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Supporting Inhalation Drug-Device Combination Product Quality Using 3D Printing Technology

Cao LN, O'Connor T, Siddiqui A, Tian G, Coowanitwong I, Abd El-Shafy M, Delvadia RR, Coburn J, Di Prima M, Lee SL, Liu X.

RDD Europe 2019. Volume 1, 2019: 149-154.

Abstract:

One of the important factors influencing drug deposition in the lung by metered dose inhalers (MDIs) is the design of device components. In this study, a solution-type beclomethasone dipropionate MDI was used to compare the aerosol performance of actuators taken from three commercially available, FDA-approved MDI products to actuators made in-house by three-dimensional (3D) printing. Variables evaluated included spray orifice dimensions, surface roughness, and aerosol properties such as spray pattern and aerodynamic particle size. In at least one case, the 3D printed actuator performed similarly to the commercial actuator on which its design was based, suggesting that printed models may be useful to identify critical quality attributes in orally inhaled drug products (OIDPs). When properly validated, data generated using 3D printed inhalation device components has the potential to provide supporting information for the scientific review of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for OIDPs submitted to the Agency.