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RU2408368C2 - Препараты соли бупропиона с модифицированным высвобождением - Google Patents

Препараты соли бупропиона с модифицированным высвобождением Download PDF

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RU2408368C2
RU2408368C2 RU2007147343/15A RU2007147343A RU2408368C2 RU 2408368 C2 RU2408368 C2 RU 2408368C2 RU 2007147343/15 A RU2007147343/15 A RU 2007147343/15A RU 2007147343 A RU2007147343 A RU 2007147343A RU 2408368 C2 RU2408368 C2 RU 2408368C2
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composition according
bupropion
composition
drug
release
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RU2007147343A (ru
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Вернер ОБЕРЕГГЕР (CA)
Вернер Обереггер
Фанг ЖУ (US)
Фанг Жу
Паул МАЕС (CA)
Паул МАЕС
Стефано ТУРЧЕТТА (IT)
Стефано ТУРЧЕТТА
Грэхэм ДЖЕКСОН (IE)
Грэхэм ДЖЕКСОН
Пьетро МАССАРДО (IT)
Пьетро МАССАРДО
Мохаммад Ашти САЛЕХ (CA)
Мохаммад Ашти САЛЕХ
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Биовэйл Лэборэториз Интернэшнл С.Р.Л.
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Abstract

Настоящее изобретение относится к лекарственным формам, содержащим действующее количество фармакологически приемлемой соли бупропиона - бупропиона гидробромида, а также к применению таких лекарственных форм при лечении одного или большего числа состояний пациентов, по отношению к которым допустимо применение бупропиона или его фармакологически приемлемых солей. Лекарственные формы с бупропионом гидробромидом обладают более высокой стабильностью по сравнению с лекарственными формами, включающими бупропиона гидрохлорид, что подтверждается меньшим ослаблением активности композиций после хранения в течение минимум 3 или 6 месяцев при форсированных условиях при 40°С и относительной влажности 75%. 6 н. и 75 з.п. ф-лы, 69 ил., 73 табл.

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Claims (81)

