Analytical and formulation attributes in developing generic sterile injectable liquid and lyophilized drugs (part 2)

摘要

Analytical development is a principal element with formulation development in the successful development and launch of a generic drug product. New generic filings must meet current industry standard and guidelines, however the branded drug company is often not required to update methods that were developed-and filed under out-dated requirements and prior to the recent advancements in separation sciences and regulatory guidelines. Part 1 of this article (13) discussed several aspects of the generic sterile injectable development processes including deformulation, API selection, container closure, filter validation and product compatibility studies. In the second part of this article, scale up considerations, lyophilization development is discussed along with the analytical development. Relevant USP/ICH guidelines with respect to the generic development are also highlighted.