Formulation and Quality – Chemical
2019 PharmSci 360
The storage stability, i.e, drug content, and respirability of pure insulin pulmonary powder (Ins_SD) loaded in Quali-V®-I capsules capsules packed in blister were investigated. Ins_SD was prepared by spray drying. The in vitro respirability was assessed using the RS01® at 65L/min by the Next Generation Impactor. Ins_SD powder possessed six month stability at RT.The in vivo study was conducted in male Wistar rats. After intratracheally administration (n=9) of insulin powders, insulin and glucose plasma profiles were determined.The results showed that Ins_SD exhibited a respirability higher with FPF of 91% than 70% of Afrezza®. In vivo data showed that Ins_SD was promptly absorbed, reaching the maximum concentration (Cmax4.9±1.5 mU/ml) 15 minutes post-dosing. Afrezza® had a slower absorption (tmax30 min), a lower Cmax(1.8±0.37mU/ml). Following the glucose injection, Ins_SD determined a rapid glucose reduction, similar to Afrezza®. There was no inflammation in the lung tissue by BALF and histological analysis.