Vijayabhaskar Veeravalli
GVK BIO Pvt. Ltd, India
Title: Formulation Excipients (The Good, The Bad, The Ugly)
Biography
Biography: Vijayabhaskar Veeravalli
Abstract
Formulation excipients are used at high concentrations in preclinical formulations to solubilise NCEs of varying lipophilicities. The good (Measuring plasma concentrations of formulation excipient acts as quality control check for in vivo PK studies), the bad (Matrix effects arising from formulation excipients cause differential ionisation between calibration standards and study samples, producing false concentration levels) and the ugly (altered pharmacokinetic parameters resulting in false positive and false negatives) aspects of using formulation excipients in preclinical formulations will be discussed in detail. Bioanalytical approaches to identify and nullify the matrix effects will also be presented.