Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
Name of the ingredient
Bacillus coagulans (ABN)
Definition of the ingredient
The Bacillus coagulans species is a lactic-acid producing, gram-positive, spore-forming, rod-shaped bacterium that is aerobic to microaerophilic. The B. coagulans strain designated by Microbial Type Culture Collection (MTCC) accession number 5260 is a pure, specific strain of Bacillus coagulans Hammer intended for oral use. It is isolated from soil samples contaminated with healthy human faecal matter. The ingredient is prepared by fermentation of culture of MTCC strain 5260 to NLT 300 billion CFU/g. The cell concentrate is spray-dried onto powder. The quality and safety of the microorganism B. coagulans was assessed for the MTCC strain 5260 and the specific requirements listed below are strain specific.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual evaluation | Brown coloured powder with characteristic odour |
| Characteristics | ||
| Loss on drying | USP-NF <731> | NMT 5.0% |
| Identification | ||
| Identity | Microscopic examination | The spores are seen as small terminal oval-shaped retractile bodies at the end of each vegetative cell |
| Lactic acid producing capacity | JPC <111462> Spore forming lactic acid bacteria | NLT 10mL of 0.05N NaOH should be consumed |
| Phenotypic identification | ||
| Purity | Macroscopic examination | White colonies with smooth margins |
| Gram staining | USP <1113> Gram staining | Gram positive rods |
| 16s rRNA gene sequencing | Sudha, MR. et al. (2010)[1] | Match B. coagulans MTCC strain 5260 |
| Gastric juice tolerance | Tokatlı, M. et al. (2015)[2] | >50% survival |
| Bile tolerance | Tokatlı, M. et al. (2015)[2] | Growth on 1.0% bile salt plates |
| Antibiotic resistance | CLSI methods[3] | Sensitive to ampicillin, chloramphenicol, ciprofloxacin, clindamycin, erythormycin, gentamycin, kanamycin, streptomycin, tetracycline and trimethoprim |
| Casein hydrolysis | Hemraj, V. et al. (2013)[4] | Positive - presence of clear zone around colony on casein agar plate |
| Gelatin liquefaction | ASM methods[5] | Positive |
| Starch hydrolysis | ASM methods[6] | Positive - presence of clear zone around colony after addition of iodine |
| Viable spore count | ||
| Viable spore count | JPC <111462> Spore forming lactic acid bacteria - modified | NLT 300 billion CFU/g |
Key to abbreviations
ASM = American Society for Microbiology
CFU = Colony forming units
CLSI = Clinical and Laboratory Standards Institute
ISO = International Organization for Standardization
JPC = Japanese Pharmaceutical Codex
NLT = Not less than
NMT = Not more than
USP = United States Pharmacopoeia
USP-NF = United States Pharmacopeia National Formulary
References
| [1] | Sudha MR. et al. Molecular typing and probiotic attributes of a new strain of Bacillus coagulans – unique IS-2: a Potential Biotherapeutic Agent. Genetic Engineering and Biotechnology Journal. 2010. |
|---|---|
| [2] | Tokatlı M. et al. In Vitro Properties of Potential Probiotic Indigenous Lactic Acid Bacteria Originating from Traditional Pickles. Biomed Res Int. 2015; 2015:315819. |
| [3] | CLSI Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; approved standard, 9th ed. M07-A9. Clinical and Laboratory Standards Institute, Wayne, PA: Clinical and Laboratory Standards Institute, 2012. |
| [4] | Hemraj, V. et al. A Review on Commonly Used Biochemical Test for Bacteria. Innovare J Life Sci. 2013; 1(1):1-7. |
| [5] | dela Cruz, T. E. E. & Torres, J. M. O. Gelatin Hydrolysis Test Protocol. Am Soc Microbiol, 2012. |
| [6] | Sigmon, J. The Starch Hydrolysis Test. Am Soc Microbiol, 2008. |