BR112018013409A2 - composição farmacêutica que compreendente dutasterida e monolaurato de propileno glicol e o método de preparação da mesma - Google Patents

composição farmacêutica que compreendente dutasterida e monolaurato de propileno glicol e o método de preparação da mesma

Info

Publication number
BR112018013409A2
BR112018013409A2 BR112018013409A BR112018013409A BR112018013409A2 BR 112018013409 A2 BR112018013409 A2 BR 112018013409A2 BR 112018013409 A BR112018013409 A BR 112018013409A BR 112018013409 A BR112018013409 A BR 112018013409A BR 112018013409 A2 BR112018013409 A2 BR 112018013409A2
Authority
BR
Brazil
Prior art keywords
dutasteride
pharmaceutical composition
propylene glycol
glycol monolaurate
preparation
Prior art date
Application number
BR112018013409A
Other languages
English (en)
Inventor
Kim Ju-Hee
Ahn Kyeongjin
Kim Seyeon
Baik Taegon
Park Young-Joon
Original Assignee
Yuyu Pharma Inc
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 Yuyu Pharma Inc filed Critical Yuyu Pharma Inc
Publication of BR112018013409A2 publication Critical patent/BR112018013409A2/pt

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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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

Landscapes

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

Abstract

a presente invenção se refere a uma composição farmacêutica compreendendo dutasterida e monolaurato de propileno glicol, que melhora a estabilidade da dutasterida, que é um fármaco pouco solúvel como um inibidor da 5-alfa-redutase, e um processo para a sua preparação. mais particularmente, o presente invenção também se refere a uma formulação em cápsula que é menor em tamanho do que uma formulação comercial de cápsula de dutasterida (avodart®), mas tem a taxa de dissolução equivalente preparando uma composição farmacêutica compreendendo o monolaurato de propileno glicol e a dutasterida, o que pode melhorar a estabilidade da dutasterida. uma formulação de dutasterida que melhora a adesão do paciente e melhora a estabilidade e um método para fabricar a mesmas são fornecidos.
BR112018013409A 2015-12-31 2016-12-29 composição farmacêutica que compreendente dutasterida e monolaurato de propileno glicol e o método de preparação da mesma BR112018013409A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020150190815A KR101679992B1 (ko) 2015-12-31 2015-12-31 프로필렌글리콜 모노라우레이트를 포함하는 두타스테리드의 약학적 조성물 및 이의 제조 방법
PCT/KR2016/015533 WO2017116190A1 (en) 2015-12-31 2016-12-29 Pharmaceutical composition comprising dutasteride and propylene glycol monolaurate and preparation method of the same

Publications (1)

Publication Number Publication Date
BR112018013409A2 true BR112018013409A2 (pt) 2018-12-11

Family

ID=57706722

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018013409A BR112018013409A2 (pt) 2015-12-31 2016-12-29 composição farmacêutica que compreendente dutasterida e monolaurato de propileno glicol e o método de preparação da mesma

Country Status (8)

Country Link
US (1) US10561619B2 (pt)
EP (1) EP3397248A4 (pt)
JP (1) JP2019500416A (pt)
KR (1) KR101679992B1 (pt)
CN (1) CN108430460A (pt)
BR (1) BR112018013409A2 (pt)
TW (1) TWI654981B (pt)
WO (1) WO2017116190A1 (pt)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101679380B1 (ko) * 2015-09-10 2016-11-25 주식회사 유유제약 두타스테리드를 포함하는 약학적 조성물 및 이를 포함하는 캡슐 제형
KR101679992B1 (ko) 2015-12-31 2016-11-28 주식회사 유유제약 프로필렌글리콜 모노라우레이트를 포함하는 두타스테리드의 약학적 조성물 및 이의 제조 방법
KR20200093008A (ko) 2017-11-27 2020-08-04 유메크린 코그니션 에이비 3α-에티닐-3β-하이드록시안드로스탄-17-온 옥심의 약학적 제형
KR102353002B1 (ko) * 2018-12-14 2022-01-20 주식회사 종근당 두타스테리드를 포함하는 조성물
WO2020181163A1 (en) * 2019-03-06 2020-09-10 Tobira Therapeutics, Inc. Lipid-based formulation of cenicriviroc
KR102352888B1 (ko) * 2020-01-15 2022-01-18 한국프라임제약주식회사 두타스테리드를 포함하는 경구용 약제학적 조성물
CN111759821B (zh) * 2020-08-24 2021-10-08 四川奥邦投资有限公司 一种度他雄胺软胶囊药物组合物
CN113598227A (zh) * 2021-06-29 2021-11-05 安徽曦强乳业集团有限公司 一种具有养胃、降脂功效的老酸奶及其制备方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9717428D0 (en) * 1997-08-19 1997-10-22 Glaxo Group Ltd Pharmaceutical composition
US20040220240A1 (en) * 2001-11-28 2004-11-04 Pellegrini Cara A. Method of increasing the extent of absorption of tizanidine
JP2007516259A (ja) 2003-12-09 2007-06-21 メッドクリスタルフォームズ、エルエルシー 活性剤との混合相共結晶の調製方法
AU2006236564B2 (en) 2005-04-15 2011-02-17 Tolmar, Inc. Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
WO2010092596A1 (en) * 2009-02-10 2010-08-19 Genepharm India Private Limited An oral pharmaceutical composition of dutasteride
EP2468262A1 (en) * 2010-12-06 2012-06-27 Krka Tovarna Zdravil, D.D., Novo Mesto Pharmaceutical composition comprising dutasteride
DK2667854T3 (en) 2011-01-24 2019-04-23 Anterios Inc NANO PARTICLE FORMATIONS
KR101679380B1 (ko) * 2015-09-10 2016-11-25 주식회사 유유제약 두타스테리드를 포함하는 약학적 조성물 및 이를 포함하는 캡슐 제형
KR101679992B1 (ko) 2015-12-31 2016-11-28 주식회사 유유제약 프로필렌글리콜 모노라우레이트를 포함하는 두타스테리드의 약학적 조성물 및 이의 제조 방법
KR101716878B1 (ko) 2016-05-12 2017-03-15 주식회사 유유제약 글리세롤 지방산에스테르유도체 또는 프로필렌글리콜 지방산에스테르유도체를 함유한 두타스테리드와 타다라필의 복합 캡슐제제 조성물 및 이의 제조방법

Also Published As

Publication number Publication date
WO2017116190A1 (en) 2017-07-06
KR101679992B1 (ko) 2016-11-28
EP3397248A1 (en) 2018-11-07
TW201729815A (zh) 2017-09-01
CN108430460A (zh) 2018-08-21
US10561619B2 (en) 2020-02-18
TWI654981B (zh) 2019-04-01
JP2019500416A (ja) 2019-01-10
US20190008785A1 (en) 2019-01-10
EP3397248A4 (en) 2019-07-31

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notice of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements
B350 Update of information on the portal [chapter 15.35 patent gazette]