Rashmitha V¹, Shravan Kumar Y¹*, K Srinivas Reddy¹² and V Srilekha¹

¹Department of Pharmaceutics, Vaagdevi College of Pharmacy, Ramnagar, Hanamkonda, Telangana, 506009. (Affiliated to Kakatiya University), India
²Department of Pharmacognosy, Vaagdevi College of Pharmacy, Ramnagar, Hanamkonda, Telangana, 506009. (Affiliated to Kakatiya University), India

*Corresponding Author: Shravan Kumar Y, Professor, HOD, Department of Pharmaceutics, Vaagdevi College of Pharmacy, Ramnagar, Hanamkonda, Telangana, 506009. (Affiliated to Kakatiya University), India.

Received: March 05, 2025; Published: March 11, 2025

Abstract

Background: Simvastatin is often used to treat hyperlipidemia by decreasing cholesterol levels in general (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), while increasing high-density lipoprotein cholesterol (HDL-C). Despite its efficacy, simvastatin suffers from poor water solubility, leading to limited bioavailability. To address this issue, this study focuses on enhancing the solubility and bioavailability of simvastatin through the development of solid self-micro emulsifying drug delivery systems (S-SMEDDS).

Objective: The objective of this investigation was to improve the solubility and bioavailability of simvastatin by formulating it into a solid self-micro emulsifying drug delivery system (S-SMEDDS) using clove oil, Tween 40, and PEG 600.

Method: A solubility study identified clove oil as the optimal oil phase for the formulation. Tween 40 was chosen as the surfactant and PEG 600 as the co-surfactant based on their emulsification properties. A ternary phase diagram was constructed to optimize the proportions of clove oil, Tween 40, and PEG 600 using the oil titration method. The drug-loaded self-microemulsion was optimized with clove oil (F1), Tween 40 (F2), and PEG 400 (F3) as independent variables. All batches of the drug-loaded self-microemulsion were characterized by in-vitro drug release studies, and the optimized formulation was further evaluated for zeta potential and self-emulsification properties.

The solid self-microemulsion was prepared using the liquid solid compact technique, employing microcrystalline cellulose (MCC) as the carrier material and Aerosil 200 as the coating material. The prepared S-SMEDDS was evaluated for bulk density, tapped density, angle of repose, and in-vitro drug release. Fourier-transform infrared spectroscopy (FT-IR) was conducted to check for interactions between the drug and excipients. A stability study was performed to assess changes in the formulation over time.

Results: The optimized self-microemulsion formulation consisted of clove oil, Tween 40, and PEG 400. The solid self-microemulsion showed no significant changes in bulk density, tapped density, angle of repose, and in-vitro drug release during stability studies. Among all the formulations, the F7 formulation, containing clove oil, Tween 40, and PEG 600 with a drug-to-excipient ratio of 2:1, exhibited the best performance, achieving 97.5% drug release within 90 minutes.

Conclusion: Simvastatin's solubility and bioavailability were successfully increased in the present study by incorporating it into a solid self-micro emulsifying drug delivery system.

The optimized formulation demonstrated excellent in-vitro drug release and stability, making it a promising approach for improving the therapeutic efficacy of simvastatin.

Keywords: Solid Self-Micro Emulsifying Drug Delivery System; Clove Oil; Tween 40; PEG 600; Aerosil 200

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Citation

Citation: Shravan Kumar Y., et al. “Development of a Solid Self-Micro Emulsifying Drug Delivery System for Improved Solubility and Bioavailability of Simvastatin". Acta Scientific Pharmaceutical Sciences 9.4 (2025): 15-28.

Copyright

Copyright: © 2025 Shravan Kumar Y., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.