# Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC Method

**Authors:** Mateusz Przywara, Regina Lech-Przywara, Patrycja Rupar, Wojciech Zapała

PMC · DOI: 10.3390/molecules30153119 · 2025-07-25

## 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.

## Key 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 hardest tablets and best API content uniformity, although high-energy processing introduced variability at longer mixing times. The analytical method proved fast and robust, allowing for reliable API quantification without full chromatographic separation. These findings underscore the need to balance mechanical blending energy with formulation properties and support the use of streamlined analytical strategies in pharmaceutical development.

## Linked entities

- **Chemicals:** naproxen sodium (PubChem CID 23681059), PVP (PubChem CID 6917), calcium carbonate (PubChem CID 10112), magnesium stearate (PubChem CID 11177)

## Full-text entities

- **Chemicals:** calcium carbonate (MESH:D002119), Sodium Naproxen (MESH:D009288), cellulose (MESH:D002482), magnesium stearate (MESH:C031183), PVP (-)

## Figures

15 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12348599/full.md

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Source: https://tomesphere.com/paper/PMC12348599