DEVELOPMENT OF DISSOLUTION TEST FOR FENBENDAZOLE AND PRAZIQUANTEL TABLETS FOR VETERINARY USE

SILVANA E. VIGNADUZZO; MARÍA ALEJANDRA OPERTO; PATRICIA M. CASTELLANO

Córdoba

Congreso; 3° reunión Internacional de Ciencias Farmacéuticas; 2014

RICIFa

Fenbendazole (FEN) and Praziquantel (PRA) association is widely used in veterinary treatment of parasitic diseases. However, this association is not included in any renowned Pharmacopoeia. Consequently, the aim of this work was to develop a dissolution test for this association. A batch of capsules containing 500 mg of FEN and 50 mg of PRA were prepared in our laboratory as a reference formulation. A published HPLC method was revalidated and used to determine analytes during dissolution experiments.1 All the tests and assays were carried out according to the USP 35 Pharmacopoeia. In the screening phase, two factors, HCl concentration and ethanol proportion, were found to be significant in the dissolution of analytes. In the optimization phase a full factorial 32 experimental design was carried out. The optimal conditions for the dissolution test were: 900 mL dissolution medium composed of a mixture of 300 mL of ethanol and 600 mL 0.5 N HCl, USP apparatus 2, 75 rpm in a bath thermostated to 37.0 ± 0.5 °C. Two brands of commercial tablets were evaluated and the optimized conditions were used to build the dissolution profiles of both brands. The amount of drug dissolved for brand 1 was greater than 80 % (Qproposed) for both analytes after an hour of dissolution. However, brand 2 failed the dissolution test. Other quality parameter tablets were also evaluated. Brand 1 complied with the disintegration test, while Brand 2 did not pass this test, which agrees with the results obtained in the dissolution test. In addition, hardness obtained for both brands shows some differences, brand 1, 12 Kg (RSD 7) and brand 2, 15 Kg (RSD 14). On the other hand, the brands met the general pharmacopoeial requirements of uniformity of dosage units, dose control and friability, showing the need to carry out dissolution test to detect failures in formulation.