WO2011139044A2 - 탐스로신 또는 이의 약학적으로 허용 가능한 염을 포함하는 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제 - Google Patents

탐스로신 또는 이의 약학적으로 허용 가능한 염을 포함하는 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제 Download PDF

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Publication number
WO2011139044A2
WO2011139044A2 PCT/KR2011/003098 KR2011003098W WO2011139044A2 WO 2011139044 A2 WO2011139044 A2 WO 2011139044A2 KR 2011003098 W KR2011003098 W KR 2011003098W WO 2011139044 A2 WO2011139044 A2 WO 2011139044A2
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Prior art keywords
controlled
release
pharmaceutical composition
pharmaceutically acceptable
acceptable salts
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PCT/KR2011/003098
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English (en)
French (fr)
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WO2011139044A3 (ko
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정호진
박상엽
배철민
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주식회사 삼양사
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Application filed by 주식회사 삼양사 filed Critical 주식회사 삼양사
Priority to US13/695,814 priority Critical patent/US20130052264A1/en
Priority to CN2011800318466A priority patent/CN102970985A/zh
Publication of WO2011139044A2 publication Critical patent/WO2011139044A2/ko
Publication of WO2011139044A3 publication Critical patent/WO2011139044A3/ko

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    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/18—Sulfonamides
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (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)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

본 발명은 활성성분으로 탐스로신(tamsulosin) 또는 이의 약학적으로 허용 가능한 염을 포함하는 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제에 관한 것이다. 보다 상세하게는 탐스로신 또는 이의 약학적으로 허용 가능한 염을 포함하는 코어, 상기 코어 상에 형성된 방출 제어용 고분자 코팅층, 및 상기 방출 제어용 고분자 코팅층 상에 형성된 장용성 고분자 외피층을 포함하는 복수 개의 미립구 (microsphere)를 포함하되, 상기 방출 제어용 고분자 코팅층의 평균 두께가 상이한 제 1 및 제 2 미립구 군을 포함하는 약학 조성물; 및 이를 포함하는 경구용 제제에 관한 것이다. 본 발명에 따른 방출 제어용 약학 조성물은 장관 내 pH 변화에 따른 활성성분의 방출 정도 및 소장 내에서의 활성성분의 방출 패턴 조절이 용이하고, 그에 따라 활성성분이 혈중으로 급속히 이행되는 것을 방지하여 부작용을 최소화할 수 있고, 활성성분의 유효 혈중농도를 일정시간 동안 유지할 수 있을 뿐만 아니라, 구강 내에 노출되어도 일정시간 동안 쓴 맛을 차폐할 수 있어 경구 투여시 환자에 대한 치료 효과를 증대시킬 수 있다.
PCT/KR2011/003098 2010-05-04 2011-04-27 탐스로신 또는 이의 약학적으로 허용 가능한 염을 포함하는 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제 WO2011139044A2 (ko)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US13/695,814 US20130052264A1 (en) 2010-05-04 2011-04-27 Controlled-release pharmaceutical composition including tamsulosin or pharmaceutically acceptable salts thereof, and oral formulation including the same
CN2011800318466A CN102970985A (zh) 2010-05-04 2011-04-27 包含坦洛新或其药学可接受的盐的控释药物组合物及包含所述药物组合物的口服制剂

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020100042055A KR101423237B1 (ko) 2010-05-04 2010-05-04 탐스로신 또는 이의 약학적으로 허용 가능한 염을 포함하는 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제
KR10-2010-0042055 2010-05-04

Publications (2)

Publication Number Publication Date
WO2011139044A2 true WO2011139044A2 (ko) 2011-11-10
WO2011139044A3 WO2011139044A3 (ko) 2012-03-01

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2011/003098 WO2011139044A2 (ko) 2010-05-04 2011-04-27 탐스로신 또는 이의 약학적으로 허용 가능한 염을 포함하는 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제

Country Status (4)

Country Link
US (1) US20130052264A1 (ko)
KR (1) KR101423237B1 (ko)
CN (1) CN102970985A (ko)
WO (1) WO2011139044A2 (ko)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104586771A (zh) * 2013-10-30 2015-05-06 广州朗圣药业有限公司 一种盐酸坦洛新缓释微丸制剂

