Olgac Seval, Yilmaz Usta Duygu, Incecayir Tuba
Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, Etiler 06330, Ankara, Turkey.
Saudi Pharm J. 2021 Dec;29(12):1486-1491. doi: 10.1016/j.jsps.2021.11.005. Epub 2021 Nov 15.
Tablet splitting is a common practice in clinical settings to lower doses, facilitate swallowing or save costs. Splitting devices can be used when hand splitting is difficult or painful. However, data on the accuracy of tablet splitting are limited and it presents a number of patient or formulation-related problems. Thirty nebivolol IR tablets on the Turkish market were split by hand, a tablet cutter (Rabır®) or a knife, and tested for weight variation, loss of mass, disintegration, and friability. The accuracy of split tablets was in the range of 75.4-121, 82.4-115, and 86.9-115% when split by hand, the cutter, and knife, respectively. No significant difference in accuracy was determined between the left and right sides split by the cutter (p = 0.222). The differences were significant for hand and knife splittings (p < 0.005). The precision was 9.02, 7.87, and 6.11% (CV%) for hand, tablet cutter, and knife, respectively. Only hand splitting failed to comply with the subdivision test of European Pharmacopoeia. The split portions met USP standards for friability (<1%). Splitting decreased the disintegration time (4.5 vs. 2.2 min). Overall, the accuracy of the tablet cutter was more favorable than hand splitting and knife. The study demonstrated that the splitting technique may result in inaccurate dosing and significant drug fluctuations for nebivolol tablets.
片剂分割是临床中降低剂量、便于吞咽或节省成本的常见做法。当手工分割困难或疼痛时，可使用分割装置。然而，关于片剂分割准确性的数据有限，并且它存在一些与患者或制剂相关的问题。对土耳其市场上的30片奈必洛尔速释片用手、片剂切割器（Rabır®）或刀进行分割，并测试其重量差异、质量损失、崩解和脆碎度。用手、切割器和刀分割时，分割片剂的准确性分别在75.4 - 121%、82.4 - 115%和86.9 - 115%范围内。切割器分割的左右两侧在准确性上没有显著差异（p = 0.222）。手工和用刀分割的差异显著（p < 0.005）。手工、片剂切割器和刀分割的精密度分别为9.02%、7.87%和6.11%（变异系数）。只有手工分割不符合欧洲药典的细分测试。分割后的部分符合美国药典的脆碎度标准（<1%）。分割缩短了崩解时间（4.5分钟对2.2分钟）。总体而言，片剂切割器的准确性比手工分割和用刀分割更有利。该研究表明，分割技术可能导致奈必洛尔片剂的剂量不准确和显著的药物波动。
