Preparation and Evaluation of Ivosidenib Nanoparticles

Abstract

Polymeric nanoparticles are a promising novel drug delivery system and have advantages in abnormal lipids therapy. Ivosidenib is an Antineoplastic Agent that is used in the treatment of a acute myeloid leukemia and locally advanced or metastatic cholangiocarcinoma therapy. The aim of the present study was to prepare and evaluate novel polymeric nanoparticles containing Ivosidenib. The objective of the present study was to formulate and evaluate polymeric nanoparticles of Ivosidenib byEmulsification sonication method using Sodium alginate, Chitosan and Ethyl cellulose as a polymer. The nanoparticles were characterized for FTIR, particle size, poly-dispersity index, entrapment efficiency (EE), zeta potential, morphological study, DSC and invitro study. Infrared studies showed that there was no drug excipients interaction. Negative values of zetapotential indicated the good stabilization of the prepared nanoparticles.

Nine formulations of Ivosidenibnanoparticles were prepared using Emulsification sonication method. The particles sizes and zeta potential were measured using zeta-plus analyzer. The particle morphology was also studied using scanning electron microscopy (SEM). The in-vitro release of the drug from the nanoparticles was carried out in phosphate buffer saline pH 6.8.

The particle sizes of the prepared NPs were in nano size which ranged from (140.5 to 173.9nm) with positive zeta potential. The drug entrapment efficiency was varied with the drug polymer ratio from 52.30% to 76.25%. The SEM showed uniform shape and regularly distributed particle sizes. The in-vitro drug release study exhibited the sustained release of Ivosidenibwith burst release. The cumulative percentage released after 12 hr. were between were 80.62 and 99.13%.

The studies, therefore, indicate the successful formulation development of NPs with distinctly improved bioavailability potential and can be used as drug carrier for sustained or prolonged drug release.