Rasagiline formulations and processes for their preparation
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsJeffrey Sterling, David Lerner, Harel Rosen, Leonid Bronov, Dalia Medini-Green, Berta Iosefzon, Tirtsah Berger-Peskin, Ramy Lidor-Hadas, Eliezer Bahar
Life of this patent
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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: and any salts of the compound.
Claims20
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.
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:
- wherein one of R1, R2 or R3 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.
Dependencies are inferred from the claim text.