Effect of spray dried formulation on the aerosol performance of a novel dry powder inhaler
Serena Bonasera1, Dale R. Farkas2, P. Worth Longest1,2 Bryce Beverlin II3 & Michael Hindle1
1Department of Pharmaceutics, Virginia Commonwealth University, Richmond, VA, USA
2Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA
3Quench Medical Inc., St Paul, MN, USA
Dry powder inhalers (DPIs) remain a widely used option for the delivery of aerosols despite their relatively low drug delivery efficiency to the lungs with fine particle fractions ranging from 20-40%. Laser diffraction particle sizing and realistic in vitro mouth-throat aerosol delivery experiments were employed to characterize the emitted dose of aerosols using two capsule air inlet aperture positions with a novel dry powder inhaler (CC90-3D) for two spray dried excipient enhanced growth (EEG) powder formulations. For budesonide-EEG aerosols, the mean volumetric diameter was not affected by the position of the air inlet aperture. For the albuterol sulfate-EEG aerosols, positioning the air inlet aperture in the side wall of the capsule head produced a beneficial lower mean volumetric diameter compared to positioning the air inlet aperture in the perpendicular axis of the capsule head. Irrespective of capsule air inlet positioning, the duration of aerosol emission was different for the two powder EEG formulations. The budesonide-EGG formulation was delivered from the inhaler over a duration of 1.5-1.9s compared to the dose emission for the albuterol sulfate-EEG formulation being delivered over 0.6-0.7s. Capsule drug retention was lower when the air inlet aperture was positioned in the perpendicular axis of the capsule head for both EEG formulations. Mouth-throat depositions for all the EEG formulations were low (<7%) except for the poorly dispersed albuterol sulfate-EEG formulation which had a mouth-throat deposition of 16.2%. Aerosolization conditions should be optimized for each individual spray dried EEG formulation in order to ensure high efficiency aerosol performance.