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A new method to evaluate plume characteristics of hydrofluoroalkane and chlorofluorocarbon metered dose inhalers
B J Gabrio1, S W Stein, D J Velasquez
13M Pharmaceuticals, St. Paul, MN 55144-1000, USA. bjgabrio@mmm.com
Abstract:
Two concerns raised when comparing metered dose inhalers (MDIs) to other inhalation devices are their relatively high throat deposition and the 'cold-Freon' effect seen in a small number of patients. The cold-Freon effect is presumed to be a result of the cold, forceful MDI plume impacting on the back of a patient's throat. This in vitro study uses a new plume characterization method to determine the spray force and plume temperature of various MDIs. Spray force measurements were made for 28 marketed products consisting of bronchodilators, steroids, press-and-breathe, breath-actuated and nasal inhalers. Results show that chlorofluorocarbon (CFC)-containing MDIs produce extremely forceful and cold plumes. Several hydrofluoralkane (HFA)-containing MDIs produced much softer and warmer plumes, but two HFA products had spray forces similar to the CFC products. Although the type of propellant used can affect spray force, actuator orifice diameter is the most important factor. Data obtained from marketed products and experimental inhalers show that MDIs that have a low spray force also have low throat deposition.
Insights
New metered dose inhaler (MDI) studies reveal that lower spray force and temperature correlate with reduced throat deposition. Actuator orifice diameter significantly impacts MDI plume characteristics, influencing patient experience.
Area of Science:
- Respiratory Medicine
- Pharmaceutical Technology
- Inhalation Device Engineering
Background:
- Metered dose inhalers (MDIs) are widely used for respiratory drug delivery.
- Concerns include high throat deposition and the 'cold-Freon' effect impacting patient comfort and efficacy.
Purpose of the Study:
- To characterize the spray force and plume temperature of various MDIs using a novel in vitro method.
- To investigate the relationship between MDI plume characteristics and throat deposition.
Main Methods:
- An in vitro study utilizing a new plume characterization technique.
- Spray force and plume temperature measurements were conducted on 28 marketed MDI products.
- Analysis included bronchodilators, steroids, press-and-breathe, breath-actuated, and nasal inhalers.
Main Results:
- Chlorofluorocarbon (CFC)-containing MDIs exhibited forceful and cold plumes.
- Hydrofluoralkane (HFA)-containing MDIs generally produced softer, warmer plumes, though some HFA products were similar to CFCs.
- Actuator orifice diameter was identified as the primary determinant of spray force, more so than propellant type.
Conclusions:
- MDIs with lower spray force demonstrate reduced throat deposition.
- Optimizing actuator orifice diameter is key to mitigating forceful and cold MDI plumes.
- Findings suggest potential for improved MDI design to enhance patient outcomes.
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