CA2323536A1 - Pharmaceutical formulation comprising a 2-[[(2-pyridinyl)methyl]sulfinyl]benzimidazole having anti-ulcer activity and a process for the preparation of such formulation - Google Patents

Pharmaceutical formulation comprising a 2-[[(2-pyridinyl)methyl]sulfinyl]benzimidazole having anti-ulcer activity and a process for the preparation of such formulation Download PDF

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Publication number
CA2323536A1
CA2323536A1 CA002323536A CA2323536A CA2323536A1 CA 2323536 A1 CA2323536 A1 CA 2323536A1 CA 002323536 A CA002323536 A CA 002323536A CA 2323536 A CA2323536 A CA 2323536A CA 2323536 A1 CA2323536 A1 CA 2323536A1
Authority
CA
Canada
Prior art keywords
formulation
preparation
benzimidazole
sulfinyl
pyridinyl
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.)
Granted
Application number
CA002323536A
Other languages
French (fr)
Other versions
CA2323536C (en
Inventor
Kristian Lund Henriksen
Helle Kann
Karen Eichstedt Sorensen
Soren Bols Pedersen
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.)
Hexal AS
Original Assignee
Individual
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=8093069&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2323536(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2323536A1 publication Critical patent/CA2323536A1/en
Application granted granted Critical
Publication of CA2323536C publication Critical patent/CA2323536C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61K9/5073—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • 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

Abstract

Oral pharmaceutical formulation comprising granules having an inert core coated with a layer, comprising a 2-[[(2-pyridinyl)methyl]sulfinyl]benzimidazole having anti-ulcer activity, a disintegrant and a surfactant in a matrix of a melt coating substance essentially consisting of one or more esters of glycerol and fatty acids, a separating layer and an enteric coating layer, and a process for the preparation of such formulation using a melt coating technique for the preparation of the benzimidazole containing layer.
CA002323536A 1998-03-20 1999-03-17 Pharmaceutical formulation comprising a 2-[[(2-pyridinyl)methyl]sulfinyl]benzimidazole having anti-ulcer activity and a process for the preparation of such formulation Expired - Fee Related CA2323536C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DK199800397A DK173431B1 (en) 1998-03-20 1998-03-20 Pharmaceutical formulation comprising a 2 - [[(2-pyridinyl) methyl] sulfinyl] benzimidazole with anti-ulcer activity and progress
DK0397/98 1998-03-20
PCT/DK1999/000137 WO1999048498A1 (en) 1998-03-20 1999-03-17 Pharmaceutical formulation comprising a 2- [[(2- pyridinyl) methyl] sulfinyl] benzimidazole having anti-ulcer activity and a process for the preparation of such formulation

Publications (2)

Publication Number Publication Date
CA2323536A1 true CA2323536A1 (en) 1999-09-30
CA2323536C CA2323536C (en) 2009-05-19

Family

ID=8093069

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002323536A Expired - Fee Related CA2323536C (en) 1998-03-20 1999-03-17 Pharmaceutical formulation comprising a 2-[[(2-pyridinyl)methyl]sulfinyl]benzimidazole having anti-ulcer activity and a process for the preparation of such formulation

Country Status (20)

Country Link
US (1) US6391342B1 (en)
EP (1) EP1061920B1 (en)
AR (1) AR014753A1 (en)
AT (1) ATE218863T1 (en)
AU (1) AU744596B2 (en)
CA (1) CA2323536C (en)
CZ (1) CZ291943B6 (en)
DE (1) DE69901804T2 (en)
DK (2) DK173431B1 (en)
EA (1) EA002502B1 (en)
ES (1) ES2177246T3 (en)
HU (1) HU226580B1 (en)
IS (1) IS2265B (en)
NO (1) NO20004667L (en)
NZ (1) NZ507115A (en)
PL (1) PL192437B1 (en)
TR (1) TR200002696T2 (en)
TW (1) TW529951B (en)
WO (1) WO1999048498A1 (en)
ZA (1) ZA200004757B (en)

