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Pharm Res ; 31(10): 2618-29, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24760448

ABSTRACT

PURPOSE: The aim of current study was to develop a dried inactivated polio vaccine (IPV) formulation with minimal loss during the drying process and improved stability when compared with the conventional liquid IPV. METHODS: Extensive excipient screening was combined with the use of a Design of Experiment (DoE) approach in order to achieve optimal results with high probability. RESULTS: Although it was shown earlier that the lyophilization of a trivalent IPV while conserving its antigenicity is challenging, we were able to develop a formulation that showed minimal loss of potency during drying and subsequent storage at higher temperatures. CONCLUSION: This study showed the potential of a highly stable and safe lyophilized polio vaccine, which might be used in developing countries without the need of a cold-chain.


Subject(s)
Poliovirus Vaccine, Inactivated/chemistry , Poliovirus Vaccine, Oral/chemistry , Poliovirus/immunology , Technology, Pharmaceutical/methods , Chemistry, Pharmaceutical , Drug Stability , Excipients/chemistry , Freeze Drying , Particle Size , Poliovirus Vaccine, Inactivated/immunology , Poliovirus Vaccine, Oral/immunology , Temperature , Transition Temperature
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