Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC Method
Mateusz Przywara, Regina Lech-Przywara, Patrycja Rupar, Wojciech Zapała

TL;DR
This study examines how different mixing technologies affect the quality and consistency of sodium naproxen tablets.
Contribution
The paper introduces a streamlined HPLC method for API quantification and evaluates mixing techniques for tablet homogeneity.
Findings
V-type mixer produced tablets with consistent weight and thickness despite poor blend flow.
Vibratory milling improved API content uniformity but introduced variability with prolonged mixing.
A simplified HPLC method provided reliable API quantification without full chromatographic separation.
Abstract
The uniform distribution of APIs is essential in tablet formulations, particularly in direct compression, where powder blending is the only means of ensuring dose homogeneity. This study evaluated the influence of three mixing techniques—V-type mixer, planetary ball mill, and vibratory ball mill—on the physical properties and content uniformity of naproxen sodium tablets. Blends consisting of naproxen sodium, cellulose, PVP, calcium carbonate, and magnesium stearate were prepared under varied mixing intensities and characterized in terms of flowability, compressibility, and particle size distribution. The resulting tablets were analyzed for weight, thickness, hardness, friability, and API content using a simplified bypass HPLC method. The V-type mixer yielded tablets with the most consistent weight and thickness, despite the poorest blend flow properties. Vibratory milling produced the…
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Taxonomy
TopicsDrug Solubulity and Delivery Systems · Analytical Methods in Pharmaceuticals · Analytical Chemistry and Chromatography
