la abertura secundaria permite que sea introducido el agente reconstituyente o diluyente hasta la cámara contenedora única, donde entrará en contacto con la composición farmacéutica envasada dentro de éste.  The existence of the secondary opening allows a second access to collect an additional attachment, for example a needle syringe. Thus, the secondary opening allows the reconstituting agent or diluent to be introduced into the single container chamber, where it will come into contact with the pharmaceutical composition packaged therein.
Para realizar ía reconstitución o de dilución de la composición farmacéutica o de bioproducto, envasada en el frasco vial motivo de la presente invención, la abertura secundaria tiene engargolados, enroscados, sus propios elementos del medio de cierre y paso correspondientes. El experto en la materia, reconocerá que los elementos del medio de cierre y paso, para la el proceso de reconstitución o de dilución de los ingredientes de las composiciones farmacéuticas son de dos tipos; la combinación de tapón para frasco vial fabricado de material resiliente (20), con un casquíllo metáíico (21 } o bien tapa metálica para su engargolado o enroscado en la abertura secundaria; y la combinación de válvula de cierre y paso tipo "luer", para uso con jeringa sin aguja, con su casquüfo metálico o tapa metálica para su engargolado o enroscado en la abertura secundaria. In order to carry out the reconstitution or dilution of the pharmaceutical or bioproduct composition, packaged in the vial which is the subject of the present invention, the secondary opening has its own elements of the corresponding closure and passage means screwed, screwed. The person skilled in the art will recognize that the elements of the closure and passage means for the process of reconstitution or dilution of the ingredients of the pharmaceutical compositions are of two types; the combination of a vial bottle cap made of resilient material (20), with a metal bushing (21) or a metal cap for crimping or screwing in the secondary opening; and the combination of a shut-off valve "luer" type, for use with a syringe without a needle, with its metal cap or metal cap for crimping or screwed into the secondary opening.
El experto en la materia también reconocerá que aunque hay varias posibilidades, ia mejor combinación de elementos para ía reconstitución o la dilución, es la combinación de tapón para frasco vial fabricado de material resiiiente farmacéuticamente aceptable y casquillo metálico o tapa metálica roscada, firmemente engargolado o enroscada al labio o rosca de la abertura secundaria de este frasco vial de dos aberturas. The person skilled in the art will also recognize that although there are several possibilities, the best combination of elements for reconstitution or dilution, is the combination of a vial vial cap made of pharmaceutically acceptable resistant material and metal cap or threaded metal cap, firmly crimped or screwed to the lip or thread of the secondary opening of this vial of two openings.
La combinación del tapón para frasco vial fabricado de material resiiiente y su casquillo metálico o tapa metálica roscada, siempre deja registro de su uso, al tener que quitar el selio del casquillo metálico o de la tapa metálica para realizar el acoplamiento con fa jeringa, mientras que esto no siempre ocurre en la combinación de válvula de cierre y paso con casquillo metálico.  The combination of the vial vial cap made of resistant material and its metallic cap or threaded metal cap, always leaves a record of its use, having to remove the seal from the metal cap or the metal cap to make the coupling with a syringe, while This does not always happen in the combination of a shut-off valve and a metal bushing.
Por lo tanto, la presente invención emplea como medio de cierre y paso, la combinación de tapón para frasco vial, fabricado de material resiliente y su casquillo metálico o tapa metálica, engargolado o enroscado a la abertura secundaria, para realizar la reconstitución o la dilución de las composiciones farmacéuticas. Therefore, the present invention employs as a means of closure and passage, the combination of a vial vial cap, made of resilient material and its metal cap or metal cap, crimped or screwed into the secondary opening, to perform reconstitution or dilution of the pharmaceutical compositions.
El cuerpo del frasco vial de dos aberturas cuenta con estructuras semejantes a las del frasco vial de abertura única, es decir, un cuerpo con piso o fondo esencialmente piano y bien definido, hombro del cuerpo con forma exterior bien definida, que une el contenedor del cuerpo con el cuello de la abertura principal. El contenedor del cuerpo (8), (81 } y (82), del frasco viai de la presente invención, comienza donde termina el hombro del cuerpo, hasta el piso o fondo plano. Puede tener forma exterior muy diversa que va desde (a forma cilindrica perfecta y la ovaf, pasando por la formada por caras piañas, convexas o cóncavas y cualquier combriacíón de las mismas. The body of the two-opening vial has structures similar to those of the single-opening vial, that is, a body with an essentially piano and well-defined floor or bottom, shoulder of the body with a well-defined exterior shape, which joins the container of the body with the neck of the main opening. The container of the body (8), (81} and (82), of the vial viai of the present invention, begins where the shoulder of the body ends, to the floor or flat bottom. have a very diverse exterior shape that goes from (to a perfect cylindrical shape and the ovaf, passing through the shape formed by conical, concave or concave faces and any combination thereof.
Para hacer práctico y ergonómico el tamaño del frasco vial de la presente invención, su aitura totaí mide de 35 a 66 milímetros. Esta altura total se mide, siguiendo el eje verticai piso-abertura principal, desde ei piso o fondo, hasta ei límite distal de la abertura principal.  To make the size of the vial of the present invention practical and ergonomic, its totaí aitura measures 35 to 66 millimeters. This total height is measured, following the vertical axis of the main floor-opening, from the floor or bottom, to the distal limit of the main opening.
Ai igual que en el frasco vial farmacéutico de abertura única, el frasco vial farmacéutico que posee dos aberturas motivo de la presente invención, puede ser fabricado usando los siguientes materiales siempre con calidad farmacéutica: vidrio, poltetiieno, poíietileno de baja densidad, políetiientereftaiato, polipropileno, cloruro de poiivínilo o pvc, el copolímero de olefina cíclica o cicloolefina, así como cualquier otro material conocido en el estado de la técnica.  Just as in the single-opening pharmaceutical vial, the pharmaceutical vial that has two openings that are the subject of the present invention, can be manufactured using the following materials always with pharmaceutical quality: glass, polytethiene, low density polyethylene, polyether phosphate, polypropylene , polyvinyl chloride or pvc, the cyclic olefin or cycloolefin copolymer, as well as any other material known in the state of the art.
Los materiales de calidad farmacéutica muy útiles en la fabricación de los frascos viales motivo de la presente invención, pueden ser claros o transparentes, así como también de cofor ámbar en sus muy diferentes tonalidades. The pharmaceutical grade materials very useful in the manufacture of the vial vials motive of the present invention, can be clear or transparent, as well as amber coffer in its very different shades.
