Formulation and Evaluation of Modified Release Etodolac Tablets Enhanced with Serratiopeptidase for Improved Anti-Inflammatory Efficacy

Author: Santosh Kitawat and Amul Mishra

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Abstract

This research focuses on creating and testing a modified release tablet that contains the non-steroidal anti-inflammatory medicine (NSAID) etodolac along with the proteolytic enzyme serratiopeptidase, which has fibrinolytic and anti-inflammatory qualities. Conventional NSAID therapy often results in gastrointestinal irritation, systemic toxicity, and frequent dosing requirements, leading to reduced patient compliance. The incorporation of Serratiopeptidase aims to enhance anti-inflammatory efficacy while mitigating gastrointestinal side effects and improving drug absorption. In order to achieve regulated medication release, hydrophilic and hydrophobic polymers are used in the formulation of modified release tablets. Various preformulation studies, including drug-excipient compatibility using IR and DSC, were conducted to ensure stability. The developed formulations were evaluated for physicochemical properties such as hardness, friability, weight change, and in vitro dissolving studies in order to determine the drug release profile. The goal is to achieve modified release of Etodolac while optimizing the enzymatic activity of Serratiopeptidase for enhanced therapeutic benefits

Keywords

Serratiopeptidase, Formulation, Eudragit L-100, Anti-inflammatory agent, Evaluation, Etodolac

Conclusion

The granules were prepared according to the formulation. The granules were characterized using the sieve analysis, LOD, bulk density, taped density, compressibility index, and Hausner ratio results of all experiments; the results demonstrated excellent flow behavior. In accordance with pharmacopeial requirements, the tablets in every trial underwent a number of evaluation tests, including weight fluctuation, friability, thickness, hardness, and disintegration time. The disintegration thickness, LOD and friability, and weight variation were all within acceptable bounds. In F1: When the serratiopeptidase pill was compressed, a rough surface was seen. During compression, a slight sticking was noticed. In acidic media, enteric-coated Serratiopeptidase granules break down in two hours. Therefore, substitute magnesium stearate for magnesium sulphate and increase the enteric coat on serratiopeptidase granules. In F2: Mate's completed tablet was seen when it was compressed. Every physical parameter was deemed adequate. Assay and dissolution on the lower side. Film coating was therefore applied to the tablet. In F3: Every physical parameter was deemed adequate. Assay and dissolution on the lower side prompted us to redesign the formulation with a fresh twist, like the inlay tablet. The tablet formulation with the drug release controlling polymer was the most successful, according to the experimental study mentioned above, since it showed zero order release kinetics, acceptable hardness, and a drug content and release profile (in a more controlled manner over an extended period of time). Additionally, it offers a helpful tool to increase patient compliance and convenience

References

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How to cite this article

Santosh Kitawat and Amul Mishra (2023). Formulation and Evaluation of Modified Release Etodolac Tablets Enhanced with Serratiopeptidase for Improved Anti-Inflammatory Efficacy. Biological Forum – An International Journal, 15(6): 1002-1011