In Vitro Comparative Assessment and Characterization of Vibrating Mesh Nebulizers with Glycopyrronium Nebulizing Solution: New Generation Impactor Study

ABSTRACT

Background: Inhalation therapy involving nebulization remains important modality of therapy for severe or high-risk obstructive airwaydiseases including bronchial asthma. The likely incremental factors for the translational impact of this delivery strategy includes fine particledose (FPD), fine particle fraction (FPF), mass median aerodynamic diameter (MMAD), and respirable fraction (RF) of the pharmaceuticalaerosols playing a key role in site-specific delivery to the lungs. The new generation active vibrating mesh nebulizers (VMNs) offer aconvenient, portable strategy in above clinical cases without compromising the delivery efficiency for improved therapeutic outcomes.Aim: This in vitro study was conducted to validate the improved efficiency and aerodynamic effect of glycopyrronium solutionnebulization with novel patented active and passive VMN devices.Materials and Methods: A in vitro lung deposition study was conducted using drug samples of glycopyrronium bromide(25 mcg/2 ml and 1 ml) using new generation cascade impactor at a flow rate of 15 L/min at Glenmark R&D Center, Sinnar, India.Results: Three samples of glycopyrronium nebulizing solution were analyzed using next generation impactor at a flow rate of15 L/min for aerodynamic aerosol parameters (FPF and RF) and total/active substance delivered (FPD and delivered dose) whenloaded with active (NEBZMART*, 2 ml) and passive (E-flow*, 1 ml) VMN. The results demonstrated comparable aerodynamicaerosol, particle size, and total delivered dose as FPF (64.9% vs. 72.8%), FPD (16.4 vs. 14.2 mcg), MMAD (3.9 vs. 3.2), andGSD (1.8 vs. 1.62) for active and passive VMN, respectively. The nebulization time was observed as 3–5 min for both thedevices demonstrating higher efficiency for active VMN.Conclusion: The results showed comparable aerodynamic aerosol, particle size, and total delivered dose or RF forglycopyrronium nebulizing solution delivered by the VMNs.