Abstract

NEAR INFRARED SPECTROSCOPY METHOD: EFFECT OF DRYING PARAMETERS ON IBUPROFEN GRANULES PHASE TRANSFORMATION

Idalise Toro Diaz* and Evone S. Ghaly

ABSTRACT

X Ray Diffraction (XRD) and Differential Scanning Calorimeter (DSC) are used for the identification of different solid-state forms but these technologies represent limitation due to sampling effect. The near infrared analysis can be done directly without sample preparation. Ibuprofen formulations were produced according to the Box Behnken experimental design for 3 factors and 3 levels. The first factor was the temperature. The levels for this factor were 50 °C, 70 °C, and 90 °C. The second factor was the time of granules drying and its levels were 5, 7 and 9 hours. The third factor was the diluent and the levels were Mannitol, Lactose and MCC. The calibration and validation models were optimized in order to obtain better predictions. A paired t-test was performed to determine significant differences between the values obtained using the reference methods and the predicted values by NIR. In all cases, the optimized models were able to predict the enthalpy of the formulations and the peak intensity values. NIR is an alternative method to DSC and XRD to determine formulations phase transformation and solid state.since the models constructed showed no significant differences between NIR methods and conventional methods such as DSC and XRD.

Keywords: Near infrared; phase transformation; ibuprofen; models for predicting