RU2011115060A - Фармацевтические композиции и соответствующие способы доставки - Google Patents

Фармацевтические композиции и соответствующие способы доставки Download PDF

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RU2011115060A
RU2011115060A RU2011115060/15A RU2011115060A RU2011115060A RU 2011115060 A RU2011115060 A RU 2011115060A RU 2011115060/15 A RU2011115060/15 A RU 2011115060/15A RU 2011115060 A RU2011115060 A RU 2011115060A RU 2011115060 A RU2011115060 A RU 2011115060A
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fatty acid
acid salt
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RU2011115060/15A
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RU2552324C2 (ru
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Пол САЛАМА (IL)
Пол САЛАМА
Рони МАМЛЮК (IL)
Рони МАМЛЮК
Карен МАРОМ (IL)
Карен МАРОМ
Ирина ВАЙНШТЕЙН (IL)
Ирина ВАЙНШТЕЙН
Моше ЦАБАРИ (IL)
Моше ЦАБАРИ
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Киазма Инк. (Us)
Киазма Инк.
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Abstract

1. Композиция, содержащая суспензию, которая включает смесь гидрофобной среды и твердой формы, где твердая форма содержит терапевтически эффективное количество терапевтического средства и, по меньшей мере, одну соль жирной кислоты со средней длиной цепи, причем соль жирной кислоты со средней длиной цепи присутствует в композиции в количестве 10% по массе или более. ! 2. Композиция по п.1, отличающаяся тем, что соль жирной кислоты со средней длиной цепи присутствует в композиции в количестве от 11% до 40% по массе. ! 3. Композиция по п.2, отличающаяся тем, что соль жирной кислоты со средней длиной цепи присутствует в композиции в количестве от 12% до 18% по массе, преимущественно 15% по массе. ! 4. Композиция по п.1, которые дополнительно содержат полимер, формирующий матрицу. ! 5. Композиция по п.4, отличающаяся тем, что полимер, формирующий матрицу представляет собой декстран или поливинилпирролидон (ПВП). ! 6. Композиция по п.5, отличающаяся тем, что поливинилпирролидон присутствует в композиции в количестве приблизительно от 2% до 20% по массе. ! 7. Композиция по п.6, отличающаяся тем, что поливинилпирролидон присутствует в композиции в количестве приблизительно от 5% до 15% по массе. ! 8. Композиция, содержащая суспензию, которая включает смесь гидрофобной среды и твердой формы, где твердая форма включает терапевтически эффективное количество терапевтического средства и, по меньшей мере, одну соль жирной кислоты со средней длиной цепи и полимер, формирующий матрицу, где полимер, формирующий матрицу, присутствует в композиции в количестве 3% или более по массе. ! 9. Способ получения фармацевтической композиции, который включает приготовл

Claims (24)

