JP2017522283A5 - - Google Patents
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- Publication number
- JP2017522283A5 JP2017522283A5 JP2016572477A JP2016572477A JP2017522283A5 JP 2017522283 A5 JP2017522283 A5 JP 2017522283A5 JP 2016572477 A JP2016572477 A JP 2016572477A JP 2016572477 A JP2016572477 A JP 2016572477A JP 2017522283 A5 JP2017522283 A5 JP 2017522283A5
- Authority
- JP
- Japan
- Prior art keywords
- composition according
- pharmaceutical composition
- water
- surfactant
- 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.)
- Granted
Links
- 239000008194 pharmaceutical composition Substances 0.000 claims 13
- 239000004094 surface-active agent Substances 0.000 claims 10
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 6
- 150000002646 long chain fatty acid esters Chemical class 0.000 claims 5
- 239000002736 nonionic surfactant Substances 0.000 claims 5
- 229960000746 testosterone undecanoate Drugs 0.000 claims 4
- UDSFVOAUHKGBEK-CNQKSJKFSA-N testosterone undecanoate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](OC(=O)CCCCCCCCCC)[C@@]1(C)CC2 UDSFVOAUHKGBEK-CNQKSJKFSA-N 0.000 claims 4
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 3
- OVYMWJFNQQOJBU-UHFFFAOYSA-N 1-octanoyloxypropan-2-yl octanoate Chemical compound CCCCCCCC(=O)OCC(C)OC(=O)CCCCCCC OVYMWJFNQQOJBU-UHFFFAOYSA-N 0.000 claims 2
- GHHURQMJLARIDK-UHFFFAOYSA-N 2-hydroxypropyl octanoate Chemical compound CCCCCCCC(=O)OCC(C)O GHHURQMJLARIDK-UHFFFAOYSA-N 0.000 claims 2
- LVGKNOAMLMIIKO-UHFFFAOYSA-N Elaidinsaeure-aethylester Natural products CCCCCCCCC=CCCCCCCCC(=O)OCC LVGKNOAMLMIIKO-UHFFFAOYSA-N 0.000 claims 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 2
- LVGKNOAMLMIIKO-QXMHVHEDSA-N ethyl oleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC LVGKNOAMLMIIKO-QXMHVHEDSA-N 0.000 claims 2
- 229940093471 ethyl oleate Drugs 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 239000008389 polyethoxylated castor oil Substances 0.000 claims 2
- ZORQXIQZAOLNGE-UHFFFAOYSA-N 1,1-difluorocyclohexane Chemical compound FC1(F)CCCCC1 ZORQXIQZAOLNGE-UHFFFAOYSA-N 0.000 claims 1
- NFIHXTUNNGIYRF-UHFFFAOYSA-N 2-decanoyloxypropyl decanoate Chemical compound CCCCCCCCCC(=O)OCC(C)OC(=O)CCCCCCCCC NFIHXTUNNGIYRF-UHFFFAOYSA-N 0.000 claims 1
- ZVTDEEBSWIQAFJ-KHPPLWFESA-N 2-hydroxypropyl (z)-octadec-9-enoate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC(C)O ZVTDEEBSWIQAFJ-KHPPLWFESA-N 0.000 claims 1
- JZSMZIOJUHECHW-GTJZZHROSA-N 2-hydroxypropyl (z,12r)-12-hydroxyoctadec-9-enoate Chemical compound CCCCCC[C@@H](O)C\C=C/CCCCCCCC(=O)OCC(C)O JZSMZIOJUHECHW-GTJZZHROSA-N 0.000 claims 1
- BHIZVZJETFVJMJ-UHFFFAOYSA-N 2-hydroxypropyl dodecanoate Chemical compound CCCCCCCCCCCC(=O)OCC(C)O BHIZVZJETFVJMJ-UHFFFAOYSA-N 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- 206010058359 Hypogonadism Diseases 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 235000011187 glycerol Nutrition 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 229940026235 propylene glycol monolaurate Drugs 0.000 claims 1
- 239000001593 sorbitan monooleate Substances 0.000 claims 1
- 235000011069 sorbitan monooleate Nutrition 0.000 claims 1
- 229940035049 sorbitan monooleate Drugs 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- PHYFQTYBJUILEZ-IUPFWZBJSA-N triolein Chemical group CCCCCCCC\C=C/CCCCCCCC(=O)OCC(OC(=O)CCCCCCC\C=C/CCCCCCCC)COC(=O)CCCCCCC\C=C/CCCCCCCC PHYFQTYBJUILEZ-IUPFWZBJSA-N 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14172805 | 2014-06-17 | ||
| EP14172805.5 | 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 |
|---|---|
| JP2017522283A JP2017522283A (ja) | 2017-08-10 |
| JP2017522283A5 true JP2017522283A5 (OSRAM) | 2018-07-26 |
