OSD Early Stage: Getting Oral Products Into Clinic Early

Accelerating the development of oral solid dose (OSD) products into the clinic is a critical challenge for biotech companies, where time is the ultimate currency. With drugs typically taking 12 to 15 years to move from discovery to market, and 90% failing before Phase 1, the early stage is paramount for success.

The journey to the first-in-human (FIH) trial is complicated by the fact that many new chemical entities are poorly soluble, unstable, or available only in limited supply. Poor solubility and limited permeability, often seen in Biopharmaceutics Classification System (BCS) Class II and IV compounds, can lead to unpredictable drug absorption. Strategic formulation choices, like selecting capsules over tablets and using powder-in-capsule (PIC) methods, can dramatically speed up timelines by simplifying manufacturing.

Prioritizing simplicity and leveraging enabling technologies are key to navigating technical complexities and ensuring compliance. Discover how careful selection of phase-appropriate strategies and early solubility screening can get your promising molecule into the clinic faster.