Stabilization of alum-adjuvanted immunologically active agents

A - Human Necessities – 61 – K

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A61K 9/70 (2006.01) A61B 17/20 (2006.01) A61K 9/16 (2006.01) A61K 39/145 (2006.01) A61M 37/00 (2006.01)

Patent

CA 2579471

A composition and method for formulating and delivering an adjuvanted immunological active agent, especially a vaccine, wherein adjuvant coagulation and concomitant loss of vaccine efficacy enhancement is mitigated or avoided. The adjuvanted, immunologically-active agent can be subjected to freezing, drying, freeze-drying, or lyophilization, and when reconstituted, retains a high level of potency. The present invention further provides for a composition and method for formulating and delivering a stable, adjuvanted, immunologically-active agent capable of being deposited on a transdermal delivery device or microprojection or array thereof.

L'invention concerne une composition et un procédé de formulation et d'administration d'un agent immunologiquement actif complété d'un adjuvant, particulièrement un vaccin, dans lesquels la coagulation de l'adjuvant et la perte concomitante de l'efficacité de rendement du vaccin sont atténuées ou évitées. L'agent immunologiquement actif complété d'un adjuvant peut être soumis à la congélation, au séchage, à la congélation-séchage ou à la lyophilization et, lorsqu'il est reconstitué, retient un niveau de puissance élevé. L'invention concerne également une composition et un procédé de formulation et d'administration d'un agent immunologiquement actif complété d'un adjuvant, stable, pouvant être déposé sur un dispositif de diffusion transdermique, ou une microprojection ou un réseau dudit dispositif.

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