Device for intranasal administration

Abstract

Disclosed herein are devices and processes for preparing a vial for an intranasal administration of a medicament where the vial comprises reduced oxygen content.

1 .- 37 . (canceled) 
     
     
         38 . A drug delivery system for intranasal administration of ketorolac or a pharmaceutically acceptable salt thereof, comprising a vial having a cap and a spray system, wherein
 the vial has a concave or V-shaped inner bottom,   the vial has a volume between the cap and inner bottom of 10 mL or less and contains a solution comprising ketorolac or a pharmaceutically acceptable salt thereof,   the vial comprises a dip tube attached to the spray system, wherein the dip tube dips into the solution and an end of the dip tube is proximate to a bottommost portion of the inner bottom, and   a head space defined by the space between a top surface of the solution and the cap comprises less than 10% v/v oxygen.   
     
     
         39 . The drug delivery system of  claim 38 , wherein the head space comprises no more than 80% of the volume of the vial. 
     
     
         40 . The drug delivery system of  claim 38 , wherein the solution comprises from about 12.5% w/v to about 38% w/v of ketorolac tromethamine. 
     
     
         41 . The drug delivery system of  claim 38 , wherein the solution comprises from about 13% w/v to about 20% w/v of ketorolac tromethamine. 
     
     
         42 . The drug delivery system of  claim 38 , wherein the solution comprises about 15% w/v of ketorolac tromethamine. 
     
     
         43 . The drug delivery system of  claim 38 , wherein the solution comprises about 30% w/v of ketorolac tromethamine. 
     
     
         44 . The drug delivery system of  claim 38 , wherein the solution further comprises about 4% to about 10% w/v lidocaine hydrochloride. 
     
     
         45 . The drug delivery system of  claim 38 , wherein the solution is stable when stored in the vial at room temperatures for two years or more. 
     
     
         46 . The drug delivery system of  claim 38 , wherein the dip tube is notched. 
     
     
         47 . A method for administering a solution comprising ketorolac or a pharmaceutically acceptable salt thereof, comprising intranasally administering the solution from a drug delivery system according to  claim 38 . 
     
     
         48 . The method of  claim 47 , wherein the solution is administered to treat pain or inflammation in a subject in need thereof.