(499d) Feed-Forward Process Control Strategy for Pharmaceutical Tablet Development

A feed-forward process control strategy which can compensate for the effect of raw material lot-to-lot variability on final tablet attributes in pharmaceutical tablet development is presented. The approach involves building PLS (partial least squares) models that combine raw material attributes and tablet process parameters to relate these to final tablet attributes. Prior to a manufacturing batch, the resulting models are used in an optimization framework to find optimal process conditions which can satisfy desired final tablet attributes while taking into account the attributes of specific raw material lots used in the batch. The effectiveness of the methodologies is illustrated through an industrial tablet manufacturing case study.