WO2019103373A3 - 두타스테리드의 고체분산체, 이의 제조방법, 및 이를 포함하는 약학적 조성물 - Google Patents

두타스테리드의 고체분산체, 이의 제조방법, 및 이를 포함하는 약학적 조성물 Download PDF

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Publication number
WO2019103373A3
WO2019103373A3 PCT/KR2018/013684 KR2018013684W WO2019103373A3 WO 2019103373 A3 WO2019103373 A3 WO 2019103373A3 KR 2018013684 W KR2018013684 W KR 2018013684W WO 2019103373 A3 WO2019103373 A3 WO 2019103373A3
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WIPO (PCT)
Prior art keywords
dutasteride
same
solid dispersion
pharmaceutical composition
producing
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PCT/KR2018/013684
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English (en)
French (fr)
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WO2019103373A2 (ko
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김대익
신우철
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한국프라임제약주식회사
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Priority to JP2020526281A priority Critical patent/JP6966644B2/ja
Priority to US16/761,990 priority patent/US11324760B2/en
Priority to CN201880074719.6A priority patent/CN111356449B/zh
Publication of WO2019103373A2 publication Critical patent/WO2019103373A2/ko
Publication of WO2019103373A3 publication Critical patent/WO2019103373A3/ko

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    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K9/143—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 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
    • A61K9/141—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

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

Abstract

본 발명은, 난용성 약물인 두타스테리드의 용해성 또는 용출성을 개선시키기 위한, 두타스테리드의 고체분산체, 이의 제조방법, 및 이를 포함하는 약학적 조성물에 관한 것이다. 보다 상세히는, 두타스테리드, 및 수용성 고분자 담체를 포함하는 공침물; 및 흡착제를 포함하는 두타스테리드 고체분산체로서, 상기 공침물은, 두타스테리드 : 수용성 고분자 담체 = 1 : 10 ~ 100 의 중량비로 함유하는 것을 특징으로 한다. 본 발명은, 아보다트® 연질캡슐과 동등 이상의 용출율을 나타내며, 이와 동시에, 보다 유연물질의 발생을 최소화되어 우수한 보관 안정성을 나타낸다.
PCT/KR2018/013684 2017-11-21 2018-11-12 두타스테리드의 고체분산체, 이의 제조방법, 및 이를 포함하는 약학적 조성물 WO2019103373A2 (ko)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2020526281A JP6966644B2 (ja) 2017-11-21 2018-11-12 デュタステリドの固体分散体、その製造方法、及びこれを含む薬学的組成物
US16/761,990 US11324760B2 (en) 2017-11-21 2018-11-12 Solid dispersion of dutasteride, method for preparing the solid dispersion, and pharmaceutical composition including the solid dispersion
CN201880074719.6A CN111356449B (zh) 2017-11-21 2018-11-12 度他雄胺的固体分散体及其制备方法和含有它的药学组合物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020170155985A KR101897995B1 (ko) 2017-11-21 2017-11-21 두타스테리드의 고체분산체, 이의 제조방법, 및 이를 포함하는 약학적 조성물
KR10-2017-0155985 2017-11-21

Publications (2)

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WO2019103373A2 WO2019103373A2 (ko) 2019-05-31
WO2019103373A3 true WO2019103373A3 (ko) 2019-07-18

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PCT/KR2018/013684 WO2019103373A2 (ko) 2017-11-21 2018-11-12 두타스테리드의 고체분산체, 이의 제조방법, 및 이를 포함하는 약학적 조성물

Country Status (5)

Country Link
US (1) US11324760B2 (ko)
JP (1) JP6966644B2 (ko)
KR (1) KR101897995B1 (ko)
CN (1) CN111356449B (ko)
WO (1) WO2019103373A2 (ko)

Families Citing this family (7)

* 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
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
KR102378590B1 (ko) 2020-09-28 2022-03-24 (주)위바이오트리 난용성 약물을 포함하는 금속 (수)산화물 복합체, 이의 제조 방법 및 이를 포함하는 약학적 조성물
WO2022065618A1 (ko) 2020-09-28 2022-03-31 주식회사 위바이오트리 난용성 약물을 포함하는 금속 (수)산화물 복합체, 이의 제조 방법 및 이를 포함하는 약학적 조성물
CN113750051B (zh) * 2021-10-20 2023-05-23 沈阳药科大学 一种供口服给药的固体化穿心莲内酯溶液及其制备方法
WO2024019439A1 (ko) * 2022-07-19 2024-01-25 (주)인벤티지랩 두타스테라이드를 포함하는 서방성 주사용 조성물
US20240165108A1 (en) * 2022-08-09 2024-05-23 Glaxosmithkline Intellectual Property Development Limited Novel use

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KR101897995B1 (ko) * 2017-11-21 2018-09-12 한국프라임제약주식회사 두타스테리드의 고체분산체, 이의 제조방법, 및 이를 포함하는 약학적 조성물

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Also Published As

Publication number Publication date
JP6966644B2 (ja) 2021-11-17
WO2019103373A2 (ko) 2019-05-31
US20200306266A1 (en) 2020-10-01
CN111356449B (zh) 2022-12-02
JP2021501195A (ja) 2021-01-14
CN111356449A (zh) 2020-06-30
KR101897995B1 (ko) 2018-09-12
US11324760B2 (en) 2022-05-10

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