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A High Throughput Protein Formulation Platform: Case Study of Salmon Calcitonin

Capelle, Martinus ; Gurny, Robert ; Arvinte, Tudor

In: Pharmaceutical Research, 2009, vol. 26, no. 1, p. 118-128

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    Titre
    • A High Throughput Protein Formulation Platform: Case Study of Salmon Calcitonin
    Auteur
    • Capelle, Martinus. Department of Pharmaceutics and Biopharmaceutics, School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Quai E-Ansermet 30, 1211, Geneva 4, Switzerland
    • Gurny, Robert. Department of Pharmaceutics and Biopharmaceutics, School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Quai E-Ansermet 30, 1211, Geneva 4, Switzerland
    • Arvinte, Tudor. Department of Pharmaceutics and Biopharmaceutics, School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Quai E-Ansermet 30, 1211, Geneva 4, Switzerland
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Pharmaceutical Research, 2009, vol. 26, no. 1, p. 118-128. Springer US; http://www.springer-ny.com
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:319618
    Summary
    Purpose: The feasibility of using high throughput spectroscopy for characterization and selection of physically stable protein formulations was studied. Materials and Methods: A hundred aqueous formulations of salmon calcitonin (sCT) were prepared using 20 buffer compositions. The solutions had pH values between 2.5 and 10.5. The stability of the sCT formulations was analyzed over 1week by the following assays: (1) protein concentration, (2) volume control by measuring pathlength, (3) turbidity (absorbance at 350nm), (4) intrinsic tyrosine fluorescence, (5) 1-anilino-naphthalene-8-sulfonate (ANS) fluorescence, (6) Nile Red fluorescence. Addition of the dyes (Nile Red and ANS) was used to study protein conformational changes. Results: After 1day, 27 out of the 100 formulations of salmon calcitonin were stable. After 7days, 12 stable sCT formulations remained. The best salmon calcitonin formulation was in 10mM sodium acetate buffer with pH values between 3.5 and 5.5. Conclusions: The findings are in accordance with the sCT formulations that were patented and used commercially. This can be considered as a proof of concept for the high throughput protein formulation platform