Sustained release hydromorphone formulations exhibiting bimodal characteristics

A solid sustained release once-a-day oral dosage form comprising hydromorphone or a pharmaceutically acceptable salt thereof together with a sustained release carrier, the dosage providing a relatively rapid rise in plasma concentration to a first initial early peak concentration (Cmax #1) in about 0.3 to about 4 hours after oral administration of the dosage form, followed by a second peak concentration (Cmax #2) which occurs in about 10 to about 19 hours after oral administration of the dosage form, said dosage form providing a maximum hydromorphone plasma concentration which is less than twice the plasma level of hydromorphone at about 24 hours after administration of the dosage form, said dosage form providing effective treatment of pain for about 24 hours or more after administration to a human patient.

A solid sustained release once-a-day oral dosage form comprising hydromorphone or a pharmaceutically acceptable salt thereof together with a sustained release carrier, the dosage providing a first peak concentration (Cmax #1), followed by a second peak concentration (Cmax #2), said dosage form providing a maximum hydromorphone plasma concentration (i) which is less than twice the plasma level of hydromorphone at the Cmin which occurs between Cmax #1 and Cmax #2, and (ii) which is less than twice the plasma level of hydromorphone at about 24 hours after administration of the dosage form, said dosage form providing effective treatment of pain for about 24 hours or more after administration to a human patient.