Large scale preparation of alpha-1 proteinase inhibitor and use thereof

Abstract

A pharmaceutical preparation containing a purified, active API in the form of a ready to use sterile solution that optionally includes an excipient, diluent or a carrier. At least 90% to 95% of the API is active and is present at a concentration between about 1% to about 10%. The pH of the preparation is in the range of 6.5-7.5 and the preparation is preferably devoid of a protein stabilizer. The API is stable for at least 3 months when stored at a temperature of between 20° C. to 25° C. and is stable for a minimum of at least 12 months, at least 21 months, or at least 36 months when the pharmaceutical composition is stored at a temperature of between 2° C. to 8° C. The composition is formulated to be administered intravenously or by inhalation.

1 . A pharmaceutical preparation comprising a purified, active API in the form of a ready to use sterile solution. 
     
     
         2 . The pharmaceutical preparation of  claim 1 , wherein the API comprises at least 90% active API out of the total API. 
     
     
         3 . The pharmaceutical preparation of  claim 2 , wherein the API comprises at least 95% active API out of the total API. 
     
     
         4 . The pharmaceutical preparation of  claim 1 , wherein pH of the preparation is in the range of 6.5-7.5. 
     
     
         5 . The pharmaceutical preparation of  claim 1  having an API concentration between about 1% to about 10%. 
     
     
         6 . The pharmaceutical preparation of  claim 5 , which is devoid of a protein stabilizer. 
     
     
         7 . The pharmaceutical preparation of  claim 6 , wherein the API is stable for at least 3 months when stored at a temperature of between 20° C. to 25° C. 
     
     
         8 . The pharmaceutical preparation of  claim 6 , wherein the API is stable for a minimum of at least 12 months, at least 21 months, or at least 36 months when the pharmaceutical composition is stored at a temperature of between 2° C. to 8° C. 
     
     
         9 . The pharmaceutical preparation of  claim 1 , further comprising an excipient, diluent or a carrier. 
     
     
         10 . The pharmaceutical composition of  claim 1 , formulated to be administered intravenously. 
     
     
         11 . The pharmaceutical composition of  claim 9 , formulated to be administered intravenously. 
     
     
         12 . The pharmaceutical composition of  claim 1 , formulated to be administered by inhalation. 
     
     
         13 . The pharmaceutical composition of  claim 9 , formulated to be administered by inhalation.