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Optimization of electrostatically dosed dry powder inhaler

A fixed-dose and inhaler technology, applied in the direction of inhalers, respirators, therapeutic insufflators, etc., can solve the problems that the precise dosage is not well developed, and the device does not reach a high enough degree of decondensation.

Inactive Publication Date: 2003-12-17
MICRODRUG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In general, prior art devices do not achieve a high enough degree of deagglomeration, precise dosing is not well developed, and when it comes to dose consistency and lung deposition efficiency of the drug, there is much room for improvement

Method used

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  • Optimization of electrostatically dosed dry powder inhaler
  • Optimization of electrostatically dosed dry powder inhaler
  • Optimization of electrostatically dosed dry powder inhaler

Examples

Experimental program
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Effect test

preparation example Construction

[0071] Deagglomeration #2 is measured using the prepared DPI of step 140 .

[0072] Deagglomeration was then calculated using the electropowder particle size specification as input material, and HPLC analysis of the particle size distribution was performed as output after standard suction of the powder from the device components. Then compare the amount of powder less than 3 μm and 5 μm in the original electro-powder, and calculate the deagglomeration of the electro-dose as the percentage of de-agglomerated electro-dose at 3 μm, DD3 μm, 5 μm, and DD5 μm.

[0073] Figure 17 and 18 Calculations of deagglomeration at 3 μm and 5 μm are shown, respectively, and in the graphical representation the areas of the initial and final distributions are marked under the particle size distribution curve, respectively. The curve drawn with circles represents the initial electropowder size distribution, while the curve drawn with squares represents the final size distribution from the mouth...

example 1

[0089] Two different settings for the DPI intended in step 100 were prepared according to the following specifications, which were suitable for electrodosing in step 150 with 100 μg of albuterol (TBS) for local pulmonary delivery.

[0090] see Figure 6 , to determine the specification of the DPI by preparing and then analyzing the electrical dose. Figure 6 Indicates the decondensation of the electrical dose of TBS as a function of power in watts.

[0091] A typical set point for regional lung delivery is an inspiratory flow rate of 60 L / min, thus, from Figure 6 It is possible to calculate the pressure drop across the DPI that will achieve decondensation within the set specifications of the EDPI of the TBS.

[0092] By adjusting different sizes inside the DPI, it is possible to achieve the above set values. Figure 13 Represents a pictorial example of a mouthpiece with an electrical dose just below the opening. In this design it is possible, for example, to vary the dist...

example 2

[0172] Two different settings for the DPI planned in step 100 were prepared according to the following specifications, which were suitable for electrodosing in step 150 with 800 μg insulin (INS) for local pulmonary delivery.

[0173] see Figure 6 , to determine the specification of the DPI by preparing and then analyzing the electrical dose. Figure 6 Indicates the decondensation of the electrical dose of the INS as a function of power in watts.

[0174] A typical setpoint for deep lung delivery is an inspiratory flow rate of 40 L / min, thus, from Figure 6 It is possible to calculate the pressure drop across the DPI that will achieve decondensation within the set specifications of the EDPI of the INS.

[0175] DPI A

[0176] Suction flow rate 40 l / min

[0177] Suction pressure 1.5 kPa

[0178] Activation pressure 1.0 kPa

[0179] Dose delivery time t s 0.5 s

[0180] Dose delivery time T s 2.0 s

[0181] Activation time DPI T-t 3.0 s

[0182] Closin...

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Abstract

A method and a process are disclosed for optimizing an electrostatically dosed 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 system 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 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 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 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.

Description

technical field [0001] The present invention relates to the administration of pharmaceutical powders into the respiratory tract by releasing electrostatically dosed powders to be inhaled, and in particular to methods for optimizing the functionality of electrostatically dosed dry powder inhalers (EDPIs) in relation to pre-metered doses. method. Background technique [0002] In today's medical care, the dosing of drugs can be administered in many different ways. In health care, there is increasing interest in the possibility of administering powdered pharmaceuticals directly into the airways and lungs of the user by means of inhalers in order to achieve effective, rapid and user-friendly administration of such substances sex. But today dose quality is not good enough for a wide range of drugs. Especially in the case of bulk delivery by inhalation via a dry powder inhaler (DPI) this means that it is potentially comparable to an injectable needle which is important for many ...

Claims

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Application Information

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IPC IPC(8): A61M13/00A61M15/00A61M15/02A61M16/00
CPCA61M2016/0039A61M15/02A61M15/0028A61M2202/064A61M15/0083A61M15/00
Inventor T·尼尔松
Owner MICRODRUG