MA35264B1 - Particules sphériques de clopidogrel bisulfate, composition pharmaceutique comprenant celles-ci et procédé de fabrication correspondant - Google Patents

Particules sphériques de clopidogrel bisulfate, composition pharmaceutique comprenant celles-ci et procédé de fabrication correspondant

Info

Publication number
MA35264B1
MA35264B1 MA36661A MA36661A MA35264B1 MA 35264 B1 MA35264 B1 MA 35264B1 MA 36661 A MA36661 A MA 36661A MA 36661 A MA36661 A MA 36661A MA 35264 B1 MA35264 B1 MA 35264B1
Authority
MA
Morocco
Prior art keywords
spherical particles
clopidogrel bisulfate
manufacture
pharmaceutical composition
particle diameter
Prior art date
Application number
MA36661A
Other languages
English (en)
Inventor
Eui Hwan Cho
Hee Jong Shin
Woo Heon Song
Sun Hwan Lee
Jong Bae Yoon
Jong Sung Park
Original Assignee
Astech Co Ltd
Samjin Pharm 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 Astech Co Ltd, Samjin Pharm Co Ltd filed Critical Astech Co Ltd
Publication of MA35264B1 publication Critical patent/MA35264B1/fr

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
    • A61K9/14—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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D495/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms
    • C07D495/02—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms in which the condensed system contains two hetero rings
    • C07D495/04—Ortho-condensed systems
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne des particules sphériques de clopidogrel bisulfate qui présentent un diamètre de particules en volume à 10% (d0.1) supérieur ou égal à 30 µm, et un diamètre de particules en volume à 50% (d0.5) compris entre 50 et 200 µm, et une composition pharmaceutique comprenant ces particules. Les particules sphériques de l'invention permettent non seulement d'améliorer considérablement des propriétés défavorables d'une préparation pharmaceutique classique de clopidogrel bisulfate, telles que de mauvaises caractéristiques de compression et d'écoulement et une force électrostatique superficielle élevée, mais aussi de réduire considérablement des inconvénients liés à la fabrication de comprimés, tels que des écarts de poids et une adhérence pendant une préparation utilisant une technique de compression directe de poudre, ainsi que le risque d'une transformation cristalline. Cette composition possède ainsi une stabilité physiochimique améliorée, et, grâce à ses effets anticoagulants, peut être utilisée efficacement comme agent thérapeutique pour traiter l'artériosclérose, l'accident vasculaire cérébral, l'infarctus du myocarde et l'athérosclérose.
MA36661A 2011-07-12 2014-01-08 Particules sphériques de clopidogrel bisulfate, composition pharmaceutique comprenant celles-ci et procédé de fabrication correspondant MA35264B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020110069039A KR101324862B1 (ko) 2011-07-12 2011-07-12 클로피도그렐 황산수소염의 구형 입자, 이를 포함하는 약학적 조성물 및 이의 제조방법
PCT/KR2011/008071 WO2013008981A1 (fr) 2011-07-12 2011-10-27 Particules sphériques de clopidogrel bisulfate, composition pharmaceutique comprenant celles-ci et procédé de fabrication correspondant

Publications (1)

Publication Number Publication Date
MA35264B1 true MA35264B1 (fr) 2014-07-03

Family

ID=47506246

Family Applications (1)

Application Number Title Priority Date Filing Date
MA36661A MA35264B1 (fr) 2011-07-12 2014-01-08 Particules sphériques de clopidogrel bisulfate, composition pharmaceutique comprenant celles-ci et procédé de fabrication correspondant

Country Status (8)

Country Link
US (1) US20140154330A1 (fr)
EP (1) EP2732810A1 (fr)
JP (1) JP2014506919A (fr)
KR (1) KR101324862B1 (fr)
CN (1) CN103717207A (fr)
BR (1) BR112014000814A2 (fr)
MA (1) MA35264B1 (fr)
WO (1) WO2013008981A1 (fr)

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CN104817571B (zh) * 2014-12-31 2016-04-20 天津大学 一种制备球形硫酸氢氯吡格雷i晶型的方法
KR101710922B1 (ko) 2015-06-03 2017-02-28 경동제약 주식회사 클로피도그렐 황산염 결정형 i형의 제조방법
CN105012298B (zh) * 2015-07-17 2016-06-01 深圳信立泰药业股份有限公司 一种含有球形硫酸氢氯吡格雷i晶型的药物组合物及其制备方法
CN105748419B (zh) * 2015-07-17 2018-09-14 深圳信立泰药业股份有限公司 一种含有球形硫酸氢氯吡格雷i晶型的药物组合物及其制备方法
CN105061459B (zh) * 2015-07-21 2016-08-24 深圳信立泰药业股份有限公司 一种硫酸氢氯吡格雷i晶型球形结晶的制备方法
KR102532121B1 (ko) * 2017-10-18 2023-05-12 고려제약주식회사 돌미나리 추출물 및 항혈전제를 포함하는 항혈전용 조성물
US11478432B2 (en) * 2018-04-16 2022-10-25 Jiangsu Vcare Pharma Tech Co., Ltd. Instant release pharmaceutical preparation of anticoagulant and preparation method therefor
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Also Published As

Publication number Publication date
KR20130010098A (ko) 2013-01-25
WO2013008981A1 (fr) 2013-01-17
BR112014000814A2 (pt) 2017-02-21
KR101324862B1 (ko) 2013-11-01
US20140154330A1 (en) 2014-06-05
EP2732810A1 (fr) 2014-05-21
CN103717207A (zh) 2014-04-09
JP2014506919A (ja) 2014-03-20

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