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ASSESSING OF LOW-TECH SOLUTIONS FOR AEROSOL DELIVERY: COMPARATIVE PERFORMANCE STUDY OF MANUFACTURED VERSUS HOMEMADE SPACERS.
International Journal of Pharmaceutics 2023 January 27
PURPOSE: This study aims to evaluate the performance of low-cost homemade spacers compared with manufactured valved holding chambers (VHCs) for fluticasone propionate delivery via a pMDI (pressurized Metered Dose Inhaler).
METHODS: The Total Emitted Dose (TED) and particle size distribution were measured for pMDI alone or connected to the different spacers, according to CAN/CSA-Z264.1-02 standard. Two types of low-cost alternative and manufactured spacers were investigated: 500mL plastic bottle and 553mL aluminium can; non-antistatic plastic VHCs and aluminium antistatic VHCs.
RESULTS: The TED of homemade plastic bottle vs. plastic VHC were similar in the 20-23% range. In contrast, the TED of homemade aluminium can was higher compared to aluminium VHC (83% vs. 68%). The Fine Particle Fraction (FPF) was similar for the two plastic-based spacers (in the 12.68-17.60% range), although it was greater for the aluminium can compared to aluminium VHC (51% vs. 42%). However, all spacers have limited large particles fraction, mainly deposited in the oropharyngeal tract, potentially decreasing side effects.
CONCLUSION: We demonstrated that low-tech solutions as homemade spacers have at least similar performances to VHC medical devices composed of same material (aluminium or plastic). Thus, low-cost homemade spacers represent alternatives in case of emergency and without VHCs nearby.
METHODS: The Total Emitted Dose (TED) and particle size distribution were measured for pMDI alone or connected to the different spacers, according to CAN/CSA-Z264.1-02 standard. Two types of low-cost alternative and manufactured spacers were investigated: 500mL plastic bottle and 553mL aluminium can; non-antistatic plastic VHCs and aluminium antistatic VHCs.
RESULTS: The TED of homemade plastic bottle vs. plastic VHC were similar in the 20-23% range. In contrast, the TED of homemade aluminium can was higher compared to aluminium VHC (83% vs. 68%). The Fine Particle Fraction (FPF) was similar for the two plastic-based spacers (in the 12.68-17.60% range), although it was greater for the aluminium can compared to aluminium VHC (51% vs. 42%). However, all spacers have limited large particles fraction, mainly deposited in the oropharyngeal tract, potentially decreasing side effects.
CONCLUSION: We demonstrated that low-tech solutions as homemade spacers have at least similar performances to VHC medical devices composed of same material (aluminium or plastic). Thus, low-cost homemade spacers represent alternatives in case of emergency and without VHCs nearby.
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