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US 12,616,693 B2Granted
Bromocriptine formulations
AssigneeVeroScience LLC
InventorsAnthony H. Cincotta, Craig Michael Bowe, Paul Clark Stearns, Laura Jean Weston
Life of this patent
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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.
Claims7
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 micronized bromocriptine mesylate has a Dv90 of less than about 20 μm, a Dv50 of about 7.2 μm or less, a Dv10 of about 2.5 μm or less, and has a particle size distribution with a span of about 1.8 or lower, and not more than about 20% of the bromocriptine mesylate has a particle size of less than 1 μm;
- and
- wherein the oral tablet has a dissolution profile wherein not more than 50% of the bromocriptine mesylate has been released at about 7 minutes, not more than about 75% of the bromocriptine mesylate has been released at about 10 minutes, and 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.
3 more elements
Dependencies are inferred from the claim text.