Patent ID: 8506998

Claim:
A solid, oral, controlled release pharmaceutical dosage form, comprising one pharmaceutically active ingredient consisting of a pharmaceutically acceptable salt, of morphine, diamorphone, tramadol and dihydrocodeine, the pharmaceutically active ingredient having a solubility in water of greater than 1 gm in 250 ml water at 25° C., dispersed in a matrix of a controlled release material consisting of a hydrophobic fusible material having a melting point of greater than 40° C., and a hydrophilic, organic, polymeric fusible wicking agent, wherein the weight ratio of the hydrophobic fusible material to the hydrophilic, organic polymeric wicking agent in said matrix is in the range from 8:1 to 16:1, and the dosage form provides, as tested by the Ph. Eur. Basket method at 100 rpm 900 ml aqueous buffer (pH 6.5) containing 0.05% w/w Polysorbate 80 at 37° C., an essentially zero order rate of release of the pharmaceutically active ingredient over a period of 8 hours, an amount of pharmaceutically active ingredient released over eight hours in the range of 15% to 45%, and, when tested in a group of at least five healthy humans, a median tmax, based on blood sampling at half hourly intervals, in the range of from 2.5 to 6 hours, a ratio of mean Cmax to the mean plasma level at 24 hours in the range of 1.5 to 3.5, and a W 50 in the range from 15 to 35 hours, and said pharmaceutically active ingredient is the only pharmaceutically active ingredient in the dosage form.