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Claims for Patent: 7,687,075

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Claims for Patent: 7,687,075

Title:Colonic purgative composition with soluble binding agent
Abstract:This invention relates to novel colonic purgative compositions in a solid dosage form, comprising at least one purgative and at least one soluble, or soluble, nonfermentable binder, such as polyethylene glycol. Further, this invention relates to methods of using the colonic purgative compositions. The present compositions and methods are designed to improve patient tolerance and compliance, while at the same time improving the quality of bowel cleansing. 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.
Inventor(s): Skiendzielewski; Stephen (Norristown, PA), Rose; Martin (Bethesda, MD), Do; Ngoc (Bel Air, MD)
Assignee: Salix Pharmaceuticals, Ltd. (Morrisville, NC)
Application Number:10/988,693
Patent Claims: 1. A colonic purgative formulation in a solid dosage tablet form comprising: (a) sodium phosphate; and (b) between 7.5% and 15% of polyethylene glycol by weight, wherein the polyethylene glycol has an average molecular weight of 7,000 to 9,000 daltons and is uniformly distributed in the tablet so that the polyethylene glycol binds the sodium phosphate together to maintain the tablet form, and wherein a dosage of the formulation comprises 42-60 grams of sodium phosphate, and wherein the tablet form is for oral administration.

2. The formulation of claim 1, wherein the sodium phosphate comprises monobasic sodium phosphate, dibasic sodium phosphate, or a combination thereof.

3. The formulation of claim 1, wherein the tablet comprises a lubricant.

4. The formulation of claim 3, wherein the lubricant comprises magnesium stearate.

5. A colonic purgative formulation in tablet form comprising: (a) sodium phosphate monobasic from 45 to 75% by weight; (b) sodium phosphate dibasic from 15 to 30% by weight; (c) polyethylene glycol 8,000 from 5 to 20% by weight, wherein the polyethylene glycol provides a matrix upon which the sodium phosphate monobasic and sodium phosphate dibasic associate together to maintain the tablet form; and (d) magnesium stearate from 0.10 to 1.50% by weight, and wherein all of the weights are based on the total weight of the formulation.

6. A colonic purgative formulation in tablet form, comprising: (a) sodium phosphate from 15 to 90% by weight; (b) polyethylene glycol 8,000 from 5 to 20% by weight, wherein the polyethylene glycol provides a matrix upon which the sodium phosphate associates to maintain the tablet form; and (c) magnesium stearate from 0.10 to 1.50% by weight, and wherein all of the weights are based on the total weight of the formulation.

7. A kit comprising a colonic purgative formulation in tablet form for oral administration, wherein each tablet comprises: (a) at least one soluble binder comprising 5 to 20% polyethylene glycol, wherein the polyethylene glycol has an average molecular weight of 7,000 to 9,000 daltons; and (b) about 1.5 grams of sodium phosphate wherein the polyethylene glycol is distributed throughout the tablet so that the polyethylene glycol binds the sodium phosphate together to maintain the tablet form.

8. The formulation of claim 1, wherein the polyethylene glycol has an average molecular weight of 8,000.

9. The formulation of claim 1, wherein the polyethylene glycol comprises 10% by weight of the formulation.

10. The formulation of claim 1, wherein the tablet disintegrates within about 11 minutes.

11. The formulation of claim 1, wherein the formulation comprises 48 g of sodium phosphate divided between 32 tablets.

12. The formulation of claim 11, wherein the dosage comprises 20 tablets of the formulation being taken as 4 tablets at a time with 8 ounces of clear liquid every 15 minutes an evening before a colonoscopy.

13. The formulation of claim 11, wherein the dosage comprises 12 tablets of the formulation being taken as 4 tablets at a time with 8 ounces of clear liquid beginning 3 to 5 hours before a colonoscopy.

14. The formulation of claim 1, wherein mean increase from baseline of inorganic phosphorus levels occurs after administration of the formulation.

15. The formulation of claim 1, wherein the dosage produces mild catharsis.

16. A colonic purgative formulation in tablet form for oral administration wherein each tablet comprises 7.5% to 15% polyethylene glycol as a binder and about 1.5 grams of sodium phosphate, wherein the polyethylene glycol is admixed with the sodium phosphate in the tablet so that the polyethylene glycol binds the sodium phosphate together to maintain the tablet form and wherein the polyethylene glycol has an average molecular weight of 7,000 to 9,000 daltons.