El experto en la fabricación de frascos viaies de calidad farmacéutica, reconocerá que ios materiales mencionados como posibles para la fabricación del presente frasco viai de dos aberturas, usan aunque sin limitación alguna en esto, maquinaria, herramientas, técnicas de inyección y de moldeado, conocidos en el estado de la técnica. The expert in the manufacture of pharmaceutical quality vial bottles will recognize that the materials mentioned as possible for the manufacture of the present vial with two openings, use, without any limitation, machinery, tools, injection and molding techniques, known in the state of the art.
Para su lavado y esterilización, los frascos viales que poseen dos aberturas motivo de la presente invención, se adaptan a las técnicas y maquinaria conocida en el estado de la técnica. Ei experto en ía materia reconocerá que, el ingreso de fas composiciones farmacéuticas y de bioproductos sólidas, semisólídas, en gel o bien líquidas, hacía eí interior de ios frascos víales motivo de la presente invención, se realiza con las técnicas, áreas, condiciones y maquinaria, comunes en el estado de la técnica. Los frascos viales que poseen dos aberturas motivo de ía presente invención, se adaptan como dosificadores de dosis medida, con la incorporación de una válvula atomizadora de dosis medidas (17), con su acíuador (18) y tapón (19) (figuras 10 y 11), para atomizar ía composición farmacéutica o de bioproducto, después de ser reconstituida o diluida. Asimismo, los frascos víales que poseen dos aberturas motivo de ía presente invención, además comprenden: un tapón para frasco viaí (20), fabricado de material resiliente engargolado por su casquillo metálico (21) (figuras 10 y 11), o bien enroscado con una tapa metálica roscada a (a abertura secundaria; y una composición farmacéutica o de bioproducto en estado físico sólido, semisólido, en gel o bien líquido, que requiere ser reconstituida o diíuída para ser administrabíe y luego atomizada. For washing and sterilization, the vial bottles that have two motive openings of the present invention, adapt to the techniques and machinery known in the state of the art. The expert in the field will recognize that the entry of pharmaceutical compositions and solid, semi-solid, gel or liquid bioproducts, into the interior of the vial vials motive of the present invention, is carried out with the techniques, areas, conditions and machinery, common in the state of the art. The vial bottles, which have two openings that are the subject of the present invention, are adapted as metered dose dispensers, with the incorporation of a metered dose atomizing valve (17), with its actuator (18) and cap (19) (figures 10 and 11), to atomize the pharmaceutical or bioproduct composition, after being reconstituted or diluted. Likewise, the vial bottles that have two motif openings of the present invention, also comprise: a vial stopper (20), made of resilient material crimped by its metal cap (21) (figures 10 and 11), or screwed with a metal cap threaded to (at secondary opening; and a pharmaceutical or bioproduct composition in solid, semi-solid, gel or liquid state, which needs to be reconstituted or digested to be administrated and then atomized.
La presente invención engargola, acopia o enrosca firmemente en su abertura principal, válvulas atomizadoras de dosis medidas, que comprenden válvulas de amplio rango de dosis, aunque sin limitación alguna en esto, administran de 50 a 140 microlitros por actuación y tienen medidas comprendidas de 13 a 21 milímetros. Sus actuadores y los tapones para estos actuadores, corresponden en tamaño a sus respectivas válvulas atomizadoras.  The present invention snaps, collects or screws tightly in its main opening, metered dose atomizing valves, which comprise valves of wide range of doses, although without any limitation in this, administer 50 to 140 microliters per actuation and have measures comprised of 13 at 21 mm. Their actuators and the caps for these actuators, correspond in size to their respective atomizing valves.
El experto en la materia reconocerá que el frasco vial de dos aberturas motivo de la presente invención, es muy propio y se adapta con la maquinaria y herramientas de rutina, para la colocación y el engargoíamíento o acoplamiento o enroscado, de ías válvulas atomizadores que se fijan firmemente a ía abertura principal. La válvula una vez fija, puede recibir su actuador y tapón; también con maquinaria y herramienta de rutina, los actuadores son fijados a éstas, guiando las bases de los actuadores sobre los pistilos de las válvulas. Los tapones de los actuadores, se colocan al fina) de esta etapa sobre los pistilos de sus respectivos actuadores. The person skilled in the art will recognize that the two-way vial flask of the present invention is very own and adapts with the machinery and routine tools, for placement and crimping or coupling or screwed on, atomizing valves that are firmly fixed to the main opening. Once the valve is fixed, it can receive its actuator and plug; also with machinery and routine tools, the actuators are fixed to them, guiding the bases of the actuators on the pistils of the valves. The caps of the actuators are placed at the end of this stage on the pistils of their respective actuators.
El experto en la materia reconocerá que, el frasco vial de dos aberturas motivo de ta presente invención es muy propio y se adapta con ía maquinaria y herramientas de rutina, para la colocación de los tapones fabricados de material resiliente en la abertura secundaria. Ya colocado el tapón fabricado de material resiliente, también con maquinaria y herramienta de rutina, éste tapón es engargolado o enroscado a la abertura secundaria por casquillos metálicos o por tapas metálicas roscadas.  The person skilled in the art will recognize that the two-way vial which is the subject of the present invention is very own and is adapted with routine machinery and tools, for placing the caps made of resilient material in the secondary opening. Once the plug made of resilient material is placed, also with machinery and routine tools, this plug is crimped or screwed to the secondary opening by metal bushings or by threaded metal caps.
La presente invención, es muy propia y se adapta para engargolarle firmemente ai labio, o bien enroscarle a la rosca de la abertura secundaria, tapones para frasco vial fabricados de material resiliente colocados en esta, usando casquillos metálicos o bien tapas metálicas roscadas. Aunque sin limitación alguna en esto, los tapones para frasco vial y los casquillos metálicos o las tapas metálicas roscadas, corresponden a medidas comprendidas de 13 a 20 milímetros.  The present invention, is very own and adapts to firmly hook the lip, or screw the thread of the secondary opening, vial caps made of resilient material placed in it, using metal caps or threaded metal caps. Although without limitation in this, the caps for vial and metal caps or threaded metal caps, correspond to measures ranging from 13 to 20 mm.
