KR20170020779A - 테스토스테론 운데카노에이트의 안정한 제제 - Google Patents

테스토스테론 운데카노에이트의 안정한 제제 Download PDF

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Publication number
KR20170020779A
KR20170020779A KR1020167035025A KR20167035025A KR20170020779A KR 20170020779 A KR20170020779 A KR 20170020779A KR 1020167035025 A KR1020167035025 A KR 1020167035025A KR 20167035025 A KR20167035025 A KR 20167035025A KR 20170020779 A KR20170020779 A KR 20170020779A
Authority
KR
South Korea
Prior art keywords
water
testosterone undecanoate
surfactant
formulation
propylene glycol
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Withdrawn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
KR1020167035025A
Other languages
English (en)
Korean (ko)
Inventor
흐리디나 헤이. 스코너스-흐리츠마
Original Assignee
머크 샤프 앤 도메 비.브이.
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 머크 샤프 앤 도메 비.브이. filed Critical 머크 샤프 앤 도메 비.브이.
Publication of KR20170020779A publication Critical patent/KR20170020779A/ko
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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
    • 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
    • A61P5/26—Androgens

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Diabetes (AREA)
  • Reproductive Health (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
KR1020167035025A 2014-06-17 2015-06-15 테스토스테론 운데카노에이트의 안정한 제제 Withdrawn KR20170020779A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14172805.5 2014-06-17
EP14172805 2014-06-17
PCT/EP2015/063292 WO2015193224A1 (en) 2014-06-17 2015-06-15 Stable formulations of testosterone undecanoate

Publications (1)

Publication Number Publication Date
KR20170020779A true KR20170020779A (ko) 2017-02-24

Family

ID=50980940

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020167035025A Withdrawn KR20170020779A (ko) 2014-06-17 2015-06-15 테스토스테론 운데카노에이트의 안정한 제제

Country Status (12)

