Simulations Plus and University of Connecticut secure FDA grant to advance long-acting injectable drug modeling
Simulations Plus, a biosimulation solutions provider for the biopharma industry, has been awarded a new FDA grant to research long-acting injectable (LAI) drug formulations.
In collaboration with the University of Connecticut’s School of Pharmacy, Simulations Plus will use its GastroPlus physiologically based pharmacokinetic (PBPK) platform to create and validate in vitro-in vivo correlations (IVIVCs) for LAI technologies.
PBPK modeling simulates how drugs move through the body, considering processes such as absorption (entry into the bloodstream), distribution (spread to tissues), metabolism (breakdown by the body), and excretion (elimination from the body).
The modeling approach allows researchers to predict how LAI formulations will release and absorb in the body, aiming to streamline the regulatory process for both brand-name and generic drugs.
The study will explore how critical quality attributes (CQAs) of LAI formulations interact with physiological factors at injection sites to predict drug release and absorption in the body.
Professor Diane Burgess from the University of Connecticut, who is leading data collection, will generate in vitro and in vivo data on current LAI suspension products. Simulations Plus will use this data to develop PBPK models and validate IVIVCs. The findings are intended to support bioequivalence testing for LAI products.
Dr. Daniela Silva Ryan, Scientist II at Simulations Plus and principal investigator for the grant, stated:
“LAI formulations are becoming increasingly important in pharmaceutical pipelines and product portfolios due to their ability to improve patient compliance and deliver extended drug release.
“Preclinical and clinical studies to evaluate new formulation designs are lengthy and expensive. With this new grant, we expect our work within GastroPlus to demonstrate how PBPK modeling can reduce development time and costs, while streamlining regulatory processes for both innovator and generic formulations.”
The FDA’s scientific and program staff will collaborate with Simulations Plus, the University of Connecticut, and industry partners on this initiative. Dr. Silva Ryan and other scientists at Simulations Plus will lead the modeling and simulation tasks for the project.
Dr. Burgess, commented on the partnership:
“It is a privilege to continue combining our expertise with Simulations Plus and the FDA to advance the research on LAI formulation performance even further.
“The agency’s trust and confidence in this partnership underscores the leadership role both organizations have in our respective spaces. Together, we aim to develop models that bridge the gap between animal and human data and reveal the intricate relationships between formulation properties and injection site physiology, providing insight into virtual BE approaches for this growing drug delivery technology.”
