Tableting process optimisation with the application of fuzzy models.

A quality-by-design (QbD) principle, including process analytical technology, is becoming the principal idea in drug development and manufacturing. The implementation of QbD into product development and manufacturing requires larger resources, both human and financial, however, large-scale production can be established in a more cost-effective manner and with improved product quality. The objective of the present work was to study the influence of particle size distribution in powder mixture for tableting, and the settings of the compression parameters on the tablet quality described by the capping coefficient, standard deviations of mass and crushing strength of compressed tablets. Fuzzy models were used for modelling of the effects of the particle size distribution and the tableting machine settings on the tablet quality. The results showed that the application of mathematical models, based on the contemporary routinely measured quantities, can significantly improve the trial-and-error procedures.