Claims for Patent: 7,091,236

Summary for Patent: 7,091,236

Title:	Method for increasing the bioavailability of glycopyrrolate
Abstract:	The invention relates to a method of increasing the bioavailability of glycopyrrolate by administration of a therapeutically effective amount of glycopyrrolate without food.
Inventor(s):	Roberts; Alan (Woodstock, GA), Venkataraman; Bala (Alpharetta, GA)
Assignee:	Sciele Pharma, Inc. (Atlanta, GA)
Application Number:	10/644,530
Patent Claims:	1. A method of increasing the oral bioavailability of glycopyrrolate to a patient receiving glycopyrrolate therapy comprising administering to the patient a pharmaceutical tablet comprising about 1 mg to about 10 mg of glycopyrrolate under fasted conditions, wherein the administration results in an increase of the maximum plasma concentration (C.sub.max) and the extent of absorption of glycopyrrolate at t=24 hours (AUC.sub.0-24hrs) as compared to the administration of glycopyrrolate under fed conditions. 2. The method of claim 1 wherein the ratio of C.sub.max following administration without food to C.sub.max following administration with food is greater than about 1.1, and wherein the ratio of AUC.sub.0-24 hrs following administration without food to AUC.sub.0-24 hrs following administration with food is greater than about 1.8. 3. The method of claim 2 wherein the ratio of C.sub.max following administration without food to C.sub.max following administration with food is greater than about 2.8, and wherein the ratio of AUC.sub.0-24 hrs following administration without food to AUC.sub.0-24 hrs following administration with food is greater than about 4.5. 4. The method of claim 2, further comprising informing the patient that the administration of the glycopyrrolate dose in a pharmaceutical composition under fasted conditions results in an increase of the maximum plasma concentration (C.sub.max) and of the extent of absorption of glycopyrrolate at t=24 hours (AUC.sub.0-24 hrs) as compared to the administration of glycopyrrolate under fed conditions. 5. The method of claim 4, wherein the pharmaceutical composition is provided to a patient in a container associated with prescribing information that advises the patient that the administration of the glycopyrrolate dose in a pharmaceutical composition under fasted conditions results in an increase of the maximum plasma concentration (C.sub.max) and of the extent of absorption of glycopyrrolate at t=24 hours (AUC.sub.0-24 hrs) as compared to the administration of glycopyrrolate under fed conditions.