Development of thermostable lyophilized inactivated polio vaccine.

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.

• Authors: Heleen Kraan, Paul van Herpen, Gideon Kersten, Jean-Pierre Amorij
• Journal: Pharmaceutical research (Pharm Res) Vol. 31 Issue 10 Pg. 2618-29 (Oct 2014) ISSN: 1573-904X [Electronic] United States
• PMID: 24760448 (Publication Type: Journal Article)

Chemical References

• Excipients
• Poliovirus Vaccine, Inactivated
• Poliovirus Vaccine, Oral

Topics

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