Development and evaluation of parenteral solution containing florfenicol and flunixin meglumine for veterinary use

Abstract

Parenteral dosage forms are one of the most commonly used pharmaceutical dosage forms in veterinary medicine, at the same time the combination therapy of multiple drug products is a common practice in this field. The aim of this research was to develop a high quality, stable solution that combines Florfenicol and Flunixin meglumine in a multidose injectable dosage form. Different organic solvents were tested to determine the optimal solvent for the active substances in the formulation. Citric acid was used in the formulation to overcome the problem of Flunixin instability and ethyl alcohol was incorporated in the formula in order to enhance syringeability and injectability of the solution. All prepared formulations were evaluated for their chemical and physical stabilities. The candidate formula showed good physical and chemical stability after two weeks of storage at both room temperature and accelerated conditions. Samples from three pilot scale batches were stored at accelerated stability conditions for 6 months and didn’t show any significant physical or chemical instability. A generic parenteral solution drug product containing Florfenicol and Flunixin meglumine for veterinary use was successfully developed using mixture of organic solvents and excipients