Theoretical Analysis of Tablet Hardness Prediction Using Chemoinformetric Near-Infrared Spectroscopy

Tanabe, Hideaki; Otsuka, Kuniko; Otsuka, Makoto

doi:10.2116/analsci.23.857

Cited by 40 publications

(23 citation statements)

References 23 publications

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“…Furthermore, PLS and MLR models were used to compare NIR reflectance data with the destructive hardness test data. Similar to the research of Tanabe et al (2007), this study also suggested that NIR absorbance increased as tablet hardness increased, but a higher correlation coefficient of 0.99 for hardness prediction was obtained from this study. successfully predicted both porosity and hardness (compression force: 73.5 MPa) of the tablets using FT-NIR spectroscopy.…”

Section: Tablet Hardnesssupporting

confidence: 85%

“…However, a spectroscopic technique (especially the NIR technique) is a rapid, non-contact, non-destructive tool, and provides real-time quantitative and qualitative measurement for tablet hardness. Tanabe et al (2007) proposed an NIR spectroscopic technique for the prediction of hardness of tablet formulations. They carried out their study on tablets prepared from berberine chloride, lactose, and potato starch with different compression pressures (59,78,98,127,and 195 MPa).…”

Section: Tablet Hardnessmentioning

confidence: 99%

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Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Kandpal

Park

Tewari

et al. 2015

Journal of Biosystems Engineering

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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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Section: Tablet Hardnesssupporting

confidence: 85%

Section: Tablet Hardnessmentioning

confidence: 99%

Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Kandpal

Park

Tewari

et al. 2015

Journal of Biosystems Engineering

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“…As the compression force increased, the total pore volume of tablets decreased. (Tanabe et al 2007) The hardness increased as the compression force increased. 64 normal tablets were compressed as a sample set using compression forces that ranged from 1.1 kN to 50.6 kN.…”

Section: Compression Force and Tablet Hardness Modelmentioning

confidence: 99%

“…The pharmaceutical applications of NIR have involved the identification of raw materials (Reich 2005;Swarbrick 2007) and the determination of content uniformity Broad et al 2001;Jarvinen et al 2013;Li et al 2009;Mantanus et al 2010;Moes et al 2008;Parris et al 2005;Trafford Andrew et al 1998). This technique has been applied for the determination of the moisture content (Corredor, Bu, and Both 2011;Mantanus et al 2009;Nieuwmeyer et al 2007), monitoring of blending (Blanco et al 2012;El-Hagrasy and Drennen 2006;Moes et al 2008;Sulub, Konigsberger, and Cheney 2011), measurement of the compression force (Gupta et al 2005a;2005b), and determination of the tablet hardness (Tanabe, Otsuka, and Otsuka 2007). NIR has also been used to monitor the particle-size distribution (Bittner et al 2011;Blanco and Peguero 2008;Ša s sić, Yu, and Zhang 2011) and tabletcoating processes (Gendre et al 2011;Moes et al 2008;Moltgen et al 2012).…”

Section: Introductionmentioning

confidence: 99%

Quantitative Analysis of Uncoated Eszopiclone Tablets by Near-Infrared Spectroscopy

Liu¹,

Luo²,

Wang³

et al. 2014

Analytical Letters

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This study employed near-infrared (NIR) spectroscopy to analyze content uniformity, moisture content, compression force, tablet hardness, average particle size, and particle-size distribution. The content uniformity, moisture content, compression force, tablet hardness, and average particle size models yielded high correlation coefficients (R 2 ) of 0.99582, 0.99725, 0.99620, 0.96294, and 0.98421, respectively, whereas the particle size distribution models showed good predictive ability. Conventional criteria such as R 2 , root-mean-square error of calibration, and the root-mean-square error of prediction were used to evaluate the accuracy and precision of the model. To ensure the accuracy and predictability of the content model for low-dose tablets, additional validation and reliability evaluations were performed using 70%, 80%, 100%, 120%, and 130% drug concentrations as well as 90% and 110% active content formulations. Near-infrared spectroscopy with multivariate modeling is a rapid, nondestructive technique for the characterization of the manufacturing process.

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“…In particular, NIR has attracted attention in a very wide range of fields in combination with chemometric technology. 8 NIR spectroscopy is used in pharmaceutical analysis to extract information on the chemical and physical factors of ingredient content, [9][10][11][12][13] moisture, [14][15][16] crystalline polymorphism, [17][18][19] particle size, 15,20,21 and density. 21 The energy level of NIR light is between visible light and infrared light (IR).…”

Section: Introductionmentioning

confidence: 99%

In-line and Real-time Monitoring of Resonant Acoustic Mixing by Near-infrared Spectroscopy Combined with Chemometric Technology for Process Analytical Technology Applications in Pharmaceutical Powder Blending Systems

et al. 2017

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Resonant acoustic® mixing (RAM) technology is a system that performs high-speed mixing by vibration through the control of acceleration and frequency. In recent years, real-time process monitoring and prediction has become of increasing interest, and process analytical technology (PAT) systems will be increasingly introduced into actual manufacturing processes. This study examined the application of PAT with the combination of RAM, near-infrared spectroscopy, and chemometric technology as a set of PAT tools for introduction into actual pharmaceutical powder blending processes. Content uniformity was based on a robust partial least squares regression (PLSR) model constructed to manage the RAM configuration parameters and the changing concentration of the components. As a result, real-time monitoring may be possible and could be successfully demonstrated for in-line real-time prediction of active pharmaceutical ingredients and other additives using chemometric technology. This system is expected to be applicable to the RAM method for the risk management of quality.

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Theoretical Analysis of Tablet Hardness Prediction Using Chemoinformetric Near-Infrared Spectroscopy

Cited by 40 publications

References 23 publications

Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Spectroscopic Techniques for Nondestructive Quality Inspection of Pharmaceutical Products: A Review

Quantitative Analysis of Uncoated Eszopiclone Tablets by Near-Infrared Spectroscopy

In-line and Real-time Monitoring of Resonant Acoustic Mixing by Near-infrared Spectroscopy Combined with Chemometric Technology for Process Analytical Technology Applications in Pharmaceutical Powder Blending Systems

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