Patent ID: 7858118

Claim:
A solid pharmaceutical composition in a capsule comprising an effective amount of Tramadol or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier; the composition comprising a fast release Tramadol tablet, and slow release Tramadol beads, said tablet comprising between 10 and 30% by wt. of a unit dose of Tramadol or salt thereof, and said beads being free of binder and comprising a Tramadol salt, sucrose stearate and being coated with a porous membrane from which the Tramadol is liberated slowly and exhibiting an at least biphasic absorption profile in vivo under fed and fasted administration conditions providing a time of Tramadol peak plasma concentration (Tmax) greater than about 10 hours after administration and peak concentration (C max ) which is less than about three times the plasma concentration obtained 24 hours after once daily administration (C 24th ) of a single dose of said composition; and wherein a first peak of plasma concentration rise occurs within about 0.5 to 4 hours after administration, and wherein the capsule comprises a gelatine or hydroxypropylmethylcellulose capsule.