WO2009113090A3 - Process for preparing an oral formulation of an acid-sensitive benzimidazole drug - Google Patents

Process for preparing an oral formulation of an acid-sensitive benzimidazole drug Download PDF

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Publication number
WO2009113090A3
WO2009113090A3 PCT/IN2009/000033 IN2009000033W WO2009113090A3 WO 2009113090 A3 WO2009113090 A3 WO 2009113090A3 IN 2009000033 W IN2009000033 W IN 2009000033W WO 2009113090 A3 WO2009113090 A3 WO 2009113090A3
Authority
WO
WIPO (PCT)
Prior art keywords
drug
layer
depositing
preparing
acid
Prior art date
Application number
PCT/IN2009/000033
Other languages
French (fr)
Other versions
WO2009113090A2 (en
Inventor
Dhananjay Sahoo
Babasaheb Aware
Mavuleti Krishna Prasad
V. Satyanarayana
Ashok Rampal
Original Assignee
Alkem Laboratories Ltd.
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 Alkem Laboratories Ltd. filed Critical Alkem Laboratories Ltd.
Publication of WO2009113090A2 publication Critical patent/WO2009113090A2/en
Publication of WO2009113090A3 publication Critical patent/WO2009113090A3/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
    • A61K31/435—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
    • A61K9/48—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
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/5073—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

Abstract

The present invention relates to A process for preparing an oral formulation comprising an acid-sensitive benzimidazole drug comprising depositing a stabilizer layer, free of the said drug and comprising an alkaline material on a core made from one or more excipients; or depositing a drug layer, free of an alkaline material and comprising the said drug, on a core made from one or more excipients; depositing one or more of the said stabilizer layer(s) on the said drug layer(s); depositing one or more of the said drug layer(s) on the said stabilizer layer(s); depositing one or more sub-coating layer(s) on the core achieved and depositing an enteric coating layer on the sub-coating layer(s) achieved.
PCT/IN2009/000033 2008-01-17 2009-01-12 Process for preparing an oral formulation of an acid-sensitive benzimidazole drug WO2009113090A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN115MU2008 2008-01-17
IN115/MUM/2008 2008-01-17

Publications (2)

Publication Number Publication Date
WO2009113090A2 WO2009113090A2 (en) 2009-09-17
WO2009113090A3 true WO2009113090A3 (en) 2009-11-05

Family

ID=41065635

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2009/000033 WO2009113090A2 (en) 2008-01-17 2009-01-12 Process for preparing an oral formulation of an acid-sensitive benzimidazole drug

Country Status (1)

Country Link
WO (1) WO2009113090A2 (en)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994002140A1 (en) * 1992-07-17 1994-02-03 Astra Aktiebolag Pharmaceutical composition containing antiulcer agent
US5690960A (en) * 1993-07-09 1997-11-25 Astra Aktiebolag Pharmaceutical formulation of omeprazole
WO1998019668A1 (en) * 1996-11-06 1998-05-14 Sharmatek, Inc. Delayed delivery system for acid-sensitive drugs
US20050214371A1 (en) * 2004-03-03 2005-09-29 Simona Di Capua Stable pharmaceutical composition comprising an acid labile drug
WO2006011159A2 (en) * 2004-06-21 2006-02-02 Torrent Pharmaceuticals Limited Stabilized pharmaceutical composition containing rabeprazole sodium with improved bioavailability
WO2007075980A2 (en) * 2005-12-20 2007-07-05 Teva Pharmaceutical Industries Ltd. Lansoprazole orally disintegrating tablets

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994002140A1 (en) * 1992-07-17 1994-02-03 Astra Aktiebolag Pharmaceutical composition containing antiulcer agent
US5690960A (en) * 1993-07-09 1997-11-25 Astra Aktiebolag Pharmaceutical formulation of omeprazole
WO1998019668A1 (en) * 1996-11-06 1998-05-14 Sharmatek, Inc. Delayed delivery system for acid-sensitive drugs
US20050214371A1 (en) * 2004-03-03 2005-09-29 Simona Di Capua Stable pharmaceutical composition comprising an acid labile drug
WO2006011159A2 (en) * 2004-06-21 2006-02-02 Torrent Pharmaceuticals Limited Stabilized pharmaceutical composition containing rabeprazole sodium with improved bioavailability
WO2007075980A2 (en) * 2005-12-20 2007-07-05 Teva Pharmaceutical Industries Ltd. Lansoprazole orally disintegrating tablets

Also Published As

Publication number Publication date
WO2009113090A2 (en) 2009-09-17

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