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Details for Patent: 7,619,117

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Details for Patent: 7,619,117

Title:Rasagiline formulations and processes for their preparation
Abstract: The subject invention provides a pharmaceutical composition comprising N-propargyl-1(R)-aminoindan mesylate; a pharmaceutically acceptable carrier; and greater than 0.7 ppm but less than 30 ppm in total of a compound having the structure: ##STR00001## and any salts of the compound.
Inventor(s): Lidor-Hadas; Ramy (Kfar Saba, IL), Bahar; Eliezer (Tel Aviv, IL)
Assignee: Teva Pharmaceutical Industries, Ltd. (Petach-Tikva, IL)
Filing Date:Sep 08, 2008
Application Number:12/283,022
Claims:1. A process of manufacturing N-2-propene-1-yl-2-chloro-aminoindan, N-2-propene-1-yl-3-chloro-cis-aminoindan, or an enantiomer or a salt of any one thereof, comprising reacting N-propargyl-1-aminoindan with hydrochloric acid in the presence of a solvent so as to produce N-2-propene-1-yl-2-chloro-aminoindan, N-2-propene-1-yl-3-chloro-cis-aminoindan, or an enantiomer or a salt of any one thereof.

2. The process of claim 1, wherein the solvent is a mixture of toluene and water.

3. A process of manufacturing (1,2,3) .sup.13C--N-2-propene-1-yl-2-chloro-aminoindan or an enantiomer or a salt thereof, comprising: a) heating a mixture of (1,2,3) .sup.13C-aminoindan and a base in a first solvent, b) adding 2,3-dichloro-1-propene to produce (1,2,3) .sup.13C--N-propargyl-1-aminoindan, c) reacting the (1,2,3) .sup.13C--N-propargyl-1-aminoindan of step b) with HCl in the presence of a second solvent to produce the compound.

4. The process of claim 3, wherein the base is K.sub.2CO.sub.3.

5. The process of claim 3, wherein the first solvent is acetonitrile.

6. The process of claim 3, wherein the second solvent is ether.

7. The process of any of claims 1-6, further comprising recovering the compound so produced.

8. The process of claim 1, wherein the product manufactured is N-2-propene-1-yl-2-chloro-aminoindan, or an enantiomer or a salt thereof.

9. The process of claim 1, wherein the product manufactured is N-2-propene-1-yl-3-chloro-cis-aminoindan, or an enantiomer or a salt thereof.

10. A process of manufacturing (1,2,3) .sup.13C--N-2-propene-1-yl-2-chloro-aminoindan, or an enantiomer or a salt thereof, comprising reacting (1,2,3) .sup.13C--N-propargyl-1-aminoindan with hydrochloric acid in the presence of a solvent so as to produce (1,2,3) .sup.13C--N-2-propene-1-yl-2-chloro-aminoindan, or an enantiomer or a salt thereof.

11. The process of claim 10, wherein the solvent is a mixture of toluene and water.
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