Safety evaluation of antibacterial and analgesic autoinjector devices for rapid administration during emergency situations: a crossover study in rabbits.

OBJECTIVE: The objective of the present study was to evaluate the safety and tolerability of autoinjector devices (AIDs) in rabbits by intramuscular (i.m.) administration, using haematological and biochemical markers. INTRODUCTION: Emergency and mass casualty situations require immediate drug delivery for which AIDs are preferred. The tolerability of amikacin as antibacterial and buprenorphine as analgesic AID has been studied in rats by intraperitoneal administration. In the present study, it was evaluated in rabbits by i.m. administration. METHODS: Water-filled glass cartridges (2.3-2.4 mL) were converted to amikacin (106 mg/mL) and buprenorphine (0.128 mg/mL) cartridges. Dual dose AID was used for i.m. administration (1.2 mL). The study was done as a crossover design on 12 rabbits. Initially, three rabbits each were given manually or AID, 57 mg/kg amikacin, and three rabbits each by manual or by AID, 0.07 mg/kg buprenorphine for 7 days. After 1 month, the injections were changed in the rabbits. In the place of manual injection, AID and in the place of amikacin, buprenorphine injection was given. This ensured that all rabbits received 14 injections, 7 manual and 7 AID consisting of 7 amikacin and 7 buprenorphine. 24 h before and 24 h after last drug administrations, blood was withdrawn from ear vein for haematological and biochemical estimations. RESULTS: The rabbits were healthy, active and no sign of any injection-related changes were observed after administration of amikacin and buprenorphine by manually or by AID. The haematological and biochemical parameters showed similar changes in manual and AID administration of amikacin and buprenorphine. CONCLUSION: The present study of amikacin and buprenorphine by AID shows the safety of the device and is recommended for further experimentation. These AIDs are intended for self-administration during emergency and mass causality situation and are suitable for adults and children, as well as farm and pet animals.