Study on the Scale-Up Possibility of a Combined Wet Grinding Technique Intended for Oral Administration of Meloxicam Nanosuspension
<b>Background/Objectives:</b> This article reports on the scalability of a combined wet grinding technique applying planetary ball mill and ZrO<sub>2</sub> pearls as the grinding medium. After the determination of the parameters in a laboratory scale, the tenfold scale-up met...
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2024-11-01
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| author | Csilla Bartos Anett Motzwickler-Németh Dávid Kovács Katalin Burián Rita Ambrus |
| author_facet | Csilla Bartos Anett Motzwickler-Németh Dávid Kovács Katalin Burián Rita Ambrus |
| author_sort | Csilla Bartos |
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| description | <b>Background/Objectives:</b> This article reports on the scalability of a combined wet grinding technique applying planetary ball mill and ZrO<sub>2</sub> pearls as the grinding medium. After the determination of the parameters in a laboratory scale, the tenfold scale-up method was set. Meloxicam (MEL) was used as a nonsteroidal anti-inflammatory drug (NSAID) intended for per os delivery. During grinding, the PVA solution was used as a dispersion medium. <b>Methods:</b> The influence of the scaling-up on the particle size, morphology, crystallinity, and intra- and interparticulate phenomena has been studied. Formulation investigations of the milled suspensions were carried out. The dissolution test and the cytotoxicity analyses were accomplished. <b>Results:</b> Submicron MEL particle-containing samples were produced in both grinding scales. After the particle size determination was achieved from the suspensions, the wet milled, dried products were studied. The particle size of the dried products fell into the same range for both scales of milling (the maximum particle size was about 580 nm). There was no significant difference in drug crystallinity after the grindings; 70% of MEL remained crystalline in both cases. A remarkable interaction between the components did not develop as a result of milling. The polarity of the products increased, which resulted in a better dissolution, especially in the case of intestinal fluid (~100% in the first 5 min). The products were not found to be toxic. <b>Conclusions:</b> This research demonstrates that the scaling-up of combined wet grinding technique is feasible by adjusting the milling parameters and the adequate amount of excipient. |
| format | Article |
| id | doaj-art-3ae7df3ecec14c88b3b72a0b7943a4bc |
| institution | Kabale University |
| issn | 1999-4923 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj-art-3ae7df3ecec14c88b3b72a0b7943a4bc2024-12-27T14:46:21ZengMDPI AGPharmaceutics1999-49232024-11-011612151210.3390/pharmaceutics16121512Study on the Scale-Up Possibility of a Combined Wet Grinding Technique Intended for Oral Administration of Meloxicam NanosuspensionCsilla Bartos0Anett Motzwickler-Németh1Dávid Kovács2Katalin Burián3Rita Ambrus4Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, 6720 Szeged, HungaryInstitute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, 6720 Szeged, HungaryInstitute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, 6720 Szeged, HungaryDepartment of Medical Microbiology, Albert Szent-Györgyi Medical School, University of Szeged, 6720 Szeged, HungaryInstitute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, 6720 Szeged, Hungary<b>Background/Objectives:</b> This article reports on the scalability of a combined wet grinding technique applying planetary ball mill and ZrO<sub>2</sub> pearls as the grinding medium. After the determination of the parameters in a laboratory scale, the tenfold scale-up method was set. Meloxicam (MEL) was used as a nonsteroidal anti-inflammatory drug (NSAID) intended for per os delivery. During grinding, the PVA solution was used as a dispersion medium. <b>Methods:</b> The influence of the scaling-up on the particle size, morphology, crystallinity, and intra- and interparticulate phenomena has been studied. Formulation investigations of the milled suspensions were carried out. The dissolution test and the cytotoxicity analyses were accomplished. <b>Results:</b> Submicron MEL particle-containing samples were produced in both grinding scales. After the particle size determination was achieved from the suspensions, the wet milled, dried products were studied. The particle size of the dried products fell into the same range for both scales of milling (the maximum particle size was about 580 nm). There was no significant difference in drug crystallinity after the grindings; 70% of MEL remained crystalline in both cases. A remarkable interaction between the components did not develop as a result of milling. The polarity of the products increased, which resulted in a better dissolution, especially in the case of intestinal fluid (~100% in the first 5 min). The products were not found to be toxic. <b>Conclusions:</b> This research demonstrates that the scaling-up of combined wet grinding technique is feasible by adjusting the milling parameters and the adequate amount of excipient.https://www.mdpi.com/1999-4923/16/12/1512combined wet grinding/millingscale-up methodmeloxicamnanonizationdissolutioncytotoxicity |
| spellingShingle | Csilla Bartos Anett Motzwickler-Németh Dávid Kovács Katalin Burián Rita Ambrus Study on the Scale-Up Possibility of a Combined Wet Grinding Technique Intended for Oral Administration of Meloxicam Nanosuspension Pharmaceutics combined wet grinding/milling scale-up method meloxicam nanonization dissolution cytotoxicity |
| title | Study on the Scale-Up Possibility of a Combined Wet Grinding Technique Intended for Oral Administration of Meloxicam Nanosuspension |
| title_full | Study on the Scale-Up Possibility of a Combined Wet Grinding Technique Intended for Oral Administration of Meloxicam Nanosuspension |
| title_fullStr | Study on the Scale-Up Possibility of a Combined Wet Grinding Technique Intended for Oral Administration of Meloxicam Nanosuspension |
| title_full_unstemmed | Study on the Scale-Up Possibility of a Combined Wet Grinding Technique Intended for Oral Administration of Meloxicam Nanosuspension |
| title_short | Study on the Scale-Up Possibility of a Combined Wet Grinding Technique Intended for Oral Administration of Meloxicam Nanosuspension |
| title_sort | study on the scale up possibility of a combined wet grinding technique intended for oral administration of meloxicam nanosuspension |
| topic | combined wet grinding/milling scale-up method meloxicam nanonization dissolution cytotoxicity |
| url | https://www.mdpi.com/1999-4923/16/12/1512 |
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