Method for increasing the bioavailability of glycopyrrolate
View Patent ↗The invention relates to a method of increasing the bioavailability of glycopyrrolate by administration of a therapeutically effective amount of glycopyrrolate without food.
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 max ) and the extent of absorption of glycopyrrolate at t=24 hours (AUC 0-24hrs ) as compared to the administration of glycopyrrolate under fed conditions.
2. The method of claim 1 wherein the ratio of C max following administration without food to C max following administration with food is greater than about 1.1, and wherein the ratio of AUC 0-24 hrs following administration without food to AUC 0-24 hrs following administration with food is greater than about 1.8.
3. The method of claim 2 wherein the ratio of C max following administration without food to C max following administration with food is greater than about 2.8, and wherein the ratio of AUC 0-24 hrs following administration without food to AUC 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 max ) and of the extent of absorption of glycopyrrolate at t=24 hours (AUC 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 max ) and of the extent of absorption of glycopyrrolate at t=24 hours (AUC 0-24 hrs ) as compared to the administration of glycopyrrolate under fed conditions.