Patent ID: 11872234
Assignee: PAR PHARMACEUTICAL, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A  C | IPC A  C

Claim 24:
25. A pharmaceutical composition in the form of a tablet, comprising about 0.85 mg to about 1.7 mg of varenicline tartrate, wherein the varenicline tartrate is dispersed in a maltodextrin matrix, wherein the maltodextrin matrix comprises less than (w/w) of N methyl varenicline impurity as measured by RS-Method III, less than 0.15% (w/w) of varenicline-N glucoside impurity as measured by RS-Method III, and the tablet comprises less than 50 ppm of N-nitroso-varenicline impurity as measured by LC-ESI-HRMS Method.