Formulation and Multivariate optimization of Microcrystalline Cellulose Pellets of highly water soluble drug

Ravindra Tiwari, Sunil Kumar Agarwal, Shweta Tiwari


Microcrystalline Cellulose (MCC)  pellets containing highly water soluble compound A was formulated with highestpellet usable yield of 86%, aspect sphericity that is (aspect ratio less than1.1 and roundness greater than 0.85), minimum friability of 0.33% by extrusionand Spheronization technique. A Central Composite Design (CCD) was executed to estimate the effect of formulation and processvariable namely water (21-41%), spheronization time (1-9 min) andSpheronization speed (200-800) to maximize responses i.e, usable yield, Sphericityaspect ratio and roundness. Least square regression analysis using responsesurface methodology permit the identification and optimization of variablesthat shows significant effect on selected responses. Polynomial model fitted tothe data were used to predict the responses in the desired value. A generalizeddesirability function is used to get maximum achievable target for responses.The optimum values for variables were water 31%, Spheronization Time of 5 minand Spheronization speed of 500 rpm. These results confirmed the usefulness of Multivariateanalysis to identify the critical variables and their interactions on thecharacteristics of pelletization


Microcrystalline Cellulose, Pelletization, Central composite Design, Response Surface Methodology

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