Design and Evaluation of the Highly Concentrated Human IgG Formulation Using Cyclodextrin Polypseudorotaxane Hydrogels
Journal Title: AAPS PharmSciTech - Year 2015, Vol 16, Issue 6
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 1H-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.
Authors and Affiliations
Taishi Higashi, Anna Tajima, Naoko Ohshita, Tatsunori Hirotsu, Irhan Ibrahim Abu Hashim, Keiichi Motoyama, Sawako Koyama, Ruriko Iibuchi, Shiuhei Mieda, Kenji Handa, Tomoaki Kimoto, Hidetoshi Arima
Keywords
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- EP ID EP682290
- DOI 10.1208/s12249-015-0309-x
- Views 59
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