Issue link: https://www.e-digitaleditions.com/i/1138630
18 July 2019 Tablets & Capsules I nnovative new drug molecules and technologies have paved the way for promising new therapies to some of the most pressing, life-threatening diseases. The FDA has affirmed that potential by granting fast-track designation to these new drug candidates and products. In 2018, there was a surge in pharmaceutical approvals, with a record 61 combined approvals from the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) divisions [1]. Notably, within those approvals, relatively large percent- ages of products were classified as first-in-class (43 per- cent) and orphan drug (56 percent), and a significant As formulators increasingly prioritize speed to market, innova- tions have led to next-generation HPMC capsules that provide consistent dissolution performance, prevent crosslinking, and improve compatibility with moisture-sensitive APIs. This arti- cle describes how these differentiators provide drug developers seeking immediate-release dosage forms with an alternative to gelatin capsules. Using next-generation HPMC polymers as an alternative to gelatin for hard capsules Matt Richardson and Nicolas Madit Lonza Pharma & Biotech capsules