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Modeling of Disintegration and Dissolution Behavior of Mefenamic Acid Formulation Using Numeric Solution of Noyes-Whitney Equation with Cellular Automata on Microtomographic and Algorithmically Generated Surfaces

1
Department of Pharmaceutical Sciences, Division of Pharmaceutical Technology, University of Basel, Klingelbergstrasse 50, CH4056 Basel, Switzerland
2
Formulation R&D Center, CMC R&D Division, SHIONOGI & CO., LTD., Hyogo 660-0813, Japan
3
Swiss Light Source, Paul Scherrer Institute, 5232 Villigen, Switzerland
*
Author to whom correspondence should be addressed.
Pharmaceutics 2018, 10(4), 259; https://doi.org/10.3390/pharmaceutics10040259
Received: 21 October 2018 / Revised: 17 November 2018 / Accepted: 23 November 2018 / Published: 3 December 2018
Manufacturing parameters may have a strong impact on the dissolution and disintegration of solid dosage forms. In line with process analytical technology (PAT) and quality by design approaches, computer-based technologies can be used to design, control, and improve the quality of pharmaceutical compacts and their performance. In view of shortcomings of computationally intensive finite-element or discrete-element methods, we propose a modeling and simulation approach based on numerical solutions of the Noyes-Whitney equation in combination with a cellular automata-supported disintegration model. The results from in vitro release studies of mefenamic acid formulations were compared to calculated release patterns. In silico simulations with our disintegration model showed a high similarity of release profile as compared to the experimental evaluation. Furthermore, algorithmically created virtual tablet structures were in good agreement with microtomography experiments. We conclude that the proposed computational model is a valuable tool to predict the influence of material attributes and process parameters on drug release from tablets. View Full-Text
Keywords: drug release simulation; disintegration simulation; poorly water-soluble drug; mefenamic acid; Noyes-Whitney equation; cellular automata; synchrotron microtomography drug release simulation; disintegration simulation; poorly water-soluble drug; mefenamic acid; Noyes-Whitney equation; cellular automata; synchrotron microtomography
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MDPI and ACS Style

Yokoyama, R.; Kimura, G.; Schlepütz, C.M.; Huwyler, J.; Puchkov, M. Modeling of Disintegration and Dissolution Behavior of Mefenamic Acid Formulation Using Numeric Solution of Noyes-Whitney Equation with Cellular Automata on Microtomographic and Algorithmically Generated Surfaces. Pharmaceutics 2018, 10, 259.

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