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Last Updated: April 29, 2024

Claims for Patent: 5,866,590

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Summary 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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