PURPOSE

This chapter provides guidance for the development, scale up, and some post approval changes of tablets labeled as having a functional score. Specifically, this chapter provides quality attributes for tablet products labeled as functionally scored that can be split into multiple split portions to have an accurate fractional dose. The split portions should be a fractional part of the dose of the intact tablet based on the number of scores and the number of the split portion (e.g., one-half, one-quarter). At the time of splitting, the intact tablets should conform to the product specification. After splitting, with the exception of dose, each split portion from tablets with functional scoring is expected to conform to the quality attributes of the whole tablets. The split portions from tablets having a functional score are to conform to the product specification and the quality attributes of the whole tablets with equivalent strength. The split portions from a functionally scored tablet should conform to the tests described in this chapter.