Dissolution test for oral suspension: an overview about use and importance

This work aims to ascertain the comprehensiveness of dissolution tests for oral suspensions registered in Brazil and USA. After consulting literature since 1994, a paucity information about methods was detected. It makes it difficult establish most appropriate test parameters. In January, 2019, there were 46 drugs Anvisa (Brazil) as suspension, being 47 reference, 173 generic 114 interchangeable similar (IS) medicines; while USA, 90 suspension by FDA, 235 Abreviatted New Drug Application 111 medicines. Out 90, only six 15 had pharmacopeial test, corresponding 70 (20.9%) 82 (23.7%) products respectively. Dissolution studies found 17 non-compendial literature. conditions established few marketable drugs, which are BCS class II or IV. Thus, investing could subsidize registration these regulators, especially IS comparing profiles, predicting their vivo behavior avoid exposure healthy individuals clinical research.