WO2010122583A3 - Oral pharmaceutical compositions of acid labile substances - Google Patents

Oral pharmaceutical compositions of acid labile substances Download PDF

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Publication number
WO2010122583A3
WO2010122583A3 PCT/IN2010/000261 IN2010000261W WO2010122583A3 WO 2010122583 A3 WO2010122583 A3 WO 2010122583A3 IN 2010000261 W IN2010000261 W IN 2010000261W WO 2010122583 A3 WO2010122583 A3 WO 2010122583A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical compositions
acid labile
oral pharmaceutical
proton pump
labile substances
Prior art date
Application number
PCT/IN2010/000261
Other languages
French (fr)
Other versions
WO2010122583A2 (en
Inventor
Pratibha Sudhir Pilgaonkar
Maharukh Tehmasp Rustomjee
Anilkumar Surendrakumar Gandhi
Atul A. Kelkar
Original Assignee
Rubicon Research Private 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 Rubicon Research Private Limited filed Critical Rubicon Research Private Limited
Publication of WO2010122583A2 publication Critical patent/WO2010122583A2/en
Publication of WO2010122583A3 publication Critical patent/WO2010122583A3/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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—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
    • A61K9/2072—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
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/288—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61K9/50—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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/5063—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • 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 oral pharmaceutical compositions of acid labile substances, particularly proton pump inhibitors. These pharmaceutical compositions comprise one or more active units with each active unit comprising a core of a proton pump inhibitor, an intermediate layer of at least one lipophilic substance and an enteric layer. The invention also relates to a method for preparing one or more active units wherein the intermediate layer of lipophilic substances is applied to the core of a proton pump inhibitor in an aqueous emulsified form.
PCT/IN2010/000261 2009-04-24 2010-04-26 Oral pharmaceutical compositions of acid labile substances WO2010122583A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1104/MUM/2009 2009-04-24
IN1104MU2009 2009-04-24

Publications (2)

Publication Number Publication Date
WO2010122583A2 WO2010122583A2 (en) 2010-10-28
WO2010122583A3 true WO2010122583A3 (en) 2011-04-28

Family

ID=42664650

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2010/000261 WO2010122583A2 (en) 2009-04-24 2010-04-26 Oral pharmaceutical compositions of acid labile substances

Country Status (1)

Country Link
WO (1) WO2010122583A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104274423A (en) * 2013-07-02 2015-01-14 杭州赛利药物研究所有限公司 Rabeprazole enteric capsule and preparation method thereof

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102552159B (en) * 2010-12-22 2013-07-17 南京长澳医药科技有限公司 Rabeprazole sodium enteric-coated micro-pellet and preparation method thereof
KR101739820B1 (en) * 2012-03-28 2017-05-25 주식회사유한양행 Pharmaceutical composition in form of non-aqueous liquid comprising revaprazan or its salt
CN105377303B (en) * 2013-07-19 2019-04-05 株式会社三和化学研究所 Oral disnitegration tablet
CA2933202C (en) 2014-01-21 2022-05-31 Jason Teckoe Immediate release film coatings containing medium chain glycerides and substrates coated therewith
CN104352481A (en) * 2014-11-06 2015-02-18 成都医路康医学技术服务有限公司 Preparation method of esomeprazole magnesium slow-release enteric micro capsule
EP3288556A4 (en) * 2015-04-29 2018-09-19 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
AR105111A1 (en) * 2015-06-26 2017-09-06 Advanced Bionutrition Corp COMPOSITION FOR ADMINISTRATION OF ACTIVE AGENTS TO AN ANIMAL
CN106831709B (en) * 2015-12-03 2019-03-12 中国科学院苏州纳米技术与纳米仿生研究所 Dexlansoprazole-nicotimine eutectic and its application
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
IT201700021879A1 (en) * 2017-02-27 2018-08-27 Bioscreen Tech S R L RELEASED COMPOSITION OF PHYSIOLOGICALLY ACTIVE SUBSTANCES AND PROCESS FOR ITS PREPARATION
IT201700021852A1 (en) * 2017-02-27 2018-08-27 Bioscreen Tech S R L RELEASED COMPOSITION OF PHYSIOLOGICALLY ACTIVE SUBSTANCES AND PROCESS FOR ITS PREPARATION
GB201804621D0 (en) * 2018-03-22 2018-05-09 Bcm Specials Ltd Formulation

