WO2004066982A8 - Stable oral benzimidazole compositions and processes for their preparation - Google Patents

Stable oral benzimidazole compositions and processes for their preparation

Info

Publication number
WO2004066982A8
WO2004066982A8 PCT/IB2004/000235 IB2004000235W WO2004066982A8 WO 2004066982 A8 WO2004066982 A8 WO 2004066982A8 IB 2004000235 W IB2004000235 W IB 2004000235W WO 2004066982 A8 WO2004066982 A8 WO 2004066982A8
Authority
WO
WIPO (PCT)
Prior art keywords
core
stable oral
processes
preparation
separating layer
Prior art date
Application number
PCT/IB2004/000235
Other languages
French (fr)
Other versions
WO2004066982A1 (en
Inventor
Kamal Mehta
Rajeev Shanker Mathur
Sanjeev Kumar Sethi
Rajiv Malik
Original Assignee
Ranbaxy Lab Ltd
Kamal Mehta
Rajeev Shanker Mathur
Sanjeev Kumar Sethi
Rajiv Malik
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 Ranbaxy Lab Ltd, Kamal Mehta, Rajeev Shanker Mathur, Sanjeev Kumar Sethi, Rajiv Malik filed Critical Ranbaxy Lab Ltd
Priority to EP04707268A priority Critical patent/EP1594479A1/en
Publication of WO2004066982A1 publication Critical patent/WO2004066982A1/en
Publication of WO2004066982A8 publication Critical patent/WO2004066982A8/en

Links

Classifications

    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release

Abstract

The present invention relates to stable oral benzimidazole compositions and processes for their preparation. The stable oral benzimidazole pharmaceutical composition includes a core, a separating layer, and an enteric coating. The core includes a benzimidazole compound, a substantially water-soluble material and, optionally, one or more pharmaceutically acceptable excipients, wherein the core is not alkaline. The separating layer surrounds the core and includes a substantially water-soluble material and, optionally, one or more pharmaceutically acceptable excipients. The enteric coating surrounds the separating layer. At least one of the core and the separating layer includes the substantially water-soluble material without any pharmaceutically acceptable excipients.
PCT/IB2004/000235 2003-01-31 2004-02-02 Stable oral benzimidazole compositions and processes for their preparation WO2004066982A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP04707268A EP1594479A1 (en) 2003-01-31 2004-02-02 Stable oral benzimidazole compositions and processes for their preparation

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN80DE2003 2003-01-31
IN80/DEL/2003 2003-01-31
IN728DE2003 2003-05-27
IN728/DEL/2003 2003-05-27

Publications (2)

Publication Number Publication Date
WO2004066982A1 WO2004066982A1 (en) 2004-08-12
WO2004066982A8 true WO2004066982A8 (en) 2005-08-25

Family

ID=32827126

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2004/000235 WO2004066982A1 (en) 2003-01-31 2004-02-02 Stable oral benzimidazole compositions and processes for their preparation

Country Status (2)

Country Link
EP (1) EP1594479A1 (en)
WO (1) WO2004066982A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI372066B (en) 2003-10-01 2012-09-11 Wyeth Corp Pantoprazole multiparticulate formulations
US20050281876A1 (en) * 2004-06-18 2005-12-22 Shun-Por Li Solid dosage form for acid-labile active ingredient
EP1830823A2 (en) * 2004-12-23 2007-09-12 Ranbaxy Laboratories Limited Stable oral benzimidazole compositions and process of preparation thereof
EP1785135A1 (en) * 2005-11-10 2007-05-16 Laboratorios Del Dr. Esteve, S.A. New stabilized galenic formulations comprising lansoprazole and their preparation
JP2009519334A (en) * 2005-12-20 2009-05-14 テバ ファーマシューティカル インダストリーズ リミティド Lansoprazole Orally Disintegrating Tablet
US20100105738A1 (en) * 2006-10-06 2010-04-29 Mitsuru Mizuno Extended release formulations of a proton pump inhibitor
US8911787B2 (en) 2008-02-26 2014-12-16 Ranbaxy Laboratories Limited Stable oral benzimidazole compositions and process of preparation thereof
DE102008047910A1 (en) 2008-09-19 2010-03-25 Molkerei Meggle Wasserburg Gmbh & Co. Kg Tabletting excipient based on lactose and cellulose

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2692146B1 (en) * 1992-06-16 1995-06-02 Ethypharm Sa Stable compositions of gastro-protected omeprazole microgranules and process for obtaining them.
SE9402431D0 (en) * 1994-07-08 1994-07-08 Astra Ab New tablet formulation
ES2094694B1 (en) * 1995-02-01 1997-12-16 Esteve Quimica Sa NEW PHARMACEUTICALLY STABLE FORMULATION OF A COMPOUND OF BENZMIDAZOLE AND ITS PROCESS OF OBTAINING.
PT859612E (en) * 1995-09-21 2003-10-31 Pharma Pass Ii Llc PHARMACEUTICAL COMPOSITION CONTAINING AN ACID-LABIL OMEPRAZOLE AND A PROCESS FOR THEIR PREPARATION
IL130602A0 (en) * 1999-06-22 2000-06-01 Dexcel Ltd Stable benzimidazole formulation
ATE297194T1 (en) * 1999-12-16 2005-06-15 Medinfar Produtos Farmaceutico NEW STABLE MULTI-UNIT SUBSTITUTED PHARMACEUTICAL PREPARATIONS CONTAINING BENZIMIDAZOLES
WO2002032427A1 (en) * 2000-10-20 2002-04-25 Galephar M/F Stable oral formulation containing benzimidazole derivative
WO2003103638A1 (en) * 2002-06-07 2003-12-18 Geneva Pharmaceuticals, Inc. Stabilized pharmaceutical compositions containing benzimidazole compounds

Also Published As

Publication number Publication date
WO2004066982A1 (en) 2004-08-12
EP1594479A1 (en) 2005-11-16

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