Muneesh Garg
Sitec Labs. Pvt. Ltd., India
Title: Bioequivalence of Ipratropium bromide HFA pMDI 20 μg/ actuation in healthy volunteers with and without charcoal blockade; and with spacer device
Biography
Biography: Muneesh Garg
Abstract
Ipratropium bromide is a short-acting anti-cholinergic bronchodilator used in the management of chronic obstructive pulmonary disease. The aim of these three studies was to determine the bioequivalence of test and reference formulations of ipratropium bromide HFA pMDI 20 μg/ actuation with and without charcoal blockade; and with spacer device. Study-1 was single dose, randomized, 4-period, 2 sequences, laboratory-blinded, crossover and replicate design conducted in 90 healthy volunteers under fasting conditions with concurrent oral charcoal blockade. Study-2 was single dose, randomized, 2-period, 2 sequences, laboratory-blinded and crossover design conducted in 24 healthy volunteers under fasting conditions without concurrent oral charcoal blockade. Study-3 was single dose, randomized, 2-period, 2 sequences, laboratory-blinded and crossover design conducted in 64 healthy volunteers under fasting conditions with AeroChamber Plus valved holding chamber. Blood samples were collected up to 24 hours post-dose for pharmacokinetic profiling. Safety evaluations included monitoring adverse events and vital signs as well as performing clinical laboratory tests. Plasma concentrations of ipratropium were determined with a validated LC-MS/MS method. The 90% CI of ipratropium were 91.30-99.91, and 90.42-97.77; 87.33- 121.30, and 88.94-120.34; 87.21-99.83, and 91.66-97.94 for Cmax, and AUC0-t for study-1, study-2, and study-3 respectively. Since the 90% CI for Cmax and AUC0-t were within the 80-125% interval, it was concluded that test and reference formulations of ipratropium bromide HFA pMDI 20 µg per actuation are bioequivalent in their rate and extent of absorption with and without charcoal blockade; and with spacer device.