Details for Patent: 7,598,420

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)
Filing Date:	Sep 08, 2008
Application Number:	12/283,105
Claims:	1. A process for producing validated batch of a pharmaceutical product containing N-propargyl-1(R)-aminoindan mesylate and at least one pharmaceutically acceptable carrier for distribution comprising a) producing a batch of the pharmaceutical product; b) performing stability testing with a sample of the batch; c) determining the total amount of N-2-propene-1-yl-2-chloro-(R)-aminoindan and any salts thereof in the sample of the batch after stability testing; and d) validating the batch for distribution only if the sample of the batch after stability testing contains less than 30 ppm in total of N-2-propene-1-yl-2-chloro-(R)-aminoindan and salts thereof. 2. The process of claim 1, wherein the batch is validated if the sample of the batch after stability testing contains a total amount greater than 0.7 ppm of N-2-propene-1-yl-2-chloro-(R)-aminoindan and salts thereof, as determined by a LC/MS:MS Method. 3. The process of claim 2, wherein the batch is validated if the sample of the batch after stability testing contains a total amount greater than 2 ppm of N-2-propene-1-yl-2-chloro-(R)-aminoindan and salts thereof, as determined by a LC/MS:MS Method. 4. The process of claim 3, wherein the batch is validated if the sample of the batch after stability testing contains a total amount greater than 4 ppm of N-2-propene-1-yl-2-chloro-(R)-aminoindan and salts thereof, as determined by a LC/MS:MS Method. 5. The process of claim 1, wherein the batch is validated only if the sample of the batch after stability testing contains a total amount less than 4 ppm of N-2-propene-1-yl-2-chloro-(R)-aminoindan and salts thereof, as determined by a LC/MS:MS Method. 6. The process of claim 5, wherein the batch is validated only if the sample of the batch after stability testing contains a total amount less than 2 ppm of N-2-propene-1-yl-2-chloro-(R)-aminoindan and salts thereof, as determined by a LC/MS:MS Method. 7. The process of claim 6, wherein the batch is validated only if the sample of the batch after stability testing contains a total amount less than 0.7 ppm of N-2-propene-1-yl-2-chloro-(R)-aminoindan and salts thereof, as determined by a LC/MS:MS Method. 8. The process of claim 1, wherein in step c), the amount is determined using a measurement of mass, ultraviolet absorption, refractive index, ionization or voltammogram. 9. A process for producing a pharmaceutical product containing N-propargyl-1(R)-aminoindan mesylate and at least one pharmaceutically acceptable carrier, which pharmaceutical product does not contain an undesirable chlorinated N-allyl aminoindan comprising a) producing a batch of the pharmaceutical product; b) analyzing a sample of the batch to detect whether the sample contains a compound having the structure: ##STR00033## wherein one of R.sub.1, R.sub.2 or R.sub.3 is Cl and the remainder are H, or a salt thereof, using a LC/MS:MS Method; and c) producing the pharmaceutical product from the batch only if the sample does not contain the undesirable chlorinated N-allyl aminoindan. 10. The process of claim 9, wherein the compound has the structure: ##STR00034## 11. The process of claim 9, wherein the compound has the structure: ##STR00035## 12. The process of claim 9, wherein the compound has the structure: ##STR00036## 13. The process of claim 9, wherein the compound has the structure: ##STR00037## 14. The process of claim 9, wherein the compound has the structure: ##STR00038## 15. The process of claim 9, wherein the compound has the structure: ##STR00039## 16. The process of claim 9, wherein the compound has the structure: ##STR00040## 17. The process of claim 9, wherein the compound has the structure: ##STR00041## 18. The process of claim 9, wherein the compound has the structure: ##STR00042## 19. The process of claim 9, wherein the compound has the structure: ##STR00043## 20. The process of claim 9, wherein the compound has the structure: ##STR00044##