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

Indian Journal of Pharmaceutical Education and Research

  • Madhuri Desai1Department of Pharmaceutics, Krishna Vishwa Vidyapeeth, Krishna Institute of Pharmacy, Karad , Maharashtra., INDIA.
  • Shalaka Dhanna2Department of Pharmaceutics, P.E. S’s Modern College of Pharmacy, Nigdi, Pune, Maharashtra, INDIA.
  • Sujata Jadhav3Department of Pharmacology, Krishna Vishwa Vidyapeeth, Krishna Institute of Medical Sciences, Karad , Maharashtra, INDIA.
  • Akshada Koparde4Department of Pharmaceutical Chemistry, Krishna Vishwa Vidyapeeth, Krishna Institute of Pharmacy, Karad, Maharashtra, INDIA.
  • Akansha Dashwanat5Department of Pharmaceutics, Krishna Institute of Pharmacy, Karad, Maharashtra, INDIA.
  • Rutuja Gharal1Department of Pharmaceutics, Krishna Vishwa Vidyapeeth, Krishna Institute of Pharmacy, Karad , Maharashtra., INDIA.

Volume 59 Issue 2s Pages s421-s432

DOI: 10.5530/ijper.20250097

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.

Keywords

  • Nanostructured Lipid Carrier
  • High-Speed Homogenization
  • Compritol 888 ATO
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