RU2001111887A - Композиция в виде множества частиц с модифицированным высвобождением - Google Patents
Композиция в виде множества частиц с модифицированным высвобождениемInfo
- Publication number
- RU2001111887A RU2001111887A RU2001111887/14A RU2001111887A RU2001111887A RU 2001111887 A RU2001111887 A RU 2001111887A RU 2001111887/14 A RU2001111887/14 A RU 2001111887/14A RU 2001111887 A RU2001111887 A RU 2001111887A RU 2001111887 A RU2001111887 A RU 2001111887A
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- Prior art keywords
- active ingredient
- composition
- modified release
- particles
- component
- Prior art date
Links
- 239000002245 particle Substances 0.000 title claims 44
- 239000000203 mixture Substances 0.000 title claims 42
- 239000004480 active ingredient Substances 0.000 claims 42
- 239000006186 oral dosage form Substances 0.000 claims 6
- 239000007787 solid Substances 0.000 claims 6
- 229920001577 copolymer Polymers 0.000 claims 3
- 230000001419 dependent Effects 0.000 claims 3
- 238000004090 dissolution Methods 0.000 claims 3
- 239000002552 dosage form Substances 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 238000000338 in vitro Methods 0.000 claims 3
- 229920000642 polymer Polymers 0.000 claims 3
- 238000002360 preparation method Methods 0.000 claims 3
- 239000003826 tablet Substances 0.000 claims 3
- MUZDXNQOSGWMJJ-UHFFFAOYSA-L 2-methylprop-2-enoate;prop-2-enoate Chemical compound [O-]C(=O)C=C.CC(=C)C([O-])=O MUZDXNQOSGWMJJ-UHFFFAOYSA-L 0.000 claims 2
- 239000007903 gelatin capsule Substances 0.000 claims 2
- 239000011159 matrix material Substances 0.000 claims 2
- 230000003278 mimic Effects 0.000 claims 2
- DUGOZIWVEXMGBE-UHFFFAOYSA-N Adhd patch Chemical group C=1C=CC=CC=1C(C(=O)OC)C1CCCCN1 DUGOZIWVEXMGBE-UHFFFAOYSA-N 0.000 claims 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- 229960001344 Methylphenidate Drugs 0.000 claims 1
- 239000003623 enhancer Substances 0.000 claims 1
- 230000002708 enhancing Effects 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 239000008273 gelatin Substances 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 235000011852 gelatine desserts Nutrition 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 239000008185 minitablet Substances 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
Claims (36)
1. Композиция в виде множества частиц с модифицированным высвобождением, содержащая по меньшей мере один активный ингредиент и имеющая первый компонент, включающий в себя первую совокупность частиц, содержащих активный ингредиент, и по меньшей мере один дополнительный компонент, причем каждый дополнительный компонент включает в себя дополнительную совокупность частиц, содержащих активный ингредиент, и причем активный ингредиент, содержащийся в первом и дополнительных компонентах, является одинаковым или разным; причем по меньшей мере одна дополнительная совокупность частиц, содержащих активный ингредиент, дополнительно содержит оболочку для модифицированного высвобождения или, альтернативно или дополнительно, матричный материал для модифицированного высвобождения, так что эта композиция после пероральной доставки субъекту доставляет активный ингредиент или активные ингредиенты импульсным образом.
2. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где эта композиция содержит первый компонент и один дополнительный компонент.
3. Композиция в виде множества частиц с модифицированным высвобождением по п. 2, где первый компонент включает в себя компонент с немедленным высвобождением, а дополнительный компонент представляет собой компонент с модифицированным высвобождением.
4. Композиция в виде множества частиц с модифицированным высвобождением по п. 3, где компонент с модифицированным высвобождением включает в себя частицы, имеющие оболочку для модифицированного высвобождения.
5. Композиция в виде множества частиц с модифицированным высвобождением по п. 3, где компонент с модифицированным высвобождением содержит матричный материал для модифицированного высвобождения.
6. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где первая совокупность частиц, содержащих активный ингредиент, и по меньшей мере одна дополнительная совокупность частиц, содержащих активный ингредиент, содержат одинаковый активный ингредиент.
7. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где первая совокупность частиц, содержащих активный ингредиент, содержит два или более чем два активных ингредиента.
8. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где по меньшей мере одна дополнительная совокупность частиц, содержащих активный ингредиент, содержит два или более чем два активных ингредиента.
9. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где активный ингредиент включает в себя по существу один оптически чистый энантиомер либо рацемическую или иную смесь энантиомеров.
10. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где по меньшей мере один из первого и дополнительных компонентов дополнительно содержит энхансер.
11. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где количество активного ингредиента, содержащегося в первом и дополнительных компонентах, является одинаковым или разным.
12. Композиция в виде множества частиц с модифицированным высвобождением по п. 11, где количество активного ингредиента, содержащегося в каждом компоненте, находится в диапазоне от примерно 0,1 мг до примерно 1 г.
13. Композиция в виде множества частиц с модифицированным высвобождением по п. 6, где активный ингредиент представляет собой метилфенидат или его фармацевтически приемлемую соль, его энантиомер или смесь энантиомеров, или их смеси.
14. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где первая и дополнительные совокупности частиц, содержащих активный ингредиент, имеют разные профили растворения in vitro.
15. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где первый компонент представляет собой компонент с немедленным высвобождением, и по меньшей мере один дополнительный компонент представляет собой компонент с модифицированным высвобождением.
16. Композиция в виде множества частиц с модифицированным высвобождением по п. 15, которая в действии высвобождает по существу весь активный ингредиент из первой совокупности частиц, содержащих активный ингредиент, перед высвобождением активного ингредиента из дополнительной совокупности частиц, содержащих активный ингредиент.
17. Композиция в виде множества частиц с модифицированным высвобождением по п. 1, где высвобождение активного ингредиента in vivo в субъекте имитирует высвобождение того же самого активного ингредиента in vivo, вводимого в форме двух или более чем двух доз форм активного ингредиента с немедленным высвобождением.
18. Композиция в виде множества частиц с модифицированным высвобождением по п. 13, где высвобождение активного ингредиента in vivo в субъекте имитирует высвобождение того же самого активного ингредиента in vivo, вводимого в форме двух или более чем двух доз форм активного ингредиента с немедленным высвобождением.
19. Композиция в виде множества частиц с модифицированным высвобождением по п. 16, где средний профиль растворения in vitro в водных средах является таким, что примерно от 50 до 100% активного ингредиента, содержащегося в первой совокупности частиц, содержащих активный ингредиент, высвобождаются в течение четырех часов после введения этой композиции, и примерно от 30 до 100% активного ингредиента, содержащегося в дополнительной совокупности частиц, содержащих активный ингредиент, высвобождаются между четырьмя и восемью часами после введения этой композиции.
20. Композиция в виде множества частиц с модифицированным высвобождением по п. 19, где средний профиль растворения in vitro в водных средах является таким, что примерно от 80 до 100% активного ингредиента, содержащегося в первой совокупности частиц, содержащих активный ингредиент, высвобождаются в течение четырех часов после введения этой композиции, и примерно от 60 до 100% активного ингредиента, содержащегося в дополнительной совокупности частиц, содержащих активный ингредиент, высвобождаются между четырьмя и восемью часами после введения этой композиции.
21. Твердая пероральная лекарственная форма, содержащая композицию в виде множества частиц с модифицированным высвобождением по п. 1.
22. Твердая пероральная лекарственная форма по п. 21, содержащая смесь первой и дополнительных совокупностей частиц, содержащих активный ингредиент, которой заполнены твердые желатиновые или мягкие желатиновые капсулы.
23. Твердая пероральная лекарственная форма по п. 21, где первый и дополнительный компоненты по отдельности и независимо спрессованы в мини-таблетки, и ими заполнены твердые или мягкие желатиновые капсулы.
24. Твердая пероральная лекарственная форма по п. 21, где первый компонент спрессован в первый слой многослойной таблетки, и по меньшей мере один дополнительный компонент спрессован в дополнительный слой многослойной таблетки.
25. Твердая пероральная лекарственная форма по п. 21, где первый и дополнительный компоненты включены в быстро растворяющуюся лекарственную форму.
