Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC Method
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...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-07-01
|
| Series: | Molecules |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1420-3049/30/15/3119 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849770674863734784 |
|---|---|
| author | Mateusz Przywara Regina Lech-Przywara Patrycja Rupar Wojciech Zapała |
| author_facet | Mateusz Przywara Regina Lech-Przywara Patrycja Rupar Wojciech Zapała |
| author_sort | Mateusz Przywara |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-2b3f96d03a6c4eb6a9ddde44835d93b8 |
| institution | DOAJ |
| issn | 1420-3049 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Molecules |
| spelling | doaj-art-2b3f96d03a6c4eb6a9ddde44835d93b82025-08-20T03:02:55ZengMDPI AGMolecules1420-30492025-07-013015311910.3390/molecules30153119Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC MethodMateusz Przywara0Regina Lech-Przywara1Patrycja Rupar2Wojciech Zapała3Department of Chemical and Process Engineering, Rzeszow University of Technology, al. Powstańców Warszawy 6, 35-959 Rzeszów, PolandDoctoral School of the Rzeszow University of Technology, al. Powstańców Warszawy 12, 35-959 Rzeszów, PolandDepartment of Chemical and Process Engineering, Rzeszow University of Technology, al. Powstańców Warszawy 6, 35-959 Rzeszów, PolandDepartment of Chemical and Process Engineering, Rzeszow University of Technology, al. Powstańców Warszawy 6, 35-959 Rzeszów, PolandThe 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.https://www.mdpi.com/1420-3049/30/15/3119naproxen sodiumcontent uniformitypowder mixingdirect compressionV-type mixerball mill |
| spellingShingle | Mateusz Przywara Regina Lech-Przywara Patrycja Rupar Wojciech Zapała Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC Method Molecules naproxen sodium content uniformity powder mixing direct compression V-type mixer ball mill |
| title | Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC Method |
| title_full | Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC Method |
| title_fullStr | Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC Method |
| title_full_unstemmed | Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC Method |
| title_short | Effect of Mixing Technology on Homogeneity and Quality of Sodium Naproxen Tablets: Technological and Analytical Evaluation Using HPLC Method |
| title_sort | effect of mixing technology on homogeneity and quality of sodium naproxen tablets technological and analytical evaluation using hplc method |
| topic | naproxen sodium content uniformity powder mixing direct compression V-type mixer ball mill |
| url | https://www.mdpi.com/1420-3049/30/15/3119 |
| work_keys_str_mv | AT mateuszprzywara effectofmixingtechnologyonhomogeneityandqualityofsodiumnaproxentabletstechnologicalandanalyticalevaluationusinghplcmethod AT reginalechprzywara effectofmixingtechnologyonhomogeneityandqualityofsodiumnaproxentabletstechnologicalandanalyticalevaluationusinghplcmethod AT patrycjarupar effectofmixingtechnologyonhomogeneityandqualityofsodiumnaproxentabletstechnologicalandanalyticalevaluationusinghplcmethod AT wojciechzapała effectofmixingtechnologyonhomogeneityandqualityofsodiumnaproxentabletstechnologicalandanalyticalevaluationusinghplcmethod |