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Abstract
The main objective of this research is to use the near‐infrared diffuse reflectance method to evaluate and quantify the effects of hardness and porosity on the near‐infrared spectras of tablets. To develop a model equation, validate the model and test the model predictive ability. Seven theophylline tablet formulations of the same composition but with seven different hardness values (3 kp, 6, 8, 10, 12, 15, and 17 kp) were prepared. Another seven theophylline tablets formulation with seven different porosity values (57.4, 50.3, 41.9, 40.3, 39.9, 37.3, and 35.1%) were prepared. Five placebo tablets formulation with different hardness and porosity values were also prepared. Laboratory hardness and porosity values were compared to near‐infrared diffuse reflectance data. Linear regression, quadratic, cubic and partial least square techniques were used to determine the relationship between hardness, porosity and the near‐infrared spectras. The results demonstrated that an increase in tablet hardness and a decrease in tablets porosity produced an increase in near‐infrared absorbance. Series of model equations depending on the mathematical technique used for regression were developed from the calibration of hardness and porosity data using laboratory equipment vs. the near‐infrared diffuse reflectance for each formulations. The results of near‐infrared hardness and porosity predictions were very similar to laboratory hardness and porosity tests. The near‐infrared diffuse reflectance spectroscopy method is an alternative nondestructive method for measurement of hardness and porosity of tablets.