Compositions and methods for the treatment or the prevention of;infections and for the eradication or reduction of;surfaces

• US 9,084,784 B2
• Filed: 01/06/2010
• Issued: 07/21/2015
• Est. Priority Date: 01/06/2009
• Status: Active Grant

• Current Assignee: Galenagen, LLC
• Original Assignee: Curelon LLC
• Inventors: Fallon, Joan M., Heil, Matthew, Fallon, James J.
• Primary Examiner(s): Carlson, Karen Cochrane
• Assistant Examiner(s): Tichy, Jennifer M. H.
• Application Number:
  US13/144,290
• Publication Number:
  US 20110280854A1
• Time in Patent Office: 2,022 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A01N 63/50 Isolated enzymes; Isolated proteins peptides A01N37/46
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/465 acting on ester bonds (3.1), e.g. lipases, ribonucleases
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• CPC Class Codes: A61K 38/4826 Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/12 Antidiarrhoeals
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 31/02 Local antiseptics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Compositions and methods for treating or preventing E. coli infections are provided. The compositions can be formulated as pharmaceutical compositions or as disinfectants, sanitizers, detergents or antiseptics, and can be used to eradicate or reduce E. coli populations and thereby treat or prevent infection by E. coli. The compositions include one or more digestive enzymes, e.g., one or more protease, lipases, and amylases. Methods of use of the compositions are also provided.

Claims

1. A method for the treatment or prevention of Escherichia coli infection in a bird or a mammal, comprising administering to the bird or mammal a therapeutically effective amount of an oral pharmaceutical composition comprising a pharmaceutically acceptable excipient and digestive enzymes comprising a protease, an amylase, and a lipase, wherein the pharmaceutical composition is bacteriocidal or bacteriostatic for Escherichia coli, wherein the pharmaceutical composition is formulated for oral administration, and wherein a ratio of total protease to total lipase ranges from about 1:

1 to about 20;

1.

2. The method of claim 1, wherein the digestive enzymes further comprise one or more cellulases, sucrases, or maltases.

3. The method of claim 1, wherein the digestive enzymes are pancreatic enzymes.

4. The method of claim 3, wherein the pancreatic enzymes are porcine pancreatic enzymes.

5. The method of claim 1, wherein the protease comprises chymotrypsin and trypsin.

6. The method of claim 1, wherein the digestive enzymes are, independently, from an animal source, a microbial source, a plant source, a fungal source, or are synthetically prepared.

7. The method of claim 1, wherein the mammal is a pig, horse, cow, dog, cat, monkey, rat, mouse, sheep, goat, or human, and wherein the bird is a chicken, duck, turkey, or goose.

8. The method of claim 6, where the digestive enzymes are from an animal source that is a pig pancreas.

9. The method of claim 1, wherein the ratio of total protease to total lipase ranges from about 4:

1 to about 10;

1.

10. The method of claim 1, wherein the pharmaceutical composition is a dosage formulation selected from the group consisting of:

pills, tablets, capsules, caplets, sprinkles, emulsions, powders, liquids, gels, and a combination of thereof.

11. The method of claim 1, wherein the pharmaceutical composition is effective against STEC (Shiga toxin-producing Escherichia coli).

12. The method of claim 1, wherein the pharmaceutical composition is effective against ETEC (Enterotoxigenic Escherichia coli) or EPEC (Enteropathogenic Escherichia coli).

13. The method of claim 1, further comprising administering a beta-lactam antibiotic to the bird or mammal.

14. The method of claim 1, wherein the ratio of total protease to total lipase is about 4:

1.

15. The method of claim 1, wherein the ratio of total protease to total lipase is about 5:

1.

16. The method of claim 1, wherein the ratio of total protease to total lipase is about 7:

1.

17. The method of claim 1, wherein the ratio of total protease to total lipase is about 10:

1.

18. The method of claim 1, wherein the ratio of total protease to total lipase is about 12:

1.

19. The method of claim 1, wherein the pharmaceutical composition comprises about 200 USP units/mg of protease, about 40 USP units/mg of lipase, and about 250 USP units/mg of amylase.