Abstract：OBJECTIVE To investigate the effects of ambient temperature,humidity and canister temperature on the inhalation drug delivery systems by examining the delivery dose and the aerodynamic particle size distribution. Two common inhalation drug delivery systems were choosenunder different conditions,the solution and the suspension type inhalation aerosol, in order to determine the formulationof the preparation and drug description, and provide the basis for guiding the clinical medication. METHODS The DUSA tube method and new generation impactor (NGI) was used to determine the delivery dose and aerodynamic particle size distribution of ipratropium bromide(IPT) and budesonide(BUD) inhaled aerosol at different ambient temperature(18 ℃, 22-25 ℃, 32 ℃), ambient humidity, and canister temperature(5 ℃, 22-25 ℃,40 ℃)respectively. RESULTS The ambient temperature, ambient humidity and canister temperature had no significant effect on the delivery dose of the two types of MDI. The ambient temperature had no significant effect on the fine particle fraction (FPF) of the two aerosol agents, and the difference of FPF under different ambient temperature was not statistically significant (P>0.05). Environmental humidity and drug canister temperature had significant effects on the FPF. Compared with low humidity 30% and medium humidity 50%, the FPF obtained at high ambient humidity 80% decreased 17.94% and 13.69% (BUD), 12.74% and 9.03% (IPT) (P<0.05), but there was no significant difference between RH 30% and RH 50%. Compared with room temperature (22-25 ℃) and high temperature (40 ℃), the FPF measured at low temperature (5 ℃) decreased by 22.80% and 21.86% (BUD), 26.55% and 26.85% (IPT) respectively(P<0.01), but there was no significant difference between room temperature and high temperature. CONCLUSION The temperature and humidity of the environment (22-25 ℃, RH 50%)and the sample canister temperature should be controlled as far as possible when the performance of the inhaled aerosol preparation are tested.At the same time, it is suggested that MDI stored at low temperature shall be recovered to room temperature before use.
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