DEVICE FOR INTRANASAL ADMINISTRATION
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.