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

• US 9,737,578 B2
• Filed: 03/11/2015
• Issued: 08/22/2017
• Est. Priority Date: 12/28/2005
• Status: Expired due to Fees

• Current Assignee: Advanced Bionutrition Corporation
• Original Assignee: Advanced Bionutrition Corporation
• Inventors: Harel, Mordechi, Kohavi-Beck, Keren
• Primary Examiner(s): HANLEY, SUSAN MARIE
• Application Number:
  US14/644,248
• Publication Number:
  US 20150190439A1
• Time in Patent Office: 895 Days
• 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 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, a saccharide, a polyol, and a probiotic bacterium, wherein the ratio of the saccharide to the polyol is in the range from 3:

1 to 1;

3.

2. The composition of 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.

3. The composition of claim 1, wherein the saccharide is selected from the group consisting of monosaccharides, disaccharides, trisaccharides and oligosaccharides.

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

5. The composition of claim 1, wherein a combination of the saccharide and the polyol 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/sorbitol.

6. The composition of claim 1, further comprising vitamin E.

7. The composition of claim 1, wherein the composition is prepared according to a method comprising:

(a) gelling a mixture comprising the polysaccharide, the saccharide, the polyol and the probiotic bacterium at a low temperature, whereby a gel mixture is made,

(b) slicing the gel mixture into small pieces, and

(c) drying the small pieces under vacuum under conditions suitable for glass formation, whereby the composition is prepared.

8. The composition of claim 7, wherein the method further comprises cross-linking the polysaccharide in step (a).

9. The composition of claim 7, wherein the method further comprises:

(d) maintaining the composition of step (c) at 40°

C.,

(e) applying to the composition from step (d) a first vacuum up to 2,500 mTORR for a first period of time; and

(f) applying to the composition from step (e) a second vacuum at 100 mTORR for a second period of time.

10. The composition of claim 9, wherein the pressure during the first period of time is reduced to 2,500 mTORR.

11. The composition of claim 10, wherein the pressure during the second period of time is reduced to less than 100 mTORR.

12. The composition of claim 10, wherein the pressure during the first period of time is reduced in increments to the pressure during the second period of time.

13. The composition of claim 10, wherein the temperature in the dryer is maintained at 10-20°

C. during the first period of time.

14. The composition of claim 10, wherein the temperature in the dryer is maintained at 40-50°

C. during the second period of time.

15. The composition of claim 10, wherein the first period of time lasts from 12 to 16 hours.

16. The composition of claim 10, wherein the second period of time stage lasts from 12 to 48 hours.

17. The composition of claim 7, 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.

18. The composition of claim 7, wherein the saccharide is selected from the group consisting of monosaccharides, disaccharides, trisaccharides and oligosaccharides.

19. The composition of claim 7, wherein the saccharide is a disaccharide.

20. The composition of claim 7, wherein the saccharide is sucrose.

21. The composition of claim 7, wherein the probiotic bacteria are selected from the group consisting of live Lactobacillus, Bifidobacterium, Enterococcus, Propionobacterium, Bacillus and Streptococcus.

22. The composition of claim 7, further comprising vitamin E.

23. The composition of claim 1, wherein the saccharide is trehalose.

24. The composition of claim 1, wherein the polyol is selected from the group consisting of mannitol, glycerol, sorbitol, xylitol, maltitol, lactitol and isomalt.