Design and Evaluation of the Highly Concentrated Human IgG Formulation Using Cyclodextrin Polypseudorotaxane Hydrogels

AAPS PharmSciTech
Taishi HigashiHidetoshi Arima

Abstract

To achieve the potent therapeutic effects of human immunoglobulin G (IgG), highly concentrated formulations are required. However, the stabilization for highly concentrated human IgG is laborious work. In the present study, to investigate the potentials of polypseudorotaxane (PPRX) hydrogels consisting of polyethylene glycol (PEG) and α- or γ-cyclodextrin (α- or γ-CyD) as pharmaceutical materials for highly concentrated human IgG, we designed the PPRX hydrogels including human IgG and evaluated their pharmaceutical properties. The α- and γ-CyDs formed PPRX hydrogels with PEG (M.W. 20,000) even in the presence of highly concentrated human IgG (>100 mg/mL). According to the results of (1)H-NMR, powder X-ray diffraction, and Raman microscopy, the formation of human IgG/CyD PPRX hydrogels was based on physical cross-linking arising from their columnar structures. The release profiles of human IgG from the hydrogels were in accordance with the non-Fickian diffusion model. Importantly, the stabilities of human IgG included into the hydrogels against thermal and shaking stresses were markedly improved. These findings suggest that PEG/CyD PPRX hydrogels are useful to prepare the formulation for highly concentrated human IgG.

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Citations

Apr 14, 2016·AAPS PharmSciTech·Paula Dos Passos MenezesAdriano Antunes de Souza Araujo
Jun 12, 2016·International Journal of Biological Macromolecules·Takaaki Kurinomaru, Kentaro Shiraki
Jan 17, 2017·Journal of Pharmaceutical Sciences·Taishi HigashiHidetoshi Arima
Apr 2, 2019·Chemical & Pharmaceutical Bulletin·Taishi Higashi
Feb 5, 2019·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Taishi HigashiHidetoshi Arima
Jan 8, 2020·Materials·Adrian DomińskiPiotr Kurcok
Apr 7, 2017·Chemical & Pharmaceutical Bulletin·Hidetoshi ArimaTaishi Higashi
Jan 2, 2021·European Journal of Medicinal Chemistry·Jiang LiuPeng Yu
Jul 28, 2020·International Journal of Pharmaceutics·Pablo F GarridoRebeca Garcia-Fandino
Jul 7, 2021·Materials Science & Engineering. C, Materials for Biological Applications·Alessandro TorchioGianluca Ciardelli

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