RU2003116058A - Композиции гидрокодона с контролируемым высвобождением - Google Patents
Композиции гидрокодона с контролируемым высвобождениемInfo
- Publication number
- RU2003116058A RU2003116058A RU2003116058/15A RU2003116058A RU2003116058A RU 2003116058 A RU2003116058 A RU 2003116058A RU 2003116058/15 A RU2003116058/15 A RU 2003116058/15A RU 2003116058 A RU2003116058 A RU 2003116058A RU 2003116058 A RU2003116058 A RU 2003116058A
- Authority
- RU
- Russia
- Prior art keywords
- dosage form
- hours
- hydrocodone
- provides
- max
- Prior art date
Links
- LLPOLZWFYMWNKH-CMKMFDCUSA-N Hydrocodone Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)CC(=O)[C@@H]1OC1=C2C3=CC=C1OC LLPOLZWFYMWNKH-CMKMFDCUSA-N 0.000 title claims 35
- 229960000240 hydrocodone Drugs 0.000 title claims 35
- 239000000203 mixture Substances 0.000 title claims 5
- 239000002552 dosage form Substances 0.000 claims 52
- 150000003839 salts Chemical class 0.000 claims 22
- 239000011780 sodium chloride Substances 0.000 claims 22
- 230000035839 C max Effects 0.000 claims 14
- 238000000338 in vitro Methods 0.000 claims 9
- 230000037098 T max Effects 0.000 claims 7
- 239000000463 material Substances 0.000 claims 7
- 210000002381 Plasma Anatomy 0.000 claims 6
- 230000001225 therapeutic Effects 0.000 claims 6
- 230000036592 analgesia Effects 0.000 claims 5
- 201000008125 pain agnosia Diseases 0.000 claims 5
- 239000012062 aqueous buffer Substances 0.000 claims 4
- 239000011159 matrix material Substances 0.000 claims 4
- 239000007787 solid Substances 0.000 claims 4
- 238000004090 dissolution Methods 0.000 claims 3
- 239000002245 particle Substances 0.000 claims 3
- -1 controlled release Substances 0.000 claims 2
- 238000006073 displacement reaction Methods 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 229940079593 drugs Drugs 0.000 claims 2
- 239000012530 fluid Substances 0.000 claims 2
- 230000002496 gastric Effects 0.000 claims 2
- 230000003364 opioid Effects 0.000 claims 2
- 239000006186 oral dosage form Substances 0.000 claims 2
- 239000008363 phosphate buffer Substances 0.000 claims 2
- 230000002459 sustained Effects 0.000 claims 2
- 230000035700 Clearance Rate Effects 0.000 claims 1
- 238000010521 absorption reaction Methods 0.000 claims 1
- 239000011324 bead Substances 0.000 claims 1
- UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Claims (39)
1. Твердая пероральная дозированная лекарственная форма с контролируемым высвобождением, подходящая для введения пациенту 1 раз в 24 ч и содержащая фармацевтически приемлемую матрицу, включающую анальгетически эффективное количество гидрокодона или его фармацевтически приемлемой соли и материал контролируемого высвобождения; причем указанная дозированная лекарственная форма после введения пациенту обеспечивает соотношение С24/Сmax от около 0,55 до около 0,85; и указанная дозированная лекарственная форма обеспечивает терапевтический эффект в течение, по меньшей мере, приблизительно 24 ч.
2. Дозированная лекарственная форма по п.1, которая обеспечивает соотношение С24/Сmax от 0,55 до 0,75.
3. Дозированная лекарственная форма по п.1, в которой указанная матрица представляет собой множество матриц, состоящих из множества частиц.
4. Дозированная лекарственная форма по п.3, в которой указанные материалы, состоящие из множества частиц, спрессованы в таблетку.
5. Дозированная лекарственная форма по п.3, в которой указанные материалы, состоящие из множества частиц, заключены в фармацевтически приемлемую капсулу.
6. Дозированная лекарственная форма по п.1, которая обеспечивает соотношение С24/Сmax от 0,60 до 0,70.
7. Дозированная лекарственная форма по п.1, которая обеспечивает in vitro скорость высвобождения вследствие растворения при измерении "корзиночным" способом по Фармакопее США при 100 об./мин в 700 мл водного буфера при рН 1,2, по меньшей мере, от 10 до около 45 мас.% гидрокодона или его соли через 1 ч.
