Clinical Studies and Empirical Ethics Department, King Faisal Specialist Hospital and Research Centre, P O Box # 3354 (MBC 03), Riyadh, 11211, Saudi Arabia.
Alfaisal University College of Medicine, Riyadh, Saudi Arabia.
BMC Res Notes. 2020 Nov 26;13(1):548. doi: 10.1186/s13104-020-05385-8.
We previously reported the pharmaceutical quality of eight brands of 50 mg enteric-coated diclofenac sodium tablet available on the Saudi market. Here, we assess the quality of reference (R1) and four generic (G1-G4) brands of 50 mg immediate-release diclofenac potassium tablet and of reference (R2) and generic (G5) brands of 100 mg sustained-release diclofenac sodium tablet.
Weight variation (range as % difference from mean), active substance content (mean (SD) as % difference from label), breaking force [mean (SD)], and friability (as % weight loss) were 95-104% and 99-102%, 100.9% (3.4%) and 105.6 (4.2%), 12.2 (1.3) and 12.9 (1.8) kg, and 0.0014% and 0.0012%, for R1 and R2, respectively. For G1-G5, they were ≤ ± 2%, 98.8% (2.7%) to 109.2% (3.8%), 6.4 (0.6) to 13.3 (1.0) kg, and 0.0007% to 0.0261%, respectively. R1 and G1-G4 disintegrated within 04:50-17:20 min: seconds and released a mean of 89-100% of label active substance content by 60 min in buffer (pH 6.8). R2 and G5 did not disintegrate or dissolve in 0.1 N HCl for 2 h, disintegrated in buffer (pH 6.8) in 01:58-02:15 h: minutes, and fulfilled dissolution criteria (pH 7.5) for both United States Pharmacopoeia test-1 and test-2. Thus all seven brands met pre-specified quality criteria.
我们之前报道了沙特市场上 8 种 50mg 肠溶片型双氯芬酸钠的药物质量。在此，我们评估了 50mg 速释型双氯芬酸钾对照品（R1）和 4 种仿制药（G1-G4）以及 100mg 控释型双氯芬酸钠对照品（R2）和仿制药（G5）的质量。
重量差异（实测值与平均值的百分比差异范围）、活性成分含量（实测值与标签值的百分比差异的平均值）、断裂力[平均值（标准差）]和脆碎度（重量损失的百分比）分别为 95-104%和 99-102%、100.9%（3.4%）和 105.6（4.2%）、12.2（1.3）和 12.9（1.8）kg，以及 0.0014%和 0.0012%，分别为 R1 和 R2。对于 G1-G5，其范围分别为≤±2%、98.8%（2.7%）至 109.2%（3.8%）、6.4（0.6）至 13.3（1.0）kg，以及 0.0007%至 0.0261%。R1 和 G1-G4 在 04:50-17:20 分钟：秒内崩解，在缓冲液（pH6.8）中 60 分钟内释放出标签活性成分含量的 89-100%。R2 和 G5 在 0.1N HCl 中 2 小时内未崩解或溶解，在缓冲液（pH6.8）中 01:58-02:15 小时：分钟内崩解，并且满足美国药典测试 1 和测试 2 的溶出标准。因此，所有 7 个品牌均符合预先指定的质量标准。
