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

Supelco
Glycine, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Sorbitol, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Sodium chloride, BioPerformance Certified, ≥99% (titration), suitable for insect cell culture, suitable for plant cell culture
SAFC
Sodium chloride solution, 5 M
Sorbitol, European Pharmacopoeia (EP) Reference Standard
Mannitol, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Lithium-7Li chloride, 99 atom % 7Li, 99% (CP)
Sigma-Aldrich
Sodium phosphate dibasic solution, BioUltra, 0.5 M in H2O
Sigma-Aldrich
Sodium chloride solution, 0.85%
Sigma-Aldrich
D-Sorbitol, 99% (GC)
Sigma-Aldrich
Sodium chloride, random crystals, 99.9% trace metals basis
Sigma-Aldrich
D-Sorbitol, liquid, tested according to Ph. Eur.
USP
Mannitol, United States Pharmacopeia (USP) Reference Standard
USP
Sorbitol, United States Pharmacopeia (USP) Reference Standard
USP
Glycine, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Lithium chloride, Molecular Biology, ≥99%
Sigma-Aldrich
myo-Inositol, ≥99% (GC), BioReagent
Sigma-Aldrich
Sodium chloride solution, 5 M in H2O, BioReagent, Molecular Biology, suitable for cell culture
Sigma-Aldrich
Lithium chloride, BioXtra, ≥99.0% (titration)
Sigma-Aldrich
Glycine, BioXtra, ≥99% (titration)
Sigma-Aldrich
Glycine, from non-animal source, meets EP, JP, USP testing specifications, suitable for cell culture, ≥98.5%
Sigma-Aldrich
D-Sorbitol, ≥98% (GC)
Sigma-Aldrich
D-Sorbitol, ≥98% (GC), Molecular Biology
Sigma-Aldrich
myo-Inositol, ≥99%
Sigma-Aldrich
Sodium chloride, Molecular Biology, DNase, RNase, and protease, none detected, ≥99% (titration)
Sigma-Aldrich
Sodium chloride, tablet
Sigma-Aldrich
D-Mannitol, ≥98% (GC), suitable for plant cell culture
Sigma-Aldrich
D-Mannitol, ACS reagent
Sigma-Aldrich
Sodium chloride, meets analytical specification of Ph. Eur., BP, USP, 99.0-100.5%
Sigma-Aldrich
Sodium chloride, BioXtra, ≥99.5% (AT)