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Application of Cyclodextrins in Antibody Microparticles: Potentials for Antibody Protection in Spray Drying Publisher Pubmed



Ramezani V1 ; Vatanara A2 ; Seyedabadi M3 ; Nabi Meibodi M1 ; Fanaei H4
Authors
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Authors Affiliations
  1. 1. Department of Pharmaceutics, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
  2. 2. Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Pharmacology, School of Medicine, Bushehr University of Medical Sciences, Bushehr, Iran
  4. 4. Department of Physiology, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran

Source: Drug Development and Industrial Pharmacy Published:2017


Abstract

Objectives: Dry powder formulations are extensively used to improve the stability of antibodies. Spray drying is one of important methods for protein drying. This study investigated the effects of trehalose, hydroxypropyl beta cyclodextrin (HPBCD) and beta cyclodextrin (BCD) on the stability and particle properties of spray-dried IgG. Methods: D-optimal design was employed for both experimental design and analysis and optimization of the variables. The size and aerodynamic behavior of particles were determined using laser light scattering and glass twin impinger, respectively. In addition, stability, ratio of beta sheets and morphology of antibody were analyzed using size exclusion chromatography, IR spectroscopy and electron microscopy, respectively. Results: Particle properties and antibody stability were significantly improved in the presence of HPBCD. In addition, particle aerodynamic behavior, in terms of fine-particle fraction (FPF), enhanced up to 52.23%. Furthermore, antibody was better preserved not only during spray drying, but also during long-term storage. In contrast, application of BCD resulted in the formation of larger particles. Although trehalose caused inappropriate aerodynamic property, it efficiently decreased antibody aggregation. Conclusion: HPBCD is an efficient excipient for the development of inhalable protein formulations. In this regard, optimal particle property and antibody stability was obtained with proper combination of cyclodextrins and simple sugars, such as trehalose. © 2017 Informa UK Limited, trading as Taylor & Francis Group.
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