STATISTICAL OPTIMIZATION OF ORALLY DISINTEGRATING TABLETS OF MEMANTINE HYDROCHLORIDE

Objective: The present work deals with the statistical optimization of memantine hydrochloride orally disintegrating tablets by the design of experimentation. The study was aimed at the development of a stable and robust formulation for the well-being of society for the treatment of Alzheimer’s disease, which is the most common form of dementia. Methods: Binder (X₁), disintegrant (X₂), and diluent (X₃) concentrations were selected as independent variables, and their levels were optimized by employing a Central composite design, whereas dissolution (Y₁) and disintegration time (Y₂) were selected as the dependent variables. Results: All formulations were evaluated for physical parameters of lubricated blend and compressed tablets. Mathematical equations and response surface plots were used to relate the dependent and independent variables. The regression equation generated for dissolution was Y₁ = 93.51 – 7.00B + 5.20C – 4.28B² – 2.28C² and for disintegration time (DT) was Y₂ = 4.80 + 0.0148A + 0.3690B -0.3181C. Conclusion: The statistical significance of each variable with respect to the model was established, and optimized formulation factors were selected by feasibility and grid search. The factorial batches were evaluated by contour plots and response surface methodology.