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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
ABSTRACT

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.

MATERIALS
Product Number
Brand
Product Description

Supelco
Glycine, analytical standard, for nitrogen determination according to Kjeldahl method
Supelco
Glycine, certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
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Phosphate Standard for IC, TraceCERT®, 1000 mg/L phosphate in water (nominal concentration)
Supelco
Sorbitol, Pharmaceutical Secondary Standard; Certified Reference Material
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Mannitol, Pharmaceutical Secondary Standard; Certified Reference Material
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Glycine, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Sodium chloride, tested according to Ph. Eur.
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Sodium chloride, BioUltra, for molecular biology, ≥99.5% (AT)
Sigma-Aldrich
Glycine, tested according to Ph. Eur.
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Sodium chloride solution, BioUltra, for molecular biology, ~5 M in H2O
Mannitol, European Pharmacopoeia (EP) Reference Standard
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D-Mannitol, ≥99.9999% (metals basis), for boron determination
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Lithium chloride, powder, ≥99.98% trace metals basis
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D-Mannitol, BioUltra, ≥99.0% (sum of enantiomers, HPLC)
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D-Mannitol, tested according to Ph. Eur.
Supelco
Lithium chloride solution, 1 M in ethanol
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D-Sorbitol, BioUltra, ≥99.0% (HPLC)
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Sodium chloride, reference material for titrimetry, certified by BAM, >99.5%
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Glycine, 99%, FCC
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D-Sorbitol, FCC, FG
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Sodium chloride, 99.999% trace metals basis
SAFC
Glycine
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Lithium chloride, AnhydroBeads, −10 mesh, ≥99.9% trace metals basis
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D-Sorbitol, 99% (GC)
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Sodium chloride-35Cl, 99 atom % 35Cl
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Sodium chloride, random crystals, optical grade, 99.9% trace metals basis
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Sodium chloride solution, 0.85%
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Sorbitol F solution, 70 wt. % in H2O, Contains mainly D-sorbitol with lesser amounts of other hydrogenated oligosaccharides
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Lithium chloride, AnhydroBeads, −10 mesh, 99.998% trace metals basis
Sigma-Aldrich
Sodium chloride, AnhydroBeads, −10 mesh, 99.999% trace metals basis