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Plume temperature emitted from metered dose inhalers
G Brambilla1, T Church, D Lewis
1Chiesi Farmaceutici SpA, Parma 43100, Italy.
International Journal of Pharmaceutics
|December 7, 2010
Summary
Pressurised metered dose inhaler (pMDI) plume temperature significantly impacts drug delivery and patient comfort. Formulation and device design can control plume temperature, with add-on spacers normalizing it to ambient conditions.
Area of Science:
- Pharmaceutical Technology
- Aerosol Science
- Inhalation Drug Delivery
Background:
- The temperature of drug plumes from pressurised metered dose inhalers (pMDIs) can cause patient discomfort and affect lung deposition.
- Variations in pMDI formulation and device hardware influence plume temperature, impacting therapeutic efficacy.
Purpose of the Study:
- To investigate the effects of formulation and device variables on pMDI plume temperature.
- To identify methods for controlling pMDI plume temperature for improved drug delivery.
Main Methods:
- Evaluated ten commercial and two development pMDI products (CFC and HFA based).
- Measured plume temperatures using a pharmacopoeial dose unit sampling apparatus (DUSA).
- Assessed the impact of formulation (co-solvent, propellant) and device hardware (actuator orifice, metering volume, spacers).
Main Results:
- Plume temperatures were lowest near the actuator mouthpiece due to propellant evaporation.
- Formulation (e.g., ethanol content) and actuator orifice diameter significantly influenced plume temperature.
- pMDI plume temperatures ranged from -54°C to +4°C, with HFA suspensions being coldest, followed by CFC suspensions, then HFA solutions.
- Add-on or integrated spacer devices effectively raised plume temperature to ambient levels.
Conclusions:
- pMDI plume temperature is controllable through strategic selection of formulation components and device design.
- Spacer devices offer a viable solution to mitigate extreme plume temperatures, enhancing patient comfort and potentially improving lung delivery.
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