在沙特阿拉伯销售的八种50毫克双氯芬酸钠肠溶片制剂：体外质量评估

Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation.

作者信息

Hammami Muhammad M, Hussein Rajaa F, AlSwayeh Reem, Alvi Syed N

机构信息

Clinical Studies and Empirical Ethics Department, King Faisal Specialist Hospital and Research Centre, MBC 03, PO Box # 3354, Riyadh, 11211, Saudi Arabia.

Alfaisal University College of Medicine, Riyadh, Saudi Arabia.

出版信息

BMC Res Notes. 2020 Sep 14;13(1):428. doi: 10.1186/s13104-020-05270-4.

DOI:10.1186/s13104-020-05270-4

PMID:32928294

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7491129/

Abstract

OBJECTIVE

To evaluate in vitro quality of enteric-coated 50 mg diclofenac sodium tablet formulations on Saudi market.

RESULTS

A reference and seven generic (G1-7) formulations were commercially available in December 2019/January 2020 and were assessed within 25-75% of manufacture-expiration period. Weight variation (range as% difference from mean, n = 20), active substance content (ASC, mean (SD) as% difference from label, n = 20), hardness (mean (SD), n = 10), and friability (% weight loss, n = 20) were 97-103%, 102.0% (3.4%), 15.4 (1.1) kg, and 0.24%, respectively, for the reference. For G2-7, they were ≤ ±5%, 98.6% (4.0%) to 109.9% (1.8%), 11.9 (0.9) to 18.3 (0.8) kg, and ≤ 0.00 to 0.75%, respectively. G1 ASC, hardness, and friability were 111.3% (1.7%), 20.1 (1.7) kg, and 1.10%, respectively. Disintegration time (n = 6) and dissolution profile (n = 8) were also determined. No formulation disintegrated or released ˃ 0.1% of label ASC in 0.1 N HCl for 2 h. The reference disintegrated in 15:00 min:seconds and released a mean (range) of 100% (99-103%) of label ASC by 45 min in phosphate buffer (pH = 6.8). G1-7 disintegrated in 8:53 to 20:37 min:seconds and released 81% (69-90%) (G1) to 109%. Except for borderline performance of G1, all formulations passed in vitro quality tests according to United States Pharmacopoeia.

摘要

目的

评估沙特市场上50毫克双氯芬酸钠肠溶片制剂的体外质量。

结果

2019年12月/2020年1月有1种参比制剂和7种仿制药（G1 - 7）在售，且在生产日期至有效期的25% - 75%范围内进行了评估。参比制剂的重量差异（范围为与均值的百分比差异，n = 20）、活性物质含量（ASC，均值（标准差）为与标签的百分比差异，n = 20）、硬度（均值（标准差），n = 10）和脆碎度（重量损失百分比，n = 20）分别为97% - 103%、102.0%（3.4%）、15.4（1.1）千克和0.24%。对于G2 - 7，它们分别为≤±5%、98.6%（4.0%）至109.9%（1.8%）、11.9（0.9）至18.3（0.8）千克和≤0.00%至0.75%。G1的ASC、硬度和脆碎度分别为111.3%（1.7%）、20.1（1.7）千克和1.10%。还测定了崩解时间（n = 6）和溶出曲线（n = 8）。在0.1 N盐酸中2小时内，没有制剂崩解或释放超过标签ASC的0.1%。参比制剂在15分00秒崩解，并在45分钟内在磷酸盐缓冲液（pH = 6.8）中释放了标签ASC的均值（范围）为100%（99% - 103%）。G1 - 7在8分53秒至20分37秒崩解，并释放了81%（69% - 90%）（G1）至109%。除G1的性能接近临界外，所有制剂均根据美国药典通过了体外质量测试。