Prediction of Drug Dissolution from Tablets Using Near‐Infrared Diffuse Reflectance Spectroscopy as a Nondestructive Method

Abstract

The goal of this study is to use near‐infrared (NIR) reflectance spectroscopy to measure the percentage drug dissolution from a series of tablets compacted at different compressional forces, calibrate NIR data vs. laboratory equipment data, develop a model equation, validate the model, and test the model predictive ability. Seven theophylline tablet formulations of the same composition but with different dissolution profiles were prepared. Laboratory dissolution profiles were compared with NIR diffuse reflectance data. Linear regression, quadratic, cubic, and partial least‐square techniques were used to determine the relationship between dissolution profiles data and NIR spectra. The results demonstrated that a decrease in the amount of drug dissolution produced an increase in NIR absorbance. A series of model equations, depending on the mathematical technique used for regression, were developed from the calibration of the percentage of drug dissolution by using laboratory equipment vs. the NIR diffuse reflectance for each formulation. The results of NIR dissolution data were similar to laboratory tests. The NIR diffuse reflectance spectroscopy method is an alternative, nondestructive method for measurement of drug dissolution from tablets.

Keywords:

• Near‐infrared spectroscopy
• Drug dissolution
• NIR diffuse reflectance spectroscopy
• Prediction
• Validation