KR102205192B1 - 비정질 실로스타졸을 함유하는 고체 분산체 - Google Patents

비정질 실로스타졸을 함유하는 고체 분산체 Download PDF

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Publication number
KR102205192B1
KR102205192B1 KR1020157023661A KR20157023661A KR102205192B1 KR 102205192 B1 KR102205192 B1 KR 102205192B1 KR 1020157023661 A KR1020157023661 A KR 1020157023661A KR 20157023661 A KR20157023661 A KR 20157023661A KR 102205192 B1 KR102205192 B1 KR 102205192B1
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South Korea
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solid dispersion
methacrylic acid
acid copolymer
cilostazol
powder
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Expired - Fee Related
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KR1020157023661A
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English (en)
Korean (ko)
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KR20150115859A (ko
Inventor
준이치 가와사키
아츠야 나카무라
나오키 가마다
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오츠카 세이야쿠 가부시키가이샤
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4709Non-condensed quinolines and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate 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
    • A61K9/146Intimate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/08Vasodilators for multiple indications
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

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  • 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)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pain & Pain Management (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (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)
KR1020157023661A 2013-02-06 2014-02-05 비정질 실로스타졸을 함유하는 고체 분산체 Expired - Fee Related KR102205192B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JPJP-P-2013-021475 2013-02-06
JP2013021475 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
KR20150115859A KR20150115859A (ko) 2015-10-14
KR102205192B1 true KR102205192B1 (ko) 2021-01-20

Family

ID=50184966

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KR1020157023661A Expired - Fee Related KR102205192B1 (ko) 2013-02-06 2014-02-05 비정질 실로스타졸을 함유하는 고체 분산체

Country Status (11)

Country Link
US (1) US9555026B2 (enExample)
EP (1) EP2953615B1 (enExample)
JP (2) JP5980449B2 (enExample)
KR (1) KR102205192B1 (enExample)
CN (1) CN105050586B (enExample)
AR (1) AR095143A1 (enExample)
AU (1) AU2014215920B2 (enExample)
CA (1) CA2899389C (enExample)
PH (1) PH12015501722A1 (enExample)
TW (1) TWI615157B (enExample)
WO (1) WO2014123244A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110381945A (zh) * 2017-02-10 2019-10-25 阿尔图姆制药股份有限公司 口服给予的镓(iii)配合物的组合物
KR102114550B1 (ko) * 2018-07-10 2020-05-22 삼육대학교산학협력단 생리학적 체내 동태 연구 모델링을 이용한 약제학적 조성물의 제조 방법
CA3136081A1 (en) * 2019-05-03 2020-11-12 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
CH683673A5 (de) * 1991-10-01 1994-04-29 Otsuka Pharma Co Ltd Antithromboseharz, Antithromboseröhrchen, Antithrombosefilm und Antithromboseüberzug.
CN1168102A (zh) * 1995-01-10 1997-12-17 大制药株式会社 树脂微粒及含该树脂微粒的药用材料和药剂
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
PT784974E (pt) * 1995-07-26 2003-09-30 Kyowa Hakko Kogyo Kk Preparacao de derivados de xantina numa dispersao solida
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
CA2508840A1 (en) * 2002-12-20 2004-07-08 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
JP2008521878A (ja) * 2004-12-02 2008-06-26 ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー 非晶質アトルバスタチンの医薬組成物及びその製造のための方法
EP1970040A4 (en) 2005-12-22 2013-05-29 Otsuka Pharma Co Ltd METHOD FOR PRODUCING MEDICINAL WAX MATRIX PARTICLES, IN THE METHOD OF USING EXTRUDERS AND CILOSTAZOL-CONTAINING PREPARATION WITH DELAYED RELEASE
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
WO2008138755A2 (en) 2007-05-11 2008-11-20 F. Hoffmann-La Roche Ag Pharmaceutical compositions for poorly soluble drugs
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
TWI615157B (zh) 2018-02-21
AU2014215920B2 (en) 2018-03-15
EP2953615B1 (en) 2018-05-23
CN105050586A (zh) 2015-11-11
CN105050586B (zh) 2017-12-08
HK1218618A1 (en) 2017-03-03
TW201440814A (zh) 2014-11-01
EP2953615A1 (en) 2015-12-16
JP2016193915A (ja) 2016-11-17
WO2014123244A1 (en) 2014-08-14
AU2014215920A1 (en) 2015-08-20
PH12015501722B1 (en) 2015-11-09
JP5980449B2 (ja) 2016-08-31
CA2899389C (en) 2021-02-16
AR095143A1 (es) 2015-09-30
JP2016506948A (ja) 2016-03-07
CA2899389A1 (en) 2014-08-14
US20150366859A1 (en) 2015-12-24
KR20150115859A (ko) 2015-10-14
PH12015501722A1 (en) 2015-11-09
US9555026B2 (en) 2017-01-31

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