The sole constant in the GI environment is the dynamic variability of its conditions. This seemingly paradoxical observation carries significant implications for oral dosage forms at the stage of development, testing, and therapeutic use. An advanced understanding of GIT physiology is, therefore, essential for the prediction of the fate of a drug in clinical trials and even more challenging in real-life conditions. Soon after intake, a dosage form encounters dynamic and variable gastric conditions, constituted by a number of physicochemical and biological parameters of the gastric
fluid such as:
Main product used in this task/job
Another huge source of gastro intestinal variability is motility which differs significantly under fasted and fed intake conditions. This activity of the GIT generates
contractions, with magnitudes ranging from 20 to 500 mbar – the value equivalent up
to 0.5 kg placed on 1 cm2 . Such contractions can disrupt or crush oral medicines,
impacting their disintegration and dissolution, and resulting in variable systemic drug
exposure.
Limitations of Conventional Dissolution Testing
Interestingly, to date the physiological conditions can not be realistically simulated
using commonly used dissolution testers. To fill this gap Physiolution developed
proprietary testing platforms – analytical instruments and computational workflows –
that provide a high-resolution simulation of the mechanic-physicochemical
environment during gastrointestinal transit.
Our innovative test devices allow for:
Our methodologies and specialized test devices have been rigorously validated against a broad spectrum of clinical datasets and are currently utilized in the routine characterization of innovative and generic oral medicinal products..
We provide a physiologically oriented device that enables biorelevant simulation of intestinal pH gradients without altering the volume or ionic strength of the simulated intestinal media. Its operation is based on gaseous pH adjustment of hydrogen carbonate—the most biologically relevant buffering system in the human gut.
Simulating GI factors such as pH and enzymatic activity allows us to assess molecular suitability for oral delivery and support physiology-driven formulation development.
We are a multidisciplinary team of scientists and engineers pioneering the development of biopredictive dissolution testers and PK/PD tools. By integrating laboratory expertise with advanced engineering and analytics, we bring predictability to the most complex challenges in oral drug development.
We gratefully acknowledge the support of:
