Przywara Mateusz, Lech-Przywara Regina, Rupar Patrycja, Zapała Wojciech
Department of Chemical and Process Engineering, Rzeszow University of Technology, al. Powstańców Warszawy 6, 35-959 Rzeszów, Poland.
Doctoral School of the Rzeszow University of Technology, al. Powstańców Warszawy 12, 35-959 Rzeszów, Poland.
Molecules. 2025 Jul 25;30(15):3119. doi: 10.3390/molecules30153119.
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.
活性药物成分（API）的均匀分布在片剂配方中至关重要，特别是在直接压片工艺中，因为粉末混合是确保剂量均匀性的唯一方法。本研究评估了三种混合技术——V型混合器、行星式球磨机和振动球磨机——对萘普生钠片物理性质和含量均匀性的影响。制备了由萘普生钠、纤维素、聚乙烯吡咯烷酮（PVP）、碳酸钙和硬脂酸镁组成的混合物，在不同混合强度下进行混合，并对其流动性、可压性和粒度分布进行表征。使用简化的旁路高效液相色谱法（HPLC）对所得片剂的重量、厚度、硬度、脆碎度和API含量进行分析。尽管混合物的流动性最差，但V型混合器生产出的片剂重量和厚度最一致。振动研磨生产出的片剂硬度最高，API含量均匀性最佳，不过长时间混合时高能加工会引入变异性。该分析方法快速且稳健，无需完全色谱分离即可实现可靠的API定量。这些发现强调了在机械混合能量与配方特性之间取得平衡的必要性，并支持在药物研发中使用简化的分析策略。
