Dry glassy composition comprising a bioactive material

• US 9,731,020 B2
• Filed: 08/11/2014
• Issued: 08/15/2017
• Est. Priority Date: 01/28/2010
• Status: Active Grant

• Current Assignee: Advanced Bionutrition Corporation
• Original Assignee: Advanced Bionutrition Corporation
• Inventors: Harel, Moti, Drewes, Roger, Scarbrough, January
• Primary Examiner(s): Pak, John
• Assistant Examiner(s): BRANSON, DANIEL L
• Application Number:
  US14/456,130
• Publication Number:
  US 20150031544A1
• Time in Patent Office: 1,100 Days
• Field of Search: None
• CPC Class Codes: A01N 31/04 Oxygen or sulfur attached to an aliphatic side-chain of a carbocyclic ring system
• CPC Class Codes: A23K 10/18 of live microorganisms
• CPC Class Codes: A23K 50/80 for aquatic animals, e.g. fish, crustaceans or molluscs
• CPC Class Codes: A23L 2/52 Adding ingredients adding preservatives A23L2/44
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2400/175 Rhamnosus
• CPC Class Codes: A23V 2400/531 Lactis
• CPC Class Codes: A61K 31/07 Retinol compounds, e.g. vitamin A retinoic acids A61K31/203
• 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 38/482 Serine endopeptidases (3.4.21)
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/1623 Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61K 9/1658 Proteins, e.g. albumin, gelatin
• 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 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: C12Y 304/21062 : Subtilisin (3.4.21.62)

Abstract

The present invention relates to formulations and methods for stabilizing and protecting of biologic materials during harsh storing and use conditions, wherein the formulations relate to embedded bioactive materials and biologics, including live bacteria, in a protective glassy matrix.

Claims

1. A method for preparing a dry glassy composition without boiling or foaming, said method comprising:

(a) combining a bioactive material, a matrix forming agent and two glass forming agents in an aqueous solvent to form a viscous slurry;

(b) snap-freezing the slurry in liquid nitrogen to form solid frozen particles in a form of beads, droplets or strings;

(c) primary drying the frozen particles by evaporation under reduced pressure and heat sufficient to maintain the particles temperature above freezing point of the frozen particles, whereby a primarily dried formulation is formed; and

(d) secondary drying the primarily dried formulation at full vacuum and a temperature of 20°

C. or higher for a time sufficient to reduce the water activity of the primarily dried formulation to Aw 0.3 or lower, whereby the dry glassy composition is prepared.

2. The method of claim 1, further comprising purging the frozen particles before primary drying the frozen particles.

3. The method of claim 1, wherein the total pressure on the frozen particles in the primary drying step is greater than 2,000 mTORR.

4. The method of claim 1, wherein the total pressure on the frozen particles in the primary drying step is between 2,000 mTORR and 4,000 mTORR.

5. The method of claim 1, wherein the total pressure on the frozen particles in the primary drying step is between 2,000 mTORR and 10,000 mTORR.

6. The method of claim 1, wherein the temperature in the primary drying step is greater than −

10°

C.

7. The method of claim 1, wherein the temperature in the primary drying step is between −

5°

C. and +5°

C.

8. The method of claim 1, wherein the temperature in the secondary drying step is between 20°

C. and 70°

C.

9. The method of claim 1, wherein the temperature or vacuum is increased during the secondary drying step.

10. The method of claim 1, further comprising cutting, crushing, milling or pulverizing the composition Into a free flowing powder.

11. The method of claim 10, wherein particle size of the powder is less than 1000 μ

m.

12. The method of claim 1, further comprising administering the composition to an animal or plant as a reconstituted liquid or as a ground powder in a food or feed product.

13. The method of claim 1, further comprising (a) mixing the composition with a component selected from the group consisting of infant formula, functional beverages, and pet food;

and (b) administering the mixture from step (a) to a human infant, a human adult, an animal or a plant.

14. A dry glassy composition, comprising a bioactive material, at least one matrix forming agent and at least two glass forming agents, wherein the composition is prepared by the method of claim 1.

15. The composition of claim 14, wherein the composition comprises total solids ranging from 30 weight percent to 70 weight percent.

16. The composition of claim 14, wherein the bioactive material comprises a cell, a microbe, a virus, a cell culture, a bacteria, a probiotic bacteria, a plant and soil probiotic bacteria, a yeast, a protein, a recombinant protein, an enzyme, a peptide, a hormone, a vaccine, a drug, an antibiotic, a vitamin, a carotenoid, a mineral, a microbiocide, a fungicide, a herbicide, an insecticide or a spermicide.

17. The composition of claim 14, wherein the matrix forming agent is selected from the group consisting of:

cellulose acetate phthalate (CAP), carboxy-methyl-cellulose, pectin, sodium alginate, salts of alginic acid, hydroxyl propyl methyl cellulose (HPMC), methyl cellulose, carrageenan, guar gum, gum acacia, xanthan gum, locust bean gum, chitosan and chitosan derivatives, starches and modified starches, cyclodextrins, Inulin, maltodextrins, dextrans, and combinations thereof.

18. The composition of claim 14, wherein the matrix forming agent is present in the composition in an amount ranging from 1 weight percent to 20 weight percent.

19. The composition of claim 14, wherein each of the glass forming agents is selected from the group consisting of proteins, carbohydrates, amino acids, methylamine, polyol, propylene glycol, polyethylene glycol, surfactants, phospholipids, and combinations thereof.

20. The composition of claim 14, wherein the glass forming agents are present in the composition in an amount ranging from 1 weight percent to 80 weight percent.