Gharaibeh Shadi F, Tahaineh Linda
PhD. Associate Professor. Faculty of Pharmacy, Jerash University. Jerash (Jordan).
PharmD, MS. Professor. Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science & Technology. Irbid (Jordan).
Pharm Pract (Granada). 2020 Apr-Jun;18(2):1776. doi: 10.18549/PharmPract.2020.2.1776. Epub 2020 Apr 23.
To determine the accuracy, variability, and weight uniformity of tablet subdivision techniques utilized to divide the tablets of five drug products that are commonly prescribed for use as half tablets in Jordan.
Ten random tablets of five commonly subdivided drug products were weighed and subdivided using three subdivision techniques: hand breaking, kitchen knife, and tablet cutter. The five commonly subdivided drug products (warfarin 5 mg, levothyroxine 50 μg, levothyroxine 100 μg, candesartan 16 mg, and carvedilol 25 mg) were weighed. The weights were analyzed for acceptance, accuracy, and variability. Weight variation acceptance criteria were adopted in this work as a tool to indicate the properness of the subdivision techniques used to produce acceptable half tablets. Other relevant physical characteristics of the five products such as tablet shape, dimensions, face curvature, score depth, and crushing strength were measured.
All tablets were round in shape, had weights that ranged between 100.63 mg (standard deviation=0.99) and 379.04 mg (standard deviation=3.00), and had crushing strengths that ranged between 23.29 N (standard deviation=3.58)and 103.35 N (standard deviation=14.98). Both candesartan and carvedilol were bi-convex in shape with an extent of face curvature equal to about 33%. In addition, percentage score depth of the tablets had a range between 0% and 24%. The accuracy and variability of subdivision varied according to the subdivision technique used and tablet characteristics. Accuracy range was between 81% and 109.8%. Moreover, the relative standard deviation was between 1.5% and 17.4%. Warfarin 5 mg subdivided tablets failed the weight variation test regardless of the subdivision technique used. Subdivision by hand produced half tablets that were acceptable for levothyroxine 50 μg and levothyroxine 100 μg. Subdivision by knife produced half tablets that were acceptable only for candesartan tablets. However, the tablet cutter produced half tablets that passed the weight variation test for four out of the five drug products tested in this study.
The tablet cutter performed better than the other subdivision techniques used. It produced half tablets that passed the weight uniformity test for four drug products out of the five.
确定用于分割约旦常用的五种药品片剂（通常作为半片使用）的片剂分割技术的准确性、变异性和重量均匀性。
对五种常用分割药品的十片随机片剂进行称重，并使用三种分割技术进行分割：手工掰断、厨房刀切割和平片切割机切割。对五种常用分割药品（华法林5毫克、左甲状腺素50微克、左甲状腺素100微克、坎地沙坦16毫克和卡维地洛25毫克）进行称重。分析重量的可接受性、准确性和变异性。本研究采用重量差异接受标准作为一种工具，以表明用于生产可接受半片的分割技术的适当性。测量了这五种产品的其他相关物理特性，如片剂形状、尺寸、表面曲率、刻痕深度和抗压强度。
所有片剂均为圆形，重量在100.63毫克（标准差=0.99）至379.04毫克（标准差=3.00）之间，抗压强度在23.29牛顿（标准差=3.58）至103.35牛顿（标准差=14.98）之间。坎地沙坦和卡维地洛均为双凸形，表面曲率程度约为33%。此外，片剂的刻痕深度百分比在0%至24%之间。分割的准确性和变异性根据所使用的分割技术和片剂特性而有所不同。准确性范围在81%至109.8%之间。此外，相对标准偏差在1.5%至17.4%之间。无论使用何种分割技术，5毫克华法林分割后的片剂均未通过重量差异测试。手工分割产生的半片对于50微克左甲状腺素和100微克左甲状腺素是可接受的。用刀分割产生的半片仅对坎地沙坦片剂是可接受的。然而，在本研究测试的五种药品中，平片切割机分割产生的半片有四种通过了重量差异测试。
平片切割机的性能优于所使用的其他分割技术。它分割产生的半片在五种药品中有四种通过了重量均匀性测试。
