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Effect of freeze-drying,cryoprotectants and storage conditions on the stability of secondary structure of insulin-loaded solid lipid nanoparticles
Authors:Sandra Soares,Pedro Fonte,Ana Costa,José   Andrade,Ví  tor Seabra,Domingos Ferreira,Salette Reis,Bruno Sarmento
Affiliation:1. Centro de Investigação em Ciências da Saúde (CICS), Instituto Superior de Ciências da Saúde – Norte, CESPU, Gandra-PRD, Portugal;2. REQUIMTE, Department of Chemistry, Faculty of Pharmacy, University of Porto, Porto, Portugal;3. Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Porto, Porto, Portugal;4. INEB – Instituto de Engenharia Biomédica, University of Porto, Porto, Portugal
Abstract:
This study aims to monitor the secondary structure behaviour of insulin when it is encapsulated into solid lipid nanoparticles (SLN), under the influence of several critical processing parameters. Insulin was used as a therapeutic protein model. Physicochemical properties of insulin-loaded SLN (Ins-SLN) were assessed, with special focus on the insulin secondary structure after its encapsulation into SLN and after freeze-drying using different cryoprotectants (glucose, fructose and sorbitol). Additionally, a 6-month stability study was performed to evaluate the maintenance of insulin secondary structure over time at different storage conditions (4 °C/60% RH, 25 °C/60% RH, 40 °C/75% RH).
Keywords:Insulin secondary structure   Solid lipid nanoparticles   Freeze-drying   Cryoprotectants   Stability study   FTIR
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