JP4688089B2 - 放出制御医薬組成物 - Google Patents

放出制御医薬組成物 Download PDF

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Publication number
JP4688089B2
JP4688089B2 JP2010531838A JP2010531838A JP4688089B2 JP 4688089 B2 JP4688089 B2 JP 4688089B2 JP 2010531838 A JP2010531838 A JP 2010531838A JP 2010531838 A JP2010531838 A JP 2010531838A JP 4688089 B2 JP4688089 B2 JP 4688089B2
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pharmaceutical composition
weight
release pharmaceutical
controlled
oral administration
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Japanese (ja)
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JPWO2010038690A1 (ja
Inventor
勇希 ▲高▼石
豊 高橋
崇 西里
大輔 村山
恵美子 村山
聡一郎 中村
和博 迫
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Astellas Pharma Inc
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Astellas Pharma Inc
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    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • 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
    • A61K47/34—Macromolecular 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
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/2009—Inorganic 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2095—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
    • 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
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2010531838A 2008-09-30 2009-09-28 放出制御医薬組成物 Active JP4688089B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10133808P 2008-09-30 2008-09-30
US61/101,338 2008-09-30
PCT/JP2009/066742 WO2010038690A1 (ja) 2008-09-30 2009-09-28 放出制御医薬組成物

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2010276634A Division JP5625855B2 (ja) 2008-09-30 2010-12-13 放出制御医薬組成物

Publications (2)

Publication Number Publication Date
JP4688089B2 true JP4688089B2 (ja) 2011-05-25
JPWO2010038690A1 JPWO2010038690A1 (ja) 2012-03-01

Family

ID=42073454

Family Applications (2)

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JP2010531838A Active JP4688089B2 (ja) 2008-09-30 2009-09-28 放出制御医薬組成物
JP2010276634A Active JP5625855B2 (ja) 2008-09-30 2010-12-13 放出制御医薬組成物

Family Applications After (1)

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Country Status (24)

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US (4) US20160184275A2 (enExample)
EP (2) EP3827826A1 (enExample)
JP (2) JP4688089B2 (enExample)
KR (1) KR101524164B1 (enExample)
CN (2) CN105232448A (enExample)
AU (1) AU2009300752C1 (enExample)
BR (1) BRPI0919466B1 (enExample)
CA (1) CA2740342C (enExample)
CY (1) CY1123724T1 (enExample)
DK (1) DK2345410T3 (enExample)
ES (1) ES2847876T3 (enExample)
HK (1) HK1216232A1 (enExample)
HR (1) HRP20210179T1 (enExample)
HU (1) HUE052874T2 (enExample)
IL (1) IL212033A (enExample)
LT (1) LT2345410T (enExample)
MX (1) MX351855B (enExample)
PL (1) PL2345410T3 (enExample)
PT (1) PT2345410T (enExample)
RU (1) RU2495666C2 (enExample)
SI (1) SI2345410T1 (enExample)
TW (1) TWI478712B (enExample)
WO (1) WO2010038690A1 (enExample)
ZA (1) ZA201102406B (enExample)

Cited By (1)

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Publication number Priority date Publication date Assignee Title
US10925861B2 (en) 2015-09-01 2021-02-23 Sawai Pharmaceutical Co., Ltd. Mirabegron-containing tablet, method for producing mirabegron-containing pharmaceutical preparation, and method for producing mirabegron-containing granulated product

