Stability of interleukin 1 beta (IL-1 beta) in aqueous solution: analytical methods, kinetics, products, and solution formulation implications.
Pharm Res
; 8(4): 485-90, 1991 Apr.
Article
en En
| MEDLINE
| ID: mdl-1871044
The thermal stability of IL-1 beta in aqueous solution as a function of temperature (5-60 degrees C), pH (2-9), buffer (acetate, citrate, tris, and phosphate), and cyroprotectants (sugars, HSA) was investigated in this study. The analytical methodologies included RP-HPLC, SEC, ELISA, IEF-PAGE, SDS-PAGE, and bioassay. The degradation and inactivation of IL-1 beta at or above 39 degrees C were attributed to autoxidation of the two cysteine residues in the denatured protein, followed by hydrophobic/covalent aggregation and precipitation. At or below 30 degrees C, IEF- and SDS-PAGE results suggest a possible deamidation reaction. The difference in mechanism of degradation precludes the prediction of formulation shelf life from accelerated temperature data. Nonetheless, the good stability observed at 5 degrees C suggests that a solution formulation may be feasible for IL-1 beta.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Interleucina-1
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
Pharm Res
Año:
1991
Tipo del documento:
Article
Pais de publicación:
Estados Unidos