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.
Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of your formulation, and increase your overall speed-to-market.
As the biopharmaceutical industry continues to evolve, the quality by design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. While QbD evolves from good practices to agency requirements, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?
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.