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Merck

Development of thermostable lyophilized inactivated polio vaccine.

Pharmaceutical research (2014-04-25)
Heleen Kraan, Paul van Herpen, Gideon Kersten, Jean-Pierre Amorij
RESUMO

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. 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.

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Sigma-Aldrich
Fosfato de sódio, ACS reagent, ≥99.0%
Sigma-Aldrich
Sacarose, for molecular biology, ≥99.5% (GC)
Sigma-Aldrich
Glicina, ReagentPlus®, ≥99% (HPLC)
Sigma-Aldrich
Cloreto de magnésio, ACS reagent, 99.0-102.0%
Sigma-Aldrich
Sacarose, ≥99.5% (GC)
Sigma-Aldrich
Glicina, suitable for electrophoresis, ≥99%
Sigma-Aldrich
D-sorbitol, ≥98% (GC)
Sigma-Aldrich
Cloreto de sódio, for molecular biology, DNase, RNase, and protease, none detected, ≥99% (titration)
Sigma-Aldrich
Fosfato de sódio, puriss. p.a., ACS reagent, anhydrous, ≥99.0% (T)
Sigma-Aldrich
Sacarose, ≥99.5% (GC), BioXtra
Sigma-Aldrich
Glicina, BioUltra, for molecular biology, ≥99.0% (NT)
Sigma-Aldrich
Sacarose, BioUltra, for molecular biology, ≥99.5% (HPLC)
Sigma-Aldrich
Sodium chloride solution, 5 M in H2O, BioReagent, for molecular biology, suitable for cell culture
Sigma-Aldrich
Sodium chloride solution, 0.9% in water, BioXtra, suitable for cell culture
Sigma-Aldrich
Cloreto de sódio, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, ≥99%
Sigma-Aldrich
Ácido cítrico, meets analytical specification of Ph. Eur., BP, USP, E330, anhydrous, 99.5-100.5% (based on anhydrous substance)
Sigma-Aldrich
Cloreto de magnésio, ReagentPlus®, ≥99.0%
Sigma-Aldrich
Fosfato de sódio, puriss., meets analytical specification of Ph. Eur., BP, USP, FCC, E 339, anhydrous, 98-100.5% (calc. to the dried substance)
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mio-inositol, ≥99% (GC), BioReagent
Sigma-Aldrich
Cloreto de magnésio, puriss., meets analytical specification of Ph. Eur., BP, FCC, E511, 99-101%, ≤0.0001% Al
SAFC
Sodium chloride solution, 5 M
Sigma-Aldrich
mio-inositol, ≥99%
Sigma-Aldrich
Glicina, from non-animal source, meets EP, JP, USP testing specifications, suitable for cell culture, ≥98.5%
Sigma-Aldrich
Lithium chloride, ReagentPlus®, 99%
Sigma-Aldrich
Sacarose, ≥99.5% (GC), BioReagent, suitable for cell culture, suitable for insect cell culture
Sigma-Aldrich
Fosfato de sódio, BioReagent, suitable for cell culture, suitable for insect cell culture, ≥99.0%
Sigma-Aldrich
Fosfato de sódio, for molecular biology, ≥98.5% (titration)
Sigma-Aldrich
D-sorbitol, BioUltra, ≥99.0% (HPLC)
SAFC
Glicina
Sigma-Aldrich
Sacarose, ≥99.5% (GC)