WO2004016242A3 - A process for manufacture of stable oral multiple units pharamceutical composition containing benzimidazoles - Google Patents

A process for manufacture of stable oral multiple units pharamceutical composition containing 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
French (fr)
Other versions
WO2004016242A8 (en
WO2004016242A2 (en
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/en
Priority to CA002496044A priority patent/CA2496044A1/en
Priority to AU2003250468A priority patent/AU2003250468A1/en
Publication of WO2004016242A2 publication Critical patent/WO2004016242A2/en
Publication of WO2004016242A3 publication Critical patent/WO2004016242A3/en
Publication of WO2004016242A8 publication Critical patent/WO2004016242A8/en
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

This invention relates to process for manufacture of a stable, oral, multiple unit pharmaceutical composition containing high concentration of benzimidazole upto about 40%w/w without the use of micronized benzimidazole, disintegrating agent and fillers. Surfactants in these compositions are in enteric polymer layer and not in contact with benzimidazole. Multiple unit pharmaceutical composition of the invention shows minimum acid degradation in 0.1 N HCI after two h ours a nd pH 6.8 buffer release of more than 85% w/w after 45 minutes. Multiple unit pharmaceutical composition is in the form unagglomerated, uniformly shaped and sized enteric-coated pellets, which are processed continuously or in batches in single equipment such as fluid bed bottom spray processor. The invention involves sequential deposition of a) alkaline material layer on non-pariel seeds to obtain treated non-pariel seeds b) drug layer to obtain drug pellets c) sealant polymer layer to obtain sealed pellets d) enteric polymer layer to obtain enteric coated pellets. The enteric-coated pellets obtained are capable of being filled in smallest size capsule (size 5) for ease of administration and patient acceptance.
PCT/IB2003/003514 2002-08-16 2003-08-04 A process for manufacture of stable oral multiple units pharamceutical composition containing benzimidazoles Ceased WO2004016242A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP03787961A EP1530460A2 (en) 2002-08-16 2003-08-04 A process for manufacture of stable oral multiple units pharamceutical composition containing benzimidazoles
CA002496044A CA2496044A1 (en) 2002-08-16 2003-08-04 A process for manufacture of stable oral multiple units pharamceutical composition containing 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 (en) 2004-02-26
WO2004016242A3 true WO2004016242A3 (en) 2004-04-08
WO2004016242A8 WO2004016242A8 (en) 2004-10-07

Family

ID=31726528

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2003/003514 Ceased WO2004016242A2 (en) 2002-08-16 2003-08-04 A process for manufacture of stable oral multiple units pharamceutical composition containing benzimidazoles

Country Status (4)

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

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1459737B1 (en) * 2001-10-17 2012-09-26 Takeda Pharmaceutical Company Limited Granules containing acid-unstable chemical in large amount
AR052225A1 (en) * 2004-11-04 2007-03-07 Astrazeneca Ab FORMULATIONS OF MODIFIED RELEASE TABLETS FOR INHIBITORS OF THE PUMP OF PROTONS
AR051654A1 (en) * 2004-11-04 2007-01-31 Astrazeneca Ab NEW FORMULATIONS OF MODIFIED RELEASE PELLETS FOR PROTON PUMP INHIBITORS
ITMO20050157A1 (en) 2005-06-22 2006-12-23 New Photocatalyst Solution Ltd SUSPENSIONS OF TITANIUM DIOXIDE AND METHOD OF OBTAINING THEM.
CN100425235C (en) * 2006-12-14 2008-10-15 湖南康普制药有限公司 Enteric omeprazole micropill and its preparing method
EP2319504A1 (en) * 2009-11-07 2011-05-11 Laboratorios Del. Dr. Esteve, S.A. Pharmaceutical solid dosage form
WO2013064535A1 (en) 2011-11-02 2013-05-10 Laboratorios Del Dr. Esteve, S.A. Pharmaceutical composition of omeprazole
CN103202818A (en) * 2012-01-15 2013-07-17 山东新时代药业有限公司 An enteric-coated tablet containing D-rabeprazole or a pharmaceutically acceptable salt thereof, and a preparation method therefor
CN103550188B (en) * 2013-11-15 2014-10-29 四川智强医药科技开发有限公司 Lansoprazole enteric-coated pellet capsule as well as preparation method thereof
WO2024228542A1 (en) * 2023-05-04 2024-11-07 풍림무약주식회사 Enteric coating composition and method for preparing tablet using same

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0502556A1 (en) * 1986-04-30 1992-09-09 Aktiebolaget Hässle Use of specific core material and layers to obtain pharmaceutical formulations stable to discolouration of acid labile compounds
EP1213015A1 (en) * 1995-07-05 2002-06-12 Byk Gulden Lomberg Chemische Fabrik GmbH Oral pharmaceutical composition with delayed release of proton pump inhibitors

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0502556A1 (en) * 1986-04-30 1992-09-09 Aktiebolaget Hässle Use of specific core material and layers to obtain pharmaceutical formulations stable to discolouration of acid labile compounds
EP1213015A1 (en) * 1995-07-05 2002-06-12 Byk Gulden Lomberg Chemische Fabrik GmbH Oral pharmaceutical composition with delayed release of proton pump inhibitors

Also Published As

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

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