This study aimed to evaluate the quality and pharmaceutical equivalence of commercial products containing HCTZ (50 mg) marketed in Argentina, based on local Pharmacopeia guidelines.

The aim of the present study was to evaluate and compare the influence of accelerated-aging conditions on the drug content and in vitro dissolution stability of eleven different ciprofloxacin (CIP) 500-mg tablets obtained from pharmacies and hospitals in Argentina. CIP, a Class II/IV drug in the Biopharmaceutics Classification System, is a fluoroquinolone antibiotic agent used in the treatment of bacterial infections. CIP content was evaluated following USP (1) specifications. Dissolution efficiency (DE) was calculated from dissolution profiles that were performed according to the British Pharmacopoeia monograph for CIP tablets (2). This determination was performed at time zero and after three (3M) and six months (6M) of storage, according to ICH accelerated-aging conditions (40 °C/75% RH). Each formulation was compared with the reference at the specified times, using ANOVA in terms of DE and similarity factor f 2 . Furthermore, ANOVA for DE values was used to evaluate the effect of aging conditions on the dissolution stability within each formulation. Although the storage conditions examined in the study affected the dissolution behavior of all CIP formulations, they did not have a significant effect on chemical stability, with the exception of one formulation that showed undesirable performance in both chemical and dissolution stability.

Furosemide is a widely used diuretic, indicated in the treatment of hypertension and edema. This active pharmaceutical ingredient is classified as Class IV in the Biopharmaceutical Classification System. The World Health Organization recommends an oral dose of 40 mg. The aim of the present work was to evaluate and compare critical quality attributes, including in vitro dissolution characteristics, of eight furosemide tablet brands from the Argentine market and determine their pharmaceutical equivalence. Furthermore, this research aimed to evaluate the effect of storage for 12 months (natural aging conditions) on those critical properties. At time zero of analysis, all evaluated samples fulfilled specifications for friability, hardness, disintegration, assay, uniformity of dosage units, and dissolution tests. After storage, all formulations fulfilled the assay and dissolution test specifications, with no statistical differences recorded for the obtained results. Comparison of dissolution profiles was also assessed in terms of the model-independent parameter called dissolution efficiency. Highly significant differences were recorded between reference and four multisource formulations. The same differences were found at the beginning of the study (time zero) and after 12 months of storage. The product with the lowest dissolution efficiency results was associated with highly significant differences when compared to the other formulations. However, the obtained results reveal that the evaluated samples complied with codified quality control tests, and consequently, can be qualified as pharmaceutical equivalents. Natural aging conditions did not affect the stability of the evaluated furosemide products.

The aim of the present study was to evaluate the influence of accelerated aging conditions on drug content and in vitro dissolution stability of three cephalexin (CE) extemporaneous suspensions obtained from pharmacies and a local state laboratory. The specific gravity, pH, and visual appearance of CE oral extemporaneous suspension were also studied. Dissolution profiles were performed according to FDA recommendations, since there is no official dissolution method codified. Analyses were performed throughout the administration period of the reconstituted suspension (7 days at room temperature storage or 14 days under refrigeration), at time zero, and during twelve months of storage of the powders under ICH accelerated aging conditions. Dissolution Efficiency (DE) values and assay results were analyzed via analysis of variance (ANOVA) to evaluate the effect of aging conditions on the stability of each formulation. From a clinical point of view, the storage conditions applied did not affect dissolution or chemical stability of CE oral extemporaneous suspensions.

Sildenafil citrate is a selective inhibitor of the enzyme phosphodiesterase type 5, used to treat erectile dysfunction in adults and pulmonary hypertension, mainly in children. This work aimed to perform a comparative study of sildenafil tablets marketed in Argentina and establish their pharmaceutical equivalence. Eight commercial formulations (immediate-release tablets) containing 50 mg of sildenafil were analyzed according to United States and Argentinian Pharmacopoeial guidelines. The assay was performed by UV spectrophotometry in 0.01 N hydrochloric acid. Similar conditions were used for dissolution tests, which were carried out in a basket apparatus at 100 rpm. All samples met pharmacopeial specifications for acceptance (i.e., assay, content uniformity, hardness, friability, disintegration, and in vitro dissolution) for immediate-release dosage forms. When compared to the reference formulation, a statistically significant difference was noted for dissolution efficiency in one case (sample F). Based on the obtained results, it is possible to conclude that the evaluated formulations of sildenafil can be considered pharmaceutical equivalents.