IP Library › Granted Patent US 9,579,340
Granted Patent B2
US 9,579,340 · App. 14/846,449 · Granted Feb 28, 2017

Prebiotic formulations and methods of use

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Quick Facts
Patent No.
US 9,579,340
App. No.
14/846,449
Granted
Feb 28, 2017
Kind
B2
Abstract

The invention provides methods and compositions for treating symptoms associated with lactose intolerance and for overall improvement in gastrointestinal health. Described herein are methods and compositions for improving overall gastrointestinal health or for decreasing symptoms of lactose intolerance by administering to subject in need thereof a prebiotic composition, optionally in combination with effective amount of a probiotic microbe or microbes.

Claims (37)

1. An oral dosage form comprising a prebiotic composition, wherein the prebiotic composition comprises 95% or more galactooligosaccharides (GOS) by weight and less than 5% digestible saccharides by weight, wherein the GOS comprises at least 45% by weight trisaccharides.

2. The oral dosage form of claim 1 , further comprising an excipient.

3. The oral dosage form of claim 1 wherein the GOS comprises 1-20% by weight pentasaccharides.

4. The oral dosage form of claim 1 , wherein the dosage form is a solid dosage form.

5. The oral dosage form of claim 1 , wherein the dosage form is a gel dosage form.

6. The oral dosage form of claim 2 , formulated for controlled release.

7. The oral dosage form of claim 2 , further comprising an enteric coating.

8. The oral dosage form of claim 1 , provided as a capsule, tablet, softgel, powder, effervescent form, chewable formulation, or lozenge.

9. The oral dosage form of claim 1 , wherein the digestible saccharides comprise lactose, galactose, or glucose.

10. The oral dosage form of claim 1 , wherein the prebiotic composition comprises about 0.001% to about 1% glucose.

11. The oral dosage form of claim 1 , wherein the prebiotic composition comprises about 0.01% to about 0.1% glucose.

12. The oral dosage form of claim 1 , wherein the prebiotic composition comprises about 0.1% galactose to about 2% galactose.

13. The oral dosage form of claim 1 , wherein the prebiotic composition comprises less than 2% lactose.

14. The oral dosage form of claim 1 , wherein the prebiotic composition comprises less than about 10 ppm heavy metals.

15. The oral dosage form of claim 1 , wherein the prebiotic composition comprises less than about 0.10% by weight sulphated ash.

16. The oral dosage form of claim 1 , comprising about 1 mg to about 20 g of the prebiotic composition.

17. The oral dosage form of claim 1 , wherein the excipient is silicone dioxide or microcrystalline cellulose.

18. The oral dosage form of claim 17 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose.

19. The oral dosage form of claim 2 , further comprising a flavoring and/or colorant.

20. The oral dosage form of claim 1 , wherein the dosage form does not comprise a probiotic.

21. A powder comprising a prebiotic composition and an excipient, wherein the prebiotic composition comprises 95% or more GOS by weight and less than 5% digestible saccharides by weight, wherein the GOS comprises at least 45% by weight trisaccharides.

22. A powder of claim 21 , wherein the GOS comprises 1-20% by weight pentasaccharides and at least 45% trisaccharides.

23. The powder of claim 21 , wherein the GOS comprises 1-10% by weight pentasaccharides.

24. The powder of claim 21 , further comprising an excipient.

25. The powder of claim 21 , comprising about 1 mg to about 20 g of the prebiotic composition.

26. The powder of claim 21 , wherein the excipient is silicone dioxide or microcrystalline cellulose.

27. The powder of claim 26 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose.

28. The powder of claim 24 , further comprising a flavoring and/or colorant.

29. The powder of claim 24 , wherein the sachet does not comprise a probiotic.

30. A sachet comprising a powder, wherein the powder comprises a prebiotic composition, and wherein the prebiotic composition comprises 95% or more GOS by weight and less than 5% digestible saccharides by weight, wherein the GOS comprises at least 45% by weight trisaccharides.

31. A sachet of claim 30 , wherein the GOS comprises 1-10% by weight pentasaccharides and at least 45% trisaccharides.

32. The sachet of claim 30 , further comprising an excipient.

33. The sachet of claim 30 , comprising about 1 mg to about 20 g of the prebiotic composition.

34. The sachet of claim 30 , wherein the excipient is silicone dioxide or microcrystalline cellulose.

35. The sachet of claim 34 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose.

36. The sachet of claim 32 , further comprising a flavoring and/or colorant.

37. The sachet of claim 32 , wherein the sachet does not comprise a probiotic.