El experto en la materia reconocerá que el tapón para frasco vial fabricado de material resiliente, colocado y engargolado o enroscado con su casquilio metálico o tapa metálica roscada, a la abertura secundaria de la presente invención, comprende a uno de butilo, clorobutifo, bromobutilo, isopreno, caucho, silicón, cíorobutilo/isopreno o butilo/poiitetrafíouroetiíeno, así como de cuaiquíer otro material descrito en ei estado de la técnica. The person skilled in the art will recognize that the vial vial cap made of resilient material, placed and crimped or screwed with its metal cap or threaded metal cap, to the secondary opening of the present invention, comprises one of butyl, chlorobutyl, bromobutyl, Isoprene, rubber, silicone, cyclobutyl / isoprene or butyl / polytetrafiuoroethiene, as well as four other material described in the prior art.
Ei frasco vial de uso farmacéutico de dos aberturas, es totalmente apto y propio para: ingresar en su cámara contenedora única, reconstituir o diluir y atomizar, composiciones farmacéuticas y de bioproductos sólidas, semísólidas, en gel y líquidas que requieren la reconstitución de sus ingredientes, antes de ser administrabas. Asimismo para cerrar sus aberturas con sus respectivos aditamentos, después de ingresar la composición a la cámara contenedora única. Dichas composiciones incluyen uno o más principios activos en estado físico sólido, semisólido y en gel, o bien liquido, para ser reconstituidos o diluidos antes de ser administrabíes. La innovación de ia presente invención, le permite a este novedoso frasco viaí que su abertura principal tenga una válvula atomízadora de dosis medidas firmemente engargolada, acoplada o enroscada, que así la cierran integrándole después su respectivo actuador y tapón, mientras que su abertura secundaría, puede tener al mismo tiempo, ios elementos del medio de cierre y paso, que consiste en la combinación de un tapón para frasco vial fabricado de material resiliente farmacéuticamente aceptable y casquiílo de aleación metálica o bien una tapa metálica roscada que lo engargola o enrosca firmemente.  The vial of pharmaceutical use of two openings, is totally suitable and proper to: enter its single container chamber, reconstitute or dilute and atomize, pharmaceutical compositions and solid, semi-solid, gel and liquid bioproducts that require the reconstitution of its ingredients , before being administered. Also to close their openings with their respective attachments, after entering the composition into the single container chamber. Said compositions include one or more active principles in solid, semi-solid and gel, or liquid physical state, to be reconstituted or diluted before being administered. The innovation of the present invention, allows this novel bottle via its main opening to have a metered dose atomizer valve firmly crimped, coupled or screwed, thus closing it by integrating its respective actuator and cap, while its secondary opening, it can have, at the same time, the elements of the closing and passage means, which consists of the combination of a vial vial cap made of pharmaceutically acceptable resilient material and metal alloy cap or a threaded metal cap that locks it or screws it tightly.
De esta manera, ía reconstitución o dilución de la composición farmacéutica o de bioproducto, ingresada en estos frascos viales de dos aberturas, cuando sus dos aberturas están ya cerradas con sus respectivos aditamentos, es posible a través de ia abertura secundaria con la ayuda de jeringa con aguja estériles y un agente reconstituyente o diluyente farmacéuticamente aceptable y también estéril, mientras que la atomización, se realiza por las actuaciones de la válvula atomizadora funcionando en coordinación con su actuador, después que ía composición ha sido reconstituida o diluida, ta posibilidad de que este innovador frasco vial de uso farmacéutico de dos aberturas y una cámara contenedora única, pueda ingresar composiciones farmacéuticas y de bíoproductos en estado físico sólido, semísóíido, o en gei, que son administradas de manera intranasaí y que requieren ser reconstituidas o diluidas antes de ser usadas, permite con eiio prolongar ios tiempos de ía vida de anaqyeí de las propias composiciones, Otro beneficio de los frascos viales motivo de la presente invención es ía posible disminución de ía incorporación de agentes conservadores en las composiciones farmacéuticas, como el cloruro de benzalconio, que es frecuentemente empleado en los actuales atomizadores nasaies. De este modo, se íogra una disminución de ios riesgos de desarrollo de hipersensibiüdad o alergia en los pacientes que usan ías composiciones así envasadas, reconstituidas o diluidas, antes de ser administrares. Para eí caso de composiciones farmacéuticas o de bíoproductos que comprenden principios activos de poca estabilidad farmacéutica y que, requieren refrigeración durante su vida útil, es importante destacar que tas composiciones farmacéuticas reconstituidas o diluidas y administrares en los frascos víales motivo de la presente invención, son totaímente compatibles con la refrigeración, pues ninguno de los elementos del frasco vial de la presente invención se contraponen a ello. In this way, the reconstitution or dilution of the pharmaceutical or bioproduct composition, entered into these two open vial vials, when its two openings are already closed with their respective attachments, it is possible through the secondary opening with the help of a syringe with sterile needle and a pharmaceutically acceptable and also sterile reconstituting agent or diluent, while the atomization is performed by the actions of the valve atomizer operating in coordination with its actuator, after the composition has been reconstituted or diluted, the possibility that this innovative vial of pharmaceutical use of two openings and a single container chamber, can enter pharmaceutical and bioproduct compositions in solid physical state, semi-solid, or in gei, that are administered intranasaí and that need to be reconstituted or diluted before being used, allows to prolong the times of the anaqyeí life of the compositions themselves, Another benefit of the vial vials reason for the present The invention is possible to reduce the incorporation of preservative agents in pharmaceutical compositions, such as benzalkonium chloride, which is frequently used in current nasaie atomizers. Thus, there is a decrease in the risks of developing hypersensitivity or allergy in patients who use the compositions so packaged, reconstituted or diluted, before being administered. In the case of pharmaceutical or bioproduct compositions that comprise active ingredients of low pharmaceutical stability and that require refrigeration during their useful life, it is important to note that the reconstituted or diluted pharmaceutical compositions administered in the vial vials of the present invention are totally compatible with refrigeration, since none of the elements of the vial of the present invention are opposed to it.
Las composiciones farmacéuticas y de bioproducto que requieren ser reconstituidas o diluidas antes de ser usadas, incluyen uno o varios principios activos así como a otros ingredientes diferentes y/o excipientes farmacéuticamente aceptables. Dentro de este grupo de otros ingredientes diferentes a ¡os principios activos, también (¡amados excipientes, las composiciones que requieren reconstitución antes de ser usadas, pueden incluir agentes solubiiizadores, de tonicidad, suspensantes, reguladores de pH, gelificantes, mejoradores de la absorción, conservadores, antioxídantes, humectantes y surfactantes descritos ampliamente en la farmacopea internacional. Pharmaceutical and bioproduct compositions that need to be reconstituted or diluted before being used, include one or more active ingredients as well as other different ingredients and / or pharmaceutically acceptable excipients. Within this group of other ingredients other than the active ingredients, too (beloved excipients, compositions that require reconstitution before being used, may include solubilizing, tonicity, suspending, pH regulating, gelling, absorption enhancers, preservatives, antioxidants, humectants and surfactants widely described in the international pharmacopoeia.
