Identifying absorption risks in early development
Early identification of potential absorption risks, such as poor solubility, dissolution, and/or permeability, is critical for rapid and efficient drug development. Upfront knowledge of absorption risks can trigger early assessment of solid form and formulation strategies designed to achieve target bioperformance. Our dedicated PBPK modeling experts work with your compound to:
- Identify absorption risks such as solubility, dissolution rate, and permeability
- Forecast fraction absorbed in preclinical and clinical species over a range of doses
- Predict the likelihood of food-drug or pH-dependent drug-drug interactions
Achieve target oral bioperformance and reduce potential for reformulation
Once an absorption risk is discovered, solid forms and formulation strategies can be identified early to mitigate these risks, avoiding unexpected reformulation. For example, salts, cocrystals, micronization, or amorphous solid dispersions are potential strategies for enhancing solubility and dissolution rate.
- Determine if bioavailability enhancement strategies are projected to mitigate poor oral absorption, food-drug, or pH-dependent drug-drug interactions
- Forecast fraction absorbed in preclinical and clinical species over a range of doses for different solid forms and formulations, such as crystalline free forms, salts, cocrystals, amorphous solid dispersions, and micronized drug
Achieve target outcomes and reduce need for repeated studies
Designing preclinical and clinical studies with respect to species, dose, prandial state, and gastric pH modification is important for maximizing the likelihood of achieving desired pharmacokinetic profiles and avoiding repeated studies.
- Design and optimize preclinical and clinical studies with respect to dose, prandial state, or gastric pH modification to maximize the likelihood of achieving desired pharmacokinetic profiles
- Forecast oral fraction absorbed in preclinical or clinical species over a range of doses for target drug product formulation(s)
Meet Josh Marsh
Bioavailability Enhancement and PBPK Lead Scientist
Bend, Oregon, USA
In this video, Josh highlights a growing trend in the early phase space where poorly soluble molecules are becoming more prevalent, posing a challenge to the current solubility enhancement technologies in the industry. The use of PBPK modeling to understand absorption risks can lead to the development of better formulation strategies, resulting in cost and time savings for our clients.