Dissolution Stability of Furosemide tablets

VARILLAS, M. A.; BREVEDAN M. I. V.; FERNANDEZ BAND, B. S.; GONZALEZ VIDAL, N. L.

Córdoba

Congreso; 3º Reunión Internacional de Ciencias Farmacéuticas; 2014

Universidad Nacional de Rosario - Universidad Nacional de Córdoba

Dissolution Stability is a critical biopharmaceutical parameter, considering the possible impact it may have on the bioavailability of the product. Therefore, it is essential that the dissolution characteristics of a formulation remain unchanged throughout its shelf life. Furosemide, a class IV drug in the Biopharmaceutics Classification System, is a loop diuretic used in the treatment of edematous states and hypertension. Our research attempted to evaluate the influence of natural aging conditions on the chemical and dissolution stability of different furosemide formulations available in Argentina, during one year of storage. Samples (A-I, reference and multisource products) of furosemide tablets (40 and 50mg) were purchased from pharmacies in Bahía Blanca. All dissolution studies were performed using USP Apparatus 2 at 50 rpm, in 900 mL of USP phosphate buffer pH 5.8 and drug concentration was determined by UV-spectrophotometry (276.1nm). Spectrophotometric assay was performed in NaOH 0.1N (271nm). The formulations were stored for twelve months under ICH natural conditions (25°C-60%R.H.). Analysis of variance (ANOVA) was used to evaluate chemical and dissolution stability, in terms of Dissolution Efficiency (DE%). At time zero and after one year of storage, product I failed to comply with assay and uniformity of dosage units test criteria. Furthermore, this product did not meet neither USP nor FA dissolution test specifications, and presented a considerably lower dissolution performance compared to other products. Significant differences in DE% results were found between A, F, H and I respect to the reference, both at time zero and after one year of storage. Moreover, the ANOVA results indicate that there were significant differences throughout the dissolution stability study for samples D, H and I, whereas only F was not chemically stable.Natural aging conditions clearly affected dissolution and chemical stability of some furosemide tablets.