Journal
PHARMACEUTICAL RESEARCH
Volume 29, Issue 6, Pages 1444-1453Publisher
SPRINGER/PLENUM PUBLISHERS
DOI: 10.1007/s11095-011-0620-5
Keywords
biopharmaceutical factors; gastrointestinal models; probiotics; viability
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To evaluate the influence of the main biopharmaceutical factors on the viability of a new probiotic yeast strain, using dynamic systems simulating human gastric/small intestinal (TIM) and large intestinal (ARCOL) environments. The viability of CNCM I-3856 throughout the artificial digestive tract was determined by microbial counting. We investigated the effects of galenic formulation, food intake, dose, mode and frequency of administration on yeast survival rate. In both fasted and fed states, yeast viability in the upper digestive tract was significantly higher when the probiotic was administered in hydroxypropylmethylcellulose (HPMC) capsules compared to tablets. Food intake led to a delay in yeast release and a two-fold increase in strain survival. Whatever the dose, yeasts were particularly sensitive to the large intestinal environment. High concentrations of probiotic could only be maintained in the colon when it was inoculated twice a day over a 5-h-period. TIM and ARCOL are complementary tools relevant for screening purposes, supplying valuable information on the effects of galenic form, food intake and dose regimen on the viability of probiotics throughout the human digestive tract.
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