Delivery vehicle for probiotic bacteria comprising a dry matrix of polysaccharides, saccharides and polyols in a glass form and methods of making same

• US 8,968,721 B2
• Filed: 04/30/2012
• Issued: 03/03/2015
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: Advanced Bionutrition Corporation
• Original Assignee: Advanced Bionutrition Corporation
• Inventors: Harel, Mordechi
• Primary Examiner(s): HANLEY, SUSAN MARIE
• Application Number:
  US13/459,408
• Publication Number:
  US 20120288483A1
• Time in Patent Office: 1,037 Days
• Field of Search: 424/93.1, 424/93.4, 424/93.44, 424/93.45, 424/93.46, 424/93.461, 424/93.462, 424/93.48
• US Class Current: 424/93.4
• CPC Class Codes: A23L 29/256 from seaweeds, e.g. alginates, agar or carrageenan
• CPC Class Codes: A23L 29/30 containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin products from apiculture A23L21/20; artificial sweetening agents A23L27/30
• CPC Class Codes: A23L 29/37 Sugar alcohols
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23P 10/30 Encapsulation of particles, e.g. foodstuff additives
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/224 Encapsulating agent
• CPC Class Codes: A23V 2200/3204 Probiotics, living bacteria to be ingested for action in the digestive tract
• CPC Class Codes: A23V 2250/5026 Alginate
• CPC Class Codes: A23V 2250/636 Trehalose
• CPC Class Codes: A23V 2250/64 Sugar alcohols
• CPC Class Codes: A61K 2035/115 Probiotics
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/19 lyophilised , i.e. freeze-dried, solutions or dispersions lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system

Abstract

The disclosure relates to a solid glass matrix of polysaccharides, monossaccharides or disaccharides in combination with polyols as delivery vehicles for preservation and post gastric administration of a probiotic. The delivery vehicle is capable of releasing the probiotic at their site of action. The present invention further includes methods of making and using the solid glass matrix delivery vehicle of the invention.

Claims

1. A dry composition in a solid glass form suitable for oral delivery, comprising a polysaccharide, one or more saccharides, a sugar alcohol, and a probiotic bacterium, wherein the ratio of the one or more saccharides to the sugar alcohol is 3:

1 to 1;

3, and wherein the sugar alcohol is selected from the group consisting of mannitol, glycerol, sorbitol, xylitol, maltitol, lactitol and isomalt.

2. The composition according to claim 1, wherein the probiotic bacterium is selected from the group consisting of live Lactobacillus, Bifidobacterium, Enterococcus, Propionobacterium, Bacillus and Streptococcus.

3. The composition according to claim 1, wherein the polysaccharide is selected from the group consisting of starch, non-digestible starch, pectin, inulin, xanthan gum, alginate, alginic acid, chitosan, carrageenan, carboxymethyl cellulose, methyl cellulose, guar gum, gum arabic, locust bean gum and combinations thereof.

4. The composition according to claim 1, wherein a combination of the one or more saccharides and the sugar alcohol is selected from the group consisting of trehalose/isomalt, sucrose/isomalt and inulin/isomalt.

5. The composition according to claim 1, further comprising an additive selected from the group consisting of proteins, amino acids, buffers, preservatives and antioxidants.

6. The composition according to claim 5, wherein the protein is albumen and the antioxidant is ascorbic acid.

7. The composition according to claim 1, wherein the ratio of the one or more saccharides to the sugar alcohol is 3:

1.

8. The composition according to claim 1, wherein a combination of the one or more saccharide and the sugar alcohol is selected from the group consisting of trehalose/glycerol, trehalose/mannitol, trehalose/maltitol, trehalose/isomalt, trehalose/adonitol, trehalose/lactitol, trehalose/sorbitol, sucrose/glycerol, sucrose/mannitol, sucrose/maltitol, sucrose/isomalt, sucrose/adonitol, sucrose/lactitol, sucrose/sorbitol, inulin/glycerol, inulin/mannitol, inulin/maltitol, inulin/isomalt, inulin/adonitol, inulin/lactitol, and Inulin inulin/sorbitol.

9. A process for producing a dry composition in a solid form suitable for oral delivery, wherein the composition comprises a polysaccharide, one or more saccharides, a sugar alcohol, and a probiotic bacterium, the process comprising:

a) dispersing under heating conditions the polysaccharide in water;

b) adding the one or more saccharides, the sugar alcohol, and the probiotic bacterium to form a slurry, wherein the ratio of the one or more saccharide to the sugar alcohol is 3;

1 to 1;

3, and wherein the sugar alcohol is selected from a group consisting of mannitol, glycerol, sorbitol, xylitol, maltitol, lactitol and isomalt;

c) contacting the slurry with a Ca⁺⁺ ion containing bath for a sufficient time to allow cross-linking thereby forming a gel matrix;

d) maintaining the temperature of the gel matrix in a drier above the freezing temperature of the gel matrix;

e) reducing the pressure during a first drying stage and maintaining the gel matrix temperature from −

10°

C. to about +40°

C. for a first period of time; and

f) further reducing the pressure during a second drying stage and increasing the gel matrix temperature to between about +40°

C. to about +50°

C. for a second period of time, whereby the composition is obtained.

10. The process according to claim 9, wherein the pressure during the first stage is reduced to about 2,500 mTOR and the pressure at the second stage is maintained less that 100 mTOR.

11. The process according to claim 9, wherein the first period of time is from 12 to 16 hours and the second period time is from 12 to 48 hours.

12. The process according to claim 9, wherein contacting the slurry of step c) comprises extruding the slurry into the Ca⁺⁺ ion containing bath and forming gel matrix strings that are crosslinked while retained in the bath.

13. The process according to claim 9, wherein the gel matrix of step c) is formed by internal cross linking the polysaccharide with the Ca⁺⁺ ion and sliced to form threads before placement in the drier.

14. The process according to claim 9, wherein the probiotic bacterium is selected from the group consisting of live Lactobacillus, Bifidobacterium, Enterococcus, Propionobacterium, Bacillus and Streptococcus.

15. The process according to claim 9, wherein the polysaccharide is selected from the group consisting of starch, non-digestible starch, pectin, inulin, xanthan gum, alginate, alginic acid, chitosan, carrageenan, carboxymethyl cellulose, methyl cellulose, guar gum, gum arabic, locust bean gum and combinations thereof.

16. The process according to claim 9, wherein a combination of the one or more saccharides and the sugar alcohol is selected from the group consisting of trehalose/isomalt, sucrose/isomalt and inulin/isomalt.

17. The process according to claim 9, wherein the ratio of the one or more saccharides to the sugar alcohol is 3:

1.