.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for Patent: 7,598,420

« Back to Dashboard

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##
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc