Manufacturing parameters may have a strong impact on the dissolution and disintegration\nof solid dosage forms. In line with process analytical technology (PAT) and quality by design\napproaches, computer-based technologies can be used to design, control, and improve the quality\nof pharmaceutical compacts and their performance. In view of shortcomings of computationally\nintensive finite-element or discrete-element methods, we propose a modeling and simulation\napproach based on numerical solutions of the Noyes-Whitney equation in combination with a cellular\nautomata-supported disintegration model. The results from in vitro release studies of mefenamic\nacid formulations were compared to calculated release patterns. In silico simulations with our\ndisintegration model showed a high similarity of release profile as compared to the experimental\nevaluation. Furthermore, algorithmically created virtual tablet structures were in good agreement\nwith microtomography experiments. We conclude that the proposed computational model is a\nvaluable tool to predict the influence of material attributes and process parameters on drug release\nfrom tablets.
Loading....