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Delay Between Shaking and Actuation of a Hydrofluoroalkane Fluticasone Pressurized Metered-Dose Inhaler
Ariel Berlinski1, Dirk von Hollen2, John N Pritchard3
1Pulmonology Section, Department of Pediatrics, University of Arkansas for Medical Sciences, College of Medicine/Pediatric Aerosol Research Laboratory, Little Rock, Arkansas. berlinskiariel@uams.edu.
Insights
Delays between shaking and actuating a pressurized metered-dose inhaler (pMDI) significantly increase the emitted dose of inhaled corticosteroids. Proper patient education on inhaler use is crucial for effective pediatric asthma management.
Area of Science:
- Pharmacology
- Respiratory Medicine
- Pediatrics
Background:
- Inhaled corticosteroids are a cornerstone of pediatric asthma management.
- Pressurized metered-dose inhalers (pMDIs) require shaking for dose consistency.
- Delays between shaking and actuation are common in pediatric aerosol delivery using valved holding chambers.
Purpose of the Study:
- To quantify the impact of shake-actuation delays on the emitted dose of fluticasone hydrofluoroalkane from a pMDI used with a valved holding chamber.
- To compare emitted doses during simulated clinical use with ideal in vitro conditions.
Main Methods:
- A clinical trial monitored shaking and actuation of pMDIs in children with asthma.
- In vitro and transport samples were generated without shake-actuation delay.
- Emitted doses were compared between delayed subject samples and non-delayed in vitro samples.
Main Results:
- Delays between shaking and actuating the pMDI significantly increased the emitted dose (mean 158.6% vs. 106.8%).
- A strong correlation (Spearman r = 0.61) was found between delay duration and increased emitted dose.
- Emitted dose increased progressively with longer delays (e.g., 227% at 30s).
Conclusions:
- Delays between shaking and actuating corticosteroid pMDIs lead to a higher emitted dose.
- This phenomenon is common during caregiver-administered treatments with holding chambers.
- Healthcare providers should educate patients and parents on correct inhaler technique to ensure accurate dosing.
Background:
Inhaled corticosteroids are used to treat pediatric asthma. The shaking of a pressurized metered-dose inhaler (pMDI) is required to ensure consistency of emitted dose. Delays between shaking and actuating the pMDI are frequent during administration of aerosols to children where a valved holding chamber is used.
Methods:
In a recent clinical trial, we used a monitoring device to record shaking and actuation of the pMDI and the inhalation profiles of children with asthma while they were inhaling fluticasone hydrofluoroalkane from a valved holding chamber onto an external filter. During the procedure, in vitro and transport samples were generated without a delay between shaking and actuating the pMDI. Emitted dose, expressed as percentage of ex-actuator nominal dose, obtained from the second actuation following a recorded shake-actuation interval for subjects and from in vitro/transport samples (no delay) were compared.
Results:
The mean emitted dose was 158.6% (95% CI 150.1-167.2%) (subjects) and 106.8% (95% CI 104.7-108.9%) (in vitro + transport) of the ex-actuator nominal dose (P < .001). The mean delay between shaking and actuating the pMDI was 12.9 s (95% CI 11.9-13.9 s) for the subject samples. A strong correlation was observed between shake and actuation delay and the emitted dose of the second actuation following the delay (Spearman correlation coefficient = 0.61). A 10-, 20-, and 30-s delay resulted in an emitted dose of the second actuation following the delay of 147, 187, and 227% of the ex-actuator nominal dose, respectively.
Conclusions:
Delays between shaking and actuating a corticosteroid suspension pMDI resulted in an increase in the emitted dose of the second actuation following the delay. This can be a common occurrence when doses are administered by a caregiver to a patient via a holding chamber. This should be addressed by practitioners educating patients and parents on proper inhaler use. (ClinicalTrials.gov registration NCT01714063.).
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