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Last Updated: April 2, 2025

Claims for Patent: 5,958,951

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Summary for Patent: 5,958,951

Title:	Modified form of the R(-)-N-(4,4-di(3-methylthien-2-yl)but-3-enyl)-nipecotic acid hydrochloride
Abstract:	The present invention provides R(-)-N-(4,4-di(3-methylthien-2-yl)but-3-enyl)-nipecotic acid hydrochloride in its pure and stable anhydrous form.
Inventor(s):	Ahrndt; Preben (.O slashed.lstykke, DK), Petersen; Henning B.o slashed.rge (Lyngby, DK), Chang; Vincent H. (Lake Forest, IL), Allen; Kimberly Ann (Silver Lake, WI), Cain; Michael H. (Grayslake, IL)
Assignee:	Novo Nordiskials (Bagsvoerd, DK)
Application Number:	08/872,380
Patent Claims:	1. Anhydrous crystalline R(-)-N-(4,4-di(3-methylthien-2yl)but-3-enyl)nipecotic acid hydrochloride having substantially the following X-ray powder diffraction peaks obtained with KBr: 6.4, 11.3, 13.0, 13.9, 15.0, 18.7, 19.4, 22.5 and 23.7. 2. Anhydrous crystalline R(-)-N-(4,4-di(3-methylthien-2yl)but-3-enyl)nipecotic acid hydrochloride substantially free of bound organic solvent and having substantially the following X-ray powder diffraction peaks obtained with KBr: 6.4, 11.3, 13.0, 13.9, 15.0, 18.7, 19.4, 22.5 and 23.7. 3. A process for the preparation of anhydrous crystalline R(-)-N-(4,4-di(3-methylthien-2yl)but-3-enyl)nipecotic acid hydrochloride having substantially the following X-ray powder diffraction peaks obtained with KBr: 6.4, 11.3, 13.0, 13.9, 15.0, 18.7, 19.4, 22.5 and 23.7 which process comprises a) dissolving tiagabine hydrochloride in an aqueous hydrochloric acid solution, and b) precipitating tiagabine hydrochloride from the aqueous hydrochloric acid solution. 4. A pharmaceutical composition comprising a therapeutically effective amount of a crystalline salt according to claim 1 together with a pharmaceutically acceptable carrier or diluent. 5. The pharmaceutical composition according to claim 4 in the form of a dosage unit containing about 1.0-1500 mg of the active ingredients. 6. A method of inhibiting GABA uptake in a mammal in need of such treatment comprising administering an effective amount of a crystalline salt according to claim 1. 7. A method of inhibiting GABA uptake in a mammal in need of such treatment comprising administering a pharmaceutical composition according to claim 4.

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