System and method for inhaler testing

Abstract

The present disclosure provides a dose collection instrument comprising a first conduit comprising a first inlet port and a first fluid flow path, and a second conduit comprising a second inlet port and a second fluid flow path.

Description

[0001] Cross-references

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 092,244, filed October 15, 2020, which is incorporated herein by reference in its entirety. Background Technology

[0003] Developers of drug delivery devices that deliver drug formulations using dry powder or aerosol sprays (such as pressurized metered-dose inhalers (pMDIs), metered-dose inhalers (MDIs), dry powder inhalers (DPIs), or nasal sprays) can test such devices to ensure that an appropriate dose of drug is delivered when the patient actuates the device. Conventional systems and manual methods for collecting aerosol spray particles emitted when the drug delivery device is actuated can be inefficient and may introduce significant variability, compromising the integrity of dose-collected data. Conventional systems and methods may also be limited to testing drug delivery devices using single or shared catheters, which is inefficient and can add significant time throughout the process, reducing yield. Furthermore, conventional testing setups exhibit limited flexibility, requiring custom fixtures and modifications to accommodate a wide variety of drug delivery devices, each potentially requiring different testing settings and / or different sets of testing parameters. Therefore, new testing systems are needed. Summary of the Invention

[0004] This disclosure addresses at least the aforementioned shortcomings of conventional testing systems. In one aspect, it provides an instrument for testing the quantity and uniformity of drug delivery dose. The instrument may include multiple catheters to enhance the completeness, flexibility, and accuracy of testing for drug delivery devices by using multiple test settings and different test parameters. This device enables developers of drug delivery devices to test them quickly and efficiently in an automated manner using multiple different dose collector modules and / or multiple different test parameters.

