Newsletter | June 10, 2020

06.10.20 -- Drug Product Optimization - From Formulation To Manufacturing

Characterize Drug Substance Properties Early To Optimize Drug Formulation

Drug substance characterization is critical to drug product formulation, but characterization and formulation are often not integrated during drug development. This creates needless difficulties, because if drug substance (DS) chemists and drug product (DP) formulators collaborate on a formulation development strategy for early Phase I first-in-human clinical studies, they can save time, money, and avoid rework.

Ensuring The Greatest Return From Your Poorly Soluble Molecule

Currently, about 70 percent of new molecular entities exhibit poor solubility in water and require some form of enhancement in order to achieve sufficient bioavailability. However, the sheer number of potential strategies for improving the solubility of a compound can overwhelm many developers, leaving them unsure how to choose a path forward.

Continuous Or Batch: Deciding On The Best Solution For Your Oral Solid Dose Product

The transition from blockbuster drugs and large-scale production to niche drugs focused on smaller patient populations has driven a greater need for increased flexibility, faster product development, and lower costs. Gaining a better understanding of continuous manufacturing and its fitness for your oral solid dose product could secure more control over the quality and safety of your product and, ultimately, the future of its success.