A Design of Experiment approach to predict product and process parameters for a spray dried influenza vaccine

Publication date: 25 September 2016 Source:International Journal of Pharmaceutics, Volume 511, Issue 2 Author(s): Gaurav Kanojia, Geert-Jan Willems, Henderik W. Frijlink, Gideon F.A. Kersten, Peter C. Soema, Jean-Pierre Amorij Spray dried vaccine formulations might be an alternative to traditional lyophilized vaccines. Compared to lyophilization, spray drying is a fast and cheap process extensively used for drying biologicals. The current study provides an approach that utilizes Design of Experiments for spray drying process to stabilize whole inactivated influenza virus (WIV) vaccine. The approach included systematically screening and optimizing the spray drying process variables, determining the desired process parameters and predicting product quality parameters. The process parameters inlet air temperature, nozzle gas flow rate and feed flow rate and their effect on WIV vaccine powder characteristics such as particle size, residual moisture content (RMC) and powder yield were investigated. Vaccine powders with a broad range of physical characteristics (RMC 1.2–4.9%, particle size 2.4–8.5μm and powder yield 42–82%) were obtained. WIV showed no significant loss in antigenicity as revealed by hemagglutination test. Furthermore, descriptive models generated by DoE software could be used to determine and select (set) spray drying process parameter. This was used to generate a dried WIV powder with predefined (predicted) characteristics. Moreover, the spray dried...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research