Families Citing this family (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100627614B1 (en) 1998-04-20 2006-09-25 에자이 가부시키가이샤 Medicament comprising stabilized compositions containing benzimidazole-type compounds
ZA9810765B (en) * 1998-05-28 1999-08-06 Ranbaxy Lab Ltd Stable oral pharmaceutical composition containing a substituted pyridylsulfinyl benzimidazole.
US6248363B1 (en) * 1999-11-23 2001-06-19 Lipocine, Inc. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
TR200103527T2 (en) 1999-06-07 2002-04-22 Byk Gulden Lomberg Chemische Fabrik Gmbh New method of preparation and administration containing an acid-labile active compound
EP1064938A1 (en) * 1999-06-28 2001-01-03 Sanofi-Synthelabo Pharmaceutical dosage forms for controlled release producing at least a timed pulse
ES2168043B1 (en) 1999-09-13 2003-04-01 Esteve Labor Dr PHARMACEUTICAL FORM ORAL SOLID MODIFIED RELEASE CONTAINING A COMPOSITE OF BENCIMIDAZOL LABIL IN THE MIDDLE ACID.
AR021347A1 (en) 1999-10-20 2002-07-17 Cipla Ltd A PHARMACEUTICAL COMPOSITION CONTAINING SISPHOSPHONIC ACID (S) OR SALT (S) OF THE SAME AND A PREPARATION PROCESS OF THE SAME
WO2001032185A1 (en) * 1999-11-02 2001-05-10 Cipla Ltd. A pharmaceutical composition containing bisphosphonic acid(s) or salt(s) thereof and a process of preparing thereof
US20030180352A1 (en) * 1999-11-23 2003-09-25 Patel Mahesh V. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
US20060034937A1 (en) * 1999-11-23 2006-02-16 Mahesh Patel Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
DE19959419A1 (en) 1999-12-09 2001-06-21 Ratiopharm Gmbh Stable pharmaceutical preparations comprising a benzimidazole and process for their preparation
ES2191521B1 (en) * 2000-11-22 2005-02-16 Laboratorios Belmac, S.A. NEW GALENIC FORMULATION OF OMEPRAZOL IN THE FORM OF TABLETS, PROCEDURE FOR THE PREPARATION AND APPLICATIONS IN HUMAN MEDICINE AND VETERINARY.
MY148805A (en) * 2002-10-16 2013-05-31 Takeda Pharmaceutical Controlled release preparation
WO2004089333A2 (en) * 2003-02-28 2004-10-21 Cadila Healthcare Limited A stable benzimidazole formulation
ES2234393B2 (en) * 2003-04-29 2006-09-01 Laboratorios Belmac, S.A. "FORMULATIONS OF PELETS OF ANTIULCEROSE BENCIMIDAZOLIC COMPOUNDS AND LABILS TO THE ACID".
TWI372066B (en) * 2003-10-01 2012-09-11 Wyeth Corp Pantoprazole multiparticulate formulations
WO2005034923A1 (en) * 2003-10-10 2005-04-21 Ethypharm Sustained-release microgranules containing gingko biloba extract and the process for manufacturing these
US20070141150A1 (en) * 2003-12-30 2007-06-21 Raghupathi Kandarapu Pharmaceutical composition
US20050181052A1 (en) * 2004-02-17 2005-08-18 Patel Satishkumar A. Lansoprazole microtablets
CA2558535A1 (en) * 2004-03-03 2005-10-06 Teva Pharmaceutical Industries Ltd. A stable pharmaceutical composition comprising an acid labile drug
JP2007536349A (en) 2004-05-07 2007-12-13 ニコメッド ゲゼルシャフト ミット ベシュレンクテル ハフツング Novel pharmaceutical dosage form and production method
WO2006009602A2 (en) * 2004-06-16 2006-01-26 Tap Pharmaceutical Products, Inc. Multiple ppi dosage form
CA2633254A1 (en) * 2005-12-16 2007-07-05 Tap Pharmaceutical Products, Inc. Pharmaceutical compositions of ilaprazole
WO2007100984A2 (en) * 2006-02-24 2007-09-07 Allergan, Inc. Beads containing pyridin-sulfinyl benzoimidazole sulfonyl phenoxy acetate derivatives
AU2007266574A1 (en) * 2006-06-01 2007-12-06 Dexcel Pharma Technologies Ltd. Multiple unit pharmaceutical formulation
US8110226B2 (en) * 2007-07-20 2012-02-07 Mylan Pharmaceuticals Inc. Drug formulations having inert sealed cores
US8486452B2 (en) 2007-07-20 2013-07-16 Mylan Pharmaceuticals Inc. Stabilized tolterodine tartrate formulations
US11304960B2 (en) 2009-01-08 2022-04-19 Chandrashekar Giliyar Steroidal compositions
US20100239681A1 (en) * 2009-03-20 2010-09-23 Biokey, Inc. Controlled Release Particulates Containing Water-Insoluble Drug
WO2010122583A2 (en) 2009-04-24 2010-10-28 Rubicon Research Private Limited Oral pharmaceutical compositions of acid labile substances
EP2319504A1 (en) 2009-11-07 2011-05-11 Laboratorios Del. Dr. Esteve, S.A. Pharmaceutical solid dosage form
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
US20180153904A1 (en) 2010-11-30 2018-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US9358241B2 (en) 2010-11-30 2016-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US20120148675A1 (en) 2010-12-10 2012-06-14 Basawaraj Chickmath Testosterone undecanoate compositions
CN103202820B (en) * 2012-01-11 2016-03-30 浙江亚太药业股份有限公司 A kind of stable lansoprazole intestine dissolving capsule and preparation method thereof
WO2016033556A1 (en) 2014-08-28 2016-03-03 Lipocine Inc. BIOAVAILABLE SOLID STATE (17-β)-HYDROXY-4-ANDROSTEN-3-ONE ESTERS
WO2016033549A2 (en) 2014-08-28 2016-03-03 Lipocine Inc. (17-ß)-3-OXOANDROST-4-EN-17-YL TRIDECANOATE COMPOSITIONS AND METHODS OF THEIR PREPARATION AND USE
US20170042806A1 (en) 2015-04-29 2017-02-16 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
US10736855B2 (en) 2016-02-25 2020-08-11 Dexcel Pharma Technologies Ltd. Compositions comprising proton pump inhibitors
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
CA3078723A1 (en) 2016-11-28 2018-05-31 Nachiappan Chidambaram Oral testosterone undecanoate therapy

