摘要 |
A stable pharmaceutical composition comprises desloratadine or a pharmaceutically acceptable salt, solvate, derivative, polymorph, hydrate or enantiomer thereof, and a carrier comprising at least one polyol. Preferred compositions comprise, in addition to desloratadine, from 50 to 80% polyol, from 5 to 15% disintegrating agent, and from 0.01 to 0.5% antioxidant and/or a chelating agent, all by weight of the composition. There is also provided the use of a polyol to stabilise a pharmaceutical composition comprising desloratadine. A process for making a stable pharmaceutical composition comprising desloratadine and one or more polyols, optionally together with other pharmaceutically acceptable excipients comprises blending the ingredients and formulating them so as to form said composition. |
申请人 |
CIPLA LIMITED;TURNER, CRAIG, ROBERT;LULLA, AMAR;MALHOTRA, GEENA;ANAND, SANKARNARAYANAN |
发明人 |
LULLA, AMAR;MALHOTRA, GEENA;ANAND, SANKARNARAYANAN |