WO2008117154A3 - Stable pharmaceutical compositions, preferably tablets, of hmg-coa reductase inhibitor and process for preparation thereof - Google Patents

Stable pharmaceutical compositions, preferably tablets, of hmg-coa reductase inhibitor and process for preparation thereof Download PDF

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Publication number
WO2008117154A3
WO2008117154A3 PCT/IB2008/000678 IB2008000678W WO2008117154A3 WO 2008117154 A3 WO2008117154 A3 WO 2008117154A3 IB 2008000678 W IB2008000678 W IB 2008000678W WO 2008117154 A3 WO2008117154 A3 WO 2008117154A3
Authority
WO
WIPO (PCT)
Prior art keywords
hmg
pharmaceutical compositions
coa reductase
reductase inhibitor
preparation
Prior art date
Application number
PCT/IB2008/000678
Other languages
French (fr)
Other versions
WO2008117154A2 (en
Inventor
Navin Ishwarlal Vaya
Monesh Pramod Dixit
Suryakant Vamanrao Navale
Original Assignee
Torrent Pharmaceuticals Limited
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 Torrent Pharmaceuticals Limited filed Critical Torrent Pharmaceuticals Limited
Publication of WO2008117154A2 publication Critical patent/WO2008117154A2/en
Publication of WO2008117154A3 publication Critical patent/WO2008117154A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars

Abstract

The present invention relates to stable pharmaceutical compositions (preferably a tablet) of HMG-CoA reductase inhibitor and process for preparation thereof. More particularly, it relates to pharmaceutical compositions of HMG-CoA reductase inhibitor comprising polyethylene glycol (PEG), one or more alkalizing agents, and pharmaceutically acceptable excipients; and process for preparing such compositions.
PCT/IB2008/000678 2007-03-26 2008-03-24 Stable pharmaceutical compositions of hmg-coa reductase inhibitor and process for preparation thereof WO2008117154A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN547MU2007 2007-03-26
IN547/MUM/2007 2007-03-26

Publications (2)

Publication Number Publication Date
WO2008117154A2 WO2008117154A2 (en) 2008-10-02
WO2008117154A3 true WO2008117154A3 (en) 2009-10-22

Family

ID=39789097

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2008/000678 WO2008117154A2 (en) 2007-03-26 2008-03-24 Stable pharmaceutical compositions of hmg-coa reductase inhibitor and process for preparation thereof

Country Status (1)

Country Link
WO (1) WO2008117154A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011001450A1 (en) * 2009-06-29 2011-01-06 Alkem Laboratories Ltd. Stable oral pharmaceutical composition comprising atorvastatin

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5686104A (en) * 1993-01-19 1997-11-11 Warner-Lambert Company Stable oral CI-981 formulation and process of preparing same
US20040180087A1 (en) * 2001-06-21 2004-09-16 Boyong Li Stable controlled release pharmaceutical compositions containing pravastatin
WO2006037347A1 (en) * 2004-10-01 2006-04-13 Lifecycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and atorvastatin
WO2006059224A1 (en) * 2004-12-02 2006-06-08 Warner-Lambert Company Llc Pharmaceutical compositions of amorphous atorvastatin and process for preparing same
WO2006084474A2 (en) * 2005-02-10 2006-08-17 Lifecycle Pharma A/S A stable pharmaceutical composition comprising a fixed dose combination of fenofibrate and an hmg-coa reductase inhibitor

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5686104A (en) * 1993-01-19 1997-11-11 Warner-Lambert Company Stable oral CI-981 formulation and process of preparing same
US20040180087A1 (en) * 2001-06-21 2004-09-16 Boyong Li Stable controlled release pharmaceutical compositions containing pravastatin
WO2006037347A1 (en) * 2004-10-01 2006-04-13 Lifecycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and atorvastatin
WO2006059224A1 (en) * 2004-12-02 2006-06-08 Warner-Lambert Company Llc Pharmaceutical compositions of amorphous atorvastatin and process for preparing same
WO2006084474A2 (en) * 2005-02-10 2006-08-17 Lifecycle Pharma A/S A stable pharmaceutical composition comprising a fixed dose combination of fenofibrate and an hmg-coa reductase inhibitor

Also Published As

Publication number Publication date
WO2008117154A2 (en) 2008-10-02

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