Title: Development of a dissolution test method for enrofloxacin tablets using factorial design

Authors: Michele Georges Issa; Marcelo Dutra Duque; Aline Rotildes De Queiros; Juliana Buono Françoso; Humberto Gomes Ferraz; Leticia Norma Carpentieri Rodrigues

Addresses: Faculdade de Ciências Farmacêuticas, Departamento de Farmácia, Universidade de São Paulo, Rua do Lago, 250, Prédio Semi-Industrial, Térreo, Cidade Universitária, Butantã, 05508-080, São Paulo, Brazil ' Faculdade de Ciências Farmacêuticas, Departamento de Farmácia, Universidade de São Paulo, Rua do Lago, 250, Prédio Semi-Industrial, Térreo, Cidade Universitária, Butantã, 05508-080, São Paulo, Brazil ' Departamento de Ciências Exatas e da Terra, Curso de Farmácia, Universidade Federal de São Paulo, Campus Diadema, Rua São Nicolau, 210, Centro, 099130-30, Diadema, Brazil ' Departamento de Ciências Exatas e da Terra, Curso de Farmácia, Universidade Federal de São Paulo, Campus Diadema, Rua São Nicolau, 210, Centro, 099130-30, Diadema, Brazil ' Faculdade de Ciências Farmacêuticas, Departamento de Farmácia, Universidade de São Paulo, Rua do Lago, 250, Prédio Semi-Industrial, Térreo, Cidade Universitária, Butantã, 05508-080, São Paulo, Brazil ' Departamento de Ciências Exatas e da Terra, Curso de Farmácia, Universidade Federal de São Paulo, Campus Diadema, Rua São Nicolau, 210, Centro, 099130-30, Diadema, Brazil

Abstract: Dissolution testing has emerged in the pharmaceutical field as a very important tool to characterise the performance of drug products. Enrofloxacin is an antimicrobial frequently used in veterinary medicine that has no dissolution method described in pharmacopoeias. In vitro dissolution tests of enrofloxacin tablets were performed using different test parameters under 'sink' conditions. A two-factor three-level factorial design was obtained using statistical software, on which nine runs were performed. The independent variables were rotation speed (50, 75 or 100 rpm) and dissolution medium (HCl 0.01 M, purified water or phosphate buffer pH 6.8). The response evaluated (dependent variable) was dissolution efficiency (%). The method using hydrochloric acid 0.01 M as the dissolution medium in USP Apparatus 2, with a rotation speed of 75 rpm proved to be the most appropriate. Under these conditions, this method was capable of distinguishing between different tablet formulations containing enrofloxacin.

Keywords: dissolution testing; dissolution optimisation; enrofloxacin tablets; factorial design; solubility; veterinary drugs; design of experiments; DOE; Biopharmaceutics Classification System; BCS; immediate release; pharmaceutical industry; antimicrobial; veterinary medicine; tablet formulations.

DOI: 10.1504/IJEDPO.2013.059666

International Journal of Experimental Design and Process Optimisation, 2013 Vol.3 No.4, pp.435 - 446

Received: 14 Sep 2013
Accepted: 19 Dec 2013
Published online: 02 Jul 2014 *

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