Stabilizing micronized particles boosts sterility and safety of vaccines

C vaccine delivery methods for prevention of global childhood diseases carry a high risk for needle contamination, vaccine wastage, and transportation and storage difficulties. Aktiv-Dry LLC’s focus is on R&D of safe and effective microparticles of vaccines and pharmaceuticals for easier storage, greater thermal stability, and ease of use. We utilize our patented CO2-Assisted Nebulization with a Bubble Dryer® (CAN-BD) system to create stable dry microparticles of compounds for administration by needle-free aerosol inhalers, sublingual solid formulations, or safer unit-dose, all-in-one auto-reconstitution syringe devices. Recently, our work has focused on vaccine prevention of measles and hepatitis B. Aktiv-Dry has developed inhalable and sublingual vaccines for measles along with a human-powered, active dry powder inhaler called the PuffHaler® for intrapulmonary delivery of the dry powder measles vaccine. CAN-BD processed measles vaccine shelf-life stability has been shown for 4 years at 2-8oC, protective immunity after intrapulmonary delivery to rhesus macaques, and no serious adverse events reported to date during on-going clinical Phase I safety trials in 60 adult males in India. We have also demonstrated stability of CAN-BD processed and dried microparticles of hepatitis B vaccine for use in a preloaded, single-dose, field-reconstitution device for parenteral delivery. Aktiv-Dry-formulated hepatitis-B vaccine was stabilized with trehalose, processed, and determined to retain stability using in-house stability assays. Our immunogenicity results from intrapulmonary mucosal membrane delivery of measles vaccine dry powder aerosols and fundamental project goals may be extended to prevention and treatment (e.g., antibiotics and antivirals) of other pulmonary diseases (e.g., tuberculosis and influenza). Jessica M.H. Thrall et al., J Vaccines Vaccin 2013, 4:5 http://dx.doi.org/10.4172/2157-7560.S1.017