WO2005009410A3 - Pharmaceutical compositions having a swellable coating - Google Patents

Pharmaceutical compositions having a swellable coating Download PDF

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Publication number
WO2005009410A3
WO2005009410A3 PCT/US2004/022910 US2004022910W WO2005009410A3 WO 2005009410 A3 WO2005009410 A3 WO 2005009410A3 US 2004022910 W US2004022910 W US 2004022910W WO 2005009410 A3 WO2005009410 A3 WO 2005009410A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical compositions
swellable coating
swellable
coating
core
Prior art date
Application number
PCT/US2004/022910
Other languages
French (fr)
Other versions
WO2005009410A2 (en
Inventor
Irukulla Srinivas
Akhilesh Ashok Dixit
Pallempalli Venkata Siva Reddy
Billa Praveen Reddy
Mailatur Sivaraman Mohan
Kodipyaka Ravinder
Vijay Nasare
Edward D Pergament
Original Assignee
Reddys Lab Inc Dr
Reddys Lab Ltd Dr
Irukulla Srinivas
Akhilesh Ashok Dixit
Pallempalli Venkata Siva Reddy
Billa Praveen Reddy
Mailatur Sivaraman Mohan
Kodipyaka Ravinder
Vijay Nasare
Edward D Pergament
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
Priority to NZ544608A priority Critical patent/NZ544608A/en
Priority to JP2006520372A priority patent/JP2007524646A/en
Priority to MXPA06000577A priority patent/MXPA06000577A/en
Priority to EP04778421A priority patent/EP1651193A2/en
Priority to BRPI0412697-1A priority patent/BRPI0412697A/en
Priority to CA002532310A priority patent/CA2532310A1/en
Application filed by Reddys Lab Inc Dr, Reddys Lab Ltd Dr, Irukulla Srinivas, Akhilesh Ashok Dixit, Pallempalli Venkata Siva Reddy, Billa Praveen Reddy, Mailatur Sivaraman Mohan, Kodipyaka Ravinder, Vijay Nasare, Edward D Pergament filed Critical Reddys Lab Inc Dr
Priority to AU2004259226A priority patent/AU2004259226B2/en
Publication of WO2005009410A2 publication Critical patent/WO2005009410A2/en
Publication of WO2005009410A3 publication Critical patent/WO2005009410A3/en
Priority to IL173053A priority patent/IL173053A0/en
Priority to HR20060016A priority patent/HRP20060016A2/en
Priority to NO20060786A priority patent/NO20060786L/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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • 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
    • 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
    • A61K9/28—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
    • 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
    • A61K9/20—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
    • A61K9/2833—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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2873—Proteins, e.g. gelatin
    • 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
    • A61K9/5021—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
    • 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
    • A61K9/5052—Proteins, e.g. albumin

Landscapes

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

Abstract

A pharmaceutical dosage form containing a pharmaceutical active that is not stable in the presence of acid comprises a core containing the active and a disintegrant, a swellable coating surrounding the core, and an enteric coating surrounding the swellable coating.
PCT/US2004/022910 2003-07-17 2004-07-16 Pharmaceutical compositions having a swellable coating WO2005009410A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
JP2006520372A JP2007524646A (en) 2003-07-17 2004-07-16 Pharmaceutical composition having a swellable coating
MXPA06000577A MXPA06000577A (en) 2003-07-17 2004-07-16 Pharmaceutical compositions having a swellable coating.
EP04778421A EP1651193A2 (en) 2003-07-17 2004-07-16 Pharmaceutical compositions having a swellable coating
BRPI0412697-1A BRPI0412697A (en) 2003-07-17 2004-07-16 pharmaceutical compositions having an expandable coating
CA002532310A CA2532310A1 (en) 2003-07-17 2004-07-16 Pharmaceutical compositions having a swellable coating
NZ544608A NZ544608A (en) 2003-07-17 2004-07-16 Pharmaceutical compositions having a swellable coating comprising prolamin
AU2004259226A AU2004259226B2 (en) 2003-07-17 2004-07-16 Pharmaceutical compositions having a swellable coating
IL173053A IL173053A0 (en) 2003-07-17 2006-01-10 Pharmaceutical compositions having a swellable coating
HR20060016A HRP20060016A2 (en) 2003-07-17 2006-01-12 Pharmaceutical compositions having a swellable coating
NO20060786A NO20060786L (en) 2003-07-17 2006-02-17 Pharmaceutical preparations with swelling coating

