Abstract

EVALUATION OF MICROBIOLOGICAL AND PHYSICOCHEMICAL PROFILE OF PROBIOTIC LACTOBACILLUS SPOROGENES AS A BIOTHERAPEUTICS AGENT

Himanshu K. Solanki* and Dushyant A. Shah

ABSTRACT

Introduction: The aim of the present study was to evaluate microbiological and physicochemical profile of probiotic Lactobacillus sporogenes spores to aid designing of stable formulations. The probiotic are susceptible to loss in viability due to formulation, processing, storage and in vivo environment. Lactobacillus sporogenes a revolutionary new friendly bacteria naturally occurring in the intestine. It is a spore-forming bacterium that makes it the choice of probiotic with enormous clinical applications. Methods: Lactobacillus sporogenes spores were studied for microbiological studies, organoleptic properties, Microscopic examination, Scanning electron microscopy (SEM), X-ray diffraction study, Grams staining, catalase test, Bile salt tolerance, Quantitative test for lactic acid Production, Microbial limit test, Loss on Drying, aqueous pH stability, flow properties and excipient compatibility. Result and Conclusions: Aqueous suspension of Lactobacillus sporogeness in buffer solutions of pH 1.2 to 8 showed rapid degradation with maximal stablility in intestinal pH 6.8. The spores were found to be compatible with the excipients evaluated, with noted exception of Sodium alginate, HPMC K4M, Sodium CMC, Carbopol 934 P. The physicochemical profiling of L. sporogenes presented in the study provides understanding of the material attributes critical to product design in terms of selection of formulation ingredients, process conditions and pack suitability.

Keywords: Probiotic, Lactobacillus sporogenes, Characterization, Stability, Biotherapeutics Agent.