Developing PBPK-model based mechanistic IVIVC for PLGA implants

NIH RePORTER · FDA · U01 · $299,364 · view on reporter.nih.gov ↗

Abstract

There is an immediate need to understand the critical formulation parameters that may affect product performance in vitro and in vivo, with a goal of developing IVIVCs for long-acting injectables. In this proposal, we will develop IVIVCs for a long-acting PLGA-based solid implant using a physiologically based pharmacokinetic (PBPK) modeling approach. PBPK modeling “provides a unique opportunity to understand how the physicochemical properties of drug molecules/polymer, implant specific properties, critical formulation attributes, and physiology, among other things, influence the in vivo release mechanisms of LAI drug products and their disposition characteristics. Successful execution of the project will entail (1) developing a bio-predictive in-vitro release testing method and determining how critical formulation and physicochemical properties impact the in-vitro release of PLGA-based buprenorphine implants; and (2) using a bottom-up PBPK approach to build IVIVCs that predict in-vivo PK profiles of PLGA-based buprenorphine implants from in-vitro data.

Key facts

NIH application ID
11063705
Project number
1U01FD008303-01
Recipient
UNIVERSITY OF TEXAS AT AUSTIN
Principal Investigator
MING HU
Activity code
U01
Funding institute
FDA
Fiscal year
2024
Award amount
$299,364
Award type
1
Project period
2024-09-01 → 2027-08-31