초록 ▼

A method and a process are disclosed for optimizing an electrostatically dosed dry powder inhaler (EDPI) for utilization of a prepared pre-metered electro-dose consisting of a electro-powder. An arrangement is set-up for measuring parameters affecting a systemic delivery or local lung delivery of a

A method and a process are disclosed for optimizing an electrostatically dosed dry powder inhaler (EDPI) for utilization of a prepared pre-metered electro-dose consisting of a 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 and DPI including analysis of dose de-agglomeration, particle size distribution as well as dose-to-dose variation together with pressures times and flows. A dry powder inhaler, DPI, is adjusted for a systemic or a local lung setting with respect to activation pressure and closing pressure having a DPI with a 20 to 60 liters/minute inhalation air flow for systemic delivery setting and 20 to 80 liters/minute for a local lung 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 4 kPa and closing pressure between 0.5 and 4 kPa to eliminate the low power at the start and end of the inhalation. The method and process then verify that the DPI meets the specifications set regarding de-agglomeration of power and opening and closing pressures together with timings within the DPI active time. Furthermore is verified that de-agglomeration difference, expressed in percent using an expression 100[1-de-agglomeration(Q1kPa)/de-agglomeration(Q)], is not 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.

대표청구항 ▼

1. A method for optimizing an electrostatically dosed dry powder inhaler (EDPI) for utilization of a prepared pre-metered electro-dose consisting of an electro-powder, comprising the steps of arranging a measurement set-up for measurement of parameters affecting a systemic delivery or local lung

1. A method for optimizing an electrostatically dosed dry powder inhaler (EDPI) for utilization of a prepared pre-metered electro-dose consisting of an electro-powder, comprising the steps of arranging a measurement set-up for measurement of parameters affecting a systemic delivery or local lung delivery of a pre-metered electro-dose from a dry powder inhaler (DPI) including analysis of dose de-agglomeration, particle size distribution as well as uniformity of dose together with pressures times and flows according to USP; adjusting said DPI for a systemic or a local lung setting with respect to an activation pressure and a closing pressure having a DPI with a 20 to 60 liters/minute inhalation air flow for a systemic delivery setting and 20 to 80 liters/minute for a local lung setting; adjusting a de-agglomeration power between 0.1 and 6 watts to be used in said DPI by optimizing a pressure drop and an inhalation flow rate by changes to a mouthpiece and/or a device member and their relation to each other; adjusting said activation pressure between 0.5 and 4 kPa and said closing pressure between 0.5 and 4 kPa to eliminate low power at the start and end of the inhalation; verifying that said DPI meets specifications set regarding the de-agglomeration power and said activation and closing pressures together with timings within an active time of the DPI; verifying that a de-agglomeration difference, expressed in percent using an expression 100[1- de-agglomeration(Q1kpa /de-agglomeration(Q)], is not more than 50%, where Q1kPa represents a pressure drop over the inhaler device reduced to 1 kPa and Q represents a reference pressure drop;