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MX2019001741A - Formulación farmacéutica para administración oral con tasa de disolución controlada, comprendiendo la preparación de perlas de liberación sostenida que contienen hidrocloruro de tamsulosina. - Google Patents

Formulación farmacéutica para administración oral con tasa de disolución controlada, comprendiendo la preparación de perlas de liberación sostenida que contienen hidrocloruro de tamsulosina.

Info

Publication number
MX2019001741A
MX2019001741A MX2019001741A MX2019001741A MX2019001741A MX 2019001741 A MX2019001741 A MX 2019001741A MX 2019001741 A MX2019001741 A MX 2019001741A MX 2019001741 A MX2019001741 A MX 2019001741A MX 2019001741 A MX2019001741 A MX 2019001741A
Authority
MX
Mexico
Prior art keywords
sustained release
tamsulosin hydrochloride
preparation
oral administration
pharmaceutical formulation
Prior art date
Application number
MX2019001741A
Other languages
English (en)
Other versions
MX393491B (es
Inventor
Hyun Park Jae
Soo Woo Jong
Cheul Kim Jin
Ii Kim Yong
Ho Kim Jae
Joon Lee Benjamin
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 MX2019001741A publication Critical patent/MX2019001741A/es
Publication of MX393491B publication Critical patent/MX393491B/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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • 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
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular 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
    • A61K9/48—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
    • 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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La presente invención proporciona: una formulación farmacéutica para administración oral con una velocidad de disolución controlada, la formulación que comprende los gránulos de liberación sostenida que contienen hidrocloruro de tamsulosina, en donde los gránulos de liberación sostenida comprenden (i) un hidrocloruro de tamsulosina, (ii) hidroxipropilmetilcelulosa (HPMC) ), (iii) un polímero acrílico resistente a los ácidos, y (iv) dos o más tipos de diluyentes insolubles; y un método de preparación para ello. De acuerdo con la presente invención, los gránulos de liberación sostenida que contienen hidrocloruro de tamsulosina con un tamaño predeterminado se pueden producir de manera reproducible, controlando así la velocidad de liberación y reduciendo el tamaño de los gránulos, mejorando así el cumplimiento del fármaco.
MX2019001741A 2016-08-12 2017-08-11 Formulación farmacéutica para administración oral con tasa de disolución controlada, comprendiendo la preparación de perlas de liberación sostenida que contienen hidrocloruro de tamsulosina. MX393491B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20160103269 2016-08-12
PCT/KR2017/008800 WO2018030862A1 (ko) 2016-08-12 2017-08-11 탐수로신 염산염 함유 서방성 펠렛을 포함하는 용출률이 제어된 경구투여용 약제학적 제제

Publications (2)

Publication Number Publication Date
MX2019001741A true MX2019001741A (es) 2019-12-09
MX393491B MX393491B (es) 2025-03-21

Family

ID=61163047

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019001741A MX393491B (es) 2016-08-12 2017-08-11 Formulación farmacéutica para administración oral con tasa de disolución controlada, comprendiendo la preparación de perlas de liberación sostenida que contienen hidrocloruro de tamsulosina.

Country Status (12)

Country Link
US (1) US20190167612A1 (es)
EP (1) EP3498264B1 (es)
JP (1) JP7004224B2 (es)
KR (1) KR102391496B1 (es)
CN (1) CN109562072B (es)
AU (1) AU2017308461A1 (es)
BR (1) BR112019002635A2 (es)
EA (1) EA201990223A1 (es)
ES (1) ES2967085T3 (es)
MX (1) MX393491B (es)
PH (1) PH12019500276A1 (es)
WO (1) WO2018030862A1 (es)

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JP6733499B2 (ja) * 2016-11-01 2020-07-29 ニプロ株式会社 ソリフェナシン含有医薬組成物とその製造方法
KR102169926B1 (ko) * 2018-01-12 2020-10-26 주식회사 종근당 탐스로신과 타다라필을 포함하는 약제학적 조성물
CN112004529B (zh) 2018-04-06 2023-08-08 比利时胶囊公司 包含聚[(甲基丙烯酸甲酯)-共-(甲基丙烯酸)]的低纵横比颗粒的喷雾干燥方法
KR20200078121A (ko) 2018-12-21 2020-07-01 한미약품 주식회사 탐수로신 및 솔리페나신을 포함하는 경구용 복합제제 및 그 제조방법
KR20200121183A (ko) 2019-04-15 2020-10-23 한미약품 주식회사 탐스로신 및 솔리페나신을 포함하는 복합제제 및 그 제조방법
KR102850275B1 (ko) * 2019-07-01 2025-08-28 한미약품 주식회사 탐수로신 또는 이의 염산염 함유 제약 조성물 및 이의 제조방법
WO2021220133A1 (en) 2020-04-27 2021-11-04 Zim Laboratories Limited Novel multiparticulate pharmaceutical composition of tamsulosin and solifenacin
CN113189239B (zh) * 2021-05-06 2023-04-14 山东省药学科学院 一种用高效液相色谱法测定右兰索拉唑缓释胶囊中小丸i含量的方法
JP2024541013A (ja) 2021-10-25 2024-11-06 ファルマリダー、ソシエダッド、アノニマ タダラフィル経口懸濁剤
CN119405627B (zh) * 2025-01-08 2025-04-15 安若维他药业泰州有限公司 一种基于速溶包衣的坦索罗辛缓释胶囊及其制备方法

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KR930007245A (ko) 1991-09-16 1993-04-22 강진구 영상신호 수신 장치
KR100762846B1 (ko) * 2003-09-29 2007-10-04 씨제이 주식회사 서방성 제제
JP2007507491A (ja) * 2003-09-29 2007-03-29 シージェー コーポレーション 徐放性製剤
KR100570419B1 (ko) * 2004-01-14 2006-04-11 코오롱제약주식회사 염산 탐술로신의 경구 투여용 서방성 펠렛 조성물 및 그제조방법
KR100582350B1 (ko) 2004-02-17 2006-05-22 한미약품 주식회사 탐수로신 염산염의 경구투여용 조성물 및 이의 서방성과립 제제
KR20060093931A (ko) * 2005-02-23 2006-08-28 센츄론(주) 펠렛타입의 방출제어형 탐술로신 제제
KR100912680B1 (ko) * 2006-03-16 2009-08-19 (주) 벡스코아 제어 방출 제형
US20110244033A1 (en) * 2008-12-09 2011-10-06 Denny Johan Marijn Van Den Heuvel Tamsulosin pellets for fixed dose combination
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
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KR20160100570A (ko) * 2015-02-16 2016-08-24 한미약품 주식회사 탐수로신 염산염 함유 서방성 과립을 포함하는 경구용 약제학적 제제

Also Published As

Publication number Publication date
WO2018030862A1 (ko) 2018-02-15
EP3498264A1 (en) 2019-06-19
BR112019002635A2 (pt) 2019-05-28
CN109562072A (zh) 2019-04-02
ES2967085T3 (es) 2024-04-26
PH12019500276A1 (en) 2019-05-15
US20190167612A1 (en) 2019-06-06
EP3498264B1 (en) 2023-11-08
CN109562072B (zh) 2022-04-05
KR20180018450A (ko) 2018-02-21
JP7004224B2 (ja) 2022-02-10
EA201990223A1 (ru) 2019-07-31
KR102391496B1 (ko) 2022-04-28
EP3498264A4 (en) 2020-03-11
MX393491B (es) 2025-03-21
JP2019527700A (ja) 2019-10-03
AU2017308461A1 (en) 2019-02-28

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