WO1996001622A8 - New oral pharmaceutical formulation containing magnesium salt of omeprazole - Google Patents

New oral pharmaceutical formulation containing magnesium salt of omeprazole

Info

Publication number
WO1996001622A8
WO1996001622A8 PCT/SE1995/000816 SE9500816W WO9601622A8 WO 1996001622 A8 WO1996001622 A8 WO 1996001622A8 SE 9500816 W SE9500816 W SE 9500816W WO 9601622 A8 WO9601622 A8 WO 9601622A8
Authority
WO
WIPO (PCT)
Prior art keywords
omeprazole
magnesium salt
oral pharmaceutical
pharmaceutical formulation
formulation containing
Prior art date
Application number
PCT/SE1995/000816
Other languages
French (fr)
Other versions
WO1996001622A1 (en
Inventor
Siv Inga Bengtsson
Kurt Ingmar Loevgren
Original Assignee
Astra Ab
Siv Inga Bengtsson
Kurt Ingmar Loevgren
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 Astra Ab, Siv Inga Bengtsson, Kurt Ingmar Loevgren filed Critical Astra Ab
Priority to BR9508261A priority Critical patent/BR9508261A/en
Priority to HU9700039A priority patent/HUT78132A/en
Priority to MX9700152A priority patent/MX9700152A/en
Priority to AU29947/95A priority patent/AU695723C/en
Priority to EE9700014A priority patent/EE03378B1/en
Priority to SK1660-96A priority patent/SK166096A3/en
Priority to PL95318464A priority patent/PL181265B1/en
Priority to NZ289958A priority patent/NZ289958A/en
Priority to JP8504257A priority patent/JPH10504288A/en
Priority to EP95926067A priority patent/EP0768872A1/en
Priority to CZ963795A priority patent/CZ379596A3/en
Priority to KR1019970700059A priority patent/KR970704426A/en
Publication of WO1996001622A1 publication Critical patent/WO1996001622A1/en
Priority to IS4398A priority patent/IS4398A/en
Priority to NO970036A priority patent/NO970036D0/en
Priority to FI970058A priority patent/FI970058A0/en
Publication of WO1996001622A8 publication Critical patent/WO1996001622A8/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • 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
    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/5078Microcapsules 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
    • 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

Abstract

A new oral pharmaceutical formulation containing a novel physical form of a magnesium salt of omeprazole coated with one or more enteric coating layers, a method for the manufacture of such a formulation, the use of such a formulation in medicine and a blister package containing the new formulation.

Description

FOR THE PURPOSES OF INFORMATION ONLY
Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.
AT Austria GB United Kingdom MR Mauritania
AU Australia GE Georgia MW Malawi
BB Barbados GN Guinea NE Niger
BE Belgium GR Greece NL Netherlands
BF Burkina Faso HU Hungary NO Norway
BG Bulgaria IE Ireland NZ New Zealand
BJ Benin IT Italy PL Poland
BR Brazil JP Japan PT Portugal
BY Belarus KE Kenya RO Romania
CA Canada KG Kyrgystan RU Russian Federation
CF Central African Republic KP Democratic People's Republic SD Sudan
CG Congo of Korea SE Sweden
CH Switzerland KR Republic of Korea SI Slovenia
CI Cδte d'lvoire KZ Kazakhstan SK Slovakia
CM Cameroon LI Liechtenstein SN Senegal
CN China LK Sri Lanka TD Chad
CS Czechoslovakia LU Luxembourg TG Togo
CZ Czech Republic LV Latvia TJ Tajikistan
DE Germany MC Monaco TT Trinidad and Tobago
DK Denmark MD Republic of Moldova UA Ukraine
ES Spain MG Madagascar US United States of America
FI Finland ML Mali uz Uzbekistan
FR France
Figure imgf000002_0002
MN Mongolia
Figure imgf000002_0003
VN Viet Nam
Figure imgf000002_0001
GA Gabon
PCT/SE1995/000816 1994-07-08 1995-07-03 New oral pharmaceutical formulation containing magnesium salt of omeprazole WO1996001622A1 (en)

