Application of a newly developed portable NIR imaging device to monitor the dissolution process of tablets
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RESEARCH PAPER
Application of a newly developed portable NIR imaging device to monitor the dissolution process of tablets Daitaro Ishikawa & Kodai Murayama & Kimie Awa & Takuma Genkawa & Makoto Komiyama & Sergei G. Kazarian & Yukihiro Ozaki
Received: 20 March 2013 / Revised: 8 July 2013 / Accepted: 9 September 2013 / Published online: 3 October 2013 # Springer-Verlag Berlin Heidelberg 2013
Abstract 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 D. Ishikawa : Y. Ozaki (*) School of Science and Technology, Kwansei Gakuin University, 2-1 Gakuen, Sanda, Hyogo 669-1337, Japan e-mail: [email protected] K. Murayama : M. Komiyama Yokogawa Electric Corporation, 2-9-32 Nakacho, Musashino, Tokyo 180-8750, Japan K. Awa Dainippon Sumitomo Pharma Co., Ltd, 3-1-98 Kasugade-naka, Konohana, Osaka 554-0022, Japan T. Genkawa Faculty of Life and Environmental Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8572, Japan S. G. Kazarian Department of Chemical Engineering, Imperial College London, London SW7 2AZ, UK
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. Keywords Single wavelength-based image . Dissolution process monitoring . NIR imaging . Pharmaceutical application . Portable spectrometer . Ratio-based image
Introduction Process analytical technology (PAT) is a system that controls quality during pharmaceutical manufacturing processes [1–4]. The goal of PAT is to ensure final product quality. In-process quality control requires noncontact, nondestructive, and highspeed techniques. Near-infrared (NIR) spectroscopy combined with chemometric techniques satisfy these requirements and thus attract attention as a useful PAT tool [5]. Therefo
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