RU2469726C2 - Композиции с контролируемым высвобождением на основе кортикостероидов для лечения ушных болезней - Google Patents
Композиции с контролируемым высвобождением на основе кортикостероидов для лечения ушных болезней Download PDFInfo
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- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
Abstract
Фармацевтическая композиция, пригодная для применения при лечении ушных болезней, включает приемлемый для уха термообратимый водный гель. Фармацевтическая композиция состоит из противовоспалительного кортикостероида в виде множества частиц и полимера на основе полиоксипропилена и полиоксиэтилена. Композицию вводят локально субъекту, страдающему от ушной болезни, путем интраимпанического введения на мембрану окна улитки уха или около нее. Композиция по изобретению обеспечивает пролонгированное высвобождение противовоспалительного кортикостероида через мембрану окна улитки в улитку внутреннего уха в течение, по меньшей мере, 5 дней после однократного введения. 11 з.п. ф-лы, 9 ил., 9 табл., 31 пр.
Description
Claims (12)
1. Фармацевтическая композиция, пригодная для применения при лечении ушных болезней путем интратимпанического введения на мембрану окна улитки уха или около нее, включающая такой приемлемый для уха термообратимый водный гель, состоящий из полимера на основе полиоксипропилена и полиоксиэтилена и противовоспалительного кортикостероида в виде множества частиц, что пролонгированное высвобождение противовоспалительного кортикостероида через мембрану окна улитки в улитку внутреннего уха происходит в течение по меньшей мере 5 дн. после однократного введения.
2. Композиция по п.1, отличающаяся тем, что величина рН композиции находится между примерно 7,0 и примерно 8,0.
3. Композиция по п.1, отличающаяся тем, что она пригодна для применения при лечении болезни Меньера, составлена так, чтобы обеспечить пролонгированное высвобождение терапевтически эффективного количества дексаметазона, метилпреднизолона или преднизолона через мембрану окна улитки в улитку внутреннего уха в течение по меньшей мере 5 дн, при этом эта композиция содержит:
между 1 мг/мл и 70 мг/мл дексаметазона, метилпреднизолона, преднизолона или их фармацевтически приемлемых пролекарства или соли в виде множества частиц;
между 16% и 21% по весу сополимера полиоксиэтилена и полиоксипропилена;
и причем фармацевтическая композиция имеет осмоляльность между 250 и 320 мОсм/кг, приемлемую для перилимфы.
между 1 мг/мл и 70 мг/мл дексаметазона, метилпреднизолона, преднизолона или их фармацевтически приемлемых пролекарства или соли в виде множества частиц;
между 16% и 21% по весу сополимера полиоксиэтилена и полиоксипропилена;
и причем фармацевтическая композиция имеет осмоляльность между 250 и 320 мОсм/кг, приемлемую для перилимфы.
4. Композиция по п.1, отличающаяся тем, что она пригодна для применения при лечении внезапной нейросенсорной потери слуха и составлена таким образом, чтобы обеспечить пролонгированное высвобождение терапевтически эффективного количества дексаметазона, метилпреднизолона или преднизолона через мембрану окна улитки в улитку внутреннего уха в течение по меньшей мере 5 дн, при этом эта композиция содержит:
между 1 мг/мл и 70 мг/мл дексаметазона, метилпреднизолона, преднизолона или их фармацевтически приемлемых пролекарства или соли в виде множества частиц;
между 16% и 21% по весу сополимера полиоксиэтилена и полиоксипропилена;
и фармацевтическая композиция имеет осмоляльность между 250 и 320 мОсм/кг.
между 1 мг/мл и 70 мг/мл дексаметазона, метилпреднизолона, преднизолона или их фармацевтически приемлемых пролекарства или соли в виде множества частиц;
между 16% и 21% по весу сополимера полиоксиэтилена и полиоксипропилена;
и фармацевтическая композиция имеет осмоляльность между 250 и 320 мОсм/кг.
5. Композиция для применения при лечении ушных болезней по п.1, отличающаяся тем, что противовоспалительный кортикостероид представляет собой дексаметазон.
6. Композиция для применения при лечении ушных болезней по п.1, отличающаяся тем, что противовоспалительный кортикостероид представляет собой метилпреднизолон.
7. Композиция для применения при лечении ушных болезней по п.1, отличающаяся тем, что противовоспалительный кортикостероид представляет собой преднизолон.
8. Композиция для применения при лечении ушных болезней по любому из пп.1-7, отличающаяся тем, что пролонгированное высвобождение происходит в течение периода, равного по меньшей мере 7 дн.
9. Композиция для применения при лечении ушных болезней по любому из пп.1-7, отличающаяся тем, что пролонгированное высвобождение происходит в течение периода, равного по меньшей мере 10 дн.
10. Композиция для применения при лечении ушных болезней по любому из пп.1-7, отличающаяся тем, что пролонгированное высвобождение происходит в течение периода, равного по меньшей мере 14 дн.
11. Композиция для примнения при лечении ушных болезней по любому из пп.1-5, отличающаяся тем, что дексаметазон, метилпреднизолон или преднизолон вводится в виде фосфатного или сложноэфирного пролекарства.
12. Композиция для применения при лечении ушных болезней по п.1, отличающаяся тем, что полимер на основе полиоксипропилена и полиоксиэтилена представляет собой полоксамер 407.
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RU2012139802/15A Division RU2012139802A (ru) | 2008-05-14 | 2012-09-18 | Композиции с контролируемым высвобождением на основе кортикостероидов для лечения ушных болезней |
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RU2010150863A RU2010150863A (ru) | 2012-06-20 |
RU2469726C2 true RU2469726C2 (ru) | 2012-12-20 |
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RU2010150863/15A RU2469726C2 (ru) | 2008-05-14 | 2009-05-14 | Композиции с контролируемым высвобождением на основе кортикостероидов для лечения ушных болезней |
RU2012139802/15A RU2012139802A (ru) | 2008-05-14 | 2012-09-18 | Композиции с контролируемым высвобождением на основе кортикостероидов для лечения ушных болезней |
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US (9) | US8030297B2 (ru) |
EP (1) | EP2303227B1 (ru) |
JP (3) | JP5551685B2 (ru) |
KR (2) | KR101534422B1 (ru) |
CN (2) | CN102026623B (ru) |
AU (1) | AU2009246870B2 (ru) |
BR (1) | BRPI0912482A2 (ru) |
CA (1) | CA2723458C (ru) |
HK (1) | HK1156533A1 (ru) |
IL (2) | IL208806A (ru) |
MX (1) | MX2010012397A (ru) |
MY (1) | MY161021A (ru) |
RU (2) | RU2469726C2 (ru) |
WO (1) | WO2009139924A2 (ru) |
ZA (1) | ZA201007482B (ru) |
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