Arafat Mosab, Fahelelbom Khairi M, Sarfraz Muhammad K, Bostanudin Mohammad F, Sharif Qurat-Ul-Ain, Esmaeil Anna, Al Hanbali Othman A, Aburuz Salahdein
College of Pharmacy, Al Ain University, Al Ain, Abu Dhabi, UAE.
Faculty of Pharmacy, The University of Sydney, Sydney, Australia.
J Pharm Bioallied Sci. 2020 Oct-Dec;12(4):489-498. doi: 10.4103/jpbs.JPBS_365_19. Epub 2020 Oct 8.
There has been a long-standing belief that generic drugs are of lower value in comparison to their branded name counterparts. They are in particular under scrutiny due to their low market price. Even though the reduction in costs is largely based on skipping expensive preclinical studies and clinical trials for generic drugs, the purity and quality of the raw materials in the production of generic drugs is debatable. Thus, the objective of the study was to analyze and assess the quality comparability of generic furosemide 40 mg (FSD) tablets to branded product available in the market.
Quality control tests, in vitro drug release assessments, and thermal analysis investigations for both analog products of FSD were performed. Various physical parameters related to the tablet quality, such as hardness, weight variation, and friability tests, were examined. In vitro drug release behavior evaluations were conducted according to United States Pharmacopeia (USP) specifications and guidelines, whereas thermal analysis was carried out using thermal gravimetric analysis (TGA), and tablets were further evaluated by Fourier transform infrared (FTIR) spectroscopy.
The results indicated a significant variation between the two products in terms of hardness, weight variation, and friability. This could be correlated to variation appeared in thermal and spectroscopic spectra between the two products using TGA and FTIR. Drug release of FSD was slightly different between both products following incubation in different pH media (1.2, 3.0, and 6.5; 120 min), however, this was in accordance with USP dissolution requirements as < 80% of drug release was obtained within the first 30 min from each product.
This study is a useful example for the independent investigations using thermal and spectroscopic analysis to confirm potential hidden variations between generic and branded products that could not be obtained by the bioequivalence studies.
长期以来，人们一直认为仿制药与品牌药相比价值较低。由于其市场价格低廉，尤其受到严格审查。尽管成本降低很大程度上是因为仿制药跳过了昂贵的临床前研究和临床试验，但仿制药生产中原材料的纯度和质量仍存在争议。因此，本研究的目的是分析和评估40毫克呋塞米仿制药（FSD）片剂与市场上现有品牌产品的质量可比性。
对FSD的两种类似产品进行了质量控制测试、体外药物释放评估和热分析研究。检查了与片剂质量相关的各种物理参数，如硬度、重量差异和脆碎度测试。体外药物释放行为评估按照美国药典（USP）的规范和指南进行，而热分析则使用热重分析（TGA）进行，片剂进一步通过傅里叶变换红外（FTIR）光谱进行评估。
结果表明，两种产品在硬度、重量差异和脆碎度方面存在显著差异。这可能与使用TGA和FTIR的两种产品在热谱和光谱上出现的差异相关。在不同pH介质（1.2、3.0和6.5；120分钟）中孵育后，两种产品的FSD药物释放略有不同，然而，这符合USP溶出要求，因为每种产品在前30分钟内药物释放均未达到80%。
本研究是一个有用的例子，展示了如何通过热分析和光谱分析进行独立研究，以确认仿制药和品牌药之间潜在的隐藏差异，而这些差异是生物等效性研究无法获得的。
