Bioequivalence Study of Budesonide Nebulising Suspension (Cipla) and Pulmicort Respules (Astra Zeneca)

Objective

To assess the bioequivalence of the test product (budesonide nebulising suspension 1.0 mg/2 ml, Cipla Ltd, India) to the reference product (Pulmicort Respules 1.0 mg/2 ml, Astra Zeneca, UK) by means of pharmacokinetic evaluation.

Randomised, single-dose, open label, two-way crossover study, with a washout period of 8 days between treatments.
36 healthy adults received budesonide suspension 1.0 mg/2 ml of the test and reference product, using Pulmoaide compressor and Devilbiss nebuliser
2 ml of diluent was added to make up the fill volume to 4 ml. Nebulisation time was 10 minutes
Subjects were dosed in a sitting position and trained to inhale slowly and steadily at a normal respiratory rate of 14 to 20 breaths/minute
Serial blood sampling was done upto 10 hours post treatment to obtain data on C_max, T_max, AUC_0-t, AUC_0-∞, t_1/2 and k_el