RU2016143081A - Натуральные комбинированные гормонозаместительные составы и терапии - Google Patents
Натуральные комбинированные гормонозаместительные составы и терапии Download PDFInfo
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Claims (76)
1. Фармацевтическая композиция для совместного введения эстрадиола и прогестерона человеческому индивиду, имеющему вазомоторные симптомы, связанные с дефицитом эстрогена, содержащая: солюбилизированный эстрадиол, суспендированный прогестерон и солюбилизирующее вещество, причем солюбилизирующее вещество содержит среднецепочечное (C6-C12) масло;
при этом введение композиции субъекту обеспечивает в образце плазмы субъекта значения одного или более параметров, выбранных из:
(i) площади под кривой (AUC)(0-t) эстрадиола, составляющей от 140,3733 пг⋅ч/мл до 219,3333 пг⋅ч/мл;
(ii) Cmax эстрадиола, составляющей от 6,4790 пг/мл до 10,1235 пг/мл;
(iii) AUC(0-t) прогестерона, составляющей от 24,0174 нг⋅ч/мл до 37,5272 нг⋅ч/мл; и
(iv) Cmax прогестерона, составляющей от 17,8444 нг/мл до 27,8819 нг/мл.
2. Фармацевтическая композиция по п. 1, причем введение композиции субъекту обеспечивает значения как AUC(0-t) эстрадиола, составляющей от 140,3733 пг⋅ч/мл до 219,3333 пг⋅ч/мл, так и Cmax эстрадиола, составляющей от 6,4790 пг/мл до 10,1235 пг/мл.
3. Фармацевтическая композиция по п. 1 или 2, причем введение композиции субъекту обеспечивает значения как AUC(0-t) прогестерона, составляющей от 24,0174 нг⋅ч/мл до 37,5272 нг⋅ч/мл, так и Cmax прогестерона, составляющей от 17,8444 нг/мл до 27,8819 нг/мл.
4. Фармацевтическая композиция по любому из пп. 1-3, причем введение композиции субъекту дополнительно обеспечивает в образце плазмы субъекта значения одного или обоих параметров, выбранных из:
(i) AUC(0-t) эстрона, составляющей от 909,6091 пг⋅ч/мл до 1421,2642 пг⋅ч/мл; и
(ii) Cmax эстрона, составляющей от 42,6549 пг/мл до 66,6483 пг/мл.
5. Фармацевтическая композиция по п. 4, причем введение композиции субъекту обеспечивает значения как AUC(0-t) эстрона, составляющей от 909,6091 пг⋅ч/мл до 1421,2642 пг⋅ч/мл, так и Cmax эстрона, составляющей от 42,6549 пг/мл до 66,6483 пг/мл.
6. Фармацевтическая композиция по любому из пп. 1-5, причем введение композиции субъекту дополнительно обеспечивает в образце плазмы субъекта значения одного или обоих параметров, выбранных из:
(i) AUC(0-t) общего эстрона, составляющей от 20,1752 нг⋅ч/мл до 31,5238 нг⋅ч/мл; и
(ii) Cmax общего эстрона, составляющей от 3,5429 нг/мл до 5,5358 нг/мл.
7. Фармацевтическая композиция по п. 6, причем введение композиции субъекту обеспечивает значения как AUC(0-t) общего эстрона, составляющей от 20,1752 нг⋅ч/мл до 31,5238 нг⋅ч/мл, так и Cmax общего эстрона, составляющей от 3,5429 нг/мл до 5,5358 нг/мл.
8. Фармацевтическая композиция для совместного введения эстрадиола и прогестерона человеческому индивиду, имеющему вазомоторные симптомы, связанные с дефицитом эстрогена, содержащая: солюбилизированный эстрадиол, суспендированный прогестерон и солюбилизирующее вещество, причем солюбилизирующее вещество содержит среднецепочечное (C6-C12) масло;
при этом введение композиции субъекту обеспечивает в образце плазмы субъекта значения одного или более параметров, выбранных из:
(i) площади под кривой (AUC)(0-t) эстрадиола, составляющей от 280,7467 пг⋅ч/мл до 438,6667 пг⋅ч/мл;
(ii) Cmax эстрадиола, составляющей от 12,9580 пг/мл до 20,2469 пг/мл;
(iii) AUC(0-t) прогестерона, составляющей от 24,0174 нг⋅ч/мл до 37,5272 нг⋅ч/мл; и
(iv) Cmax прогестерона, составляющей от 17,8444 нг/мл до 27,8819 нг/мл.
