EP2395975A4 - An oral pharmaceutical composition of dutasteride - Google Patents

An oral pharmaceutical composition of dutasteride

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Withdrawn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)
French (fr)
Other versions
EP2395975A1 (en
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/en
Publication of EP2395975A4 publication Critical patent/EP2395975A4/en
Withdrawn legal-status Critical Current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
EP10741016.9A 2009-02-10 2010-02-10 An oral pharmaceutical composition of dutasteride Withdrawn EP2395975A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN278MU2009 2009-02-10
PCT/IN2010/000073 WO2010092596A1 (en) 2009-02-10 2010-02-10 An oral pharmaceutical composition of dutasteride

Publications (2)

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

Family

ID=42561471

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10741016.9A Withdrawn EP2395975A4 (en) 2009-02-10 2010-02-10 An oral pharmaceutical composition of dutasteride

Country Status (2)

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

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2395975A4 (en) 2009-02-10 2013-05-22 Genepharm India Private Ltd 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
CN102166270A (en) * 2011-04-06 2011-08-31 西北农林科技大学 Oil-in-water type dried orange peel oil nano-emulsion and preparation method thereof
US9622981B2 (en) * 2011-11-17 2017-04-18 Mylan Inc. Liquid-filled hard gel capsule pharmaceutical formulations
CN103169712B (en) * 2011-12-20 2017-10-27 重庆华邦制药有限公司 Improve dutasteride's preparation of bioavilability and preparation method thereof
KR101976137B1 (en) * 2012-01-25 2019-05-09 한미약품 주식회사 Self-emulsifying drug delivery system composition comprising dutasteride and method for preparing the same
MX346214B (en) * 2012-03-02 2017-03-10 Colgate Palmolive Co Oral care compositions.
WO2014002015A1 (en) * 2012-06-25 2014-01-03 Ranbaxy Laboratories Limited Pharmaceutical composition comprising dutasteride
CN103655470A (en) * 2012-09-18 2014-03-26 重庆医药工业研究院有限责任公司 Dutasteride self-microemulsion composition and preparation method thereof
US20160287524A1 (en) * 2013-03-19 2016-10-06 Galenicum Health S.L. Pharmaceutical compositions comprising an active agent
CN104069084B (en) * 2013-03-25 2019-06-25 重庆华邦制药有限公司 A kind of dutasteride's soft capsule that quality is stable
CN104146966B (en) * 2013-05-15 2021-02-26 重庆医药工业研究院有限责任公司 Dutasteride self-microemulsion freeze-dried composition and preparation method thereof
KR101833280B1 (en) 2013-06-28 2018-02-28 한미약품 주식회사 Oral soft capsule formulation comprising dutasteride
BR102013020508B1 (en) 2013-08-12 2021-01-12 Ems S/A. DOSAGE FORM THAT UNDERSTANDS A 5-ALPHA REDUCTASE STEROID INHIBITOR AND AN ALPHA BLOCKER, PROCESS FOR THE PREPARATION OF A DOSAGE FORM AND USE OF THE DOSAGE FORM
ES2555485T1 (en) 2014-05-26 2016-01-04 Galenicum Health S.L. Pharmaceutical compositions containing an active agent
KR101590072B1 (en) * 2014-12-23 2016-01-29 한미약품 주식회사 Composition for self-emulsifying drug delivery system comprising dutasteride
KR102382963B1 (en) * 2015-01-14 2022-04-05 동아에스티 주식회사 Dutasteride composition in tablet form with improved stability
US9918965B2 (en) * 2015-04-10 2018-03-20 Bioresponse, L.L.C. Self-emulsifying formulations of DIM-related indoles
KR101679380B1 (en) 2015-09-10 2016-11-25 주식회사 유유제약 Pharmaceutical composition including dutasteride and capsule formulation comprising the same
KR101679992B1 (en) * 2015-12-31 2016-11-28 주식회사 유유제약 Pharmaceutical composition comprising dutasteride and propylene glycol monolaurate and preparation method of the same
KR101716878B1 (en) * 2016-05-12 2017-03-15 주식회사 유유제약 Pharmaceutical Capsule Composite Formulation of Dutasteride and Tadalafill Comprising Glycerol Fatty Acid Ester Derivative or Propylene Glycol Fatty Acid Ester Derivative And Method For Preparation thereof
WO2018062831A1 (en) * 2016-09-30 2018-04-05 Yuyu Pharma, Inc. Oral capsule composite formulation of dutasteride and tadalafil
CN110013467B (en) 2018-01-10 2021-09-17 上海汉都医药科技有限公司 Solid particle, preparation method thereof and pharmaceutical composition containing solid particle
CN111388441A (en) * 2018-12-13 2020-07-10 昆明积大制药股份有限公司 Dutasteride soft capsule
KR102352888B1 (en) * 2020-01-15 2022-01-18 한국프라임제약주식회사 Oral pharmaceutical composition comprising dutasteride
KR102199667B1 (en) * 2020-08-14 2021-01-07 (주)필인터내셔널 Pharmaceutical composition comprising dutasteride

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 (en) * 2004-11-15 2006-05-26 Smithkline Beecham Corporation Fixed dose combination op dutasteride and tamsulosin

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
BRPI0914630A2 (en) * 2008-06-26 2019-09-24 Anterios Inc dermal release
EP2395975A4 (en) 2009-02-10 2013-05-22 Genepharm India Private Ltd An oral pharmaceutical composition of dutasteride

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 (en) * 2004-11-15 2006-05-26 Smithkline Beecham Corporation Fixed dose combination op dutasteride and tamsulosin

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 (en) 2010-08-19
EP2395975A1 (en) 2011-12-21

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