Polyethylene glycol colonic purgative composition

• US 20080260682A1
• Filed: 11/02/2007
• Published: 10/23/2008
• Est. Priority Date: 05/06/2005
• Status: Abandoned Application

• Current Assignee: Salix Pharmaceuticals Limited (Bausch Health Cos., Inc.)
• Original Assignee: Salix Pharmaceuticals Incorporated (Bausch Health Cos., Inc.)
• Inventors: Rose, Martin, Skiendzielewski, Stephen, Apple, Robert
• Application Number:
  US11/982,603
• Publication Number:
  US 20080260682A1
• Time in Patent Office: Days
• US Class Current: 424/78.38
• CPC Class Codes: A61K 31/74 Synthetic polymeric materials
• CPC Class Codes: A61K 31/765 Polymers containing oxygen
• CPC Class Codes: A61K 31/77 of oxiranes
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61P 1/10 Laxatives

Abstract

This invention relates to novel colonic purgative compositions of polyethylene glycol having an average molecular weight of at least 1,000 or at least 4,000. Further, this invention relates to methods of using the colonic purgative compositions. The formulations and methods of this invention are particularly useful to cleanse the bowel prior to diagnostic and surgical procedures and can also be employed in lower dosages as a laxative to promote elimination and/or to relieve constipation.

Claims

1. A colonic purgative formulation comprising a therapeutically effective amount of polyethylene glycol having an average molecular weight of at least 4000 and optional electrolytes.

2. The formulation of claim 1, wherein the polyethylene glycol comprises an average molecular weight of from 4000 to 20000.

3. The formulation of claim 1, wherein the polyethylene glycol comprises PEG 8000.

4. A daily dosage of the formulation of claim 3 for use as a laxative, comprising from 10 to 100 g of PEG 8000 and optional electrolytes.

5. A daily dosage of the formulation of claim 3 for use as a complete purgative, comprising from 100 to 1000 g of PEG 8000 and optional electrolytes.

6. A kit comprising the colonic purgative formulation of claim 1.

7. A method of purging the colon of a patient comprising administering to the patient the colonic purgative formulation of claim 1 and allowing said formulation to purge the colon.

8. The method of claim 7, wherein the purging of the colon results in partial purgation for laxative purposes.

9. The method of claim 7, wherein the purging of the colon results in complete purgation for surgical or diagnostic purposes.

10. A method of purging the colon of a patient, comprising:

(a) administering to the patient the colonic purgative formulation of claim 1; and

(b) maintaining the elimination or promoting the elimination of feces in the bowel.

11. A method of treating a patient with, or susceptible to, a gastrointestinal disorder, comprising:

(a) administering to the patient the colonic purgative formulation of claim 1; and

(b) maintaining or promoting the elimination of feces in the bowel.

12. The method of claim 11, wherein the gastrointestinal disorder is constipation.

15. A method of treating a patient suffering from, or susceptible to, constipation, or constipation due to administration of a medication which causes constipation as a side effect in some patients comprising:

(a) administering to the patient the colonic purgative formulation of claim 1; and

(b) maintaining or promoting the elimination of feces in the bowel, wherein the constipation is due to at least one of travel;

change in daily routine;

lack of exercise;

immobility caused by injury, illness, or aging;

dehydration;

irritable bowel syndrome;

pregnancy;

diabetes;

hypothyroidism;

hypercalcemia;

cancer of the colon or rectum;

uterine prolapse;

vaginal vault prolapse;

rectal prolapse;

scarring from surgery;

injury of the colon or rectum;

Parkinson'"'"'s disease;

multiple sclerosis;

stroke;

hemorrhoids or anal fissures;

delaying bowel movements;

anxiety;

depression;

eating disorders; and

obsessive-compulsive disorder.

16. The method of claim 7, wherein the patient is administered the colonic purgative formulation in at least one application.

17. The method of claim 7, wherein the administration occurs orally, rectally, through a feeding tube, or through a nasogastric tube.

18. The method of claim 7, wherein the polyethylene glycol is dispersed or dissolved in an aqueous medium.

19. The method of claim 7, wherein the polyethylene glycol is administered in a solid form.

20. The method of claim 7, wherein the colonic purgative formulation consists essentially of from 10 to 1000 g of polyethylene glycol per unit dose and optional electrolytes.

13. (canceled)

14. (canceled)

21. A kit comprising two, two-liter containers, wherein each two-liter container contains a colonic purgative formulation of polyethylene glycol having an average molecular weight of at least 1000.

22. The kit of claim 21, wherein the polyethylene glycol has an average molecular weight of from 3000 to 8000.

25. The kit of claim 21, further comprising at least one electrolyte in each two-liter container.

29. A method of complete purgation of the colon of a patient, comprising:

(a) reconstituting or dissolving the colonic purgative formulation of claim 21 with an aqueous substance;

(b) orally ingesting the liquid colonic purgative formulation; and

(c) allowing said formulation to purge the colon.

30. The method of claim 29, further comprising supplying the patient with the kit of claim 21.

23. (canceled)

27. The kit of claim 23, wherein the polyethylene glycol is present in a dose of from 100 to 300 g in each container.

28. The kit of claim 23, wherein the two, two-liter containers are packaged together in a box, a bag, or shrink wrap.

24. (canceled)

26. (canceled)