AU3438897A - Stable drug form for oral administration and process for the preparation thereof - Google Patents

Stable drug form for oral administration and process for the preparation thereof

Info

Publication number
AU3438897A
AU3438897A AU34388/97A AU3438897A AU3438897A AU 3438897 A AU3438897 A AU 3438897A AU 34388/97 A AU34388/97 A AU 34388/97A AU 3438897 A AU3438897 A AU 3438897A AU 3438897 A AU3438897 A AU 3438897A
Authority
AU
Australia
Prior art keywords
drug form
stable drug
preparation
oral administration
resistant
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.)
Abandoned
Application number
AU34388/97A
Inventor
Gerd-Ulfert Heese
Herbert Junger
Arnim Laicher
Claudio Lorck
Thomas Profitlich
Gerd Weiss
Peter Wolfegg
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.)
Astellas Deutschland GmbH
Original Assignee
Klinge Pharma GmbH and Co
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 Klinge Pharma GmbH and Co filed Critical Klinge Pharma GmbH and Co
Publication of AU3438897A publication Critical patent/AU3438897A/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures 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

Abstract

The invention relates to a stable drug form which is for oral administration and comprises: (a) a core comprising one or more active ingredients which are not to be released until after they have passed through the stomach, together with conventional pharmaceutical adjuvants, (b) an intermediate layer applied to the core, and (c) an external layer which is resistant to gastric juice. The intermediate layer in (b) is in the form of a reactive layer comprising a polymeric layered material which is partly neutralised with alkalis, is resistant to gastric juice and has cation-exchanger capacity. A process for the preparation of the stable drug form is also disclosed.
AU34388/97A 1996-06-28 1997-06-27 Stable drug form for oral administration and process for the preparation thereof Abandoned AU3438897A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19626045A DE19626045C2 (en) 1996-06-28 1996-06-28 A stable dosage form for oral administration containing omeprazole as the active ingredient and methods of making the same
DE19626045 1996-06-28
PCT/EP1997/003388 WO1998000115A2 (en) 1996-06-28 1997-06-27 Stable drug form for oral administration and process for the preparation thereof

Publications (1)

Publication Number Publication Date
AU3438897A true AU3438897A (en) 1998-01-21

Family

ID=7798347

Family Applications (2)

Application Number Title Priority Date Filing Date
AU34388/97A Abandoned AU3438897A (en) 1996-06-28 1997-06-27 Stable drug form for oral administration and process for the preparation thereof
AU33451/97A Abandoned AU3345197A (en) 1996-06-28 1997-06-27 Stable drug form for oral administration with benzimidazole derivatives as active ingredient and process for the preparation thereof

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU33451/97A Abandoned AU3345197A (en) 1996-06-28 1997-06-27 Stable drug form for oral administration with benzimidazole derivatives as active ingredient and process for the preparation thereof

Country Status (11)

