The Choice of Jet Nebulizer, Nebulizing Flow, and Addition of Albuterol Affects the Output of Tobramycin Aerosols

Coates, Allan L.; MacNeish, Clair F.; Meisner, Dale; Kelemen, Susan; Thibert, Roch; MacDonald, J. K. L.; Vadas, Elizabeth B.

doi:10.1378/chest.111.5.1206

Cited by 80 publications

(43 citation statements)

References 28 publications

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“…21 The volume median diameter is the diameter where 50% of the aerosol volume is greater than this and 50% less. Particles Յ 5 m diameter are likely to deposit in the lungs when inhaled in older children and adults [22][23][24][25] Hence, the fraction of the mass of the aerosol in this size range is known as the respirable fraction. When the amount of aerosol captured on the filter at the "mouth" over a specific time period is multiplied by the respirable fraction, the pulmonary deposition in mg/min can be estimated.…”

Section: Methodsmentioning

confidence: 99%

Testing of Nebulizers for Delivering Magnesium Sulfate to Pediatric Asthma Patients in the Emergency Department

Coates¹,

Leung²,

Vecellio

et al. 2011

Respir Care

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BACKGROUND: As the use of intravenous magnesium sulfate (MgSO 4 ) for the treatment of refractory asthma is becoming more common, the incidence of MgSO 4 -related systemic hypotension is also rising. One option is to deliver MgSO 4 via aerosol, but compared to most inhaled medications, which are active in the microgram dose range, the MgSO 4 dose requirement is in the milligram range. This, along with inefficient aerosol delivery systems, may be the reason that some studies have found lack of efficacy with aerosol MgSO 4 . In preparation for a multicenter study of inhaled MgSO 4 in asthmatic children 2-17 years old, we conducted an in vitro study to choose the best MgSO 4 nebulizer system that would be effective over the entire age range. METHODS: We tested the Pari LC Star jet nebulizer, Omron MicroAir vibrating-mesh nebulizer, and the Aeroneb Go vibrating-mesh nebulizer with the Idehaler valve-less holding chamber. Aerosol delivery was via face mask. RESULTS: The Pari LC Star had an appropriate particle size distribution but a very slow aerosol output rate. The Omron MicroAir had an even slower output rate and a larger particle size distribution, which would be inappropriate for smaller children. In vitro lung deposition with the Aeroneb Go with Idehaler was 16.0 ؎ 0.4 mg/min in older children and approximately a fifth of that in toddlers. CONCLUSIONS: The Aeroneb Go with Idehaler was chosen for the multicenter clinical study.

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Section: Methodsmentioning

confidence: 99%

Testing of Nebulizers for Delivering Magnesium Sulfate to Pediatric Asthma Patients in the Emergency Department

Coates¹,

Leung²,

Vecellio

et al. 2011

Respir Care

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“…27 The variation between the available nebulizers in mean size and range of particle sizes generated is wide. 27 Volume of fill, surface tension of the nebulizer solution, and nebulizing flow rate also have been shown to affect drug delivery. 28 Physiologic factors, including minute ventilation, pattern of breathing, age, and disease (obstruction or inflammation), also have some effect on efficiency of aerosol drug delivery.…”

Section: Delivery Considerationsmentioning

confidence: 99%

“…Particles Ͻ1 m have too small a mass to adhere to the respiratory epithelium and thus deliver an insufficient quantity of drug. 27 The variation between the available nebulizers in mean size and range of particle sizes generated is wide. 27 Volume of fill, surface tension of the nebulizer solution, and nebulizing flow rate also have been shown to affect drug delivery.…”

