Edgar H. Cuevas Brun, Huei-An Tsai, Ciou-Ting Wang, Yuan-Ming Hsu & Ke-Ting Chen
HCmed Innovations Co. Ltd., Rm. B, 10F., No.319, Sec.2, Dunhua S. Rd., Taipei City, 10669, Taiwan
Summary
The integration of breath actuation in a mesh nebuliser has introduced new solutions that can achieve higher levels of drug delivery efficiency, while reducing the emission of fugitive aerosols. As several novel treatments involving biologic drugs tend to choose liquid formulations to protect the stability and bioactivity of inhaled drugs post-nebulisation, nebulisers have encountered a growing field for their implementation in the development of combination products. The scope of this study was intended to compare the aerosol performance and delivered dose efficiency of a continuous-output mesh nebuliser and a novel breath-actuated device using terbutaline sulphate nebulising solution. Aerodynamic particle size distribution studies revealed that both devices were capable of delivering appropriate fine particle fractions (continuous output = 50.1±0.9%; breath actuated = 64.7±0.4%), with the breath-actuated device generating a higher percentage. The delivered dose testing using a breathing simulator to mimic an adult breathing pattern showed that the delivery efficiency of the breath-actuated nebuliser was more than twice that of the continuous-output nebuliser, reaching 88% and presenting a much lower residual mass. As aerosol was generated during inhalation only with breath actuation, the treatment time of the breath-actuated nebuliser was longer when loading the same volume of medication in both devices, as it was foreseeable. The novel breath-actuated nebuliser presented in this study was shown to provide a promising performance for its use in drug-device combination products that may require high delivery efficiency, adequate aerosol characterisation for lung deposition, and low residual mass to treat diseases by delivering drugs directly into the respiratory system.
Key Message
The novel breath actuated mesh nebuliser AdheResp® generated a high delivered dose and good fine particle fraction data compared to a similar continuous-output nebulizer. The data indicate that the AdheResp will be a suitable device for delivering drugs to the lungs.