Abstract

MACHADO, Maylén et al. Stability studies of shelflife and in stress conditions of Leptospirosis vaccine vax-SPIRAL^®. Vaccimonitor [online]. 2007, vol.16, n.1, pp. 1-5. ISSN 1025-0298.

Stability studies are mandatory for Registration Applications of a new drug substance. Shelf life and stress temperature stability studies were designed and carried out to the Cuban leptospirosis vaccine vax-SPIRAL^®, in which main physico-chemical and biological properties of the product (organoleptic characteristics, pH, thiomersal concentration, unspecific innocuity, potency and sterility) were evaluated in order to recommend storage conditions and expiration date. For this purpose, part of the samples were stored between 2-8 ºC for 30 months (shelflife), and the remaining samples from each lot under study were incubated at 37 ºC for 7 days; 25 ºC for 30 days and 45 ºC for 3 days (stress temperatures). It was concluded that vax-SPIRAL^® vaccine can be considered a stable product in terms of the parameters evaluated in the present study, provided that it is stored at 2-8 ºC. Under those conditions,   a validity period of 24 months is proposed.

Keywords : Leptospira interrogans; leptospirosis vaccine; stability; shelflife; stress temperature; Cuba.

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