Anhydrous Lactose Excipient Variation in relationship to functionality – A MultiVariate Approach | CPhI North America

 

View, browse and sort the ever-growing list of sessions by pass type, track, and format. With this Session Scheduler, you can build your schedule in advance and access it during the show via export or with the Mobile App, once live. Sessions do fill up and seating is first come, first serve, so arrive early to sessions that you would like to attend.

Anhydrous Lactose Excipient Variation in relationship to functionality – A MultiVariate Approach

Sunil Kumar (Technical Manager, DFE Pharma)

Marly Bastiaan Dickhoff (Product Group Manager Lactose , DFE Pharma)

Bastiaan Dickhoff (Manager Development / Senior Product Application Specialist)

Location: Exhibitor Showcase Theater

Date: Wednesday, May 1

Time: 3:30pm - 4:15pm

Track: Exhibitor Showcase

Vault Recording: TBD

QbD has driven the use of MultiVariate Analysis (MVA), particularly Principle Component Analysis (PCA) and Partial Least Squares (PLS) regression (Tobyn, 2015; Ferreira and Tobyn, 2014). PCA is ideally suited for investigating batch-to-batch excipient (and or API) variation, as it can be used to investigate patterns or clusters in complex data sets. The use of PCA on large excipient data sets can identify the major sources of variation and identify noise (no effect) variables.
This study shows the effect of perceived variation in relationship to the excipient functionality for SuperTab® 21AN a truly anhydrous lactose grade. We demonstrate the growing need for having Multivariate oversight to ensure product success throughout the lifecycle of the finished product, which will support the Pharmaceutical Industry 4.0 effort.