RU2010119291A - Стойкая к разрушению лекарственная форма с замедленным высвобождением оксикодона гидрохлорида - Google Patents

Стойкая к разрушению лекарственная форма с замедленным высвобождением оксикодона гидрохлорида Download PDF

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Publication number
RU2010119291A
RU2010119291A RU2010119291/15A RU2010119291A RU2010119291A RU 2010119291 A RU2010119291 A RU 2010119291A RU 2010119291/15 A RU2010119291/15 A RU 2010119291/15A RU 2010119291 A RU2010119291 A RU 2010119291A RU 2010119291 A RU2010119291 A RU 2010119291A
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RU
Russia
Prior art keywords
dosage form
form according
polymer
oxide
destruction
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RU2010119291/15A
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English (en)
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RU2461381C2 (ru
Inventor
Джуди АШУОРТ (DE)
Джуди АШУОРТ
Элизабет АРКЕНАУ-МАРИЦ (DE)
Элизабет АРКЕНАУ-МАРИЦ
Иоганнес БАРТОЛОМОЙС (DE)
Иоганнес БАРТОЛОМОЙС
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Грюненталь ГмбХ (DE)
Грюненталь Гмбх
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Application filed by Грюненталь ГмбХ (DE), Грюненталь Гмбх filed Critical Грюненталь ГмбХ (DE)
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Abstract

1. Лекарственная форма, которая содержит физиологически активное вещество (А), включающее оксикодона гидрохлорид, необязательно одно или несколько физиологически совместимых вспомогательных веществ (Б), синтетический или природный полимер (В) и необязательно природный, полусинтетический или синтетический воск (Г) и обладает сопротивлением разрушению по меньшей мере 400 Н и которая в физиологических условиях по истечении 5 ч высвобождает максимум 99% оксикодона гидрохлорида. ! 2. Лекарственная форма по п.1, отличающаяся тем, что она обладает сопротивлением разрушению по меньшей мере 500 Н. ! 3. Лекарственная форма по п.1, отличающаяся тем, что она представлена в виде таблетки. ! 4. Лекарственная форма по п.1, отличающаяся тем, что она представлена в дисперсном виде с сопротивлением отдельных частиц разрушению по меньшей мере 400 Н. ! 5. Лекарственная форма по п.4, отличающаяся тем, что частицы спрессованы в таблетки или расфасованы в капсулы. ! 6. Лекарственная форма по п.1, отличающаяся тем, что полимер (В) выбран из группы, включающей полиалкиленоксид, полиэтилен, полипропилен, поливинилхлорид, поликарбонат, полистирол, полиакрилат, их сополимеры и их смеси. ! 7. Лекарственная форма по п.1, отличающаяся тем, что полимер (В) представляет собой полиалкиленоксид, выбранный из группы, включающей полиметиленоксид, полиэтиленоксид, полипропиленоксид, их сополимеры, их блоксополимеры и их смеси. ! 8. Лекарственная форма по п.6, отличающаяся тем, что полимер (В) имеет средневязкостную молекулярную массу по меньшей мере 0,5·106 г/моль. ! 9. Лекарственная форма по п.1, отличающаяся тем, что она имеет оболочковую часть (82) и расположенную внутри нее

Claims (15)

1. Лекарственная форма, которая содержит физиологически активное вещество (А), включающее оксикодона гидрохлорид, необязательно одно или несколько физиологически совместимых вспомогательных веществ (Б), синтетический или природный полимер (В) и необязательно природный, полусинтетический или синтетический воск (Г) и обладает сопротивлением разрушению по меньшей мере 400 Н и которая в физиологических условиях по истечении 5 ч высвобождает максимум 99% оксикодона гидрохлорида.
2. Лекарственная форма по п.1, отличающаяся тем, что она обладает сопротивлением разрушению по меньшей мере 500 Н.
3. Лекарственная форма по п.1, отличающаяся тем, что она представлена в виде таблетки.
4. Лекарственная форма по п.1, отличающаяся тем, что она представлена в дисперсном виде с сопротивлением отдельных частиц разрушению по меньшей мере 400 Н.
5. Лекарственная форма по п.4, отличающаяся тем, что частицы спрессованы в таблетки или расфасованы в капсулы.
6. Лекарственная форма по п.1, отличающаяся тем, что полимер (В) выбран из группы, включающей полиалкиленоксид, полиэтилен, полипропилен, поливинилхлорид, поликарбонат, полистирол, полиакрилат, их сополимеры и их смеси.
7. Лекарственная форма по п.1, отличающаяся тем, что полимер (В) представляет собой полиалкиленоксид, выбранный из группы, включающей полиметиленоксид, полиэтиленоксид, полипропиленоксид, их сополимеры, их блоксополимеры и их смеси.
8. Лекарственная форма по п.6, отличающаяся тем, что полимер (В) имеет средневязкостную молекулярную массу по меньшей мере 0,5·106 г/моль.
9. Лекарственная форма по п.1, отличающаяся тем, что она имеет оболочковую часть (82) и расположенную внутри нее сердцевину (83), с которой оболочковая часть (82) соединена бесшовно, при этом образующий оболочковую часть (82) материал и образующий сердцевину (83) материал имеют в основном одинаковый химический состав, но разную морфологию.
10. Лекарственная форма по п.9, отличающаяся тем, что образующий оболочковую часть (82) материал и образующий сердцевину (83) материал обладают разными оптическими свойствами.
11. Лекарственная форма по п.9, отличающаяся тем, что толщина слоя оболочковой части (82) составляет от 0,1 до 4 мм.
12. Лекарственная форма по п.1, отличающаяся тем, что ее объем при хранении в течение по меньшей мере 12 ч при температуре на 20°С ниже температуры плавления смеси компонента (А), компонента (В), возможно используемого компонента (Б) и возможно используемого компонента (Г) увеличивается не более чем на 20%.
13. Лекарственная форма по п.1, отличающаяся тем, что она содержит по меньшей мере один воск (Г) с температурой размягчения по меньшей мере 50°С.
14. Лекарственная форма по п.13, отличающаяся тем, что воск (Г) представляет собой карнаубский воск или пчелиный воск.
15. Лекарственная форма по п.1, отличающаяся тем, что физиологически активное вещество присутствует в замедляющей его высвобождение матрице.
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