9. Фармацевтическая композиция по п. 8, причем введение композиции субъекту обеспечивает значения как AUC(0-t) эстрадиола, составляющей от 280,7467 пг⋅ч/мл до 438,6667 пг⋅ч/мл, так и Cmax эстрадиола, составляющей от 12,9580 пг/мл до 20,2469 пг/мл.
10. Фармацевтическая композиция по п. 8 или 9, причем введение композиции субъекту обеспечивает значения как AUC(0-t) прогестерона, составляющей от 24,0174 нг⋅ч/мл до 37,5272 нг⋅ч/мл, так и Cmax прогестерона, составляющей от 17,8444 нг/мл до 27,8819 нг/мл.
11. Фармацевтическая композиция по любому из пп. 8-10, причем введение композиции субъекту дополнительно обеспечивает в образце плазмы субъекта значения одного или обоих параметров, выбранных из:
(i) AUC(0-t) эстрона, составляющей от 1819,2181 пг⋅ч/мл до 2842,5283 пг⋅ч/мл; и
(ii) Cmax эстрона, составляющей от 85,3098 пг/мл до 133,2966 пг/мл.
12. Фармацевтическая композиция по п. 11, причем введение композиции субъекту обеспечивает значения как AUC(0-t) эстрона, составляющей от 1819,2181 пг⋅ч/мл до 2842,5283 пг⋅ч/мл, так и Cmax эстрона, составляющей от 85,3098 пг/мл до 133,2966 пг/мл.
13. Фармацевтическая композиция по любому из пп. 8-12, причем введение композиции субъекту дополнительно обеспечивает в образце плазмы субъекта значения одного или обоих параметров, выбранных из:
(i) AUC(0-t) общего эстрона, составляющей от 40,3505 нг⋅ч/мл до 63,0476 нг⋅ч/мл; и
(ii) Cmax общего эстрона, составляющей от 7,0858 нг/мл до 11,0715 нг/мл.
14. Фармацевтическая композиция по п. 13, причем введение композиции субъекту обеспечивает значения как AUC(0-t) общего эстрона, составляющей от 40,3505 нг⋅ч/мл до 63,0476 нг⋅ч/мл, так и Cmax общего эстрона, составляющей от 7,0858 нг/мл до 11,0715 нг/мл.
15. Фармацевтическая композиция для совместного введения эстрадиола и прогестерона человеческому индивиду, имеющему вазомоторные симптомы, связанные с дефицитом эстрогена, содержащая: солюбилизированный эстрадиол, суспендированный прогестерон и солюбилизирующее вещество, причем солюбилизирующее вещество содержит среднецепочечное (C6-C12) масло;
при этом введение композиции субъекту обеспечивает в образце плазмы субъекта значения одного или более параметров, выбранных из:
(i) площади под кривой (AUC)(0-t) эстрадиола, составляющей от 280,7467 пг⋅ч/мл до 438,6667 пг⋅ч/мл;
(ii) Cmax эстрадиола, составляющей от 12,9580 пг/мл до 20,2469 пг/мл;
(iii) AUC(0-t) прогестерона, составляющей от 48,0348 нг⋅ч/мл до 75,0543 нг⋅ч/мл; и
(iv) Cmax прогестерона, составляющей от 35,6889 нг/мл до 55,7639 нг/мл.
16. Фармацевтическая композиция по п. 15, причем введение композиции субъекту обеспечивает значения как AUC(0-t) эстрадиола, составляющей от 280,7467 пг⋅ч/мл до 438,6667 пг⋅ч/мл, так и Cmax эстрадиола, составляющей от 12,9580 пг/мл до 20,2469 пг/мл.
17. Фармацевтическая композиция по п. 15 или 16, причем введение композиции субъекту обеспечивает значения как AUC(0-t) прогестерона, составляющей от 48,0348 нг⋅ч/мл до 75,0543 нг⋅ч/мл, так и Cmax прогестерона, составляющей от 35,6889 нг/мл до 55,7639 нг/мл.
18. Фармацевтическая композиция по любому из пп. 15-17, причем введение композиции субъекту дополнительно обеспечивает в образце плазмы субъекта значения одного или обоих параметров, выбранных из:
(i) AUC(0-t) эстрона, составляющей от 1819,2181 пг⋅ч/мл до 2842,5283 пг⋅ч/мл; и
(ii) Cmax эстрона, составляющей от 85,3098 пг/мл до 133,2966 пг/мл.
