Abstract

FORMULATION AND IN VITRO EVALUATION OF PALBOCICLIB LOADED SOLID NANOPARTICLES FOR ENCHNANCED ORAL DRUG DELIVERY: A COMPREHENSIVE REVIEW

B. Prem Kumar*, D. Dhachinamoorthi, K. Karthick

ABSTRACT

Palbociclib is a cyclin-dependent kinase (CDK 4/6) inhibitor approved for the treatment of hormone receptor-positive and HER2-negative advanced breast cancer. However, its clinical application is limited due to poor aqueous solubility, variable oral bioavailability, and gastrointestinal side effects. Solid Lipid Nanoparticles (SLNs) are promising colloidal drug delivery systems capable of improving the solubility, stability, and bioavailability of poorly water-soluble drugs. The present study aims to formulate Palbociclib-loaded Solid Lipid Nanoparticles using the hot homogenization-ultrasonication technique. Different lipids and surfactants will be optimized to obtain nanoparticles with suitable particle size, polydispersity index, zeta potential, drug entrapment efficiency, and sustained drug release characteristics. The prepared formulations will be characterized for particle size, zeta potential, morphology using SEM/TEM, drug loading, entrapment efficiency, FTIR compatibility studies, Differential Scanning Calorimetry (DSC),Powder X-ray Diffraction (PXRD), and in vitro drug release studies. Stability studies will also be carried out according to ICH guidelines. The optimized formulation is expected to enhance oral bioavailability, prolong drug release, reduce dosing frequency, and improve therapeutic efficacy.

Keywords: Palbociclib, Solid Lipid Nanoparticles, Nanotechnology, CDK4/6 inhibitor, Drug Delivery System, Breast Cancer.