Claims for Patent: 10,806,743

Summary for Patent: 10,806,743

Title:	Method of administering lactitol to reduce plasma concentration of lactitol
Abstract:	Disclosed herein are formulations comprising lactitol for the treatment of chronic idiopathic constipation. As disclosed herein, the formulations are administered after or during a meal to improve the pharmacokinetics of the formulation. In particular, administration of the formulation after or during a meal decreases the absorption of lactitol and reduces the AUC.
Inventor(s):	Mark vB Cleveland, Robert M Raleigh, Russell W Pelham
Assignee:	Sebela Bt Holdings Inc , Sebela International Development Ltd
Application Number:	US15/594,109
Patent Claims:	1. A method of reducing plasma concentration of lactitol in a subject, the method comprising administering a total dose of an effective amount of a formulation comprising lactitol after the subject has consumed a meal, wherein the meal is a high fat meal. 2. The method of claim 1, wherein the meal is a high calorie meal. 3. The method of claim 2, wherein the high calorie meal comprises at least about 500 calories. 4. The method of claim 2, wherein about 50% of the calories in the high calorie meal are attributable to fat. 5. The method of claim 1, wherein the formulation is administered as a powder. 6. The method of claim 5, wherein the formulation is administered as the powder reconstituted in a solution. 7. The method of claim 1, wherein the effective amount of lactitol comprises from about 5.0 grams to about 30 grams. 8. The method of claim 1, wherein the effective amount of lactitol comprises from about 10.0 grams to about 25 grams. 9. The method of claim 1, wherein the effective amount of lactitol comprises about 21.0 grams. 10. The method of claim 1, wherein the effective amount is divided into two or more doses. 11. The method of claim 1, wherein the effective amount is divided into two doses. 12. The method of claim 6, wherein the solution is selected from the group consisting of juice, soda, water, and balanced electrolyte solution. 13. The method of claim 1, wherein the formulation is a liquid. 14. The method of claim 13, wherein the formulation comprises one or more of natural flavoring, artificial flavoring, or preservatives. 15. The method of claim 1, wherein the formulation is a tablet. 16. The method of claim 1 further comprising administering an agent selected from the group consisting of polyethylene glycol, sulfate salts, magnesium salts, stimulant laxatives, and lubiprostone. 17. The method of claim 16, wherein the osmotic agent is lubiprostone. 18. The method of claim 1, wherein the subject has three or more spontaneous bowel movements. 19. The method of claim 18, wherein the spontaneous bowel movements occur within a seven day period. 20. The method of claim 1, wherein the formulation is provided in bulk. 21. The method of claim 1, wherein the subject has a plasma concentration of lactitol of less than 1000 ng/mL four hours after administration of the effective amount of lactitol.