RU2708238C2 - Стабильные составы тестостерона ундеканоата - Google Patents
Стабильные составы тестостерона ундеканоата Download PDFInfo
- Publication number
- RU2708238C2 RU2708238C2 RU2017101240A RU2017101240A RU2708238C2 RU 2708238 C2 RU2708238 C2 RU 2708238C2 RU 2017101240 A RU2017101240 A RU 2017101240A RU 2017101240 A RU2017101240 A RU 2017101240A RU 2708238 C2 RU2708238 C2 RU 2708238C2
- Authority
- RU
- Russia
- Prior art keywords
- composition
- water
- propylene glycol
- testosterone undecanoate
- surfactant
- Prior art date
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)
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 (3)
| Publication Number | Publication Date |
|---|---|
| RU2017101240A RU2017101240A (ru) | 2018-07-17 |
| RU2017101240A3 RU2017101240A3 (enExample) | 2019-02-22 |
| RU2708238C2 true RU2708238C2 (ru) | 2019-12-05 |
Family
ID=50980940
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017101240A RU2708238C2 (ru) | 2014-06-17 | 2015-06-15 | Стабильные составы тестостерона ундеканоата |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US9925200B2 (enExample) |
| EP (1) | EP3157505B1 (enExample) |
| JP (1) | JP6618488B2 (enExample) |
| KR (1) | KR20170020779A (enExample) |
| CN (1) | CN106456782B (enExample) |
| AU (1) | AU2015276321B2 (enExample) |
| BR (1) | BR112016028192A2 (enExample) |
| CA (1) | CA2950670A1 (enExample) |
| ES (1) | ES2749008T3 (enExample) |
| MX (1) | MX373197B (enExample) |
| RU (1) | RU2708238C2 (enExample) |
| WO (1) | WO2015193224A1 (enExample) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110160168A1 (en) | 2009-12-31 | 2011-06-30 | Differential Drug Development Associates, Llc | Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols |
| WO2014143127A1 (en) | 2013-03-15 | 2014-09-18 | Differential Drug Development Associates Llc | Emulsion formulations |
| UA128186C2 (uk) | 2017-11-27 | 2024-05-01 | Умекрайн Когнішн Аб | ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ 3<font face="Symbol">a</font>-ЕТИНІЛ-3<font face="Symbol">b</font>-ГІДРОКСІАНДРОСТАН-17-ОНУ ОКСИМУ |
| EP3824296B1 (en) | 2018-07-20 | 2026-04-01 | Lipocine Inc. | Oral pharmaceutical composition comprising testosterone tridecanoate and/or testosterone dodecanoate for treating liver diseases |
| US12403146B2 (en) | 2019-10-30 | 2025-09-02 | Marius Pharmaceuticals, Inc. | Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997040823A1 (en) * | 1996-04-26 | 1997-11-06 | R.P. Scherer Limited | Oral pharmaceutical compositions containing sex hormones |
| US6652880B1 (en) * | 1999-04-01 | 2003-11-25 | R.P. Scherer Technologies, Inc. | Oral pharmaceutical compositions containing long-chain triglycerides and liphophilic surfactants |
| RU2303981C2 (ru) * | 2000-11-01 | 2007-08-10 | Юнимед Фармасьютикалс, Инк. | Способ лечения эректильной дисфункции и повышения либидо у мужчин |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4098802A (en) | 1975-02-18 | 1978-07-04 | Akzona Incorporated | Oral pharmaceutical preparation having androgenic activity |
| 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. |
| 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 |
| CA2063791C (en) | 1989-08-17 | 2000-12-19 | Michael John Story | Hard gelatine capsule containing fat-soluble nutrients. |
| 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 |
| SE9700642D0 (sv) | 1997-02-24 | 1997-02-24 | Kronvall Stefan Med Ab | Medel och sätt för förebyggande och behandling av det metabola syndromet |
| SI0999826T1 (en) | 1997-07-29 | 2004-12-31 | Pharmacia & Upjohn Company | Self-emulsifying formulation for lipophilic compounds |