El ingreso hasta la cámara contenedora única, de las composiciones farmacéuticas y de bbproductos que requieren ser reconstituidas o diluidas antes de ser administrables, en los frascos viales de dos aberturas motivo de ta presente invención así como el cerrado de sus aberturas, se describe a continuación: El experto en ía materia reconocerá que las composiciones farmacéuticas y de bbproductos, en estado físico sólido, por su propia rmturaleza poseen menor reactividad química y son de mayor estabilidad farmacéutica, en comparación con las composiciones acuosas.  The entry into the single container chamber of the pharmaceutical compositions and bbproducts that need to be reconstituted or diluted before being administrable, in the two-way vial vials on the basis of the present invention as well as the closure of their openings, is described below. : The person skilled in the art will recognize that pharmaceutical and bb-product compositions, in solid physical state, by their own nature have lower chemical reactivity and are of greater pharmaceutical stability, compared to aqueous compositions.
El frasco víai motivo de la presente invención, es muy propio y está adaptado ai ingreso de las composiciones farmacéuticas sólidas, sem ¡sólidas o en gel, o bien líquidas que requieren ser reconstituidas o diluidas antes de administrables, así como también al cerrado de su abertura principal con su válvula atomizadora con actuador y tapón y al cerrado de su abertura secundaria con ¡os elementos del medio de cierre y paso, en áreas estériles, con condiciones de atmósfera normal, sin ei uso de atmósfera no oxidante o enriquecida con Nitrógeno, Argón, o cualquier otro elemento o gas inerte o noble no oxidante. Bajo condiciones de atmosfera de trabajo normal, en un área el ingreso de la composición hasta la cámara contenedora única y el cerrado de las aberturas deí frasco vial estéril se realiza con la secuencia que incluye: The vial via the motive of the present invention is very own and is adapted to the entry of solid, semi-solid or gel, or liquid pharmaceutical compositions that need to be reconstituted or diluted before administrable, as well as the closure of their main opening with its atomizing valve with actuator and cap and when closing its secondary opening with the elements of the closing and passage means, in sterile areas, with normal atmosphere conditions, without the use of non-oxidizing or nitrogen enriched atmosphere, Argon, or any other non-oxidizing inert or noble element or gas. Under conditions of normal working atmosphere, in one area the entry of the composition into the single container chamber and the closure of the openings of the sterile vial is carried out with the sequence that includes:
- lavar y esterilizar los frascos viales motivo de la presente invención;  - wash and sterilize the vial vials motive of the present invention;
~ a través de ia abertura principal, se ingresa la composición farmacéutica o de bíoproducto correspondiente en estado sólido, semisóíido, en gel, o bien líquido, hasta su cámara contenedora única:  ~ through the main opening, the corresponding pharmaceutical or bioproduct composition is introduced in solid, semi-solid, gel, or liquid state, to its single container chamber:
- colocar y engargolar o acoplar o roscar en la abertura principal, su válvula atomízadora con su correspondientes actuador y tapón:  - place and crimp or couple or screw in the main opening, its atomizing valve with its corresponding actuator and plug:
- y colocar el tapón para frasco vial, fabricado de material resiliente en la abertura secundaria, engargolándolo o roscándolo a esta, con su caequillo metálico o bien con su tapa metálica roscada.  - and place the vial vial cap, made of resilient material in the secondary opening, hooking it or tapping it, with its metal dropper or with its threaded metal cap.
Inmediatamente después de esta etapa, el frasco vial de la presente invención pasa a su encartonado final y le son incorporados: el agente reconstituyente o diluyente líquido farmacéuticamente aceptable y estéril, envasado en su propio frasco vial que posee una abertura única y que está cerrado por un tapón de frasco vial fabricado de material resiliente, engargolado con un casquillo metálico; también se adicionan en este encartonado final, una jeringa con aguja ambas estériles y un instructivo de uso. El frasco vial de la presente invención, pasa toda su vida de anaquel encartonado de esta manera. Immediately after this stage, the vial of the present invention passes into its final packaging and is incorporated into it: the sterile pharmaceutically acceptable liquid reconstituent or diluent, packaged in its own vial containing a single opening and which is closed by a vial vial cap made of resilient material, crimped with a metal cap; Also added in this final carton, a syringe with needle both sterile and an instruction manual. The vial of the present invention, spends its entire shelf life packed in this way.
Por reconstitución se entiende en la presente invención, a la disolución o suspensión requerida por las composiciones farmacéuticas, que por su inicial estado físico sólido, semisóíido o en gel, así lo requieren siempre, antes de poder ser administrables mediante atomizaciones de dosis medidas. Por dilución se entiende en la presente invención, al abatimiento de la concentración, requerida por las composiciones farmacéuticas y de bioproductos, que por su inicial estado físico líquido así io necesiten, antes de poder ser admínistrables mediante atomizaciones de dosis medidas, By reconstitution, the present invention is understood as the solution or suspension required by the pharmaceutical compositions, which, due to their initial solid, semi-solid or gel physical state, always require it, before they can be administered by means of metered dose sprays. Dilution is understood in the present invention, to the depletion of the concentration, required by the pharmaceutical and bioproduct compositions, which, due to their initial liquid physical state, so they need, before they can be administered by means of measured dose sprays,
El frasco vial de ia presente invención se adapta para reconstituir y diluir las composiciones farmacéuticas y de bioproductos ingresadas en su cámara contenedora única y cuando sus dos aberturas fueron ya cerradas con su válvula atomizadora con actuador y tapón y el medio de cierre y paso, primero, cuando un agente reconstituyente o düuyente farmacéuticamente aceptable, es introducido a través de la abertura secundaria, que es la parte específica del frasco vial, de ia presente invención, adaptada para este fin. The vial of the present invention is adapted to reconstitute and dilute the pharmaceutical and bioproduct compositions entered in its single container chamber and when its two openings were already closed with its atomizing valve with actuator and cap and the closing and passage means, first , when a pharmaceutically acceptable reconstituent or diluent is introduced through the secondary opening, which is the specific part of the vial, of the present invention, adapted for this purpose.
