EXTENDED-RELEASE DOSAGE FORM

摘要

Provided are pharmaceutical formulations comprising sustained release particles each having an inner core bead comprising an active pharmaceutical ingredient an intermediate coating substantially surrounding the inner core bead, and an outer coating substantially surrounding the intermediate coating comprising a pH independent polymer. Also provided is a pharmaceutical formulation comprising two bead populations wherein each of the first and second bead populations have a different drug release profile. Also provided is a method of preparing an extended release dosage composition comprising one or more bead populations.

主权项

1. A pharmaceutical formulation comprising sustained release particles having an inner core bead comprising a granulate of an active pharmaceutical ingredient, an intermediate coating substantially surrounding said inner core bead, and an outer coating comprising a pH independent polymer substantially surrounding said intermediate coating, wherein said formulation provides a dissolution profile in aqueous media such that about 50% to about 85% of said active pharmaceutical ingredient is released after about 14 hours, and about 75% to about 100% of said active pharmaceutical ingredient is released after about 24 hours.