Respiratory Drug Delivery 2006 – Lieberman et al.
`
`IN VITRO PERFORMANCE
`OF THE MyNeb™ NEBULIZER:
`A NEW PORTABLE AEROSOL
`DELIVERY SYSTEM
`Eric Lieberman,1 Dirk von Hollen,1 Shailaja Somaraju,2 and Julie Suman2
`
`1Respironics Respiratory Drug Delivery, Cedar Grove, NJ
`2Next Breath, LLC, Baltimore, MD
`
`KEYWORDS: MyNeb™, ultrasonic nebulizer, in vitro performance,
`fine particle fraction
`
`INTRODUCTION
`
`MyNeb™ (Figure 1, Respironics Respiratory Drug Delivery) is a new handheld, portable
`(h 4.96” × w 2.80” × d 1.46”) ultrasonic nebulizer utilizing a novel aerosol generating technology
`(Respironics Respiratory Drug Delivery). Without the use of moving parts or impediments to
`flow, this new technology uses focused energy to separate liquid medication into a fine particle
`aerosol stream and impel that stream through the device. The objective of this study was to com-
`pare the in vitro performance of the MyNeb with three drugs commonly used in the treatment of
`patients with asthma and COPD.
`
`1. Chimney separates large droplets
`from smaller droplets.
`
`2. Concave Piezo generates focused
`acoustic waves.
`
`3. Medium fluid carries the acoustic
`waves from the piezo through the
`plastic barrier into the drug
`
`4. Plastic barrier separates drug from
`the piezo.
`
`Figure 1. The MyNeb™ nebulizer.
`
`777
`
`Susan Myong CSR 13365
`GONDA Ph.D.
`03/14/22
`2103
`
`IPR2021-00406
`United Therapeutics EX2103
`
`

`

`Distribution of Delivered Dose
`
`100
`
`90 -
`
`80
`
`70 - -
`
`60
`
`50
`
`40
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`30
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`10
`
`ThroaVEP
`
`T T
`
`Stage 1
`
`Stage 4
`Stage 3
`Stage 2
`Marple Miller Impactor Data
`
`Stage 5
`
`Filter
`
`778
`
`In Vitro Performance of the MyNeb™ Nebulizer: A New Portable Aerosol . . . – Lieberman et al.
`
`METHODS AND RESULTS
`
`The three drug solutions for inhalation used in the study were: albuterol sulfate 2.5 mg/3 mL
`(Proventil® Inhalation Solution 0.083%, Schering-Plough), cromolyn sodium 20 mg/2 mL (In-
`tal® Nebulizer Solution 20mg/2mL, Aventis), and ipratropium bromide 0.5 mg/2.5 mL (Ipratro-
`pium Bromide Inhalation Solution 0.02%, RxElite). A pre-production MyNeb was filled with one
`ampoule of the drug solution and connected via the USP throat to a Marple-Miller Model 150
`Cascade Impactor (MMI), operated at 30 L/min. The total nebulization time for each MMI run
`was determined by sensors within the MyNeb unit. The effective cut-off diameters for the differ-
`ent Marple-Miller Impactor stages were: 10.00 µm (Stage 2), 5.00 µm (Stage 3), 2.50 µm (Stage
`4), 1.25 µm (Stage 5), and 0.63 µm (Filter). MyNeb was activated after the device had been filled,
`and produced a constant stream of aerosol until the end of the treatment (detected automatically
`as a function of the fluid level in the nebulizer medication chamber). The amount of drug recov-
`ered from each stage of the Marple-Miller Impactor was determined by high performance liquid
`chromatography (HPLC). Three separate ampoules of each drug solution (n=3) were evaluated
`in the same MyNeb device. The aerosol output characteristics were defined in terms of delivered
`dose, fine particle fraction (FPF0.5-5µm, % of drug in particles between 0.5-5.0µm), mass median
`aerodynamic diameter (MMAD), and geometric standard deviation (GSD).
`Figure 2 shows the mean amount of all three drugs recovered from the Marple-Miller
`Impactor stages, filter, and USP Throat.
`
`Figure 2. The particle size distributions for the MyNeb nebulizer with albuterol sulfate (black), cromolyn
`sodium (white), and ipratropium bromide (grey). The amount of drug is represented as a percent-
`age of the total amount of drug recovered from the USP Throat, MMI stages and filter.
`
`The majority of particles were deposited on Stages 2 to 4 of the MMI. The overall particle
`size distributions for albuterol sulfate, cromolyn sodium, and ipratropium bromide appear to be
`similar as seen in Figure 2.
`
`

`

`Albuterol Sulfate
`Mean
`SD
`%
`(mg)
`(mg)
`CV
`
`lpratropium Bromide
`Cromolyn Sodium
`SD
`Mean
`SD % Mean
`%
`(mg)
`(mg)
`(mg) CV
`(mg)
`CV
`
`1.73
`
`0.07
`
`4.04
`
`10.3
`
`0.3
`
`2.63
`
`0.3
`
`0.03
`
`8.32
`
`1.11
`
`0.01
`
`1.11
`
`6.8
`
`0.7
`
`9.63
`
`0.2
`
`0.02
`
`12.08
`
`64.43
`
`1.95
`
`3.28
`1.75
`
`0.21
`0.05
`
`3.02
`
`6.46
`2.86
`
`66.32 5.67 8.55 63.77
`
`3.11
`1.90
`
`0.27 8.74
`0.05 2.79
`
`3.39
`1.86
`
`2.86
`
`0.20
`0.02
`
`4.49
`
`5.75
`0.82
`
`Amount of
`Drug Exiting
`Nebulizer (mg)
`Amount in Fine
`Particle Dose
`(mg)
`% Drug in Fine
`Particle Dose
`MMAD
`GSD
`
`Respiratory Drug Delivery 2006 – Lieberman et al.
`
`779
`
`Refer to Table 1 for the overall performance of MyNeb with the three drug products
`tested. The delivered doses, defined as the amount of drug exiting the nebulizer mouthpiece, were
`1.7 mg (albuterol), 10.3 mg (cromolyn), and 0.3 mg (ipratropium). The delivered fine particle frac-
`tions (FPF0.5-5µm), expressed as a percent of the label claims, were approximately 64%, 66%, and
`64% for albuterol, cromolyn, and ipratropium, respectively. The MMADs for the MyNeb nebulizer
`with the three drug solutions ranged from 3.11 µm to 3.39 µm.
`
`Table 1
`MyNeb™ Performance.
`
`CONCLUSIONS
`
`The results of the characterization of the aerosols of albuterol sulfate, cromolyn sodium, and
`ipratropium bromide delivered with the MyNeb nebulizer indicate that the main aerosol de-
`scriptors were similar for the three drug solutions evaluated. The uniformity of results, based on
`FPF0.5-5µm and MMAD, demonstrates that the moving stream of aerosol produced by this new
`technology is well-suited for nebulizing various inhalation solutions. The aerosol produced by
`MyNeb has characteristics suitable for patients with chronic airway obstruction (1).
`
`REFERENCE
`
`1.
`
`Johnson, M.A. et al. (1989), “Delivery of albuterol and ipratropium bromide from two nebulizer
`systems in chronic stable asthma,” Chest, 96:1-10.
`
`

`

`Notes
`
`780
`
`Notes
`
`780
`
`