Con la ayuda de la jeringa estéril con aguja estéril provista en el encartonado final, se extrae de su propio envase, eí agente reconstituyente o düuyente farmacéuticamente aceptable en la cantidad necesaria para tal fin. Cuando la jeringa ya está cargada con eí agente reconstituyente o düuyente, a continuación se retira el sello de seguridad del casquillo metálico o tapa metálica, sobre el tapón para frasco vial engargolado o enroscado en la abertura secundaría deí frasco víal de ia presente invención y se introduce el agente reconstituyente o düuyente contenido en la jeringa, en la cantidad necesaria hasta la cámara contenedora única.  With the aid of the sterile syringe with sterile needle provided in the final carton, the pharmaceutically acceptable reconstituting agent or diluent is taken out of its own container in the amount necessary for that purpose. When the syringe is already loaded with the reconstituting agent or diluent, then the safety seal of the metal cap or metal cap is removed, on the cap for vial vial stuck or screwed into the secondary opening of the vial of the present invention and introduces the reconstituting agent or diluent contained in the syringe, in the amount necessary to the single container chamber.
En este punto y por primera vez, la composición farmacéutica o de bíoproducto dentro de la cámara contenedora única, tiene contacto con el agente reconstituyente o düuyente. A continuación, el frasco vial de la presente invención con su contenido, es agitado manualmente de forma vigorosa para lograr una reconstitución o dilución adecuada de la composición farmacéutica o de bioproducto, para que desde este punto la composición sea administrable y su atomización sea posible. At this point and for the first time, the pharmaceutical or bioproduct composition within the single container chamber has contact with the reconstituting agent or diluent. Next, the vial of the present invention, with its contents, is vigorously shaken manually to achieve adequate reconstitution or dilution of the pharmaceutical or bioproduct composition, so that from this point the composition is administrable and its atomization is possible.
Por agente reconstituyente farmacéuticamente aceptable en la presente invención, se entiende a cualquier agente farmacéuticamente aceptable capaz de lograr la disolución o suspensión necesaria, para que las composiciones farmacéuticas o de bioproducto sólidas, semisólidas o en gel, puedan ser administradles por atomizaciones de dosis medidas.  By a pharmaceutically acceptable reconstituting agent in the present invention, any pharmaceutically acceptable agent is understood as capable of achieving the necessary solution or suspension, so that solid, semi-solid or gel pharmaceutical or bioproduct compositions can be administered by measured dose sprays.
Por agente dikiyente farmacéuticamente aceptable en la presente invención, se entiende a cualquier agente farmacéuticamente aceptable, capaz de lograr el abatimiento de la concentración necesaria, para que las composiciones farmacéuticas o de bioproducto en estado líquido inicial, alcancen su fase acuosa final y completa, para que puedan ser administrabíes de mejor manera, atomizadas en dosis medidas. La válvula atomizadora de dosis medidas, usada por los atomizadores que se incorporan en los frascos viales motivo de la presente invención, consiste de un aditamento que opera correctamente hasta que la composición farmacéutica está adecuadamente reconstituida o diluida. El experto en la materia reconocerá que los agentes reconstituyentes o diluyentes farmacéuticamente aceptables, muy propios y aptos para ser usados en la presente invención, incluyen agua estéril inyectable y opcionalmente incluyen otros excipientes, tales como:  By pharmaceutically acceptable diki-agent in the present invention, any pharmaceutically acceptable agent is understood as capable of achieving a reduction in the necessary concentration, so that the pharmaceutical or bioproduct compositions in the initial liquid state reach their final and complete aqueous phase, for that can be administered in a better way, atomized in measured doses. The metered dose atomizing valve, used by the atomizers that are incorporated into the vial vials that are the subject of the present invention, consists of an attachment that operates correctly until the pharmaceutical composition is properly reconstituted or diluted. The person skilled in the art will recognize that pharmaceutically acceptable reconstituting agents or diluents, very suitable and suitable for use in the present invention, include sterile injectable water and optionally include other excipients, such as:
- reguladores de la tonicidad.  - tonicity regulators.
- reguladores de pH.  - pH regulators.
- reguiadores hidrosolubles del incremento de la viscosidad. - reguiadores no hidrosolubles del incremento de ia viscosidad. - Water soluble regulators of viscosity increase. - non-water soluble regulators of viscosity increase.
- mejoradores de la solubilidad.  - solubility enhancers.
~ excipientes conservadores.  ~ conservative excipients.
- soluciones o suspensiones formadas otros excipientes descritos en ei estado de la técnica, así como por las combinaciones de dos o más, de todos tos grupos anteriores, incluyendo como ingrediente común de cualquier opción, al agua estéril inyectable.  - solutions or suspensions formed other excipients described in the prior art, as well as by combinations of two or more, of all the above groups, including as a common ingredient of any option, to sterile injectable water.
El frasco vial farmacéutico y de btoproductos motivo de la presente invención, pasa toda su vida de anaquel en su encartonado final. A continuación, este frasco vial, permite la reconstitución o la dilución de la composición farmacéutica o de bíoproducto que ha estado en su cámara contenedora única en estado sólido, semisólído, en gel o bien líquido, para que esta sea primero admínistrable y luego se atomice manualmente. The pharmaceutical vial and btoproducts motive of the present invention, spends its entire shelf life in its final carton. This vial then allows the reconstitution or dilution of the pharmaceutical or bioproduct composition that has been in its single container chamber in a solid, semi-solid, gel or liquid state, so that it is first admirable and then atomized manually.
El método para ia reconstitución o la dilución y la atomización con el frasco vial motivo de ia presente invención, de composiciones farmacéuticas y de bioproductos sólidas, semisólidas, en gel o bien líquidas, que así k> requieren antes de ser admintstrables, está caracterizado además porque comprende: primero, proveer el frasco vial motivo de la presente invención con todos sus aditamentos y contenido, provisto en el encartonado final; cargar con la jeringa con aguja estériles ambas y provista en el encartonado final, con la cantidad necesaria del agente reconstituyente o diluyente farmacéuticamente aceptable y también provisto en el encartonado final; luego, retirar el sello de seguridad del casquiiio o tapa metálica engargolado o enroscado a su abertura secundaria; a continuación, introducir el agente reconstituyente o diluyente en su interior, para que este entre en contacto directo con te composición farmacéutica o de bíoproducto en (a cámara contenedora única; posteriormente, agitar et frasco vial con todos sus aditamentos y conteniendo de manera vigorosa, para obtener con esto, una composición farmacéutica o de bíoproducto, que es a partir de este punto administrabie, en el interior de ta cámara contenedora única; y finalmente, atomizar manualmente ia composición. The method for reconstitution or dilution and atomization with the vial vial of the present invention, of pharmaceutical compositions and of solid, semi-solid, gel or liquid bioproducts, which thus k> require before being administrable, is further characterized because it comprises: first, providing the vial vial motive of the present invention with all its attachments and content, provided in the final carton; fill with the sterile needle syringe both and provided in the final carton, with the necessary amount of the pharmaceutically acceptable reconstituting agent or diluent and also provided in the final carton; then, remove the safety seal from the casquiiio or metal cover crimped or screwed to its secondary opening; then introduce the reconstituting agent or diluent inside, to that it comes into direct contact with the pharmaceutical or bioproduct composition in (a single container chamber; subsequently, shake the vial with all its attachments and vigorously containing, to obtain with this, a pharmaceutical or bioproduct composition, which is from this point administrate, inside the single container chamber, and finally, manually atomize the composition.
