US 2006/0067943 A1 · Stabilization of alum-adjuvanted immunologically active agents

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.

Claims30

Dependent claims

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.

1 more element

Dependencies are inferred from the claim text.

Facts

Application

11/237,200Filed 27 Sep 2005

Priority

28 Sep 2004

Published

30 Mar 2006

Term ends

Not estimatedThe source records don’t support an estimate.

Classification17 codes

A61K 39/292
Hepatitis virus: serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
A61K 9/1652
Organic macromolecular compounds: polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
A61K 9/70
Medicinal preparations characterised by special physical form: web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
A61K 39/12
Medicinal preparations containing antigens or antibodies: viral antigens

Stabilization of alum-adjuvanted immunologically active agents

Life of this patent

Stabilization of alum-adjuvanted immunologically active agents

Life of this patent

Abstract

Claims30