Patent ID: 6555581
Filing Date: 2003-04-29
Classification: A61K,B01F,Y10S

Abstract:
A stable, solid, immediate release pharmaceutical composition for oral administration to treat a thyroid disorder, said composition comprising:(a) about 0.00005 wt % to about 5 wt % of a levothyroxine salt; (b) at least about 50 wt % of a &bgr;-form microcrystalline cellulose particles, said &bgr;-form microcrystalline cellulose particles having generally flat needle-shapes, a bulk density in a range of from about 0.10 g/cm3 to about 0.23 g/cm3, and a conductivity of less than about 200 &mgr;S/cm; and (c) about 0.5 wt % to about 30 wt % disintegrating agent; wherein (1) at least about 90 wt % of the levothyroxine salt in the composition dissolves in an aqueous solution in less than about 5 minutes, (2) potency loss for said levothyroxine salt is no more than about 0.3% per month for a period of at least about 18 months, and (3) said composition is essentially sugar-free.