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Unique IS-2 is a clinically tested Bacillus coagulans probiotic strain that is said to be stable at room temperature, maintaining 90% activity even after two years of storage.
Sofgel manufacturing specialist Robinson Pharma Inc. (RPI; Santa Ana, CA) has introduced the Unique IS-2 probiotic softgel. The easy-to-swallow, shelf-stable softgel is the result of an exclusive partnership with probiotic ingredient supplier Unique Biotech (Davie, FL).
Unique IS-2 is a clinically tested Bacillus coagulans probiotic strain that is said to be stable at room temperature, maintaining 90% activity even after two years of storage. It is highly resistant to extreme temperatures and humidity, the companies say. Additionally, it is resistant to gastric acids, enhancing bacterial survival during transit through the gastrointestinal tract.
“Probiotics are, and will continue to be, one of the most exciting categories in the supplement and food industry,” said Robinson Pharma in a press release. “RPI recognized more than a year ago that the category lacked an easy-to-swallow, soft gelatin capsule of a documented and researched strain offering a guaranteed shelf life.”
B&D Nutritional Ingredients Inc. (Vista, CA), the exclusive U.S. distributor of Unique IS-2, helped connect the two companies, Robinson Pharma and Unique Biotech.
Developing a successful probiotic softgel was challenging, says Robinson Pharma. “The specific challenges of creating a stable and active probiotic softgel is multifaceted and rigorous,” says Fred Jamee, senior vice president and chief quality officer at Robinson Pharma. In addition to finding a probiotic strain that can survive the softgel manufacturing process, it was even more challenging to test the probiotic bacteria’s viability after it was encapsulated. “Recovery of the active probiotic from the lipid matrix of a softgel is not easy,” Jamee explains.
He says the firm, along with teams at Unique Biotech and B&D Nutritional ingredients, hired a third-party laboratory to perform accelerated stability testing. The laboratory analyzed the probiotic’s viability, presence, and identity in this dosage form using DNA sequencing and a published analytical method.