WO2004016243A3 - Methods of administering and enhancing absorption of pharmaceutical agents - Google Patents

Methods of administering and enhancing absorption of pharmaceutical agents Download PDF

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Publication number
WO2004016243A3
WO2004016243A3 PCT/IB2003/003908 IB0303908W WO2004016243A3 WO 2004016243 A3 WO2004016243 A3 WO 2004016243A3 IB 0303908 W IB0303908 W IB 0303908W WO 2004016243 A3 WO2004016243 A3 WO 2004016243A3
Authority
WO
WIPO (PCT)
Prior art keywords
administering
methods
pharmaceutical agents
disclosed
enhancing absorption
Prior art date
Application number
PCT/IB2003/003908
Other languages
French (fr)
Other versions
WO2004016243A2 (en
Inventor
Pankaj Modi
Original Assignee
Generex Pharm Inc
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 Generex Pharm Inc filed Critical Generex Pharm Inc
Priority to MXPA05001887A priority Critical patent/MXPA05001887A/en
Priority to CA2494132A priority patent/CA2494132C/en
Priority to AU2003259466A priority patent/AU2003259466B2/en
Priority to BR0313494-6A priority patent/BR0313494A/en
Priority to JP2004528775A priority patent/JP2006501220A/en
Priority to EP03787979A priority patent/EP1556003A2/en
Publication of WO2004016243A2 publication Critical patent/WO2004016243A2/en
Publication of WO2004016243A3 publication Critical patent/WO2004016243A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4468Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids

Abstract

Pharmaceutical compositions comprising a macromolecular pharmaceutical agent in mixed micellar form are disclosed. The mixed micelles are formed from an alkali metal alkyl sulfate, and at least three different micelle-forming compounds as described in the specification. Micelle size ranges between about l and 10 nanometers. Methods for administering the compositions are also disclosed. A preferred method for administering the present composition is through the buccal region of the mouth, which has been demonstrated to achieve peak plasma levels of the pharmaceutical agent in about thirty minutes.
PCT/IB2003/003908 1998-12-21 2003-08-14 Methods of administering and enhancing absorption of pharmaceutical agents WO2004016243A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
MXPA05001887A MXPA05001887A (en) 2002-08-16 2003-08-14 Methods of administering and enhancing absorption of pharmaceutical agents.
CA2494132A CA2494132C (en) 2002-08-16 2003-08-14 Pharmaceutical composition, metered dose dispenser containing same, and use of pharmaceutical composition and metered dose dispenser in administering pharmaceutical agent to oral membranes
AU2003259466A AU2003259466B2 (en) 1998-12-21 2003-08-14 Methods of administering and enhancing absorption of pharmaceutical agents
BR0313494-6A BR0313494A (en) 2002-08-16 2003-08-14 Methods of administration and enhancement of absorption of pharmaceutical agents
JP2004528775A JP2006501220A (en) 2002-08-16 2003-08-14 Drug administration and absorption promotion method
EP03787979A EP1556003A2 (en) 2002-08-16 2003-08-14 Methods of administering and enhancing absorption of pharmaceutical agents

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/222,240 US7087215B2 (en) 1998-12-21 2002-08-16 Methods of administering and enhancing absorption of pharmaceutical agents
US10/222,240 2002-08-16

Publications (2)

Publication Number Publication Date
WO2004016243A2 WO2004016243A2 (en) 2004-02-26
WO2004016243A3 true WO2004016243A3 (en) 2004-05-21

Family

ID=31886615

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2003/003908 WO2004016243A2 (en) 1998-12-21 2003-08-14 Methods of administering and enhancing absorption of pharmaceutical agents

Country Status (8)

Country Link
US (1) US7087215B2 (en)
EP (1) EP1556003A2 (en)
JP (1) JP2006501220A (en)
BR (1) BR0313494A (en)
CA (1) CA2494132C (en)
EC (1) ECSP055604A (en)
MX (1) MXPA05001887A (en)
WO (1) WO2004016243A2 (en)

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CA2563609C (en) * 2004-04-22 2012-11-06 Duocort Ab Pharmaceutical compositions for acute glucocorticoid therapy
TW200621794A (en) * 2004-10-06 2006-07-01 Akzo Nobel Nv Pulmonary administration of an antithrombotic compound
CA2630578C (en) * 2005-11-30 2014-04-15 Generex Pharmaceuticals Inc. Orally absorbed pharmaceutical formulation and method of administration
MX2008009522A (en) 2006-01-25 2009-01-07 Insys Therapeutics Inc Sublingual fentanyl spray.
US20080085331A1 (en) * 2006-10-06 2008-04-10 Gluskin Anna E Composition and method for raising blood glucose level
GB0621707D0 (en) * 2006-10-31 2006-12-13 Univ London Pharmacy Formulations for delivery via pressurised metered dose inhalers
US8486973B2 (en) 2007-08-02 2013-07-16 Insys Therapeutics, Inc. Sublingual fentanyl spray
US20090263476A1 (en) * 2008-04-16 2009-10-22 Jobdevairakkam Christopher N Composition of Rapid Disintegrating Direct Compression Buccal Tablet
JP5892940B2 (en) 2009-11-25 2016-03-23 アリスジェン ソシエテ アノニム Mucosal delivery composition comprising a peptide complexed with a crown compound and / or counterion
MX2012009755A (en) 2010-02-26 2012-09-12 Novo Nordisk As Stable antibody containing compositions.
US20130136733A1 (en) 2010-05-28 2013-05-30 Novo Nordisk A/S Stable Multi-Dose Compositions Comprising an Antibody and a Preservative
GB2481728B (en) * 2010-06-30 2012-05-23 Londonpharma Ltd Formulations and delivery devices for the sublingual administration of opioids
US8580853B2 (en) 2011-06-13 2013-11-12 Howard PHYKITT Analgesic composition and method of making the same

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Also Published As

Publication number Publication date
US7087215B2 (en) 2006-08-08
MXPA05001887A (en) 2005-06-17
EP1556003A2 (en) 2005-07-27
WO2004016243A2 (en) 2004-02-26
CA2494132C (en) 2015-01-20
ECSP055604A (en) 2005-04-18
BR0313494A (en) 2005-07-05
CA2494132A1 (en) 2004-02-26
US20030157029A1 (en) 2003-08-21
JP2006501220A (en) 2006-01-12

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