Design, optimization of Nanostructured Lipid Carriers of Imatinib a QBD Approach

Abstract

This study evaluates the pre-formulation of imatinib-loaded nanostructured lipid carriers (NLCs), focusing on drug characterization and excipient compatibility. Fourier Transform Infrared Spectroscopy (FTIR) identified key peaks for imatinib, including a C=C aromatic peak at 1469cm⁻¹ and C-F bond peaks from 1635-1012cm⁻¹, confirming the compound's purity. Differential Scanning Calorimetry (DSC) showed a distinct endothermic peak, indicating thermal properties. Analytical method validation demonstrated linearity over 2 to 14µg/ml, with high regression coefficients for UV (0.999) and HPLC (0.9803). Precision studies yielded consistent results, while accuracy tests confirmed reliable recovery rates, with limits of detection and quantification at 0.086μg/ml and 0.261μg/ml, respectively. Process and product variable screening identified optimal excipients like Inwitor 900K and Cremophor EL, along with ideal processing conditions, including 10,000 rpm homogenization and 8 minutes of sonication. This analysis enhances the development of imatinib-loaded NLCs for improved drug delivery.