Packaging system for pharmaceutical compositions and kit for intravenous administration

Abstract

The invention refers to a new system for packaging pharmaceutical compositions comprising active principles that may be administered intravenously, in particular it concerns a system for packaging in bottles which makes it possible to ensure the complete transfer of the content of the bottle into the liquid for intravenous infusion and at the same time prevent any accidental contact with the active principle by the health-care personnel preparing said intravenous infusion, and a complete kit for intravenous administration.

1 . A packaging system comprising a pharmaceutical composition to be administered in a liquid for intravenous infusion, wherein said system is a bottle which comprises said pharmaceutical composition and an empty volume ranging from 80% to 99% of the total volume of the bottle and wherein said bottle has a capacity of more than 5 ml and said pharmaceutical composition comprises as active principle tacrolimus in a pharmaceutically acceptable oily vehicle. 
     
     
         2 . A packaging system according to  claim 1 , wherein said bottle comprises an empty volume ranging from 80% to 95% of the total volume of the bottle. 
     
     
         3 . A packaging system according to  claim 1 , wherein said bottle is made of glass. 
     
     
         4 . A packaging system according to  claim 1 , wherein said bottle has a capacity between 5 ml and 10 ml. 
     
     
         5 . A packaging system according to  claim 1 , wherein said bottle has a capacity between 6 and 9 ml. 
     
     
         6 . A packaging system according to  claim 1 , wherein said bottle has a capacity of 7 ml. 
     
     
         7 . A packaging system according to  claim 1 , wherein said pharmaceutical composition comprises 5 mg of tacrolimus dissolved in 1 ml of solvent composed of 200 mg of polyoxyethylenated hydrogenated castor oil (HCO-60) and ethanol q.s. to 1 ml. 
     
     
         8 . A packaging system according to  claim 7 , wherein said ethanol is absolute ethanol or anhydrous ethanol USP 80.0% v/v. 
     
     
         9 . A packaging system according to  claim 5 , wherein said pharmaceutical composition comprises 5 mg of tacrolimus dissolved in 1 ml of solvent composed of 200 mg of polyoxyethylenated hydrogenated castor oil (HCO-60) and ethanol q.s. to 1 ml. 
     
     
         10 . A packaging system according to  claim 9 , wherein said ethanol is absolute ethanol or anhydrous ethanol USP 80.0% v/v. 
     
     
         11 . A packaging system according to  claim 6 , wherein said pharmaceutical composition comprises 5 mg of tacrolimus dissolved in 1 ml of solvent composed of 200 mg of polyoxyethylenated hydrogenated castor oil (HCO-60) and ethanol q.s. to 1 ml. 
     
     
         12 . A packaging system according to  claim 11 , wherein said ethanol is absolute ethanol or anhydrous ethanol USP 80.0% v/v. 
     
     
         13 . A packaging system according to  claim 1 , wherein said bottle is a container for pharmaceutical compositions closed with a rubber cap, said cap being able to be pierced with needles or conventional piercing spikes.