Login Register Cart 0
Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

A Rapid and Nondestructive Method for the Prediction of Ibuprofen Tablet Hardness Using NIR Diffuse Reflectance Spectroscopy

Author(s): Qiushi Peng, Yi Bao, Tingyu Chen, Qianrong Peng* and Min Yang*

Volume 15, Issue 5, 2019

Page: [439 - 446] Pages: 8

DOI: 10.2174/1573412914666180427092727

Price: $65

Abstract

Introduction: This study aimed at developing a technology to measure the hardness of Ibuprofen (IBU) tablets and optimize the IBU formulation using Near-infrared (NIR) spectroscopy.

Materials and Methods: Tablets (400 mg±5%, 10mm in diameter) consisting of IBU, microcrystalline cellulose SH-103, carboxymethyl starch sodium, magnesium stearate, silicon dioxide were formed of various hardness (2kg, 4kg, 6kg, 8kg, 10kg, 12kg). The reflectance NIR spectra of various tablets were employed to establish 9 calibrations models, which were further used to predict tablet hardness by Partial least squares (PLS) and principal component regression (PCR) analysis.

Results and Conclusion: Cross-validation with independent samples shows that PLS is the optimal predictive model. Which R2=0.9832, RSECV=0.334 and RSE=0.0669. This study established a new, simple, rapid, nondestructive and reliable methodology to optimize the IBU tablet hardness.

Keywords: Near-infrared diffuse reflectance spectroscopy, IBU tablet, hardness, PLS, PCR, pharmaceutical.

