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Claims for Patent: 7,572,834

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Claims for Patent: 7,572,834

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): Sterling; Jeffrey (Jerusalem, IL), Lerner; David (Jerusalem, IL), Rosen; Harel (Ra'anana, IL), Bronov; Leonid (Netanya, IL), Medini-Green; Dalia (Pardes Hanna, IL), Iosefzon; Berta (Jerusalem, IL), Berger-Peskin; Tirtsah (Ra'anana, IL), Lidor-Hadas; Ramy (Kfar Saba, IL), Bahar; Eliezer (Tel Aviv, IL)
Assignee: Teva Pharmaceutical Industries, Ltd. (Petach-Tikva, IL)
Application Number:11/634,916
Patent Claims: 1. 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: ##STR00033## and any salts of the compound, wherein the compound is formed by chlorination of N-propargyl-1(R)-aminoindan in N-propargyl-1(R)-aminoindan mesylate.

2. The pharmaceutical composition of claim 1, comprising greater than 2 ppm in total of the compound and salts of the compound.

3. The pharmaceutical composition of claim 1, comprising greater than 4 ppm in total of the compound and salts of the compound.

4. The pharmaceutical composition of claim 1, comprising greater than 7 ppm of the compound and salts of the compound.

5. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable carrier does not include magnesium stearate.

6. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable carrier is mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid or talc.

7. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable carrier is mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid, and talc.

8. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition does not include maltodextrin, croscarmellose sodium, citric acid, lactose, glyceryl behenate, and hydrogenated vegetable oil type I.

9. The pharmaceutical composition of claim 1, comprising less than 20 ppm in total of the compound and salts of the compound.

10. The pharmaceutical composition of any one of claims 2-4 or 9, wherein the pharmaceutically acceptable carrier is mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid or talc.

11. The pharmaceutical composition of any one of claims 2-4 or 9, comprising mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid and talc.

12. The pharmaceutical composition of any one of claims 2-4 or 9, wherein the pharmaceutical composition does not include maltodextrin, croscarmellose sodium, citric acid, lactose, glyceryl behenate, and hydrogenated vegetable oil type I.
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