Effect of Mixing Time on the Solubilization Of Poorly, Water Soluble Drug in DC Formulation, Using Soluplus® in High Shear Granulator
This investigation analyzed the solubilization capacity of Soluplus® in dry granulation. Soluplus® is a novel, graft copolymer of polyvinyl caprolactam – polyvinyl acetate – polyethylene glycol. Carbamazepine was used as a model drug, and the homogeneity of the mixture of various excipients’ particles in the high shear mixing bowl was determined. The robustness of dry granulation method in DC formulation was measured by the content uniformity of the mixture at a given length of mixing time and quantified by the percent of drug released at different sample points and levels (top and bottom).