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CA2144077C (en) * 1992-09-18 2005-05-24 Kazuhiro Sako Hydrogel-type sustained-release preparation
TWI478712B (zh) 2008-09-30 2015-04-01 Astellas Pharma Inc 釋控性醫藥組成物
US8877214B2 (en) 2010-03-29 2014-11-04 Astellas Pharma Inc. Pharmaceutical composition for modified release
US20120070465A1 (en) * 2010-03-29 2012-03-22 Astellas Pharma Inc. Pharmaceutical composition for modified release
JP6272695B2 (ja) 2010-09-01 2018-01-31 エーザイ・アール・アンド・ディー・マネジメント株式会社 体重管理のために有用な５−ｈｔ２ｃアゴニストの改変放出剤形
JP6093762B2 (ja) * 2011-10-21 2017-03-08 武田薬品工業株式会社 徐放性製剤
WO2013147135A1 (ja) * 2012-03-30 2013-10-03 アステラス製薬株式会社 放出制御医薬組成物
US20150031734A1 (en) 2012-03-30 2015-01-29 Astellas Pharma Inc. Pharmaceutical composition containing mirabegron
EP2891493A4 (en) * 2012-08-31 2016-05-18 Astellas Pharma Inc MEDICAL COMPOSITION ADMINISTERED ORALLY
JP2017078023A (ja) * 2014-02-28 2017-04-27 アステラス製薬株式会社 経口投与用医薬組成物
CN104523635B (zh) * 2014-12-23 2017-05-03 深圳万乐药业有限公司 米拉贝隆缓释药物组合物
JP2018090490A (ja) 2015-03-31 2018-06-14 アステラス製薬株式会社 ミラベグロン含有医薬組成物
WO2017186593A1 (en) 2016-04-25 2017-11-02 Synthon B.V. Tablets comprising mirabegron and solifenacin
EP3448366A1 (en) * 2016-04-25 2019-03-06 Synthon B.V. Modified release tablet composition comprising mirabegron
PT3360866T (pt) 2017-02-14 2019-02-19 Tiefenbacher Alfred E Gmbh & Co Kg Pró-fármacos de mirabegrom
KR102051132B1 (ko) * 2017-03-17 2019-12-02 주식회사 종근당 미라베그론 또는 이의 염을 포함하는 방출조절용 약제학적 조성물
KR20170088783A (ko) * 2017-07-07 2017-08-02 지엘팜텍주식회사 미라베그론의 습식과립 조성물
KR101937713B1 (ko) * 2017-07-14 2019-01-14 주식회사 대웅제약 약제학적 제제 및 그 제조방법
WO2019013583A2 (ko) 2017-07-14 2019-01-17 주식회사 대웅제약 약제학적 제제 및 그 제조방법
EP3292864A1 (en) 2017-10-12 2018-03-14 Synthon B.V. Modified release tablet composition comprising mirabegron
US10478399B2 (en) * 2017-10-12 2019-11-19 Synthon B.V. Modified release tablet composition comprising mirabegron
EP3694492A1 (en) 2017-10-12 2020-08-19 Synthon B.V. Modified release tablet composition comprising mirabegron
KR20190089758A (ko) 2018-01-22 2019-07-31 (주)동구바이오제약 미라베그론 또는 이의 약제학적으로 허용가능한 염을 함유하는 지속 방출 제제
KR102371567B1 (ko) 2018-04-06 2022-03-07 한미약품 주식회사 미라베그론이 함유된 방출 제어 약학적 조성물
KR102659760B1 (ko) 2018-10-18 2024-04-23 한미약품 주식회사 미라베그론이 함유된 방출 제어 약제학적 조성물
KR102062791B1 (ko) 2019-02-26 2020-01-06 신일제약 주식회사 미라베그론 또는 그의 약제학적으로 허용되는 염을 함유한 방출조절 제제
JP7377782B2 (ja) * 2019-09-04 2023-11-10 信越化学工業株式会社 フィルム成形用組成物及びフィルム
AR121207A1 (es) * 2020-01-31 2022-04-27 Nippon Shinyaku Co Ltd Composición de liberación controlada
KR102546923B1 (ko) 2020-03-03 2023-06-26 동광제약 주식회사 미라베그론을 포함하는 제어 방출 제제
CN113662922A (zh) * 2020-10-29 2021-11-19 北京莱瑞森医药科技有限公司 一种米拉贝隆缓释组合物及其制备方法和应用
JP2023066053A (ja) * 2021-10-28 2023-05-15 東和薬品株式会社 放出制御医薬組成物
CN114306262B (zh) * 2021-12-30 2023-09-05 乐泰药业有限公司 米拉贝隆缓释片及其制备方法和质量检测方法
EP4338729A1 (en) * 2022-09-19 2024-03-20 Sanovel Ilac Sanayi Ve Ticaret A.S. A tablet comprising mirabegron
JP2025115978A (ja) * 2024-01-26 2025-08-07 富士化学工業株式会社 徐放性製剤
US12097189B1 (en) 2024-02-09 2024-09-24 Astellas Pharma Inc. Pharmaceutical composition for modified release

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