Design and Optimization of Sustained Release Tablets of Axitinib—A DoE based approach

Axitinib is classified as BCS class II by the Biopharmaceutical Classification System (BCS). Axitinib is used to treat renal cancer patients. However, no sustained-release tablets have been documented using the Quality by Design (QbD) method. The aim of the research work was to design sustained release formulations of AXB, using response surface methodology through Box-Behnken statistical design (BBD) by wet granulation technique. The amounts of release retardant polymers investigated were HPMC K4M (X1), HPMC K15M (X2), and Polyvinyl pyrrolidone (PVP) (X3). In vitro cumulative percentage release in 0-24 (h), such as (R1), (R2), (R3), (R4), (R5), (R6), (R7), (R8), (R9), and (R10), are employed as dependent variables. The desirability 0.793 functions were found to be optimized in sustained-release formulations. Finally, the BBD proved valuable in improving the sustained release formulation and determining the impacts of formulation factors. The research finding is to develop the ideal formulation with great strength and long-term release.