Speaker:
Dr. Viera Lukacova, Chief Scientist at Simulations Plus, Inc.; Email: [email protected]
Date:
November 19th, 2020 at 1 pm EST
Abstract:
The motivation for developing LAI microsphere formulations is to provide a means to release drug over a long period of time (weeks to months) to improve patient comfort and compliance while maintaining therapeutic efficacy and avoiding adverse effects due to fluctuations in drug concentrations. Unfortunately, developing LAI formulations is complicated by the lack of standardized in vitro dissolution/release experiments, the long release times involved, and the large variabilities observed with in vivo dosing tissue environments among patient populations. Thus, more predictive preclinical methods are needed to assess the sensitivities of critical quality attributes and their impact on the performance of LAI products. These include not only in vitro dissolution/release experiments but also mechanistic models to simulate such in vitro experiments and physiologically based pharmacokinetic (PBPK) models that facilitate translation of in vitro data into in vivo performance of these formulations.
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 on either a polymer or a 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, immune response) will be discussed and demonstrated through simulations.
How to join: http://alturl.com/iiwn6 (Zoom Meeting ID: 995 5620 8616; Passcode: 628176)