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Development of thermostable lyophilized inactivated polio vaccine.

Kraan H, van Herpen P, Kersten G, Amorij JP - Pharm. Res. (2014)

Bottom Line: 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.Extensive excipient screening was combined with the use of a Design of Experiment (DoE) approach in order to achieve optimal results with high probability.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.

View Article: PubMed Central - PubMed

Affiliation: Institute of Translational Vaccinology (Intravacc), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL, Bilthoven, The Netherlands.

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.

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Related in: MedlinePlus

DU recoveries of the best formulations from the screening experiment based on recoveries directly after lyophilization (>60% for all serotypes). Panel (a) shows the DU recoveries directly after lyophilization. Panel (b, c and d) show the recoveries after incubation for 1 week at 45°C, 2 weeks at 37°C, and 4 weeks at room temperature, respectively. The formulations are described in Table I.
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Fig3: DU recoveries of the best formulations from the screening experiment based on recoveries directly after lyophilization (>60% for all serotypes). Panel (a) shows the DU recoveries directly after lyophilization. Panel (b, c and d) show the recoveries after incubation for 1 week at 45°C, 2 weeks at 37°C, and 4 weeks at room temperature, respectively. The formulations are described in Table I.

Mentions: aFormulation selected for stability testing (as shown in Fig. 3)


Development of thermostable lyophilized inactivated polio vaccine.

Kraan H, van Herpen P, Kersten G, Amorij JP - Pharm. Res. (2014)

DU recoveries of the best formulations from the screening experiment based on recoveries directly after lyophilization (>60% for all serotypes). Panel (a) shows the DU recoveries directly after lyophilization. Panel (b, c and d) show the recoveries after incubation for 1 week at 45°C, 2 weeks at 37°C, and 4 weeks at room temperature, respectively. The formulations are described in Table I.
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4197379&req=5

Fig3: DU recoveries of the best formulations from the screening experiment based on recoveries directly after lyophilization (>60% for all serotypes). Panel (a) shows the DU recoveries directly after lyophilization. Panel (b, c and d) show the recoveries after incubation for 1 week at 45°C, 2 weeks at 37°C, and 4 weeks at room temperature, respectively. The formulations are described in Table I.
Mentions: aFormulation selected for stability testing (as shown in Fig. 3)

Bottom Line: 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.Extensive excipient screening was combined with the use of a Design of Experiment (DoE) approach in order to achieve optimal results with high probability.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.

View Article: PubMed Central - PubMed

Affiliation: Institute of Translational Vaccinology (Intravacc), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL, Bilthoven, The Netherlands.

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.

Show MeSH
Related in: MedlinePlus