26. Твердая пероральная лекарственная форма по п. 25, где быстро растворяющаяся лекарственная форма представляет собой лекарственную форму в виде быстро плавящейся таблетки.
27. Композиция в виде множества частиц с модифицированным высвобождением по п. 1 для применения в приготовлении лекарства для лечения состояния, которое характеризуется возникновением у пациента толерантности по меньшей мере к одному активному ингредиенту, содержащемуся в этой композиции.
28. Композиция в виде множества частиц с модифицированным высвобождением по п. 1 для применения в приготовлении лекарства для лечения дефицита внимания.
29. Композиция в виде множества частиц с модифицированным высвобождением по п. 13 для применения в приготовлении лекарства для лечения дефицита внимания.
30. Способ лечения состояния, которое характеризуется возникновением у пациента толерантности к активному ингредиенту, вводимому при лечении этого состояния, при котором вводят терапевтически эффективное количество композиции в виде множества частиц с модифицированным высвобождением по п. 1.
31. Способ лечения дефицита внимания, при котором вводят терапевтически эффективное количество композиции в виде множества частиц с модифицированным высвобождением по п. 1.
32. Способ лечения дефицита внимания, при котором вводят терапевтически эффективное количество композиции в виде множества частиц с модифицированным высвобождением по п. 13.
33. Композиция по п. 3, где компонент с модифицированным высвобождением содержит зависимую от рН полимерную оболочку, которая высвобождает импульс активного ингредиента из компонента с модифицированным высвобождением после некоторого периода отсрочки.
34. Композиция по п. 33, где зависимая от рН полимерная оболочка содержит метакрилатные сополимеры.
35. Композиция по п. 33, где зависимая от рН полимерная оболочка содержит смесь метакрилатных и аммониометакрилатных сополимеров в соотношении, достаточном для того, чтобы добиться импульса активного ингредиента из компонента с модифицированным высвобождением после некоторого периода отсрочки.
36. Композиция по п. 35, где соотношение метакрилатных и аммониометакрилатных сополимеров составляет 1: 1.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10672698P | 1998-11-02 | 1998-11-02 | |
US60/106,726 | 1998-11-02 |
Publications (2)
Publication Number | Publication Date |
---|---|
RU2001111887A true RU2001111887A (ru) | 2003-04-20 |
RU2236847C2 RU2236847C2 (ru) | 2004-09-27 |
Family
ID=22312931
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
RU2001111887/15A RU2236847C2 (ru) | 1998-11-02 | 1999-11-01 | Композиции в виде множества частиц с модифицированным высвобождением |
Country Status (31)
Country | Link |
---|---|
US (7) | US6228398B1 (ru) |
EP (3) | EP1126826B3 (ru) |
JP (2) | JP4613275B2 (ru) |
KR (3) | KR20080032661A (ru) |
CN (2) | CN100444830C (ru) |
AR (1) | AR021858A1 (ru) |
AT (1) | ATE411011T3 (ru) |
AU (4) | AU770645B2 (ru) |
BR (1) | BRPI9914977B8 (ru) |
CA (2) | CA2653839A1 (ru) |
CO (1) | CO5261536A1 (ru) |
CY (1) | CY1110421T1 (ru) |
CZ (1) | CZ303495B6 (ru) |
DE (1) | DE69939748D1 (ru) |
DK (1) | DK1126826T6 (ru) |
ES (1) | ES2313797T7 (ru) |
HK (1) | HK1050487A1 (ru) |
HU (1) | HU230454B1 (ru) |
ID (1) | ID29852A (ru) |
IL (4) | IL142896A0 (ru) |
MX (1) | MXPA01004381A (ru) |
MY (1) | MY122159A (ru) |
NO (1) | NO343240B1 (ru) |
NZ (1) | NZ511442A (ru) |
PE (1) | PE20001322A1 (ru) |
PL (1) | PL205109B1 (ru) |
PT (1) | PT1126826E (ru) |
RU (1) | RU2236847C2 (ru) |
SK (1) | SK287674B6 (ru) |
TR (1) | TR200101216T2 (ru) |
WO (1) | WO2000025752A1 (ru) |
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