European Journal of Biomedical and Pharmaceutical Sciences

MELT GRANULATION: AN APPROACH TO ENHANCE THE DISSOLUTION RATE OF DOMPERIDONE

Tatapudi Naga Aparna* and Dr. Ambati Sambasiva Rao

ABSTRACT

Melt granulation is one of the most widely applied processing technique in the array of pharmaceutical manufacturing operations. The wide spread interest in this technique is because it offers a means of facilitating the dissolution and bioavailability of poorly soluble drugs when combined with hydrophilic meltable polymers. Advantage of this technique over conventional granulation is that it negates the risk originating from residual solvents and is less time consuming. The focus of the present study was to evaluate the feasibility of this technique to improve the dissolution characteristics of domperidone, a BCS class II drug indicated for treatment and prevention of nausea and vomiting especially in cytotoxic and radiotherapy. Granules were prepared using hydrophilic polymers like Myrj S40, Pluronic F 127, and Pluronic F 68 with primellose as disintegrant. Prepared granules were subjected to preformulation studies and were compressed into tablets. These tablets were evaluated for various parameters and a remarkable increase in dissolution rate was observed compared to their commercial counterparts. Physicochemical characterization was done by FTIR, DSC and XRD. Stability studies performed as per ICH guidelines ascertained that the formulations are stable. Mathematical modeling of dissolution data indicated best fitting with first order kinetics.

Keywords: Domperidone, Myrj S40, Pluronic F 68, Similarity Factor.