Miyazaki Y, Uchino T, Kagawa Y
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences, University of Shizuoka, Japan;, Email:
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences, University of Shizuoka, Japan.
Pharmazie. 2022 Apr 10;77(3):103-106. doi: 10.1691/ph.2022.11059.
A granulation method using a planetary centrifugal mixer, called planetary centrifugal granulation, has been developed for small-scale production, such as extemporaneous preparation in pharmacies. Although the impact of its operational parameters on granulation is described, the scale effect has not been investigated. Therefore, we aimed to reveal the effects of vessel size and vessel filling rate on granule properties. In this study, ibuprofen 20% granules consisting of lactose, cornstarch, sodium carmellose, and talc were used as model granules. Granulation was performed using geometrically similar containers, 6-58 mL, with a filling rate of 20-70%. After granulation, we monitored the granule properties, for example, median diameter (d50), span of particle size distribution, and sphericity. At filling rates of 40% and 50% in the 58-mL vessel, the granules grew larger in diameter, and at a rate of 30%, the granules showed a higher sphericity. When the filling rate was 30%, d50 became larger and the span decreased as the vessel size increased. The yields of the granules were higher than 95% when using the 12-58 mL vessel. Lastly, the drug content uniformity and drug dissolution behavior of the granules produced in different vessel size were examined. The granules showed similar drug consistencies and drug dissolution profiles. In conclusion, the quality of the products was not affected by changes in vessel size. Thus, pharmacists could prepare and compound the granule formulations with high yield and appropriate quality using an adequate vessel in the same manner.
一种使用行星式离心混合器的制粒方法，称为行星离心制粒，已被开发用于小规模生产，如药房的临时制剂制备。尽管描述了其操作参数对制粒的影响，但尚未研究规模效应。因此，我们旨在揭示容器尺寸和容器填充率对颗粒性质的影响。在本研究中，由乳糖、玉米淀粉、羧甲基纤维素钠和滑石粉组成的布洛芬20%颗粒用作模型颗粒。使用6-58 mL几何相似的容器进行制粒，填充率为20-70%。制粒后，我们监测了颗粒性质，例如，中位直径（d50）、粒度分布跨度和球形度。在58 mL容器中填充率为40%和50%时，颗粒直径增大，在30%的填充率下，颗粒显示出更高的球形度。当填充率为30%时，随着容器尺寸的增加，d50变大且跨度减小。使用12-58 mL容器时颗粒产率高于95%。最后，检查了不同容器尺寸生产的颗粒的药物含量均匀性和药物溶出行为。颗粒显示出相似的药物一致性和药物溶出曲线。总之，产品质量不受容器尺寸变化的影响。因此，药剂师可以使用合适的容器以相同方式高产率且高质量地制备和配制颗粒制剂。
