A method of lyophilizing vaccines containing aluminum salts into a dry powder without causing particle aggregation or decreasing the immunogenicity following reconstitution

Journal of Controlled Release : Official Journal of the Controlled Release Society
Xinran LiZhengrong Cui

Abstract

Many currently licensed and commercially available human vaccines contain aluminum salts as vaccine adjuvants. A major limitation with these vaccines is that they must not be exposed to freezing temperatures during transport or storage such that the liquid vaccine freezes, because freezing causes irreversible coagulation that damages the vaccines (e.g., loss of efficacy). Therefore, vaccines that contain aluminum salts as adjuvants are formulated as liquid suspensions and are required to be kept in cold chain (2-8°C) during transport and storage. Formulating vaccines adjuvanted with aluminum salts into dry powder that can be readily reconstituted before injection may address this limitation. Spray freeze-drying of vaccines with low concentrations of aluminum salts and high concentrations of trehalose alone, or a mixture of sugars and amino acids, as excipients can convert vaccines containing aluminum salts into dry powder, but fails to preserve the particle size and/or immunogenicity of the vaccines. In the present study, using ovalbumin as a model antigen adsorbed onto aluminum hydroxide or aluminum phosphate, a commercially available tetanus toxoid vaccine adjuvanted with potassium alum, a human hepatitis B vaccine adjuvanted...Continue Reading

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Citations

Apr 4, 2015·Journal of Controlled Release : Official Journal of the Controlled Release Society·Kinam Park
Jan 5, 2017·Human Vaccines & Immunotherapeutics·Sachin G ThakkarZhengrong Cui
Oct 3, 2018·Human Vaccines & Immunotherapeutics·Tauheed HasanLaishram Rajendrakumar Singh
May 12, 2020·Journal of Dairy Science·Marina LomónacoKarina Trono
Aug 8, 2020·AAPS PharmSciTech·Jieliang WangRobert O Williams
Mar 12, 2021·Advanced Drug Delivery Reviews·Yajie ZhangRobert O Williams
Mar 17, 2021·Expert Review of Vaccines·Yizhi Qi, Christopher B Fox
Apr 10, 2021·AAPS PharmSciTech·Khaled AboulFotouhRobert O Williams
Oct 20, 2018·Journal of Controlled Release : Official Journal of the Controlled Release Society·Sachin G ThakkarZhengrong Cui
Sep 25, 2021·International Journal of Pharmaceutics·Haiyue XuZhengrong Cui

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