Abstract

DEVELOPMENT OF PACLITAXEL-LOADED SOLID LIPID NANOPARTICLES USING A TEMPERATURE-MODULATED SOLIDIFICATION TECHNIQUE FOR SUSTAINED DRUG DELIVERY APPLICATIONS

Ameya Abhay Deshpande*, Junkyu Shin, Steven Gollmer, Elisha Injeti, Jerry Nesamony

Abstract

Objective: The objective of this research was to formulate, characterize, and evaluate paclitaxel-loaded solid lipid nanoparticles (SLNs) using a temperature-modulated solidification technique, with the goal of achieving sustained drug delivery. Methods: SLNs were prepared by incorporating paclitaxel into glyceryl monostearate (GMS) with Tween 80 as an emulsifier, using a temperature-modulated solidification process. Particle size and morphology were assessed via dynamic light scattering (DLS), transmission electron microscopy (TEM), and atomic force microscopy (AFM). Zeta potential analysis was conducted to evaluate physical stability. The solid-state characteristics were investigated through differential scanning calorimetry (DSC), powder X-ray diffraction (P-XRD), and Fourier transform infrared spectroscopy (ATR-FTIR). Entrapment efficiency was quantified, and in-vitro drug release studies were performed to determine the release kinetics. Results: The nanoparticles exhibited a spherical shape and nanometer size range. Zeta potential measurements indicated physical stability owing to a negative surface charge. AFM revealed minimal aggregation and uniformity in shape. DSC, P-XRD, and ATR-FTIR analyses confirmed the successful entrapment of paclitaxel within the lipid matrix and transformation of bulk lipid to nanoparticles. The formulation demonstrated an entrapment efficiency of approximately 62%. In-vitro drug release studies showed sustained release of paclitaxel over a period of one week, following the Higuchi drug-release model. Conclusion: These findings highlight the potential of SLNs as an effective and physiologically safe drug delivery system for paclitaxel. The temperature-modulated solidification technique facilitated high drug entrapment and stable nanoparticle formation. The sustained release profile and compatibility with GRAS lipids underscore the feasibility of SLNs for improved chemotherapy applications. Further in-vivo studies and clinical evaluations are warranted to corroborate these promising results and advance the SLN platform for oncology therapeutics.

Keywords: P-XRD, ATR-FTIR, DSC, nanometer, colloidal, sustained release.