Floating Drug Delivery of Sustained Release Anti-depressant Mirtazapine Tablets by Box-Behnken Design: Formulation and Optimization

Background: Mirtazapine widely prescribed Antidepressant drug that belongs to BCS Class II drug with low solubility and high permeability characteristics. Aim: The Box Behnken design was used to statistically optimize the formulation on the efficacy of gastroretentive floating tablets of mirtazapine. Materials and Methods: The 3 components of 3 levels of the design were used to examine the replies and create a polynomial model using design expert software. Three different independent factors were compared. The concentration of Methocel K100 M premium (X1) Concentrations of ethyl cellulose(X2), cetyl alcohol (hexadecanol) (X3). To find properties of prepared tablets, swelling-erosion index, floating properties, in vitro dissolution, Comparison of marketed with F9 and Optimized formulation, drug release kinetics, and counter and 3D surface plots. Results and Conclusion: The formulations F1, F2, F3, F4, F6, F8, F9, and F12 release zero orders release and F5, F7, F10, F11, F13, F14, and F15, the high R₂ first order is seen. The release exponent formulations F1, F2, F3, F4, F5, F7, F9, F10, F11, F12, F13, and F14 are proven to be Fickain diffusion, while the release exponent formulations F6, F8, and F15 are noticed to be non-Fickain diffusion. In the marketed (Mirtafresh 15-MD) tablet, 100% of the medicine is released in 20 min, 100% in the F9 formulation in 6.5 hr, and 100% in the optimized formulation in 12 hr. The obtained optimized formulation underwent statistical optimization to ensure that it satisfied all of the dissolution criteria to validate the theoretical prediction.