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首页> 外文期刊>Journal of pharmaceutical sciences. >Quality by design, part III: study of curing process of sustained release coated products using NIR spectroscopy.
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Quality by design, part III: study of curing process of sustained release coated products using NIR spectroscopy.

机译：通过设计保证质量，第三部分：使用NIR光谱研究缓释包衣产品的固化过程。

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This study investigated the potential of near infrared spectroscopy (NIRS) to assess film coat curing for tablets coated with methacrylate copolymers. The ability of NIRS to monitor film coat curing was studied and compared to conventional methods like differential scanning calorimetry (DSC) and hot-stage microscopy (HSOM). This study showed that variation in the curing temperature and duration affected the NIR spectra for all formulations. These results and the DSC and HSOM results showed that the spectral changes are due to polymer curing. In addition, glass beads, theophylline and orbifloxacin tablets were coated using Eudragit RL, RS, and L 30-D with varying ratios. Principal component analysis (PCA) was performed on the NIR spectra to investigate the effect of curing time and temperature on cast films, uncoated tablets, coated tablets and coated glass beads. Score plots showed that curing duration and temperature affected coated glass beads, uncoated and coated tablets significantly. The amount ofdrug released at 250 min, and the NIR spectra of cured tablets were used to develop and validate a 7-factor partial least square (PLS) regression calibration for theophylline tablets coated with Eudragit RL:RS 30-D (1:4). This study demonstrated the potential of NIRS in film coat curing and release monitoring.
机译：这项研究调查了近红外光谱（NIRS）评估涂有甲基丙烯酸酯共聚物的片剂的薄膜包衣固化的潜力。研究了NIRS监测薄膜涂层固化的能力，并将其与差示扫描量热法（DSC）和热台显微镜（HSOM）等常规方法进行了比较。这项研究表明，固化温度和持续时间的变化会影响所有配方的NIR光谱。这些结果以及DSC和HSOM结果表明，光谱变化是由于聚合物固化引起的。另外，使用Eudragit RL，RS和L 30-D以不同比例包被玻璃珠，茶碱和奥比沙星片剂。在近红外光谱上进行主成分分析（PCA），以研究固化时间和温度对流延薄膜，未包衣片剂，包衣片剂和包衣玻璃珠的影响。得分图显示，固化时间和温度会显着影响包衣玻璃珠，未包衣和包衣片剂。 250分钟时释放的药物量以及固化片剂的NIR光谱用于开发和验证涂有Eudragit RL：RS 30-D（1：4）的茶碱片剂的7因子偏最小二乘（PLS）回归校准。这项研究证明了NIRS在涂膜固化和脱模监控中的潜力。

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