Device for intranasal administration
View Patent ↗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 method for reducing ketorolac degradation under ambient conditions wherein said ketorolac is in an aqueous composition maintained in an enclosed vial having a defined gaseous headspace and containing from about 12 to 38% w/v ketorolac wherein the method comprises:
a) placing said ketorolac vial on an assembly line;
b) moving the vial on said assembly line wherein the vial is exposed to a flow of an inert gas directly over and into the vial to purge at least a portion of the oxygen out of the vial and subsequently capping the vial, wherein the rate of the gas flow and capping process are adjusted such that the amount of oxygen remaining in the head space of the capped vial is about 5-10% v/v; and
c) capping the vial.
2. The method of claim 1 , wherein the inert gas is nitrogen.
3. The method of claim 1 , wherein the inert gas is a noble gas.
4. The method of claim 3 , wherein the inert gas is argon.
5. The method of claim 1 , wherein the ketorolac aqueous composition is preserved for at least 2 years at room temperature.
6. The method of claim 1 , wherein from about 100 to about 210 purged vials are capped per minute.