Formulation And Evaluation of Ibrutinib Nanosuspension

Abstract

The aim of the present work is to develop Oral Nanosuspension of Ibrutinib by Nano Precipitation method using various Carriers & Surfactant such as Urea, Pluronic F 127, PVP K-30 and SLS various formulation as well as process parameters were optimized in order to achieve desirable size and saturation solubility. Ibrutinib is an inhibitor of Burton's tyrosine kinase which is used for the treatment of chronic lymphocytic leukemia. Evaluation    of the prepared Nanosuspension was done with respect to percentage yield, drug content, entrapment efficiency, viscosity, Sedimentation volume, Surface morphology study (SEM), particle size, zeta potential, saturation solubility, in-vitro diffusion study and release kinetics. All the evaluations were passed within the limits in that formulation NS12 having more potential and its show best results in all Characterization when compared to other formulations. The Zeta potential value for the optimized formulation (NS12) was found to be 0.2 mv which was found to be within the acceptable limits. The Average particle size of Nano suspension of optimized formulations (NS12) which is in 1:1 ratio with PVP K-30 was found to be 185.42 nm. From the invitro studies, we can say that optimized formulation NS12 shows best drug release of 99.65±1.84% within 30 minutes whereas all the other formulations didn’t release high amount of the drug. The drug release from the Nanosuspension was explained by the using mathematical model equations such as zero order, first order, and equation methods. Based on the regression values it was concluded that the optimized formulation NS12 follows zero order kinetics with super case-II transport mechanism.