Pharmaceutical compositions of varenicline and process thereof
AssigneeTenshi Kaizen L Private Limited
InventorsSathurappan BALAJI, Venkat IYER
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Abstract
The present invention discloses a pharmaceutical composition comprising of Varenicline or its pharmaceutically acceptable salts which is substantially free of nitrosamine impurity. More particularly the present invention discloses the pharmaceutical composition of Varenicline or its pharmaceutically acceptable salts and ion-exchange resin. Furthermore, the present invention discloses a stable freeze-dried rapidly disintegrating tablet of Varenicline or its pharmaceutically acceptable salts prepared through lyophilisation process or sublimation techniques.
Claims18
A pharmaceutical composition comprising:
- (i) varenicline or a pharmaceutical acceptable salt thereof;
- (ii) an ion exchange resin;
- and
- (iii) a pharmaceutically acceptable excipient;
- wherein the pharmaceutical composition is substantially free of a nitrosamine impurity.
A stable freeze-dried rapidly disintegrating tablet comprising varenicline or a pharmaceutically acceptable salt thereof and an ion exchange resin substantially free of a nitrosamine impurity.
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Dependencies are inferred from the claim text.