19. Фармацевтическая композиция по п. 18, причем введение композиции субъекту обеспечивает значения как AUC(0-t) эстрона, составляющей от 1819,2181 пг⋅ч/мл до 2842,5283 пг⋅ч/мл, так и Cmax эстрона, составляющей от 85,3098 пг/мл до 133,2966 пг/мл.
20. Фармацевтическая композиция по любому из пп. 15-19, причем введение композиции субъекту дополнительно обеспечивает в образце плазмы субъекта значения одного или обоих параметров, выбранных из:
(i) AUC(0-t) общего эстрона, составляющей от 40,3505 нг⋅ч/мл до 63,0476 нг⋅ч/мл; и
(ii) Cmax общего эстрона, составляющей от 7,0858 нг/мл до 11,0715 нг/мл.
21. Фармацевтическая композиция по п. 20, причем введение композиции субъекту обеспечивает значения как AUC(0-t) общего эстрона, составляющей от 40,3505 нг⋅ч/мл до 63,0476 нг⋅ч/мл, так и Cmax общего эстрона, составляющей от 7,0858 нг/мл до 11,0715 нг/мл.
22. Фармацевтическая композиция для совместного введения эстрадиола и прогестерона человеческому индивиду, имеющему вазомоторные симптомы, связанные с дефицитом эстрогена, содержащая: солюбилизированный эстрадиол, суспендированный прогестерон и солюбилизирующее вещество, причем солюбилизирующее вещество содержит среднецепочечное (C6-C12) масло;
при этом введение композиции субъекту обеспечивает в образце плазмы субъекта значения одного или более параметров, выбранных из:
(i) площади под кривой (AUC)(0-t) эстрадиола, составляющей от 561,4933 пг⋅ч/мл до 877,3333 пг⋅ч/мл;
(ii) Cmax эстрадиола, составляющей от 25,9161 пг/мл до 40,4939 пг/мл;
(iii) AUC(0-t) прогестерона, составляющей от 48,0348 нг⋅ч/мл до 75,0543 нг⋅ч/мл; и
(iv) Cmax прогестерона, составляющей от 35,6889 нг/мл до 55,7639 нг/мл.
23. Фармацевтическая композиция по п. 22, причем введение композиции субъекту обеспечивает значения как AUC(0-t) эстрадиола, составляющей от 561,4933 пг⋅ч/мл до 877,3333 пг⋅ч/мл, так и Cmax эстрадиола, составляющей от 25,9161 пг/мл до 40,4939 пг/мл.
24. Фармацевтическая композиция по п. 22 или 23, причем введение композиции субъекту обеспечивает значения как AUC(0-t) прогестерона, составляющей от 48,0348 нг⋅ч/мл до 75,0543 нг⋅ч/мл, так и Cmax прогестерона, составляющей от 35,6889 нг/мл до 55,7639 нг/мл.
25. Фармацевтическая композиция по любому из пп. 22-24, причем введение композиции субъекту дополнительно обеспечивает в образце плазмы субъекта значения одного или обоих параметров, выбранных из:
(i) AUC(0-t) эстрона, составляющей от 3638,4363 пг⋅ч/мл до 5685,0567 пг⋅ч/мл; и
(i) Cmax эстрона, составляющей от 170,6197 пг/мл до 266,5933 пг/мл.
26. Фармацевтическая композиция по п. 25, причем введение композиции субъекту обеспечивает значения как AUC(0-t) эстрона, составляющей от 3638,4363 пг⋅ч/мл до 5685,0567 пг⋅ч/мл, так и Cmax эстрона, составляющей от 170,6197 пг/мл до 266,5933 пг/мл.
27. Фармацевтическая композиция по любому из пп. 22-26, причем введение композиции субъекту дополнительно обеспечивает в образце плазмы субъекта значения одного или обоих параметров, выбранных из:
(i) AUC(0-t) общего эстрона, составляющей от 80,7010 нг⋅ч/мл до 126,0953 нг⋅ч/мл; и
(ii) Cmax общего эстрона, составляющей от 14,1716 нг/мл до 22,1431 нг/мл.
28. Фармацевтическая композиция по п. 27, причем введение композиции субъекту обеспечивает значения как AUC(0-t) общего эстрона, составляющей от 80,7010 нг⋅ч/мл до 126,0953 нг⋅ч/мл, так и Cmax общего эстрона, составляющей от 14,1716 нг/мл до 22,1431 нг/мл.