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
IN580/CHE/03 2003-07-17
IN580CH2003 2003-07-17
IN1064CH2003 2003-12-30
IN1064/CHE/03 2003-12-30
US56370704P 2004-04-20 2004-04-20
US60/563,707 2004-04-20

Publications (2)

Publication Number Publication Date
WO2005009410A2 WO2005009410A2 (en) 2005-02-03
WO2005009410A3 true WO2005009410A3 (en) 2005-05-19

Family

ID=34108415

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/022910 WO2005009410A2 (en) 2003-07-17 2004-07-16 Pharmaceutical compositions having a swellable coating

Country Status (12)

Country Link
EP (1) EP1651193A2 (en)
JP (1) JP2007524646A (en)
KR (1) KR20060065632A (en)
AU (1) AU2004259226B2 (en)
BR (1) BRPI0412697A (en)
CA (1) CA2532310A1 (en)
HR (1) HRP20060016A2 (en)
IL (1) IL173053A0 (en)
MX (1) MXPA06000577A (en)
NO (1) NO20060786L (en)
NZ (1) NZ544608A (en)
WO (1) WO2005009410A2 (en)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050147663A1 (en) * 2003-07-17 2005-07-07 Mohan Mailatur S. Method of treatment for improved bioavailability
FR2878159B1 (en) * 2004-11-24 2008-10-17 Flamel Technologies Sa ORAL MEDICATION WITH MODIFIED RELEASE OF AT LEAST ONE ACTIVE PRINCIPLE IN MULTIMICROCAPSULAR FORM
CA2608444A1 (en) * 2005-05-13 2007-03-15 Combino Pharm, S.L. Formulations containing pantoprazole free acid and its salts
EA015535B1 (en) * 2005-07-11 2011-08-30 Никомед Данмарк Апс Benzimidazole formulation
EP1973532A1 (en) 2006-01-16 2008-10-01 Jubilant Organosys Limited Stable pharmaceutical formulation of an acid labile compound and process for preparing the same
AR070863A1 (en) 2008-03-11 2010-05-12 Takeda Pharmaceutical SOLID PREPARATION OF ORAL DISINTEGRATION AND METHOD TO SUPPRESS THE RUPTURE OF FINE GRANULES DURING PRODUCTION OF A TABLET
EP2319504A1 (en) * 2009-11-07 2011-05-11 Laboratorios Del. Dr. Esteve, S.A. Pharmaceutical solid dosage form
US20130216617A1 (en) * 2010-06-29 2013-08-22 Cadila Healthcare Limited Pharmaceutical compositions of (r)-lansoprazole
EP3378472A1 (en) 2012-08-09 2018-09-26 Dynamis Therapeutics, Inc. Combinations of meglumine
JP6856326B2 (en) * 2016-07-15 2021-04-07 富士化学工業株式会社 Intestinal release particle composition
KR101907116B1 (en) 2016-07-25 2018-10-11 한미약품 주식회사 Pharmaceutical Formulation with Improved pH-Dependent Drug Release Properties, Comprising Esomeprazole, or Pharmaceutically Acceptable Salt thereof
KR101877350B1 (en) * 2016-10-28 2018-08-09 한미약품 주식회사 Combined capsules containing esomeprazole and a process for the preparation thereof
JP6336651B1 (en) * 2016-12-15 2018-06-06 大原薬品工業株式会社 Tablets containing esomeprazole salts with improved chemical stability
EA202090166A1 (en) * 2017-09-28 2020-06-29 Ханми Фарм. Ко., Лтд. PHARMACEUTICAL COMPOSITION, INCLUDING MULTI-COMPONENT SPHEROID FORM TABLET CONTAINING ESOMEPRAZOLE AND ITS PHARMACEUTICAL ACCEPTABLE SALT, AND METHOD FOR PREPARATION
JP7026510B2 (en) * 2018-01-11 2022-02-28 株式会社Ｓｃｒｅｅｎホールディングス Printed matter, readers, reading methods, printing methods, and printing devices
CN111728124A (en) * 2020-07-08 2020-10-02 江苏宏远药业有限公司 Food-grade white pigment with high safety

