Vitakey Inc. — Department of Health and Human Services SBIR Phase I: 300

Description

Project Summary/Abstract Enteral feeding (EF) is an essential medical procedure used to supply nutrients directly to the gastrointestinal (GI) tract of patients who are unable to eat independently. EF formula is often purchased as a ready-to-use liquid that contains carbohydrates, protein, fats, and micronutrients to ensure adequate nutritional benefit for the patient. The addition of therapeutic probiotics to EF formula has been shown to improve patient health and recovery, while reducing the cost burden to patients and hospitals. However, specific challenges remain which have prevented widespread use. These include:an instability of probiotics in nutrient rich, complex liquid mediums, includinghigh fat, salt, or sugar liquids and biphasic systems such as emulsions andcollo ids,a narrow list of compatible probiotics with marginal therapeutic benefit,a risk of cross-contamination during handling/reconstitution of powder probiotics,sedimentation/aggregation of probiotics, causing blockage of the feeding tube,inactivation of the probiotics by the acidic stomach environment, anda lack of proper adhesion and growth in the gastrointestinal tract. A platform drug delivery technology which encapsulates cells and stabilizes the compounds during storage and digestion while facilitating both mucoadhesion and direct growth on intestinal surfaces has previously been developed and will be optimized for use in liquid EF nutritional formula in this proposal. Lactobacillus rhamnosus HN001, a microbe reported to support gut health and the immune system, will be coated with the platform technology and evaluated for performance and shelf life stability in a complex liquid EF formula. Furthermore, multiple excipients with moisture barrier features will be explored in an effort to extend the liquid shelf life stability.