WO2006011159A3 - Stabilized pharmaceutical composition containing rabeprazole sodium with improved bioavailability - Google Patents

Stabilized pharmaceutical composition containing rabeprazole sodium with improved bioavailability Download PDF

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Publication number
WO2006011159A3
WO2006011159A3 PCT/IN2005/000207 IN2005000207W WO2006011159A3 WO 2006011159 A3 WO2006011159 A3 WO 2006011159A3 IN 2005000207 W IN2005000207 W IN 2005000207W WO 2006011159 A3 WO2006011159 A3 WO 2006011159A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
composition containing
rabeprazole sodium
improved bioavailability
stabilized pharmaceutical
Prior art date
Application number
PCT/IN2005/000207
Other languages
French (fr)
Other versions
WO2006011159A2 (en
Inventor
Sheth Rakesh
Gupta Vinodkumar
Chaubey Sushil
Kulkarni Gopal
Mehta Tushar
Original Assignee
Torrent Pharmaceuticals 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 Torrent Pharmaceuticals Ltd filed Critical Torrent Pharmaceuticals Ltd
Publication of WO2006011159A2 publication Critical patent/WO2006011159A2/en
Publication of WO2006011159A3 publication Critical patent/WO2006011159A3/en

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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
    • A61K9/20—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • 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
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/48—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention relates to stable pharmaceutical composition of rabeprazole sodium in a form of enteric coated pellets, either alone or in combination with one or more prokinetic agent, preferably mosapride in a form of sustained release tablets, in a single unit dosage form, which provides enhanced bioavailability of rabeprazole. Present invention also discloses process for preparation of said pharmaceutical formulation.
PCT/IN2005/000207 2004-06-21 2005-06-17 Stabilized pharmaceutical composition containing rabeprazole sodium with improved bioavailability WO2006011159A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN674/MUM/2004 2004-06-21
IN674MU2004 2004-06-21

Publications (2)

Publication Number Publication Date
WO2006011159A2 WO2006011159A2 (en) 2006-02-02
WO2006011159A3 true WO2006011159A3 (en) 2006-07-06

Family

ID=35786587

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2005/000207 WO2006011159A2 (en) 2004-06-21 2005-06-17 Stabilized pharmaceutical composition containing rabeprazole sodium with improved bioavailability

Country Status (1)

