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Claims for Patent: 7,816,396

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Claims for Patent: 7,816,396

Title:Method for increasing the bioavailability of glycopyrrolate
Abstract:The invention relates to a method of treating sialorrhea in a human patient, which comprises orally administering glycopyrrolate in a liquid solution to the human patient under fasted conditions.
Inventor(s): Roberts; Alan (Woodstock, GA), Venkataraman; Balaji (Alpharetta, GA)
Assignee: Shionogi Pharma, Inc. (Atlanta, GA)
Application Number:12/648,068
Patent Claims: 1. A method of treating sialorrhea in a human patient, which comprises orally administering about 1 mg to about 10 mg of glycopyrrolate in a liquid solution to the human patient under fasted conditions, wherein the ratio of the extent of absorption of glycopyrrolate at t=.infin. (AUC.sub.0-.infin.) following administration without food to AUC.sub.0-.infin. following administration with food is greater than 1.8, and wherein the patient has not consumed food during the period from 30 minutes prior to the administration of glycopyrrolate to 1 hour after the administration of glycopyrrolate.

2. The method of claim 1, wherein the AUC.sub.0-.infin. following administration under fasted conditions is greater than 1.0 ng*hr/mL.

3. The method of claim 1, wherein the AUC.sub.0-.infin. following administration under fasted conditions is greater than 1.7 ng*hr/mL.

4. A method of treating sialorrhea in a human patient, which comprises orally administering about 1 mg to about 10 mg of glycopyrrolate in a liquid solution to the human patient under fasted conditions, wherein the administration of glycopyrrolate under fasted conditions 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.0-24 hrs) as compared to the administration of glycopyrrolate under fed conditions, wherein the ratio of C.sub.max following administration without food to C.sub.max following administration with food is greater than 1.1, 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 1.8, wherein the AUC.sub.0-24 hrs following administration under fasted conditions is greater than 1.0 ng*hr/mL, and wherein the patient has not consumed food during the period from 30 minutes prior to the administration of glycopyrrolate to 1 hour after the administration of glycopyrrolate.

5. The method of claim 4, wherein the AUC.sub.0-24 hrs following administration under fasted conditions is greater than 1.7 ng*hr/mL.

6. The method of claim 4, wherein the ratio of the extent of absorption of glycopyrrolate at t=.infin. (AUC.sub.0-.infin.) following administration without food to AUC.sub.0-.infin. following administration with food is greater than 1.8.

7. The method of claim 6, wherein the extent of absorption of glycopyrrolate at t=.infin. (AUC.sub.0-.infin.) following administration under fasted conditions is greater than 1.0 ng*hr/mL.

8. The method of claim 7, wherein the AUC.sub.0-.infin. following administration under fasted conditions is greater than 1.7 ng*hr/mL.
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