[Photosensitivity and stability of freeze-dried and/or reconstituted measles vaccines (Biken CAM-70 strain)].
Three different lots of measles vaccines produced with the Biken CAM-70 virus strain were requested from the central cold store of the Public Health Department of the State of S. Paulo, Brazil, and assays on photosensitivity at 2-8 degrees C, and on stability at 28, 36.5 and 45 degrees C were carried out to find out for how long these vaccines would maintain their minimum potency, established as being 3.70 log10 or 5000 TCID50 (50% tissue culture infective dose) per human dose. The analysis of the adjusted straight regression lines indicated that, with the passage of time, the potency of lyophilized or reconstituted vaccines, as well as of vaccines exposed to or protected from light decreased. Light-exposed vaccines, however, became less potent than vaccines protected from the light. None of the vaccine lots studied, reconstituted and stored at 2-8 degrees C, exhibited homogeneity as to sensitivity to light. When freeze-dried vaccines had their photosensitivity studied at 2-8 degrees C, lots 1 and 2 presented greater thermal degradation when exposed to light than when protected from it. However, in both instances, it was found that potency fell below that taken as minimum for the Biken CAM-70 virus strain. At all other temperatures considered, even when protected from light, lots 1 and 2 did not retain the minimum potency. Lot 3 kept the expected stability for 60 days at 2-8 degrees C when protected from light and for 40 days when unprotected, but its thermal degradation at other temperatures was more intense (28 degrees C: 5 days; 36.5 degrees C: 2 days; 45 degrees C: 0.5 day).(ABSTRACT TRUNCATED AT 250 WORDS)
de Rizzo
E
E
Seção de Cultura de Tecidos e Controle, Virologia do Instituto Butantan, São Paulo, Brasil.
Pereira
C A
CA
Fang
F L
FL
Takata
C S
CS
Tenório
E C
EC
Pral
M M
MM
Mendes
I F
IF
Gallina
N M
NM
D004355:Drug Stability; D004356:Drug Storage; D005069:Evaluation Studies as Topic; D005612:Freeze Drying; D006358:Hot Temperature / Q000009:adverse effects; D008027:Light / Q000009:adverse effects; D008458:Measles Vaccine / Q000592:standards*; D014613:Vaccines, Attenuated / Q000592:standards
D008458:Measles Vaccine; D014613:Vaccines, Attenuated
Fotossensibilidade e termoestabilidade de vacinas contra o sarampo (cepa Biken CAM-70) liofilizadas e/ou reconstituídas para administração.