Formulations to increase in vivo survival of probiotic bacteria and extend their shelf-life
View Patent ↗Disclosed is a formulation for preserving the life of probiotic bacteria during passage through the stomach, while permitting their release in the intestine, and which has a low water activity and correspondingly long shelf life. These formulations are designed to retain potency up to the product expiration date. The formulation includes a substantially water-free mixture of probiotic bacteria with monovalent alginate salts, wherein the mixture has been formed and is maintained in a substantially water-free environment. The alginate salts include sodium-alginate and potassium alginate, but not divalent salts such as magnesium alginate or calcium alginate. Generally, an enteric coating (e.g., gelatin or cellulose encapsulation) for the formulation is provided.
1. A process of forming a formulation of mixture of probiotic bacteria with monovalent alginate salts, comprising:
drying the monovalent alginate salts to a moisture content below 5%; and mixing probiotic bacteria with the dried monovalent alginate salts.
2. The process of claim 1 wherein the method of drying is low temperature vacuum drying.
3. The process according to claim 1 wherein the method of drying is low temperature infrared convection drying.
4. The process of claim 1 further including the step of encapsulating the formulation.
5. The process of claim 4 wherein the formulation is encapsulated in capsule materials that contain one or more of gelatin, cellulose or the capsules include Hydroxypropyl Methylcellulose.
6. The process of claim 5 wherein the capsule materials do not contain any alginates.
7. The process of claim 1 wherein the formulation includes grape skin extract.
8. The process of claim 1 wherein the formulations contain one or more of the following microcrystalline cellulose, anhydrous dextrose, food grade starch, kaolin clay and silica.
9. The process of claim 1 further including the step of freeze-drying or spray drying the probiotic bacteria.
10. The method of claim 1 wherein the formulation has a water activity of between 0.01–0.07.
11. The method of claim 1 wherein the alginate salt is sodium alginate or potassium alginate.
12. The method of claim 1 wherein the probiotic bacteria is from the Lactobacillus or Bifidobacterium genera.
13. The method of claim 1 wherein the weight ratio of sodium alginate to mixture is 10–99%.
14. The method of claim 13 wherein the weight ratio of sodium alginate to mixture is 20%.