Long-term stabilization of recombinant human interferon alpha 2b in aqueous solution without serum albumin.
Int J Pharm
; 264(1-2): 57-72, 2003 Oct 02.
Article
em En
| MEDLINE
| ID: mdl-12972336
The development of parenteral solution dosage forms of interferon alpha 2 (rhIFN-alpha2) without human albumin may significantly diminish the problem of forming highly immunogenic rhIFN-alpha 2b aggregates and the potential risk of blood-transmitted diseases caused by infectious viruses and often living pathogens that may be present in the plasma. With this purpose, we evaluated the compatibility of type I borosilicate glass vials and chlorobutyl stoppers with rhIFN-alpha 2b in an aqueous solution. At the same time, we carried out a targeted formulation screen at 37 degrees C of single or combined (e.g. polysorbate 80, EDTA Na(2), PEG 400) potentially stabilizing excipients. Quantified biochemical results from 12 independent batches of rhIFN-alpha 2b in a polysorbate/benzyl alcohol-based vehicle formulated at pH 7.4 were all found within the limits established by the World Health Organization for this cytokine. Real-time storage data confirmed the excellent biochemical long-term (30 months) stability of rhIFN-alpha 2b in this aqueous solution formulation. Analyses were performed at intervals throughout the time period using reverse-phase high-performance liquid chromatography, a sandwich-type enzyme-linked immunosorbent assay, and antiviral activity as stability-indicating assays. Furthermore, both the physical stability (color, odor, appearance, pH, and absence of particulate material) and the sterility of this formulation were maintained under the proposed shelf conditions.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Antivirais
/
Interferon-alfa
Idioma:
En
Revista:
Int J Pharm
Ano de publicação:
2003
Tipo de documento:
Article
País de afiliação:
Cuba
País de publicação:
Holanda