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公开(公告)号：US20230293440A1
公开(公告)日：2023-09-21
申请号：US18180801
申请日：2023-03-08
Applicant: ACCESS TO ADVANCED HEALTH INSTITUTE
Inventor： Christopher B. FOX , Thomas VEDVICK , Lucien BARNES, V , Ryan M. KRAMER , Steven G. REED
CPC classification number: A61K9/19 , A61K39/00 , A61K39/04 , A61K39/39 , A61K47/22 , A61K47/26 , A61K47/10 , A61K2039/55572 , A61K2039/552 , A61K2039/55511
Abstract: The invention provides for thermostable lyophilized formulations, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response, and methods of use thereof. The lyophilized formulations generally comprise an antigen and/or an adjuvant, a metabolizable oil, and a cake-forming excipient.
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公开(公告)号：US20230310323A1
公开(公告)日：2023-10-05
申请号：US18024733
申请日：2021-07-02
Applicant: ACCESS TO ADVANCED HEALTH INSTITUTE
Inventor： Ryan M. KRAMER , Emily VOIGHT , Alana GERHARDT , Michelle ARCHER
CPC classification number: A61K9/19 , A61K9/1075 , A61K39/12 , A61K2039/55555
Abstract: This disclosure provides thermostable, lyophilized compositions of nano structured lipid carrier (NLC) particles, methods of making the compositions, and methods of using the compositions for stimulating an immune response. The lyophilized compositions are in the form of cakes that form oil-in-water emulsions upon reconstitution. The compositions comprise NLC particles lyophilized in the presence of a cake-forming excipient. The compositions may be lyophilized with a bioactive agent, or the bioactive agent may be added after reconstitution. The bioactive agent may be RNA that encodes an antigen such as a viral protein. The thermostable, lyophilized compositions have uses as vaccine platforms or vaccines. The lyophilized cake maintains shape, structure, and color for at least 21 months stored at room temperature. Integrity and activity of the bioactive agent is maintained for at least eight months at room temperature and at least 21 months refrigerated.
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