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.