CA2899389C - Solid dispersion comprising amorphous cilostazol - Google Patents

Solid dispersion comprising amorphous cilostazol Download PDF

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Publication number
CA2899389C
CA2899389C CA2899389A CA2899389A CA2899389C CA 2899389 C CA2899389 C CA 2899389C CA 2899389 A CA2899389 A CA 2899389A CA 2899389 A CA2899389 A CA 2899389A CA 2899389 C CA2899389 C CA 2899389C
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CA
Canada
Prior art keywords
solid dispersion
cilostazol
methacrylic acid
acid copolymer
powder
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.)
Active
Application number
CA2899389A
Other languages
English (en)
French (fr)
Other versions
CA2899389A1 (en
Inventor
Junichi Kawasaki
Atsuya NAKAMURA
Naoki Kamada
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.)
Otsuka Pharmaceutical Co Ltd
Original Assignee
Otsuka Pharmaceutical 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 Otsuka Pharmaceutical Co Ltd filed Critical Otsuka Pharmaceutical Co Ltd
Publication of CA2899389A1 publication Critical patent/CA2899389A1/en
Application granted granted Critical
Publication of CA2899389C publication Critical patent/CA2899389C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2072—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P9/08—Vasodilators for multiple indications
    • 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
    • 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
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
CA2899389A 2013-02-06 2014-02-05 Solid dispersion comprising amorphous cilostazol Active CA2899389C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2013021475 2013-02-06
JP2013-021475 2013-02-06
PCT/JP2014/053232 WO2014123244A1 (en) 2013-02-06 2014-02-05 Solid dispersion comprising amorphous cilostazol

Publications (2)

Publication Number Publication Date
CA2899389A1 CA2899389A1 (en) 2014-08-14
CA2899389C true CA2899389C (en) 2021-02-16

Family

ID=50184966

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2899389A Active CA2899389C (en) 2013-02-06 2014-02-05 Solid dispersion comprising amorphous cilostazol

Country Status (11)

Country Link
US (1) US9555026B2 (https=)
EP (1) EP2953615B1 (https=)
JP (2) JP5980449B2 (https=)
KR (1) KR102205192B1 (https=)
CN (1) CN105050586B (https=)
AR (1) AR095143A1 (https=)
AU (1) AU2014215920B2 (https=)
CA (1) CA2899389C (https=)
PH (1) PH12015501722B1 (https=)
TW (1) TWI615157B (https=)
WO (1) WO2014123244A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020513030A (ja) * 2017-02-10 2020-04-30 アルタム ファーマシューティカルズ インコーポレイテッドＡｌｔｕｍ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｃ． 経口投与用のガリウム（ｉｉｉ）錯体の組成物
KR102114550B1 (ko) * 2018-07-10 2020-05-22 삼육대학교산학협력단 생리학적 체내 동태 연구 모델링을 이용한 약제학적 조성물의 제조 방법
US20200345645A1 (en) * 2019-05-03 2020-11-05 Azora Therapeutics, Inc. Compositions comprising indigo and/or an indigo derivative and methods of use thereof

