RU2018133932A - Фармацевтическая композиция стероидного гормона - Google Patents
Фармацевтическая композиция стероидного гормона Download PDFInfo
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- 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
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- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
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- 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
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- 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
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
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- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- 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
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- 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
- A61K9/4875—Compounds of unknown constitution, e.g. material from plants or animals
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- 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
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- 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
- A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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- 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
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- 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
- A61P5/34—Gestagens
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Claims (32)
1. Фармацевтическая композиция, подходящая для введения стероидного гормона нуждающемуся в этом субъекту, причем фармацевтическая композиция содержит стероидный гормон, систему липофильных поверхностно-активных веществ, содержащую первое липофильное поверхностно-активное вещество и второе липофильное поверхностно-активное вещество, причем первое и второе липофильные поверхностно-активные вещества отличаются друг от друга, систему гидрофильных поверхностно-активных веществ, содержащую первое и второе гидрофильные поверхностно-активные вещества, и необязательный терпен, причем фармацевтическая композиция полностью или по существу не содержит фракционированных растительных масел.
2. Фармацевтическая композиция по п. 1, в которой первое липофильное поверхностно-активное вещество представляет собой первый неполный триглицерид.
3. Фармацевтическая композиция по п. 2, в которой второе липофильное поверхностно-активное вещество представляет собой второй неполный триглицерид.
4. Фармацевтическая композиция по п. 3, в которой первый и второй неполные триглицериды выбраны из группы, состоящей из IMWITOR 988, IMWITOR 742, IMWITOR 308, CAPMUL МСМ NF, CAPMUL 708G и глицерилдилаурата.
5. Фармацевтическая композиция по п. 4, в которой первый неполный триглицерид представляет собой CAPMUL МСМ NF, а второй неполный триглицерид представляет собой CAPMUL 708G.
6. Фармацевтическая композиция по п. 5, в которой первое гидрофильное поверхностно-активное вещество представляет собой производное полноксиэтиленсорбитана и жирной кислоты.
7. Фармацевтическая композиция по п. 6, в которой производное полно ксиэтиленсорбитана и жирной кислоты представляет собой TWEEN 20 или TWEEN 80.
8. Фармацевтическая композиция по п. 6, в которой второе гидрофильное поверхностно-активное вещество представляет собой этоксилат касторового масла или гидрогенизированного касторового масла.
9. Фармацевтическая композиция по п. 8, в которой этоксилат касторового масла или гидрогенизированного касторового масла представляет собой CREMOPHOR EL, CREMOPHOR RH40, ETOCAS 40, CRODURET 60 или KOLLIPHOR HS 15.
10. Фармацевтическая композиция по п. 9, в которой этоксилат касторового масла или гидрогенизированного касторового масла представляет собой CREMOPHOR RH40.
11. Фармацевтическая композиция по п. 1, в которой второе гидрофильное поверхностно-активное вещество представляет собой LABRASOL, TPGS или аскорбил-6-пальмитат.
12. Фармацевтическая композиция по п. 11, в которой второе гидрофильное поверхностно-активное вещество представляет собой TPGS.
13. Фармацевтическая композиция по п. 1, в которой терпен не является необязательным и выбран из группы, состоящей из d-лимонена, ментена, ментола, фелландрена, терпинена или терпинеола.
14. Фармацевтическая композиция по п. 13, в которой терпен представляет собой d-лимонен.
15. Фармацевтическая композиция по п. 1, в которой стероидный гормон представляет собой прогестерон.
16. Способ лечения заболевания или состояния, связанного с пониженными уровнями прогестерона, включающий в себя введение нуждающемуся в этом субъекту фармацевтической композиции по п. 1.
17. Способ по п. 16, в котором первое липофильное поверхностно-активное вещество представляет собой первый неполный триглицерид.
18. Способ по п. 16, в котором второе липофильное поверхностно-активное вещество представляет собой второй неполный триглицерид.
19. Способ по п. 18, в котором первый и второй неполные триглицериды выбраны из группы, состоящей из IMWITOR 988, IMWITOR 742, IMWITOR 308, CAPMUL МСМ NF, CAPMUL 708G и глицерилдилаурата.
20. Способ по п. 19, в котором первый неполный триглицерид представляет собой CAPMUL МСМ NF, а второй неполный триглицерид представляет собой CAPMUL 708G.
21. Способ по п. 20, в котором первое гидрофильное поверхностно-активное вещество представляет собой производное полиоксиэтиленсорбитана и жирной кислоты.
22. Способ по п. 21, в котором производное полиоксиэтиленсорбитана и жирной кислоты представляет собой TWEEN 20 или TWEEN 80.
23. Способ по п. 21, в котором второе гидрофильное поверхностно-активное вещество представляет собой этоксилат касторового масла или гидрогенизированного касторового масла.
24. Способ по п. 23, в котором этоксилат касторового масла или гидрогенизированного касторового масла представляет собой CREMOPHOR EL, CREMOPHOR RH40, ETOCAS 40, CRODURET 60 или KOLLIPHOR HS 15.
25. Способ по п. 24, в котором этоксилат касторового масла или гидрогенизированного касторового масла представляет собой CREMOPHOR RH40.
26. Способ по п. 21, в котором второе гидрофильное поверхностно-активное вещество представляет собой LABRASOL, TPGS или аскорбил-6-пальмитат.
27. Способ по п. 26, в котором второе гидрофильное поверхностно-активное вещество представляет собой TPGS.
28. Способ по п. 16, в котором терпен не является необязательным и выбран из группы, состоящей из d-лимонена, ментена, ментола, фелландрена, терпинена или терпинеола.
