Comparison between branded and generic furosemide 40 mg tablets using thermal gravimetric analysis and Fourier transform infrared spectroscopy

Abstract

A BSTRACT Background and Purpose: 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. Materials and Methods: 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. Results: 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. Conclusion: 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.

Amphiphilic Alkylated Pectin Hydrogels for Enhanced Topical Delivery of Fusidic Acid: Formulation and In Vitro Investigation

“…In general, the principal characteristic peaks of alkylated pectin were identical to those of native pectin. The extensive and intense absorption band at 3329 cm −1 (seen in the spectra of both native and alkylated pectin, Figure 2) can be ascribed to -OH stretching absorption because of hydrogen bonding found in the galacturonic acid subunits [25]. The bands at 2921-2884 cm −1 are caused by -CH vibrations [11].…”

Investigations of pectin nanostructures for enhanced percutaneous delivery of fusidic acid

“…In general, GBE‐PEC revealed major characteristic peaks identical to that of native pectin. Due to hydrogen bonding present in the galacturonic acid subunits, the widespread and powerful absorption band at 3333 cm −1 (occurring in the spectra of both native and altered pectin, Figure 2) can be attributed to O–H stretching absorption 30 . C–H vibrations are responsible for the bands at 2923–2894 cm −1 21 .…”

Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments

“…Overall, the release of SDF from the polymer matrices was strongly controlled by the dual effects of hydrophilicity and swelling. However, several factors, including physicochemical properties of the drug and excipients, dosage form design, and manufacturing conditions can affect the final release profile [ 40 , 41 ]. Hence, it can help to define the release pattern of the drug as it governs the efficacy of the dosage form.…”