Formulation Development and Evaluation of Moxifloxacin.HCL Fast Dissolving Tablets
The main objective of present research investigation is to formulate the Moxifloxacin.HCl Fast Dissolving tablets. Moxifloxacin.HCl, a synthetic fluoroquinolone antibacterial agent, and used to treatacute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis. The Fast Dissolving tablets of Moxifloxacin.HCl were prepared employing different concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrants by Direct Compression technique using 32 factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1 and X2 respectively whereas, wetting time, Disintegration time, t50%, and t90% were selected as dependent variables. Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, In-vitro drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines the formulation (F5) containing combination of 7.5% Crospovidone and 7.5% Croscarmellose, is the most similar formulation (similarity factor f2=68.88, dissimilarity factor f1= 3.35& No significant difference, t= 0.00354) to marketed product (AVELOX-400). The selected formulation (F5) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion Super Case-II Transport (n= 1.902).