WO2004016242A3 - Procede pour produire une composition pharmaceutique stable a unites multiples d'administration orale contenant des benzimidazoles - Google Patents

Procede pour produire une composition pharmaceutique stable a unites multiples d'administration orale contenant des benzimidazoles Download PDF

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Publication number
WO2004016242A3
WO2004016242A3 PCT/IB2003/003514 IB0303514W WO2004016242A3 WO 2004016242 A3 WO2004016242 A3 WO 2004016242A3 IB 0303514 W IB0303514 W IB 0303514W WO 2004016242 A3 WO2004016242 A3 WO 2004016242A3
Authority
WO
WIPO (PCT)
Prior art keywords
enteric
benzimidazole
pharmaceutical composition
pellets
multiple unit
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/IB2003/003514
Other languages
English (en)
Other versions
WO2004016242A8 (fr
WO2004016242A2 (fr
Inventor
Amit Krishna Antarkar
Jawed Abdul Sattar Abdul
Rajendra Ghanshamlal Lala
Ketaki Kishore Joshi
Parag Narayan Gadkari
Gaurang Hasmukhlal Thanawala
Maya Janak Shah
Janak Ramanlal Shah
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.)
Themis Laboratories Pvt Ltd
Original Assignee
Themis Laboratories Pvt Ltd
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 Themis Laboratories Pvt Ltd filed Critical Themis Laboratories Pvt Ltd
Priority to EP03787961A priority Critical patent/EP1530460A2/fr
Priority to CA002496044A priority patent/CA2496044A1/fr
Priority to AU2003250468A priority patent/AU2003250468A1/en
Publication of WO2004016242A2 publication Critical patent/WO2004016242A2/fr
Publication of WO2004016242A3 publication Critical patent/WO2004016242A3/fr
Publication of WO2004016242A8 publication Critical patent/WO2004016242A8/fr
Priority to US11/057,386 priority patent/US20050191353A1/en
Anticipated expiration legal-status Critical
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
    • A61K9/48—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
    • 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
    • A61K9/5005—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un procédé pour produire une composition pharmaceutique stable, à unités multiples, d'administration orale, contenant une concentration élevée de benzimidazole pouvant aller jusqu'à 40 % M/M, sans utiliser de benzimidazole micronisé, d'agents de désintégration ni de charges. Les tensioactifs de ces compositions se trouvent dans une couche polymère entéro-soluble et ne sont pas en contact avec le benzimidazole. La composition pharmaceutique à unités multiples de l'invention a une dégradation acide minimale dans 0.1 N de HCl au bout de deux heures et une libération tampon dans un pH de 6.8 supérieure à 85 % M/M au bout de 45 minutes. Cette composition pharmaceutique à unités multiples se présente sous forme de granules non agglomérées, uniformes et de même dimension, dotées d'un enrobage gastro-résistant, ces granules étant traitées de manière continue ou en lots dans une seule installation telle qu'un dispositif de pulvérisation à lit fluidisé. La présente invention porte également sur le dépôt séquentiel a) d'une couche de matière alcaline sur des graines sans équivalentes pour obtenir des graines traitées sans équivalentes, b) d'une couche médicamenteuse pour obtenir des granules médicamenteuses, c) d'une couche polymère d'enrobage pour obtenir des granules enrobées, d) d'une couche polymère entéro-soluble pour obtenir des granules à enrobage gastro-résistant. Les granules à enrobage gastro-résistant ainsi obtenues peuvent être disposées dans des capsules de toute petite taille (calibre 5) pour en faciliter l'administration et favoriser l'acceptation du patient.
PCT/IB2003/003514 2002-08-16 2003-08-04 Procede pour produire une composition pharmaceutique stable a unites multiples d'administration orale contenant des benzimidazoles Ceased WO2004016242A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP03787961A EP1530460A2 (fr) 2002-08-16 2003-08-04 Procede pour produire une composition pharmaceutique stable a unites multiples d'administration orale contenant des benzimidazoles
CA002496044A CA2496044A1 (fr) 2002-08-16 2003-08-04 Procede pour produire une composition pharmaceutique stable a unites multiples d'administration orale contenant des benzimidazoles
AU2003250468A AU2003250468A1 (en) 2002-08-16 2003-08-04 A process for manufacture of stable oral multiple units pharamceutical composition containing benzimidazoles
US11/057,386 US20050191353A1 (en) 2002-08-16 2005-02-15 Process for manufacture of stable oral multiple unit pharmaceutical composition containing benzimidazoles

