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

Stabilizing potential of the excipients sucrose (SUC), trehalose (TRE), mannitol (MAN), dextran (DEX) and NaCl on DU recovery directly after lyophilization. Main and interaction effects that contribute (per serotype) to the best model, according to the model performance parameters (Q2 = 0.650, R2 = 0.905 (type 1); Q2 = 0.592, R2 = 0.873 (type 2); Q2 = 0.671, R2 = 0.929 (type 3)), are depicted in coefficient plots (a). Surface response plots of the DU recovery for each serotype based on formulations containing sucrose and trehalose in combination with 10% mannitol (without dextran or NaCl) (b).
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Fig1: Stabilizing potential of the excipients sucrose (SUC), trehalose (TRE), mannitol (MAN), dextran (DEX) and NaCl on DU recovery directly after lyophilization. Main and interaction effects that contribute (per serotype) to the best model, according to the model performance parameters (Q2 = 0.650, R2 = 0.905 (type 1); Q2 = 0.592, R2 = 0.873 (type 2); Q2 = 0.671, R2 = 0.929 (type 3)), are depicted in coefficient plots (a). Surface response plots of the DU recovery for each serotype based on formulations containing sucrose and trehalose in combination with 10% mannitol (without dextran or NaCl) (b).

Mentions: A partial least squares (PLS) regression model was fitted and optimized per serotype, which resulted in valid models to predict the DU recoveries directly after lyophilization according to the model performance parameters. For serotype 1, 2 and 3, the Q2 values were, respectively, 0.650, 0.592 and 0.671, while the R2 values were 0.905, 0.873 and 0.929. The effects of the different stabilizers, after optimization (excluding non-significant parameters) on the DU recovery after lyophilization are presented in Fig. 1a.Fig. 1


Development of thermostable lyophilized inactivated polio vaccine.

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

Stabilizing potential of the excipients sucrose (SUC), trehalose (TRE), mannitol (MAN), dextran (DEX) and NaCl on DU recovery directly after lyophilization. Main and interaction effects that contribute (per serotype) to the best model, according to the model performance parameters (Q2 = 0.650, R2 = 0.905 (type 1); Q2 = 0.592, R2 = 0.873 (type 2); Q2 = 0.671, R2 = 0.929 (type 3)), are depicted in coefficient plots (a). Surface response plots of the DU recovery for each serotype based on formulations containing sucrose and trehalose in combination with 10% mannitol (without dextran or NaCl) (b).
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig1: Stabilizing potential of the excipients sucrose (SUC), trehalose (TRE), mannitol (MAN), dextran (DEX) and NaCl on DU recovery directly after lyophilization. Main and interaction effects that contribute (per serotype) to the best model, according to the model performance parameters (Q2 = 0.650, R2 = 0.905 (type 1); Q2 = 0.592, R2 = 0.873 (type 2); Q2 = 0.671, R2 = 0.929 (type 3)), are depicted in coefficient plots (a). Surface response plots of the DU recovery for each serotype based on formulations containing sucrose and trehalose in combination with 10% mannitol (without dextran or NaCl) (b).
Mentions: A partial least squares (PLS) regression model was fitted and optimized per serotype, which resulted in valid models to predict the DU recoveries directly after lyophilization according to the model performance parameters. For serotype 1, 2 and 3, the Q2 values were, respectively, 0.650, 0.592 and 0.671, while the R2 values were 0.905, 0.873 and 0.929. The effects of the different stabilizers, after optimization (excluding non-significant parameters) on the DU recovery after lyophilization are presented in Fig. 1a.Fig. 1

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