29. Способ по п. 28, в котором терпен представляет собой d-лимонен.
30. Способ по п. 16, в котором заболевание или состояние, связанное с пониженными уровнями прогестерона, выбрано из группы, состоящей из гиперплазии эндометрия; вторичной аменореи; профилактики преждевременных родов; и остеопороза.
31. Способ по п. 16, в котором заболевание или состояние, связанное с пониженными уровнями прогестерона, представляет собой менопаузу.
32. Фармацевтическая композиция по п. 15, в которой прогестерон полностью солюбилизирован.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662317060P | 2016-04-01 | 2016-04-01 | |
| US62/317,060 | 2016-04-01 | ||
| PCT/US2017/024994 WO2017173071A1 (en) | 2016-04-01 | 2017-03-30 | Steroid hormone pharmaceutical composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2018133932A true RU2018133932A (ru) | 2020-05-12 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2018133932A RU2018133932A (ru) | 2016-04-01 | 2017-03-30 | Фармацевтическая композиция стероидного гормона |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US9931349B2 (ru) |
| EP (1) | EP3435977A4 (ru) |
| JP (1) | JP2019513709A (ru) |
| KR (1) | KR20180126582A (ru) |
| AR (1) | AR108073A1 (ru) |
| AU (1) | AU2017239645A1 (ru) |
| BR (1) | BR112018070199A2 (ru) |
| CA (1) | CA3020153A1 (ru) |
| IL (1) | IL261930A (ru) |
| MX (1) | MX2018011705A (ru) |
| RU (1) | RU2018133932A (ru) |
| WO (1) | WO2017173071A1 (ru) |
| ZA (1) | ZA201806414B (ru) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9301920B2 (en) | 2012-06-18 | 2016-04-05 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| MX365818B (es) | 2011-11-23 | 2019-05-30 | Therapeuticsmd Inc | Formulaciones y terapias de reemplazo hormonal de combinacion naturales. |
| US10806697B2 (en) | 2012-12-21 | 2020-10-20 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10806740B2 (en) | 2012-06-18 | 2020-10-20 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| US10471072B2 (en) | 2012-12-21 | 2019-11-12 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US11266661B2 (en) | 2012-12-21 | 2022-03-08 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US11246875B2 (en) | 2012-12-21 | 2022-02-15 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10537581B2 (en) | 2012-12-21 | 2020-01-21 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US9180091B2 (en) | 2012-12-21 | 2015-11-10 | Therapeuticsmd, Inc. | Soluble estradiol capsule for vaginal insertion |
| US10568891B2 (en) | 2012-12-21 | 2020-02-25 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10206932B2 (en) | 2014-05-22 | 2019-02-19 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| US10328087B2 (en) | 2015-07-23 | 2019-06-25 | Therapeuticsmd, Inc. | Formulations for solubilizing hormones |
| AU2017239645A1 (en) * | 2016-04-01 | 2018-10-18 | Therapeuticsmd, Inc. | Steroid hormone pharmaceutical composition |
| WO2017173044A1 (en) | 2016-04-01 | 2017-10-05 | Therapeuticsmd Inc. | Steroid hormone compositions in medium chain oils |
| US11633405B2 (en) | 2020-02-07 | 2023-04-25 | Therapeuticsmd, Inc. | Steroid hormone pharmaceutical formulations |
| US11337987B1 (en) | 2021-05-07 | 2022-05-24 | Lipocine Inc. | Compositions and methods for treating central nervous system disorders |
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- 2017-03-30 AU AU2017239645A patent/AU2017239645A1/en not_active Abandoned
- 2017-03-30 CA CA3020153A patent/CA3020153A1/en not_active Abandoned
- 2017-03-30 US US15/473,733 patent/US9931349B2/en active Active
- 2017-03-30 RU RU2018133932A patent/RU2018133932A/ru not_active Application Discontinuation
- 2017-03-30 WO PCT/US2017/024994 patent/WO2017173071A1/en active Application Filing
- 2017-03-30 BR BR112018070199A patent/BR112018070199A2/pt not_active Application Discontinuation
- 2017-03-30 MX MX2018011705A patent/MX2018011705A/es unknown
- 2017-03-30 KR KR1020187031878A patent/KR20180126582A/ko unknown
- 2017-03-30 JP JP2018550564A patent/JP2019513709A/ja active Pending
- 2017-03-30 EP EP17776645.8A patent/EP3435977A4/en not_active Withdrawn
- 2017-04-03 AR ARP170100830A patent/AR108073A1/es unknown
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2018
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- 2018-09-25 IL IL261930A patent/IL261930A/en unknown
- 2018-09-26 ZA ZA201806414A patent/ZA201806414B/en unknown
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| AR108073A1 (es) | 2018-07-11 |
| AU2017239645A1 (en) | 2018-10-18 |
| US10532059B2 (en) | 2020-01-14 |
| US20170281645A1 (en) | 2017-10-05 |
| US9931349B2 (en) | 2018-04-03 |
| MX2018011705A (es) | 2019-06-10 |
| ZA201806414B (en) | 2019-11-27 |
| EP3435977A1 (en) | 2019-02-06 |
| CA3020153A1 (en) | 2017-10-05 |
| KR20180126582A (ko) | 2018-11-27 |
| EP3435977A4 (en) | 2019-10-16 |
| BR112018070199A2 (pt) | 2019-01-29 |
| IL261930A (en) | 2018-11-29 |
| US20180280411A1 (en) | 2018-10-04 |
| JP2019513709A (ja) | 2019-05-30 |
| WO2017173071A1 (en) | 2017-10-05 |
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