Priority Applications (15)

Application Number Priority Date Filing Date Title
BR9508261A BR9508261A (en) 1994-07-08 1995-07-03 Enterically coated oral formulation using the same process to prepare the formulation to inhibit gastric acid secretion in mammals and humans and to treat gastric acid-related diseases in humans and humans and cross-pressure blister pack
HU9700039A HUT78132A (en) 1994-07-08 1995-07-03 New oral pharmaceutical formulation containing magnesium salt of omeprazole
MX9700152A MX9700152A (en) 1994-07-08 1995-07-03 New oral pharmaceutical formulation containing magnesium salt of omeprazole.
AU29947/95A AU695723C (en) 1994-07-08 1995-07-03 New oral pharmaceutical formulation containing magnesium salt of omeprazole
EE9700014A EE03378B1 (en) 1994-07-08 1995-07-03 Oral dosage form containing magnesium salt of omeprazole
NZ289958A NZ289958A (en) 1994-07-08 1995-07-05 Oral enteric coated medicament containing a magnesium salt of omeprazole having a degree of crystallinity which is higher than 70%, used to inhibit gastric acid secretion
PL95318464A PL181265B1 (en) 1994-07-08 1995-07-05 Novel pharmaceutic preparation for oral administration containing a magnesium salt of omeprasole
SK1660-96A SK166096A3 (en) 1994-07-08 1995-07-05 New oral pharmaceutical formulation containing magnesium salt of omeprazole
JP8504257A JPH10504288A (en) 1994-07-08 1995-07-05 Novel oral pharmaceutical formulations containing magnesium salt of omeprazole
EP95926067A EP0768872A1 (en) 1994-07-08 1995-07-05 New oral pharmaceutical formulation containing magnesium salt of omeprazole
CZ963795A CZ379596A3 (en) 1994-07-08 1995-07-05 Novel oral pharmaceutical preparation containing omeprazol magnesium salt
KR1019970700059A KR970704426A (en) 1994-07-08 1995-07-05 A New Oral Pharmaceutical Formulation Containing Magnesium Salt of Omeprazole Containing Magnesium Salt of Omeprazole
IS4398A IS4398A (en) 1994-07-08 1996-12-17 New oral oral formulations containing magnesium salt of omeprazole
NO970036A NO970036D0 (en) 1994-07-08 1997-01-06 New oral pharmaceutical preparation containing magnesium salt of omeprazole
FI970058A FI970058A0 (en) 1994-07-08 1997-01-07 A new oral pharmaceutical preparation containing the magnesium salt of omeprazole

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US31320894A 1994-07-08 1994-07-08
SEPCT/SE94/00679 1994-07-08
SE9400679 1994-07-08

Publications (2)

Publication Number Publication Date
WO1996001622A1 WO1996001622A1 (en) 1996-01-25
WO1996001622A8 true WO1996001622A8 (en) 1999-12-23

Family

ID=20393105

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE1995/000816 WO1996001622A1 (en) 1994-07-08 1995-07-03 New oral pharmaceutical formulation containing magnesium salt of omeprazole

Country Status (15)