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US341338A (en) * 1886-05-04 Blind
DD273197A5 (en) * 1986-04-30 1989-11-08 �����@������������������k�� PROCESS FOR PREPARING AN ORAL PHARMACEUTICAL PREPARATION CONTAINING OMEPRAZOLE
US5882715A (en) * 1995-06-20 1999-03-16 Pharma-Vinci A/S Method of preparing an oral preparation provided on the outer side with an enteric coating, as well as an oral preparation obtained by the method
US5997903A (en) * 1991-06-17 1999-12-07 Byk Gulden Lomberg Chemische Fabrik Gmbh Oral-administration forms of a medicament containing pantoprazol
EP1092434A1 (en) * 1995-09-21 2001-04-18 Pharma Pass LLC Novel composition containing lansoprazole and process for its preparation
US6479075B1 (en) * 1997-10-06 2002-11-12 Isa Odidi Pharmaceutical formulations for acid labile substances
US6500459B1 (en) * 1999-07-21 2002-12-31 Harinderpal Chhabra Controlled onset and sustained release dosage forms and the preparation thereof
US6635206B1 (en) * 2000-05-03 2003-10-21 The Board Of Trustees Of The University Of Illinois Method of manufacturing improved corn zein resin films, sheets, and articles

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6368628B1 (en) * 2000-05-26 2002-04-09 Pharma Pass Llc Sustained release pharmaceutical composition free of food effect
PE20050150A1 (en) * 2003-05-08 2005-03-22 Altana Pharma Ag A DOSAGE FORM CONTAINING (S) -PANTOPRAZOLE AS AN ACTIVE INGREDIENT

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US341338A (en) * 1886-05-04 Blind
DD273197A5 (en) * 1986-04-30 1989-11-08 �����@������������������k�� PROCESS FOR PREPARING AN ORAL PHARMACEUTICAL PREPARATION CONTAINING OMEPRAZOLE
US5997903A (en) * 1991-06-17 1999-12-07 Byk Gulden Lomberg Chemische Fabrik Gmbh Oral-administration forms of a medicament containing pantoprazol
US5882715A (en) * 1995-06-20 1999-03-16 Pharma-Vinci A/S Method of preparing an oral preparation provided on the outer side with an enteric coating, as well as an oral preparation obtained by the method
EP1092434A1 (en) * 1995-09-21 2001-04-18 Pharma Pass LLC Novel composition containing lansoprazole and process for its preparation
EP1308159A1 (en) * 1995-09-21 2003-05-07 Pharma Pass II LLC Pharmaceutical composition containing an acid-labile omeprazole and process for its preparation
US6479075B1 (en) * 1997-10-06 2002-11-12 Isa Odidi Pharmaceutical formulations for acid labile substances
US6500459B1 (en) * 1999-07-21 2002-12-31 Harinderpal Chhabra Controlled onset and sustained release dosage forms and the preparation thereof
US6635206B1 (en) * 2000-05-03 2003-10-21 The Board Of Trustees Of The University Of Illinois Method of manufacturing improved corn zein resin films, sheets, and articles

Also Published As

Publication number Publication date
NO20060786L (en) 2006-04-10
CA2532310A1 (en) 2005-02-03
NZ544608A (en) 2008-07-31
KR20060065632A (en) 2006-06-14
HRP20060016A2 (en) 2006-02-28
AU2004259226A1 (en) 2005-02-03
BRPI0412697A (en) 2006-10-03
AU2004259226B2 (en) 2009-09-24
EP1651193A2 (en) 2006-05-03
MXPA06000577A (en) 2006-07-03
IL173053A0 (en) 2006-06-11
JP2007524646A (en) 2007-08-30
WO2005009410A2 (en) 2005-02-03

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