Design, Formulation, and Evaluation of anOral Drop of Probiotic for Infants
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Abstract
Background: Probiotics are helpful in treating conditions like diarrhea and eczema in infants. The lactic acid
bacteria, from diverse sources, are of great importance as probiotics. The current study deals with the formulation
development and optimization of oral probiotic drop of Bacillus coagulans for infants by the central composite
design (CCD). Materials and Methods: Oral probiotic drops of B. coagulans for infants were manufactured with
the help of fennel oil, pepsin enzyme, lecithin, and distilled water. The formula was optimized through CCD design
and taken further for pepsin activity and viability assessment in SGF. Results: In this study, the CCD method was
used to successfully design and optimize an oral probiotic drop of B. coagulans for newborns. The pepsin enzyme
was discovered to be compatible with the B. coagulans spores. The emulsifier (lecithin) concentration and probe
sonication time both had an impact on the responses (independent variables), droplet size (DS), polydispersity
index (PDI), and zeta potential (ZP). The researchers concluded that the ideal formulation of B. coagulans oral
probiotic drop should be made with an emulsifier (lecithin) of 7 mg, with a probe sonication time of 10 min, and
DS, PDI, and ZP measured at 161.24 nm, 0.219, and −33 mV, respectively. The optimized formulation shows
about 50% of pepsin activity, viability of probiotic in simulated gastric fluid of 1 × 107 colony-forming unit (CFU),
total viable count of formulation containing pepsin enzyme is 4.1 × 107 CFU, and total viable count of formulation
without pepsin enzyme is 2.02 × 107 CFU. Finally, stability tests performed at room temperature highlighted a
bacterial viability of 4.1 × 107 CFU and 4.04 × 107 CFU after 1 and 3 months, respectively. Conclusion: The
optimized formulation was demonstrated for the viability of the oral probiotic drop containing B. coagulans in
simulated gastric conditions, pepsin activity, total viable count, and a 3-month stability study was performed.
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