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Claims for Patent: 8,491,524

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Claims for Patent: 8,491,524

Title:Needleless injector drug capsule and a method for filling thereof
Abstract: A method for tilling 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)
Application Number:13/495,390
Patent Claims: 1. A needle free injector drug capsule, comprising: a container comprised of borosilicate glass strengthened with ion exchange; and a liquid formulation in the container, wherein the liquid formulation is comprised of a drug, and the liquid formulation has been purged by 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 formulation; wherein the inert gas solubility in the formulation is such that gas does not come out of solution during storage over a range of temperatures of 0.degree. C. to 30.degree. C.

2. A needle free injector drug capsule 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.

3. A needle free injector drug capsule as claimed in claim 2, wherein the inert gas does not include helium.

4. The needle free injector drug capsule as claimed in claim 1, wherein the inert gas is helium.

5. A needle free injector drug capsule, comprising: a container comprised of glass strengthened with ion exchange; and a liquid formulation in the container, wherein the liquid formulation is comprised of a drug, and the liquid formulation has been purged by an inert gas soluble in the liquid formulation.

6. The needle free injector drug capsule of claim 5, wherein the inert gas solubility in the formulation over a range of temperatures from 0.degree. C. to 30.degree. C. is such that the inert gas does not come out of solution during temperature cycling.

7. A needle free injector drug capsule as claimed in claim 6, wherein the inert gas is selected from the group consisting of helium, argon, neon, krypton, xenon, nitrogen, a chlorofluorocarbon, a hydrofluorocarbons, and a mixture thereof.

8. A needle free injector drug capsule as claimed in claim 7, wherein the inert gas is helium.

9. The needle free injector drug capsule of claim 5, wherein the inert gas solubility in the formulation is such that gas does not come out of solution during storage over a range of temperatures of from 0.degree. C. to 30.degree. C. and the glass is borosilicate glass.

10. A needle free injector drug capsule, comprising: a container comprised of glass strengthened with ion exchange; and a liquid formulation in the container, wherein the liquid formulation is comprised of a drug.

11. The needle free injector drug capsule of claim 10, wherein the liquid formulation has been purged by an inert gas soluble in the liquid formulation.

12. The needle free injector drug capsule of claim 11, wherein the inert gas solubility in the formulation over a range of temperatures from 0.degree. C. to 30.degree. C. is such that the inert gas does not come out of solution during temperature cycling.

13. The needle free injector drug capsule as claimed in claim 12, 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.

14. The needle free injector drug capsule as claimed in claim 13, wherein the inert gas is helium.

15. The needle free injector drug capsule of claim 11, wherein the inert gas solubility in the formulation is such that gas does not come out of solution during storage over a range of temperatures of from 0.degree. C. to 30.degree. C. and the glass is borosilicate glass.
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