GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, Singapore 117543, Singapore.
Int J Pharm. 2010 Oct 15;398(1-2):39-49. doi: 10.1016/j.ijpharm.2010.07.020. Epub 2010 Jul 22.
The Supercell coater is a newly introduced coater which utilizes air fluidization for tablet coating. The aim of this study was to define a suitable, fast and non-destructive method for the quantification of coat thickness for Supercell-coated tablets. Various coat thickness characterization methods were carried out on tablets coated at different process conditions. These include the use of optical microscopy, micrometer, X-ray fluorescence (XRF), Raman and near-infrared (NIR) spectroscopy. Coat thicknesses obtained from direct measurements were used to calibrate the spectral data from spectroscopic methods for model generation. The models were subsequently validated to evaluate their prediction capabilities, especially the ability to differentiate tablets coated at different conditions. XRF spectroscopy was viewed to be more suitable for the assessment of process yield and efficiency but both Raman and NIR spectroscopy were shown to be more appropriate methods for the rapid prediction and evaluation of coat thickness. However, only Raman spectroscopy was able to differentiate tablets coated under different conditions accurately. In conclusion, direct thickness measurements were more time-consuming but provided assured coat thickness data. On the other hand, XRF, Raman and NIR spectroscopy methods were viable alternatives to provide complementary information for the study of tablet coatings.
超级流化床包衣机是一种新引入的包衣机，利用空气流化技术进行片剂包衣。本研究旨在定义一种合适、快速且无损的方法，用于定量测定超级流化床包衣片剂的包衣厚度。在不同的工艺条件下对包衣片剂进行了各种包衣厚度的表征方法，包括使用光学显微镜、测微计、X 射线荧光（XRF）、拉曼和近红外（NIR）光谱法。直接测量得到的包衣厚度用于校准光谱数据，以生成模型。随后对模型进行验证，以评估其预测能力，特别是区分不同条件下包衣片剂的能力。XRF 光谱法被认为更适合评估工艺收率和效率，但拉曼和 NIR 光谱法都被证明是更适合快速预测和评估包衣厚度的方法。然而，只有拉曼光谱法能够准确地区分不同条件下包衣的片剂。总之，直接厚度测量虽然耗时较长，但能提供可靠的包衣厚度数据。另一方面，XRF、拉曼和 NIR 光谱法是可行的替代方法，可以为片剂包衣的研究提供补充信息。
