Physicochemical Properties and Excipient Compatibility Studies of Probiotic Bacillus coagulans Spores

Abstract

The probiotic formulations are susceptible to loss in viability due to formulation, processing, storage and in vivo environment. The aim of the present study was to perform preformulation studies of probiotic Bacillus coagulans spores to aid designing of stable formulations. Bacillus coagulans spores were studied for hygroscopicity, resistance to compaction force, aqueous pH stability, and excipient compatibility. The spores were found to be moderately hygroscopic with a significant loss of microbiological assay at water activity value of more than 0.5. Progressive loss of viability from 95% to 58% was observed with increase in compaction force from 1000 to 4000 psi. Aqueous suspension of Bacillus coagulans spores in buffer solutions of pH 1.2 to 8 showed rapid degradation with maximal stablility in pH 6.8. Excipient compatibility studies showed reduced assay with citric acid monohydrate, meglumine and sodium starch glycolate. The loss of activity seemed to be related to the moisture uptake, free and bound water present in the bulk.

Development of effervescent products, in powder and tablet form, supplemented with probiotics Lactobacillus acidophilus and Saccharomyces boulardii

“…Conversely, Bora, Puri and Bansal (2009) observed a decline in spore formation in Bacillus coagulans probiotic with an increase in the compression force, indicating that survival also depends on the probiotic species and on the diluent used in the formulation. Maggi et al (2000) also verified a reduction Madureira et al (2005) observed that when pre-incubated in artificial gastric juice for 120 minutes, Lactobacillus acidophilus strain LAC-1 showed a decrease in the number of viable cells by approximately three logarithmic cycles, which also occurred during the 30 minutes of subsequent contact with the bile salts.…”

Structural Stability and Viability of Microencapsulated Probiotic Bacteria: A Review

“…Bacillus coagulans ( BC , formerly Bacillus sporogenes ), a thermotolerant facultative anaerobe lactic acid bacterium, is the most common species of the genus Bacillus in manufactured goods. BC (37 PubMed entries) has not been studied as much as Bacillus subtilis or Bacillus cereus , although it has resulted in the greatest number of pharmaceutical and prepared food developments (including bread and low‐calorie sweeteners) and it is not considered harmful (Bora and others ; Jurenka ). The complete genome sequence of BC strain 36D1 was recently published by Rhee and others (), and its predicted proteome shows a dual phylogeny with Bacillus spp .…”

Physicochemical, microbiological and spoilage analysis of probiotic processed cheese analogues with reduced emulsifying salts during refrigerated storage

“…This fact contributes not only to the flavor of the cheeses but also has an impact on the growth and activity of starter and probiotic microorganisms (Vinderola et al 2002). On the other hand, Bora et al (2009) revealed that aqueous suspension of B. coagulans spores in buffer solutions of pH 1.2 to 8.0 had rapid degradation with maximal stability in pH 6.8. A reduction in pH of probiotic samples up to 5.2 by extending storage time can lead to a decrease in the survival and growth of B. coagulans spores.…”