WO2006076338A3 - Dosage form for treating gastrointestinal disorders - Google Patents

Dosage form for treating gastrointestinal disorders Download PDF

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Publication number
WO2006076338A3
WO2006076338A3 PCT/US2006/000782 US2006000782W WO2006076338A3 WO 2006076338 A3 WO2006076338 A3 WO 2006076338A3 US 2006000782 W US2006000782 W US 2006000782W WO 2006076338 A3 WO2006076338 A3 WO 2006076338A3
Authority
WO
WIPO (PCT)
Prior art keywords
proton pump
pump inhibitor
enteric coating
dosage form
gastrointestinal disorders
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2006/000782
Other languages
French (fr)
Other versions
WO2006076338A2 (en
Inventor
John R Plachetka
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pozen Inc
Original Assignee
Pozen Inc
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 AU2006205087A priority Critical patent/AU2006205087A1/en
Priority to CA002592542A priority patent/CA2592542A1/en
Priority to BRPI0606333-0A priority patent/BRPI0606333A2/en
Priority to EP06717923A priority patent/EP1841409A2/en
Priority to JP2007551316A priority patent/JP2008534438A/en
Priority to MX2007008417A priority patent/MX2007008417A/en
Priority to EA200701499A priority patent/EA200701499A1/en
Application filed by Pozen Inc filed Critical Pozen Inc
Publication of WO2006076338A2 publication Critical patent/WO2006076338A2/en
Publication of WO2006076338A3 publication Critical patent/WO2006076338A3/en
Priority to IL184456A priority patent/IL184456A0/en
Anticipated expiration legal-status Critical
Priority to NO20073716A priority patent/NO20073716L/en
Ceased legal-status Critical Current

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
    • A61K9/2072—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
    • 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
    • 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
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/48—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
    • A61K9/5073—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

Landscapes

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

Abstract

The present invention is directed to drug dosage forms that can be used to treat diseases characterized by abnormal gastric acid secretion. The dosage forms have a core containing a proton pump inhibitor surrounded by an enteric coating or multiple particles containing proton pump inhibitor, each particle being surrounded by an enteric coating. The enteric coating delays the release of drug until the surrounding pH has risen. The tablets also include an outer coating that contains either a proton pump inhibitor or an H2 blocker. The outer coating is designed to rapidly dissolve in a patient's stomach.
PCT/US2006/000782 2005-01-12 2006-01-11 Dosage form for treating gastrointestinal disorders Ceased WO2006076338A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
CA002592542A CA2592542A1 (en) 2005-01-12 2006-01-11 Dosage form for treating gastrointestinal disorders
BRPI0606333-0A BRPI0606333A2 (en) 2005-01-12 2006-01-11 pharmaceutical composition, uses of a pharmaceutical composition, and methods for making a tablet unit dosage form, or a coated drug pellet for inclusion in a tablet or capsule
EP06717923A EP1841409A2 (en) 2005-01-12 2006-01-11 Dosage form for treating gastrointestinal disorders
JP2007551316A JP2008534438A (en) 2005-01-12 2006-01-11 Dosage forms for treating gastrointestinal disorders
MX2007008417A MX2007008417A (en) 2005-01-12 2006-01-11 Dosage form for treating gastrointestinal disorders.
AU2006205087A AU2006205087A1 (en) 2005-01-12 2006-01-11 Dosage form for treating gastrointestinal disorders
EA200701499A EA200701499A1 (en) 2005-01-12 2006-01-11 DOSAGE FOR THE TREATMENT OF GASTROINTESTINAL DISORDERS
IL184456A IL184456A0 (en) 2005-01-12 2007-07-05 Dosage form for treating gastrointestinal disorders
NO20073716A NO20073716L (en) 2005-01-12 2007-07-18 Dosage form for treatment of gastrointestinal disorders

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US64313705P 2005-01-12 2005-01-12
US60/643,137 2005-01-12
US11/328,259 US20060165797A1 (en) 2005-01-12 2006-01-10 Dosage form for treating gastrointestinal disorders

Publications (2)

Publication Number Publication Date
WO2006076338A2 WO2006076338A2 (en) 2006-07-20
WO2006076338A3 true WO2006076338A3 (en) 2006-11-02

Family

ID=36697056

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/000782 Ceased WO2006076338A2 (en) 2005-01-12 2006-01-11 Dosage form for treating gastrointestinal disorders

Country Status (8)

Country Link
US (1) US20060165797A1 (en)
JP (2) JP2008534438A (en)
AU (1) AU2006205087A1 (en)
BR (1) BRPI0606333A2 (en)
CA (1) CA2592542A1 (en)
IL (1) IL184456A0 (en)
NO (1) NO20073716L (en)
WO (1) WO2006076338A2 (en)

Families Citing this family (31)

