Laxative/antidiarrheal composition comprising polyethylene glycol and fiber bulking agent

• US 5,710,183 A
• Filed: 07/14/1995
• Issued: 01/20/1998
• Est. Priority Date: 07/14/1995
• Status: Expired due to Fees

• Current Assignee: Braintree Laboratories Incorporated (Sebela International Limited)
• Original Assignee: George M. Halow
• Inventors: Halow, George M.
• Primary Examiner(s): Reamer, James H.
• Application Number:
  US08/502,773
• Time in Patent Office: 921 Days
• Field of Search: 514/892, 514/723, 424/283, 424/195
• US Class Current: 424/738
• 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 36/235 Foeniculum (fennel)
• CPC Class Codes: A61K 36/68 Plantaginaceae (Plantain Family)

Abstract

The invention provides a composition for the improvement of bowel function comprising polyethylene glycol and, preferably, a fiber bulking agent, in, preferably, at least about equal parts by weight of polyethylene glycol; an optional wetting agent to promote solubility/dispersability of the composition in liquid medium; and an optional gas-reducing agent to counteract effects of intestinal gas production attributable to the ingestion of poorly digestible fiber. The products are quickly effective, do not compromise bowel integrity, and are suitable for long-term use in the clinical or veterinary treatment of constipation and/or diarrhea.

Claims

1. A composition for the improvement of bowel function comprising polyethylene glycol and a fiber bulking agent, wherein the polyethylene glycol is present in a weight ratio of polyethylene glycol to fiber of at least about 1:

2 and no more than about 7;

1.

2. The composition of claim 1, wherein the polyethylene glycol is present in a weight ratio of polyethylene glycol to fiber of at least about 1:

1.

3. The composition of claim 2, wherein the polyethylene glycol is a solid at about 25°

C.

4. The composition of claim 2, wherein the polyethylene glycol is a liquid at about 25°

C.

5. The composition of claim 2, wherein the fiber is psyllium fiber.

6. The compositon of claim 2, wherein the fiber is methyl cellulose fiber.

7. The composition of claim 3, dissolved or dispersed in an aqueous medium.

8. The composition of claim 3, incorporated into a foodstuff.

9. The composition of claim 4, dissolved or dispersed in an aqueous medium.

10. The composition of claim 4, incorporated into a foodstuff.

11. The composition of claim 2, further including a gas-reducing agent in an amount sufficient to counteract intestinal gas production.

12. The composition of claim 11, wherein the gas-reducing agent is derived from fennel seed.

13. The composition of claim 2, further including a wetting agent in an amount sufficient to promote dispersion of the composition in the medium.

14. The composition of claim 13, wherein the wetting agent is a sugar.

15. The composition of claim 4, further including a wetting agent in an amount sufficient to promote dispersion of the composition in the medium.

16. The composition of claim 3, wherein the polyethylene glycol is PEG 3350.

17. The composition of claim 7, wherein the fiber is psyllium, wherein the polyethylene glycol is present in a weight ratio of polymer to fiber of from about 5:

1 to about 6;

1; and

wherein the composition further includes a gas-reducing agent in an amount sufficient to counteract intestinal gas production.

18. The composition of claim 17, wherein the gas-reducing agent is derived from fennel seed.

19. The composition of claim 18, further including a wetting agent in an amount sufficient to promote dispersion of the composition in the medium.

20. The composition of claim 19, wherein the wetting agent is a sugar.

21. The composition of claim 20, wherein the wetting agent is dextrose.

22. The composition of claim 7, wherein the fiber is methyl cellulose, wherein the polyethylene glycol is present in a weight ratio of polymer to fiber of from about 1:

1 to about 1.5;

1; and

wherein the composition further includes a gas-reducing agent in an amount sufficient to counteract intestinal gas production.

23. The composition of claim 22, wherein the gas-reducing agent is derived from fennel seed.

24. The composition of claim 23, further including a wetting agent in an amount sufficient to promote dispersion of the composition in the medium.

25. The composition of claim 24, wherein the wetting agent is a sugar.

26. The composition of claim 25, wherein the wetting agent is dextrose.

27. A dosage for oral administration of the composition of claim 3, containing from about 15 to 25 g of polyethylene glycol.

28. The dosage of the composition of claim 27, containing about 20 g polyethylene glycol.

29. The dosage of claim 27, dissolved or dispersed in from about 6 to 10 fl.oz. of aqueous medium.

30. The dosage of claim 29, wherein the composition further contains a gas-reducing agent derived from fennel seed in an amount sufficient to counteract intestinal gas production.

31. The dosage of claim 30, wherein the composition further comprises a wetting agent in an amount sufficient to disperse the composition in the aqueous medium.

32. A method for improving bowel function in a mammal, comprising orally administering the composition of claim 1 to the mammal, in an amount sufficient to improve bowel motility, stool formation, or both.

33. A method for improving bowel function in a mammal, comprising orally administering polyethylene glycol to the mammal, in an amount sufficient to improve bowel motility, stool formation, or both.