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US 2021/0228576 A1Published application
Bromocriptine formulations
AssigneeVeroScience LLC
InventorsAnthony H. Cincotta, Craig Michael Bowe, Paul Clark Stearns, Laura Jean Weston
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Abstract
The present application describes pharmaceutical formulations of bromocriptine mesylate and methods of manufacturing and using such formulations. The formulations are useful for improving glycemic control in the treatment of type 2 diabetes.
Claims22
A dosage form comprising:
- bromocriptine and one or more excipients;
- wherein the dosage form provides for absorption of a substantial amount of bromocriptine through the gastric and/or intestinal mucosa when administered to a subject;
- wherein the bromocriptine has a DV90 less than 15 μm and Dv10 of less than 2 μm;
- and
- wherein the dosage form exhibits a pharmacokinetic profile wherein the time to maximum plasma concentration (Tmax) of bromocriptine is between about 30 and about 60 minutes following oral administration of the dosage form to the subject under fasting conditions or the Tmax of bromocriptine is between about 90 and about 120 minutes following oral administration of the dosage form to the subject under high fat fed conditions.
2 more elements
A dosage form comprising:
- bromocriptine and one or more excipients;
- wherein the dosage form provides for absorption of a substantial amount of bromocriptine through the gastric and/or intestinal mucosa when administered to a subject;
- wherein the bromocriptine has a Dv90 of about 15 μm or lower, a Dv50 of about 8 μm or lower and a Dv10 of about 3 μm or lower;
- and
- wherein the dosage form exhibits a pharmacokinetic profile wherein the time to maximum plasma concentration (Tmax) of bromocriptine is between about 30 and about 60 minutes following oral administration of the dosage form to the subject under fasting conditions or the Tmax of bromocriptine is between about 90 and about 120 minutes following oral administration of the dosage form to the subject under high fat fed conditions.
2 more elements
Dependencies are inferred from the claim text.