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WO2017160106A3 - Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor - Google Patents

Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor Download PDF

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Publication number
WO2017160106A3
WO2017160106A3 PCT/KR2017/002862 KR2017002862W WO2017160106A3 WO 2017160106 A3 WO2017160106 A3 WO 2017160106A3 KR 2017002862 W KR2017002862 W KR 2017002862W WO 2017160106 A3 WO2017160106 A3 WO 2017160106A3
Authority
WO
WIPO (PCT)
Prior art keywords
dutasteride
tamsulosin
independent part
hard capsule
preparation
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/KR2017/002862
Other languages
French (fr)
Korean (ko)
Other versions
WO2017160106A2 (en
Inventor
이벤자민준
김진철
김재호
김용일
박재현
우종수
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hanmi Pharmaceutical Co Ltd
Hanmi Pharmaceutical Industries Co Ltd
Original Assignee
Hanmi Pharmaceutical Co Ltd
Hanmi Pharmaceutical Industries 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 Pharmaceutical Co Ltd, Hanmi Pharmaceutical Industries Co Ltd filed Critical Hanmi Pharmaceutical Co Ltd
Priority to EA201891843A priority Critical patent/EA201891843A1/en
Priority to MX2018011208A priority patent/MX2018011208A/en
Priority to AU2017233134A priority patent/AU2017233134A1/en
Priority to CN201780029107.0A priority patent/CN109152743B/en
Priority to BR112018068686A priority patent/BR112018068686A2/en
Publication of WO2017160106A2 publication Critical patent/WO2017160106A2/en
Publication of WO2017160106A3 publication Critical patent/WO2017160106A3/en
Priority to PH12018501985A priority patent/PH12018501985A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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

Abstract

An aspect of the present invention provides a hard capsule complex and a preparation method therefor, the hard capsule complex comprising, in a separate state: a dutasteride independent part comprising a dutasteride or a pharmaceutically acceptable salt thereof; and a tamsulosin independent part comprising a tamsulosin or a pharmaceutically acceptable salt thereof, wherein the dutasteride independent part is a preparation containing a self-emulsifying emulsion consisting of a dutasteride, an oil and a surfactant; the tamsulosin independent part is a solid preparation containing a sustained-release agent; the dutasteride independent part and the tamsulosin independent part are included in a separate state and can be filled into capsules 0 to 3.
PCT/KR2017/002862 2016-03-16 2017-03-16 Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor Ceased WO2017160106A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
EA201891843A EA201891843A1 (en) 2016-03-16 2017-03-16 Dutusteride- and Tamsulozine-Holding Complex in the Form of a Solid Causule and Method of Its Production
MX2018011208A MX2018011208A (en) 2016-03-16 2017-03-16 Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor.
AU2017233134A AU2017233134A1 (en) 2016-03-16 2017-03-16 Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor
CN201780029107.0A CN109152743B (en) 2016-03-16 2017-03-16 Hard capsule compound containing dutasteride and tamsulosin and preparation method thereof
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
PH12018501985A PH12018501985A1 (en) 2016-03-16 2018-09-14 Dutasteride-and tamsulosin-containing hard capsule complex and preparation method therefor

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20160031468 2016-03-16
KR10-2016-0031468 2016-03-16

Publications (2)

Publication Number Publication Date
WO2017160106A2 WO2017160106A2 (en) 2017-09-21
WO2017160106A3 true WO2017160106A3 (en) 2018-09-07

Family

ID=59850978

Family Applications (1)

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

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)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006055659A2 (en) * 2004-11-15 2006-05-26 Smithkline Beecham Corporation Fixed dose combination op dutasteride and tamsulosin
WO2014002015A1 (en) * 2012-06-25 2014-01-03 Ranbaxy Laboratories Limited Pharmaceutical composition comprising dutasteride
KR101590072B1 (en) * 2014-12-23 2016-01-29 한미약품 주식회사 Composition for self-emulsifying drug delivery system comprising dutasteride
KR20160021095A (en) * 2013-06-21 2016-02-24 욱크하르트 리미티드 Pharmaceutical compostions of tamsulosin or salts thereof

Family Cites Families (7)

* 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
SI1618873T1 (en) * 2004-07-14 2007-10-31 Siegfried Generics Int Ag Granule for the controlled release of tamsulosin, containing alginate
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
RU2015144543A (en) * 2013-03-19 2017-04-27 Галеникум Хелс С.Л. PHARMACEUTICAL COMPOSITIONS CONTAINING AN ACTIVE SUBSTANCE
ES2555485T1 (en) * 2014-05-26 2016-01-04 Galenicum Health S.L. Pharmaceutical compositions containing an active agent

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006055659A2 (en) * 2004-11-15 2006-05-26 Smithkline Beecham Corporation Fixed dose combination op dutasteride and tamsulosin
WO2014002015A1 (en) * 2012-06-25 2014-01-03 Ranbaxy Laboratories Limited Pharmaceutical composition comprising dutasteride
KR20160021095A (en) * 2013-06-21 2016-02-24 욱크하르트 리미티드 Pharmaceutical compostions of tamsulosin or salts thereof
KR101590072B1 (en) * 2014-12-23 2016-01-29 한미약품 주식회사 Composition for self-emulsifying drug delivery system comprising dutasteride

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CHOO, G.-H.: "Formulation and in vivo evaluation of a self- microemulsifying drug delivery system of dutasteride", DRUG RESEARCH, vol. 63, no. 4, 2013, pages 203 - 209, XP055557063, DOI: doi:10.1055/s-0033-1334965 *

Also Published As

Publication number Publication date
MX2018011208A (en) 2019-05-30
CN109152743A (en) 2019-01-04
WO2017160106A2 (en) 2017-09-21
CN109152743B (en) 2022-01-07
KR101968754B1 (en) 2019-04-12
AU2017233134A1 (en) 2018-10-04
KR20170107933A (en) 2017-09-26
EA201891843A1 (en) 2019-04-30
PH12018501985A1 (en) 2019-07-08
BR112018068686A2 (en) 2019-01-15

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