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首页> 外文期刊>Chemical and Pharmaceutical Bulletin >Application of Near-Infrared Spectrometry to Evaluate the Mechanism of Wet Granulation Using a High-Speed Mixer with Porous Calcium Silicate and Sugar Alcohols
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Application of Near-Infrared Spectrometry to Evaluate the Mechanism of Wet Granulation Using a High-Speed Mixer with Porous Calcium Silicate and Sugar Alcohols

机译：应用近红外光谱技术评估多孔硅酸钙和糖醇的高速混合机的湿法制粒机理

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The current study examined the mechanism of wet granulation with a high-speed mixer using porous calcium silicate (PCS) as the excipient and low-molecular-weight sugar alcohols (erythritol, mannitol, maltitol, or xylitol) as the binder. Granules did not form when erythritol or mannitol was used as the binder. No major changes in X-ray powder diffraction data and near-infrared (NIR) spectroscopy spectra were noted when erythritol was used in granulation. Meanwhile, granules formed when xylitol was used as the binder. The NIR spectra of the obtained granules had a widened band near 5100?cm?1 due to hydroxyl groups. From the peak fitting near 4800?cm?1 using the Gaussian–Lorentzian product function, the contribution of hydrogen bonds in water species increased during granulation. The NIR spectra of these potential binders revealed a band of hydroxyl groups for intramolecular hydrogen bonds near 6900?cm?1 when maltitol or xylitol was used as the binder, whereas no band was observed for erythritol and mannitol. Changes in the NIR spectra assigned to water were useful in evaluating the progression of granulation as a process analytical technology. Moreover, X-ray powder diffraction illustrated that the peak due to xylitol crystals disappeared. Xylitol existed in an amorphous state in the granules, suggesting molecular interactions. Thus, hydroxyl groups in sugar alcohols facilitate hydrogen bonding between PCS (silanol groups) and molecules via water, and this is considered to be the mechanism by which granules are formed.
机译：当前的研究使用高速混合机，使用多孔硅酸钙（PCS）作为赋形剂和低分子量糖醇（赤藓醇，甘露醇，麦芽糖醇或木糖醇）作为粘合剂，研究了湿法制粒的机理。当赤藓糖醇或甘露糖醇用作粘合剂时，不会形成颗粒。当赤藓糖醇用于制粒时，X射线粉末衍射数据和近红外（NIR）光谱没有重大变化。同时，当木糖醇用作粘合剂时形成颗粒。所得颗粒的NIR光谱由于羟基而在5100Ωcm-1附近具有较宽的能带。使用高斯-洛伦兹乘积函数，从4800？cm？1附近的峰拟合，造粒过程中水物种中氢键的贡献增加。当使用麦芽糖醇或木糖醇作为粘合剂时，这些潜在的粘合剂的NIR光谱显示在6900Ωcm-1附近的分子内氢键的羟基带，而对于赤藓糖醇和甘露醇没有观察到带。分配给水的NIR光谱的变化对于评估制粒的过程作为一种过程分析技术很有用。此外，X射线粉末衍射表明，由于木糖醇晶体引起的峰消失了。木糖醇以无定形状态存在于颗粒中，表明存在分子相互作用。因此，糖醇中的羟基通过水促进PCS（硅烷醇基）与分子之间的氢键，这被认为是形成颗粒的机理。

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