Antistatic Cipla Spacer: Influence on Aerosolized Drug Half-Life

Objective

To determine the impact of actuation-inhalation delay time using currently available Valved Holding Chambers (VHCs) on total emitted dose (TED), fine particle dose (FPD) and the half-life of aerosol in the holding chamber.

Pressurized metered dose inhaler (pMDI) containing 25 ?g of Salmeterol & 125 ?g of Fluticasone per actuation, was the test formulation used for evaluation (5 canisters per each VHC evaluated).
Three VHCs used for the study were Zerostat-V (Cipla Ltd, India), Aerochamber Plus™ and Aerochamber MAX™ (Trudell Medical international).
Pre-primed canisters were used and study was conducted using 8-stage cascade impactor at a constant flow rate of 28.3L/min (±+0.5L/min).
Five doses from the pMDI were actuated into each VHC with a 30 sec delay between each actuation. Drug quantitatively recovered from the cascade impactor was assayed by HPLC-UV.
The performance parameters studied were Total Emitted Dose (TED), Fine Particle Dose (FPD) and Half-life of aerosol.

The half-life of Salmeterol was ∼50 secs in the anti-static Cipla spacer, ∼30 secs in Aerochamber MAX™ and between 0-5 secs in Aerochamber Plus™.
The initial TED and FPD for Salmeterol was significantly greater for Zerostat-V than the other two comparative chambers (p<0.001).
The half-life of Fluticasone was ∼50 secs in the anti-static Cipla spacer, ∼35 secs in Aerochamber MAX™ and between 0-5 secs in Aerochamber Plus™.
The initial TED and FPD for Fluticasone was significantly greater for the anti-static Cipla spacer than the other two comparative chambers (p<0.001).

The half-Life of aerosolized drug was prolonged in the anti-static Cipla spacer than Aerochamber MAX™ and Aerochamber Plus™.
The anti-static Cipla spacer delivered higher fine particle dose (FPD), which suggests that it was less prone to losses due to static charge than the other two VHCs studied.

Data on file, Cipla Ltd