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Hum Antibodies ; 20(3-4): 95-101, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-22129679

RESUMO

BACKGROUND: Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant vascular dysplasia and severe, recurrent epistaxis is a common clinical phenotype associated with HHT. An intranasal treatment regime of diluted Avastin™ (Bevacizumab; recombinant humanized anti-vascular epithelial growth factor immunoglobin G1) using apulsatile nasal irrigator has proven efficacious in clinical practice. However, concerns regarding the stability of Avastin™ following dilution and prolonged storage in standard containers used for drug delivery, such as polyethylene bottles, have so far prevented a more widespread clinical use. Compatibility with the preservative benzalkonium chloride was also unknown. OBJECTIVE: This study aimed at determining, whether dilution, prolonged refrigerated storage and the presence of the preservative benzalkonium chloride - as required for novel Avastin™ formulations - affected the biochemical and electrochemical properties of the drug. METHODS: We performed a detailed biochemical and electrochemical analysis of Avastin™, including native and sodium dodecyl sulfate polyacrylamide gel electrophoresis, enzyme-linked immunosorbent assay and isoelectric focusing. RESULTS: We did not detect any evidence of degeneration or aggregation following dilution and prolonged, refrigerated storage or from the presence of benzalkonium chloride. All biochemical and electrochemical properties of Avastin™ after dilution and prolonged, refrigerated storage were undistinguishable from control. CONCLUSIONS: Our data provide important insight into the stability of Avastin™ and allow the consideration of novel Avastin™ formulations, including its use in a metered-dose nasal spray for the treatment of HHT and other applications.


Assuntos
Receptores de Activinas Tipo II/imunologia , Inibidores da Angiogênese/imunologia , Anticorpos Monoclonais Humanizados/imunologia , Compostos de Benzalcônio/química , Epistaxe/tratamento farmacológico , Telangiectasia Hemorrágica Hereditária/tratamento farmacológico , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Receptores de Activinas Tipo II/genética , Administração Intranasal , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/uso terapêutico , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/uso terapêutico , Bevacizumab , Estabilidade de Medicamentos , Eletroforese em Gel de Poliacrilamida , Ensaio de Imunoadsorção Enzimática , Epistaxe/complicações , Epistaxe/imunologia , Epistaxe/metabolismo , Humanos , Focalização Isoelétrica , Sprays Nasais , Polietileno/química , Conservantes Farmacêuticos/química , Telangiectasia Hemorrágica Hereditária/complicações , Telangiectasia Hemorrágica Hereditária/imunologia , Telangiectasia Hemorrágica Hereditária/metabolismo , Fator A de Crescimento do Endotélio Vascular/imunologia
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