Preparation and Characterization of Ibrutinib Amorphous Solid Dispersions: a Discussion of Interaction Force

Shi Xiangjun; Fan Baibai; Zhou XiyueChen QifengShen ShuimeiXing XiaoyiDeng Yu

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Preparation and Characterization of Ibrutinib Amorphous Solid Dispersions: a Discussion of Interaction Force

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The aim of this study was to improve the solubility and dissolution of Ibrutinib (IBR), a biopharmaceutical classification system (BCS) class II drug, by preparing binary and ternary amorphous solid dispersions (ASDs). The physicochemical properties of the ASD formulations were evaluated. Compared with crystalline IBR Form A, ASDs showed prominent improvement both in solubility and dissolution. The solubility and dissolution of IBR-HPMCAS (1:3) ASD were increased up to 9 times and 15 times than IBR Form A in the pH 6.8 buffer. Moreover, IBR-HPMCAS (1:3) ASD kept a stable amorphous state for 180 days under the accelerated stability condition (40 degrees C/75 RH). From Fourier Transform-Infrared spectra and Delta Tg analysis, the possible hydrogen-bond interactions in IBR ASDs were pointed out to explain the improvement of solubility and stability. The results of this study demonstrated that ASD is a promising strategy to improve solubility and dissolution of poorly water soluble IBR.

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《journal of pharmaceutical innovation》 |2022年第4期|1074-1083|共10页
作者
Shi Xiangjun; Fan Baibai; Zhou XiyueChen QifengShen ShuimeiXing XiaoyiDeng Yu;
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作者单位

Zhejiang Univ Technol;

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正文语种英语
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Ibrutinib; Amorphous solid dispersion; Solubility; Dissolution; Interaction; Stability; ORAL BIOAVAILABILITY; DISSOLUTION; SOLUBILITY; DRUGS; STRATEGIES;

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Preparation and Characterization of Ibrutinib Amorphous Solid Dispersions: a Discussion of Interaction Force

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