1. Существенно чистая полиморфная форма I бупропиона гидробромида, имеющая дифрактограмму рентгеновских лучей на порошке, показанную на фиг.54.
2. Существенно чистая полиморфная форма II бупропиона гидробромида, имеющая дифрактограмму рентгеновских лучей на порошке, показанную на фиг.56.
3. Существенно чистая полиморфная форма III бупропиона гидробромида, имеющая дифрактограмму рентгеновских лучей на порошке, показанную на фиг.58.
4. Стабильная фармацевтическая композиция, содержащая бупропион в качестве активного фармацевтического ингредиента, характеризующаяся тем, что она содержит фармацевтически эффективное количество гидробромидной соли бупропиона.
5. Композиция по п.4, пригодная для перорального введения в организм пациента, нуждающегося в приеме бупропиона.
6. Композиция по п.4, более стабильная, чем эквивалентная в других отношениях композиция бупропиона гидрохлорида, при хранении в течение минимум 3 месяцев при 40°С и относительной влажности 75%.
7. Композиция по п.6, более стабильная при хранении в течение минимум 6 месяцев при 40°С и относительной влажности 75%.
8. Композиция по п.6, которая содержит меньшее количество минимум одного примесного продукта, характерного для разложения бупропиона после хранения при 40°С и относительной влажности 75%, чем аналогичные в других отношениях композиции бупропиона гидрохлорида, хранившиеся в тех же условиях.
9. Композиция бупропиона гидробромида по п.6, на кривой растворения которой in vitro в минимум одной растворяющей среде колебания являются менее выраженными, чем на кривых растворения для аналогичных в других отношениях композиций бупропиона гидрохлорида, после хранения в течение минимум 3 месяцев при 40°С и относительной влажности 75%.
10. Композиция по п.4, покрытая минимум одной оболочкой, препятствующей выбросу дозы при нахождении указанной композиции в 40%-ном этаноле.
11. Композиция по п.10, в которой покрытие включает не растворимый в воде полимер, водорастворимый полимер и, при необходимости, пластификатор.
12. Композиция по п.4, содержащая не менее одного фармакологически приемлемого носителя или вспомогательного вещества.
13. Композиция по п.4, выполненная в виде таблетки, которая биоэквивалентна таблеткам Велбутрина (Wellbutrin™) или Зибана/Велбутрина SR (Zyban™/Wellbutrin™ SR) при однократном в сутки введении нуждающемуся в этом пациенту.
14. Композиция по п.13, не проявляющая лекарственно-пищевого взаимодействия.
15. Композиция по п.13, содержащая 150, 174, 300 или 348 мг бупропиона гидробромида.
16. Композиция по п.4, пригодная для введения с помощью средств местного применения.
17. Композиция по п.4, пригодная для трансмукозальной или трансдермальной доставки.
18. Композиция по п.4, пригодная для инъекции.
19. Композиция по п.4, пригодная для введения ингаляционным путем.
20. Композиция по п.4, в которой не менее 90% присутствующего в ней бупропиона являются одной из энантиомерных форм соли бупропиона.
21. Композиция по п.4, в которой не менее 95-99% присутствующего в ней бупропиона являются одной из энантиомерных форм соли бупропиона.
22. Композиция по п.4, в которой не менее 90% присутствующего в ней бупропиона являются (+)энантиомером.
23. Композиция по п.4, в которой не менее 90% присутствующего в ней бупропиона являются (-)энантиомером.
24. Композиция по п.4, в которой не менее 95-99% присутствующего в ней бупропиона являются (-)энантиомером.
25. Композиция по п.4, в которой не менее 95-99% присутствующего в ней бупропиона являются (+)энантиомером.
26. Композиция по п.4, которая содержит как минимум одну из полиморфных форм I, II и III, охарактеризованных в пп.1-3.
27. Композиция по п.26, содержащая полиморфные формы I, II и III.
28. Композиция по п.4, выполненная в виде таблетированного препарата.
29. Композиция по п.4, выполненная в виде капсулированного препарата.
30. Композиция по п.4, представляющая собой препарат с продолжительным высвобождением.
31. Композиция по п.4, представляющая собой препарат с отсроченным высвобождением.
32. Композиция по п.4, представляющая собой препарат с улучшенным всасыванием.
33. Композиция по п.4, выполненная в виде матричной таблетки с регулируемым высвобождением.
34. Композиция по п.4, выполненная в виде системы доставки с осмотическим высвобождением.
35. Композиция по п.4, пригодная для введения один раз в сутки.
36. Композиция по п.4, пригодная для введения дважды в сутки.
37. Композиция по п.4, содержащая 50-400 мг бупропиона.
38. Композиция по п.4, содержащая 150 или 174 мг бупропиона.
39. Композиция по п.4, содержащая 300 или 348 мг бупропиона.
40. Композиция по п.4, имеющая не менее одного функционального или нефункционального покрытия.
41. Композиция по п.40, в которой указанные покрытия представляют собой гидроизолирующие барьеры, регулирующие высвобождение оболочки, желудочно-резистентные оболочки, покрытия, влияющие на физическую стабильность, и/или покрытия, влияющие на внешний вид композиции.
42. Композиция по п.41, имеющая гидроизолирующий барьер.
43. Композиция по п.4, содержащая ядро, которое включает указанную соль бупропиона, связующее и смазывающее вещество; и имеющее регулирующую высвобождение оболочку, по существу, окружающую указанное ядро, причем указанная композиция обеспечивает регулируемое высвобождение указанной соли бупропиона.
