Technical Data
Particle Specifications
A series of aerosol performance tests were performed using an 8 stage cascade impactor at a sampling flow rate of 15 l/min equipped with a USP <601> induction port throat. Aerosol was sampled directly from the outlet. Three (3) device samples were tested with 3 runs each, for a total of 9 sample points per each drug.
The specifications are listed below with intervals given for a 95% confidence level.
Mean / Std. Dev | Pulmicort® | Intal® | Salbutamol® | |||
(250μg/mL) | (10mg/mL) | (5mg/mL) | ||||
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Total Delivered Dose (μg) | 391.11 | ± 16.51 | 12368.89 ± 269.61 | 7883.33 | ± 116.96 | |
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Total Delivered Dose Fraction (%) | 78.2% | ± 3.3% | 61.8% ± 3.1% | 77.0% | ± 2.5% | |
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Particle size (MMAD) μm | 3.88 ± 0.28 | 2.91 ± 0.14 | 2.54 ± 0.28 | |||
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Geometric Standard Deviation | 1.93 ± 0.20 | 2.27 ± 0.02 | 2.62 ± 0.03 | |||
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Respirable Fraction | 61.9% ± 4.0% | 70.5% ± 1.3% | 66.4% ± 1.6% | |||
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Total Respirable Dose | 242.17 | ± 18.90 | 8729.49 ± 497.57 | 5235.02 | ± 233.61 | |
(μg between | ||||||
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Medication Captured on USP Throat | 13.34 | ± 3.40 | 253.66 ± 27.42 | 144.94 | ± 16.32 | |
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Medication Captured on USP | 3.4% ± 0.4% | 2.0% ± 0.1% | 1.8% ± 0.1% | |||
Throat Fraction (%) | ||||||
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Medication Retained in Device | 96.11 ± 9.61 | 8000.00 ± 438.21 | 2072.22 | ± 257.90 | ||
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Medication Retained in Device | 19.2% | ± 1.9% | 40% ± 2.2% | 41.4% | ± 5.2% | |
Fraction (%) | ||||||
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Coarse Particle Fraction (%) (>4.7μm) | 37.1% ± 2.9% | 27.7% ± 1.5% | 26.6% ± 2.3% | |||
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Fine Particle Fraction (%) (<4.7μm) | 59.6% ± 3.5% | 70.2% ± 1.5% | 71.6% | ± 2.3% | ||
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3.5% ± 1.7% | 8.9% ± 2.1% | 16.9% | ± 5.3% | |||
(<1.0μm) | ||||||
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Note: Course particles
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