BR112018068686A2 - hard capsule composite formulation, fixed dose composite formulation and method of preparing the hard capsule composite formulation - Google Patents

hard capsule composite formulation, fixed dose composite formulation and method of preparing the hard capsule composite formulation

Info

Publication number
BR112018068686A2
BR112018068686A2 BR112018068686A BR112018068686A BR112018068686A2 BR 112018068686 A2 BR112018068686 A2 BR 112018068686A2 BR 112018068686 A BR112018068686 A BR 112018068686A BR 112018068686 A BR112018068686 A BR 112018068686A BR 112018068686 A2 BR112018068686 A2 BR 112018068686A2
Authority
BR
Brazil
Prior art keywords
composite formulation
hard capsule
dutasteride
preparing
tamsulosin
Prior art date
Application number
BR112018068686A
Other languages
Portuguese (pt)
Inventor
Joon Lee Benjamin
Ho Kim Jae
Hyun Park Jae
Cheul Kim Jin
Soo Woo Jong
Il Kim Yong
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 BR112018068686A2 publication Critical patent/BR112018068686A2/en

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
    • A61K9/48—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
    • 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
    • A61K31/56—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A61K9/5052—Proteins, e.g. albumin
    • A61K9/5057—Gelatin
    • 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

Landscapes

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

Abstract

um aspecto da presente invenção proporciona um complexo de cápsula dura e um método de preparação do mesmo, em que o complexo de cápsula dura compreendendo, em um estado separado: uma parte independente de dutasterida compreendendo dutasterida ou um sal farmaceuticamente aceitável da mesma; e uma parte independente de tansulosina compreendendo tansulosina ou um sal farmaceuticamente aceitável da mesma, em que a parte independente de dutasterida é uma preparação contendo uma emulsão autoemulsificante que consiste em dutasterida, um óleo e um tensoativo; a parte independente de tansulosina é uma preparação sólida contendo um agente de liberação prolongada; e a parte independente de dutasterida e a parte independente de tansulosina estão incluídas em um estado separado e podem ser inseridas em cápsulas 0 a 3.One aspect of the present invention provides a hard capsule complex and a method of preparing it, wherein the hard capsule complex comprising, in a separate state: an independent dutasteride moiety comprising dutasteride or a pharmaceutically acceptable salt thereof; and a tamsulosin independent part comprising tamsulosin or a pharmaceutically acceptable salt thereof, wherein the dutasteride independent part is a preparation containing a self-emulsifying emulsion consisting of dutasteride, an oil and a surfactant; the tamsulosin-independent part is a solid preparation containing a sustained release agent; and the dutasteride independent part and the tamsulosin independent part are included in a separate state and may be enclosed in capsules 0 to 3.

BR112018068686A 2016-03-16 2017-03-16 hard capsule composite formulation, fixed dose composite formulation and method of preparing the hard capsule composite formulation BR112018068686A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20160031468 2016-03-16
PCT/KR2017/002862 WO2017160106A2 (en) 2016-03-16 2017-03-16 Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor

Publications (1)

Publication Number Publication Date
BR112018068686A2 true BR112018068686A2 (en) 2019-01-15

Family

ID=59850978

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018068686A BR112018068686A2 (en) 2016-03-16 2017-03-16 hard capsule composite formulation, fixed dose composite formulation and method of preparing the hard capsule composite formulation

Country Status (8)

Country Link
KR (1) KR101968754B1 (en)
CN (1) CN109152743B (en)
AU (1) AU2017233134A1 (en)
BR (1) BR112018068686A2 (en)
EA (1) EA201891843A1 (en)
MX (1) MX2018011208A (en)
PH (1) PH12018501985A1 (en)
WO (1) WO2017160106A2 (en)

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW369521B (en) 1993-09-17 1999-09-11 Smithkline Beecham Corp Androstenone derivative
UA80393C2 (en) 2000-12-07 2007-09-25 Алтана Фарма Аг Pharmaceutical preparation comprising an pde inhibitor dispersed on a matrix
PT1618873E (en) * 2004-07-14 2007-09-04 Siegfried Generics Int Ag Granule for the controlled release of tamsulosin, containing alginate
WO2006055659A2 (en) * 2004-11-15 2006-05-26 Smithkline Beecham Corporation Fixed dose combination op dutasteride and tamsulosin
CN102247379A (en) * 2011-01-12 2011-11-23 北京润德康医药技术有限公司 Compound preparation and preparation method thereof
CN102145007B (en) * 2011-03-03 2013-03-20 王致中 Finasteride soft capsule and amsulosin hydrochloride capsule compound preparation, used capsule and preparing method
WO2014002015A1 (en) * 2012-06-25 2014-01-03 Ranbaxy Laboratories Limited Pharmaceutical composition comprising dutasteride
US20160287524A1 (en) * 2013-03-19 2016-10-06 Galenicum Health S.L. Pharmaceutical compositions comprising an active agent
CN105073100A (en) * 2013-06-21 2015-11-18 沃克哈特有限公司 Pharmaceutical compositions of tamsulosin or salts thereof
EP2949319A1 (en) * 2014-05-26 2015-12-02 Galenicum Health S.L. Pharmaceutical compositions comprising an active agent
KR101590072B1 (en) * 2014-12-23 2016-01-29 한미약품 주식회사 Composition for self-emulsifying drug delivery system comprising dutasteride

Also Published As

Publication number Publication date
WO2017160106A3 (en) 2018-09-07
AU2017233134A1 (en) 2018-10-04
PH12018501985A1 (en) 2019-07-08
MX2018011208A (en) 2019-05-30
CN109152743A (en) 2019-01-04
KR101968754B1 (en) 2019-04-12
WO2017160106A2 (en) 2017-09-21
EA201891843A1 (en) 2019-04-30
KR20170107933A (en) 2017-09-26
CN109152743B (en) 2022-01-07

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Legal Events

Date Code Title Description
B11A Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing
B11Y Definitive dismissal - extension of time limit for request of examination expired [chapter 11.1.1 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]