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J Pharm Sci ; 98(10): 3691-706, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19226627

RESUMO

The similarity of an intranasal salmon calcitonin (sCT) employing chlorobutanol as preservative (Calcitonin Salmon Nasal Spray) was compared to the reference listed drug (RLD) employing benzalkonium chloride as preservative (Miacalcin Nasal Spray). Various orthogonal methods assessed peptide structuring, dynamics, and aggregation state. Mass spectrometry, amino acid analysis, and N-terminal sequencing all demonstrated similarity in primary structure. Near- and far-UV circular dichroism (CD) data supported similarity in secondary and tertiary sCT structure. Nuclear magnetic resonance studies further supported similarity of three-dimensional structure and molecular dynamics of the peptide. Other methods, such as sedimentation velocity and size exclusion chromatography, demonstrated similarity in peptide aggregation state. These latter methods, in addition to reversed phase chromatography, were also employed for monitoring stability under forced degradation, and at the end of recommended shelf storage and patient use conditions. In all cases and for all methodologies employed, similarity to the RLD was observed with respect to extent of aggregation and other degradation processes. Finally, ELISA and bioassay data demonstrated similarity in biological properties. These investigations comprehensively demonstrate physicochemical similarity of Calcitonin Salmon Nasal Spray and the RLD, and should prove a useful illustration to pharmaceutical scientists developing alternative and/or generic peptide or protein products.


Assuntos
Antiasmáticos/administração & dosagem , Compostos de Benzalcônio/química , Calcitonina/administração & dosagem , Clorobutanol/química , Peptídeos/química , Conservantes Farmacêuticos/química , Administração Intranasal , Aerossóis , Aminoácidos/análise , Antiasmáticos/química , Bioensaio , Calcitonina/química , Varredura Diferencial de Calorimetria , Química Farmacêutica , Cromatografia em Gel , Cromatografia Líquida de Alta Pressão , Dicroísmo Circular , Armazenamento de Medicamentos , Ensaio de Imunoadsorção Enzimática , Fracionamento por Campo e Fluxo , Espectroscopia de Ressonância Magnética , Padrões de Referência , Espectrometria de Massas por Ionização e Dessorção a Laser Assistida por Matriz , Espectrofotometria Ultravioleta , Ultracentrifugação
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