Method for increasing the bioavailability of glycopyrrolate
DCFirst Claim
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 (Cmax) and the extent of absorption of glycopyrrolate at t=24 hours (AUC0-24hrs) as compared to the administration of glycopyrrolate under fed conditions, and wherein the ratio of Cmax following administration without food to Cmax following administration with food is greater than 1.1, and wherein the ratio of AUC0-24hrs following administration without food to AUC0-24hrs following administration with food is greater than 1.8.
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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.
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7 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 (Cmax) and the extent of absorption of glycopyrrolate at t=24 hours (AUC0-24hrs) as compared to the administration of glycopyrrolate under fed conditions, and wherein the ratio of Cmax following administration without food to Cmax following administration with food is greater than 1.1, and wherein the ratio of AUC0-24hrs following administration without food to AUC0-24hrs following administration with food is greater than 1.8.
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