Publications by authors named "Sharyl Rich"
Article Synopsis
- Extemporaneous preparation (EP) formulations can speed up the development of new drugs for human trials, and this study focused on creating a suspension formulation for the drug candidate GDC-6599.
- The formulation used 0.6% methylcellulose as a suspending agent and included a small amount of denatonium benzoate to mask the taste, while ensuring consistency across different concentrations and passing stability tests.
- The developed EP formulation showed high drug recovery rates and bioaccessibility, successfully supporting the early phases of a clinical study, and the methodology can be applied to other new drug formulations.
Tau PET imaging using the tau specific PET tracer [F]GTP1 has been and is part of therapeutic trials in Alzheimer's disease to monitor the accumulation of tau aggregates in the brain. Herein, we examined the metabolic processes of GTP1 and assessed the influence of smoking on its metabolism through in vitro assays. The tracer metabolic profile was assessed by incubating GTP1 with human liver microsomes (HLM) and human hepatocytes.
View Article and Find Full Text PDFWith the advent of continuous direct compression (CDC) process, it becomes increasingly desirable to characterize inherent powder blend heterogeneity at a small batch scale for a robust and CDC-amenable formulation. To accomplish this goal, a near infrared spectroscopy (NIRS)-based characterization approach was developed and implemented on multiple direct compression (DC) blends in this study, with the intended purpose of complementing existing formulation development tools and enabling to build an early CMC data package for late-phased process analytical technology (PAT) method development. Three fumaric acid DC blends, designed to harbor varied degrees of inherent blend heterogeneity, were employed.
View Article and Find Full Text PDF