Después de haber sido reconstituidas o diluidas en la cámara contenedora del frasco vial motivo de ¡a presente invención, las composiciones farmacéuticas y de bioproductos, que fueron íniciaimente sólidas, semisólidas, en gel o bien líquidas, son administrables a partir de este punto y su atomización ahora es posible.  After having been reconstituted or diluted in the container chamber of the vial subject to the present invention, the pharmaceutical and bioproduct compositions, which were solid, semi-solid, gel or liquid, are administrable from this point and their Atomization is now possible.
El frasco vial motivo de la presente invención se adapta con la válvula atomizadora de dosis medidas en coordinación con su actuador, así como con ia manipulación del usuario para la atomización, de las composiciones farmacéuticas y de bioproductos ya administrables, es decir después de que estas fueron reconstituidas o diluidas.  The vial vial motive of the present invention is adapted with the metered dose atomizing valve in coordination with its actuator, as well as with the manipulation of the user for the atomization, of the pharmaceutical compositions and of already administrable bioproducts, that is to say after these They were reconstituted or diluted.
A partir de este punto, la atomización puede llevarse a cabo en cualquier momento, sosteniendo el frasco vial motivo de la presente invención, con todos sus aditamentos engargolados, acoplados o enroscados y su composición farmacéutica o de bíoproducto ya administrabie en el interior la cámara contenedora única, de la siguiente manera:  From this point on, the atomization can be carried out at any time, holding the vial vial motive of the present invention, with all its attachments hooked, coupled or screwed and its pharmaceutical or bioproduct composition already administered inside the container chamber unique, as follows:
~ colocar el dedo pulgar contra el piso del cuerpo del frasco vial y sujetar entre tos dedos anular y medio el actuador ya sin su tapón.  ~ place your thumb against the floor of the vial bottle and hold the actuator between the ring and middle fingers without its cap.
- agitar el atomizador vigorosamente. - colocar el actuador en posición y cerrar coordinadamente estos dedos, para una atomización local ø inmediata, - shake the atomizer vigorously. - place the actuator in position and close these fingers in coordination, for an immediate local ø atomization,
ta atomización se realiza directamente con ía manipulación del usuario, atomizando dosis medidas de 50 a 140 microütros por cada actuación, adminístrable de manera íntranasal. The atomization is carried out directly with the manipulation of the user, atomizing measured doses of 50 to 140 micro-meters for each action, manageable intranasally.

Claims

REIVINDICACIONES
1. - Un frasco vial de calidad farmacéutica que posee dos aberturas, cada una de estas tiene su propio cuello y su propio borde distal exterior, que es un labio o bien una rosca, la primera abertura o principal se ubica en el hombro del cuerpo, en posición completamente opuesta al piso o fondo que es esencialmente plano, ei hombro del cuerpo cuya forma exterior es bien definida, une ei cuello de la abertura principal con el contenedor del cuerpo y este a su vez, se une con el piso o fondo, ¡a segunda abertura o secundaria se ubica sobre la pared del contenedor del cuerpo, con su eje central en posición transversal de 30 a 90° respecto al eje vertical piso-abertura principal, ambas aberturas se comunican entre sí por medio de una cámara contenedora única. 1. - A pharmaceutical quality vial that has two openings, each of these has its own neck and its own outer distal edge, which is a lip or a thread, the first or main opening is located on the shoulder of the body , in a position completely opposite to the floor or bottom which is essentially flat, the shoulder of the body whose exterior shape is well defined, joins the neck of the main opening with the container of the body and this in turn, joins with the floor or bottom , the second or secondary opening is located on the wall of the body container, with its central axis in a transverse position of 30 to 90° with respect to the vertical axis floor-main opening, both openings communicate with each other by means of a containing chamber only.
2. - El frasco vial de conformidad con la reivindicación 1, caracterizado además porque ei diámetro exterior de su abertura principal mide de 12 a 21 milímetros. 2. - The vial bottle according to claim 1, further characterized in that the outer diameter of its main opening measures 12 to 21 millimeters.
3 - El frasco vial de conformidad con la reivindicaciones 1 y 2, caracterizado además porque si la abertura principal tiene labio, la altura de este iabio mide de 3 a 6 milímetros. 3 - The vial bottle according to claims 1 and 2, further characterized in that if the main opening has a lip, the height of this lip measures 3 to 6 millimeters.
4 - El frasco vial de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque el diámetro exterior del cuello de la abertura principal mide de a 8 a 17 milímetros. 4 - The vial bottle according to any of the preceding claims, further characterized in that the outer diameter of the neck of the main opening measures 8 to 17 millimeters.
5.- El frasco vial de conformidad con cualquiera de las reivindk^ciones anteriores, caracterizado además porque el largo del cuello de la abertura principal mide de a 3 a 20 milímetros. 5.- The vial bottle in accordance with any of the previous claims, further characterized in that the length of the neck of the main opening measures from 3 to 20 millimeters.
6.- El frasco vial de conformidad con la reivindicación 1, caracterizado además porque el diámetro exterior de su abertura secundaría mide de 12 a 21 milímetros. 6.- The vial bottle according to claim 1, further characterized in that the external diameter of its secondary opening measures 12 to 21 millimeters.
7.~ El frasco vial de conformidad con la reivindicaciones 1 y 6, caracterizado además porque si la abertura secundaria tiene labio, la altura de este labio mide de 3 a 6 milímetros. 7.~ The vial bottle according to claims 1 and 6, further characterized in that if the secondary opening has a lip, the height of this lip measures 3 to 6 millimeters.
