Patent ID: 8158147

Claim:
A method for treating pain in a patient in need thereof, comprising, administering a composition to the patient in need thereof in an amount sufficient to treat the pain, wherein the composition is a unit dosage of a delayed and extended release pharmaceutical composition for oral administration suitable for once daily, comprising per unit dosage: a) an immediate release core comprising about 100 to about 400 mg of tramadol hydrochloride, wherein about 70 to about 98% by weight of the core dry weight is tramadol hydrochloride in combination with about 2 to about 30% by weight of the core dry weight of a plurality of pharmaceutically acceptable excipients, and b) about 8 to about 30% by weight of the core dry weight of a coating completely surrounding said core, said coating comprising a water-insoluble film-forming polymer in an amount from about 20% to about 89% by weight of the coating dry weight, a water-soluble polymer present in the coating in an amount of from about 10% to about 75% of the coating dry weight, and a plasticizer present in the coating from about 1% to about 30% of the coating dry weight, wherein, in the presence of an aqueous medium, the coating completely surrounding the core becomes permeable to the tramadol hydrochloride in the presence of the aqueous medium; and wherein the composition provides a delayed and extended release of the tramadol hydrochloride such that the mean plasma concentration of the tramadol hydrochloride reaches a therapeutically effective level at a time which is after at least about 3 hours after first administration of said composition in the fasted state, wherein in the fed state, the mean time to reach maximum plasma concentration of the tramadol hydrochloride after first administration of said composition is delayed by at least about one hour compared to that in the fasted state, and wherein at steady state the composition has a fluctuation index lower than an immediate-release composition of the tramadol hydrochloride administered 3 or 4 times a day.