The Unique IS-2 Bacillus coagulans strain has been the subject of numerous human clinical trials. The challenge and accomplishment was putting these organisms into an easy-to-swallow, shelf stable, soft gelatin dosage.
Probiotics are, and will continue to be, one of the most exciting categories in the supplement and foods industries, RPI noted. The massive growth in category sales and well developed consumer awareness is driven by a strong pedigree of clinical research supporting manifold benefits. 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. Filling this key market niche was the goal of the company’s program.
The Unique IS-2 probiotic softgel in based on the Unique IS-2 Bacillus coagulans strain, a trademarked bacterium that has demonstrated high resistance to extreme temperature and humidity. In addition to temperature stability, the strain is also resistant to gastric acids and the ability to survive transit through the gastro-intestinal tract. The strain type has been the subject of published peer reviewed journal articles investigating safety and relevance to specific health conditions.
“The specific challenges of creating a stable and active probiotic softgel is multifaceted and rigorous,” stated Fred Jamee, senior vice president and chief quality officer at RPI. “First one must identify a strain type that has the potential to survive the manufacturing process. More challenging is testing for the presence and viability of the probiotic after encapsulation. Recovery of the active probiotic from the lipid matrix of a softgel is not easy. Finally and more rigorous still, is creating a product that can withstand the challenges of time, in this case passing an accelerated stability study. Collaboration between the teams at Unique Biotech, B&D Nutritional Ingredients and Robinson Pharma Inc. resulted in a successful solution to these challenges. The analytical results of this project were confirmed by a reputable third party laboratory using a published analytical method. Genus species and strain confirmation in finished product was confirmed through genome analysis utilizing DNA sequencing. “
Upon the recent completion of this work, B&D Nutritional Ingredients, the exclusive U.S. distributor of Unique IS-2, signed an exclusive agreement for the production and sale of soft gelatin capsules containing this high value strain. Robinson Pharma has initiated marketing. For more information www.RobinsonPharma.com