Abstract
OBJECTIVES: This design study was implemented within the scope of the quality by design approach, which included the "International Conference on Harmonization" guidelines. We evaluated the quality of a modified-release tablet formulation of quetiapine fumarate, which was designed using artificial neural networks (ANN), and determined a new formulation that was similar to the reference product. MATERIALS AND METHODS: Twelve different formulations were produced and tested. The reference product's results and our experimental results were used as outputs for the training of the ANN programs of Intelligensys Ltd. RESULTS: Dissolution tests were performed with the new formulation (F13) suggested by the INForm V.4 ANN program in three different pHs of the gastrointestinal system. The compliance of this formulation was confirmed by comparing the results with an f2 similarity test. CONCLUSION: Use of these programs supports research and development processes with multiple evaluation methods and alternative formulations may be determined faster and at lower cost.