Comparison between Branded and Generic Furosemide 40 mg Tablets Using Thermal Gravimetric Analysis and Fourier Transform Infrared Spectroscopy

• Published in: Journal of pharmacy & bioallied science Vol. 12; no. 4; pp. 489 - 498
• Main Authors: Arafat, Mosab, Fahelelbom, Khairi M, Sarfraz, Muhammad K, Bostanudin, Mohammad F, Sharif, Qurat-Ul-Ain, Esmaeil, Anna, Al Hanbali, Othman A, Aburuz, Salahdein
• Format: Journal Article
• Language: English
• Published: India Medknow Publications and Media Pvt. Ltd 01.10.2020; Wolters Kluwer - Medknow
• Subjects: Brand name products; Furosemide; Generic drugs; Infrared spectroscopy; Marketing; Medical research; Medicine, Experimental; Original; Raw materials; Tetracycline; Tetracyclines; furosemide; quality control test; Fourier transform infrared spectroscopy; thermal gravimetric analysis; Dissolution test; thermal analysis
• ISSN: 0976-4879; 0975-7406; 0975-7406
• DOI: 10.4103/jpbs.JPBS_365_19

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.