Formulation and multivariate optimization of microcrystalline cellulose pellets of highly water soluble drug
Keywords:
Microcrystalline Cellulose, Pelletization, Central composite Design, Response Surface MethodologhyAbstract
Microcrystalline Cellulose (MCC) pellets containing highly water soluble compound A was formulated with highest pellet usable yield of 86%, aspect sphericity that is (aspect ratio less than 1.1 and roundness greater than 0.85), minimum friability of 0.33% by extrusion and Spheronization technique. A Central Composite Design (CCD) was executed to estimate the effect of formulation and process variable namely water (21-41%), spheronization time (1-9 min) and Spheronization speed (200-800) to maximize responses i.e, usable yield, Sphericity aspect ratio and roundness. Least square regression analysis using response surface methodology permit the identification and optimization of variables that shows significant effect on selected responses. Polynomial model fitted to the data were used to predict the responses in the desired value. A generalized desirability function is used to get maximum achievable target for responses. The optimum values for variables were water 31%, Spheronization Time of 5 min and Spheronization speed of 500 rpm. These results confirmed the usefulness of Multivariate analysis to identify the critical variables and their interactions on the characteristics of pelletization
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