| 초록 |
Solid forms of a crystalline drug such as polymorph and saltcan influence key product attributes including stability, bioavailability, and manufacturability. With costly product recalls resulting from the late discovery of a thermodynamic form and clinical failures due to non-bioequivalence, the importance of identifying a thermodynamically stable crystalline form for new drug candidates early in the development process is well recognized within the pharmaceutical industry. Onemethodisto implement a solid form selection strategy based on BCS classification. Moreover, for poorly solublecompounds, polymorph screening is necessary to select the thermodynamically stable polymorph prior to animal studies because the solubility differences betweenthe formsof these insoluble compounds oftenresults in differences in bioavailability. |
