Chief Scientist Simulations Plus, Inc. Lancaster, California
We will discuss the use of mechanistic in vitro and in vivo modeling of LAIs. The mechanistic in vitro model will be used to evaluate the effect of formulation parameters on the in vitro drug release from polymeric (PLGA) microspheres. The PBPK modeling approach will be used to evaluate the in vivo behavior of LAI products relying low solubility of the drug to limit the dissolution rate after injection in vivo. The possible influences of drug- and formulation-dependent parameters (solubility, particle size, diffusion rate) and physiological response (inflammation) will be discussed and demonstrated through simulations.
Learning Objectives:
Identify processes that impact the drug release from PLGA particles
Identify processes that impact the in vivo drug dissolution from long acting injectable crystalline suspensions
Define areas for further development to increase the predictability of PBPK models
