Method of achieving overnight laxation and control of bowel function

• US 6,645,481 B1
• Filed: 09/28/2000
• Issued: 11/11/2003
• Est. Priority Date: 09/28/2000
• Status: Expired due to Term

• Current Assignee: Braintree Laboratories Incorporated (Sebela International Limited)
• Original Assignee: Braintree Laboratories Incorporated (Sebela International Limited)
• Inventors: Pelham, Russell W., Cleveland, Mark vB.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): EVANS, CHARESSE L
• Application Number:
  US09/675,105
• Time in Patent Office: 1,139 Days
• Field of Search: 424/78.01, 424/400, 514/892
• US Class Current: 424/78.01
• CPC Class Codes: A61K 31/765 Polymers containing oxygen
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/06 Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
• CPC Class Codes: A61P 1/10 Laxatives

Abstract

Overnight relief of constipation symptoms is achieved, and control of bowel function is enhanced by oral administration of an effective or sufficient amount of a composition comprising polyethylene glycol (PEG), preferably dispersed and or dissolved in an aqueous medium. The PEG compositions used for the present invention are preferably substantially free of ancillary electrolytes.

Claims

1. A method of achieving overnight relief of constipation symptoms in a patient experiencing constipation, the method comprising the step of administering a laxation-inducing composition consisting essentially of polyethylene glycol, in an amount sufficient to induce a controlled bowel movement within 12 to 24 hours.

2. The method of claim 1 wherein the composition is substantially free of electrolytes.

3. The method of claim 1 wherein the polyethylene glycol has an average molecular weight greater than 1000.

4. The method of claim 1 wherein the polyethylene glycol has an average molecular weight ranging from 3000 to 8000.

5. The method of claim 4 wherein the polyethylene glycol is PEG 3350.

6. The method of claim 1 wherein the composition comprises a dosage from about 5 to about 200 g of polyethylene glycol.

7. The method of claim 6 wherein the composition comprises from about 10 to about 34 g of polyethylene glycol per dose.

8. The method of claim 7 wherein the composition comprises 17 g of polyethylene glycol per dose.

9. The method of claim 8 wherein the polyethylene glycol is dispersed in an aqueous medium.

10. The method of claim 8 wherein the polyethylene glycol is in solid form.

11. The method of claim 8 wherein the composition is administered up to four times per day.

12. The method of claim 1 wherein overnight relief of constipation symptoms in a patient experiencing constipation is achieved by alternately administering the laxation inducing composition for a first period of time and discontinuing administration of the compound for a second period of time.

13. The method of claim 12 wherein the first and the second time periods are of equal duration.

14. The method of claim 12 wherein the first and the second time periods are unequal in duration.

26. The method of claim 12 wherein control is achieved for several days even after the composition is discontinued.

15. A method of enhancing a patient'"'"'s control of bowel function, the method comprising the step of administering a laxation-inducing composition consisting essentially of polyethylene glycol, in an amount sufficient to enhance control of bowel function within 12 to 24 hours.

16. The method of claim 15 wherein the composition is substantially free of electrolytes.

17. The method of claim 15 wherein the polyethylene glycol has an average molecular weight greater than 1000.

18. The method of claim 15 wherein the polyethylene glycol has an average molecular weight ranging from 3000 to 8000.

19. The method of claim 18 wherein the polyethylene glycol is PEG 3350.

20. The method of claim 15 wherein the composition comprises a dosage from about 5 to about 200 g of polyethylene glycol.

21. The method of claim 20 wherein the composition comprises from about 10 to about 34 g of polyethylene glycol per dose.

22. The method of claim 21 wherein the composition comprises 17 g of polyethylene glycol per dose.

23. The method of claim 22 wherein the polyethylene glycol is dispersed in an aqueous medium.

24. The method of claim 22 wherein the polyethylene glycol is in solid form.

25. The method of claim 22 wherein the composition is administered up to four times per day.

27. The method of claim 15 wherein the patient'"'"'s control of bowel function is enhanced by alternately administering the laxation inducing composition for a first period of time and discontinuing administration of the compound for a second period of time.

28. The method of claim 27 wherein the first and the second time periods are of equal duration.

29. The method of claim 27 wherein the first and the second time periods are unequal in duration.