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Int J Pharm. 2016 Aug 11. pii: S0378-5173(16)30762-1. doi: 10.1016/j.ijpharm.2016.08.022. [Epub ahead of print]
A Design of Experiment approach to predict product and process parameters for a spray dried influenza vaccine.
Kanojia G1, Willems GJ2, Frijlink HW3, Kersten GF4, Soema PC5, Amorij JP2.
Author information
Abstract
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 vaccine powders retained their antigenic stability even after storage for 3 months at 60?C. The approach used here enabled the generation of a thermostable, antigenic WIV vaccine powder with desired physical characteristics that could be potentially used for pulmonary administration.
Copyright ? 2016. Published by Elsevier B.V.
KEYWORDS:
Nozzle gas flow rate; Process optimization; Process parameters; Quality by design; Spray drying
PMID: 27523619 DOI: 10.1016/j.ijpharm.2016.08.022
[PubMed - as supplied by publisher]
A Design of Experiment approach to predict product and process parameters for a spray dried influenza vaccine.
Kanojia G1, Willems GJ2, Frijlink HW3, Kersten GF4, Soema PC5, Amorij JP2.
Author information
Abstract
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 vaccine powders retained their antigenic stability even after storage for 3 months at 60?C. The approach used here enabled the generation of a thermostable, antigenic WIV vaccine powder with desired physical characteristics that could be potentially used for pulmonary administration.
Copyright ? 2016. Published by Elsevier B.V.
KEYWORDS:
Nozzle gas flow rate; Process optimization; Process parameters; Quality by design; Spray drying
PMID: 27523619 DOI: 10.1016/j.ijpharm.2016.08.022
[PubMed - as supplied by publisher]