Country Link
EP (1) EP0768872A1 (en)
KR (1) KR970704426A (en)
BR (1) BR9508261A (en)
CA (1) CA2193681A1 (en)
CZ (1) CZ379596A3 (en)
EE (1) EE03378B1 (en)
FI (1) FI970058A0 (en)
HU (1) HUT78132A (en)
IS (1) IS4398A (en)
MX (1) MX9700152A (en)
NO (1) NO970036D0 (en)
NZ (1) NZ289958A (en)
PL (1) PL181265B1 (en)
SK (1) SK166096A3 (en)
WO (1) WO1996001622A1 (en)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9500478D0 (en) * 1995-02-09 1995-02-09 Astra Ab New pharmaceutical formulation and process
US6489346B1 (en) 1996-01-04 2002-12-03 The Curators Of The University Of Missouri Substituted benzimidazole dosage forms and method of using same
US5840737A (en) 1996-01-04 1998-11-24 The Curators Of The University Of Missouri Omeprazole solution and method for using same
US5900258A (en) * 1996-02-01 1999-05-04 Zeolitics Inc. Anti-bacterial compositions
SI9700186B (en) 1997-07-14 2006-10-31 Lek, Tovarna Farmacevtskih In Kemicnih Izdelkov, D.D. Novel pharmaceutical preparation with controlled release of active healing substances
US6096340A (en) * 1997-11-14 2000-08-01 Andrx Pharmaceuticals, Inc. Omeprazole formulation
US6174548B1 (en) 1998-08-28 2001-01-16 Andrx Pharmaceuticals, Inc. Omeprazole formulation
SE9704870D0 (en) * 1997-12-22 1997-12-22 Astra Ab New pharmaceutical formulation I
SE9704869D0 (en) * 1997-12-22 1997-12-22 Astra Ab New pharmaceutical formulaton II
US6733778B1 (en) 1999-08-27 2004-05-11 Andrx Pharmaceuticals, Inc. Omeprazole formulation
SE9802973D0 (en) 1998-09-03 1998-09-03 Astra Ab Immediate release tablet
US6316020B1 (en) * 1999-08-26 2001-11-13 Robert R. Whittle Pharmaceutical formulations
EP1133987A1 (en) * 2000-03-09 2001-09-19 Ian Whitcroft Treatment of inflammatory dermatoses with combinations of erythromycin or clarythromycin, metronidazole and a hydrogen pump inhibitor
CA2413923A1 (en) * 2000-03-09 2001-09-13 Andrew Ilchyshyn Treatment of inflammatory dermatoses comprising erythromycin or clarythromycin metronidazole and a gastrointestinal hydrogen pump inhibitor
ES2534713T3 (en) 2002-10-16 2015-04-27 Takeda Pharmaceutical Company Limited Stable solid preparations
US8993599B2 (en) 2003-07-18 2015-03-31 Santarus, Inc. Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them
US8906940B2 (en) 2004-05-25 2014-12-09 Santarus, Inc. Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them
EP1755566A2 (en) * 2004-06-15 2007-02-28 Teva Pharmaceutical Industries Ltd Stable pharmaceutical formulations of benzimidazole compounds
CN105106168B (en) * 2015-08-19 2018-03-06 德州德药制药有限公司 A kind of esomeprazole magnesium intestines capsule and preparation method thereof

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2189698A (en) * 1986-04-30 1987-11-04 Haessle Ab Coated omeprazole tablets
JPH0768125B2 (en) * 1988-05-18 1995-07-26 エーザイ株式会社 Oral formulation of acid labile compounds
SE9302396D0 (en) * 1993-07-09 1993-07-09 Ab Astra A NOVEL COMPOUND FORM
SE9302395D0 (en) * 1993-07-09 1993-07-09 Ab Astra NEW PHARMACEUTICAL FORMULATION

Also Published As

Publication number Publication date
KR970704426A (en) 1997-09-06
PL181265B1 (en) 2001-06-29
AU695723B2 (en) 1998-08-20
EP0768872A1 (en) 1997-04-23
NO970036L (en) 1997-01-06
EE03378B1 (en) 2001-04-16
HU9700039D0 (en) 1997-02-28
BR9508261A (en) 1997-12-23
AU2994795A (en) 1996-02-09
WO1996001622A1 (en) 1996-01-25
MX9700152A (en) 1997-04-30
PL318464A1 (en) 1997-06-09
FI970058A (en) 1997-01-07
CZ379596A3 (en) 1997-08-13
NZ289958A (en) 1998-09-24
FI970058A0 (en) 1997-01-07
SK166096A3 (en) 1997-09-10
HUT78132A (en) 2000-06-28
NO970036D0 (en) 1997-01-06
EE9700014A (en) 1997-06-16
IS4398A (en) 1996-12-17
CA2193681A1 (en) 1996-01-25

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