Skip to Content
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

Sucrose, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Magnesium chloride hexahydrate, ReagentPlus®, ≥99.0%
Sigma-Aldrich
Sodium phosphate dibasic, puriss. p.a., ACS reagent, anhydrous, ≥99.0% (T)
Sigma-Aldrich
Magnesium chloride hexahydrate, ACS reagent, 99.0-102.0%
Sigma-Aldrich
Sodium phosphate dibasic, ACS reagent, ≥99.0%
Supelco
Electrolyte solution, nonaqueous, LiCl in ethanol (saturated)
Supelco
Citric acid, Anhydrous, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Electrolyte solution, nonaqueous, 2 M LiCl in ethanol
Sigma-Aldrich
Citric acid, ACS reagent, ≥99.5%
USP
Sucrose, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Citric acid, ≥99.5%, FCC, FG
Millipore
Sucrose, suitable for microbiology, ACS reagent, ≥99.0%
Sigma-Aldrich
Sucrose, BioUltra, Molecular Biology, ≥99.5% (HPLC)
Sigma-Aldrich
Sodium phosphate dibasic, ReagentPlus®, ≥99.0%
Sigma-Aldrich
Sodium phosphate dibasic, Molecular Biology, ≥98.5% (titration)
Sigma-Aldrich
Magnesium chloride hexahydrate, BioReagent, suitable for cell culture, suitable for insect cell culture
Sigma-Aldrich
Magnesium chloride hexahydrate, BioXtra, ≥99.0%
Sigma-Aldrich
Sucrose, ACS reagent
Supelco
Sucrose, analytical standard, for enzymatic assay kit SCA20
Sigma-Aldrich
Sucrose, ≥99.5% (GC), BioXtra
Sigma-Aldrich
Sucrose, ≥99.5% (GC)
Sigma-Aldrich
Sucrose, Molecular Biology, ≥99.5% (GC)
Sigma-Aldrich
Sucrose, ≥99% (GC), Grade I, suitable for plant cell culture
Sigma-Aldrich
Citric acid, 99%
Citric acid, anhydrous, European Pharmacopoeia (EP) Reference Standard
Supelco
Sucrose, Pharmaceutical Secondary Standard; Certified Reference Material
USP
Citric acid, United States Pharmacopeia (USP) Reference Standard
Supelco
Sodium chloride, Pharmaceutical Secondary Standard; Certified Reference Material
Glycine, European Pharmacopoeia (EP) Reference Standard
USP
Glycine, United States Pharmacopeia (USP) Reference Standard