SCIENTIFIC RESEARCH BRIEF
Geraldine Su, Ken Strassberger, Craig Kramer, Xinqun Huang, and Mike Markham
Probing the Source of an Unstable Impurity and Controlling Its Formation at Release
APT-76 is an anti-neoplastic agent and currently being developed as an extended-release formulation (enteric coating) for an ongoing early Phase 1 clinical trial. The finished drug product is a capsule filled with mini tablets. Two major issues related to impurities were encountered during the formulation and analytical stages:
