Leuprolide injection

Abstract

The present invention provides a sterile solution comprising leuprolide acetate in a pharmaceutically acceptable vehicle, wherein solution is present as a reservoir in a multiple dose pen injection device, the device being adapted to subcutaneously inject a portion of the said reservoir in a single daily dose and further being adapted to provide multiple portions of solution said while the reservoir remains sterile.

We claim: 
     
         1 . A sterile solution comprising leuprolide acetate in a pharmaceutically acceptable vehicle, wherein solution is present as a reservoir in a multiple dose pen injection device, the device being adapted to subcutaneously inject a portion of the said reservoir in a single daily dose and further being adapted to provide multiple portions of the said solution, while the reservoir remains sterile. 
     
     
         2 . The sterile solution as claimed in  claim 1  wherein leuprolide acetate ranges from 5 mg to 20 mg per milliliter of the solution. 
     
     
         3 . The sterile solution as claimed in  claim 2  wherein leuprolide acetate is present in amount of 10 mg per milliliter of the solution. 
     
     
         4 . The sterile solution as claimed in  claim 3  wherein a single subcutaneous injection of 100 microlitres delivers 1000 μg of leuprolide acetate. 
     
     
         5 . The sterile solution as claimed in  claim 1  wherein the reservoir contains 28 doses.