Formulations containing nalbuphine and uses thereof

Abstract

Immediate release, oral, pharmaceutical formulation including nalbuphine or a pharmaceutically acceptable salt thereof, and at least one hydrophilic granulation carrier, one hydrophilic binder and one lubricant.

1 . Immediate release, oral pharmaceutical formulation comprising nalbuphine or a pharmaceutically acceptable salt thereof, and at least one hydrophilic granulation carrier, one hydrophilic binder and one lubricant. 
     
     
         2 . The pharmaceutical formulation according to  claim 1 , wherein it only contains nalbuphine or one of the pharmaceutically acceptable salts thereof. 
     
     
         3 . The pharmaceutical formulation according to  claim 1 , wherein the hydrophilic granulation carrier is selected from the group consisting of mannitol, polyvinyl pyrrolidone or a derivative thereof, a polyol, lactose, a cellulose derivative, polyethylene glycol or a derivative thereof and a silica derivative. 
     
     
         4 . The pharmaceutical formulation according to  claim 1 , wherein the hydrophilic granulation carrier is lactose. 
     
     
         5 . The pharmaceutical formulation according to  claim 1 , wherein the hydrophilic binder is selected from the group consisting of polyvinyl pyrrolidone or a derivative thereof, a polyol, lactose, a cellulose derivative, polyethylene glycol or a derivative thereof, gums and carbomers. 
     
     
         6 . The pharmaceutical formulation according to  claim 1 , wherein the hydrophilic binder is polyvinylpyrrolidone. 
     
     
         7 . The pharmaceutical formulation according to  claim 1 , wherein the lubricant is selected from the group consisting of silicon dioxide, magnesium stearate, anhydrous colloidal silica, sodium stearyl fumarate and talcum. 
     
     
         8 . The pharmaceutical formulation according to  claim 1 , wherein it comprises at least 45% by weight of hydrophilic granulation carrier, relative to the total weight of the formulation. 
     
     
         9 . The pharmaceutical formulation according to  claim 1 , wherein it comprises less than 10% by weight of hydrophilic binder, relative to the total weight of the formulation. 
     
     
         10 . The pharmaceutical formulation according to  claim 1 , wherein it comprises less than 10% by weight of lubricant, relative to the total weight of the formulation. 
     
     
         11 . The pharmaceutical formulation according to  claim 1 , wherein it comprises less than 30% by weight of nalbuphine, relative to the total weight of the formulation. 
     
     
         12 . The pharmaceutical formulation according to  claim 1 , wherein it further comprises:
 at least one disintegrating agent; and optionally   at least one excipient.   
     
     
         13 . The pharmaceutical formulation according to  claim 1 , wherein it comprises:
 from 4 to 30% by weight of nalbuphine;   from 45 to 70% by weight of lactose;   from 2 to 10% by weight of PVP; and   from 0.9 to 7% by weight of at least one lubricant.   
     
     
         14 . The pharmaceutical formulation according to  claim 1 , wherein it is in solid form. 
     
     
         15 . The pharmaceutical formulation according to  claim 14 , wherein it is in a form selected from the group consisting of tablets, granules, pellets, micro-granules, capsules and lozenges. 
     
     
         16 . The pharmaceutical formulation according to  claim 1 , for its use in the treatment of pain. 
     
     
         17 . The pharmaceutical formulation for use according to  claim 16 , wherein pain is generated by a treatment for opioid addiction. 
     
     
         18 . The pharmaceutical formulation for use according to  claim 1 , its use in the treatment of opioid addiction.