29. Способ лечения субъекта, имеющего вазомоторные симптомы, связанные с дефицитом эстрогена, содержащий этапы, на которых субъекту вводят эффективное количество фармацевтического состава по любому из пп. 1-28.
30. Способ по п. 29, в котором субъект является женщиной.
31. Способ по п. 29 или 30, в котором субъект является женщиной, имеющей матку.
32. Способ лечения субъекта, имеющего вазомоторные симптомы, связанные с дефицитом эстрогена, фармацевтической композицией для совместного введения эстрадиола и прогестерона, содержащий этапы, на которых:
субъекту вводят фармацевтическую композицию, содержащую солюбилизированный эстрадиол, суспендированный прогестерон и солюбилизирующее вещество, при этом солюбилизирующее вещество содержит среднецепочечное (C6-C12) масло;
получают образец плазмы у субъекта через от около 24 часов до 36 часов после однократного введения или первого введения фармацевтической композиции; и
измеряют один или более фармакокинетических параметров, выбранных из площади под кривой (AUC)(0-t) эстрадиола, Cmax эстрадиола, AUC(0-t) прогестерона, Cmax прогестерона, AUC(0-t) эстрона, Cmax эстрона, AUC(0-t) общего эстрона и Cmax общего эстрона, для определения фармакокинетических значений одного или более фармакокинетических параметров;
причем наличие одного или более из фармакокинетических значений, описанных в любой из таблиц 18-21, является показателем терапевтически эффективной дозы фармацевтической композиции.
33. Способ по п. 32, в котором фармацевтическая композиция содержит около 0,25 мг эстрадиола и около 50 мг прогестерона, и при этом наличие одного или более фармакокинетических значений, описанных в таблице 18, является показателем терапевтически эффективной дозы фармацевтической композиции.
34. Способ по п. 32, в котором фармацевтическая композиция содержит около 0,50 мг эстрадиола и около 50 мг прогестерона, и при этом наличие одного или более фармакокинетических значений, описанных в таблице 19, является показателем терапевтически эффективной дозы фармацевтической композиции.
35. Способ по п. 32, в котором фармацевтическая композиция содержит около 0,50 мг эстрадиола и около 100 мг прогестерона, и при этом наличие одного или более фармакокинетических значений, описанных в таблице 20, является показателем терапевтически эффективной дозы фармацевтической композиции.
36. Способ по п. 32, в котором фармацевтическая композиция содержит около 1 мг эстрадиола и около 100 мг прогестерона, и при этом наличие одного или более фармакокинетических значений, описанных в таблице 21, является показателем терапевтически эффективной дозы фармацевтической композиции.
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-
2015
- 2015-05-22 AU AU2015264003A patent/AU2015264003A1/en not_active Abandoned
- 2015-05-22 CA CA2947767A patent/CA2947767A1/en not_active Abandoned
- 2015-05-22 EP EP15727528.0A patent/EP3145489A1/en not_active Withdrawn
- 2015-05-22 US US14/719,933 patent/US10206932B2/en active Active
- 2015-05-22 MX MX2016014281A patent/MX2016014281A/es unknown
- 2015-05-22 AR ARP150101608A patent/AR100562A1/es unknown
- 2015-05-22 JP JP2016565647A patent/JP2017516768A/ja active Pending
- 2015-05-22 WO PCT/US2015/032213 patent/WO2015179782A1/en active Application Filing
- 2015-05-22 KR KR1020167032773A patent/KR20170005819A/ko unknown
- 2015-05-22 RU RU2016143081A patent/RU2016143081A/ru not_active Application Discontinuation
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2016
- 2016-11-15 IL IL248985A patent/IL248985A0/en unknown
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2019
- 2019-01-09 US US16/244,020 patent/US20190314386A1/en active Pending
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2020
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US11103513B2 (en) | 2021-08-31 |
US20190314386A1 (en) | 2019-10-17 |
EP3145489A1 (en) | 2017-03-29 |
CA2947767A1 (en) | 2015-11-26 |
US10206932B2 (en) | 2019-02-19 |
JP2017516768A (ja) | 2017-06-22 |
MX2016014281A (es) | 2017-02-22 |
KR20170005819A (ko) | 2017-01-16 |
WO2015179782A1 (en) | 2015-11-26 |
US20200281938A1 (en) | 2020-09-10 |
AU2015264003A1 (en) | 2016-11-17 |
US20150342963A1 (en) | 2015-12-03 |
IL248985A0 (en) | 2017-01-31 |
AR100562A1 (es) | 2016-10-12 |
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