budesonide (Reig Jofre Group)

This budesonide inhalation formulation is a generic version developed by Reig Jofre Group for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The active ingredient, budesonide, is a synthetic corticosteroid with potent glucocorticoid activity. It functions as a glucocorticoid receptor agonist, exerting anti-inflammatory effects by inhibiting multiple cell types and mediators involved in airway inflammation. The formulation is a pressurized inhalation suspension delivered at 200 µg per puff, designed to be bioequivalent to the reference product Budesonida Pulmictan®. Reig Jofre Group has evaluated this formulation in a Phase 1 bioequivalence study (NCT02593500) to demonstrate comparable pharmacokinetic profiles to the existing marketed product in healthy volunteers.

Other names

budesonide 200 µg pressurized inhalation suspension