Compositions for treatment of gastro-esophageal reflux disorders

• US 20080213320A1
• Filed: 07/03/2007
• Published: 09/04/2008
• Est. Priority Date: 03/01/2007
• Status: Abandoned Application

• Current Assignee: Jeremy B. Eisenstein
• Original Assignee: Jeremy B. Eisenstein
• Inventors: Eisenstein, Mayer, Eisenstein, Jeremy B.
• Application Number:
  US11/825,005
• Publication Number:
  US 20080213320A1
• Time in Patent Office: Days
• US Class Current: 424/400
• 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 35/745 Bifidobacteria
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 36/28 Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
• CPC Class Codes: A61K 38/46 Hydrolases (3)
• 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 38/48 acting on peptide bonds (3.4)
• CPC Class Codes: A61K 38/4873 Cysteine endopeptidases (3.4.22), e.g. stem bromelain, papain, ficin, cathepsin H
• CPC Class Codes: A61K 38/54 Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
• 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 9/0065 Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents

Abstract

The present invention provides compositions for treatment of gastro-esophageal reflux disorders. The compositions include at least two of the following: (i) one or more digestive enzymes; (ii) one or more probiotics; and (iii) stevia. Also provided are processes for preparing the compositions useful for treatment of gastro-esophageal reflux disorders, and methods of treating subjects against gastro-esophageal reflux disorders, which include administering to a subject a therapeutically effective amount of the compositions of the present invention.

Claims

1. A composition for treatment of a gastro-esophageal reflux disorder, comprising at least two of:

(i) one or more digestive enzymes;

(ii) one or more probiotics; and

(iii) stevia.

2. The composition of claim 1 wherein the one or more digestive enzymes comprises one or more of peptidase, protease, bromelain, papain, amylase, lactase, lipase, and hemicellulase.

3. The composition of claim 1 further comprising about 5,000 HUT to about 30,000 HUT peptidase.

4. The composition of claim 1 further comprising about 15,000 HUT to about 50,000 HUT protease.

5. The composition of claim 1 further comprising about 100 GDU to about 400 GDU bromelain.

6. The composition of claim 1 further comprising about 100,000 PU to about 200,000 PU papain.

7. The composition of claim 1 further comprising about 5,000 DU to about 25,000 DU amylase.

8. The composition of claim 1 further comprising about 500 ALU to about 1,500 ALU lactase.

9. The composition of claim 1 further comprising about 2,500 LU to about 8,000 LU lipase.

10. The composition of claim 1 further comprising about 50 HCU to about 250 HUC hemicellulase.

11. The composition of claim 1 wherein the one or more probiotics comprises one or more of Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium breve, and Bifidobacterium longum.

12. The composition of claim 1 further comprising about 2,500,000,000 CFU of probiotics.

13. The composition of claim 1 further comprising about 10 mg to about 20 mg stevia.

14. The composition of claim 1 wherein the gastro-esophageal reflux disorder is a gastro-esophageal reflux disease (GERD), acid indigestion, over-indulgence of food or drink, acid stomach, sour stomach, waterbrash/regurgitation, heartburn, or dyspepsia.

32. A method of treating a subject against a gastro-esophageal reflux disorder, which comprises administering to the subject a therapeutically effective amount of the composition of claim 1.

15. An oral composition for treatment of a gastro-esophageal reflux disorder, comprising:

a) a vehicle for oral delivery;

b) a water soluble portion; and

c) a coating layer including at least two of;

(i) one or more digestive enzymes;

(ii) one or more probiotics; and

(iii) stevia.

16. The oral composition of claim 15 wherein the one or more digestive enzymes comprises one or more of peptidase, protease, bromelain, papain, amylase, lactase, lipase, and hemicellulase.

17. The oral composition of claim 15 further comprising about 5,000 HUT to about 30,000 HUT peptidase.

18. The oral composition of claim 15 further comprising about 15,000 HUT to about 50,000 HUT protease.

19. The oral composition of claim 15 further comprising about 100 GDU to about 400 GDU bromelain.

20. The oral composition of claim 15 further comprising about 100,000 PU to about 200,000 PU papain.

21. The oral composition of claim 15 further comprising about 5,000 DU to about 25,000 DU amylase.

22. The oral composition of claim 15 further comprising about 500 ALU to about 1,500 ALU lactase.

23. The oral composition of claim 15 further comprising about 2,500 LU to about 8,000 LU lipase.

24. The oral composition of claim 15 further comprising about 50 HCU to about 250 HUC hemicellulase.

25. The oral composition of claim 15 wherein the one or more probiotics comprises one or more of Lactobacillus acidophilus, Lactobacillus casei Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium breve, and Bifidobacterium longum.

26. The oral composition of claim 15 further comprising about 2,500,000,000 CFU of probiotics.

27. The oral composition of claim 15 further comprising about 10 mg to about 20 mg stevia.

28. The oral composition of claim 15 wherein the gastro-esophageal reflux disorder is a gastro-esophageal reflux disease (GERD), acid indigestion, over-indulgence of food or drink, acid stomach, sour stomach, waterbrash/regurgitation, heartburn, or dyspepsia.

33. A method of treating a subject against a gastro-esophageal reflux disorder, which comprises administering to the subject a therapeutically effective amount of the oral composition of claim 15.

29. A process for preparing a composition for treatment of a gastro-esophageal reflux disorder which comprises incorporating at least two of:

(i) one or more digestive enzymes;

(ii) one or more probiotics; and

(iii) stevia, admixing the ingredients until a uniform mixture is obtained and thereafter forming the mixture into a composition suitable for administration to a subject with gastro-esophageal reflux disorder.

30. The process of claim 29 wherein the mixture can be formed into a coating for an oral composition.

31. The process of claim 29 wherein the composition suitable for administration to a subject with gastro-esophageal reflux disorder is a dietary supplement.