44. Композиция по п.43, имеющая не менее одного дополнительного покрытия.
45. Композиция по п.43, в которой указанные дополнительные покрытия представляют собой гидроизолирующие барьеры, желудочно-резистентные оболочки, регулирующие высвобождение оболочки, покрытия, влияющие на физическую стабильность и/или покрытия, влияющие на внешний вид композиции.
46. Композиция по п.45, в которой указанные дополнительные оболочки, по существу, окружают ядро и/или регулирующую высвобождение оболочку.
47. Композиция по п.43, в которой указанным связующим является поливиниловый спирт.
48. Композиция по п.43, в которой имеется гидроизолирующий барьер, или желудочно-резистентная оболочка вокруг ядра и/или регулирующая высвобождение оболочка,
49. Композиция по п.43, в которой в качестве указанного смазывающего вещества использован глицерилбегенат.
50. Композиция по п.43, в которой указанная регулирующая высвобождение оболочка включает не растворимый в воде полимер, водорастворимый полимер и, при необходимости, пластификатор.
51. Композиция по п.50, в которой в качестве указанного не растворимого в воде полимера использована этилцеллюлоза.
52. Композиция по п.50, в которой в качестве указанного водорастворимого полимера использован поливинилпирролидон.
53. Композиция по п.50, в которой указанный пластификатор, если его наличие предусмотрено, представляет собой смесь полиэтиленгликоля 4000 и дибутилсебацината.
54. Композиция по п.50, в которой указанная регулирующая высвобождение оболочка включает водную дисперсию нейтрального сложноэфирного сополимера без каких-либо функциональных групп, полигликоль с температурой плавления выше прибл. 55°С и одно или большее число фармакологически приемлемых вспомогательных веществ, причем указанная оболочка нанесена на указанные ядра и отверждена при температуре, минимум равной температуре плавления полигликоля или превышающей ее.
55. Композиция по п.54, содержащая минимум одну дополнительную оболочку.
56. Композиция по п.53, в которой указанное ядро является микрочастицей.
57. Композиция по п.53, в которой указанное ядро является ядром с немедленным высвобождением.
58. Композиция по п.4, дополнительно содержащая второе лекарство.
59. Композиция по п.58, в которой указанное второе лекарство выбрано из группы, включающей антидепрессанты, сосудорасширяющие, седативные средства, противовоспалительные, болеутоляющие средства, средства от мигрени, средства для лечения наркомании, алкоголизма или никотиновой зависимости, противовирусные средства, модуляторы сна, антимиметики, подавители или усилители аппетита и невропсихиатрические средства.
60. Композиция по п.58, в которой второе лекарство является антидепрессантом.
61. Композиция по п.58, в которой второе лекарство является немедленно высвобождаемым после введения в организм.
62. Композиция по п.58, в которой второе лекарство не соприкасается с первым лекарством в композиции.
63. Композиция по п.62, в которой бупропион и второе лекарство содержатся в разных слоях, частях композиции или разных микрочастицах, составляющих композицию.
64. Композиция по п.58, в которой указанным вторым лекарством является циталопрам.
65. Композиция по п.58, в которой указанным вторым лекарством является эсциталопрам.
66. Композиция по п.58, в которой указанным вторым лекарством является венлафаксин.
67. Способ лечения пациента, страдающего от состояния, при котором введение бупропиона оказывает благоприятный эффект, включающий введение композиции по любому из пп.4-66.
68. Способ по п.67, в котором указанное состояние выбрано из группы, включающей депрессию, токсикоманию, явления, связанные с отказом от курения, ожирение и сезонное аффективное расстройство.
69. Способ по п.67, в котором указанным состоянием является ожирение.
70. Способ по п.67, в котором состоянием является ожирение.
71. Способ по п.67, в котором состоянием являются явления, связанные с отказом от курения.
72. Способ по п.67, в котором состоянием является сезонное аффективное расстройство.
73. Применение бупропиона гидробромида для приготовления медикамента для лечения состояний, при которых введение бупропиона оказывает благоприятный эффект.
74. Применение по п.73, в котором указанный медикамент содержит меньшее количество минимум одного структурного образования, характерного для разложения бупропиона, чем аналогичные в других отношениях композиции бупропиона гидрохлорида, при хранении указанных композиций в течение минимум 3 или 6 месяцев при 40°С и относительной влажности 75%.
75. Применение по п.73, в котором указанный медикамент характеризуется меньшим разбросом кривой растворения in vitro в минимум одной растворяющей среде по сравнению с аналогичной в других отношениях композицией бупропиона гидрохлорида после хранения указанных композиций в течение минимум 3 и/или 6 месяцев при 40°С и относительной влажности 75%.
76. Применение по п.73, в котором медикамент выполнен в виде таблетки.
77. Применение по п.73, в котором медикамент выполнен в виде капсулы.
78. Применение по п.73, в котором медикамент содержит второе лекарство.
79. Применение по п.78, в котором вторым лекарством является циталопрам.
80. Применение по п.78, в котором вторым лекарством является эсциталопрам.
81. Применение по п.78, в котором вторым лекарством является венлафаксин.
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