Abstract

FORMULATION AND EVALUATION OF SORAFENIB TOSYLATE IMMEDIATE RELEASE FILM COATED TABLETS FOR RENAL CANCER

Dr. T. Mangilal*, M. Satish Kumar, M. Ravi kumar, I. Nagaraju, L. Thirupathi and P. Veeresh kumar

ABSTRACT

Developing new drug delivery techniques is essential for pharmaceutical companies in product development to improve safety, efficacy and patient compliance. Immediate release drug formulation is a novel type of drug delivery system which disintegrates rapidly and gets dissolved to release the medicaments after administration. Sorafenib is kinase inhibitors, used to treat renal cell carcinoma. Our work involves the formulation, optimization and post compressed evaluation studies of immediate release sorafenib tablets. The Wet granulation method was employed for formulating tablets. Tablet composition contains sorafenib tosylate, lactose monohydrate as a filler, lycatab as disintegrate, HPC LH 11 as a binder, sodium steayl fumarate as a lubricant and sodium dodecyl sulfate as a surfactant. The prepared tablets were evaluated for physico-chemical properties and post evaluation studies such as drug content, assay and in vitro dissolution. Furthermore, stability studies were conducted to know the elements of drug decomposition. Finally, it was concluded that all the pre-formulation and post compression studies of sorafenib tablet met with required specifications and also showed comparably a good rate of dissolution like that of a commercial product, NEXAVAR.

Keywords: Immediate release tablet, Renal cancer, Sorafenib tosylate.