GRF-containing lyophilized pharmaceutical compositions

Abstract

Human growth hormone factor (GFR) containing pharmaceutical compositions are described, and more precisely, lyophilized compositions of hGRF stabilized by means of saccharose.

1 . A pharmaceutical composition comprising a solid intimate mixture of human growth releasing factor (hGRF) and a stabilizing amount of saccharose, alone or in combination with other excipients.  
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the solid intimate mixture is a lyophilizate.  
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the stabilizing agent is a saccharose alone.  
     
     
         4 . The pharmaceutical composition according to  claim 1 , containing 3 or 10 mg/vial of hGRF.  
     
     
         5 . The pharmaceutical composition according to  claim 1  comprising 3 or 10 mg/vial of hGRF and 20.52 or 68.4 mg/vial of saccharose.  
     
     
         6 . The pharmaceutical composition according to  claim 1  further comprising buffering agents.  
     
     
         7 . A process for preparing a pharmaceutical composition according to  claim 1 , comprising the preparation of an aqueous solution of the components, the distribution within containers and the lyophilization in the containers.  
     
     
         8 . Forms of presentation of said pharmaceutical composition comprising the solid mixture according to  claim 1 , hermetically closed in a sterile condition within a container suited for a storage before use and for reconstitution of the mixture into a solvent or into a solution for injectables.  
     
     
         9 . A solution comprising the solid mixture according to  claim 1 , reconstituted in a solvent or a solution for injectables.  
     
     
         10 . The pharmaceutical composition according to  claim 2 , wherein the stabilizing agent is a saccharose alone.  
     
     
         11 . The pharmaceutical composition according to  claim 2 , containing 3 or 10 mg/vial of hGRF.  
     
     
         12 . The pharmaceutical composition according to  claim 1  comprising 3 or 10 mg/vial of hGRF and 20.52 to 68.4 mg/vial of saccharose.  
     
     
         13 . The pharmaceutical composition according to  claim 2  further comprising buffering agents.  
     
     
         14 . The pharmaceutical composition according to  claim 13  buffered to a pH between 2 and 7.  
     
     
         15 . The pharmaceutical composition according to  claim 14  buffered to a pH of 4 to 6.  
     
     
         16 . A pharmaceutical composition consisting of a lypholized solid intimate mixture of human growth releasing factor (hGRF) and a stabilizing amount of saccharose as the sole stabilizing agent, a buffer which maintains the pH between 2 and 7, and optionally, excipients.  
     
     
         17 . The pharmaceutical composition according to  claim 16  in which the buffer maintains the pH between 4 and 6.  
     
     
         18 . A unit dose of the pharmaceutical composition according to  claim 17  in which the amount of hGRF is 3 to 10 mg and the amount of saccharose is from 20.52 to 68.4 mg.