Manufacturing & Analytical Characterization
Diane Burgess, Ph.D. (she/her/hers)
Distinguished Professor
University of Connecticut
Storrs, Connecticut
Thilak Mudalige, Ph.D. (he/him/his)
Research Chemist
US Food and Drug Administration
Jefferson, Arkansas
This presentation will discuss "suspension" and "for suspension" long acting injectables (LAIs). The development of suitable in vitro release testing methods to achieve in vitro-in vivo correlation (IVIVC) of these long acting dosage forms will be described along with the IVIVCs developed. In vitro release testing methods utilizing USP apparatus 2 and USP apparatus 4 will be described as well as suitable adapters for use with the USP apparatus. The presentation will focus on the RLD Depo SubQ Provers 104 and compositionally equivalent medroxyprogesterone acetate LAIs.