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 . A vial having a cap, wherein the cap comprises a spray system and wherein the vial has a volume of no more than about 10 mL, the vial comprising: a solution comprising ketorolac, a dip tube attached to the spray system and dipping into the solution, and a head space above the solution and below the cap, wherein the head space comprises about 2% to about 10% v/v oxygen. 
     
     
         2 . (canceled) 
     
     
         3 . The vial of  claim 1 , wherein the head space comprises no more than about 8% v/v oxygen. 
     
     
         4 . The vial of  claim 1 , wherein the head space comprises no more than about 6% v/v oxygen. 
     
     
         5 . The vial of  claim 1 , wherein the head space comprises no more than about 5% v/v oxygen. 
     
     
         6 . The vial of  claim 1 , wherein the head space comprises between about 5% to about 10% v/v oxygen. 
     
     
         7 . The vial of  claim 1 , wherein the head space comprises between about 2% to about 5% v/v oxygen. 
     
     
         8 . The vial of  claim 1 , wherein the vial is glass. 
     
     
         9 . The vial of  claim 1 , wherein the spray system is a nasal spray system. 
     
     
         10 . The vial of  claim 1 , wherein the solution has a sufficiently high ketorolac concentration so that a gaseous atmosphere with reduced oxygen content is needed to prevent or reduce the degradation of ketorolac by air at room temperature. 
     
     
         11 . The vial of  claim 1 , wherein the solution comprises from about 12.5% w/v to about 38% w/v of ketorolac tromethamine. 
     
     
         12 . The vial of  claim 1 , wherein the solution comprises about 15% w/v of ketorolac tromethamine. 
     
     
         13 . The vial of  claim 1 , wherein the ketorolac solution comprises about 30% w/v of ketorolac tromethamine. 
     
     
         14 . (canceled) 
     
     
         15 . The vial of  claim 1 , wherein the solution can be stored in the vial for at least about two years at room temperature. 
     
     
         16 . The vial of  claim 1 , wherein the about 2% to about 10% v/v oxygen in the head space keeps the solution stable for about two years. 
     
     
         17 . The vial of  claim 1 , wherein the about 2% to about 10% v/v oxygen in the head space increases the shelf life of the solution as compared to the vial containing an ambient atmosphere. 
     
     
         18 . The vial of  claim 1 , which is a high recovery vial capped with a spray system having a concave or a V shaped inner bottom. 
     
     
         19 . The vial of  claim 18 , further comprising a notched dip tube. 
     
     
         20 . The vial of  claim 1 , in combination with labeling instructions for use in treating a pain or inflammation in a human subject. 
     
     
         21 . The vial of  claim 20 , wherein the pain is the result of a trauma inflicted on the subject. 
     
     
         22 . The vial of  claim 20 , wherein the pain is the result of a medical operation performed on the subject. 
     
     
         23 . The vial of  claim 20 , wherein the pain is pathological. 
     
     
         24 . The vial of  claim 20 , wherein the pain is neuropathic. 
     
     
         25 . The vial of  claim 20 , wherein the pain is migraine or other headache pain. 
     
     
         26 . A nasal spray device, comprising: a vial having a volume of no more than about 10 mL and a nasal spray system capped to the vial wherein the vial comprises a solution comprising ketorolac, a dip tube attached to the nasal spray system and dipping into the solution, and a head space above the solution, wherein the head space comprises about 2% to about 10% v/v oxygen. 
     
     
         27 . The nasal spray device of  claim 26 , in combination with labeling instructions for use in treating a pain or inflammation in a human subject. 
     
     
         28 . A method of preparing a vial comprising a solution and a head space, the method comprising: purging the air out of the vial with an inert gas wherein the purging reduces an oxygen content in the head space of the vial to about 2% to about 10% v/v oxygen. 
     
     
         29 . The method of  claim 28 , wherein the inert gas is nitrogen. 
     
     
         30 . The method of  claim 28 , wherein the inert gas is a noble gas. 
     
     
         31 . The method of  claim 30 , wherein the noble gas is argon. 
     
     
         32 .- 37 . (canceled)