8. Дозированная лекарственная форма по п.1, которая обеспечивает in vitro скорость высвобождения гидрокодона или его фармацевтически приемлемой соли вследствие растворения при измерении "корзиночным" способом по Фармакопее США при 100 об/мин в 700 мл имитированной желудочной жидкости (SGF) при 37°С в течение 1 ч, с последующим переключением на 900 мл с фосфатным буфером до рН 7,5 при 37°С, по меньшей мере, 20 мас.% гидрокодона или его соли, высвобождаемых через 4 ч, от около 20 мас.% до около 65 мас.% гидрокодона или его соли, высвобождаемых через 8 часов, от около 45 до около 85 мас.% гидрокодона или его соли, высвобождаемых через 12 ч, и, по меньшей мере, 80 мас.% гидрокодона или его соли, высвобождаемых через 24 ч.
9. Дозированная лекарственная форма по п.1, которая обеспечивает время до достижения максимальной концентрации (Tmax) гидрокодона в плазме от около 4 до около 14 ч после перорального введения дозированной лекарственной формы.
10. Дозированная лекарственная форма по п.1, которая обеспечивает время до достижения максимальной концентрации (Tmax) гидрокодона в плазме от около 6 до около 12 ч после перорального введения дозированной лекарственной формы.
11. Дозированная лекарственная форма по п.1, которая обеспечивает Cmax гидрокодона, составляющее менее чем 60% от Cmax эквивалентной дозы эталонной композиции гидрокодона немедленного высвобождения.
12. Дозированная лекарственная форма по п.1, где указанное введение представляет первое введение.
13. Дозированная лекарственная форма по п.1, где указанное введение представляет собой введение в стационарном состоянии.
14. Дозированная лекарственная форма по п.1, где указанное соотношение обеспечивается у популяции пациентов.
15. Твердая пероральная дозированная лекарственная форма с контролируемым высвобождением, подходящая для введения пациенту 1 раз в 24 ч и содержащая анальгетически эффективное количество гидрокодона или его фармацевтически приемлемой соли и материал контролируемого высвобождения, причем указанная дозированная лекарственная форма после перорального введения пациенту обеспечивает скорость всасывания в течение периода времени от Tmax до около 24 ч после перорального введения дозированной лекарственной формы, что составляет от около 45 до около 85% скорости выведения из организма в течение того же периода времени, причем указанная дозированная лекарственная форма настоящего изобретения обеспечивает терапевтический эффект в течение, по меньшей мере, около 24 ч.
16. Способ обеспечения эффективной анальгезии у пациента в течение, по меньшей мере, 24 ч, включающий пероральное введение дозированной лекарственной формы, содержащей фармацевтически приемлемую матрицу, включающую анальгетически эффективное количество гидрокодона или его фармацевтически приемлемой соли и материал контролируемого высвобождения, причем указанная дозированная лекарственная форма после введения пациенту обеспечивает соотношение С24/Сmax от около 0,55 до около 0,85 и терапевтический эффект в течение, по меньшей мере, приблизительно 24 ч.
17. Способ приготовления твердой пероральной дозированной лекарственной формы с контролируемым высвобождением, состоящий во включении анальгетически эффективного количества гидрокодона или его фармацевтически приемлемой соли в материал контролируемого высвобождения с формированием матричной композиции контролируемого высвобождения, причем указанная дозированная лекарственная форма после введения пациенту обеспечивает соотношение С24/Сmax от около 0,55 до около 0,85 и терапевтический эффект в течение, по меньшей мере, приблизительно 24 ч.
18. Твердая пероральная дозированная лекарственная форма с контролируемым высвобождением, подходящая для введения пациенту 1 раз в 24 ч и содержащая множество фармацевтически приемлемых шариков, включающих анальгетически эффективное количество гидрокодона или его фармацевтически приемлемой соли и материал контролируемого высвобождения, причем указанная дозированная лекарственная форма обеспечивает скорость высвобождения in vitro гидрокодона или его фармацевтически приемлемой соли при измерении "корзиночным" способом по Фармакопее США при 100 об./мин в 900 мл водного буфера при рН от 1,6 до 7,2 при 37°С от 0 до около 35% через 1 ч, от около 10 до около 70% через 4 ч, от около 20 до около 75% через 8 ч, от около 30 до около 80 через 12 ч, от около 40 до около 90% через 18 ч, и более чем около 60% через 24 ч; причем скорость высвобождения in vitro по существу независима от рН, так что различие в любое данное время между количеством опиоида, высвободившимся при одном рН, и количеством, высвободившимся при любом другом рН при измерении in vitro с использованием "лопастного" способа по Фармакопее США XXII (1990) при 100 об/мин в 900 мл водного буфера составляет не более чем 10%; причем указанная дозированная лекарственная форма после введения пациенту обеспечивает соотношение С24/Сmax от около 0,55 до около 0,85 и терапевтический эффект в течение, по меньшей мере, приблизительно 24 ч.
