KR102238478B1 - 구강 전달용 지방균형잡힌 장쇄 테스토스테론 에스테르 - Google Patents
구강 전달용 지방균형잡힌 장쇄 테스토스테론 에스테르 Download PDFInfo
- Publication number
- KR102238478B1 KR102238478B1 KR1020157021653A KR20157021653A KR102238478B1 KR 102238478 B1 KR102238478 B1 KR 102238478B1 KR 1020157021653 A KR1020157021653 A KR 1020157021653A KR 20157021653 A KR20157021653 A KR 20157021653A KR 102238478 B1 KR102238478 B1 KR 102238478B1
- Authority
- KR
- South Korea
- Prior art keywords
- testosterone
- composition
- group
- lipophilic
- administered
- 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.)
- Active
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Classifications
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- 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
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- 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
- 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
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
-
- 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
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
-
- 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
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)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gynecology & Obstetrics (AREA)
- Diabetes (AREA)
- Pregnancy & Childbirth (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13/843,403 | 2013-03-15 | ||
| US13/843,403 US20130225544A1 (en) | 2009-01-08 | 2013-03-15 | Lipobalanced long chain testosterone esters for oral delivery |
| PCT/US2014/030604 WO2014145781A1 (en) | 2013-03-15 | 2014-03-17 | Lipobalanced long chain testosterone esters for oral delivery |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| KR20150129671A KR20150129671A (ko) | 2015-11-20 |
| KR102238478B1 true KR102238478B1 (ko) | 2021-04-09 |
Family
ID=51538095
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020157021653A Active KR102238478B1 (ko) | 2013-03-15 | 2014-03-17 | 구강 전달용 지방균형잡힌 장쇄 테스토스테론 에스테르 |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US20160193227A1 (https=) |
| EP (2) | EP2968363B1 (https=) |
| JP (1) | JP6307711B2 (https=) |
| KR (1) | KR102238478B1 (https=) |
| CN (1) | CN105073118A (https=) |
| AR (1) | AR095538A1 (https=) |
| AU (2) | AU2014232475A1 (https=) |
| BR (1) | BR112015020849A2 (https=) |
| CA (1) | CA2942005C (https=) |
| IL (1) | IL240958B (https=) |
| MX (1) | MX2015010594A (https=) |
| RU (1) | RU2722592C2 (https=) |
| TW (1) | TW201521731A (https=) |
| UY (1) | UY35445A (https=) |
| WO (1) | WO2014145781A1 (https=) |
| ZA (1) | ZA201507700B (https=) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2983643T3 (es) * | 2016-11-30 | 2024-10-24 | Lipocine Inc | Terapia oral con tridecanoato de testosterona |
| AU2019308326B2 (en) * | 2018-07-20 | 2025-07-31 | Lipocine Inc. | Liver disease |
| JP6945874B2 (ja) * | 2019-12-24 | 2021-10-06 | 一般財団法人バイオダイナミックス研究所 | 経口投与用医薬組成物 |
| WO2024005770A1 (en) * | 2022-06-22 | 2024-01-04 | Lipocine, Inc. | (17-)-3-oxoandrost-4-en-17-yl dodecanoate compositions and methods of preparation and use |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7138389B2 (en) | 2004-02-09 | 2006-11-21 | University Of Washington | Oral androgen therapy using modulators of testosterone bioavailability |
| US20110251167A1 (en) | 2010-04-12 | 2011-10-13 | Clarus Therapeutics, Inc. | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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. |
| US4147783A (en) * | 1974-02-28 | 1979-04-03 | Akzona Incorporated | Oral pharmaceutical preparation |
| GB1567515A (en) * | 1976-05-28 | 1980-05-14 | Akzo Nv | Esters of testo-sterone and 5 -dihydro-testosterone |
| US20050101517A1 (en) * | 2000-08-23 | 2005-05-12 | Henrick De Nijs | Novel testosterone ester formulation for human use |
| US20030022875A1 (en) * | 2001-07-27 | 2003-01-30 | Wilson Leland F. | As-needed administration of orally active androgenic agents to enhance female sexual desire and responsiveness |
| JO2505B1 (en) * | 2003-03-14 | 2009-10-05 | باير شيرنغ فارما اكتنجيسيلشافت | Pharmacy methods and formulations for obtaining acceptable serum testosterone levels |
| CA2604943C (en) * | 2005-04-15 | 2013-09-17 | Clarus Therapeutics, Inc. | Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same |
| CN101217963A (zh) * | 2005-04-15 | 2008-07-09 | 克劳拉斯医疗有限公司 | 疏水性药物给药系统及含有疏水性药物的组合物 |
| US9034858B2 (en) * | 2010-11-30 | 2015-05-19 | Lipocine Inc. | High-strength testosterone undecanoate compositions |
-
2014
- 2014-03-12 TW TW103108750A patent/TW201521731A/zh unknown
- 2014-03-14 UY UY35445A patent/UY35445A/es not_active Application Discontinuation
- 2014-03-14 AR ARP140101150A patent/AR095538A1/es not_active Application Discontinuation
- 2014-03-17 EP EP14764607.9A patent/EP2968363B1/en active Active
- 2014-03-17 JP JP2016503427A patent/JP6307711B2/ja active Active
- 2014-03-17 BR BR112015020849A patent/BR112015020849A2/pt not_active Application Discontinuation
- 2014-03-17 RU RU2015128028A patent/RU2722592C2/ru active
- 2014-03-17 WO PCT/US2014/030604 patent/WO2014145781A1/en not_active Ceased
- 2014-03-17 KR KR1020157021653A patent/KR102238478B1/ko active Active
- 2014-03-17 CN CN201480010890.2A patent/CN105073118A/zh active Pending
- 2014-03-17 MX MX2015010594A patent/MX2015010594A/es active IP Right Grant