| JP6618488B2 JP6618488B2 (ja) | 2019-12-11 |
Family
ID=50980940
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016572477A Expired - Fee Related JP6618488B2 (ja) | 2014-06-17 | 2015-06-15 | テストステロンウンデカノエートの安定な製剤 |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US9925200B2 (OSRAM) |
| EP (1) | EP3157505B1 (OSRAM) |
| JP (1) | JP6618488B2 (OSRAM) |
| KR (1) | KR20170020779A (OSRAM) |
| CN (1) | CN106456782B (OSRAM) |
| AU (1) | AU2015276321B2 (OSRAM) |
| BR (1) | BR112016028192A2 (OSRAM) |
| CA (1) | CA2950670A1 (OSRAM) |
| ES (1) | ES2749008T3 (OSRAM) |
| MX (1) | MX373197B (OSRAM) |
| RU (1) | RU2708238C2 (OSRAM) |
| WO (1) | WO2015193224A1 (OSRAM) |
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 |
| ES2907284T3 (es) | 2013-03-15 | 2022-04-22 | Marius Pharmaceuticals Llc | Formulaciones de emulsión |
| CN111432805B (zh) | 2017-11-27 | 2023-02-17 | 梅克里内科尼蒂翁公司 | 3α-乙炔基-3β-羟基雄甾烷-17-酮肟的药物制剂 |
| US12150945B2 (en) | 2018-07-20 | 2024-11-26 | Lipocine Inc. | Liver disease |
| 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)
| 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 |
| FI920646A0 (fi) | 1989-08-17 | 1992-02-14 | Cortecs Ltd | Farmaceutiska preparat. |
| 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 |
| 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 |
| US6652880B1 (en) | 1999-04-01 | 2003-11-25 | R.P. Scherer Technologies, Inc. | Oral pharmaceutical compositions containing long-chain triglycerides and liphophilic surfactants |
| GB9907715D0 (en) * | 1999-04-01 | 1999-05-26 | Scherer Corp R P | Pharmaceutical compositions |
| ES2222199T3 (es) | 1999-04-01 | 2005-02-01 | Akzo Nobel N.V. | Preparacion que comprende testosterona undecanoato y aceite de ricino. |
| 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 |
| US8492369B2 (en) | 2010-04-12 | 2013-07-23 | Clarus Therapeutics Inc | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
| DK2985026T3 (da) | 2005-04-15 | 2022-10-31 | Clarus Therapeutics Inc | Farmaceutiske leveringssystemer til hydrofobe lægemidler og sammensætninger dermed |
| 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 |
| US20130303495A1 (en) * | 2009-12-31 | 2013-11-14 | Sov Therapeutics | Emulsion formulations |
| DK2558073T3 (en) * | 2010-04-12 | 2014-12-08 | Clarus Therapeutics Inc | ORAL testosterone ester FORMULATIONS AND METHODS FOR TREATMENT OF testosterone deficiency INCLUDING THE 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 |
| US20140303129A1 (en) | 2013-03-15 | 2014-10-09 | Clarus Therapeutics, Inc. | Methods of treating testosterone deficiency |
| WO2015100406A1 (en) | 2013-12-26 | 2015-07-02 | Clarus Therapeutics, Inc. | Use of oral pharmaceutical products combining testosterone esters with hypolipidemic agents |
-
2015
- 2015-06-15 US US15/317,132 patent/US9925200B2/en active Active
- 2015-06-15 RU RU2017101240A patent/RU2708238C2/ru active
- 2015-06-15 CA CA2950670A patent/CA2950670A1/en not_active Abandoned
- 2015-06-15 WO PCT/EP2015/063292 patent/WO2015193224A1/en not_active Ceased
- 2015-06-15 KR KR1020167035025A patent/KR20170020779A/ko not_active Withdrawn
- 2015-06-15 JP JP2016572477A patent/JP6618488B2/ja not_active Expired - Fee Related
- 2015-06-15 BR BR112016028192A patent/BR112016028192A2/pt not_active Application Discontinuation
- 2015-06-15 MX MX2016016612A patent/MX373197B/es active IP Right Grant
- 2015-06-15 CN CN201580032121.7A patent/CN106456782B/zh not_active Expired - Fee Related
- 2015-06-15 ES ES15728552T patent/ES2749008T3/es active Active
- 2015-06-15 AU AU2015276321A patent/AU2015276321B2/en not_active Ceased
- 2015-06-15 EP EP15728552.9A patent/EP3157505B1/en active Active
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