Experts in excipient characterization
Excipia is an excipient characterization and research service centre. It was commenced after experiencing the disadvantageous consequences of unpredictable reactivity and batch-to-batch variability of some widely used excipients during drug formulation development. The observed excipient performance could not be or related to or explained by the typically limited information on the Certificate of Analysis of these excipients.
Within Excipia, we have spent tens of thousands of hours setting up numerous specific analytical procedures to investigate the physicochemical composition of a wide variety of excipients and reveal undesirable ‘hidden features’.
Excipia offers hands-on troubleshooting services and solutions to pharmaceutical, generics, drug development and food companies that are encountering challenges with stability, dissolution profiles, reproducibility, batch variations, etc.
With the unique knowledge of Excipa we can examine batch-to-batch product performance variations, implement excipient related Quality by Design (QbD) approaches, perform quantitative deformulation and competitor research and analysis. In addition, monitor site changes or manufacturing process optimization, and select excipient batches to improve drug product performance without the necessity to change a registered drug product formulation.