Formulation and Evaluation of Simvastatin Loaded Nanostructured Lipid Carrier for Topical Drug Delivery

Abstract

Introduction: Simvastatin, a BCS II drug, has poor water solubility and low bioavailability. Nanostructured Lipid Carriers (NLCs) can enhance its bioavailability. This study investigates the potential of NLCs to improve simvastatin's bioavailability. Objectives: The primary objective was to enhance simvastatin's bioavailability by formulating it into NLCs using High-Speed Homogenization (HPH). The study also aimed to characterize the NLCs and evaluate their stability and irritation potential. Materials and Methods: Simvastatin-loaded NLCs were prepared with Compritol 888 ATO, oleic acid, linseed oil, Tween 80 and distilled water using high-speed homogenization. Characterization included FTIR, DSC and PXRD. The optimized batch (F-II) was assessed for entrapment efficiency, particle size, polydispersity index, zeta potential and drug content. Stability and irritation potential were evaluated following ICH guidelines and Primary Irritation Index (PII) assessment. Results: FTIR showed no drug-excipient interactions. XRD confirmed the amorphous nature of simvastatin in NLCs. The optimized batch (F-II) had 78% EE, 148.4 nm particle sizes, 0.369 PDI,-2.90 mV ZP and 89.6% drug content. Stability studies confirmed robustness and PII was 0.11, indicating negligible irritation. Conclusion: HPH successfully prepared simvastatin-loaded NLCs, significantly enhancing bioavailability with favorable %EE, particle size and drug content. The formulation was stable and showed minimal irritation potential, making NLCs optimistic techniques for improving the bioavailability of poorly soluble drugs like simvastatin.