Bone Marrow Delivery of Nilotinib Hydrochloride Through Nanoparticles for Therapy of Chronic Myeloid Leukemia

Document Type

Article

Publication Title

Bionanoscience

Abstract

Chronic myeloid leukemia (CML) presents a serious health challenge, demanding effective treatment strategies. Nilotinib hydrochloride (NIL), a tyrosine kinase inhibitor, holds promise in CML management despite its challenges of low aqueous solubility and permeability, necessitating high dosages for efficacy. This study aimed to formulate NIL-loaded bovine serum albumin (BSA) nanoparticles (NIL-BSA NPs) using a desolvation technique and optimize following the Taguchi model. Initial investigations focused on discerning drug-excipient interactions through FT-IR and DSC, confirming formulation compatibility. Subsequently, five batches of NPs, with varying polymer concentrations, were prepared and characterized for percentage yield and percentage NIL loading. Based on the initial investigation results, further formulation optimization was done. The optimization studies explored the impact of independent variables (stirring speed, stirring time, volume of ethanol, and pH) on dependent variables: drug loading, drug release, and particle size. Biodistribution studies were carried out in adult Wistar rats. Stirring speed positively influenced drug loading and particle size, while stirring time initially enhanced drug release before plateauing. Ethanol volume escalation inversely impacted NIL loading, release, and particle size, and pH elevation augmented NIL loading but suppressed drug release and particle size. Comprehensive characterization of NIL-BSA NPs encompassed zeta potential analysis, in vitro drug release studies, transmission electron microscopy, and biodistribution studies. Results showed spherical NP morphology, variable cumulative drug release at 24 h in phosphate buffer pH. Biodistribution studies confirmed enhanced femur bone concentration with NIL-BSA NPs compared to pure drug solution, emphasizing their therapeutic potential. Statistical analyses validated the significance of animal studies, affirming the translational potential of NIL-BSA NPs as a promising drug delivery system for combating CML.

DOI

10.1007/s12668-025-01878-7

Publication Date

6-1-2025

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