Overcoming Complex Formulation Challenges: Integrated Strategies For Poor Solubility, Modified Release & Pediatrics

Drug development for any molecule type is challenging, however complex molecules requiring solubility enhancement or specialized formulation expertise like modified release or pediatrics, have even greater challenges achieving clinical and commercial success. These types of molecules require a development program that advances these challenging molecules rapidly to the next milestone while keeping an eye on downstream process development and commercialization.

With the ultimate goal being to get treatments to patients faster, drug developers can leverage an integrated approach to rapidly screen formulation technologies and dosage forms in as early as the preclinical stage. Using biorelevant in-vitro screening tools and physiologically based in-silico models they can flag developability problems that could impact the downstream success of the program. This approach is essential before quickly transitioning drug candidates into first-in-human (FIH) clinical studies to understand a molecule’s full potential. There are also many benefits of employing an integrated approach when expediting complex molecules from FIH into proof-of-concept (POC) trials. The seamless integration of formulation development, drug product manufacturing and clinical testing capabilities enables real-time clinical data to help guide dosage form design, ensuring better decision making; and supporting a more streamlined approach to outsourcing.

Using case studies on modified release, poor solubility, and pediatrics, John McDermott, Executive Drug Development Consultant, Quotient Sciences, demonstrates how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.

Watch this webinar to understand how an integrated program design can simplify drug development processes for complex molecules, reduce overall costs, and improve the likelihood of clinical & commercial success.

Viewers will learn:

• How it is possible to screen and evaluate multiple formulation technologies for poorly soluble molecules in a single clinical protocol
• The use of design space concepts in evaluating and optimizing formulation modified release performance in “real-time” using clinical data
• Product considerations when designing acceptable, palatable pediatric products including formulation, clinical assessment and manufacturing