WO2019013583A3 - 약제학적 제제 및 그 제조방법 - Google Patents

약제학적 제제 및 그 제조방법 Download PDF

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Publication number
WO2019013583A3
WO2019013583A3 PCT/KR2018/007950 KR2018007950W WO2019013583A3 WO 2019013583 A3 WO2019013583 A3 WO 2019013583A3 KR 2018007950 W KR2018007950 W KR 2018007950W WO 2019013583 A3 WO2019013583 A3 WO 2019013583A3
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WO
WIPO (PCT)
Prior art keywords
preparation
release
active ingredient
mirabegron
controlling
Prior art date
Application number
PCT/KR2018/007950
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English (en)
French (fr)
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WO2019013583A2 (ko
Inventor
윤재희
강한
Original Assignee
주식회사 대웅제약
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Publication date
Priority claimed from KR1020180007928A external-priority patent/KR101937713B1/ko
Application filed by 주식회사 대웅제약 filed Critical 주식회사 대웅제약
Priority to CN201880044152.8A priority Critical patent/CN110869008B/zh
Priority to EP18832644.1A priority patent/EP3653202B1/en
Priority to US16/626,084 priority patent/US11433054B2/en
Priority to JP2020520420A priority patent/JP6870177B2/ja
Publication of WO2019013583A2 publication Critical patent/WO2019013583A2/ko
Publication of WO2019013583A3 publication Critical patent/WO2019013583A3/ko
Priority to PH12020550009A priority patent/PH12020550009A1/en

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Classifications

    • 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
    • A61K31/41Heterocyclic 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
    • A61K31/425Thiazoles
    • A61K31/4261,3-Thiazoles
    • 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
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (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)
  • Medicinal Preparation (AREA)

Abstract

본 발명의 약제학적 제제는 활성성분과 활성성분의 방출을 조절하는 방출제어제를 포함하고, 활성성분은 미라베그론 및 그의 약학적으로 허용가능한 염 중에서 선택된 적어도 하나이고, 방출제어제는 하이드로겔 형성 고분자이며, 하이드로겔 형성 고분자는 폴리에틸렌옥시드, 히드록시프로필메틸셀룰로오스, 히드록시프로필셀룰로오스, 카르복시메틸셀룰로오스나트륨, 및 히드록시에틸셀룰로오스 중에서 선택된 적어도 하나이고, 평균 분자량은 10만 내지 800만이다. 본 발명은, 제제 중 불순물 생성은 억제하고, 미라베그론 및 그의 약학적으로 허용가능한 염 중에서 선택된 적어도 하나의 방출을 효과적으로 제어할 수 있다는 장점을 갖는다.
PCT/KR2018/007950 2017-07-14 2018-07-13 약제학적 제제 및 그 제조방법 WO2019013583A2 (ko)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN201880044152.8A CN110869008B (zh) 2017-07-14 2018-07-13 药物制剂及其制备方法
EP18832644.1A EP3653202B1 (en) 2017-07-14 2018-07-13 Pharmaceutical preparation and preparation method therefor
US16/626,084 US11433054B2 (en) 2017-07-14 2018-07-13 Pharmaceutical preparation and preparation method therefor
JP2020520420A JP6870177B2 (ja) 2017-07-14 2018-07-13 薬剤学的製剤およびその製造方法
PH12020550009A PH12020550009A1 (en) 2017-07-14 2020-01-07 Pharmaceutical preparation and preparation method therefor

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20170089900 2017-07-14
KR10-2017-0089900 2017-07-14
KR10-2018-0007928 2018-01-22
KR1020180007928A KR101937713B1 (ko) 2017-07-14 2018-01-22 약제학적 제제 및 그 제조방법

Publications (2)

Publication Number Publication Date
WO2019013583A2 WO2019013583A2 (ko) 2019-01-17
WO2019013583A3 true WO2019013583A3 (ko) 2019-03-07

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WO (1) WO2019013583A2 (ko)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
WO2024128995A1 (en) * 2022-12-16 2024-06-20 Santa Farma Ilac Sanayii A.S. Pharmaceutical compositions of mirabegron

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20050107298A (ko) * 2003-03-06 2005-11-11 아스텔라스세이야쿠 가부시키가이샤 방출 제어용 의약 조성물 및 이의 제조방법
KR20150045500A (ko) * 2012-08-31 2015-04-28 아스텔라스세이야쿠 가부시키가이샤 경구 투여용 의약 조성물
KR20160117596A (ko) * 2014-02-07 2016-10-10 오스펙스 파마슈티칼스, 인코포레이티드 신규 제약 제제
JP2016188181A (ja) * 2015-03-30 2016-11-04 アステラス製薬株式会社 ミラベグロン含有放出制御錠剤
JP2017048136A (ja) * 2015-09-01 2017-03-09 沢井製薬株式会社 ミラベグロン含有錠剤、ミラベグロン含有製剤の製造方法及びミラベグロン含有造粒物の製造方法

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6346532B1 (en) 1997-10-17 2002-02-12 Yamanouchi Pharmaceutical Co., Ltd. Amide derivatives or salts thereof
ZA200503510B (en) 2002-11-07 2006-12-27 Yamanouchi Pharma Co Ltd Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
TWI478712B (zh) 2008-09-30 2015-04-01 Astellas Pharma Inc 釋控性醫藥組成物

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20050107298A (ko) * 2003-03-06 2005-11-11 아스텔라스세이야쿠 가부시키가이샤 방출 제어용 의약 조성물 및 이의 제조방법
KR20150045500A (ko) * 2012-08-31 2015-04-28 아스텔라스세이야쿠 가부시키가이샤 경구 투여용 의약 조성물
KR20160117596A (ko) * 2014-02-07 2016-10-10 오스펙스 파마슈티칼스, 인코포레이티드 신규 제약 제제
JP2016188181A (ja) * 2015-03-30 2016-11-04 アステラス製薬株式会社 ミラベグロン含有放出制御錠剤
JP2017048136A (ja) * 2015-09-01 2017-03-09 沢井製薬株式会社 ミラベグロン含有錠剤、ミラベグロン含有製剤の製造方法及びミラベグロン含有造粒物の製造方法

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WO2019013583A2 (ko) 2019-01-17

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