Country Link
EP (1) EP0934058B1 (en)
JP (1) JP4641075B2 (en)
AT (1) ATE247457T1 (en)
AU (2) AU3438897A (en)
CA (1) CA2258918C (en)
DE (2) DE19626045C2 (en)
DK (1) DK0934058T3 (en)
ES (1) ES2205243T3 (en)
PT (1) PT934058E (en)
WO (2) WO1998000115A2 (en)
ZA (2) ZA975827B (en)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5840737A (en) 1996-01-04 1998-11-24 The Curators Of The University Of Missouri Omeprazole solution and method for using same
US6489346B1 (en) 1996-01-04 2002-12-03 The Curators Of The University Of Missouri Substituted benzimidazole dosage forms and method of using same
SE9704869D0 (en) * 1997-12-22 1997-12-22 Astra Ab New pharmaceutical formulaton II
UA73092C2 (en) * 1998-07-17 2005-06-15 Брістол-Майерс Сквібб Компані Tablets with enteric coating and method for their manufacture
DE69930648T2 (en) 1998-08-12 2006-12-21 Altana Pharma Ag ORAL PHARMACEUTICAL FORM OF PYRIDINE-2-YLMETHYLSULFINYL-1H-BENZIMIDAZOLE
DE19845358A1 (en) * 1998-10-02 2000-04-06 Roehm Gmbh Coated drug forms with controlled drug delivery
IL130602A0 (en) 1999-06-22 2000-06-01 Dexcel Ltd Stable benzimidazole formulation
US6420473B1 (en) * 2000-02-10 2002-07-16 Bpsi Holdings, Inc. Acrylic enteric coating compositions
AR030557A1 (en) 2000-04-14 2003-08-27 Jagotec Ag A TABLET IN MULTI-MAP OF CONTROLLED RELEASE AND TREATMENT METHOD
US7316819B2 (en) * 2001-03-08 2008-01-08 Unigene Laboratories, Inc. Oral peptide pharmaceutical dosage form and method of production
KR100479637B1 (en) * 2002-02-01 2005-03-31 한국화학연구원 Oral dosage form comprising Lansoprazole and preparation method for the same
AU2003244647B2 (en) 2002-08-02 2008-04-17 Ratiopharm Gmbh Pharmaceutical preparation containing a benzimidazole compound mixed with microcrystalline cellulose and a method for its preparation
DE10235475B4 (en) * 2002-08-02 2006-04-27 Ratiopharm Gmbh Medicaments containing a benzimidazole compound in admixture with microcrystalline cellulose and process for their preparation
US8993599B2 (en) 2003-07-18 2015-03-31 Santarus, Inc. Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them
AR045068A1 (en) * 2003-07-23 2005-10-12 Univ Missouri FORMULATION OF IMMEDIATE RELEASE OF PHARMACEUTICAL COMPOSITIONS
PT2446881E (en) * 2003-07-24 2014-06-11 Glaxosmithkline Llc Orally dissolving films
EP1721604A4 (en) * 2004-03-04 2008-04-30 Takeda Pharmaceutical Stable capsule preparation
US8906940B2 (en) 2004-05-25 2014-12-09 Santarus, Inc. Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them
EP1833469A2 (en) * 2005-01-03 2007-09-19 Lupin Ltd. Pharmaceutical composition of acid labile substances
DE102005032806A1 (en) * 2005-07-12 2007-01-18 Röhm Gmbh Use of a partially neutralized, anionic (meth) acrylate copolymer as a coating for the preparation of a dosage form with a release of active ingredient at reduced pH values
DE102006006532B4 (en) 2006-02-10 2007-11-08 Biogenerics Pharma Gmbh Pharmaceutical preparation
EP2152250B1 (en) 2007-05-07 2019-09-04 Evonik Röhm GmbH Solid dosage forms comprising an enteric coating with accelerated drug release
DE102008056312A1 (en) 2008-11-07 2010-05-12 Biogenerics Pharma Gmbh Use of micro-tablets as food and feed additive
DE102010052847A1 (en) * 2010-11-29 2012-05-31 Temmler Werke Gmbh Process for the preparation of a PPI-containing pharmaceutical preparation
US8951996B2 (en) * 2011-07-28 2015-02-10 Lipocine Inc. 17-hydroxyprogesterone ester-containing oral compositions and related methods
WO2014136494A1 (en) * 2013-03-08 2014-09-12 富士フイルム株式会社 Enteric-coated fine particle and drug composition
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
US10758489B2 (en) * 2018-04-12 2020-09-01 Bpsi Holdings Llc Acidifying coatings and disintegration-resistant substrates coated therewith

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS57171428A (en) * 1981-04-13 1982-10-22 Sankyo Co Ltd Preparation of coated solid preparation
JPS584730A (en) * 1981-06-29 1983-01-11 Shin Etsu Chem Co Ltd Enteric coating composition and its preparation
GB2189698A (en) * 1986-04-30 1987-11-04 Haessle Ab Coated omeprazole tablets
DE3822095A1 (en) * 1988-06-30 1990-01-04 Klinge Co Chem Pharm Fab NEW MEDICAMENT FORMULATION AND METHOD FOR THE PRODUCTION THEREOF
IT1230576B (en) * 1988-10-20 1991-10-28 Angeli Inst Spa ORAL PHARMACEUTICAL FORMULATIONS WITH SELECTIVE LIBERATION IN THE COLON
US5225202A (en) * 1991-09-30 1993-07-06 E. R. Squibb & Sons, Inc. Enteric coated pharmaceutical compositions
JPH0733659A (en) * 1992-07-17 1995-02-03 Yoshitomi Pharmaceut Ind Ltd Antiulcer agent-containing pharmaceutical preparation
AU4513393A (en) * 1992-07-17 1994-02-14 Astra Aktiebolag Pharmaceutical composition containing antiulcer agent
SE9302395D0 (en) * 1993-07-09 1993-07-09 Ab Astra NEW PHARMACEUTICAL FORMULATION

Also Published As

Publication number Publication date
CA2258918C (en) 2005-11-22
JP2000514051A (en) 2000-10-24
WO1998000115A2 (en) 1998-01-08
DK0934058T3 (en) 2003-12-01
ZA975828B (en) 1998-01-30
DE19626045A1 (en) 1998-01-08
AU3345197A (en) 1998-01-21
EP0934058B1 (en) 2003-08-20
ATE247457T1 (en) 2003-09-15
ES2205243T3 (en) 2004-05-01
EP0934058A2 (en) 1999-08-11
DE19626045C2 (en) 1998-12-03
WO1998000114A3 (en) 1998-02-26
PT934058E (en) 2004-01-30
WO1998000115A3 (en) 1998-02-26
CA2258918A1 (en) 1998-01-08
ZA975827B (en) 1998-01-30
WO1998000114A2 (en) 1998-01-08
DE59710629D1 (en) 2003-09-25
JP4641075B2 (en) 2011-03-02

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