Found 192 results in Expert Content

Abstract: Micronization is a proven approach for improving the bioavailability and performance of poorly soluble drug compounds, but its impact extends far beyond particle size reduction alone.

Abstract: Particle size plays a critical role in the performance of poorly soluble, highly potent, and inhaled drug products.

Abstract: Modern drug development is being tested on two fronts: molecules are increasingly difficult to formulate, and global manufacturing routes are increasingly difficult to rely on.

Poorly soluble oral small molecules often face compounded development risks, including food effects, high dose requirements, variability in exposure, and the need for rapid onset.

Summary: Early clinical trials are becoming more complex as sponsors face rising regulatory requirements and the challenges of developing advanced drug candidates.

Early-phase trials are often delayed by rigid manufacturing models, fixed-dose formats, and limited API availability.

Formulating Beyond Rule of Five (bRo5) molecules presents significant bioavailability and development challenges, especially for small or emerging pharma with limited API and constrained budgets.

Developers of innovative drug products dealing with protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant challenges in achieving efficient and scalable manufacturing solutions.

Summary: This article provides an in-depth review of milling equipment, including jet, pin, hammer, conical, and cryogenic mills.

In this webinar, participants will learn about a comprehensive strategy to streamline development and derisk clinical studies. Experts will focus on the importance of physiologically based pharmacokinetic (PBPK) modeling, formulation, and technology expertise while sparing API and managing funding and timeline challenges.