Development of a blending design space model to control uniformity... - ERP Spain.com - España y América Latina

Full title: Development of a blending design space model to control uniformity in a Mini-Batch Direct Compression line Blending is a common manufacturing unit operation for oral solid forms that is typically evaluated during formulation and process development with the aim to ensure proper distribution of the drug substance in the formulation, which is ultimately assessed during drug product release by means of the uniformity of dosage units by content uniformity. A common approach on how blend uniformity is controlled (but not tested) during commercial manufacturing consists in establishing appropriate blending conditions during the scale up from pilot to commercial scale. Those conditions are determined with a reduced number of experiments that usually do not provide the necessary process understanding on blending.  Another alternative is to define the Design Space for blending, where a surface response curve allows setting the boundaries of the critical process parameters and critical material attributes by means of a multivariate process model. The current webinar explores the development and verification of a design space model around blending on a Mini-Batch continuous Direct Compression line. This approach allows ensuring blend uniformity within specification for all Mini-Batches that are blended within the obtained design space. The approach brings flexibility to adjust changes in API particle size or fill level while ensuring proper blend uniformity.