Comparative study to evaluate the voluntary acceptance of two liquid oral formulations of ciclosporin in dogs

Abstract Background The purpose of this study was to determine and compare the voluntary acceptance of two oral liquid formulations of ciclosporin, investigational Atopica® oral solution (Elanco Animal Health) and Cyclavance® Oral Solution (Virbac), when given orally via syringe or offered freely after mixing with food to dogs. Twenty-five adult mixed breed dogs were selected for this two-phase study. In Phase 1, 12 (Group I) and 13 (Group II) dogs received Atopica® oral solution and Cyclavance® Oral Solution, respectively, daily for 7 days via an oral syringe. After a 3-day washout period, the dosing was switched for a further 7 days. For Phase 2, dosing was by acceptance from freely offered test article mixed in a small amount of food, approximately 6 h after the routine morning feeding. During the first part of this phase, normal daily ration of food offered in the morning was continuously left in the cage. Group I was offered Atopica® oral solution and Group II was offered Cyclavance® Oral Solution mixed with ~ 25 g of food for 3 days. After another 2-day washout period, the test articles were switched for another 3 days but the animals received food for only 1 h in the morning. Five hours after the food was removed, the test articles with food were offered in the same manner as in the first part of Phase 2. Animals were also monitored for adverse events (AEs). Results During Phase I, voluntary acceptance rates of 100 and 98.9% were noted for Atopica® oral solution and Cyclavance® Oral Solution, respectively. The corresponding immediate prehension rates during Phase 2 (Period 1) were 61.1 and 56.4%, respectively. During Phase 2 (Period 2), the immediate prehension rates were 69.2, 69.4 and 92.0% for Atopica® oral solution, Cyclavance® Oral Solution and the positive control (DYNE®; High Calorie Liquid Dietary Supplement), respectively. Two adverse events of diarrhea and vomiting, with a probable relationship to the test articles, were reported. Conclusion There was no significant difference in acceptance of the two oral ciclosporin solutions, the investigational Atopica® oral solution (Elanco) and Cyclavance® (Virbac) for dogs.