19. Дозированная лекарственная форма по п.18, которая обеспечивает соотношение С24/Сmax от 0,55 до 0,75.
20. Дозированная лекарственная форма по п.18, которая обеспечивает время до достижения максимальной концентрации (Tmax) гидрокодона в плазме от около 4 до около 14 ч после перорального введения дозированной лекарственной формы.
21. Дозированная лекарственная форма по п.18, которая обеспечивает время до достижения максимальной концентрации (Tmax) гидрокодона в плазме от около 6 до около 12 ч после перорального введения дозированной лекарственной формы.
22. Дозированная лекарственная форма по п.18, которая обеспечивает Cmax гидрокодона, составляющее менее чем 60% от Cmax эквивалентной дозы эталонной композиции гидрокодона немедленного высвобождения.
23. Дозированная лекарственная форма по п.18, где указанное введение представляет первое введение.
24. Дозированная лекарственная форма по п.18, где указанное введение представляет введение в стационарном состоянии.
25. Дозированная лекарственная форма по п.18, где указанное соотношение обеспечивается у популяции пациентов.
26. Способ обеспечения эффективной анальгезии у пациента в течение, по меньшей мере, 24 ч, включающий пероральное введение дозированной лекарственной формы по п.18 пациенту.
27. Пероральная дозированная лекарственная форма пролонгированного высвобождения, включающая (а) двухслойное ядро, содержащее: (i) лекарственный слой, включающий анальгетически эффективное количество гидрокодона или его фармацевтически приемлемой соли, и (ii) слой смещения, включающий осмополимер; и (b) полупроницаемую стенку, окружающую двухслойное ядро и имеющую расположенный в ней канал для высвобождения указанного гидрокодона или его фармацевтически приемлемой соли, причем указанная дозированная лекарственная форма обеспечивает соотношение С24/Сmax от около 0,55 до около 0,85 и указанная дозированная лекарственная форма обеспечивает терапевтический эффект в течение, по меньшей мере, приблизительно 24 ч после перорального введения пациенту.
28. Дозированная лекарственная форма по п.27, которая обеспечивает соотношение С24/Сmax от 0,55 до 0,75.
29. Дозированная лекарственная форма по п.27, которая обеспечивает время до достижения максимальной концентрации (Tmax) гидрокодона в плазме от около 4 до около 14 ч после перорального введения дозированной лекарственной формы.
30. Дозированная лекарственная форма по п.27, которая обеспечивает время до достижения максимальной концентрации (Tmax) гидрокодона в плазме от около 6 до около 12 ч после перорального введения дозированной лекарственной формы.
31. Дозированная лекарственная форма по п.27, которая обеспечивает Cmax гидрокодона, составляющее менее чем 60% от Cmax эквивалентной дозы эталонной композиции гидрокодона немедленного высвобождения.
32. Дозированная лекарственная форма по п.27, где указанное введение представляет первое введение.
33. Дозированная лекарственная форма по п.27, где указанное введение представляет введение в стационарном состоянии.
34. Дозированная лекарственная форма по п.27, которая обеспечивает in vitro скорость высвобождения вследствие растворения гидрокодона или его фармацевтически приемлемой соли при измерении "корзиночным" способом по Фармакопее США при 100 об./мин в 700 мл имитированной желудочной жидкости (SGF) при 37°С в течение 1 ч, с последующим переключением на 900 мл с фосфатным буфером до рН 7,5 при 37°С, по меньшей мере, 20 мас.% гидрокодона или его соли, высвобождаемых через 4 ч, от около 20 до около 65 мас.% гидрокодона или его соли, высвобождаемых через 8 ч, от около 45 до около 85 мас.% гидрокодона или его соли, высвобождаемых через 12 ч, и, по меньшей мере, 80 мас.% гидрокодона или его соли, высвобождаемых через 24 ч.
