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TW200727898A - Stabilized pharmaceutical oral preparation containing clopidogrel bisulfate - Google Patents

Stabilized pharmaceutical oral preparation containing clopidogrel bisulfate

Info

Publication number
TW200727898A
TW200727898A TW095138977A TW95138977A TW200727898A TW 200727898 A TW200727898 A TW 200727898A TW 095138977 A TW095138977 A TW 095138977A TW 95138977 A TW95138977 A TW 95138977A TW 200727898 A TW200727898 A TW 200727898A
Authority
TW
Taiwan
Prior art keywords
oral preparation
clopidogrel bisulfate
preparation containing
pharmaceutical oral
stabilized pharmaceutical
Prior art date
Application number
TW095138977A
Other languages
Chinese (zh)
Inventor
Joon-Gyo Oh
Dong-Chul Shin
Ji-Young Shin
Won-No Youn
Key-An Um
Dong-Sun Min
Jae-Sun Kim
Nam Ho Kim
Nam Kyu Lee
Original Assignee
Sk Chemicals Co 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 Sk Chemicals Co Ltd filed Critical Sk Chemicals Co Ltd
Publication of TW200727898A publication Critical patent/TW200727898A/en

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
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4365—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

Landscapes

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

Abstract

The present invention relates to a stabilized oral preparation comprising clopidogrel bisulfate, and in particular the oral preparation herein further comprises starch and cellulose along with the crystalline form 1 or form 2 clopidogrel bisulfate, which is susceptible to moisture and produces hydrated product-related impurities when formulated into oral preparations, thus showing storage stability even in the same dosage form with the conventional preparations.
TW095138977A 2005-10-24 2006-10-23 Stabilized pharmaceutical oral preparation containing clopidogrel bisulfate TW200727898A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020050100460A KR20070044323A (en) 2005-10-24 2005-10-24 Oral solution containing clopidogrel hydrogen sulfate with improved storage stability

Publications (1)

Publication Number Publication Date
TW200727898A true TW200727898A (en) 2007-08-01

Family

ID=37967949

Family Applications (1)

Application Number Title Priority Date Filing Date
TW095138977A TW200727898A (en) 2005-10-24 2006-10-23 Stabilized pharmaceutical oral preparation containing clopidogrel bisulfate

Country Status (4)

Country Link
KR (1) KR20070044323A (en)
AR (1) AR056721A1 (en)
TW (1) TW200727898A (en)
WO (1) WO2007049868A1 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ584521A (en) * 2007-10-10 2011-03-31 Avantor Performance Mat Inc Directly compressible high functionality granular microcrystalline cellulose based excipient, manufacturing process and use thereof
EP2095815B1 (en) 2008-02-26 2011-10-26 Laboratorios Lesvi, S.L. Pharmaceutical formulations containing clopidogrel
KR101324862B1 (en) * 2011-07-12 2013-11-01 (주)에이에스텍 Spherical particle of clopidogrel bisulfate, pharmaceutical composition comprising the same and method of preparation thereof
HUP1400294A2 (en) 2014-06-13 2015-12-28 Skillpharm Kft Novel application of clopidogrel
CN109528669A (en) * 2018-12-25 2019-03-29 哈尔滨珍宝制药有限公司 Bisulfate clopidogrel composition, clopidogrel hydrogen sulfate tablet and preparation method thereof
CN112999180B (en) * 2019-12-20 2022-08-30 青岛黄海制药有限责任公司 Clopidogrel hydrogen sulfate crystal form II tablet and preparation method thereof
CN111166745A (en) * 2020-01-19 2020-05-19 成都施贝康生物医药科技有限公司 Composition and application containing racemic pidogrel or its salt

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2792836B3 (en) * 1999-04-30 2001-07-27 Sanofi Sa PHARMACEUTICAL COMPOSITION IN UNIT FORM CONTAINING ASPIRIN AND CLOPIDOGREL HYDROGENOSULFATE
CA2363053C (en) * 2001-11-09 2011-01-25 Bernard Charles Sherman Clopidogrel bisulfate tablet formulation
WO2005070464A2 (en) * 2004-01-21 2005-08-04 Biofarma Ilac Sanayi Ve Ticaret A.S. A tablet formulation of clopidogrel bisulphate

Also Published As

Publication number Publication date
KR20070044323A (en) 2007-04-27
AR056721A1 (en) 2007-10-17
WO2007049868A1 (en) 2007-05-03

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