Country Link
US (1) US9925200B2 (cg-RX-API-DMAC7.html)
EP (1) EP3157505B1 (cg-RX-API-DMAC7.html)
JP (1) JP6618488B2 (cg-RX-API-DMAC7.html)
KR (1) KR20170020779A (cg-RX-API-DMAC7.html)
CN (1) CN106456782B (cg-RX-API-DMAC7.html)
AU (1) AU2015276321B2 (cg-RX-API-DMAC7.html)
BR (1) BR112016028192A2 (cg-RX-API-DMAC7.html)
CA (1) CA2950670A1 (cg-RX-API-DMAC7.html)
ES (1) ES2749008T3 (cg-RX-API-DMAC7.html)
MX (1) MX373197B (cg-RX-API-DMAC7.html)
RU (1) RU2708238C2 (cg-RX-API-DMAC7.html)
WO (1) WO2015193224A1 (cg-RX-API-DMAC7.html)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2822435C (en) 2009-12-31 2018-09-11 Differential Drug Development Associates, Llc Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
ES2907284T3 (es) 2013-03-15 2022-04-22 Marius Pharmaceuticals Llc Formulaciones de emulsión
IL274893B2 (en) 2017-11-27 2024-08-01 Umecrine Cognition Ab Pharmaceutical formulation of 3 alpha-ethynyl-3 beta-hydroxyandrostan-17-one oxime
JP2021531348A (ja) * 2018-07-20 2021-11-18 リポシン，インク． 肝臓病
US12403146B2 (en) 2019-10-30 2025-09-02 Marius Pharmaceuticals, Inc. Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4147783A (en) 1974-02-28 1979-04-03 Akzona Incorporated Oral pharmaceutical preparation
NL189235C (nl) 1974-02-28 1993-02-16 Akzo Nv Werkwijze voor de bereiding van een oraal toe te dienen farmaceutisch preparaat met androgene werking.
US4098802A (en) 1975-02-18 1978-07-04 Akzona Incorporated Oral pharmaceutical preparation having androgenic activity
NL7510104A (nl) 1975-08-27 1977-03-01 Akzo Nv Werkwijze ter bereiding van een oraal werkzaam farmaceutisch preparaat.
US5532002A (en) 1989-08-17 1996-07-02 Cortecs Limited Gelatin pharmaceutical formulations
EP0487575B1 (en) 1989-08-17 1994-11-02 Cortecs Limited Pharmaceutical formulations
CN1102095A (zh) 1993-10-30 1995-05-03 浙江医科大学 长效雄激素类制剂——十一酸睾丸注射液
GB9405304D0 (en) 1994-03-16 1994-04-27 Scherer Ltd R P Delivery systems for hydrophobic drugs
GB9608719D0 (en) * 1996-04-26 1996-07-03 Scherer Ltd R P Pharmaceutical compositions
SE9700642D0 (sv) 1997-02-24 1997-02-24 Kronvall Stefan Med Ab Medel och sätt för förebyggande och behandling av det metabola syndromet
ATE265847T1 (de) 1997-07-29 2004-05-15 Upjohn Co Selbstemulgierbare formulierung enthaltend lipophile verbindungen
US7396526B1 (en) * 1998-11-12 2008-07-08 Johnson & Johnson Consumer Companies, Inc. Skin care composition
US6652880B1 (en) 1999-04-01 2003-11-25 R.P. Scherer Technologies, Inc. Oral pharmaceutical compositions containing long-chain triglycerides and liphophilic surfactants
PT1189620E (pt) 1999-04-01 2004-10-29 Akzo Nobel Nv Formulacao que compreende undecanoato de testosterona e oleo de ricino
GB9907715D0 (en) 1999-04-01 1999-05-26 Scherer Corp R P Pharmaceutical compositions
RU2303981C2 (ru) * 2000-11-01 2007-08-10 Юнимед Фармасьютикалс, Инк. Способ лечения эректильной дисфункции и повышения либидо у мужчин
EP1817012A2 (en) * 2004-11-24 2007-08-15 Merck & Co., Inc. Liquid and semi-solid pharmaceutical formulations for oral administration of a substituted amide
AU2006236564B2 (en) 2005-04-15 2011-02-17 Besins Healthcare Luxembourg S.A.R.L. Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
US8492369B2 (en) 2010-04-12 2013-07-23 Clarus Therapeutics Inc Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
CA2822435C (en) * 2009-12-31 2018-09-11 Differential Drug Development Associates, Llc Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
US20130303495A1 (en) 2009-12-31 2013-11-14 Sov Therapeutics Emulsion formulations
MX352328B (es) 2010-04-12 2017-11-21 Clarus Therapeutics Inc Formulaciones orales de ester de testosterona y metodos para el tratamiento de la deficiencia de testosterona que comprende estos.
US20120135074A1 (en) * 2010-11-30 2012-05-31 Chandrashekar Giliyar High-Strength Testosterone Undecanoate Compositions
US9034858B2 (en) * 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
CA2905703A1 (en) 2013-03-15 2014-09-18 Clarus Therapeutics, Inc. Methods of treating testosterone deficiency
US10245273B2 (en) 2013-12-26 2019-04-02 Clarus Therapeutics, Inc. Oral pharmaceutical products and methods of use combining testosterone esters with hypolipidemic agents

Also Published As

Publication number Publication date
BR112016028192A2 (pt) 2017-08-22
JP2017522283A (ja) 2017-08-10
US9925200B2 (en) 2018-03-27
AU2015276321A1 (en) 2016-11-10
EP3157505B1 (en) 2019-07-24
ES2749008T3 (es) 2020-03-18
WO2015193224A1 (en) 2015-12-23
AU2015276321B2 (en) 2019-10-24
RU2708238C2 (ru) 2019-12-05
EP3157505A1 (en) 2017-04-26
CA2950670A1 (en) 2015-12-23
MX373197B (es) 2020-05-12
JP6618488B2 (ja) 2019-12-11
CN106456782B (zh) 2020-02-18
US20170136033A1 (en) 2017-05-18
MX2016016612A (es) 2017-03-20
RU2017101240A (ru) 2018-07-17
RU2017101240A3 (cg-RX-API-DMAC7.html) 2019-02-22
CN106456782A (zh) 2017-02-22

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Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20161214

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20200604

Comment text: Request for Examination of Application

PC1202 Submission of document of withdrawal before decision of registration

Comment text: [Withdrawal of Procedure relating to Patent, etc.] Withdrawal (Abandonment)

Patent event code: PC12021R01D

Patent event date: 20200825

WITB Written withdrawal of application