Abstract
The purpose of this research was to apply near-infrared (NIR) spectroscopy in combination with chemometrics to predict particle size and flow characteristics of a meloxicam powder blends for tableting. In order to develop calibration models for particle size (mean particle size, poly-dispersion index), and flow properties (angle of repose and time of flow) prediction, the NIR reflection spectra of different meloxicam powder blends prepared according to an experimental design were analyzed using different preprocessing methods by partial last-square (PLS) regression followed by leaveone-out cross-validation. Very good prediction ability was found for mean particle size, poly-dispersion index, angle of repose, and time of flow in models in whose development no preprocessing spectrum was applied. Also, a good prediction was found preprocessing spectrum such smoothing - moving average for particle size characteristics, and unit vector normalization for powder flow properties. Therefore, NIR-chemometric methods developed in this work can be useful for the prediction of the granulometric properties and parameters related to the flowability of the meloxicam powder blends and may be used as process analytical technology (PAT) tools for process control during meloxicam tablets manufacturing.
Highlights
In the manufacturing process of tablets powder characteristics as homogeneity and free flowing are essential to ensure uniformity of mass and drug content per dose unite
In order to develop a calibration model for the particle size and the flow characteristics prediction, ten synthetic powder blends according to the experimental design matrix were prepared
According to obtained results (Figure 1) a very good correlation was found between the fraction used in the preparation of the synthetic mixtures and particle size and flow characteristics, respectively
Summary
In the manufacturing process of tablets powder characteristics as homogeneity and free flowing are essential to ensure uniformity of mass and drug content per dose unite. Both homogeneity and flowability are influenced by particle size and particle size distribution. Direct analysis of intact solid dosage forms or pharmaceutical powder blends (as intermediate product) is considered to be an important goal for NIR analysis in the pharmaceutical industry, with the increasing needs for in-line, on-line, or at-line testing [3,4,5]. Particle size characteristics (such are: mean particle size and poly-dispersion index) and flow characteristics (such are: time of flow and angle of repose) are well-known and important parameters of powders used in the pharmaceutical industry for manufacturing solid dosage forms [6,7,8]
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