8 - El frasco vial de conformidad con las reivindicaciones 6 y 7, caracterizado además porque el diámetro exterior del cuello de la abertura secundaria mide de a 8 a 17 milímetros. 8 - The vial bottle according to claims 6 and 7, further characterized in that the outer diameter of the neck of the secondary opening measures 8 to 17 millimeters.
9.- El frasco viai de conformidad con las reivindicaciones 6 a 8, caracterizado además porque el largo del cuello de la abertura secundaria mide de a 3 a 20 milímetros. 9.- The viai bottle according to claims 6 to 8, further characterized in that the length of the neck of the secondary opening measures 3 to 20 millimeters.
10.- El frasco vial de conformidad con la reivindicactón 1, caracterizado además porque el hombro del cuerpo puede tener forma exterior p\am perfecta; redondeada; con caras planas, convexas o cóncavas y combinaciones de las mismas. 10.- The vial bottle according to claim 1, further characterized in that the shoulder of the body can have a perfect exterior shape; rounded; with flat, convex or concave faces and combinations thereof.
11 - Eí frasco vial de conformidad con la reivindicación 1, caracterizado además porque el contenedor del cuerpo del frasco vial puede tener forma exterior cilindrica perfecta; oval; cúbica; trapezoide; con caras planas, convexas o cóncavas y combinaciones de las mismas. 11 - The vial bottle according to claim 1, further characterized in that the container of the body of the vial bottle can have a perfect cylindrical exterior shape; oval; cubic; trapezoid; with flat, convex or concave faces and combinations thereof.
12. - El frasco vial de conformidad con la reivindícadón 11, caracterizado además porque el perímetro exterior del contenedor del cuerpo mide de 50 a 130 milímetros. 12. - The vial bottle according to claim 11, further characterized in that the outer perimeter of the body container measures from 50 to 130 millimeters.
13. - Ei frasco vial de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque su altura total mide de 35 a 66 milímetros. 13. - The vial bottle in accordance with any of the previous claims, further characterized in that its total height measures from 35 to 66 millimeters.
14. - El frasco vial de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque está fabricado con cualquiera de los materiales que comprenden: vidrio, poíietííeno, poiiettleno de baja densidad, políetitentereftaíato, polipropileno, cloruro de polívinilo o pvc y copoltmero de defina cíclica o cicloolefína, así como cualquier otro material conocido en el estado de ia técnica; donde los materiales de calidad farmacéutica pueden ser claros o transparentes, así como también de color ámbar en diferentes tonalidades. 14. - The vial bottle according to any of the previous claims, further characterized in that it is manufactured with any of the materials that comprise: glass, polyethylene, low density polyethylene, polyethylene terephthalate, polypropylene, polyvinyl chloride or PVC and define copolymer. cyclic or cycloolefin, as well as any other material known in the state of the art; where pharmaceutical grade materials can be clear or transparent, as well as amber in different shades.
15. - El frasco vial de conformidad con la reivindicación 14, caracterizado además porque está fabricado por inyección y moldeado. 15. - The vial bottle according to claim 14, further characterized in that it is manufactured by injection and molding.
16 - El frasco vial de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque se adapta con las técnicas y maquinaria descritas en el estado de ia técnica, para su lavado y esterilizado. 16 - The vial bottle in accordance with any of the previous claims, further characterized in that it is adapted with the techniques and machinery described in the state of the art, for washing and sterilizing.
17. · El frasco vial de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque se adapta con cualquier composición farmacéutica o de bíoproducto sólida, semisólida, en gel, o bien líquida, que debe ser reconstituida o diluida antes de ser adminístrale al usuario, ingresada hasta su cámara contenedora única. 17. The vial bottle according to any of the preceding claims, further characterized in that it adapts to any solid, semi-solid, gel, or liquid pharmaceutical or bioproduct composition, which must be reconstituted or diluted before being administered to the user. , entered into its unique containing chamber.
18. - El frasco vial de conformidad con la reivindicación 17, caracterizado además porque se adapta con esterilidad y condiciones de atmósfera normal, sin el uso de atmósfera no oxidante o enriquecida con Nitrógeno, Argón, o cualquier otro elemento o gas inerte o noble no oxidante, durante el ingreso de la composición hasta su cámara contenedora única y el cerrado de sus dos aberturas. 18. - The vial bottle according to claim 17, further characterized in that it is adapted with sterility and normal atmosphere conditions, without the use of non-oxidizing atmosphere or enriched with Nitrogen, Argon, or any other element or inert or noble gas. oxidant, during the entry of the composition into its single containing chamber and the closing of its two openings.
19. - Ef frasco vial de conformidad con las reivindicaciones 17 y 18, caracterizado además porque su abertura principa} está adaptada, como la vía de ingreso de la composición farmacéutica o de bwproducto hacia la cámara contenedora única, antes de contar con cualquier aditamento adicional engargolado, acoplado o roscado en esta. 19. - This vial bottle in accordance with claims 17 and 18, further characterized in that its main opening is adapted as the entry route of the pharmaceutical composition or product into the single container chamber, before having any additional accessory. crimped, coupled or threaded on it.
20. - El frasco vial de conformidad con las reivindicaciones 17 a 19, caracterizado además porque se adapta, con una válvula atomizadora de dosis medidas, firmemente engargolada, acoplada o roscada, cerrando así su abertura principal, integrándole después su respectivo actuador y tapón, así como con el medio de cierre y paso firmemente engargolado o roscado, cerrando así su abertura secundaría. 20. - The vial bottle according to claims 17 to 19, further characterized in that it is adapted, with a metered dose atomizing valve, firmly crimped, coupled or threaded, thus closing its main opening, then integrating its respective actuator and cap, as well as with the closure and passage means firmly crimped or threaded, thus closing its secondary opening.
21 El frasco vial de conformidad con la reivindicación 20, caracterizado además porque el medio de cierre y paso, consiste en la combinación de un tapón para frasco vial, fabricado de material resiliente farmacéuticamente aceptable y casquíllo metálico o bien tapa metálica roscada, que lo engargola o enrosca firmemente. 21 The vial bottle according to claim 20, further characterized in that the closure and passage means consists of the combination of a cap for the vial bottle, made of pharmaceutically acceptable resilient material and a metal cap or threaded metal cap, which engages it. or screw tightly.
