Formulation and Evaluation of Serratiopeptidase Loaded Ethosomes for Topical Delivery

Aim: The current study aims to formulate ethosomal gel loaded with serratiopeptidase to improve bioavailability and reduce systemic side effects. Methods: An ethosomal gel formulation loaded with serratiopeptidase was developed, optimized, and evaluated to facilitate topical drug delivery for enhanced therapeutic efficacy. Ethosomes were prepared using ethanol injection technique and 3² factorial design was used for optimization. Nine distinct ethosomal formulations with two different concentrations of soya lecithin and ethanol were evaluated for their % entrapment efficiency, vesicle size, drug content, and zeta potential. The optimized ethosomal formulations were mixed into the gelling base containing Carbopol 934(1%), triethanolamine and methylparaben. The drug content, viscosity, pH, spreadability and in-vitro drug release study employing Franz diffusion cell were further assessed for the generated ethosomal gel. Results: The optimized serratiopeptidase loaded ethosomal formulation F6 with Ethanol: Soya lecithin ratio of (0:1) showed a low vesicle size 158.6nm, % entrapment efficiency of 86.58 % and ZP was found to be -18.1 and PDI was 0.306. The cumulative present release of optimized ethosomal gel (F6) was shown the maximum release was found to be 79.10. TEM analyses for ethosomes nanoparticles were identified to be in spherical shape. On the basis of obtained results of serratiopeptidase loaded ethosomes, gel was formulated by incorporation of optimized formulation F6 into gel base. The gel of serratiopeptidase-loaded ethosomes was prepared by utilizing carbopol 934. The viscosity was found to be 1742±1.20, spreadability 4.3±0.11 and pH 6.32±0.12. The SRP formulation was found to be stable too as per ICH guidelines. Conclusion: The study was successfully completed, focusing on formulating serratiopeptidase-loaded ethosomes for topical delivery to minimize oral side effects and improve drug bioavailability. This approach presents a more effective option for drug delivery through the topical route.