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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
RESUMEN

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 sodio dibasic, ACS reagent, ≥99.0%
Sigma-Aldrich
Sacarosa, for molecular biology, ≥99.5% (GC)
Sigma-Aldrich
Glicina, ReagentPlus®, ≥99% (HPLC)
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Cloruro de magnesio hexahydrate, ACS reagent, 99.0-102.0%
Sigma-Aldrich
Cloruro de litio, ACS reagent, ≥99%
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Sacarosa, ≥99.5% (GC)
Sigma-Aldrich
Glicina, suitable for electrophoresis, ≥99%
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D-Sorbitol, ≥98% (GC)
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Cloruro de sodio, for molecular biology, DNase, RNase, and protease, none detected, ≥99% (titration)
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Fosfato de sodio dibasic, puriss. p.a., ACS reagent, anhydrous, ≥99.0% (T)
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Sacarosa, ≥99.5% (GC), BioXtra
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Glicina, BioUltra, for molecular biology, ≥99.0% (NT)
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Sacarosa, BioUltra, for molecular biology, ≥99.5% (HPLC)
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Sodium chloride solution, 5 M in H2O, BioReagent, for molecular biology, suitable for cell culture
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Sodium chloride solution, 0.9% in water, BioXtra, suitable for cell culture
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Cloruro de sodio, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, ≥99%
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Ácido cítrico, meets analytical specification of Ph. Eur., BP, USP, E330, anhydrous, 99.5-100.5% (based on anhydrous substance)
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Cloruro de magnesio hexahydrate, ReagentPlus®, ≥99.0%
USP
Sacarosa, United States Pharmacopeia (USP) Reference Standard
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Cloruro de litio, anhydrous, free-flowing, Redi-Dri, ReagentPlus®, 99%
Sigma-Aldrich
Fosfato de sodio dibasic, 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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myo-Inositol, ≥99% (GC), BioReagent
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Cloruro de litio, for molecular biology, ≥99%
Sigma-Aldrich
Cloruro de magnesio hexahydrate, puriss., meets analytical specification of Ph. Eur., BP, FCC, E511, 99-101%, ≤0.0001% Al
SAFC
Sodium chloride solution, 5 M
Sigma-Aldrich
Cloruro de litio, anhydrous, free-flowing, Redi-Dri, ACS reagent, ≥99%
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myo-Inositol, ≥99%
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Glicina, from non-animal source, meets EP, JP, USP testing specifications, suitable for cell culture, ≥98.5%
Sigma-Aldrich
Cloruro de litio, ReagentPlus®, 99%
Sigma-Aldrich
Cloruro de litio, powder, ≥99.98% trace metals basis