22, - El frasco vial de conformidad con la reivindicación 21, caracterizado además porque el tapón para frasco vial fabricado de material resiliente, comprende a uno de butilo, ciorobutilo, bromobutilo, isopreno, caucho, silicón, ciorobutilo/isopreno o butíto/poiitetraflouroetíteno, así como de cualquier otro material conocido en el estado de la técnica. 22, - The vial bottle according to claim 21, further characterized in that the stopper for the vial bottle made of resilient material, comprises one of butyl, cyorobutyl, bromobutyl, isoprene, rubber, silicone, cyorobutyl / isoprene or butite / poiitetraflouroethitene, as well as any other material known in the state of the art.
23. - El frasco vial de conformidad con las reivindicaciones 21 y 22, caracterizado además porque la combinación de tapón para frasco vial fabricado de material resiliente y su casquiílo metálico o tapa metálica deja registro de su uso. 23. - The vial bottle in accordance with claims 21 and 22, further characterized in that the combination of the vial bottle cap made of resilient material and its metal cap or metal cap leaves a record of its use.
24 - El frasco vial de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque se adapta, con: un agente reconstituyente o diiuyente farmacéuticamente aceptable y estéril, envasado en su propio frasco viaí que posee una abertura única y que está cerrado con un tapón para frasco vial fabricado de material resiliente, engargolado con su casquilío metálico; una jeringa con aguja, ambos estériles; y un instructivo de uso, todo esto en el interior de un empaque final de cartón, que es como pasa toda su vida de anaquel. 24 - The vial bottle according to any of the preceding claims, further characterized in that it is adapted, with: a pharmaceutically acceptable and sterile restorative agent or diluent, packaged in its own vial bottle that has a single opening and is closed with a stopper for vial bottle made of resilient material, hooked with its metal cap; a syringe with a needle, both sterile; and a user manual, all of this inside a final cardboard packaging, which is how it spends its entire shelf life.
25. - El frasco vial de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado además porque se adapta con la manipulación del usuario y un aditamento adicional, para ingresar el agente reconstituyente o diiuyente provisto en el mismo encartonado, hasta la cámara contenedora única. 25. - The vial bottle in accordance with any of the previous claims, further characterized in that it adapts with the manipulation of the user and an additional accessory, to enter the restorative agent or diluent provided in the same carton, up to the single containing chamber.
26. - El frasco viai de conformidad con la reivindicación 25, caracterizado además porque ei aditamento adicional es la jeringa con aguja ambas estériles, provista en el mismo encartonado final. 26. - The bottle is in accordance with claim 25, further characterized in that the additional accessory is the syringe with needle, both sterile, provided in the same final packaging.
27. - Un método para reconstituir o diluir y atomizar, composiciones farmacéuticas y de bioproductos, sólidas, semisólidas, en gel o bien liquidas, caracterizado porque comprende: a) proveer el frasco vial de conformidad con cualquiera de las reivindicaciones anteriores; b) cargar la jeringa con aguja, ambas estériles, provistas en el encartonado final, con la cantidad necesaria del agente reconstituyente o diiuyente farmacéuticamente aceptable, también provisto en ei encartonado final; c) retirar el seiio de seguridad del casquilío o tapa metálica engargolado o enroscado a la abertura secundaria del frasco vial; d) introducir el agente reconstituyente o diiuyente al interior del frasco vial, para que entre en contacto directo con la composición farmacéutica o de bioproducto en la cámara contenedora única; e) agitar de manera vigorosa el frasco vial con su contenido, para obtener desde este punto en el interior de la cámara contenedora única, una composición farmacéutica o de bioproducto administrable; y f) atomizar manualmente la composición farmacéutica o de bioproducto, una vez que esta es administrable. 27. - A method to reconstitute or dilute and atomize, solid, semi-solid, gel or liquid pharmaceutical and bioproduct compositions, characterized in that it comprises: a) providing the vial in accordance with any of the previous claims; b) load the syringe with needle, both sterile, provided in the final carton, with the necessary amount of the pharmaceutically acceptable restorative agent or diluent, also provided in the final carton; c) remove the safety seal from the metal cap or cap crimped or screwed to the secondary opening of the vial; d) introduce the reconstituting agent or diluent into the vial, so that it enters the direct contact with the pharmaceutical or bioproduct composition in the single containing chamber; e) vigorously shake the vial with its contents, to obtain from this point inside the single containing chamber, a pharmaceutical composition or administrable bioproduct; and f) manually atomize the pharmaceutical or bioproduct composition, once it is administrable.
28 - El método para reconstituir o diluir y atomizar, de conformidad con la reivindicación 27, caracterizado además porque atomizar manualmente la composición comprende: colocar el dedo pulgar contra el piso del cuerpo del frasco víai y sujetar entre los dedos anular y medio el actuador ya sin su tapón; agitar vigorosamente; colocar el actuador en posición y cerrar coordinadamente estos dedos, para una atomización local e inmediata. 28 - The method for reconstituting or diluting and atomizing, according to claim 27, further characterized in that manually atomizing the composition comprises: placing the thumb against the floor of the body of the viai bottle and holding the actuator between the ring and middle fingers and without its stopper; shake vigorously; Place the actuator in position and coordinately close these fingers, for local and immediate atomization.
29 - El método para reconstituir o diluir y atomizar, de conformidad con las reivindicaciones 27 y 28, caracterizado además porque atomiza, dosis medidas de 50 a 140 microlitros por cada actuación, administrable de manera intranasal. 29 - The method to reconstitute or dilute and atomize, in accordance with claims 27 and 28, further characterized in that it atomizes, measured doses of 50 to 140 microliters for each action, administrable intranasally.
PCT/MX2015/000071 2014-05-06 2015-05-04 Pharmaceutical vial bottle having two openings WO2015170956A1 (en)

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MX2014005427A MX2014005427A (en) 2014-05-06 2014-05-06 Pharmaceutical vial bottle having two openings.

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3156383A (en) * 1962-04-05 1964-11-10 Maison Ind Tecnico Chimiche Ne Expansible single use dispensing container
US3938520A (en) * 1974-06-10 1976-02-17 Abbott Laboratories Transfer unit having a dual channel transfer member
US4113129A (en) * 1978-01-05 1978-09-12 Respiratory Care, Inc. Container for sterile liquids

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3156383A (en) * 1962-04-05 1964-11-10 Maison Ind Tecnico Chimiche Ne Expansible single use dispensing container
US3938520A (en) * 1974-06-10 1976-02-17 Abbott Laboratories Transfer unit having a dual channel transfer member
US4113129A (en) * 1978-01-05 1978-09-12 Respiratory Care, Inc. Container for sterile liquids

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