Formulation complexity, especially in small molecule drugs, has been getting more attention as research and technological capabilities continue to improve.

Yet even as these formulations hold potential for more targeted delivery, challenges remain in solubility and scale-up.

For this Pharma Matters Q&A, Asma Patel, Vice President, Global Commercial and Scientific Consulting—Drug Product at Quotient Sciences, takes the journey from development to the commercial stage. Patel also stops along the way to address the biggest challenges in the process. Finally, she provides a roadmap for keeping robust speed to clinic while focusing on efficiency and reducing risk.

Contract Pharma: Complex small molecule formulations are gaining momentum right now. However, these present challenges in factors like solubility, bioavailability, and ultimately, delivery. In solving these and other issues, what have you seen that is working? What’s been less successful?

Asma Patel: Addressing solubility and bioavailability challenges in complex small molecules is most effective when formulation design is tightly coupled to in vivo performance, rather than relying on in vitro prediction models alone. Integrated approaches such as…