ES2195342T3 - Formulacion farmaceutica de omeprazol. - Google Patents

Formulacion farmaceutica de omeprazol.

Info

Publication number
ES2195342T3
ES2195342T3 ES98924700T ES98924700T ES2195342T3 ES 2195342 T3 ES2195342 T3 ES 2195342T3 ES 98924700 T ES98924700 T ES 98924700T ES 98924700 T ES98924700 T ES 98924700T ES 2195342 T3 ES2195342 T3 ES 2195342T3
Authority
ES
Spain
Prior art keywords
omeprazole
active ingredient
enantiomer
core material
pharmaceutical formulation
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.)
Expired - Lifetime
Application number
ES98924700T
Other languages
English (en)
Inventor
Magnus Erickson
Lars Josefsson
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.)
AstraZeneca AB
Original Assignee
AstraZeneca AB
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=20407122&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2195342(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by AstraZeneca AB filed Critical AstraZeneca AB
Application granted granted Critical
Publication of ES2195342T3 publication Critical patent/ES2195342T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61K9/28—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
    • 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
    • A61K9/14—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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Se presenta una formulación farmacéutica oral revestida entérica que comprende como ingrediente activo un compuesto seleccionado entre el grupo de omeprazola, una sal alcalina de omeprazola, el (-)-enantiómero de omeprazola y una sal alcalina del (-)-enantiómero de omeprazola, en donde la formulación comprende un material de núcleo del ingrediente activo y opcionalmente un compuesto reactivo alcalino, el ingrediente activo se mezcla con un excipiente farmacológicamente aceptable, tal como, por ejemplo, un agente amalgamador y sobre el material de núcleo se dispone una capa de separación y una capa de revestimiento entérica. Se utiliza una metilcelulosa de hidroxipropilo (HPMC) de baja viscosidad con un punto de enturbiamiento específico en la fabricación de las formulaciones farmacéuticas. Además, la invención describe un proceso para la preparación y el uso de las formulaciones reivindicadas en medicina.
ES98924700T 1997-05-28 1998-05-18 Formulacion farmaceutica de omeprazol. Expired - Lifetime ES2195342T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
SE9702000A SE9702000D0 (sv) 1997-05-28 1997-05-28 New pharmaceutical formulation

Publications (1)

Publication Number Publication Date
ES2195342T3 true ES2195342T3 (es) 2003-12-01

Family

ID=20407122

Family Applications (1)

Application Number Title Priority Date Filing Date
ES98924700T Expired - Lifetime ES2195342T3 (es) 1997-05-28 1998-05-18 Formulacion farmaceutica de omeprazol.

Country Status (40)

Country Link
US (1) US6090827A (es)
EP (1) EP0984773B1 (es)
JP (1) JP4649001B2 (es)
KR (1) KR100540721B1 (es)
CN (1) CN1123338C (es)
AR (1) AR012698A1 (es)
AT (1) ATE234078T1 (es)
AU (1) AU722879B2 (es)
BR (1) BR9809484A (es)
CA (1) CA2290531C (es)
CZ (1) CZ298972B6 (es)
DE (1) DE69812089T2 (es)
DK (1) DK0984773T3 (es)
DZ (1) DZ2494A1 (es)
EE (1) EE03903B1 (es)
EG (1) EG24044A (es)
ES (1) ES2195342T3 (es)
HR (1) HRP980260B1 (es)
HU (1) HU229154B1 (es)
ID (1) ID24654A (es)
IL (1) IL132895A0 (es)
IS (1) IS2856B (es)
MA (1) MA26497A1 (es)
MY (1) MY122298A (es)
NO (1) NO328100B1 (es)
NZ (1) NZ500886A (es)
PL (1) PL194634B1 (es)
PT (1) PT984773E (es)
RS (1) RS49629B (es)
RU (1) RU2207121C2 (es)
SA (1) SA98190304B1 (es)
SE (1) SE9702000D0 (es)
SI (1) SI0984773T1 (es)
SK (1) SK286625B6 (es)
TN (1) TNSN98068A1 (es)
TR (1) TR199902890T2 (es)
TW (1) TW575435B (es)
UA (1) UA71541C2 (es)
WO (1) WO1998053803A1 (es)
ZA (1) ZA984178B (es)

