Hydromorphone therapy

Abstract

A hydromorphone composition, a hydromorphone dosage form and a method for administering hydromorphone are disclosed, indicated for the management of pain.

1 . A formulation comprising hydromorphone given once daily that provides a maximum plasma concentration around 0.16 ng/mL per mg hydromorphone at steady state, wherein the formulation comprises a wall comprised of cellulose acetate, the wall defining an internal compartment comprising hydromorphone, the wall having at least one exit that connects the internal compartment with an exterior environment in the gastrointestinal tract. 
     
     
         2 . A method for treating pain in a patient comprising administering a hydromorphone-containing dosage form that produced a hydromorphone plasma concentration profile in the patient having a maximum of 0.16 ng/ml per mg of hydromorphone over an extended time up to 24 hours, wherein the dosage form comprises a wall comprised of cellulose acetate, the wall defining an internal compartment comprising hydromorphone, the wall having at least one exit that connects the internal compartment with an exterior environment in the gastrointestinal tract of the patient. 
     
     
         3 . The method of  claim 2 , wherein the profile has a minimum of 0.075 ng/ml per mg of hydromorphone. 
     
     
         4 . The method of  claim 2 , wherein the formulation comprises 16 mg of hydromorphone. 
     
     
         5 . The method of  claim 2 , wherein the maximum of the profile occurs at 14.7 hours following administration. 
     
     
         6 . The method of  claim 2 , wherein the profile has a maximum of 0.075 ng/mL per mg hydromorphone at steady state. 
     
     
         7 . The method of  claim 6 , wherein the minimum of the profile occurs at 13.1 hours following administration. 
     
     
         8 . The method of  claim 2 , wherein the formulation releases hydromorphone to said patient over 24 hours following administration. 
     
     
         9 . The method of  claim 2 , wherein the formulation eliminates dose-dumping of hydromorphone to said patient. 
     
     
         10 . The method of  claim 1 , wherein the maximum concentration occurs at 14.7 hours following administration. 
     
     
         11 . The method of  claim 1 , wherein the formulation comprises 16 mg of hydromorphone. 
     
     
         12 . The method of  claim 1 , wherein the formulation provides a minimum concentration around 0.075 ng/ml per mg of hydromorphone. 
     
     
         13 . The method of  claim 12 , wherein the minimum concentration occurs at 13.1 hours following administration. 
     
     
         14 . The method of  claim 1 , wherein the formulation releases hydromorphone to said patient over 24 hours following administration. 
     
     
         15 . The method of  claim 1 , wherein the formulation eliminates dose-dumping of hydromorphone to said patient. 
     
     
         16 . A method for providing hydromorphone therapy to a patient comprising administering orally to the patient a controlled-release pharmaceutical formulation comprising a wall comprised of cellulose acetate, the wall defining an internal compartment comprising 1 mg to 500 mg of at least one of hydromorphone and a hydromorphone pharmaceutically acceptable salt in a pharmaceutically acceptable carrier, the wall having at least one exit that connects the internal compartment with an exterior environment in the gastrointestinal tract of the patient, and which formulation produces a hydromorphone plasma concentration profile in said patient having a maximum of 0.16 ng/mL per mg hydromorphone at steady state. 
     
     
         17 . The method of  claim 16 , wherein said formulation comprises 16 mg of hydromorphone. 
     
     
         18 . The method of  claim 16 , wherein the maximum of the profile occurs at 14.7 hours following administration. 
     
     
         19 . The method of  claim 16 , wherein the profile has a maximum of 0.075 ng/mL per mg hydromorphone at steady state. 
     
     
         20 . The method of  claim 19 , wherein the minimum of the profile occurs at 13.1 hours following administration. 
     
     
         21 . The method of  claim 16 , wherein the formulation releases hydromorphone to said patient over 24 hours following administration. 
     
     
         22 . The method of  claim 16 , wherein the formulation eliminates dose-dumping of hydromorphone to said patient. 
     
     
         23 . A controlled-release pharmaceutical formulation comprising a wall comprised of cellulose acetate and defining an internal compartment comprising 1 mg to 500 mg of at least one of hydromorphone and a hydromorphone pharmaceutically acceptable salt in a pharmaceutically acceptable carrier, the wall having at least one exit that connects the internal compartment with an exterior environment in the gastrointestinal tract of the patient, and said formulation adapted to produce a hydromorphone plasma concentration profile in said patient having a maximum of 0.16 ng/mL per mg hydromorphone at steady state following administration. 
     
     
         24 . The formulation of  claim 23  comprising 16 mg of hydromorphone. 
     
     
         25 . The formulation of  claim 23 , wherein the profile has a minimum of 0.075 ng/mL per mg hydromorphone at steady state. 
     
     
         26 . A method for producing hydromorphone therapy in a patient comprising administering orally to the patient an controlled-release pharmaceutical formulation comprising a wall comprised of cellulose acetate and defining an internal compartment comprising 16 mg of at least one of hydromorphone and a hydromorphone pharmaceutically acceptable salt in a pharmaceutically acceptable carrier, the wall having at least one exit that connects the internal compartment with an exterior environment in the gastrointestinal tract of the patient, and which produces a hydromorphone plasma concentration profile in said patient having a maximum of 2.6 ng/mL at steady state. 
     
     
         27 . The method of  claim 26 , wherein the maximum of the profile occurs at 14.7 hours following administration. 
     
     
         28 . The method of  claim 26 , wherein the profile has a minimum of 1.2 ng/ml at steady state. 
     
     
         29 . The method of  claim 28 , wherein the minimum of the profile occurs at 13.1 hours following administration. 
     
     
         30 . A controlled-release pharmaceutical formulation comprising a wall comprised of cellulose acetate and defining an internal compartment comprising 16 mg of at least one of hydromorphone and a hydromorphone pharmaceutically acceptable salt in a pharmaceutically acceptable carrier, the wall having at least one exit that connects the internal compartment with an exterior environment in the gastrointestinal tract of the patient, and said formulation adapted to produce a hydromorphone plasma concentration profile in said patient having a maximum of 2.6 ng/mL at steady state following administration. 
     
     
         31 . The formulation of  claim 30 , wherein the profile has a minimum of 1.2 ng/mL at steady state.