MX2021007557A - Composicion farmaceutica que contiene clorhidrato de tamsulosina con excelente resistencia al acido y metodo de preparacion de la misma. - Google Patents

Composicion farmaceutica que contiene clorhidrato de tamsulosina con excelente resistencia al acido y metodo de preparacion de la misma.

Info

Publication number
MX2021007557A
MX2021007557A MX2021007557A MX2021007557A MX2021007557A MX 2021007557 A MX2021007557 A MX 2021007557A MX 2021007557 A MX2021007557 A MX 2021007557A MX 2021007557 A MX2021007557 A MX 2021007557A MX 2021007557 A MX2021007557 A MX 2021007557A
Authority
MX
Mexico
Prior art keywords
tamsulosin hydrochloride
acid resistance
pharmaceutical composition
preparation
composition containing
Prior art date
Application number
MX2021007557A
Other languages
English (en)
Inventor
Yong Il Kim
Ho Taek Im
Seung Jun Lee
Eun Ho Ha
Original Assignee
Hanmi Pharm Ind 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 Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of MX2021007557A publication Critical patent/MX2021007557A/es

Links

Classifications

    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—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
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente invención se refiere a una composición farmacéutica resistente al ácido que incluye clorhidrato de tamsulosina, y un método para preparar la misma. La composición farmacéutica es formulada en tabletas preparando perlillas de núcleo que incluyen clorhidrato de tamsulosina como un ingrediente activo, recubriendo las perlillas de núcleo con una solución de recubrimiento entérico que incluye una cantidad específica de plastificador, agregando una porción de la mezcla posterior que incluye un amortiguador para ajustar la densidad y un lubricante a las perlillas de núcleo recubiertas entéricas, y realizar el tableteado. La capa de recubrimiento entérico no se rompe durante el proceso de tableteado. De este modo, se mantiene la resistencia al ácido de la composición farmacéutica. La composición farmacéutica puede ser fácilmente formulada en tabletas, asegura buena uniformidad de unidad de dosificación, reduce la velocidad de disolución de clorhidrato de tamsulosina, tiene buena resistencia al ácido, y es estable no presentando descomposición significante del clorhidrato de tamsulosina.
MX2021007557A 2018-12-21 2019-11-25 Composicion farmaceutica que contiene clorhidrato de tamsulosina con excelente resistencia al acido y metodo de preparacion de la misma. MX2021007557A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020180167767A KR20200078146A (ko) 2018-12-21 2018-12-21 내산성이 우수한 탐수로신 염산염 함유 제약 조성물 및 이의 제조방법
PCT/KR2019/016280 WO2020130385A1 (ko) 2018-12-21 2019-11-25 내산성이 우수한 탐수로신 염산염 함유 제약 조성물 및 이의 제조방법

Publications (1)

Publication Number Publication Date
MX2021007557A true MX2021007557A (es) 2021-08-11

Family

ID=71102875

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021007557A MX2021007557A (es) 2018-12-21 2019-11-25 Composicion farmaceutica que contiene clorhidrato de tamsulosina con excelente resistencia al acido y metodo de preparacion de la misma.

Country Status (9)

Country Link
US (1) US20220016058A1 (es)
EP (1) EP3881832A4 (es)
JP (1) JP2022514040A (es)
KR (1) KR20200078146A (es)
CN (1) CN113347963A (es)
BR (1) BR112021012259A2 (es)
EA (1) EA202191757A1 (es)
MX (1) MX2021007557A (es)
WO (1) WO2020130385A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20210003323A (ko) * 2019-07-01 2021-01-12 한미약품 주식회사 탐수로신 또는 이의 염산염 함유 제약 조성물 및 이의 제조방법

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IN192381B (es) * 2002-12-20 2004-04-10 Ranbaxy Lab
AU2003286415A1 (en) * 2003-12-03 2005-06-24 Natco Pharma Limited An improved pharmaceutical formulation containing tamsulosin salt and a process for its preparation
KR100615952B1 (ko) * 2004-05-27 2006-08-28 한국화학연구원 서방형 약물 전달 시스템
KR100678421B1 (ko) * 2005-02-11 2007-02-02 주식회사 씨티씨바이오 염산 탐스로신 함유 방출조절 제제
KR20070044911A (ko) * 2005-10-26 2007-05-02 주식회사 씨티씨바이오 염산 탐스로신 함유 방출조절 제제
KR100745515B1 (ko) * 2006-04-10 2007-08-02 주식회사 대웅제약 염산 탐술로신 함유 서방성 펠렛 및 그의 제조방법
KR101686033B1 (ko) * 2010-04-12 2016-12-13 주식회사 대웅제약 탐술로신 또는 이의 약제학적 허용 가능한 염을 유효성분으로 함유하는 장용성 서방형 펠렛부와 속방부로 이루어진 의약 조성물
KR101423237B1 (ko) * 2010-05-04 2014-07-30 주식회사 삼양바이오팜 탐스로신 또는 이의 약학적으로 허용 가능한 염을 포함하는 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제
BR112019000721A2 (pt) 2016-07-15 2019-05-07 Hanmi Pharm. Co., Ltd. formulação farmacêutica oral, e método de preparação de uma formulação farmacêutica oral
KR102246658B1 (ko) 2017-06-21 2021-04-30 한미약품 주식회사 탐수로신 염산염 함유 서방성 과립을 포함하는 경구용 약제학적 제제

Also Published As

Publication number Publication date
EA202191757A1 (ru) 2021-10-08
CN113347963A (zh) 2021-09-03
US20220016058A1 (en) 2022-01-20
EP3881832A4 (en) 2022-08-31
WO2020130385A1 (ko) 2020-06-25
KR20200078146A (ko) 2020-07-01
JP2022514040A (ja) 2022-02-09
EP3881832A1 (en) 2021-09-22
BR112021012259A2 (pt) 2021-08-31

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