IP Library Granted Patent US 6,946,149
Granted Patent B2
US 6,946,149 · App. 10/135,857 · Granted Sep 20, 2005

Salt solution for colon cleansing

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Quick Facts
Patent No.
US 6,946,149
App. No.
10/135,857
Granted
Sep 20, 2005
Kind
B2
Abstract

The field of colonic diagnostic and surgical procedures is hampered by the lack of optimal means available to cleanse the colon. A compromise between convenient, distasteful, solid or low volume, hyperosmotic solutions which cause considerable fluid and electrolyte imbalances in patients and large volume, difficult to consume, iso-osmotic solutions has had to be made heretofore. This invention describes a low volume, hyper-osmotic solution consisting of sulfate salts with and with out polyethylene glycol. Unlike prior art, this composition is useful for the cleansing of the bowel and, in lower volumes, as a laxative, without producing clinically significant changes in bodily function.

Claims (29)

1. A composition for inducing purgation of the colon of a patient, the composition comprising a small volume of an aqueous hypertonic solution which comprises an effective amount of one or more salts selected from the group consisting of Na 2 SO 4 , MgSO 4 , and K 2 SO 4 , and an effective amount of PEG, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

2. A composition according to claim 1 , wherein the solution comprises an effective amount of Na 2 SO 4 , an effective amount of MgSO 4 , an effective amount of K 2 SO 4 , and an effective amount of PEG.

3. A composition according to claim 2 , wherein the solution comprises between about 2 grams and about 40 grams of Na 2 SO 4 , between about 2 grams and about 20 grams of MgSO 4 , between about 1 gram and about 10 grams of K 2 SO 4 , and between about 0.1 gram and about 50 grams of PEG.

4. A composition for inducing purgation of the colon of a patient according to claim 1 , wherein the solution comprises about 20 grams of Na 2 SO 4 , about 20 grams of MgSO 4 , about 3 grams of K 2 SO 4 , and about 34 grams of PEG.

5. A composition for inducing purgation of the colon of a patient according to claim 4 , wherein the solution has a volume of less than 500 ml.

6. A composition for inducing purgation of the colon of a patient, comprising a small volume of an aqueous hypertonic solution consisting essentially of an effective amount of one or more salts selected from the group consisting of Na 2 SO 4 , MgSO 4 , and K 2 SO 4 , and an effective amount of PEG, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

7. A composition for inducing purgation of the colon of a patient according to claim 6 , wherein the solution consists essentially of about 20 grams of Na 2 SO 4 , about 20 grams of MgSO 4 , about 3 grams of K 2 SO 4 , and about 34 grams of PEG in about 330 ml of water.

8. A composition according to claim 1 , wherein the solution is from about 100 ml to about 500 ml in volume.

9. A composition according to claim 1 , wherein the solution comprises an effective amount of two or more salts selected from the group consisting of Na 2 SO 4 , MgSO 4 , and K 2 SO 4 , and an effective amount of PEG.

10. A method for inducing colonic purgation in a patient, comprising the steps of:

(a) orally administering an effective amount of the composition of claim 1 to a patient; and

(b) allowing the administered composition to induce colonic purgation.

11. A method for inducing colonic purgation according to claim 10 , wherein the solution consists essentially of about 20 grams of Na 2 SO 4 , about 20 grams of MgSO 4 , about 3 grams of K 2 SO 4 , and about 34 grams of PEG in about 330 ml of water.

12. A method for inducing colonic purgation in a patient according to claim 10 , wherein the effective amount of the composition is administered in two or more doses within a treatment period.

13. The method of claim 10 , wherein about 100 ml to about 500 ml of the solution is administered to the patient.

14. The method of claim 10 , wherein the solution comprises an effective amount of two or more salts selected from group the consisting of Na 2 SO 4 , MgSO 4 , and K 2 SO 4 , and an effective amount of PEG.

15. A composition for inducing purgation of the colon of a patient, the composition comprising a small volume of an aqueous hypertonic solution comprising an effective amount of Na 2 SO 4 , an effective amount of MgSO 4 , and an effective amount of K 2 SO 4 , wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

16. A composition according to claim 15 , wherein the solution comprises between about 2 grams and about 40 grams of Na 2 SO 4 , between about 2 grams and about 20 grams of MgSO 4 , and between about 1 gram and about 10 grams of K 2 SO 4 .

17. A composition according to claim 15 , wherein the solution is from about 100 ml to about 500 ml in volume.

18. A composition for inducing purgation of the colon of a patient comprising a small volume of an aqueous hypertonic solution consisting essentially of an effective amount of Na 2 SO 4 , an effective amount of MgSO 4 , and an effective amount of K 2 SO 4 , wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

19. A method for inducing colonic purgation in a patient, comprising the steps of:

(a) orally administering an effective amount of the composition of claim 18 to a patient; and

(b) allowing the administered composition to induce colonic purgation.

20. A method for inducing colonic purgation in a patient, comprising the steps of:

(a) orally administering an effective amount of the composition of claim 15 to a patient; and

(b) allowing the administered composition to induce colonic purgation.

21. The method of claim 20 , wherein about 100 ml to about 500 ml of the solution is administered to the patient.

22. A method for inducing colonic purgation according to claim 20 , wherein the solution consists essentially of about 20 grams of Na 2 SO 4 , about 20 grams of MgSO 4 , and about 3 grams of K 2 SO 4 .

23. A method for inducing colonic purgation in a patient according to claim 20 , wherein the effective amount of the composition is administered in two or more doses within a treatment period.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2025
From: BRAINTREE LABORATORIES, INC.; SEBELA IRELAND LIMITED
To: AZURITY PHARMACEUTICALS, INC.
Reel/Frame 073290/0852 →
RELEASE OF SECURITY INTEREST Recorded Jul 13, 2021
From: BIOPHARMA CREDIT PLC
To: BRAINTREE LABORATORIES, INC
Reel/Frame 056838/0248 →
SECURITY INTEREST Recorded May 1, 2018
From: BRAINTREE LABORATORIES, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 046050/0242 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 11, 2009
From: CLEVELAND, MARK VB.; FORDTRAN, JOHN S.
To: BRAINTREE LABORATORIES, INC.
Reel/Frame 023502/0181 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2002
From: CLEVELAND, MARK VB.
To: BRAINTREE LABORATORIES, INC.
Reel/Frame 012858/0147 →