Method for treating irritable bowel syndrome

• US 20050152989A1
• Filed: 07/09/2004
• Published: 07/14/2005
• Est. Priority Date: 07/09/2003
• Status: Abandoned Application

• Current Assignee: Braintree Laboratories Incorporated (Sebela International Limited)
• Original Assignee: Braintree Laboratories Incorporated (Sebela International Limited)
• Inventors: DiPalma, Jack A., Cleveland, Mark vB., Pelham, Russell W.
• Application Number:
  US10/887,684
• Publication Number:
  US 20050152989A1
• Time in Patent Office: Days
• US Class Current: 424/601
• 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 31/7016 Disaccharides, e.g. lactose, lactulose lactobionic acid A61K31/7032
• CPC Class Codes: A61K 31/717 Celluloses
• CPC Class Codes: A61K 31/736 Glucomannans or galactomannans, e.g. locust bean gum, guar gum
• CPC Class Codes: A61K 31/765 Polymers containing oxygen
• CPC Class Codes: A61K 31/77 of oxiranes
• CPC Class Codes: A61K 31/78 of acrylic acid or derivatives thereof
• CPC Class Codes: A61K 33/04 Sulfur, selenium or tellurium; Compounds thereof
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/42 Phosphorus; Compounds thereof
• CPC Class Codes: A61K 36/48 Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
• CPC Class Codes: A61K 36/68 Plantaginaceae (Plantain Family)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/10 Laxatives

Abstract

The invention provides a method for treating irritable bowel syndrome, comprising administering an osmotic laxative and fiber in a therapeutically effective regimen to a patient in need of such treatment. The therapeutically effective regimen includes administering the formulation in a dose and at a frequency and duration sufficient to reduce or eliminate the symptoms of irritable bowel syndrome or to provide symptomatic or palliative relief to the patient.

Claims

1. A method for treating irritable bowel syndrome, comprising administering a therapeutically effective amount of a formulation comprising an osmotic laxative and a fiber to a patient in need of such treatment.

2. The method of claim 1, wherein the osmotic laxative is selected from the group consisting of magnesium sulphate, magnesium hydroxide, magnesium citrate, sodium phosphate, sodium sulphate, potassium sodium tartrate, lactulose, sorbitol, mannitol, glycerin and polyethylene glycol.

3. The method of claim 1, wherein the osmotic laxative is a polyethylene glycol.

4. The method of claim 3, wherein the osmotic laxative is a polyethylene glycol having an average molecular weight of about 2,000 D to about 10,000 D.

5. The method of claim 4, wherein the osmotic laxative is a polyethylene glycol having an average molecular weight of about 3,000 D to about 4,000 D.

6. The method of claim 3, wherein the osmotic laxative is polyethylene glycol 3350.

7. The method of claim 3, wherein the osmotic laxative is polyethylene glycol 4000.

8. The method of claim 1, wherein the fiber is selected from the group consisting of psyllium fiber, ispaghula, calcium polycarbophil, guar gum, cellulose, methylcellulose, and combinations thereof.

9. The method of claim 1, wherein the fiber is selected from the group consisting of psyllium fiber and cellulose.

10. The method of claim 1, wherein the fiber is psyllium fiber.

11. The method of claim 1, wherein the fiber is cellulose.

12. The method of claim 1, wherein the formulation is administered orally.

13. The method of claim 12, wherein the formulation is administered once daily.

14. The method of claim 12, wherein the formulation is administered at least twice daily.

15. The method of claim 12, wherein the osmotic laxative and fiber-bulking are present in the formulation in a ratio of about 3:

1 by weight.

16. The method of claim 12, wherein the osmotic laxative and fiber are present in the formulation in a ratio of about 1:

3 by weight.

17. The method of claim 12, wherein the osmotic laxative and fiber are present in the formulation in a ratio of about 1:

1 by weight.

18. The method of claim 1, wherein the osmotic laxative is present in the formulation in a concentration of about 1% to about 40% by weight.

19. The method of claim 18, wherein the osmotic laxative is present in the formulation in a concentration of about 2% to about 20% by weight.

20. The method of claim 18, wherein the osmotic laxative is present in the formulation in a concentration of about 5% to about 15% by weight.

21. The method of claim 1, wherein the fiber agent is present in the formulation in a concentration of about 1% to about 40% by weight.

22. The method of claim 21, wherein the fiber is present in the formulation in a concentration of about 2% to about 20% by weight.

23. The method of claim 21, wherein the fiber is present in the formulation in a concentration of about 5% to about 15% by weight.

24. The method of claim 1, wherein the formulation comprises about 17 grams of PEG 3350 and about 3 grams to about 6 grams of psyllium.

25. The method of claim 24, wherein the formulation is administered once daily for up to about 12 weeks.

26. The method of claim 1, wherein the formulation comprises about 17 grams of PEG 3350 and about 15 grams to about 24 grams of cellulose.

27. The method of claim 26, wherein the formulation is administered once daily for up to about 12 weeks.