Short Term Effect of Temperature on Kibow Biotics™

Beena Patel, Rahul Dheer, Joe Marczely, Pari Ranganathan, Tushar Chordia, Natarajan Ranganathan
Kibow Biotech Inc., Philadelphia, PA
3rd World Congress of Nephrology poster presentation, June 26 – 30, 2005, Singapore

Purpose of this study was to evaluate the viability (microbial counts) and potency (urea utilization) of Kibow Biotics™ in simulated environmental conditions. Temperature and humidity was recorded at regular intervals throughout the 14 day study.

Sets of three bottles of Kibow BioticsTM (60 capsule/bottle) were incubated at -20°C, 4°C, 25 ± 2°C (Room Temperature), 37°C, 45°C, and 55°C in temperature controlled incubators. Temperature and humidity measurements were recorded each day using a hygro-thermometer. Product was analyzed every day for viability and potency. The counts for the microbes (Streptococcus thermophilus and Lactobacillus acidophilus) were enumerated on selective media. Potency of the product was determined by measuring urea hydrolysis in AIF (Artificial intestinal fluid) fortified with uremic solutes.

Results show that S. thermophilus and L. acidophilus counts for samples at -20°C, 4°C, and 25±2°C temperatures were stable throughout the 14 day study. Samples at 37°C and 45°C showed a decrease in count after four to five days of incubation, reaching up to greater than 3 to 4 log decreased by the end of study. Cell counts for the 55°C sample decreased by a factor of more than 3 log after 24 hours of incubation.

Potency of Kibow BioticsTM was stable at -20°C, 4°C, 25±2°C and 37°C throughout the study. Even though the viability of product decreased at 45°C, we observed almost 49% urea hydrolysis after 14 days of incubation. At 55°C a decline in urea hydrolysis to 54% was observed after 24 hours.

Data obtained from this study shows that S. thermophilus and L.acidophilus viability was maintained at -20°C, 4°C and 25 ± 2°C throughout 14 days of incubation without any change in the potency of the product.