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20130067695A (ko) * 2011-12-14 2013-06-25 주식회사 바이오파마티스 구강 붕해정 및 이의 제조방법
KR101951075B1 (ko) 2013-03-21 2019-02-21 유프락시아 파마수티컬스 유에스에이 엘엘씨 주입가능한 서방성 방출 조성물 및 관절 내 염증 및 이와 관련된 통증을 치료하기 위해 이를 사용하는 방법
KR20160021095A (ko) * 2013-06-21 2016-02-24 욱크하르트 리미티드 탐술로신 또는 이의 염의 약학 조성물
CN103435424B (zh) * 2013-09-02 2016-03-30 济宁道淼新材料科技有限公司 一种含高分子微纳米粒的缓控释包膜材料
KR20160100570A (ko) * 2015-02-16 2016-08-24 한미약품 주식회사 탐수로신 염산염 함유 서방성 과립을 포함하는 경구용 약제학적 제제
EP3206672B1 (en) 2015-10-27 2018-03-14 Eupraxia Pharmaceuticals Inc. Sustained release formulations of local anesthetics
ES2933177T3 (es) * 2016-03-31 2023-02-02 Hanmi Pharm Ind Co Ltd Preparación de cápsulas compuestas, que contienen tadalafilo y tamsulosina, y que tienen una estabilidad y una tasa de elución mejoradas
CN106008788B (zh) * 2016-05-18 2017-11-07 连云港万泰医药辅料技术有限公司 一种低渗透性缓释包衣材料及其制备方法
CN108066304B (zh) * 2016-11-16 2022-09-16 深圳万和制药有限公司 具有缓释性能的坦索罗辛口腔崩解片组合物
KR101879133B1 (ko) * 2017-07-11 2018-07-17 (주)동구바이오제약 비뇨기 질환 예방 또는 치료용 제제 및 이의 제조방법
KR20200078146A (ko) * 2018-12-21 2020-07-01 한미약품 주식회사 내산성이 우수한 탐수로신 염산염 함유 제약 조성물 및 이의 제조방법
KR20210003323A (ko) * 2019-07-01 2021-01-12 한미약품 주식회사 탐수로신 또는 이의 염산염 함유 제약 조성물 및 이의 제조방법
CN115300506A (zh) * 2022-08-11 2022-11-08 南京红地生物科技有限公司 含有坦索罗辛和米拉贝隆的复方制剂及其制备方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20050023396A (ko) * 2002-07-05 2005-03-09 템렐 인코포레이티드 방출 제어형 조성물
KR20050112599A (ko) * 2004-05-27 2005-12-01 한국화학연구원 서방형 약물 전달 시스템
KR20050114921A (ko) * 2004-06-02 2005-12-07 씨제이 주식회사 방출제어형 약제학적 조성물
KR20070069105A (ko) * 2003-09-29 2007-07-02 씨제이 주식회사 서방성 제제

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE20220604U1 (de) * 2001-07-27 2004-02-26 Yamanouchi Pharmaceutical Co., Ltd. Zusammensetzung, enthaltend feine Partikel zur Langzeitfreisetzung für schnell in der Mundhöhle zerfallende Tabletten
CA2491355A1 (en) * 2002-07-05 2004-01-15 Temrel Limited Controlled release compositions comprising coated pellets having non-uniform coating thicknesses
IN192381B (ko) * 2002-12-20 2004-04-10 Ranbaxy Lab

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20050023396A (ko) * 2002-07-05 2005-03-09 템렐 인코포레이티드 방출 제어형 조성물
KR20070069105A (ko) * 2003-09-29 2007-07-02 씨제이 주식회사 서방성 제제
KR20050112599A (ko) * 2004-05-27 2005-12-01 한국화학연구원 서방형 약물 전달 시스템
KR20050114921A (ko) * 2004-06-02 2005-12-07 씨제이 주식회사 방출제어형 약제학적 조성물

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104586771A (zh) * 2013-10-30 2015-05-06 广州朗圣药业有限公司 一种盐酸坦洛新缓释微丸制剂
CN104586771B (zh) * 2013-10-30 2018-01-16 广州朗圣药业有限公司 一种盐酸坦洛新缓释微丸制剂

Also Published As

Publication number Publication date
KR101423237B1 (ko) 2014-07-30
US20130052264A1 (en) 2013-02-28
KR20110122504A (ko) 2011-11-10
CN102970985A (zh) 2013-03-13
WO2011139044A3 (ko) 2012-03-01

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