Evaluation of Vibratory Ball Mill Mixing as an Alternative to Wet Granulation in the Manufacturing of Sodium Naproxen Tablets with Dolomite-Based Formulations
The development of robust and scalable tablet manufacturing methods remains a key objective in pharmaceutical technology, especially when dealing with active pharmaceutical ingredients (APIs) and excipients that exhibit suboptimal processing properties. This study evaluated two alternative manufactu...
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MDPI AG
2025-06-01
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| Online Access: | https://www.mdpi.com/2076-3417/15/13/6966 |
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| author | Mateusz Przywara Klaudia Jękot Wiktoria Jednacz |
| author_facet | Mateusz Przywara Klaudia Jękot Wiktoria Jednacz |
| author_sort | Mateusz Przywara |
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| description | The development of robust and scalable tablet manufacturing methods remains a key objective in pharmaceutical technology, especially when dealing with active pharmaceutical ingredients (APIs) and excipients that exhibit suboptimal processing properties. This study evaluated two alternative manufacturing strategies for tablets containing sodium naproxen (20%, API), dolomite (65%, sustainable mineral filler), cellulose (7%), polyvinylpyrrolidone (5%, binder), and magnesium stearate (3%, lubricant). The direct compression method used a vibrating ball mill (SPEX SamplePrep 8000M), while the indirect method employed wet granulation using a pan granulator at different inclination angles. Physical properties of raw materials and granules were assessed, and final tablets were evaluated for mass, thickness, mechanical resistance, abrasiveness, and API content uniformity. Direct compression using vibratory mixing for 5–10 min (DT2, DT3) resulted in average tablet masses close to the target (0.260 g) and improved reproducibility compared to a reference V-type blender. Wet granulation produced tablets with the lowest abrasiveness (<1.0%) and minimal variability in dimensions and API content. The best uniformity (SD < 0.5%) was observed in batch IT2. Overall, vibratory mixing proved capable of achieving tablet quality comparable to that of wet granulation, while requiring fewer processing steps. This highlights its potential as an efficient and scalable alternative in solid dosage manufacturing. |
| format | Article |
| id | doaj-art-fa76a4ed95064d1b9ffa252a04ac6d31 |
| institution | DOAJ |
| issn | 2076-3417 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Applied Sciences |
| spelling | doaj-art-fa76a4ed95064d1b9ffa252a04ac6d312025-08-20T03:16:42ZengMDPI AGApplied Sciences2076-34172025-06-011513696610.3390/app15136966Evaluation of Vibratory Ball Mill Mixing as an Alternative to Wet Granulation in the Manufacturing of Sodium Naproxen Tablets with Dolomite-Based FormulationsMateusz Przywara0Klaudia Jękot1Wiktoria Jednacz2Department 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, PolandDepartment of Chemical and Process Engineering, Rzeszow University of Technology, al. Powstańców Warszawy 6, 35-959 Rzeszów, PolandThe development of robust and scalable tablet manufacturing methods remains a key objective in pharmaceutical technology, especially when dealing with active pharmaceutical ingredients (APIs) and excipients that exhibit suboptimal processing properties. This study evaluated two alternative manufacturing strategies for tablets containing sodium naproxen (20%, API), dolomite (65%, sustainable mineral filler), cellulose (7%), polyvinylpyrrolidone (5%, binder), and magnesium stearate (3%, lubricant). The direct compression method used a vibrating ball mill (SPEX SamplePrep 8000M), while the indirect method employed wet granulation using a pan granulator at different inclination angles. Physical properties of raw materials and granules were assessed, and final tablets were evaluated for mass, thickness, mechanical resistance, abrasiveness, and API content uniformity. Direct compression using vibratory mixing for 5–10 min (DT2, DT3) resulted in average tablet masses close to the target (0.260 g) and improved reproducibility compared to a reference V-type blender. Wet granulation produced tablets with the lowest abrasiveness (<1.0%) and minimal variability in dimensions and API content. The best uniformity (SD < 0.5%) was observed in batch IT2. Overall, vibratory mixing proved capable of achieving tablet quality comparable to that of wet granulation, while requiring fewer processing steps. This highlights its potential as an efficient and scalable alternative in solid dosage manufacturing.https://www.mdpi.com/2076-3417/15/13/6966sodium naproxendolomitedirect compressionwet granulationvibratory mixingtablet formulation |
| spellingShingle | Mateusz Przywara Klaudia Jękot Wiktoria Jednacz Evaluation of Vibratory Ball Mill Mixing as an Alternative to Wet Granulation in the Manufacturing of Sodium Naproxen Tablets with Dolomite-Based Formulations Applied Sciences sodium naproxen dolomite direct compression wet granulation vibratory mixing tablet formulation |
| title | Evaluation of Vibratory Ball Mill Mixing as an Alternative to Wet Granulation in the Manufacturing of Sodium Naproxen Tablets with Dolomite-Based Formulations |
| title_full | Evaluation of Vibratory Ball Mill Mixing as an Alternative to Wet Granulation in the Manufacturing of Sodium Naproxen Tablets with Dolomite-Based Formulations |
| title_fullStr | Evaluation of Vibratory Ball Mill Mixing as an Alternative to Wet Granulation in the Manufacturing of Sodium Naproxen Tablets with Dolomite-Based Formulations |
| title_full_unstemmed | Evaluation of Vibratory Ball Mill Mixing as an Alternative to Wet Granulation in the Manufacturing of Sodium Naproxen Tablets with Dolomite-Based Formulations |
| title_short | Evaluation of Vibratory Ball Mill Mixing as an Alternative to Wet Granulation in the Manufacturing of Sodium Naproxen Tablets with Dolomite-Based Formulations |
| title_sort | evaluation of vibratory ball mill mixing as an alternative to wet granulation in the manufacturing of sodium naproxen tablets with dolomite based formulations |
| topic | sodium naproxen dolomite direct compression wet granulation vibratory mixing tablet formulation |
| url | https://www.mdpi.com/2076-3417/15/13/6966 |
| work_keys_str_mv | AT mateuszprzywara evaluationofvibratoryballmillmixingasanalternativetowetgranulationinthemanufacturingofsodiumnaproxentabletswithdolomitebasedformulations AT klaudiajekot evaluationofvibratoryballmillmixingasanalternativetowetgranulationinthemanufacturingofsodiumnaproxentabletswithdolomitebasedformulations AT wiktoriajednacz evaluationofvibratoryballmillmixingasanalternativetowetgranulationinthemanufacturingofsodiumnaproxentabletswithdolomitebasedformulations |