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Application of a newly developed portable NIR imaging device to monitor the dissolution process of tablets

机译:新开发的便携式近红外成像设备在监测片剂溶出过程中的应用

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We have recently developed a novel portable NIR imaging device (D-NIRs), which has a high speed and high wavelength resolution. This NIR imaging approach has been developed by utilizing D-NIRs for studying the dissolution of a model tablet containing 20 % ascorbic acid (AsA) as an active pharmaceutical ingredient and 80 % hydroxypropyl methylcellulose, where the tablet is sealed by a special cell. Diffuse reflectance NIR spectra in the 1,000 to 1,600 nm region were measured during the dissolution of the tablet. A unique band at around 1,361 nm of AsA was identified by the second derivative spectra of tablet and used for AsA distribution NIR imaging. Two-dimensional change of AsA concentration of the tablet due to water penetration is clearly shown by using the band-based image at 1,361 nm in NIR spectra obtained with high speed. Moreover, it is significantly enhanced by using the intensity ratio of two bands at 1,361 and 1,354 nm corresponding to AsA and water absorption, respectively, showing the dissolution process. The imaging results suggest that the amount of AsA in the imaged area decreases with increasing water penetration. The proposed NIR imaging approach using the intensity of a specific band or the ratio of two bands combined with the developed portable NIR imaging instrument, is a potentially useful practical way to evaluate the tablet at every moment during dissolution and to monitor the concentration distribution of each drug component in the tablet. [Figure not available: see fulltext.]
机译:我们最近开发了一种新颖的便携式NIR成像设备(D-NIR),它具有高速和高波长分辨率。通过使用D-NIR来研究这种含20%抗坏血酸(AsA)作为活性药物成分和80%羟丙基甲基纤维素的模型片剂的溶出度,开发了这种NIR成像方法,其中该片剂用特殊的细胞密封。在片剂溶解过程中测量了1,000至1,600 nm区域的漫反射NIR光谱。平板电脑的二阶导数光谱确定了AsA约1,361 nm处的唯一谱带,并用于AsA分布NIR成像。通过在高速获得的NIR光谱中使用1,361 nm处的基于带的图像,可以清楚地显示出片剂因水渗透而产生的AsA浓度的二维变化。此外,通过使用分别对应于AsA和吸水率的1,361和1,354 nm处的两个谱带的强度比,可以显着提高溶解度。成像结果表明,随着水渗透的增加,成像区域中的AsA量会减少。拟议的使用特定谱带强度或两个谱带之比的NIR成像方法与已开发的便携式NIR成像仪器相结合,是一种潜在有用的实用方法,可用于评估溶出过程中每时每刻的片剂并监测每种片剂的浓度分布片剂中的药物成分。 [图不可用:请参见全文。]

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