35. Дозированная лекарственная форма по п.27, где указанное соотношение обеспечивается у популяции пациентов.
36. Способ обеспечения эффективной анальгезии у пациента в течение, по меньшей мере, 24 ч, включающий пероральное введение дозированной лекарственной формы по п.27 пациенту.
37. Пероральная дозированная лекарственная форма пролонгированного высвобождения, включающая: (а) двухслойное ядро, содержащее: (i) лекарственный слой, включающий анальгетически эффективное количество гидрокодона или его фармацевтически приемлемой соли, и (ii) слой смещения, включающий осмополимер; и (b) полупроницаемую стенку, окружающую двухслойное ядро и имеющую расположенный в ней канал для высвобождения указанного гидрокодона или его фармацевтически приемлемой соли, причем указанная дозированная лекарственная форма обеспечивает скорость высвобождения in vitro гидрокодона или его фармацевтически приемлемой соли при измерении "корзиночным" способом по Фармакопее США при 100 об./мин в 900 мл водного буфера при рН от 1,6 до 7,2 при 37°С от 0 до около 35% через 1 ч, от около 10 до около 70% через 4 ч, от около 20 до около 75% через 8 ч, от около 30 до около 80% через 12 ч, от около 40 до около 90% через 18 ч, и более чем около 60% через 24 ч; причем скорость высвобождения in vitro по существу независима от рН, так что различие в любое данное время между количеством опиоида, высвободившимся при одном рН, и количеством, высвободившимся при любом другом рН, при измерении in vitro с использованием "лопастного" способа по Фармакопее США XXII (1990) при 100 об/мин в 900 мл водного буфера составляет не более чем 10%.
38. Способ обеспечения эффективной анальгезии у пациента в течение, по меньшей мере, 24 ч, включающий пероральное введение дозированной лекарственной формы по п.37 пациенту.
39. Применение дозированной лекарственной формы по пп.1-15, 17-25, 27-35 или 37 для обеспечения анальгезии пациенту, по меньшей мере, в течение около 24 ч.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US24442400P | 2000-10-30 | 2000-10-30 | |
| US60/244,424 | 2000-10-30 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2003116058A true RU2003116058A (ru) | 2004-09-10 |
| RU2253452C2 RU2253452C2 (ru) | 2005-06-10 |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2003116058A RU2253452C2 (ru) | 2000-10-30 | 2001-10-30 | Композиции гидрокодона с контролируемым высвобождением |
Country Status (14)
| Country | Link |
|---|---|
| US (25) | US6733783B2 (ru) |
| EP (5) | EP2295042A1 (ru) |
| JP (6) | JP2004512354A (ru) |
| KR (5) | KR101167465B1 (ru) |
| CN (4) | CN100518827C (ru) |
| AU (2) | AU2738302A (ru) |
| BR (1) | BR0115382A (ru) |
| CA (1) | CA2427815C (ru) |
| HK (1) | HK1216613A1 (ru) |
| HU (2) | HU230686B1 (ru) |
| IL (6) | IL155637A0 (ru) |
| MX (1) | MXPA03003895A (ru) |
| RU (1) | RU2253452C2 (ru) |
| WO (1) | WO2002036099A1 (ru) |
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| KR20020059653A (ko) | 1999-10-29 | 2002-07-13 | 그린 마틴, 브라이언 쥐 테슬리 | 서방성 하이드로코돈 제형 |
| HU230686B1 (en) | 2000-10-30 | 2017-08-28 | Euro Celtique Sa | Controlled release hydrocodone compositions |
| UA81224C2 (ru) * | 2001-05-02 | 2007-12-25 | Euro Celtic S A | Дозированная форма оксикодона и ее применение |
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| WO2004022002A2 (en) * | 2002-09-09 | 2004-03-18 | Endo Pharmaceuticals Inc. | Combined immediate release and extended release analgesic composition |
| US8487002B2 (en) * | 2002-10-25 | 2013-07-16 | Paladin Labs Inc. | Controlled-release compositions |
| TWI319713B (en) * | 2002-10-25 | 2010-01-21 | Sustained-release tramadol formulations with 24-hour efficacy | |
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