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J Pharm Sci ; 103(11): 3648-3656, 2014 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-25228114

RESUMEN

As a result of the Montreal Protocol on Substances that Deplete the Ozone Layer, manufacturers of metered dose inhalers began reformulating their products to use hydrofluoroalkanes (HFAs) as propellants in place of chlorofluorocarbons (CFCs). Although the new products are considered safe and efficacious by the US Food and Drug Administration (FDA), a large number of complaints have been registered via the FDA's Adverse Events Reporting System (FAERS)-more than 7000 as of May 2013. To develop a better understanding of the measurable parameters that may, in part, determine in vitro performance and thus patient compliance, we compared several CFC- and HFA-based products with respect to their aerodynamic performance in response to changes in actuator cleaning interval and interactuation delay interval. Comparison metrics examined in this study were: total drug delivered ex-actuator, fine particle dose (<5 µm), mass median aerodynamic diameter, plume width, plume temperature, plume impaction force, and actuator orifice diameter. Overall, no single metric or test condition distinguishes HFA products from CFC products, but, for individual products tested, there were a combination of metrics that differentiated one from another.


Asunto(s)
Propelentes de Aerosoles/química , Clorofluorocarburos/química , Hidrocarburos Fluorados/química , Cumplimiento de la Medicación , Inhaladores de Dosis Medida , Satisfacción del Paciente , Fármacos del Sistema Respiratorio/química , Administración por Inhalación , Propelentes de Aerosoles/administración & dosificación , Propelentes de Aerosoles/efectos adversos , Aerosoles , Química Farmacéutica , Clorofluorocarburos/administración & dosificación , Clorofluorocarburos/efectos adversos , Diseño de Equipo , Humanos , Hidrocarburos Fluorados/administración & dosificación , Hidrocarburos Fluorados/efectos adversos , Tamaño de la Partícula , Fármacos del Sistema Respiratorio/administración & dosificación , Fármacos del Sistema Respiratorio/efectos adversos , Medición de Riesgo , Solventes/química , Temperatura
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