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Nowadays pharmaceutical industries and regulatory authorities suggest new approaches such as Quality by Design principles to reduce experiments of formulation studies, improve product quality, save cost and time. SeDeM Expert System is a predictive approach for the preformulation studies and it provides information about suitability of API for direct compression by evaluating 12 parameters. The system also allows selecting appropriate excipients by determining same parameters to improve compressibility of API. The objective of this study was to develop direct compressed memantine orally disintegrating tablets using SeDeM Expert System. Memantine was found to have poor flow and compressibility properties. Three different direct compressibility and super disintegrating agents (Ludiflash, Ludipress and Parteck) were used to improve compressibility of memantine and according to SeDeM diagrams, Parteck was selected for final formulation. Memantine direct compressed tablets showed proper friability, hardness and thickness. The disintegration time of the tables were found below 15 s which was suitable for ODTs. It was found that SeDeM Expert System was easy to use and application of this method provided to develop memantine direct compressed ODT formulation was successful.

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Because drug-surfactant interactions are specific, careful choice of surfactant media is required to develop dissolution tests for Biopharmaceutics Classification System (BCS) Class II drugs. The purpose of this study was to investigate the effects of cationic hexadecyltrimethylammonium bromide (CTAB) and nonionic surfactants (polysorbate 80) on the dissolution of bioequivalent immediate-release formulations of a BCS Class II anticancer drug, tamoxifen citrate (TMX), and to identify the most suitable surfactant medium reflecting the formulation differences and in vivo dissolution of the drug. Dissolution behaviors of the reference and test products were studied using USP apparatus II at pH 1.2, 4.5, and 6.8 with and without surfactant. At pH 6.8, the effects of 0.5% (w/v) CTAB and 0.5% (w/v) polysorbate 80 on dissolution of the formulations were much more pronounced compared to pH 1.2. Based on model-dependent and modelindependent approaches, test products were found to be different from the reference in all surfactant media. Overall, none of the surfactant media reflected the bioequivalence of test products to the reference; however, polysorbate 80 may provide a discriminative test for certain formulation changes, and it may be physiologically meaningful to mimic in vivo solubilization and sink conditions due to continuous intestinal absorption of TMX.

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