Performance of simvastatin microsponges as a local treatment for chronic periodontitis – Randomized clinical trial

Abstract

Simvastatin (SV) is a lipid lowering drug exhibits anti-inflammatory and anabolic effects on the bone, so it could be utilized for the local treatment of periodontitis. However, the poor solubility of SV limits its penetration through the gingival sulcus. Encapsulating SV into microsponges may have the potential to enhance the dissolution and subsequently its local penetration. In this study, SV microsponges had been prepared using the emulsion-solvent evaporation technique where, Eudragit RS-100 was employed as the polymer. The % encapsulation efficiency(%EE) of drug approached 77.32 ± 2.03. The prepared microsponges were free flowing, spherical in shape having narrow size distribution range. The particle size of the prepared microsponges was 93.79 ± 7.21 μm in diameter with a small polydispersity index (PDI) of 0.0059 ± 0.0008. In-vitro dissolution studies of SV microsponges showed that the solubility of SV had significantly enhanced upon inclusion inside the microsponges. Fourier transform infrared (FT-IR) spectroscopy indicated hydrogen bond formation between SV and Eudragit RS-100. The prepared microsponges were incorporated in chitosan 2% gels. A clinical study was conducted on 24 selected patients having bony periodontal defects to compare the efficacy of chitosan 2% gel containing free (SV) with that containing SV microsponge in treatment of chronic periodontitis. Results showed that the chitosan gels containing SV microsponges exhibited significant reduction in both pocket depth and clinical attachment loss compared to those prepared with free SV. This might be attributed to hydrogen bond formation between microsponges entrapped SV and chitosan, thus microsponges are auspicious as a carrier for SV for local treatment of periodontitis.