In vitro performance characterization of the new sidestream plus breath-enhanced jet nebulizer
In vitro Performance Characterization of the New Sidestream® Plus Breath-Enhanced Jet Nebulizer
J.P. Young, T.J. Hurren, R.K. Harrington, R.H.M. Hatley, T. Dyche
Respironics Respiratory Drug Delivery (UK) Ltd, Chichester Business Park, Chichester, West
We compared in vitro the performance of a new breath-enhanced Sidestream Plus® (SP) nebulizer (NEB) in terms of particle size, respirable fraction and dose with that of an available breath-enhanced NEB (Pari LC Plus; LCP). Two drugs were used: 2mg/mL salbutamol sulphate (SALB), and 250mg/mL ipratropium bromide (IB). Particle size - mass median aerodynamic diameters (MMAD) - and respirable fractions (% particles <5m) - were measured with a Marple cascade impactor. For simulated treatment tests each NEB was connected via an inhalation filter to a Harvard pump and run until 60s after onset of sputter. Inhalation valve aerosol leakage was tested using a fume hood with extraction filter. Respirable dose was calculated from respirable fraction × inhalation filter dose. Tests were run in triplicate/drug and drug analyses performed with
IB with LCP 3.98µm. Respirable fractions: SALB with SP 63%, SALB with LCP 58%, IB with SP 68%, IB with LCP 60%. Respirable dose: SALB with SP 959 µg, SALB with LCP 1121 µg, IB with SP 64 µg, IB with LCP 81 µg. Extraction filter: SALB with SP <1 µg, SALB with LCP 11 µg, IB with SP 0µg, IB with LCP 0 µg. The new SP NEB compared favorably with the LCP, delivering an aerosol with a higher respirable fraction.
Figure 1. The new Sidestream Plus jet nebulizer
Sidestream® Plus is a new breath-enhanced jet nebulizer (Respironics Respiratory Drug Delivery (UK) Ltd) designed to deliver an aerosol with a high respirable fraction in a short nebulization time. For the introduction of a new jet nebulizer, it is of clinical value to compare the performance in terms of particle size, respirable fraction, respirable dose, and nebulization time with an available jet nebulizer within the same design category. We have therefore compared the performance of Sidestream Plus in terms of particle size and simulated treatment with that of an available breath-enhanced jet nebulizer (Pari LC Plus; Pari GmbH, Germany). Material and Methods
One nebulizer of each brand was tested in triplicate for each of two drugs: 2mg/mL salbutamol sulphate, and 250g/mL ipratropium bromide. The particle sizes - mass median aerodynamic diameters (MMAD) – and the respirable fractions (percent particles <5 m) were measured with a Marple cascade impactor with nebulizer fills of 2.5mL salbutamol sulfate, and 4mL ipratropium bromide. For simulated treatment tests each nebulizer was filled with 3mL albuterol, and 2mL ipratropium bromide, connected via an inhalation filter to a Harvard pump set to generate the CEN simulated breathing pattern (Vt = 500 mL, f = 15 breaths / min, I:E ratio = 1:1) and run until 60s after onset of sputter. Exhaled drug was caught on exhalation filters. Inhalation valve aerosol leakage was tested using a fume hood with extraction filter. The respirable dose was calculated from the respirable fraction × the inhalation filter dose. The tests were run in triplicate per drug and drug analyses were performed with HPLC. Results
Table 1. Mean results of the performance characterization There was a difference of 10-15% between the nebulizers for most of the performance parameters, apart from exhaled drug, which was approximately 45% less for Sidestream Plus compared with LC Plus.
Aerosol leakage caught by the extraction hood filter
Figure 2. Amount of drug caught on the extraction hood filter for the Sidestream Plus and LC Plus nebulizers. No aerosol leakage was detected when nebulizing ipratropium bromide, the largest amount of aerosol leakage was detected when nebulizing salbutamol sulphate through the LC Plus nebulizer. Discussion
These tests conducted with one device of each brand suggest that the performance of the new Sidestream Plus jet nebulizer will compare favorably with the performance of the LC Plus jet nebulizer. The results showed an aerosol mass median aerodynamic diameter from the Sidestream Plus approximately 10% smaller than the LC Plus, and a respirable fraction approximately 10% greater than the LC Plus. The amount of aerosol wasted to the atmosphere was approximately 45% less from the Sidestream Plus compared to the LC Plus, this could be of importance for those in the vicinity of patients nebulizing drug formulations with unwanted side effect profiles. The time to sputter was also approximately 15% shorter for the Sidestream Plus, which could be advantageous for patients taking multiple daily nebulizer treatments. The inhalation valve of the Sidestream Plus seemed to operate more efficiently than the inhalation valve on the LC Plus in these tests. These results need to be confirmed in a larger sample of nebulizers. Conclusions
It is of clinical importance to compare the characteristics of a new breath-enhanced nebulizer with those of existing nebulizers. The new Sidestream Plus nebulizer compared favorably with the LC Plus, it had a higher respirable fraction, lower exhaled dose, and shorter time to sputter.
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