Citations (9)

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Publication number Priority date Publication date Assignee Title
JPS5920219A (en) * 1982-07-26 1984-02-01 Shin Etsu Chem Co Ltd Preparation of enteric coated pharmaceutical
US20010053387A1 (en) * 1997-05-23 2001-12-20 Hamied Yusuf Khwaja Benzimidazole pharmaceutical composition and process of prepatation
US20050042277A1 (en) * 2003-07-17 2005-02-24 Irukulla Srinivas Pharmaceutical compositions having a swellable coating
US20060018964A1 (en) * 2004-07-26 2006-01-26 Astrazeneca Ab Pharmaceutical formulation and process for its preparation
WO2006111853A2 (en) * 2005-04-18 2006-10-26 Aurobindo Pharma Limited Stable solid dosage forms of acid labile drug
US20070122470A1 (en) * 2005-11-30 2007-05-31 Dick Johansson New Combination Dosage Form
US20080096979A1 (en) * 2004-11-08 2008-04-24 Rubicon Research Pvt. Ltd. Aqueous Pharmaceutical Coating
WO2008065107A1 (en) * 2006-11-28 2008-06-05 Monteresearch S.R.L. Storage stable tablets based on benzimidazole derivatives coated with a gastro-resistant film
US20080317841A1 (en) * 2004-12-15 2008-12-25 Pascal Grenier Pharmaceutical Composition Containing Coated, Floating Particles

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JPS6150978A (en) 1984-08-16 1986-03-13 Takeda Chem Ind Ltd Pyridine derivative and preparation thereof
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FR2692146B1 (en) 1992-06-16 1995-06-02 Ethypharm Sa Stable compositions of gastro-protected omeprazole microgranules and process for obtaining them.
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JPS5920219A (en) * 1982-07-26 1984-02-01 Shin Etsu Chem Co Ltd Preparation of enteric coated pharmaceutical
US20010053387A1 (en) * 1997-05-23 2001-12-20 Hamied Yusuf Khwaja Benzimidazole pharmaceutical composition and process of prepatation
US20050042277A1 (en) * 2003-07-17 2005-02-24 Irukulla Srinivas Pharmaceutical compositions having a swellable coating
US20060018964A1 (en) * 2004-07-26 2006-01-26 Astrazeneca Ab Pharmaceutical formulation and process for its preparation
US20080096979A1 (en) * 2004-11-08 2008-04-24 Rubicon Research Pvt. Ltd. Aqueous Pharmaceutical Coating
US20080317841A1 (en) * 2004-12-15 2008-12-25 Pascal Grenier Pharmaceutical Composition Containing Coated, Floating Particles
WO2006111853A2 (en) * 2005-04-18 2006-10-26 Aurobindo Pharma Limited Stable solid dosage forms of acid labile drug
US20070122470A1 (en) * 2005-11-30 2007-05-31 Dick Johansson New Combination Dosage Form
WO2008065107A1 (en) * 2006-11-28 2008-06-05 Monteresearch S.R.L. Storage stable tablets based on benzimidazole derivatives coated with a gastro-resistant film

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104274423A (en) * 2013-07-02 2015-01-14 杭州赛利药物研究所有限公司 Rabeprazole enteric capsule and preparation method thereof
CN104274423B (en) * 2013-07-02 2018-08-17 杭州赛利药物研究所有限公司 Rabeprazole capsulae enterosolubilis and preparation method thereof

Also Published As

Publication number Publication date
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