EP2395975A4 - Composition pharmaceutique orale de dutastéride - Google Patents

Composition pharmaceutique orale de dutastéride

Info

Publication number
EP2395975A4
EP2395975A4 EP10741016.9A EP10741016A EP2395975A4 EP 2395975 A4 EP2395975 A4 EP 2395975A4 EP 10741016 A EP10741016 A EP 10741016A EP 2395975 A4 EP2395975 A4 EP 2395975A4
Authority
EP
European Patent Office
Prior art keywords
dutasteride
pharmaceutical composition
oral pharmaceutical
oral
composition
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.)
Withdrawn
Application number
EP10741016.9A
Other languages
German (de)
English (en)
Other versions
EP2395975A1 (fr
Inventor
Deepak Murpani
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.)
GENEPHARM INDIA PRIVATE Ltd
Original Assignee
GENEPHARM INDIA PRIVATE 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 GENEPHARM INDIA PRIVATE Ltd filed Critical GENEPHARM INDIA PRIVATE Ltd
Publication of EP2395975A1 publication Critical patent/EP2395975A1/fr
Publication of EP2395975A4 publication Critical patent/EP2395975A4/fr
Withdrawn legal-status Critical Current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
    • A61K9/10—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/28—Antiandrogens

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP10741016.9A 2009-02-10 2010-02-10 Composition pharmaceutique orale de dutastéride Withdrawn EP2395975A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN278MU2009 2009-02-10
PCT/IN2010/000073 WO2010092596A1 (fr) 2009-02-10 2010-02-10 Composition pharmaceutique orale de dutastéride

Publications (2)

Publication Number Publication Date
EP2395975A1 EP2395975A1 (fr) 2011-12-21
EP2395975A4 true EP2395975A4 (fr) 2013-05-22

Family

ID=42561471

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10741016.9A Withdrawn EP2395975A4 (fr) 2009-02-10 2010-02-10 Composition pharmaceutique orale de dutastéride

Country Status (2)

Country Link
EP (1) EP2395975A4 (fr)
WO (1) WO2010092596A1 (fr)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2395975A4 (fr) 2009-02-10 2013-05-22 Genepharm India Private Ltd Composition pharmaceutique orale de dutastéride
EP2468262A1 (fr) 2010-12-06 2012-06-27 Krka Tovarna Zdravil, D.D., Novo Mesto Composition pharmaceutique contenant de la dutastéride
CN102166270A (zh) * 2011-04-06 2011-08-31 西北农林科技大学 一种水包油型陈皮油纳米乳及其制备方法
US9622981B2 (en) * 2011-11-17 2017-04-18 Mylan Inc. Liquid-filled hard gel capsule pharmaceutical formulations
CN103169712B (zh) * 2011-12-20 2017-10-27 重庆华邦制药有限公司 提高生物利用度的度他雄胺制剂及其制备方法
KR101976137B1 (ko) * 2012-01-25 2019-05-09 한미약품 주식회사 두타스테라이드 함유 자가 유화 약물전달 시스템용 조성물 및 이의 제조 방법
AU2012371612B2 (en) * 2012-03-02 2014-11-13 Colgate-Palmolive Company Oral care compositions
WO2014002015A1 (fr) * 2012-06-25 2014-01-03 Ranbaxy Laboratories Limited Composition pharmaceutique comprenant du dutastéride
CN103655470A (zh) * 2012-09-18 2014-03-26 重庆医药工业研究院有限责任公司 一种度他雄胺自微乳组合物及其制备方法
BR112015021769A2 (pt) * 2013-03-19 2017-07-18 Galenicum Health Sl composições farmacêuticas compreendendo um agente ativo
CN104069084B (zh) * 2013-03-25 2019-06-25 重庆华邦制药有限公司 一种质量稳定的度他雄胺软胶囊
CN104146966B (zh) * 2013-05-15 2021-02-26 重庆医药工业研究院有限责任公司 一种度他雄胺自微乳冻干组合物及其制备方法
KR101833280B1 (ko) * 2013-06-28 2018-02-28 한미약품 주식회사 두타스테라이드를 포함하는 경구용 연질 캡슐 제형
BR102013020508B1 (pt) 2013-08-12 2021-01-12 Ems S/A. Forma de dosagem que compreende um inibidor de esteroide 5-alfa-redutase e um bloqueador alfa, processo para a preparaçãode uma forma de dosagem e uso da forma de dosagem
ES2555485T1 (es) 2014-05-26 2016-01-04 Galenicum Health S.L. Composiciones farmacéuticas que contienen un agente activo
KR101590072B1 (ko) * 2014-12-23 2016-01-29 한미약품 주식회사 두타스테라이드를 포함하는 자가유화 약물전달 시스템용 조성물
KR102382963B1 (ko) * 2015-01-14 2022-04-05 동아에스티 주식회사 안정성이 개선된 정제형태의 두타스테리드 조성물
CA2982162C (fr) * 2015-04-10 2023-10-10 Bioresponse, L.L.C. Formulations auto-emulsifiantes d'indoles associes au dim
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
US20190224195A1 (en) * 2016-09-30 2019-07-25 Yuyu Pharma, Inc. Oral Capsule Composite Formulation of Dutasteride and Tadalafil
CN110013467B (zh) 2018-01-10 2021-09-17 上海汉都医药科技有限公司 一种固体微粒及其制备方法和含其的药物组合物
CN111388441A (zh) * 2018-12-13 2020-07-10 昆明积大制药股份有限公司 度他雄胺软胶囊
KR102352888B1 (ko) * 2020-01-15 2022-01-18 한국프라임제약주식회사 두타스테리드를 포함하는 경구용 약제학적 조성물
KR102199667B1 (ko) * 2020-08-14 2021-01-07 (주)필인터내셔널 두타스테리드를 포함하는 약학적 조성물

