(357g) Development of a Database Tool for Understanding Excipient Properties and Variability

There has been a push within the pharmaceutical manufacturing community to move toward a QbD approach to the development of drug formulations. Excipients, which are the inactive ingredients in these formulations, are frequently derived from natural sources. As a result, excipients can have considerable variation in their properties, depending on their origin and seasonal climate variations. In order to enable formulation design, it is first necessary to gain a clear understanding of excipient properties and their effect on formulations. The objective of this project is to obtain a better understanding of excipient properties, including lot-to-lot and vendor-to-vendor variability, through the development of a collaborative database tool. This publicly available, web-based tool will enable users to view and analyze property measurements for a variety of excipient products. A thorough survey was performed to collect and assess results and test methods published in the literature. Within the data available, there exists considerable scatter in measured properties.  In addition, incomplete reporting of testing conditions and methodology makes it difficult to assess the source of discrepancies. To address this issue, measurements of material properties were performed in the laboratory to ensure consistent test methods and reporting of a complete set of test conditions. This report aims to quantify the natural variability of excipients through the analysis of lot-to-lot and vendor-to-vendor variability of a number of excipients. The properties and test methods critical to the characterization of excipients are also discussed. Finally, the implementation and features of a collaborative database tool and its applicability to the understanding of excipient properties are presented.