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US 2024/0131026 A1Published application
Bromocriptine formulations
AssigneeVeroScience LLC
InventorsAnthony H. Cincotta, Craig Michael Bowe, Paul Clark Stearns, Laura Jean Weston
Life of this patent
Estimating the term…
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.
Claims21
(canceled)
A dosage form comprising micronized bromocriptine mesylate and one or more excipients in the form of an oral tablet;
- wherein the micronized bromocriptine mesylate is present in an amount that provides a dose of at least about 0.8 mg of bromocriptine per said oral tablet;
- and
- wherein the oral tablet has a dissolution profile wherein at least about 90% of the bromocriptine mesylate has been released at about 30 minutes, when tested in USP Apparatus Type 2 Paddle Method at 50 rpm in 500 mL of 0.1 N hydrochloric acid at about 37° C.
A dosage form comprising
- micronized bromocriptine mesylate and one or more excipients in the form of an oral tablet;
- wherein the micronized bromocriptine mesylate is present in an amount that provides a dose of at least about 0.8 mg of bromocriptine per said oral tablet;
- and
- wherein not more than about 50% of the bromocriptine mesylate has been released at about 7 minutes and not more than about 75% of the bromocriptine mesylate has been released at about 10 minutes when tested in USP Apparatus Type 2 Paddle Method at 50 rpm in 500 mL of 0.1 N hydrochloric acid at about 37° C.
1 more element
A dosage form comprising
- micronized bromocriptine mesylate and one or more excipients in the form of an oral tablet;
- wherein the micronized bromocriptine mesylate is present in an amount that provides a dose of at least about 0.8 mg of bromocriptine per said oral tablet;
- and wherein
- said 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 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 administration of the dosage form to the subject under high fat fed conditions.
1 more element
A dosage form comprising
- micronized bromocriptine mesylate and one or more excipients in the form of an oral tablet;
- wherein the micronized bromocriptine mesylate is present in an amount that provides a dose of at least about 0.8 mg of bromocriptine per said oral tablet;
- and
- wherein the oral tablet has a dissolution profile wherein at least about 80% of the bromocriptine mesylate has been released at about 30 minutes, when tested in USP Apparatus Type 2 Paddle Method at 50 rpm in 500 mL of 0.1 N hydrochloric acid at about 37° C.
1 more element
Dependencies are inferred from the claim text.