| 摘要 |
A method and a process are disclosed for optimizing an electrostatically dos ed dry powder inhaler (EDP1) for utilization of a prepared pre-metered electro- dose consisting of an electro-powder. An arrangement is set-up for measuring parameters affecting a systemic delivery or local lung delivery of a pre- metered electro-dose from a DPI including analysis of dose de-agglomeration, particle size distribution as well as dose-to-dose variation together wit pressures times and flows. A dry powder inhaler, DPI, is adjusted for a syst em or a local lung setting with respect to activation pressure and closing pressure having a DPI with a 20 to 60 liters per minute inhalation air flow for systemic delivery setting and 20 to 80 liters per minute for a local lun g setting. Furthermore the de-agglomeration power is adjusted between 0.1 and 6 watts to be used in the DPI by optimizing the pressure drop and inhalation flow rate by changes to the mouthpiece and/or the device member and their relation to each other. The DPI activation pressure is further adjusted to a value between 0.5 and 4kPa to eliminate the low power at the start of the inhalation. The method and process then verify that the DPI meets the specifications set regarding de-agglomeration of powder and opening and closing pressures together with timings within the DPI active time. Furthermore is verified that de-agglomeration difference, expressed in perce nt using an expression 100[1-de-agglomeration(Q1kPa)/de-agglomeration(Q)], is n ot more than 50%. Finally if the DPI is not approved as an EDPI the tested DPI and/or electro-dose is further adjusted to check if the DPI can meet the specifications of an EDPI. |
