Formulation and Evaluation of Enteric Coated Tablets of Serratiopeptidase

The present study is aimed at formulating serratiopeptidase enteric coated tablets by utilizing the direct compression method and aqueous solvent-based coating. Seven formulations of serratiopeptidase were developed by using excipients such as Magnesium stearate, Talcum, Primojel, and Avicel in varying concentrations. Pre-compression analysis such as bulk density, tapped density, Hausner’s, ratio and angle of repose was performed for all the formulations. After direct compression, tablets were analyzed for hardness, friability, disintegration, assay, and formulation compatibility study. After initial trials, formulation (FRSP 05) was selected for enteric coating using Eudragit® L30 D55 as polymer with 35, 40, 45, and 50% concentration and water as solvent. The dissolution study was performed, and the drug release profile was compared with the market product. The caseinolytic activity and stability study was assessed for 6 months in accelerated conditions. Pre and post-compression analysis showed that the results were within the acceptable range. Prepared formulation and market product showed a drug release of 97.47% and 94.4%, respectively, within 45 min. The drug release profile of the prepared formulation and market product followed the Korsmeyer-Peppas model and Zero-order models, respectively. The caseinolytic activity was positive with 2006 U/mg, and the product was stable at accelerated stability conditions. Enteric coated tablets of serratiopeptidase were prepared successfully by direct compression and aqueous solvent-based coating.