(104) Scaling Rules for Designing Intra-vaginal Rings and PK Studies in Animals vs. Humans
Introduction: Intravaginal rings (IVRs) are an important vaginal mucosal dosage form. They are commonly evaluated in PK studies in sheep, macaques and humans. IVR designs and PK data/interpretations should be rationally linked across species. Allometric scaling is limited in incorporating many species-specific determinants of mucosal delivery, and thus in determining IVR loading. We present deterministic IVR PK modeling, and create trans-species scaling rules for IVRs delivering mucosally-acting antiretroviral drugs (ARV). We contrast IVR loading and mucosal PK in the 3 species for the ARV Islatravir (ISL).
Learning Objectives:
Understand the importance of mass-transport theory in modeling PK for topical mucosal drug delivery.
Understand deterministic scaling rules-driven design of IVRs for PK studies in different species.