Section: Delivery Considerationsmentioning

confidence: 99%

Technical Report: Precautions Regarding the Use of Aerosolized Antibiotics

Prober¹,

Walson²,

Jones³

2000

Pediatrics

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ABSTRACT. In 1998, the Food and Drug Administration (FDA) approved the licensure of tobramycin solution for inhalation (TOBI). Although a number of additional antibiotics, including other aminoglycosides, ␤-lactams, antibiotics in the polymyxin class, and vancomycin, have been administered as aerosols for many years, none are approved by the FDA for administration by inhalation.TOBI was approved by the FDA for the maintenance therapy of patients 6 years or older with cystic fibrosis (CF) who have between 25% and 75% of predicted forced expiratory volume in 1 second (FEV 1 ), are colonized with Pseudomonas aeruginosa, and are able to comply with the prescribed medical regimen. TOBI was not approved for the therapy of acute pulmonary exacerbations in patients with CF nor was it approved for use in patients without CF. Currently, no other antibiotics are approved for administration by inhalation to patients with or without CF.The purpose of this statement is to briefly summarize the data that supported approval for licensure of TOBI and to provide recommendations for its safe use. The pharmacokinetics of inhaled aminoglycosides and problems associated with aerosolized antibiotic treatment, including environmental contamination, selection of resistant microbes, and airway exposure to excipients in intravenous formulations, will be discussed. Pediatrics 2000;106(6). URL: http://www.pediatrics.org/cgi/content/ full/106/6/e89; aerosolized antibiotics, tobramycin solution for inhalation; cystic fibrosis; Pseudomonas aeruginosa.ABBREVIATIONS. TOBI, tobramycin solution for inhalation; CF, cystic fibrosis; FEV 1 , forced expiratory volume in 1 second; FDA, Food and Drug Administration; MIC, minimal inhibitory concentration. APPROVED INDICATION FOR TOBRAMYCIN SOLUTION FOR INHALATION (TOBI)TOBI is approved for maintenance therapy of patients with cystic fibrosis (CF) who are known to be colonized with Pseudomonas aeruginosa. The results of 2 randomized, double-blind, placebo-controlled, multicentered, 24-week clinical studies demonstrated the favorable effects of this therapy. 1,2 Each study enrolled subjects 6 years or older who had Ն25% and Յ75% of predicted forced expiratory volume in 1 second (FEV 1 ). Subjects with serum creatinine concentrations above 2 mg/dL and those colonized with Burkholderia cepacia were excluded. Study participants received alternating 28-day cycles of drug therapy. Two hundred fifty-eight patients received 300 mg of TOBI twice daily and 262 received inhaled saline placebo. Both drug and placebo were delivered by a PARI LC Plus nebulizer (PARI Respiratory Equipment Inc, Monterey, CA) with a Pulmo-Aide compressor (DeVilbiss Air Power Co, Jackson, TN). The drug recipients experienced significant improvement in pulmonary function compared with the placebo recipients; the average improvement in FEV 1 at the end of the study (week 24) relative to baseline (week 0) was 7% to 11% in the treatment group versus 0% to 1% in the placebo group (P Ͻ .001). Furthermore, TOBI resulted in a significant reduction...

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“…The in vitro respirable fraction depends only on measured particle size distribution 21 and is based on the probability that this fraction of the mass of the particles within a certain size range will, if entering the upper airway, deposit below the vocal cords. Based on previous literature, [22][23][24] the in vitro size cutoff was Յ 5 m, and the in vivo agreement is support for this choice. A priori it was recognized that in vivo measurements would be less than in vitro, because during the last phase of inspiration aerosol enters the anatomical dead space, predominately the trachea, and some aerosol that remains in suspension is exhaled.…”

Section: Discussionmentioning

confidence: 56%

Respiratory System Deposition with a Novel Aerosol Delivery System in Spontaneously Breathing Healthy Adults

Coates¹,

Leung²,

Chan

et al. 2013

Respir Care

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BACKGROUND: Intravenous magnesium sulfate (MgSO 4 ) in children and adults with refractory acute asthma is effective, but therapy may be limited by systemic hypotension that might be avoided with the aerosol route. Inhaled MgSO 4 has a relatively high dose (volume) requirement. This, plus the use of inefficient delivery systems, may explain the lack of efficacy of inhaled MgSO 4 in some studies. An in vitro study suggested that the AeroNeb Go with the Idehaler Pocket and a face mask would deliver 16 mg/min of MgSO 4 to the respiratory system in older children, and approximately a fifth for toddlers, but no in vivo data exist. METHODS: Saline mixed with a radiolabel was used as a proxy for the 100 mg/mL MgSO 4 solution. In 5 adult males the rate of deposition was measured using nuclear medicine techniques. The radiolabel deposition below the vocal cords was converted to the rate of deposition of MgSO 4 and compared to the results from an in vitro model using adult respiratory patterns. RESULTS: The mean ؎ SD rate of deposition was 12.6 ؎ 1.9 mg/min. The reasons for this lower deposition, compared to the in vitro estimate, was most likely the exhalation of anatomical dead space aerosol, which would have been captured on the inspiratory filter in vitro. CONCLUSIONS: These in vivo data confirm the deposition data predicted in the in vitro study, although caution should be used in extrapolating the results to children. This device appears suitable for the clinical trial of inhaled MgSO 4 in children and adults with refractory asthma.

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The Choice of Jet Nebulizer, Nebulizing Flow, and Addition of Albuterol Affects the Output of Tobramycin Aerosols

Cited by 80 publications

References 28 publications

Testing of Nebulizers for Delivering Magnesium Sulfate to Pediatric Asthma Patients in the Emergency Department

Testing of Nebulizers for Delivering Magnesium Sulfate to Pediatric Asthma Patients in the Emergency Department

Technical Report: Precautions Regarding the Use of Aerosolized Antibiotics

Respiratory System Deposition with a Novel Aerosol Delivery System in Spontaneously Breathing Healthy Adults

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