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Claims for Patent: 7,638,552

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Claims for Patent: 7,638,552

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. The invention also provides a kit comprising a pharmaceutical composition comprising a therapeutically effective amount of glycopyrrolate and a pharmaceutically acceptable carrier, prescribing information including advice regarding the administration of glycopyrrolate without food to improve bioavailability, and a container.
Inventor(s): Roberts; Alan (Woodstock, GA), Venkataraman; Balaji (Alpharetta, GA)
Assignee: Sciele Pharma, Inc. (Atlanta, GA)
Application Number:12/325,755
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 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.0-24hrs) as compared to the administration of glycopyrrolate under fed conditions, and wherein the ratio of C.sub.max following administration without food to C.sub.max following administration with food is greater than 1.1, and wherein the ratio of AUC.sub.0-24hrs following administration without food to AUC.sub.0-24hrs following administration with food is greater than 1.8.

2. The method of claim 1, wherein the liquid solution is an aqueous liquid solution.

3. The method of claim 2, wherein the aqueous liquid solution further comprises at least one ingredient selected from the group consisting of solvents, buffering agents, sweeteners, anti-microbial preservatives, flavoring agents, and mixtures thereof.

4. The method of claim 3, wherein the solvent is selected from the group consisting of sorbital, glycerin, propylene glycol, water, and mixtures thereof, the buffering agent is selected from the group consisting of citric acid, sodium citrate, phosphoric acid, potassium phosphate, and mixtures thereof, the sweetener is selected from the group consisting of saccharin sodium, sucrose, mannitol, and mixtures thereof, and the anti-microbial preservative is selected from the group consisting of methylparaben, propylparaben, sodium benzoate, benzalkonium chloride, and mixtures thereof.

5. The method of claim 1, wherein the aqueous liquid solution comprises a therapeutically effective amount of glycopyrrolate, purified water, sorbitol, glycerin, citric acid, sodium citrate, propylene glycol, methylparaben, and propylparaben.

6. The method of claim 1, wherein the therapeutically effective amount of glycopyrrolate is about 1 mg to about 2 mg.

7. 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 2.8, and wherein the ratio of AUC.sub.0-24hrs following administration without food to AUC.sub.0-24hrs following administration with food is greater than 4.5.
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