Country Link
WO (1) WO2006011159A2 (en)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2660648A1 (en) * 2006-06-15 2007-12-21 Novartis Ag Compositions and methods for treating diseases
US20100105738A1 (en) * 2006-10-06 2010-04-29 Mitsuru Mizuno Extended release formulations of a proton pump inhibitor
ITMI20062290A1 (en) * 2006-11-28 2008-05-29 Monteres S R L TABLETS STABLE WITH STORAGE BASED ON BENZIMIDAZOLE DERIVATIVES COATED WITH GASTRO-RESISTANT FILM
WO2008131259A1 (en) 2007-04-19 2008-10-30 Concert Pharmaceuticals Inc. Deuterated morpholinyl compounds
CN101292977B (en) * 2007-04-28 2010-12-08 天津药物研究院 Pharmaceutical combination with stable strontium ranelate and its preparations
WO2009113090A2 (en) * 2008-01-17 2009-09-17 Alkem Laboratories Ltd. Process for preparing an oral formulation of an acid-sensitive benzimidazole drug
EA024112B1 (en) * 2008-11-28 2016-08-31 КРКА, д.д., НОВО МЕСТО Solid pharmaceutical composition of desloratadine comprising a stabilizing agent
WO2011107855A2 (en) * 2010-03-04 2011-09-09 Torrent Pharmaceuticals Limited Sustained release oral liquid suspension dosage form
KR101246553B1 (en) 2010-04-09 2013-03-26 현대약품 주식회사 Sustained-release composition and process for producing the same
EP2563341A1 (en) * 2010-04-26 2013-03-06 Mahmut Bilgic Pharmaceutical compositions inducing synergistic effect
CN103421877B (en) * 2012-05-15 2014-09-17 齐鲁制药有限公司 Sterility test method for antibiotic sustained-release pharmaceutical preparation
US20170042806A1 (en) 2015-04-29 2017-02-16 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
WO2016209061A1 (en) * 2015-06-26 2016-12-29 한국유나이티드제약 주식회사 Composite preparation of mosapride and rabeprazole
KR101882946B1 (en) * 2015-06-26 2018-08-24 한국유나이티드제약 주식회사 Combination formulation comprising mosapride and rabeprazole
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
CN108969487A (en) * 2017-06-02 2018-12-11 浙江普利药业有限公司 Rabeprazole enteric dry suspensoid agent and preparation method thereof
CN107456444B (en) * 2017-08-14 2021-07-02 南京百思福医药科技有限公司 Mosapride sustained-release dry suspension and preparation method thereof
CN107744509B (en) * 2017-10-24 2020-06-12 浙江昂利康制药股份有限公司 Mosapride citrate tablet and preparation method thereof
KR102034694B1 (en) * 2017-12-14 2019-10-22 한국유나이티드제약 주식회사 Cored tablet comprising mosapride and rabeprazole
TR201723047A2 (en) * 2017-12-29 2019-07-22 Neutec Ar Ge Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical composition comprising a proton pump inhibitor and prukaloprid.
CN109444301A (en) * 2018-12-18 2019-03-08 江苏省中医院 A kind of method of general reed Ka Bili concentration in measurement blood plasma
CN109646413B (en) * 2018-12-28 2021-06-15 正大制药（青岛）有限公司 Sodium magnesium olmesate tablet
KR102334701B1 (en) * 2019-11-29 2021-12-06 한국유나이티드제약 주식회사 Cored Tablet Comprising Proton Pump Inhibitor and Mosapride
KR102334699B1 (en) * 2019-12-10 2021-12-06 한국유나이티드제약 주식회사 Cored Tablet Comprising Proton Pump Inhibitor and Mosapride
KR102497608B1 (en) * 2020-04-27 2023-02-08 한국유나이티드제약 주식회사 Fixed Dose Combination Comprising Mosapride and Proton Pump Inhibitor
CN112843002B (en) * 2021-04-06 2022-12-13 南京纽邦生物科技有限公司 Gamma-aminobutyric acid oral sustained-release dry suspension and preparation method thereof
CN115177594B (en) * 2022-07-04 2023-08-15 武汉大学中南医院 Acetinib pharmaceutical preparation and preparation method thereof

Citations (4)

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WO2002026210A2 (en) * 2000-09-29 2002-04-04 Geneva Pharmaceuticals Inc. Proton pump inhibitor formulation
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Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
US20020045646A1 (en) * 1996-01-04 2002-04-18 Phillips Jeffrey O. Novel substituted benzimidazole dosage forms and method of using same
WO1998052564A1 (en) * 1997-05-23 1998-11-26 Cipla Limited Benzimidazole pharmaceutical composition and process of preparation
US6362202B1 (en) * 1999-03-02 2002-03-26 Sepracor Inc. Methods and compositions using (−) norcisapride in combination with proton pump inhibitors or H2 receptor antagonists
WO2002026210A2 (en) * 2000-09-29 2002-04-04 Geneva Pharmaceuticals Inc. Proton pump inhibitor formulation

Non-Patent Citations (2)

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Title
LEW E A: "Review article: pharmacokinetic concerns in the selection of anti-ulcer therapy.", ALIMENTARY PHARMACOLOGY & THERAPEUTICS. OCT 1999, vol. 13 Suppl 5, October 1999 (1999-10-01), pages 11 - 16, XP002375912, ISSN: 0269-2813 *
POHLE T ET AL: "Results of short- and long-term medical treatment of gastroesophageal reflux disease (GERD)", LANGENBECK'S ARCHIVES OF SURGERY, vol. 385, no. 5, August 2000 (2000-08-01), pages 317 - 323, XP002375911, ISSN: 1435-2443 *

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Publication number Publication date
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