DEVICE FOR INTRANASAL ADMINISTRATION
Disclosed herein are vials and devices containing a ketorolac solution for intranasal administration and a head space comprising no more than about 10% v/v oxygen and which vials and devices are stored in an oxygen-impermeable pouch. Also disclosed are processes for preparing the vials and devices.
1 .- 29 . (canceled)
30 . A method of treating migraine, comprising intranasally administering to a subject in need thereof a ketorolac composition comprising from about 25% w/v to about 38% w/v of ketorolac or a pharmaceutically acceptable salt thereof, wherein the ketorolac composition is administered from a device comprising a vial having metered dose spray system configured to deliver about 50 to 125 μL of the ketorolac composition per spray.
31 . The method of claim 30 , wherein the ketorolac composition comprises an amount of ketorolac or a pharmaceutically acceptable salt thereof selected from about 25%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, and 38% w/v.
32 . The method of claim 30 , wherein the ketorolac composition comprises ketorolac tromethamine.
33 . The method of claim 30 , wherein the ketorolac composition comprises about 25% w/v ketorolac tromethamine.
34 . The method of claim 30 , wherein the metered dose spray system is configured to deliver from about 50 to about 100 μL of the ketorolac composition per spray.
35 . The method of claim 30 , wherein the metered dose spray system is configured to deliver about 50 μL of the ketorolac composition per spray.
36 . The method of claim 30 , wherein the metered dose spray system is configured to deliver about 100 μL of the ketorolac composition per spray.
37 . The method of claim 30 , wherein the ketorolac composition further comprises a chelator.
38 . The method of claim 37 , wherein the chelator is selected from sodium ethylenediamine tetraacetic acid and edetate disodium.
39 . The method of claim 37 , wherein the ketorolac composition comprises chelator in an amount from about 0.01% w/v to about 0.1% w/v.
40 . The method of claim 30 , wherein the ketorolac composition has a pH of about 4.5 to 8.
41 . The method of claim 30 , wherein the ketorolac composition has a pH of about 7.2.
42 . The method of claim 30 , wherein the ketorolac composition further comprises a pharmaceutically acceptable base.
43 . The method of claim 42 , wherein the pharmaceutically acceptable base is sodium hydroxide.
44 . The method of claim 30 , wherein the ketorolac composition further comprises a pharmaceutically acceptable buffer.
45 . The method of claim 44 , wherein the ketorolac composition comprises about 0.6 to 0.8% w/v potassium phosphate monobasic.
46 . The method of claim 30 , wherein the ketorolac composition further comprises lidocaine or a pharmaceutically acceptable salt thereof at a concentration of from about 4% w/v to about 10% w/v.
47 . The method of claim 30 , wherein the ketorolac composition further comprises lidocaine hydrochloride at a concentration of from about 4% w/v to about 10% w/v.