Formulation & Delivery US 2024

Presentation title: 

First in Human (FIH) Tablet Development for an Amorphous Unstable Prodrug with Enteric Coating Using an API Sparing Approach

Abstract: This presentation will explore the formulation and development process of First-In-Human (FIH) enteric-coated tablets at three dose strengths for an amorphous prodrug highly susceptible to hydrolysis under both acidic and basic conditions. We will delve into the scientific approaches employed to mitigate degradation pathways, ensure product stability through carefully selected excipients and optimized manufacturing techniques, and how material science-based approaches can lead to successful FIH product development within tight timelines.