09.23.22 -- De-Risk Early-Phase Oral Small Molecule Drug Development

This e-book discusses how to expedite the development pathway for early-phase compounds and how lipid-based formulations provide an innovative approach to enhance bioavailability for challenging molecules. It also presents how the lipid-based delivery provides a tool for highly potent, poorly soluble, and unstable APIs.

In designing products with the patient in mind by utilizing superior formulation and drug delivery technologies in the early phases of development, pharmaceutical companies can minimize the many risks they encounter on the path to clinic and to market.

Oral dosage forms have remained a cornerstone of drug development, despite the proliferation of alternative dosage forms to address unmet medical needs. To better understand the landscape today, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.

Many issues related to the performance characteristics of an API can be resolved by thoroughly examining various aspects of the molecule before making decisions about solubility enhancement and the delivery method. A team of experts discusses risk-reduction strategies, critical formulation considerations, and careful technology selection.