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE8301182D0 (en) 1983-03-04 1983-03-04 Haessle Ab NOVEL COMPOUNDS
CA1327010C (en) 1986-02-13 1994-02-15 Tadashi Makino Stabilized solid pharmaceutical composition containing antiulcer benzimidazole compound and its production
GB2189699A (en) 1986-04-30 1987-11-04 Haessle Ab Coated acid-labile medicaments
GB2189698A (en) 1986-04-30 1987-11-04 Haessle Ab Coated omeprazole tablets
US5026560A (en) 1987-01-29 1991-06-25 Takeda Chemical Industries, Ltd. Spherical granules having core and their production
ES2024993A6 (en) 1990-12-31 1992-03-01 Genesis Para La Investigacion Procedure for obtaining an oral pharmaceutical preparation containing omeprazole
TW209174B (en) 1991-04-19 1993-07-11 Takeda Pharm Industry Co Ltd
YU48263B (en) 1991-06-17 1997-09-30 Byk Gulden Lomberg Chemische Fabrik Gmbh. PROCEDURE FOR OBTAINING PANTOPRAZOLE PHARMACEUTICAL PRODUCT
DE69127275T2 (en) * 1991-06-21 1998-03-12 Ilsan Ilac Ve Hammaddeleri San New galenic process for pellets containing omeprazole
SE9200858L (en) 1992-03-20 1993-09-21 Kabi Pharmacia Ab Method for producing delayed release pellets
FR2692146B1 (en) 1992-06-16 1995-06-02 Ethypharm Sa Stable compositions of gastro-protected omeprazole microgranules and process for obtaining them.
WO1994002140A1 (en) 1992-07-17 1994-02-03 Astra Aktiebolag Pharmaceutical composition containing antiulcer agent
ES2087823B1 (en) 1994-07-13 1997-02-16 Estudes Et Richerches Pharma E FORMULATION OF GASTRORESISTENT MICROGRANULES OF OMEPRAZOLE AND ITS MANUFACTURING PROCEDURE.
ES2094694B1 (en) 1995-02-01 1997-12-16 Esteve Quimica Sa NEW PHARMACEUTICALLY STABLE FORMULATION OF A COMPOUND OF BENZMIDAZOLE AND ITS PROCESS OF OBTAINING.
SE9500478D0 (en) 1995-02-09 1995-02-09 Astra Ab New pharmaceutical formulation and process
US5708017A (en) * 1995-04-04 1998-01-13 Merck & Co., Inc. Stable, ready-to-use pharmaceutical paste composition containing proton pump inhibitors
CH687810A5 (en) 1995-05-24 1997-02-28 Mepha Ag Pellet Formulation with omeprazole.
DE69628444T2 (en) 1995-09-21 2004-05-06 Pharma Pass Ii Llc, Irvine ACID CONTAINING PHARMACEUTICAL COMPOSITION CONTAINING ACID, AND METHOD FOR THE PRODUCTION THEREOF
SE9600072D0 (en) * 1996-01-08 1996-01-08 Astra Ab New oral formulation of two active ingredients II
PT101826A (en) 1996-02-06 1997-09-30 Medinfar Produtos Farmaceutico Process for the preparation of microgranules containing omeprazole
EP0968204A1 (en) 1997-03-07 2000-01-05 A/S GEA Farmaceutisk Fabrik Process for the preparation of 2- (2-pyridinyl)methyl]sulfinyl]-1h-benzimidazoles and novel compounds of use for such purpose

Also Published As

Publication number Publication date
CZ20003458A3 (en) 2001-03-14
DK173431B1 (en) 2000-10-23
HUP0101178A2 (en) 2001-08-28
AU2714899A (en) 1999-10-18
IS2265B (en) 2007-07-15
NO20004667D0 (en) 2000-09-19
AR014753A1 (en) 2001-03-28
TW529951B (en) 2003-05-01
WO1999048498A1 (en) 1999-09-30
AU744596B2 (en) 2002-02-28
PL192437B1 (en) 2006-10-31
CA2323536C (en) 2009-05-19
ES2177246T3 (en) 2002-12-01
EP1061920A1 (en) 2000-12-27
NO20004667L (en) 2000-11-09
TR200002696T2 (en) 2000-12-21
HU226580B1 (en) 2009-04-28
CZ291943B6 (en) 2003-06-18
ZA200004757B (en) 2001-05-30
EP1061920B1 (en) 2002-06-12
US6391342B1 (en) 2002-05-21
EA200000970A1 (en) 2001-02-26
DK39798A (en) 1999-09-21
NZ507115A (en) 2002-09-27
ATE218863T1 (en) 2002-06-15
EA002502B1 (en) 2002-06-27
IS5628A (en) 2000-09-13
PL342840A1 (en) 2001-07-16
DK1061920T3 (en) 2002-07-15
DE69901804T2 (en) 2002-12-12
DE69901804D1 (en) 2002-07-18

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