| US7396526B1 (en) * | 1998-11-12 | 2008-07-08 | Johnson & Johnson Consumer Companies, Inc. | Skin care composition |
| GB9907715D0 (en) * | 1999-04-01 | 1999-05-26 | Scherer Corp R P | Pharmaceutical compositions |
| JP2002541111A (ja) | 1999-04-01 | 2002-12-03 | アクゾ・ノベル・エヌ・ベー | ウンデカン酸テストステロンとヒマシ油を含む調合物 |
| AU2005309808A1 (en) * | 2004-11-24 | 2006-06-01 | Merck & Co., Inc. | Liquid and semi-solid pharmaceutical formulations for oral administration of a substituted amide |
| US8492369B2 (en) | 2010-04-12 | 2013-07-23 | Clarus Therapeutics Inc | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
| US8241664B2 (en) | 2005-04-15 | 2012-08-14 | Clarus Therapeutics, Inc | Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same |
| US20130303495A1 (en) * | 2009-12-31 | 2013-11-14 | Sov Therapeutics | Emulsion formulations |
| US20110160168A1 (en) * | 2009-12-31 | 2011-06-30 | Differential Drug Development Associates, Llc | Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols |
| WO2011129812A1 (en) * | 2010-04-12 | 2011-10-20 | Clarus Therapeutics, Inc. | Oral testosterone ester formulations and methods of treating testoterone deficiency comprising same |
| 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 |
| EP4234015A3 (en) | 2013-03-15 | 2023-11-22 | Tolmar, 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 |
-
2015
- 2015-06-15 WO PCT/EP2015/063292 patent/WO2015193224A1/en not_active Ceased
- 2015-06-15 JP JP2016572477A patent/JP6618488B2/ja not_active Expired - Fee Related
- 2015-06-15 EP EP15728552.9A patent/EP3157505B1/en active Active
- 2015-06-15 US US15/317,132 patent/US9925200B2/en active Active
- 2015-06-15 MX MX2016016612A patent/MX373197B/es active IP Right Grant
- 2015-06-15 KR KR1020167035025A patent/KR20170020779A/ko not_active Withdrawn
- 2015-06-15 CA CA2950670A patent/CA2950670A1/en not_active Abandoned
- 2015-06-15 BR BR112016028192A patent/BR112016028192A2/pt not_active Application Discontinuation
- 2015-06-15 AU AU2015276321A patent/AU2015276321B2/en not_active Ceased
- 2015-06-15 ES ES15728552T patent/ES2749008T3/es active Active
- 2015-06-15 RU RU2017101240A patent/RU2708238C2/ru active
- 2015-06-15 CN CN201580032121.7A patent/CN106456782B/zh not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997040823A1 (en) * | 1996-04-26 | 1997-11-06 | R.P. Scherer Limited | Oral pharmaceutical compositions containing sex hormones |
| US6652880B1 (en) * | 1999-04-01 | 2003-11-25 | R.P. Scherer Technologies, Inc. | Oral pharmaceutical compositions containing long-chain triglycerides and liphophilic surfactants |
| RU2303981C2 (ru) * | 2000-11-01 | 2007-08-10 | Юнимед Фармасьютикалс, Инк. | Способ лечения эректильной дисфункции и повышения либидо у мужчин |
Also Published As
| Publication number | Publication date |
|---|---|
| MX373197B (es) | 2020-05-12 |
| JP2017522283A (ja) | 2017-08-10 |
| AU2015276321A1 (en) | 2016-11-10 |
| RU2017101240A (ru) | 2018-07-17 |
| CA2950670A1 (en) | 2015-12-23 |
| MX2016016612A (es) | 2017-03-20 |
| CN106456782B (zh) | 2020-02-18 |
| EP3157505A1 (en) | 2017-04-26 |
| WO2015193224A1 (en) | 2015-12-23 |
| BR112016028192A2 (pt) | 2017-08-22 |
| CN106456782A (zh) | 2017-02-22 |
| RU2017101240A3 (enExample) | 2019-02-22 |
| EP3157505B1 (en) | 2019-07-24 |
| KR20170020779A (ko) | 2017-02-24 |
| ES2749008T3 (es) | 2020-03-18 |
| US20170136033A1 (en) | 2017-05-18 |
| US9925200B2 (en) | 2018-03-27 |
| AU2015276321B2 (en) | 2019-10-24 |
| JP6618488B2 (ja) | 2019-12-11 |
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