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5834026A (en) * 1996-04-26 1998-11-10 Abc Health International, Inc. Water dispersible dietary composition
US20030235595A1 (en) * 1999-06-30 2003-12-25 Feng-Jing Chen Oil-containing, orally administrable pharmaceutical composition for improved delivery of a therapeutic agent
US20030236236A1 (en) * 1999-06-30 2003-12-25 Feng-Jing Chen Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs
WO2006055659A2 (fr) * 2004-11-15 2006-05-26 Smithkline Beecham Corporation Composition pharmaceutique

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060204588A1 (en) * 2005-03-10 2006-09-14 Elan Pharma International Limited Formulations of a nanoparticulate finasteride, dutasteride or tamsulosin hydrochloride, and mixtures thereof
SG10201608732VA (en) * 2008-06-26 2016-12-29 Anterios Inc Dermal delivery
EP2395975A4 (fr) 2009-02-10 2013-05-22 Genepharm India Private Ltd Composition pharmaceutique orale de dutastéride

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5834026A (en) * 1996-04-26 1998-11-10 Abc Health International, Inc. Water dispersible dietary composition
US20030235595A1 (en) * 1999-06-30 2003-12-25 Feng-Jing Chen Oil-containing, orally administrable pharmaceutical composition for improved delivery of a therapeutic agent
US20030236236A1 (en) * 1999-06-30 2003-12-25 Feng-Jing Chen Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs
WO2006055659A2 (fr) * 2004-11-15 2006-05-26 Smithkline Beecham Corporation Composition pharmaceutique

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CONSTANTINIDES P P ET AL: "FORMULATION AND INTESTINAL ABSORPTION ENHANCEMENT EVALUATION OF WATER-IN-OIL MICROEMULSIONS INCORPORATING MEDIUM-CHAIN GLYCERIDES", PHARMACEUTICAL RESEARCH, KLUWER ACADEMIC PUBLISHERS, NEW YORK, NY, US, vol. 11, no. 10, 1 January 1994 (1994-01-01), pages 1385 - 1390, XP002923381, ISSN: 0724-8741, DOI: 10.1023/A:1018927402875 *
See also references of WO2010092596A1 *
TANG B ET AL: "Development of solid self-emulsifying drug delivery systems: preparation techniques and dosage forms", DRUG DISCOVERY TODAY, ELSEVIER, RAHWAY, NJ, US, vol. 13, no. 13-14, 1 July 2008 (2008-07-01), pages 606 - 612, XP022797178, ISSN: 1359-6446, [retrieved on 20080603], DOI: 10.1016/J.DRUDIS.2008.04.006 *

Also Published As

Publication number Publication date
WO2010092596A1 (fr) 2010-08-19
EP2395975A1 (fr) 2011-12-21

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