Delivery of dornase alfa via breath-actuated nebulizer: In-vitro measures of performance
Bibliographic record
Abstract
RATIONALE: Pulmozyme® is indicated in the management of cystic fibrosis to improve lung function and is typically delivered by continuous nebulization to tidal-breathing patients. During the exhalation phase medication is discharged into the environment. Breath-actuated nebulizers (BANs) only operate during inhalation. This study was designed to evaluate medication output from a BAN configuration (AeroEclipse®-XL/Ombra® compressor (AE-XL); TMI) compared with a continuous nebulizer configuration (PARI LC-plus®/PARI Boy®SX compressor (LC+)). METHODS: Each nebulizer was filled with a 2.5 mL Pulmozyme® ampoule (1 mg/mL dornase alfa) and run until onset of sputtering. Aerosol was captured by a filter at the mouthpiece, and the nebulizer connected to a breathing simulator (tidal volume = 600 mL; duty cycle = 33%; rate = 10 cycles/min). Fine droplet mass (µg < 5.4 µm diameter (FM pulm )) and fine droplet fraction (% < 5.4µm, (FMF pulm ) were determined by Next Generation Impactor operated at 15 L/min with assay for dornase alfa by HPLC. RESULTS: Device (n=10) FMFpulm (%) FMpulm (μg) AE -XL / Ombra 83.3 ± 2.2 428 ± 40 LC+ / Pari Boy SX 83.8 ± 2.2 349 ± 62 CONCLUSIONS: The AE-XL BAN exhibited a little higher delivery of Pulmozyme® to the LC+, although well within the demonstrated patient tolerability (Pulmozyme® Nebuliser solution SPC, Roche). In addition, clinicians should be aware that, unlike the LC+, the operation of the BAN only occurs due to patient inhalation thereby eliminating nearly all fugitive emissions and ensuring delivery to the patient at their own pace.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".