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Claims for Patent: 5,866,590

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Claims for Patent: 5,866,590

Title: Pharmaceutical composition containing tiagabine hydrochloride and the process for its preparation
Abstract:The present invention provides a new stable pharmaceutical composition containing tiagabine hydrochloride as active ingredient.
Inventor(s): Svensson; J.o slashed.rgen Ryhl (Frederikssund, DK), Nygaard; Lars (Valby, DK), Andersen; Tina Meinertz (Hoersholm, DK), Weibel; Helle (Hilleroed, DK), Hjorth; Thyge Borup (Farum, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:08/945,585
Patent Claims: 1. A pharmaceutical composition comprising

(a) tiagabine or a pharmaceuticaly acceptable salt thereof,

(b) ascorbic acid in an amount sufficient to stabilize tiagabine or its pharmaceutically acceptable salt and

(c) a pharmaceutically acceptable carrier.

2. The composition according to claim 1, wherein the antioxidant is in the form of a powder.

3. The composition according to claim 1, wherein the amount of ascorbic acid is from 5-25 parts by weight per 100 parts of tiagabine hydrochloride.

4. A process for the preparation of the composition according to claim 1, which comprises forming a mixture of:

(a) tiagabine or a pharmaceutically acceptable salt thereof,

(b) ascorbic acid and

(c) a pharmaceutically acceptable carrier.

5. The process according to claim 4 which further comprises carrying out a melt granulation of the mixture of tiagabine or a pharmaceutically acceptable salt thereof, ascorbic acid and a pharmaceutically acceptable carrier.

6. The process according to claim 4, wherein said process is carried out at low water vapor pressure and low oxygen pressure.

7. A pharmaceutical composition comprising

(a) tiagabine or a pharmaceuticaly acceptable salt thereof,

(b) a mixture of alpha-tocopherol and ascorbyl palmitate in an amount sufficient to stabilize tiagabine or its pharmaceutically acceptable salt and

(c) a pharmaceutically acceptable carrier.

8. The composition according to claim 7, wherein the antioxidant is in the form of a powder.

9. The composition according to claim 7, wherein the amount of alpha-tocopherol and ascorbyl palmitate is from 5-25 parts by weight per 100 parts of tiagabine hydrochloride.

10. A process for the preparation of the composition according to claim 7, which comprises forming a mixture of:

(a) tiagabine or a pharmaceutically acceptable salt thereof,

(b) alpha-tocopherol and ascorbyl palmitate and

(c) a pharmaceutically acceptable carrier.

11. The process according to claim 10, which further comprises carrying out a melt granulation of the mixture of tiagabine or a pharmaceutically acceptable salt thereof, alpha-tocopherol and ascorbyl palmitate and a pharmaceutically acceptable carrier.

12. The process according to claim 10, wherein said process is carried out at low water vapor pressure and low oxygen pressure.
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