Predict the Unpredictable - Physiology Driven Testing of Oral Dosages

The only constant in the gastrointestinal (GI) tract is its inherent physiological variability. While this may seem paradoxical, it presents a profound and ongoing challenge in the development and assessment of oral drug products. In this presentation, I will explore how we simulate the key physiological parameters that influence the dissolution of oral medicines—namely, GI peristaltic activity, pH fluctuations, and temperature gradients.

I will discuss the typical ranges of variability for these parameters and introduce our simulation strategies, which are based on purpose-built, abstract models. These include:

pHysio-grad®, a dynamic pH control system that reproduces high-resolution pH gradients using both liquid and gas-phase titration;

AMP®, a versatile device platform that simulates the mechanical and physicochemical conditions within the GI tract;

PhysioCell®, a flow-through system tailored for evaluating immediate-release (IR) formulations, capable of mimicking pH transitions, fluid flow, and mechanical stress during GI transit.

These advanced biopredictive tools enable a physiology-based approach to drug characterization, supporting formulation development, clinical trial readiness, and the assessment of post-approval changes. Importantly, they are specifically designed to generate high-quality data sets suitable for absorption modeling and pharmacokinetic (PK) simulations, thus helping to bridge the gap between the vitro and in vivo drug delivery performance.