Understanding the impact of excipient variability on oral solid dosage form performance: A possible role for...

The development of a robust oral solid dosage form requires knowledge of all the sources of variation that could impact the dosage form's performance and stability. One of those sources of variability is in the excipients that can make up the bulk of the dosage form. Raw material and manufacturing variability can make a difference to the physical properties and performance of the excipient. It is, however, also important to note that sources of variation in data include analytical and sampling variation, which affect the reported data without directly impacting the performance of the dosage form. Working closely with an excipient supplier, drug product manufacturers can substantially improve their understanding of the sources of variability in the excipients that they use. This helps to strengthen the regulatory design space for their asset and will helps stabilise the product during its commercial life cycle. The use of multivariate analysis to examine reported data, along with targeted experimentation, is a demonstrated way to work towards this goal. In this paper we give examples of how this can be achieved.