Related Experiment Video
Updated: May 18, 2026

Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
Published on: August 28, 2015
Predicting feasibility and characterizing performance of extended-release formulations using physiologically based
Jonathan Brown1, John Crison, Peter Timmins
1Drug Product Science & Technology, Bristol-Myers Squibb, Reeds Lane, Moreton, Merseyside CH46 IQW, UK.
Physiologically based pharmacokinetic modeling aids extended-release (ER) formulation development by optimizing drug release rates for improved clinical performance. This in silico approach is increasingly vital for efficient drug product design and quality by design.
Area of Science:
- Pharmacokinetics and Drug Delivery
- Computational Modeling in Pharmaceutical Development
Background:
- Extended-release (ER) formulations aim to optimize drug delivery and clinical performance.
- Physiologically based pharmacokinetic (PBPK) modeling offers a powerful in silico tool for drug development.
Purpose of the Study:
- To review nine case studies demonstrating the application of PBPK modeling in ER formulation design.
- To highlight how PBPK models address unique compound-specific challenges in optimizing drug release.
Main Methods:
- Case study review of PBPK model applications in ER formulation development.
- Analysis of PBPK model use in understanding absorption, drug concentration, and pharmacokinetic predictions.
- Integration of PBPK models with pharmacodynamic models for clinical efficacy prediction.
Main Results:
- PBPK modeling successfully addressed diverse challenges, including colonic absorption, BCS class 3 and 4 compounds, prodrugs, and interspecies scaling.
- Optimized drug release rates were achieved, leading to enhanced clinical performance.
- PBPK models coupled with PD models accurately predicted clinical efficacy based on simulated plasma concentrations.
Conclusions:
- PBPK modeling is a valuable component of Quality by Design (QbD) for ER formulation development.
- The use of these in silico tools is becoming standard practice, moving from exception to necessity.
- Increased availability of PBPK examples in literature will further drive its adoption in pharmaceutical development.
More Related Videos
08:59An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
13:54A Workflow for Lipid Nanoparticle (LNP) Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models (SVEM)
Published on: August 18, 2023
Related Concept Videos
Pharmacokinetic Models: Comparison and Selection Criterion
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Pharmacokinetic Models: Overview
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal assumptions,...
Pharmacokinetic–Pharmacodynamic Relationship: Model Components
Model Approaches for Pharmacokinetic Data: Distributed Parameter Models
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
Physiological Pharmacokinetic Models: Incorporating Hepatic Transporter-Mediated Clearance
A recent model describes pravastatin's hepatobiliary excretion, mediated...