Stabilization of alum-adjuvanted immunologically active agents
First Claim
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1. An immunologically active agent-containing formulation, the formulation comprising:
- a biologically effective amount of an immunologically active agent;
a stabilizing amount of a carbohydrate sugar; and
an amount of an aluminum salt to minimize the loss of immunogenicity of the immunologically active agent when being subjected to drying.
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Abstract
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.
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30 Claims
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1. An immunologically active agent-containing formulation, the formulation comprising:
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a biologically effective amount of an immunologically active agent;
a stabilizing amount of a carbohydrate sugar; and
an amount of an aluminum salt to minimize the loss of immunogenicity of the immunologically active agent when being subjected to drying. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method of preparing an alum-adjuvanted immunologically active agent coating, the method comprising the steps of:
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preparing a coating composition comprising one or more aluminum salts in a suitable solvent, wherein the total aluminum salt concentration is less than about 3 weight percent based on the total weight of the coating composition, at least one carbohydrate sugar, an optional viscosity-enhancing agent, and an immunologically active agent;
applying said coating composition to a substrate; and
drying, or allowing to dry, said applied coating composition to prepare said dried coating. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification