A Comparative Evaluation of Bifilac Clausi Vs Enterogermina and Other Selected Brands for Probiosimilarity

Abstract

Purpose: To compare the qualitative and quantitative parameters of various Bacillus clausii brands that are available in the Indian market with the International reference product, Enterogermina. Study Centre: JSS College of Pharmacy, Ooty Study Period: 06th Nov 2022 to 30th Dec 2022 Methods & Materials: Various parameters like total spore count, number of strains isolated (based on their sensitivity/ resistance pattern to antibiotics), pH & Transmittance, antibiotic resistance test, microbial purity, DNA sequencing and species identification were tested with various Bacillus Clausii brands that are available in Indian market and were compared with the International reference product, Enterogermina. Results: Only Bifilac Clausi (Bacillus clausii - TIL 19T, TIL 21C, TIL 28S, TIL 30R) a product of Tablets (India) Limited passed all the qualitative and quantitative parameters in terms of assay, same number of strains (4 strains), taxonomical similarity, pH and suspension clarity, as well as resistance/sensitivity pattern to commonly used antibiotics. Conclusion: Based on the results of the testing of various Bacillus clausii formulations, we conclude that only Bifilac Clausi (Bacillus clausii - TIL 19T, TIL 21C, TIL 28S, TIL 30R) showed a similarity to the International reference product, Enterogermina. Hence Bifilac Clausi was found to be probiosimilar to Enterogermina and is a viable alternative to Enterogermina to provide similar probiotic benefits. Keywords: [Probiosimilar, Bacillus clausii formulation, Indian market, Qualitative & Quantitative parameters, 16S RNA sequence]