17. The formulation of claim 16, wherein the tablet comprises about 1100 milligrams of sodium phosphate monobasic.

18. The formulation of claim 16, wherein the tablet comprises about 398 milligrams of sodium phosphate dibasic.

19. The formulation of claim 16, wherein the tablet comprises magnesium stearate.

20. The formulation of claim 16, wherein the tablet comprises about 8.4 milligrams of magnesium stearate.

21. The formulation of claim 16, wherein the tablet has a mass of about 1676 milligrams.

22. The formulation of claim 16, wherein the polyethylene glycol is polyethylene glycol 8000.

23. The formulation of claim 22, wherein the formulation comprises about 10% w/w of polyethylene glycol 8000.

24. A formulation in tablet form for oral administration, wherein each tablet comprises about 167 milligrams of polyethylene glycol having an average molecular weight between 7000 and 9000 daltons, about 1100 milligrams of sodium phosphate monobasic and about 398 milligrams of sodium phosphate dibasic.

25. The formulation of claim 24, wherein the polyethylene glycol is polyethylene glycol 8000.

26. The formulation of claim 24, further comprising magnesium stearate.

27. A purgative for cleansing a colon prior to a colonoscopy, the purgative comprising 48 grams of sodium phosphate in tablet form, wherein each tablet comprises about 1.5 grams of sodium phosphate and wherein the tablet also comprises 7.5% to 15% polyethylene glycol 8000, and wherein the polyethylene glycol is admixed with the sodium phosphate in the tablet so that the polyethylene glycol binds the sodium phosphate together to maintain the tablet form.

28. The purgative of claim 27, wherein each tablet comprises about 1102 milligrams of sodium phosphate monobasic and about 398 milligrams of sodium phosphate dibasic.

29. The purgative of claim 27, wherein each tablet comprises magnesium stearate.

30. The purgative of claim 27, wherein a dosage of the purgative comprises four tablets taken every 15 minutes.

31. A colonic purgative formulation in tablet form for oral administration, comprising sodium phosphate and polyethylene glycol, wherein the polyethylene glycol has an average molecular weight between 7000 and 9000 daltons and is distributed in the tablet so that the polyethylene glycol binds the sodium phosphate together to maintain the tablet form, the tablet made by a method comprising: heating a mixture comprising the sodium phosphate and the polyethylene glycol to the melting point of the polyethylene glycol; and compressing the formulation into a tablet.

32. The colonic purgative formulation of claim 31, wherein the polyethylene glycol is polyethylene glycol 8000.

33. The colonic purgative formulation of claim 31, wherein the mixture is allowed to cool down prior to compressing the formulation into a tablet.

34. The colonic purgative formulation of claim 33, wherein the mixture is allowed to cool down overnight prior to compressing the formulation into a tablet.

35. The formulation of claim 5, wherein the tablet disintegrates within about 11 minutes.

36. The formulation of claim 6, wherein the tablet disintegrates within about 11 minutes.

37. The formulation of claim 16, wherein the tablet disintegrates within about 11 minutes.

38. The formulation of claim 24, wherein the tablet disintegrates within about 11 minutes.

39. The formulation of claim 5, wherein the formulation comprises 32 tablets.

40. The formulation of claim 5, wherein the formulation comprises 40 tablets.

41. The formulation of claim 6, wherein the formulation comprises 32 tablets.

42. The formulation of claim 6, wherein the formulation comprises 40 tablets.

43. The formulation of claim 16, wherein the formulation comprises 32 tablets.

44. The formulation of claim 16, wherein the formulation comprises 40 tablets.

45. The purgative of claim 27, wherein the tablet comprises about 10% w/w of polyethylene glycol 8000.

46. The purgative of claim 27, wherein a dosage of the purgative comprises four tablets taken every 15 minutes for a total of 20 tablets the evening before a colonoscopy procedure.

47. The purgative of claim 27, wherein a dosage of the purgative comprises four tablets taken every 15 minutes for a total of 12 tablets the day of a colonoscopy procedure.

48. The formulation of claim 16 wherein the tablet binder consists essentially of polyethylene glycol.
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