Consequences of not-shaking and shake-fire delays on the emitted dose of some commercial solution and suspension pressurized metered dose inhalers.

Abstract:

BACKGROUND:Pressurized metered-dose inhalers (pMDIs) include hydrofluoroalkane (HFA) propellant to generate a drug aerosol upon actuation and drugs can be formulated as solution or suspension. Suspended particles can cream or sediment depending on density differences between drug and propellant and shaking the pMDI is an essential step to ensure a uniform drug dose release. RESEARCH DESIGN AND METHODS:The effect of the delay (0, 10, 30, 60 seconds) in pMDI actuation after shaking and the effect of no-shaking during the canister life on the emitted dose (ED) for commercial solution and suspension pMDIs was investigated. RESULTS:The ED for solutions was unaffected by no-shaking or by the progressive increasing delay in actuation after shaking (between 77% and 97%). For all the suspension products, shaking was demonstrated to be critical to assure the close to nominal drug delivery. In detail, the actuation delay after shaking led to an increase up to 380% or a drop to 32% of ED in relation to the label claim with high variability. CONCLUSION:The drug delivered can vary widely for no-shaking and over different shake-fire delays with suspension pMDIs while solution formulations appear to remain stable.

journal_name

Expert Opin Drug Deliv

authors

Chierici V,Cavalieri L,Piraino A,Paleari D,Quarta E,Sonvico F,Melani AS,Buttini F

doi

10.1080/17425247.2020.1767066

subject

Has Abstract

pub_date

2020-07-01 00:00:00

pages

1025-1039

issue

7

eissn

1742-5247

issn

1744-7593

journal_volume

17

pub_type

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