« Previous Next »
Graphical Abstract

[1]
Donoso, M.; Kildsig, D.O.; Ghaly, E.S. Prediction of tablet hardness and porosity using near‐infrared diffuse reflectance spectroscopy as a nondestructive method. Pharm. Dev. Technol., 2003, 8(4), 357-366.
[2]
Freitas, M.P.; Sabadin, A.; Silva, L.M.; Giannotti, F.M.; do Couto, D.A.; Tonhi, E.; Martins, J.A. Prediction of drug dissolution profiles from tablets using NIR diffuse reflectance spectroscopy: A rapid and nondestructive method. J. Pharm. Biomed. Anal., 2005, 39(1), 17-21.
[3]
Morisseau, K.M.; Rhodes, C.T. Near-infrared spectroscopy as a nondestructive alternative to conventional tablet hardness testing. Pharm. Res., 1997, 14(1), 108-111.
[4]
Dempster, M.A.; MacDonald, B.F.; Gemperline, P.J.; Boyer, N.R. A near-infrared reflectance analysis method for the noninvasive identification of film-coated and non-film-coated, blister-packed tablets. Anal. Chim. Acta, 1995, 310(1), 43-51.
[5]
Workman, J. Jerome, J. Review of process and non-invasive near-infrared and infrared spectroscopy: 1993-1999. Appl. Spectrosc. Rev., 1999, 34(1-2), 1-89.
[6]
Li, M.; Wang, J.; Du, F.; Diallo, B.; Xie, G.H. High-throughput analysis of chemical components and theoretical ethanol yield of dedicated bioenergy sorghum using dual-optimized partial least squares calibration models. Biotechnol. Biofuels, 2017, 10(1), 206.
[7]
Tenhunen, J.; Kopola, H.; Myllylä, R. Non-invasive glucose measurement based on selective near infrared absorption; requirements on instrumentation and spectral range. Measurement, 1998, 24(3), 173-177.
[8]
Berntsson, O.; Danielsson, L.G.; Johansson, M.O.; Folestad, S. Quantitative determination of content in binary powder mixtures using diffuse reflectance near infrared spectrometry and multivariate analysis. Anal. Chim. Acta, 2000, 419(1), 45-54.
[9]
Roggo, Y.; Jent, N.; Edmond, A.; Chalus, P.; Ulmschneider, M. Characterizing process effects on pharmaceutical solid forms using near-infrared spectroscopy and infrared imaging. Eur. J. Pharm. Biopharm., 2005, 61(1), 100-110.
[10]
Tanabe, H.; Otsuka, K.; Otsuka, M. Theoretical analysis of tablet hardness prediction using chemoinformetric near-infrared spectroscopy. Anal. Sci., 2007, 23(7), 857-862.
[11]
Jamrógiewicz, M. Application of the near-infrared spectroscopy in the pharmaceutical technology. J. Pharm. Biomed. Anal., 2012, 66, 1-10.
[12]
Freitas, M.P.; Sabadin, A.; Silva, L.M.; Giannotti, F.M.; do Couto, D.A.; Tonhi, E.; Martins, J.A. Prediction of drug dissolution profiles from tablets using NIR diffuse reflectance spectroscopy: A rapid and nondestructive method. J. Pharm. Biomed. Anal., 2005, 39(1), 17-21.
[13]
Blanco, M.; Alcalá, M.; González, J.M.; Torras, E. A process analytical technology approach based on near infrared spectroscopy: tablet hardness, content uniformity, and dissolution test measurements of intact tablets. J. Pharm. Sci-US., 2006, 95(10), 2137-2144.
[14]
Blanco, M.; Bautista, M.; Alcalà, M. API determination by NIR spectroscopy across pharmaceutical production process. AAPS PharmSciTech, 2008, 9(4), 1130-1135.
[15]
Scheibelhofer, O.; Balak, N.; Wahl, P.R.; Wahl, D.M. Koller, Benjamin J. Glasser, and Johannes. G. Khinast. Monitoring blending of pharmaceutical powders with multipoint NIR spectroscopy. AAPS PharmSciTech, 2013, 14(1), 234.
[16]
Sun, H.L.; Jun, H.L.; Soohwa, C.; Sung-Ho, D.; Young-Ah, W. End point determination of blending process for trimebutine tablets using principle component analysis (PCA) and partial least squares (PLS) regression. Arch. Pharm. Res., 2012, 35(9), 1599.
[17]
Hattori, Y.; Otsuka, M. NIR spectroscopic study of the dissolution process in pharmaceutical tablets. Vib. Spectrosc., 2011, 57(2), 275-281.
[18]
Hakan, W.M.; Romero-Torres, S.; Wongweragiat, S.; Williams, J.A.S.; Grant, E.R.; Taylor, L.S. On-line content uniformity determination of tablets using low‐resolution raman spectroscopy. Appl. Spectrosc., 2006, 37(35), 672.
[19]
Kandpal, L.M.; Tewari, J.; Gopinathan, N.; Stolee, J.; Strong, R.; Boulas, P.; Byoung-Kwan, C. Quality assessment of pharmaceutical tablet samples using Fourier transform near infrared spectroscopy and multivariate analysis. Infrared Phys. Technol., 2017, 85, 300-306.
[20]
Xiao-Meng, C.; Wen-Bo, Z.; Shang-Chen, Y.; Chang-Qin, Hu. Rapid analysis of the quality of amoxicillin and clavulanate potassium tablets using diffuse reflectance near-infrared spectroscopy. AAPS PharmSciTech, 2016, 18(4), 1-7.
[21]
Dégardin, K.; Guillemain, A.; Guerreiro, N.V.; Roggo, Y. Near infrared spectroscopy for counterfeit detection using a large database of pharmaceutical tablets. J. Pharm. Biomed. Anal., 2016, 128, 89.
[22]
Yang, Y.; Jin, Y.; Wu, Y.; Chen, Y. Application of near infrared spectroscopy combined with competitive adaptive reweighted sampling partial least squares for on-line monitoring of the concentration process of Wangbi tablet. J. Near Infrared Spectrosc., 2016, 24(2), 171-178.
[23]
Li, W.; Bagnol, L.; Berman, M.; Chiarella, R.A.; Gerber, M. Applications of NIR in early stage formulation development. Part II. Content uniformity evaluation of low dose tablets by principal component analysis. Int. J. Pharm., 2009, 380(1-2), 49-54.
[24]
Wang, Y.; Wu, Z.; Wang, Z.; Xu, M.; Shi, M.; Qiao, Y. Rapid analysis of spatial distribution of PVPP and hardness of Yinhuang dispersible tablets by NIR-CI. Jiohs., 2016, 9(2), 1550016.
[25]
Esbensen, K.H.; Guyot, D.; Westad, F.; Houmoller, L.P. Multivariate data analysis: in practice: an introduction to multivariate data analysis and experimental design; Multivariate Data Anal, 2002.

Rights & Permissions Print Cite
Article Metrics
67
3
© 2024 Bentham Science Publishers | Privacy Policy