Method for increasing the bioavailability of glycopyrrolate
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First Claim
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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=∞
- (AUC0-∞
) following administration without food to AUC0-∞
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.
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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.
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8 Claims
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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=∞
- (AUC0-∞
) following administration without food to AUC0-∞
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. - View Dependent Claims (2, 3)
- (AUC0-∞
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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 (Cmax) and the extent of absorption of glycopyrrolate at t=24 hours (AUC0-24 hrs) as compared to the administration of glycopyrrolate under fed conditions, wherein the ratio of Cmax following administration without food to Cmax following administration with food is greater than 1.1, wherein the ratio of AUC0-24 hrs following administration without food to AUC0-24 hrs following administration with food is greater than 1.8, wherein the AUC0-24 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.
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Litigation Data
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Current AssigneeMERZ Pharmaceuticals LLC (Merz Pharma GmbH & Company Kgaa)
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Original AssigneeShionogi Pharma Incorporated (Shionogi & Co., Ltd.)
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InventorsRoberts, Alan, Venkataraman, Balaji
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Primary Examiner(s)Spivack; Phyllis G.
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Application NumberUS12/648,068Time in Patent Office295 DaysField of SearchNoneUS Class Current514/424CPC Class CodesA61K 31/40 having five-membered rings ...
