Process for Manufacturing Stable Epinephrine

Abstract

Epinephrine formulated in aqueous solvent at a basic pH of about 8.5 remains in solid state. My data show that epinephrine formulated at a pH of about 8.5 is surprisingly resistant to oxidation. I here teach how to formulate solid-state epinephrine in basic solution, and how to use solid-state epinephrine to make pharmaceutical dosage forms.

1 . A process for manufacturing a solid-state epinephrine pharmaceutical dosage form, the process comprising: mixing epinephrine in an aqueous solvent and at least one basic-pH excipient to produce a mixture having a pH of about 8.5, whereby the epinephrine remains in solid state. 
     
     
         2 . The process of  claim 1 , said mixture substantially free of antioxidant. 
     
     
         3 . The process of  claim 1 , said mixture substantially free of chelating agent. 
     
     
         4 . The process of  claim 1 , said mixture comprising antioxidant. 
     
     
         5 . The process of  claim 1 , said mixture comprising chelating agent. 
     
     
         6 . The process of  claim 1 , said mixture comprising gelatin. 
     
     
         7 . The process of  claim 1 , further comprising removing the aqueous solvent to produce a dry dosage form. 
     
     
         8 . The process of  claim 7 , wherein the dry dosage form is a powder. 
     
     
         9 . The process of  claim 7 , wherein the dry dosage form is a tablet. 
     
     
         10 . A solid-state epinephrine pharmaceutical dosage form produced by the process of  claim 1 . 
     
     
         11 . A solid-state epinephrine pharmaceutical dosage form produced by the process of  claim 2 . 
     
     
         12 . A solid-state epinephrine pharmaceutical dosage form produced by the process of  claim 3 . 
     
     
         13 . A solid-state epinephrine pharmaceutical dosage form produced by the process of  claim 4 . 
     
     
         14 . A solid-state epinephrine pharmaceutical dosage form produced by the process of  claim 5 . 
     
     
         15 . A solid-state epinephrine pharmaceutical dosage form produced by the process of  claim 6 . 
     
     
         16 . A solid-state epinephrine pharmaceutical dry dosage form produced by the process of  claim 7 . 
     
     
         17 . A solid-state epinephrine pharmaceutical dry dosage form produced by the process of  claim 8 . 
     
     
         18 . A solid-state epinephrine pharmaceutical dry dosage form produced by the process of  claim 9 .