跳轉至內容
Merck

Development of thermostable lyophilized inactivated polio vaccine.

Pharmaceutical research (2014-04-25)
Heleen Kraan, Paul van Herpen, Gideon Kersten, Jean-Pierre Amorij
摘要

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.

材料
產品編號
品牌
產品描述

Sigma-Aldrich
磷酸钠 二元, ACS reagent, ≥99.0%
Sigma-Aldrich
蔗糖, for molecular biology, ≥99.5% (GC)
Sigma-Aldrich
甘氨酸, ReagentPlus®, ≥99% (HPLC)
Sigma-Aldrich
氯化镁 六水合物, ACS reagent, 99.0-102.0%
Sigma-Aldrich
氯化锂, ACS reagent, ≥99%
Sigma-Aldrich
蔗糖, ≥99.5% (GC)
Sigma-Aldrich
甘氨酸, suitable for electrophoresis, ≥99%
Sigma-Aldrich
氯化钠, for molecular biology, DNase, RNase, and protease, none detected, ≥99% (titration)
Sigma-Aldrich
磷酸钠 二元, puriss. p.a., ACS reagent, anhydrous, ≥99.0% (T)
Sigma-Aldrich
D -山梨醇, ≥98% (GC)
Sigma-Aldrich
蔗糖, ≥99.5% (GC), BioXtra
Sigma-Aldrich
甘氨酸, BioUltra, for molecular biology, ≥99.0% (NT)
Sigma-Aldrich
蔗糖, BioUltra, for molecular biology, ≥99.5% (HPLC)
Sigma-Aldrich
氯化钠 溶液, 5 M in H2O, BioReagent, for molecular biology, suitable for cell culture
Sigma-Aldrich
氯化钠 溶液, 0.9% in water, BioXtra, suitable for cell culture
Sigma-Aldrich
无水柠檬酸粉末, meets analytical specification of Ph. Eur., BP, USP, E330, anhydrous, 99.5-100.5% (based on anhydrous substance)
Sigma-Aldrich
氯化钠, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, ≥99%
Sigma-Aldrich
氯化镁 六水合物, ReagentPlus®, ≥99.0%
USP
蔗糖, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
氯化锂, anhydrous, free-flowing, Redi-Dri, ReagentPlus®, 99%
Sigma-Aldrich
磷酸钠 二元, puriss., meets analytical specification of Ph. Eur., BP, USP, FCC, E 339, anhydrous, 98-100.5% (calc. to the dried substance)
Sigma-Aldrich
氯化锂, for molecular biology, ≥99%
Sigma-Aldrich
肌醇 -肌醇, ≥99% (GC), BioReagent
SAFC
氯化钠 溶液, 5 M
Sigma-Aldrich
氯化镁 六水合物, puriss., meets analytical specification of Ph. Eur., BP, FCC, E511, 99-101%, ≤0.0001% Al
Sigma-Aldrich
肌醇 -肌醇, ≥99%
Sigma-Aldrich
氯化锂, anhydrous, free-flowing, Redi-Dri, ACS reagent, ≥99%
Sigma-Aldrich
甘氨酸, from non-animal source, meets EP, JP, USP testing specifications, suitable for cell culture, ≥98.5%
Sigma-Aldrich
氯化锂, ReagentPlus®, 99%
Sigma-Aldrich
氯化锂, powder, ≥99.98% trace metals basis