* Cited by examiner, † Cited by third party
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US8206741B2 (en) 2001-06-01 2012-06-26 Pozen Inc. Pharmaceutical compositions for the coordinated delivery of NSAIDs
TWI372066B (en) * 2003-10-01 2012-09-11 Wyeth Corp Pantoprazole multiparticulate formulations
AR051654A1 (en) * 2004-11-04 2007-01-31 Astrazeneca Ab NEW FORMULATIONS OF MODIFIED RELEASE PELLETS FOR PROTON PUMP INHIBITORS
RU2496480C2 (en) * 2005-12-28 2013-10-27 Такеда Фармасьютикал Компани Лимитед Controlled release solid preparation
MY151470A (en) * 2005-12-28 2014-05-30 Takeda Pharmaceutical Controlled release solid preparation
WO2008043740A1 (en) * 2006-10-10 2008-04-17 Novartis Ag Use of lansoprazole for the treatment of frequent heartburn
BRPI0720472A2 (en) * 2006-12-22 2014-01-14 Yuhan Corp SOLID DISPERSION CONTAINING REVAPRAZAN AND PROCESS FOR PREPARING IT
US20080194307A1 (en) * 2007-02-13 2008-08-14 Jeff Sanger Sports-based game of chance
US20090280173A1 (en) * 2008-05-09 2009-11-12 Ishwar Chauhan Multilayer Omeprazole Tablets
WO2009137648A1 (en) * 2008-05-09 2009-11-12 Aptapharma, Inc. Multilayer proton pump inhibitor tablets
EP2364145A4 (en) * 2008-05-30 2013-11-13 Pozen Inc Dosage forms for the rapid and sustained elevation of gastric ph
US9220698B2 (en) 2008-09-09 2015-12-29 Pozen Inc. Method for delivering a pharmaceutical composition to patient in need thereof
WO2010138441A1 (en) * 2009-05-28 2010-12-02 Aptapharma, Inc. Multilayer oral tablets containing a non-steroidal anti-inflammatory drug and/or acetaminophen
KR20120030106A (en) 2009-06-25 2012-03-27 아스트라제네카 아베 Method for treating a patient at risk for developing an nsaid-associated ulcer
EP2445344A4 (en) * 2009-06-25 2013-01-23 Pozen Inc Method for treating a patient in need of aspirin therapy
US20120141584A1 (en) * 2009-08-26 2012-06-07 Aptapharma, Inc. Multilayer Minitablets
WO2011080502A2 (en) * 2009-12-29 2011-07-07 Orexo Ab New pharmaceutical dosage form for the treatment of gastric acid-related disorders
WO2011080500A2 (en) * 2009-12-29 2011-07-07 Orexo Ab New pharmaceutical dosage form for the treatment of gastric acid-related disorders
US20120294937A1 (en) * 2009-12-29 2012-11-22 Novartis Ag New pharmaceutical dosage form for the treatment of gastric acid-related disorders
US8563035B2 (en) 2010-05-05 2013-10-22 Sanovel Ilac Sanayi Ve Ticaret Anomin Sirketi Oral tablet compositions of dexlansoprazole
EP2384746A3 (en) 2010-05-05 2012-03-07 Sanovel Ilac Sanayi ve Ticaret A.S. Dual release oral tablet compositions of dexlansoprazole
EP2384747A3 (en) * 2010-05-05 2012-01-18 Sanovel Ilac Sanayi ve Ticaret A.S. Oral Tablet Compositions Of Dexlansoprazole
EP2384745A3 (en) 2010-05-05 2012-01-18 Sanovel Ilac Sanayi ve Ticaret A.S. Modified release pharmaceutical compositions of dexlansoprazole
TR201006225A1 (en) * 2010-07-28 2012-02-21 Sanovel İlaç San.Ve Ti̇c.A.Ş. Double-release dexlansoprazole oral tablet compositions
US20120164233A1 (en) * 2010-07-30 2012-06-28 Ranbaxy Laboratories Limited Pulsatile release pharmaceutical formulation of dexlansoprazole
KR101730865B1 (en) 2011-02-11 2017-04-27 주식회사유한양행 Pharmaceutical compositions comprising revaprazan-containing nanoparticles and processes for the preparation thereof
WO2012111024A1 (en) * 2011-02-18 2012-08-23 Suven Nishtaa Pharma Pvt Ltd Pharmaceutical compositions of dexlansoprazole
EP2797600A4 (en) 2011-12-28 2015-09-16 Pozen Inc Improved compositions and methods for delivery of omeprazole plus acetylsalicylic acid
KR101739820B1 (en) * 2012-03-28 2017-05-25 주식회사유한양행 Pharmaceutical composition in form of non-aqueous liquid comprising revaprazan or its salt
UY39094A (en) * 2020-02-27 2021-07-30 Hk Inno N Corp PHARMACEUTICAL COMPOSITION INCLUDING BENZIMIDAZOLE DERIVATIVE COMPOUND
MX2024005292A (en) 2021-11-05 2024-05-17 Cinclus Pharma Holding Ab Publ Polymorphs of the hydrochloride salt of linaprazan glurate.

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US6632451B2 (en) * 1999-06-04 2003-10-14 Dexcel Pharma Technologies Ltd. Delayed total release two pulse gastrointestinal drug delivery system

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Also Published As

Publication number Publication date
JP2009102335A (en) 2009-05-14
IL184456A0 (en) 2007-10-31
BRPI0606333A2 (en) 2009-11-10
CA2592542A1 (en) 2006-07-20
WO2006076338A2 (en) 2006-07-20
NO20073716L (en) 2007-08-09
JP2008534438A (en) 2008-08-28
AU2006205087A1 (en) 2006-07-20
US20060165797A1 (en) 2006-07-27

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