Optimization of formulation and process variable of nanosuspension: An industrial perspective.

The objective of this study was to identify and optimize formulation and process variables affecting characteristic and scale up of nanosuspension manufacturing process on bead mill considering industrial perspective. Box-Behnken design was used for this study. Formulation factors evaluated were ratio of polymer to drug and ratio of surfactant to drug, whereas process parameters were milling time and milling speed. Responses measured in this study include zeta potential and, particle size distribution d(90). The ANOVA test reveals that ratio of polymer to drug and milling speed has significant effect on zeta potential whereas milling time and milling speed has significant effect on the particle size distribution of nanosuspension. The X-RD pattern of drug milled at high and low speed reveals no form conversion when compared to unmilled drug. The Box-Behnken design used in this study helped in identifying the factors affecting the particle size distribution d(90), zeta potential and, scalability of nanosuspension. The derived polynomial equation and contour graph aid in predicting the values of selected independent variables for preparation of optimum nanosuspension formulations with desired properties.