Claims for Patent: 6,946,149

Summary for Patent: 6,946,149

Title:	Salt solution for colon cleansing
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.
Inventor(s):	Cleveland; Mark vB. (Duxbury, MA)
Assignee:	Braintree Laboratories, Inc. (Braintree, MA)
Application Number:	10/135,857
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,946,149
Patent Claims:	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.sub.2 SO.sub.4, MgSO.sub.4, and K.sub.2 SO.sub.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.sub.2 SO.sub.4, an effective amount of MgSO.sub.4, an effective amount of K.sub.2 SO.sub.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.sub.2 SO.sub.4, between about 2 grams and about 20 grams of MgSO.sub.4, between about 1 gram and about 10 grams of K.sub.2 SO.sub.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.sub.2 SO.sub.4, about 20 grams of MgSO.sub.4, about 3 grams of K.sub.2 SO.sub.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.sub.2 SO.sub.4, MgSO.sub.4, and K.sub.2 SO.sub.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.sub.2 SO.sub.4, about 20 grams of MgSO.sub.4, about 3 grams of K.sub.2 SO.sub.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.sub.2 SO.sub.4, MgSO.sub.4, and K.sub.2 SO.sub.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.sub.2 SO.sub.4, about 20 grams of MgSO.sub.4, about 3 grams of K.sub.2 SO.sub.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.sub.2 SO.sub.4, MgSO.sub.4, and K.sub.2 SO.sub.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.sub.2 SO.sub.4, an effective amount of MgSO.sub.4, and an effective amount of K.sub.2 SO.sub.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.sub.2 SO.sub.4, between about 2 grams and about 20 grams of MgSO.sub.4, and between about 1 gram and about 10 grams of K.sub.2 SO.sub.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.sub.2 SO.sub.4, an effective amount of MgSO.sub.4, and an effective amount of K.sub.2 SO.sub.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.sub.2 SO.sub.4, about 20 grams of MgSO.sub.4, and about 3 grams of K.sub.2 SO.sub.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.