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN742/MUM/2002 2002-08-16
IN742MU2002 2002-08-16

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/057,386 Continuation US20050191353A1 (en) 2002-08-16 2005-02-15 Process for manufacture of stable oral multiple unit pharmaceutical composition containing benzimidazoles

Publications (3)

Publication Number Publication Date
WO2004016242A2 WO2004016242A2 (fr) 2004-02-26
WO2004016242A3 true WO2004016242A3 (fr) 2004-04-08
WO2004016242A8 WO2004016242A8 (fr) 2004-10-07

Family

ID=31726528

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2003/003514 Ceased WO2004016242A2 (fr) 2002-08-16 2003-08-04 Procede pour produire une composition pharmaceutique stable a unites multiples d'administration orale contenant des benzimidazoles

Country Status (4)

Country Link
EP (1) EP1530460A2 (fr)
AU (1) AU2003250468A1 (fr)
CA (1) CA2496044A1 (fr)
WO (1) WO2004016242A2 (fr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1459737B1 (fr) * 2001-10-17 2012-09-26 Takeda Pharmaceutical Company Limited Granules contenant un agent chimique instable en milieu acide, en concentration elevee
AR052225A1 (es) * 2004-11-04 2007-03-07 Astrazeneca Ab Formulaciones de tabletas de liberacion modificada par inhibidores de la bomba de protones
AR051654A1 (es) * 2004-11-04 2007-01-31 Astrazeneca Ab Nuevas formulaciones de pellets de liberacion modificada para inhibidores de la bomba de protones
ITMO20050157A1 (it) 2005-06-22 2006-12-23 New Photocatalyst Solution Ltd Sospensioni di biossido di titanio e metodo per ottenerle.
CN100425235C (zh) * 2006-12-14 2008-10-15 湖南康普制药有限公司 奥美拉唑肠溶微丸及其制备方法
EP2319504A1 (fr) * 2009-11-07 2011-05-11 Laboratorios Del. Dr. Esteve, S.A. Forme pharmaceutique solide
WO2013064535A1 (fr) 2011-11-02 2013-05-10 Laboratorios Del Dr. Esteve, S.A. Composition pharmaceutique d'oméprazole
CN103202818A (zh) * 2012-01-15 2013-07-17 山东新时代药业有限公司 一种含有右旋雷贝拉唑或其可药用盐的肠溶片剂及其制备方法
CN103550188B (zh) * 2013-11-15 2014-10-29 四川智强医药科技开发有限公司 兰索拉唑肠溶微丸胶囊及其制备方法
WO2024228542A1 (fr) * 2023-05-04 2024-11-07 풍림무약주식회사 Composition de revêtement entérique et procédé de préparation de comprimé utilisant celle-ci

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0502556A1 (fr) * 1986-04-30 1992-09-09 Aktiebolaget Hässle Utilisation d'un matériau à noyau et de couches pour obtenir des formulations pharmaceutiques stable au changement de couleur des composés sensibles aux acides
EP1213015A1 (fr) * 1995-07-05 2002-06-12 Byk Gulden Lomberg Chemische Fabrik GmbH Composition pharmaceutique orale à libération retardée d'inhibiteurs de pompes à protons

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0502556A1 (fr) * 1986-04-30 1992-09-09 Aktiebolaget Hässle Utilisation d'un matériau à noyau et de couches pour obtenir des formulations pharmaceutiques stable au changement de couleur des composés sensibles aux acides
EP1213015A1 (fr) * 1995-07-05 2002-06-12 Byk Gulden Lomberg Chemische Fabrik GmbH Composition pharmaceutique orale à libération retardée d'inhibiteurs de pompes à protons

Also Published As

Publication number Publication date
AU2003250468A8 (en) 2004-03-03
CA2496044A1 (fr) 2004-02-26
AU2003250468A1 (en) 2004-03-03
WO2004016242A8 (fr) 2004-10-07
EP1530460A2 (fr) 2005-05-18
WO2004016242A2 (fr) 2004-02-26

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