EP4342536A3 — Bromocriptine formulations

USPTO Abstract

A dosage form comprising: bromocriptine mesylate 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; wherein the bromocriptine has a particle size distribution with a span of about 2 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; wherein the dosage form is in the form of a solid dosage form.