- 2014-03-17 AU AU2014232475A patent/AU2014232475A1/en not_active Abandoned
- 2014-03-17 EP EP20191415.7A patent/EP3797762A1/en not_active Withdrawn
- 2014-03-17 CA CA2942005A patent/CA2942005C/en active Active
-
2015
- 2015-08-31 IL IL240958A patent/IL240958B/en active IP Right Grant
- 2015-10-14 ZA ZA2015/07700A patent/ZA201507700B/en unknown
-
2016
- 2016-02-04 US US15/016,164 patent/US20160193227A1/en not_active Abandoned
- 2016-02-04 US US15/016,168 patent/US20160193228A1/en not_active Abandoned
-
2019
- 2019-01-08 AU AU2019200097A patent/AU2019200097B2/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7138389B2 (en) | 2004-02-09 | 2006-11-21 | University Of Washington | Oral androgen therapy using modulators of testosterone bioavailability |
| US20110251167A1 (en) | 2010-04-12 | 2011-10-13 | Clarus Therapeutics, Inc. | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
Also Published As
| Publication number | Publication date |
|---|---|
| IL240958B (en) | 2019-07-31 |
| IL240958A0 (en) | 2015-11-30 |
| EP2968363A4 (en) | 2016-08-17 |
| UY35445A (es) | 2014-10-31 |
| EP2968363B1 (en) | 2020-08-19 |
| KR20150129671A (ko) | 2015-11-20 |
| AR095538A1 (es) | 2015-10-21 |
| JP2016514706A (ja) | 2016-05-23 |
| CA2942005C (en) | 2022-02-01 |
| EP3797762A1 (en) | 2021-03-31 |
| MX2015010594A (es) | 2015-12-16 |
| JP6307711B2 (ja) | 2018-04-11 |
| WO2014145781A1 (en) | 2014-09-18 |
| US20160193228A1 (en) | 2016-07-07 |
| RU2722592C2 (ru) | 2020-06-02 |
| AU2019200097B2 (en) | 2021-02-04 |
| CN105073118A (zh) | 2015-11-18 |
| RU2015128028A (ru) | 2017-04-21 |
| CA2942005A1 (en) | 2014-09-18 |
| EP2968363A1 (en) | 2016-01-20 |
| US20160193227A1 (en) | 2016-07-07 |
| AU2019200097A1 (en) | 2019-01-31 |
| AU2014232475A1 (en) | 2015-08-06 |
| BR112015020849A2 (pt) | 2017-07-18 |
| TW201521731A (zh) | 2015-06-16 |
| ZA201507700B (en) | 2017-02-22 |
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|---|---|---|
| US11364250B2 (en) | High-strength testosterone undecanoate compositions | |
| US20190175615A1 (en) | Lipobalanced long chain testosterone esters for oral delivery | |
| US9358241B2 (en) | High-strength testosterone undecanoate compositions | |
| US20190240235A1 (en) | Lipobalanced long chain testosterone esters for oral delivery | |
| US20140309202A1 (en) | High-strength testosterone undecanoate compositions | |
| AU2019200097B2 (en) | Lipobalanced long chain testosterone esters for oral delivery |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PA0105 | International application |
St.27 status event code: A-0-1-A10-A15-nap-PA0105 |
|
| PG1501 | Laying open of application |
St.27 status event code: A-1-1-Q10-Q12-nap-PG1501 |
|
| P22-X000 | Classification modified |
St.27 status event code: A-2-2-P10-P22-nap-X000 |
|
| A201 | Request for examination | ||
| P11-X000 | Amendment of application requested |
St.27 status event code: A-2-2-P10-P11-nap-X000 |
|
| P13-X000 | Application amended |
St.27 status event code: A-2-2-P10-P13-nap-X000 |
|
| PA0201 | Request for examination |
St.27 status event code: A-1-2-D10-D11-exm-PA0201 |
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| E902 | Notification of reason for refusal | ||
| PE0902 | Notice of grounds for rejection |
St.27 status event code: A-1-2-D10-D21-exm-PE0902 |
|
| T11-X000 | Administrative time limit extension requested |
St.27 status event code: U-3-3-T10-T11-oth-X000 |
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| T11-X000 | Administrative time limit extension requested |
St.27 status event code: U-3-3-T10-T11-oth-X000 |
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| E13-X000 | Pre-grant limitation requested |
St.27 status event code: A-2-3-E10-E13-lim-X000 |
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| P11-X000 | Amendment of application requested |
St.27 status event code: A-2-2-P10-P11-nap-X000 |
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| P13-X000 | Application amended |
St.27 status event code: A-2-2-P10-P13-nap-X000 |
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| E701 | Decision to grant or registration of patent right | ||
| PE0701 | Decision of registration |
St.27 status event code: A-1-2-D10-D22-exm-PE0701 |
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| GRNT | Written decision to grant | ||
| PR0701 | Registration of establishment |
St.27 status event code: A-2-4-F10-F11-exm-PR0701 |
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| PR1002 | Payment of registration fee |
St.27 status event code: A-2-2-U10-U12-oth-PR1002 Fee payment year number: 1 |
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| PG1601 | Publication of registration |
St.27 status event code: A-4-4-Q10-Q13-nap-PG1601 |
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| PR1001 | Payment of annual fee |
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| PR1001 | Payment of annual fee |
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| PR1001 | Payment of annual fee |
St.27 status event code: A-4-4-U10-U11-oth-PR1001 Fee payment year number: 6 |
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| U11 | Full renewal or maintenance fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-OTH-PR1001 (AS PROVIDED BY THE NATIONAL OFFICE) Year of fee payment: 6 |