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2266892B (en) * 1991-10-01 1996-04-17 Otsuka Pharma Co Ltd Antithrombotic resin, antithrombotic tube, antithrombotic film and antithrombotic coat
JP3799093B2 (ja) * 1995-01-10 2006-07-19 大塚製薬株式会社 樹脂粒状物およびこれを含有する医療製剤
WO1996021448A1 (en) 1995-01-10 1996-07-18 Otsuka Pharmaceutical Co., Ltd. Resin particle, medical material and pharmaceutical preparation containing said resin particle
US6254889B1 (en) 1995-07-26 2001-07-03 Kyowa Hakko Kogyo Co., Ltd. Solid dispersion dosage form of amorphous xanthine derivative and enteric-coating polymer
JPH11246404A (ja) * 1998-03-04 1999-09-14 Taiho Yakuhin Kogyo Kk 吸収を改善した医薬組成物
US6350786B1 (en) 1998-09-22 2002-02-26 Hoffmann-La Roche Inc. Stable complexes of poorly soluble compounds in ionic polymers
JP4748839B2 (ja) 1999-03-25 2011-08-17 大塚製薬株式会社 シロスタゾール製剤
EG23951A (en) 1999-03-25 2008-01-29 Otsuka Pharma Co Ltd Cilostazol preparation
EP1961419B1 (en) * 2002-12-20 2010-03-24 Pfizer Products Inc. Dosage forms comprising a CETP inhibitor and an HMG-CoA reductase inhibitor
CN1241566C (zh) * 2004-03-15 2006-02-15 深圳海王药业有限公司 西洛他唑固体分散体及其片剂制备方法
US20090088465A1 (en) 2004-12-02 2009-04-02 Stephen Craig Dyar Pharmaceutical Compositions of Amorphous Atorvastatin and Process for Preparing Same
CA2634059C (en) 2005-12-22 2015-11-24 Otsuka Pharmaceutical Co., Ltd. Method of producing drug-containing wax matrix particles, extruder to be used in the method and sustained-release preparation containing cilostazol
US20100172989A1 (en) * 2006-01-21 2010-07-08 Abbott Laboratories Abuse resistant melt extruded formulation having reduced alcohol interaction
JP2007308480A (ja) * 2006-04-20 2007-11-29 Shin Etsu Chem Co Ltd 腸溶性固体分散体を含んでなる固形製剤
US20110165236A1 (en) * 2006-09-22 2011-07-07 Biokey, Inc. Controlled release hydrogel formulation
KR20080076440A (ko) * 2007-02-16 2008-08-20 (주)아모레퍼시픽 실로스타졸의 제어방출 제제 및 그 제조방법
CN101702878B (zh) 2007-05-11 2012-11-28 弗·哈夫曼-拉罗切有限公司 可溶性差的药物的药物组合物
RU2465916C2 (ru) * 2007-10-19 2012-11-10 Оцука Фармасьютикал Ко., Лтд. Твердый фармацевтический препарат матричного типа
AR071706A1 (es) * 2008-05-15 2010-07-07 Otsuka Pharma Co Ltd Una formulacion farmaceutica de cilostazol solida de liberacion sostenida y metodo de preparacion.
TW201010743A (en) * 2008-09-05 2010-03-16 Otsuka Pharma Co Ltd Pharmaceutical solid preparation
WO2011027656A1 (en) 2009-09-04 2011-03-10 Semiconductor Energy Laboratory Co., Ltd. Transistor and display device
KR101282847B1 (ko) * 2011-07-27 2013-07-05 조선대학교산학협력단 실로스타졸을 함유하는 고체분산체 및 이를 포함하는 약학 조성물

Also Published As

Publication number Publication date
JP2016193915A (ja) 2016-11-17
PH12015501722A1 (en) 2015-11-09
CA2899389A1 (en) 2014-08-14
JP5980449B2 (ja) 2016-08-31
TW201440814A (zh) 2014-11-01
AR095143A1 (es) 2015-09-30
EP2953615A1 (en) 2015-12-16
PH12015501722B1 (en) 2015-11-09
US20150366859A1 (en) 2015-12-24
KR20150115859A (ko) 2015-10-14
WO2014123244A1 (en) 2014-08-14
HK1218618A1 (en) 2017-03-03
CN105050586A (zh) 2015-11-11
CN105050586B (zh) 2017-12-08
EP2953615B1 (en) 2018-05-23
AU2014215920B2 (en) 2018-03-15
AU2014215920A1 (en) 2015-08-20
TWI615157B (zh) 2018-02-21
KR102205192B1 (ko) 2021-01-20
JP2016506948A (ja) 2016-03-07
US9555026B2 (en) 2017-01-31

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