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[Spacer, Aerosol Therapy through Space and Time].

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Spacers improve pressurized metered dose inhaler (pMDI) use by reducing coordination issues and mouth-throat deposition. However, newer pMDIs may not benefit, and spacer choice significantly impacts drug delivery, necessitating specific recommendations.

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Area of Science:

  • Respiratory medicine
  • Pharmaceutical technology
  • Inhaler device engineering

Background:

  • Pressurized metered dose inhalers (pMDIs) are widely used for respiratory drug delivery.
  • Coordination between actuation and inhalation is crucial for effective pMDI use.
  • Spacers are commonly used with pMDIs to improve drug delivery efficiency.

Purpose of the Study:

  • To review and evaluate the application of spacers with pMDIs.
  • To analyze the impact of guidelines and product authorizations on spacer use.
  • To assess the interplay between pMDI characteristics and spacer performance.

Main Methods:

  • Literature analysis and revision of existing studies on pMDI spacers.
  • Evaluation of effects of spacers on aerosol deposition and coordination.
  • Assessment of regulatory considerations for pMDI-spacer combinations.

Main Results:

  • Spacers generally aid in avoiding coordination problems during pMDI actuation.
  • All pMDI-spacer combinations show reduced mouth-throat deposition compared to pMDI alone.
  • Newer pMDIs may have aerosol characteristics that diminish the added benefit of spacers.
  • Significant variations in delivered drug mass and aerosol quality occur with different spacers.
  • Changing spacers can alter the applied dose by up to 50% in either direction.

Conclusions:

  • For pMDIs developed post-2009, the Summary of Product Characteristics (SmPC) should recommend specific spacers based on in vitro/in vivo data.
  • Using a non-recommended spacer can lead to unpredictable changes in the effectively delivered dose.
  • Careful consideration of spacer selection is essential for optimal and consistent pMDI therapy.