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US6699885B2 (en) * 1996-01-04 2004-03-02 The Curators Of The University Of Missouri Substituted benzimidazole dosage forms and methods of 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
US5840737A (en) 1996-01-04 1998-11-24 The Curators Of The University Of Missouri Omeprazole solution and method for using same
US6174548B1 (en) * 1998-08-28 2001-01-16 Andrx Pharmaceuticals, Inc. Omeprazole formulation
US6096340A (en) 1997-11-14 2000-08-01 Andrx Pharmaceuticals, Inc. Omeprazole formulation
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SE9803772D0 (sv) 1998-11-05 1998-11-05 Astra Ab Pharmaceutical formulation
SE9902386D0 (sv) * 1999-06-22 1999-06-22 Astra Ab New formulation
US6245913B1 (en) 1999-06-30 2001-06-12 Wockhardt Europe Limited Synthetic procedure for 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methylthio]-IH-benzimidazole hydrochloride and its conversion to omeprazole
ES2168043B1 (es) 1999-09-13 2003-04-01 Esteve Labor Dr Forma farmaceutica solida oral de liberacion modificada que contiene un compuesto de bencimidazol labil en medio acido.
AU782538B2 (en) 1999-10-20 2005-08-04 Eisai Co. Ltd. Method for stabilizing benzimidazole compounds
US20040092511A1 (en) * 1999-12-10 2004-05-13 Billstein Stephan Anthony Pharmaceutical combinations and their use in treating gastrointestinal and abdominal viscera disorders
US20020192299A1 (en) * 2000-12-28 2002-12-19 Rajneesh Taneja Pharmaceutical compositions of a non-enteric coated proton pump inhibitor with a carbonate salt and bicarbonate salt combination
JP2002234842A (ja) * 2001-02-09 2002-08-23 Kyowa Yakuhin Kogyo Kk 内服腸溶性製剤
WO2003063840A2 (en) * 2002-01-25 2003-08-07 Santarus, Inc. Transmucosal delivery of proton pump inhibitors
US20040082618A1 (en) * 2002-07-03 2004-04-29 Rajneesh Taneja Liquid dosage forms of acid labile drugs
FR2843121B3 (fr) 2002-08-02 2004-09-10 Rhodia Chimie Sa Agent ignifugeant, procede de preparation et l'utilisation de cet agent
US20040121004A1 (en) * 2002-12-20 2004-06-24 Rajneesh Taneja Dosage forms containing a PPI, NSAID, and buffer
US20070243251A1 (en) * 2002-12-20 2007-10-18 Rajneesh Taneja Dosage Forms Containing A PPI, NSAID, and Buffer
US20040146558A1 (en) * 2003-01-28 2004-07-29 Kyowa Pharmaceutical Co., Ltd. Oral enteric-coated preparation
RU2359671C2 (ru) * 2003-01-29 2009-06-27 Такеда Фармасьютикал Компани Лимитед Способ получения препарата с покрытием
CN1761465B (zh) * 2003-01-29 2010-10-13 武田药品工业株式会社 制备被覆制剂的方法
JP4567340B2 (ja) * 2003-01-29 2010-10-20 武田薬品工業株式会社 被覆製剤の製造方法
EP1588708A4 (en) * 2003-01-29 2006-03-01 Takeda Pharmaceutical METHOD FOR PRODUCING COATED PREPARATION
WO2004073654A2 (en) * 2003-02-20 2004-09-02 Santarus, Inc. A novel formulation, omeprazole antacid complex-immediate release for rapid and sustained supression of gastric acid
US20050042277A1 (en) * 2003-07-17 2005-02-24 Irukulla Srinivas Pharmaceutical compositions having a swellable coating
US8993599B2 (en) 2003-07-18 2015-03-31 Santarus, Inc. Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them
US20070292498A1 (en) * 2003-11-05 2007-12-20 Warren Hall Combinations of proton pump inhibitors, sleep aids, buffers and pain relievers
CN1311824C (zh) * 2004-04-21 2007-04-25 常州市第四制药厂有限公司 奥美拉唑肠溶微粒制剂及制备方法
US8815916B2 (en) * 2004-05-25 2014-08-26 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
DE602005013372D1 (de) * 2005-07-29 2009-04-30 Rottapharm Spa Kombination aus Itriglumid und PPI zur Behandlung von gastrointestinalen- und assozierten Krankheiten
CA2654402A1 (en) * 2006-06-01 2007-12-06 Adel Penhasi Multiple unit pharmaceutical formulation
KR101436516B1 (ko) * 2007-07-23 2014-09-02 주식회사태평양제약 코팅된 펠렛을 함유하는 현탁정 및 이의 제조방법
CN104940127A (zh) * 2007-09-28 2015-09-30 西梯茜生命工学股份有限公司 含有埃索美拉唑的药物组合物
DK2273985T3 (en) * 2008-03-28 2016-04-25 Ferrer Int Capsule for the prevention of cardiovascular diseases
RU2554347C2 (ru) 2008-08-19 2015-06-27 Ксенопорт, Инк. Пролекарства метилгидрофумарата, фармацевтические композиции с ними и способы применения
US10945984B2 (en) 2012-08-22 2021-03-16 Arbor Pharmaceuticals, Llc Methods of administering monomethyl fumarate and prodrugs thereof having reduced side effects
CA2882730C (en) 2012-08-22 2019-12-31 Arbor Pharmaceuticals, Llc Oral dosage forms of methyl hydrogen fumarate and prodrugs thereof
CN102961356A (zh) * 2012-12-11 2013-03-13 山西云鹏制药有限公司 一种含奥美拉唑的蓝色肠溶片剂的制备方法
US10179118B2 (en) 2013-03-24 2019-01-15 Arbor Pharmaceuticals, Llc Pharmaceutical compositions of dimethyl fumarate
US9416096B2 (en) 2013-09-06 2016-08-16 Xenoport, Inc. Crystalline forms of (N,N-Diethylcarbamoyl)methyl methyl (2E)but-2-ene-1,4-dioate, methods of synthesis and use
WO2015042294A1 (en) * 2013-09-18 2015-03-26 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
US9999672B2 (en) 2014-03-24 2018-06-19 Xenoport, Inc. Pharmaceutical compositions of fumaric acid esters
US20170042806A1 (en) 2015-04-29 2017-02-16 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
US20230058473A1 (en) 2020-01-27 2023-02-23 Towa Pharmaceutical Co., Ltd. Esomeprazole oral preparation and method for producing the same
KR102432084B1 (ko) 2021-11-16 2022-08-12 알리코제약(주) S-오메프라졸을 함유하는 안정성이 개선되고 소형화된 정제
JP2025532389A (ja) 2022-10-04 2025-09-29 ザビリュク，アルセニー 大動脈弁の石灰化の抑制