1. Композиция, содержащая суспензию, которая включает смесь гидрофобной среды и твердой формы, где твердая форма содержит терапевтически эффективное количество терапевтического средства и, по меньшей мере, одну соль жирной кислоты со средней длиной цепи, причем соль жирной кислоты со средней длиной цепи присутствует в композиции в количестве 10% по массе или более.
2. Композиция по п.1, отличающаяся тем, что соль жирной кислоты со средней длиной цепи присутствует в композиции в количестве от 11% до 40% по массе.
3. Композиция по п.2, отличающаяся тем, что соль жирной кислоты со средней длиной цепи присутствует в композиции в количестве от 12% до 18% по массе, преимущественно 15% по массе.
4. Композиция по п.1, которые дополнительно содержат полимер, формирующий матрицу.
5. Композиция по п.4, отличающаяся тем, что полимер, формирующий матрицу представляет собой декстран или поливинилпирролидон (ПВП).
6. Композиция по п.5, отличающаяся тем, что поливинилпирролидон присутствует в композиции в количестве приблизительно от 2% до 20% по массе.
7. Композиция по п.6, отличающаяся тем, что поливинилпирролидон присутствует в композиции в количестве приблизительно от 5% до 15% по массе.
8. Композиция, содержащая суспензию, которая включает смесь гидрофобной среды и твердой формы, где твердая форма включает терапевтически эффективное количество терапевтического средства и, по меньшей мере, одну соль жирной кислоты со средней длиной цепи и полимер, формирующий матрицу, где полимер, формирующий матрицу, присутствует в композиции в количестве 3% или более по массе.
9. Способ получения фармацевтической композиции, который включает приготовление водорастворимой композиции, содержащей эффективное количество терапевтического средства, и, по меньшей мере, одну соль жирной кислоты со средней длиной цепи, высушивание водорастворимой композиции до получения твердого порошка, и суспендирование твердого порошка в гидрофобной среде для того, чтобы получить суспензию, содержащую в твердой форме терапевтическое средство и соль жирной кислоты с средней длиной цепи, и посредством этого получить фармацевтическую композицию, где фармацевтическая композиция содержит 10% или более соли жирной кислоты с средней длиной цепи по массе.
10. Способ по п.9, отличающийся тем, что соль жирной кислоты со средней длиной цепи присутствует в композиции в количестве от около 11% до около 40% по массе.
11. Способ по п.10, отличающийся тем, что соль жирной кислоты со средней длиной цепи присутствует в композиции в количестве от около 11% до около 28% по массе.
12. Способ по п.11, отличающийся тем, что соль жирной кислоты со средней длиной цепи присутствует в композиции в количестве 15% по массе.
13. Способ по п.9, отличающийся тем, что водорастворимая композиция дополнительно содержит формирующий матрикс полимер.
14. Способ по п.13, отличающийся тем, что формирующий матрикс полимер представляет собой поливинилпирролидон и присутствует в композиции в количестве от около 2% до около 20% по массе.
15. Способ по п.14, отличающийся тем, что поливинилпирролидон присутствует в композиции в количестве около 10% по массе.
16. Композиция, содержащая суспензию, которая включает смесь гидрофобной среды и твердой формы, где твердая форма содержит терапевтически эффективное количество октреотида и как минимум одну соль жирной кислоты со средней длиной цепи.
17. Композиция по п.16, отличающаяся тем, что гидрофобная среда включает глицерилтрикаприлат, и твердая форма дополнительно содержит ПВП-12 и октаноат натрия.
18. Композиция по п.17, отличающаяся тем, что гидрофобная среда дополнительно содержит предпочтительно касторовое масло и глицерилмонокаприлат или их комбинацию и поверхностно-активное вещество.
19. Композиция по п.18, отличающаяся тем, что гидрофобная среда содержит глицерилтрикаприлат, глицерилмонокаприлат или полиоксиэтиленсорбитан моноолеат (Твин 80).
20. Композиция по п.19, отличающаяся тем, что твердая форма содержит преимущественно активный октреотид, ПВП-12 и октаноат натрия.
21. Композиция по п.20, отличающаяся тем, что содержит около 41% глицерилтрикаприлата, около 27% касторового масла, около 4% глицерилмонокаприлата, около 2% Твина 80, около 15% октаноата натрия, около 10% ПВП-12, около 1% воды и около 0,058% октреотида.
22. Композиция по п.20, отличающаяся тем, что содержит около 68% глицерилтрикаприлата, около 4% глицерилмонокаприлата, около 2% Твина 80, около 15% октаноата натрия, около 10% ПВП-12, около 1% воды и около 0,058% октреотида.
23. Способ лечения субъекта, страдающего акромегалией, аномальной перистальтикой ЖКТ, приливами, связанными с карциноидным синдромом, портальной гипертензией, опухолью эндокринной железы, астропарезисом, диареей, панкреатическим подтеканием или панкреатической псевдокистой, отличающийся тем, что включает введение субъекту композиции по пп.16-22 в количестве, достаточном для лечения симптомов.
24. Способ предотвращения варикозного кровотечения у субъекта, отличающийся тем, что включает введение субъекту композиции по пп.16-22 в количестве, достаточном для предотвращения кровотечения.
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