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

• US 8,097,245 B2
• Filed: 12/28/2006
• Issued: 01/17/2012
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: Advanced Bionutrition Corporation
• Original Assignee: Advanced Bionutrition Corporation
• Inventors: Harel, Mordechi, Kohavi-Beck, Keren
• Primary Examiner(s): HANLEY, SUSAN MARIE
• Application Number:
  US12/159,407
• Publication Number:
  US 20090246184A1
• Time in Patent Office: 1,846 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, 435/243, 435/252.1, 435/252.31, 435/252.35, 435/252.4, 435/252.5, 435/252.9, 435/252.3
• 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 33/125 containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates indigestible substances A23L33/21
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23L 5/00 Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
• 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 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/742 Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• CPC Class Codes: A61K 35/745 Bifidobacteria
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• 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
• CPC Class Codes: A61P 1/14 : Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents

Abstract

The disclosure relates to a solid glass matrix of polysaccharide, saccharides and polyols as delivery vehicle 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 process for producing a glass matrix comprising a probiotic bacteria, the process comprising:

a) dispersing under heating conditions at least one polysaccharide in water;

b) adding trehalose, a sugar alcohol and a probiotic bacteria to the dispersed polysaccharide to form a slurry, wherein the ratio of trehalose to 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 bath comprising Ca⁺⁺ ions for a sufficient time to allow cross-linking thereby forming a gel matrix

d) harvesting the gel matrix and placing the harvested gel matrix in a drier wherein the temperature of the harvested gel matrix is maintained above the freezing temperature of water;

e) reducing the pressure during a first drying stage and maintaining the temperature at about 10-20°

C. for a first period of time; and

f) further reducing the pressure during a second drying stage and increasing the temperature to between about 40-50°

C. for a second period of time to produce the glass matrix comprising the probiotic bacteria.

2. The process according to claim 1, 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.

3. The process according to claim 1, wherein the first drying stage is from 12 to 16 hours and the second drying stage is from 12 to 48 hours.

4. The process according to claim 1, wherein pressure during the first stage is slowly reduced in increments to the lower pressure of the second drying stage.

5. The process according to claim 4, wherein the reduction in pressure is in increments of 125 mTOR/hr.

6. The process according to claim 1, wherein contacting the slurry of step c) comprises extruding the slurry into the Ca⁺⁺ ion containing bath and forming matrix strings that crosslink while retained in the bath.

7. The process according to claim 1, wherein the gel matrix of step c) is sliced to form threads before placement in the drier.

8. The process according to claim 1, wherein the probiotic bacteria is selected from the group consisting of Lactobacillus, Bifodobacterium, Enterococcus, Proionobacterium, Bacillus and Streptococcus, wherein said probiotic bacteria is live.

9. The process according to claim 1, wherein the polysaccharide is selected from the group consisting of starch, a 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.

10. The process according to claim 1, wherein the ratio of trehalose to the polyol is about 3:

1.