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|Title:||Needleless injector drug capsule and a method for filling thereof|
|Abstract:||A method for filling needleless injector capsules with liquid drug, whereby dissolved gas within the drug is replaced by a less soluble gas in order to reduce the inclusion of gas bubbles, or to prevent the growth of bubbles during storage and thereby prevent breakage of the capsules.|
|Inventor(s):||Henry; William (Trumpington, GB), Lewis; Andrew (Trumpington, GB)|
|Assignee:||Zogenix, Inc. (Emeryville, CA)|
1. A method of reducing breakage of a needle-free injector drug capsule, comprising: preventing growth of bubbles in a liquid drug during storage by sparging the liquid
drug with an inert gas having a solubility of 0.5 cm.sup.3 to 25 cm.sup.3 in 100 cm.sup.3 of the liquid drug to obtain a sparged liquid drug; loading the sparged liquid drug into a glass capsule strengthened with ion exchange; and storing the capsule.
2. The method of claim 1, wherein prior to loading the liquid drug into the capsule the capsule is evacuated to about 0.5 mbar.
3. The method as claimed in claim 1, further comprising: sealing the capsule in an atmosphere of the inert gas prior to loading the capsule.
4. The method as claimed in claim 1, wherein the inert gas is selected from the group consisting of helium, argon, neon, krypton, xenon, nitrogen, a chlorofluorocarbon, a hydrofluorocarbon, and a mixture thereof.
5. The method as claimed in claim 1, wherein the inert gas does not comprise helium.
6. The method as claimed in claim 1, wherein the inert gas comprises helium.
7. The method as claimed in claim 1, wherein the liquid drug is chosen from: a solution, and a suspension.
8. The method as claimed in claim 1, further comprising: forcing the inert gas through a filter comprising apertures of not more than 0.2 .mu.m prior to contacting the gas with the liquid drug.
9. The method as claimed in claim 1, wherein bubbles are prevented from growing above 2 .mu.l in volume.
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