Development of an inhalable pMDI solution formulation of theophylline for COPD

Mary Goud, Mehra Haghi, Bing Zhu, Paul M. Young, Daniela Traini

Background: Theophylline (TP) is a drug used to treat Chronic Obstructive Pulmonary Disease (COPD) that has been associated with multiple side effects, tempering its present use. This study aims to improve COPD treatment by creating a low-dose pressurized metered dose inhaler (pMDI) formulation with theophylline (TP). Methods: Aerosol performance was assessed using Andersen Cascade Impaction (ACI) and morphology of the particles was analyzed with a Scanning Electron Microscope (SEM). Calu-3 cell viability assay and cell transport were conducted to study the impact of the formulation on lung epithelial cells. Results: The mass deposition profile of the formulation showed an emitted dose of 250.04 ± 14.48 µg per 5 actuations, achieving the designed nominal dose (50µg/dose). SEM showed that the emitted particles were spherical and hollow. Conclusion: A suitable solution pMDI formulation of TP was developed that could be used for the treatment of COPD.

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