Dissolution performance of different batches of Furosemide tablets

BREVEDAN M. I. V.; VARILLAS, M.A; GONZALEZ VIDAL, N. L.

Rosario

Congreso; 4º Reunión Internacional de Ciencias Farmacéuticas; 2016

Universidad Nacional de Rosario - Universidad Nacional de Cordoba

Furosemide, a BCS Class IV drug, is a diuretic indicated in the treatment of hypertension and edema. The WHO recommend an oral dose of 40mg. Dissolution performance and stability are critical biopharmaceutical parameters that can influence the bioavailability of the product. In a previous study, different commercial formulations were analyzed, and one of them (product I) presented a significantly lower dissolution performance. Our research attempted to rule out a particular problem of the tested lot, by studying new batches of the same formulation. Samples I, J and K, different batches of Furosemide diethylaminoethanol (50mg) tablets, 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. Spectrophotometric assay was performed in NaOH 0.1N. The formulations were stored twelve months under ICH natural conditions (25°C-60%RH). ANOVA was used to evaluate chemical and dissolution stability, the latter in terms of Dissolution Efficiency (DE %). At time zero (T0) and after 12 months (Tf) of storage, samples I, J and K met the assay (T0: 91.1, 95.1 and 97.7; Tf: 96.3, 93.9 and 95.4 % of labeled amount) and uniformity of dosage units test criteria. The three batches met the dissolution test, both at T0 and Tf. However, the dissolution profiles of J and K differ from batch I. The latter presented a considerably lower dissolution performance. High significant differences in DE % results were found between I respect to J and K, both at T0 (56.0 versus 87.2 and 84.4) and at Tf (61.1 versus 83.3 and 80.1). The three batches showed significant differences in DE % after 12 months of storage.In conclusion, the reduced dissolution performance of sample I was due to a particular batch problem.