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

[ Vol. 15 , Issue. 5 ]

Author(s):

Qiushi Peng, Yi Bao, Tingyu Chen, Qianrong Peng* and Min Yang*   Pages 439 - 446 ( 8 )

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.

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.

Affiliation:

School of Pharmaceutical Sciences, Guizhou University, Guiyang 550025, School of Pharmaceutical Sciences, Guizhou University, Guiyang 550025, School of Pharmaceutical Sciences, Guizhou University, Guiyang 550025, Technology Center, China Tobacco Guizhou Industrial Co., Ltd., Guizhou 550009, School of Pharmaceutical Sciences, Guizhou University, Guiyang 550025



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