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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

Sigma-Aldrich
Citric acid, anhydrous, free-flowing, Redi-Dri, ACS reagent, ≥99.5%
Sucrose, European Pharmacopoeia (EP) Reference Standard
Supelco
Citric acid, certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
Sigma-Aldrich
Sodium phosphate dibasic, puriss., meets analytical specification of Ph. Eur., BP, USP, FCC, E 339, anhydrous, 98-100.5% (calc. to the dried substance)
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
Magnesium chloride hexahydrate, puriss., meets analytical specification of Ph. Eur., BP, FCC, E511, 99-101%, ≤0.0001% Al
Sigma-Aldrich
Sodium phosphate dibasic, ACS reagent, ≥99.0%
Sigma-Aldrich
Citric acid, meets analytical specification of Ph. Eur., BP, USP, E330, anhydrous, 99.5-100.5% (based on anhydrous substance)
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
Magnesium chloride hexahydrate, 99.995% trace metals basis
Sigma-Aldrich
2-Hydroxybutyric acid sodium salt, 97%
Sigma-Aldrich
Sodium phosphate dibasic, 99.95% trace metals basis
Sigma-Aldrich
Citric acid, ACS reagent, ≥99.5%
USP
Sucrose, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Citric acid, ≥99.5%, FCC, FG
Sigma-Aldrich
Magnesium chloride hexahydrate, BioUltra, ≥99.0% (KT)
Millipore
Sucrose, suitable for microbiology, ACS reagent, ≥99.0%
Sigma-Aldrich
Magnesium chloride hexahydrate, tested according to Ph. Eur.
Sigma-Aldrich
Sucrose, puriss., meets analytical specification of Ph. Eur., BP, NF
Sigma-Aldrich
Sodium phosphate dibasic, purum p.a., anhydrous, ≥98.0% (T)
Sigma-Aldrich
Sodium phosphate dibasic, BioUltra, Molecular Biology, ≥99.5% (T)
Sigma-Aldrich
Magnesium chloride hexahydrate, BioUltra, Molecular Biology, ≥99.0% (KT)
Sigma-Aldrich
Citric acid, BioUltra, anhydrous, ≥99.5% (T)
Sigma-Aldrich
Sucrose, BioUltra, Molecular Biology, ≥99.5% (HPLC)
Sigma-Aldrich
Sodium phosphate dibasic, ReagentPlus®, ≥99.0%
Sigma-Aldrich
Sodium phosphate dibasic, BioReagent, suitable for cell culture, suitable for insect cell culture, ≥99.0%
Sigma-Aldrich
Sodium phosphate dibasic, BioXtra, ≥99.0%