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WO2016126058A3 - 두타스테라이드 함유 고체 분산체 및 이를 포함하는 조성물 - Google Patents

두타스테라이드 함유 고체 분산체 및 이를 포함하는 조성물 Download PDF

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Publication number
WO2016126058A3
WO2016126058A3 PCT/KR2016/001035 KR2016001035W WO2016126058A3 WO 2016126058 A3 WO2016126058 A3 WO 2016126058A3 KR 2016001035 W KR2016001035 W KR 2016001035W WO 2016126058 A3 WO2016126058 A3 WO 2016126058A3
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WO
WIPO (PCT)
Prior art keywords
solid dispersion
dutasteride
same
preparing
composition containing
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/KR2016/001035
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English (en)
French (fr)
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WO2016126058A2 (ko
Inventor
안병락
민미홍
박진형
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.)
WHANIN PHARMACEUTICAL CO Ltd
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WHANIN PHARMACEUTICAL CO Ltd
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Publication date
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Priority to EP16746799.2A priority Critical patent/EP3254699B1/en
Priority to JP2017538405A priority patent/JP6666352B2/ja
Publication of WO2016126058A2 publication Critical patent/WO2016126058A2/ko
Publication of WO2016126058A3 publication Critical patent/WO2016126058A3/ko
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A61K47/40—Cyclodextrins; 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/14—Drugs for dermatological disorders for baldness or alopecia

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

본 발명은 두타스테라이드를 함유하는 약제학적 조성물 및 이의 제조방법에 관한 것으로서, 보다 상세하게는 두타스테라이드 함유 고형제제를 제조하기 위해 고형화가 유리한 감마-시클로덱스트린으로 포접물을 제조하고, 여기에 점증제 및/또는 계면활성제와 함께 고체분산체를 제조하여, 약물의 용해도를 증진시켰다. 본 발명에 따라 제조된 고체 분산체 과립물로 이루어진 경구 투여용 고형제제는 아보다트 연질캡슐과 PK 프로파일이 동등하다.
PCT/KR2016/001035 2015-02-02 2016-01-29 두타스테라이드 함유 고체 분산체 및 이를 포함하는 조성물 Ceased WO2016126058A2 (ko)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP16746799.2A EP3254699B1 (en) 2015-02-02 2016-01-29 Solid dispersion containing dutasteride, and composition containing same
JP2017538405A JP6666352B2 (ja) 2015-02-02 2016-01-29 デュタステリド含有固体分散体及びこれを含む組成物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2015-0016251 2015-02-02
KR1020150016251A KR101561406B1 (ko) 2015-02-02 2015-02-02 두타스테라이드 함유 고체 분산체 및 이를 포함하는 조성물

Publications (2)

Publication Number Publication Date
WO2016126058A2 WO2016126058A2 (ko) 2016-08-11
WO2016126058A3 true WO2016126058A3 (ko) 2016-09-29

Family

ID=54365862

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2016/001035 Ceased WO2016126058A2 (ko) 2015-02-02 2016-01-29 두타스테라이드 함유 고체 분산체 및 이를 포함하는 조성물

Country Status (4)

Country Link
EP (1) EP3254699B1 (ko)
JP (1) JP6666352B2 (ko)
KR (1) KR101561406B1 (ko)
WO (1) WO2016126058A2 (ko)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101897995B1 (ko) * 2017-11-21 2018-09-12 한국프라임제약주식회사 두타스테리드의 고체분산체, 이의 제조방법, 및 이를 포함하는 약학적 조성물
KR102165548B1 (ko) * 2017-11-28 2020-10-14 (주)아이엠디팜 두타스테라이드가 봉입된 나노 가용화 다공체, 이를 포함하는 약학 조성물 및 이의 제조방법
WO2020066392A1 (ja) * 2018-09-25 2020-04-02 日新製薬株式会社 経口固形製剤およびその製造法
KR102352888B1 (ko) * 2020-01-15 2022-01-18 한국프라임제약주식회사 두타스테리드를 포함하는 경구용 약제학적 조성물
EP4272733A4 (en) * 2020-12-31 2024-07-10 Dong Kook Pharm. Co., Ltd PHARMACEUTICAL COMPOSITION CONTAINING TADALAFIL OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND DUTASTERIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF HAVING A NOVEL DISSOLUTION RATE

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050096296A1 (en) * 2003-11-03 2005-05-05 David Fikstad Pharmaceutical compositions with synchronized solubilizer release
KR20080077258A (ko) * 2005-12-08 2008-08-21 기린 홀딩스 가부시키가이샤 이소후물론류 포접체 및 그것을 함유하는 조성물
EP2050436A1 (en) * 2007-12-21 2009-04-22 Siegfried Generics International AG Pharmaceutical composition containing dutasteride
KR100962447B1 (ko) * 2010-02-24 2010-06-14 (주)비씨월드제약 난용성 약물인 두타스테라이드의 자가유화 조성물과 이로부터 제조된 정제
KR101055412B1 (ko) * 2010-11-19 2011-08-08 (주)비씨월드제약 두타스테라이드를 포함하는 자가유화 에멀젼 조성물 및 이의 제조방법

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011030351A2 (en) * 2009-09-03 2011-03-17 Rubicon Research Private Limited Taste - masked pharmaceutical compositions
CN102232949A (zh) * 2010-04-27 2011-11-09 孙远 提高药物溶出度的组合物及其制备方法
US8951996B2 (en) * 2011-07-28 2015-02-10 Lipocine Inc. 17-hydroxyprogesterone ester-containing oral compositions and related methods

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050096296A1 (en) * 2003-11-03 2005-05-05 David Fikstad Pharmaceutical compositions with synchronized solubilizer release
KR20080077258A (ko) * 2005-12-08 2008-08-21 기린 홀딩스 가부시키가이샤 이소후물론류 포접체 및 그것을 함유하는 조성물
EP2050436A1 (en) * 2007-12-21 2009-04-22 Siegfried Generics International AG Pharmaceutical composition containing dutasteride
KR100962447B1 (ko) * 2010-02-24 2010-06-14 (주)비씨월드제약 난용성 약물인 두타스테라이드의 자가유화 조성물과 이로부터 제조된 정제
KR101055412B1 (ko) * 2010-11-19 2011-08-08 (주)비씨월드제약 두타스테라이드를 포함하는 자가유화 에멀젼 조성물 및 이의 제조방법

Also Published As

Publication number Publication date
EP3254699A4 (en) 2018-08-08
WO2016126058A2 (ko) 2016-08-11
EP3254699A2 (en) 2017-12-13
JP6666352B2 (ja) 2020-03-13
EP3254699B1 (en) 2023-08-09
KR101561406B1 (ko) 2015-10-16
JP2018508487A (ja) 2018-03-29

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