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RISS 인기검색어
- 검색키워드
- 저자 : ( Jagdish Tewari ) (검색결과 4 건)
- 무료
- 기관 내 무료
- 유료
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Kandpal, Lalit Mohan,Tewari, Jagdish,Gopinathan, Nishanth,Stolee, Jessica,Strong, Rick,Boulas, Pierre,Cho, Byoung-Kwan Elsevier 2017 Infrared physics & technology Vol.85 No.-
<P><B>Abstract</B></P> <P>Determination of the content uniformity, assessed by the amount of an active pharmaceutical ingredient (API), and hardness of pharmaceutical materials is important for achieving a high-quality formulation and to ensure the intended therapeutic effects of the end-product. In this work, Fourier transform near infrared (FT-NIR) spectroscopy was used to determine the content uniformity and hardness of a pharmaceutical mini-tablet and standard tablet samples. Tablet samples were scanned using an FT-NIR instrument and tablet spectra were collected at wavelengths of 1000–2500nm. Furthermore, multivariate analysis was applied to extract the relationship between the FT-NIR spectra and the measured parameters. The results of FT-NIR spectroscopy for API and hardness prediction were as precise as the reference high-performance liquid chromatography and mechanical hardness tests. For the prediction of mini-tablet API content, the highest coefficient of determination for the prediction ( <SUP> R 2 </SUP> p ) was found to be 0.99 with a standard error of prediction (SEP) of 0.72mg. Moreover, the standard tablet hardness measurement had a <SUP> R 2 </SUP> p value of 0.91 with an SEP of 0.25kg. These results suggest that FT-NIR spectroscopy is an alternative and accurate nondestructive measurement tool for the detection of the chemical and physical properties of pharmaceutical samples.</P> <P><B>Highlights</B></P> <P> <UL> <LI> FT-NIR technique was used for investigation of content uniformity and hardness of pharmaceutical tablet samples. </LI> <LI> Multivariate analysis predicted API and hardness of tablets with higher accuracy. </LI> <LI> FT-NIR demonstrated a great potential tool for detection of chemical and physical properties of the pharmaceutical samples. </LI> </UL> </P>
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Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review
Kandpal, Lalit Mohan,Park, Eunsoo,Tewari, Jagdish,Cho, Byoung-Kwan Korean Society for Agricultural Machinery 2015 바이오시스템공학 Vol.40 No.4
Spectroscopy is an emerging technology for the quality assessment of pharmaceutical samples, from tablet manufacturing to final quality assurance. The traditional methods for the quality management of pharmaceutical tablets are time consuming and destructive, while spectroscopic techniques allow rapid analysis in a non-destructive manner. The advantage of spectroscopy is that it collects both spatial and spectral information (called hyperspectral imaging), which is useful for the chemical imaging of pharmaceutical samples. These chemical images provide both qualitative and quantitative information on tablet samples. In the pharmaceutics, spectroscopic techniques are used for a variety of applications, such as analysis of the homogeneity of powder samples as well as determination of particle size, product composition, and the concentration, uniformity, and distribution of the active pharmaceutical ingredient in solid tablets. This review paper presents an introduction to the applications of various spectroscopic techniques such as hyperspectroscopy and vibrational spectroscopies (Raman spectroscopy, FT-NIR, and IR spectroscopy) for the quality and safety assessment of pharmaceutical solid dosage forms. In addition, various chemometric techniques that are highly essential for analyzing the spectroscopic data of pharmaceutical samples are also reviewed.
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( Lalit Mohan Kandpal ),( Eunsoo Park ),( Jagdish Tewari ),( Byoung Kwan Cho ) 한국농업기계학회 2015 바이오시스템공학 Vol.40 No.4
Spectroscopy is an emerging technology for the quality assessment of pharmaceutical samples, from tablet manufacturing to final quality assurance. The traditional methods for the quality management of pharmaceutical tablets are time consuming and destructive, while spectroscopic techniques allow rapid analysis in a non-destructive manner. The advantage of spectroscopy is that it collects both spatial and spectral information (called hyperspectral imaging), which is useful for the chemical imaging of pharmaceutical samples. These chemical images provide both qualitative and quantitative information on tablet samples. In the pharmaceutics, spectroscopic techniques are used for a variety of applications, such as analysis of the homogeneity of powder samples as well as determination of particle size, product composition, and the concentration, uniformity, and distribution of the active pharmaceutical ingredient in solid tablets. This review paper presents an introduction to the applications of various spectroscopic techniques such as hyperspectroscopy and vibrational spectroscopies (Raman spectroscopy, FT-NIR, and IR spectroscopy) for the quality and safety assessment of pharmaceutical solid dosage forms. In addition, various chemometric techniques that are highly essential for analyzing the spectroscopic data of pharmaceutical samples are also reviewed.
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Raman spectral imaging technique for API detection in pharmaceutical microtablets
Kandpal, Lalit Mohan,Cho, Byoung-Kwan,Tewari, Jagdish,Gopinathan, Nishanth Elsevier 2018 Sensors and actuators. B, Chemical Vol.260 No.-
<P><B>Abstract</B></P> <P>In pharmaceutical manufacturing, quality monitoring of end products is essential to gain regulatory approval. In particular, monitoring the quantity of an active pharmaceutical ingredient (API) in the administered dosage is key to ensuring the content uniformity of the product. Thus, we herein aim to demonstrate the ability of the newly developed line-scan Raman hyperspectral imaging (RHSI) technique for the quantitative analysis of APIs in microtablet samples. Microtablets containing the API of interest and appropriate excipients of varying concentrations (i.e., 60–130% (w/w) API) were prepared by direct compression. The microtablet RHSI spectra were obtained over a wavelength range of 400–1800 cm<SUP>−1</SUP>. High-performance liquid chromatography was also employed as a reference method for the API assay. Multivariate analysis methods, including partial least squares and least-squares support vector machines, were employed to predict the API concentrations using the spectral and reference values of the microtablets. The developed models exhibited excellent prediction abilities for the API concentration, with a coefficient of correlation (R<SUP>2</SUP>) >0.95, which was associated with an error of <5% (w/w) API. Furthermore, visualization of the API concentrations and distributions in the microtablets was achieved through chemical imaging. These results confirmed that line-scan RHSI is a powerful tool for the characterization of pharmaceutical products. In addition, this approach is suitable for application in the pharmaceutical production line for the online inspection of bulk products and would be expected to easily replace conventional measurement techniques.</P> <P><B>Highlights</B></P> <P> <UL> <LI> The quantitative analysis of active pharmaceutical ingredients (APIs) was examined. </LI> <LI> Line-scan Raman hyperspectral imaging (RHSI) was employed for API analysis. </LI> <LI> Microtablets containing the API of interest were analyzed by RHSI. </LI> <LI> RHSI is suitable for use in the pharmaceutical production line for nondestructive quality control. </LI> </UL> </P>
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