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JPH05255088A (ja) * 1991-11-05 1993-10-05 Yoshitomi Pharmaceut Ind Ltd 抗潰瘍剤含有製剤
JP2669446B2 (ja) * 1992-03-23 1997-10-27 信越化学工業株式会社 医薬品コーティング液用原料粉粒体
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JPH0733659A (ja) * 1992-07-17 1995-02-03 Yoshitomi Pharmaceut Ind Ltd 抗潰瘍剤含有製剤
SE9301830D0 (sv) * 1993-05-28 1993-05-28 Ab Astra New compounds
SE9302395D0 (sv) * 1993-07-09 1993-07-09 Ab Astra New pharmaceutical formulation
SE9302396D0 (sv) * 1993-07-09 1993-07-09 Ab Astra A novel compound form
DK0723436T3 (da) * 1994-07-08 2001-11-26 Astrazeneca Ab Tabletteret flerenhedsdoseringsform
SE9500422D0 (sv) * 1995-02-06 1995-02-06 Astra Ab New oral pharmaceutical dosage forms

Also Published As

Publication number Publication date
SA98190304B1 (ar) 2006-10-11
HUP0002182A2 (hu) 2002-05-29
PL337237A1 (en) 2000-08-14
AU722879B2 (en) 2000-08-10
MA26497A1 (fr) 2004-12-20
PL194634B1 (pl) 2007-06-29
CA2290531A1 (en) 1998-12-03
AU7680398A (en) 1998-12-30
TW575435B (en) 2004-02-11
WO1998053803A1 (en) 1998-12-03
BR9809484A (pt) 2000-06-20
HRP980260B1 (en) 2003-10-31
SK159099A3 (en) 2000-06-12
EP0984773B1 (en) 2003-03-12
DE69812089T2 (de) 2004-03-04
TR199902890T2 (xx) 2000-02-21
CZ298972B6 (cs) 2008-03-26
HUP0002182A3 (en) 2003-02-28
KR20010013104A (ko) 2001-02-26
EG24044A (en) 2008-04-13
EE03903B1 (et) 2002-12-16
EP0984773A1 (en) 2000-03-15
NZ500886A (en) 2001-11-30
RU2207121C2 (ru) 2003-06-27
CZ420299A3 (cs) 2000-05-17
NO995809D0 (no) 1999-11-26
EE9900540A (et) 2000-06-15
IS2856B (is) 2013-11-15
CN1258217A (zh) 2000-06-28
IL132895A0 (en) 2001-03-19
US6090827A (en) 2000-07-18
SK286625B6 (sk) 2009-02-05
AR012698A1 (es) 2000-11-08
CN1123338C (zh) 2003-10-08
JP2002500665A (ja) 2002-01-08
YU60899A (sh) 2002-06-19
PT984773E (pt) 2003-07-31
HRP980260A2 (en) 1999-02-28
TNSN98068A1 (fr) 2005-03-15
DK0984773T3 (da) 2003-07-07
RS49629B (sr) 2007-08-03
JP4649001B2 (ja) 2011-03-09
DE69812089D1 (de) 2003-04-17
HK1025744A1 (en) 2000-11-24
ATE234078T1 (de) 2003-03-15
ID24654A (id) 2000-07-27
UA71541C2 (uk) 2004-12-15
DZ2494A1 (fr) 2003-01-25
NO328100B1 (no) 2009-12-07
KR100540721B1 (ko) 2006-01-10
NO995809L (no) 2000-01-28
SI0984773T1 (en) 2003-10-31
ZA984178B (en) 1998-11-30
SE9702000D0 (sv) 1997-05-28
CA2290531C (en) 2006-12-12
IS5245A (is) 1999-11-11
HU229154B1 (en) 2013-09-30
MY122298A (en) 2006-04-29

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