Development of an Injectable Formulation of Diclofenac 5% for Veterinary Use

Abstract

Introduction: Diclofenac is a non-steroidal anti-inflammatory drug that also possesses analgesic and antipyretic action. It also has antibacterial activity against gram-positive and gram-negative bacteria. It is used both in humans and in different animal species such as cattle, buffaloes, horses, swine and dogs.

Objective: To develop an injectable solution of diclofenac 5% for veterinary use.

Methods: Four formulation variants were developed and the one with the highest stability was selected, from which toxicological studies of dermal irritability and acute intramuscular toxicity in rats with histopathology were carried out. A long-term stability study was carried out on three pilot batches of the selected formulation as well as the stability in use of the product.

Results: The formulation variant selected for being the most stable, proved to be non-toxic and with similar reactions to the products currently marketed. The three batches analyzed complied with the quality specifications established for this pharmaceutical form under the storage conditions proposed during the period analyzed.

Conclusions: Formulation 3 of a 5% diclofenac injectable solution is safe and stable for 18 months and 28 days once the vial is opened, at room temperature, in 20 mL bulbs with chlorobutyl rubber stopper and 20 mm anodized aluminum seals, so it can be used as a non-steroidal anti-inflammatory drug in veterinary medicine.