コンテンツへスキップ
Merck

Development of thermostable lyophilized inactivated polio vaccine.

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

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
製品番号
ブランド
製品内容

Sigma-Aldrich
リン酸ナトリウム 二塩基性, ACS reagent, ≥99.0%
Sigma-Aldrich
スクロース, for molecular biology, ≥99.5% (GC)
Sigma-Aldrich
グリシン, ReagentPlus®, ≥99% (HPLC)
Sigma-Aldrich
塩化マグネシウム 六水和物, ACS reagent, 99.0-102.0%
Sigma-Aldrich
塩化リチウム, ACS reagent, ≥99%
Sigma-Aldrich
スクロース, ≥99.5% (GC)
Sigma-Aldrich
グリシン, suitable for electrophoresis, ≥99%
Sigma-Aldrich
D-ソルビトール, ≥98% (GC)
Sigma-Aldrich
塩化ナトリウム, for molecular biology, DNase, RNase, and protease, none detected, ≥99% (titration)
Sigma-Aldrich
リン酸ナトリウム 二塩基性, puriss. p.a., ACS reagent, anhydrous, ≥99.0% (T)
Sigma-Aldrich
スクロース, ≥99.5% (GC), BioXtra
Sigma-Aldrich
グリシン, BioUltra, for molecular biology, ≥99.0% (NT)
Sigma-Aldrich
スクロース, BioUltra, for molecular biology, ≥99.5% (HPLC)
Sigma-Aldrich
塩化ナトリウム 溶液, 5 M in H2O, BioReagent, for molecular biology, suitable for cell culture
Sigma-Aldrich
塩化ナトリウム 溶液, 0.9% in water, BioXtra, suitable for cell culture
Sigma-Aldrich
塩化ナトリウム, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, ≥99%
Sigma-Aldrich
クエン酸, meets analytical specification of Ph. Eur., BP, USP, E330, anhydrous, 99.5-100.5% (based on anhydrous substance)
Sigma-Aldrich
塩化マグネシウム 六水和物, ReagentPlus®, ≥99.0%
USP
スクロース, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
塩化リチウム, anhydrous, free-flowing, Redi-Dri, ReagentPlus®, 99%
Sigma-Aldrich
リン酸ナトリウム 二塩基性, puriss., meets analytical specification of Ph. Eur., BP, USP, FCC, E 339, anhydrous, 98-100.5% (calc. to the dried substance)
Sigma-Aldrich
myo-イノシトール, ≥99% (GC), BioReagent
Sigma-Aldrich
塩化リチウム, for molecular biology, ≥99%
Sigma-Aldrich
塩化マグネシウム 六水和物, puriss., meets analytical specification of Ph. Eur., BP, FCC, E511, 99-101%, ≤0.0001% Al
Sigma-Aldrich
塩化リチウム, anhydrous, free-flowing, Redi-Dri, ACS reagent, ≥99%
Sigma-Aldrich
myo-イノシトール, ≥99%
Sigma-Aldrich
グリシン, from non-animal source, meets EP, JP, USP testing specifications, suitable for cell culture, ≥98.5%
Sigma-Aldrich
塩化リチウム, ReagentPlus®, 99%
Sigma-Aldrich
塩化リチウム, powder, ≥99.98% trace metals basis
Sigma-Aldrich
スクロース, ≥99.5% (GC), BioReagent, suitable for cell culture, suitable for insect cell culture