[0005] In one aspect, a dose collection apparatus is provided, comprising: (a) a first conduit including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collection module; (b) a second conduit including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collection module; (c) a movable platform configured to match an inhaler to at least one of the first or second inlet ports; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first or second conduit, wherein the dose includes a sample dose or a waste dose. In some cases, the first dose collection module is a dose unit sampling instrument (DUSA). In some cases, the first dose collection module includes a low-resistance filter configured to capture the dose delivered by the inhaler. In some cases, the low-resistance filter is configured to retain aerosol particles with a particle size range of about 0.1 micrometers (μm) to about 10 μm. In some cases, the low-resistance filter has a flow resistance of approximately 150 Pascals at a flow rate of approximately 90 liters of air per minute. In some cases, the first dose collector module is a cascaded impactor. In some cases, the first dose collector module is an optical nebulizer or aerosol analyzer. In some cases, the second dose collector module is a waste collector. In some cases, the first inlet port is located at one end of the first conduit, and the first dose collector module is located at the opposite end of the first conduit. In some cases, the second inlet port is located at one end of the second conduit, and the second dose collector module is located at the opposite end of the second conduit. In some cases, the instrument includes a manifold configured to converge the first and second conduits into an outlet conduit, wherein the outlet conduit includes an outlet port in fluid communication with a vacuum source. In some cases, at most one of the first and second conduits is operable at a given time. In some cases, the vacuum source includes a breathing simulator configured to induce (i) flow from one end of a first or second catheter to the opposite end of the respective first or second catheter to simulate inhalation, and (ii) flow in the opposite direction from the opposite end to one end to simulate exhalation. In some cases, the breathing simulator is configured to induce flow through at most one of the first and second catheters at a given time. In some cases, the breathing simulator is configured to generate a user-programmable output trigger signal. In some cases, the output trigger signal is programmed to trigger at a user-specified time within the time period required for the breathing simulator to perform a breathing profile. In some cases, the actuator is configured to (i) shake the inhaler and / or (ii) actuate the inhaler to deliver a dose to at least one of the first and second catheters.In some cases, the actuator is configured to receive an output trigger signal as described in any of the preceding claims. In some cases, the actuator is configured to actuate the device upon receiving an output trigger signal as described in any of the preceding claims. In some cases, the first conduit includes a pressure sensor. In some cases, the pressure sensor is a differential pressure sensor. In some cases, the first conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the first conduit. In some cases, the instrument includes a plurality of flow regulating valves configured to independently control or regulate flow through each of a plurality of conduits, wherein the plurality of conduits includes at least a first conduit and a second conduit. In some cases, the first conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the first conduit. In some cases, the instrument also includes an electric motor operatively coupled to the flow regulating valve, wherein the electric motor is configured to control the flow regulating valve. In some cases, the flow regulating valve includes a control valve, gate valve, check valve, ball valve, shut-off valve, butterfly valve, diaphragm valve, needle valve, pinch valve, proportional valve, or stepper motor valve. In some cases, the instrument also includes an electric motor operatively coupled to a flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor. In some cases, the pressure sensor includes a differential pressure sensor, and wherein the at least one measurement includes a real-time flow rate measurement through the first conduit. In some cases, the flow control valve includes a triple-biased butterfly valve or a proportional valve. In some cases, the instrument also includes a controller configured to provide at least one command to the electric motor to progressively open and close the flow control valve to a predetermined position or orientation. In some cases, at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from the first pressure sensor. In some cases, the second conduit includes a pressure sensor. In some cases, the pressure sensor is a differential pressure sensor. In some cases, the second conduit includes a flow control valve configured to regulate the flow rate of fluid through the second conduit. In some cases, the second conduit includes both a pressure sensor and a flow control valve configured to regulate the flow rate of fluid through the second conduit. In some cases, the instrument also includes an electric motor operably coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve. In some cases, the instrument also includes an electric motor operably coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor. In some cases, the pressure sensor includes a differential pressure sensor, and the at least one measurement includes a real-time flow rate measurement through a second conduit. In some cases, the flow control valve includes a triple-biased butterfly valve or a proportional valve.In some cases, the instrument also includes a controller configured to provide at least one command to an electric motor to progressively open and close the flow regulating valve to a predetermined position or orientation. In some cases, at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from a first pressure sensor. In some cases, the instrument also includes a controller. In some cases, the instrument also includes a mating plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or inhaler relative to a first input port or a second input port. In some cases, the mating plane sensor is configured to detect the position of the first input port or the second input port relative to the movable platform. In some cases, the mating plane sensor is configured to detect when the inhaler is aligned with the first input port or the second input port. In some cases, the mating plane sensor is configured to detect the offset between the position or orientation of the inhaler and the position or orientation of the first input port or the second input port. In some cases, the mating plane sensor is configured to (i) obtain positioning information associated with at least one of the inhaler, the movable platform, or the first and second input ports, and (ii) provide the positioning information to a controller to adjust the position, orientation, movement, or path of the movable plate relative to the first or second input port. In some cases, the instrument also includes a controller configured to receive multiple inputs from the mating plane sensor and adjust the position or orientation of the movable platform based at least in part on the multiple inputs, including (i) positioning information of the movable platform and (ii) user input corresponding to the selection of a desired input port. In some cases, the first and second inlet ports include a mating ring configured to be releasably coupled to the inhaler to form a seal. In some cases, the inhaler includes a mating ring fitted onto a portion of the inhaler. In some cases, the mating ring is configured to form a seal between the inhaler and the first or second inlet port when the inhaler is positioned adjacent to the first or second inlet port. In some cases, the mating ring comprises soft silicone rubber or a flexible material configured to form a reliable seal between the inhaler and the first or second inlet port. In some cases, at least one or two of the first or second conduit include at least one, two, or three of a laminar flow regulator, a flow tube, or a flow tester. In some cases, the instrument further includes a third conduit comprising a third inlet port and a third fluid flow path, wherein the third fluid flow path is in fluid communication with the third inlet port.In some cases, the portable platform is configured to match the inhaler to at least one of a first inlet port, a second inlet port, or a third inlet port in response to user input corresponding to the selection of a desired input port. In some cases, the flow tester is configured to obtain one or more measurements corresponding to the flow rate or mass flow rate through the first or second catheter. In some cases, the flow tester is configured to provide one or more measurements to a mass flow controller, which is configured to adjust the operation of the breathing simulator.

[0006] In another aspect, a dose collection device is provided, the device comprising: (a) a first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) a second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) a movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose, wherein the first dose collector module includes a low-resistance filter configured to capture the dose delivered by the inhaler.

[0007] In another aspect, a dose collection instrument is provided, the instrument comprising (a) a first conduit including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) a second conduit including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) a movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first conduit or the second conduit, wherein the dose includes a sample dose or a waste dose, wherein the first dose collector module is an optical nebulizer or an aerosol analyzer.

[0008] In another aspect, a dose collection instrument is provided, the instrument comprising: (a) a first conduit including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) a second conduit including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) a movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first conduit or the second conduit, wherein the dose includes a sample dose or a waste dose, wherein the instrument includes a manifold configured to converge the first conduit and the second conduit into an outlet conduit, wherein the outlet conduit includes an outlet port in fluid communication with a vacuum source.

[0009] In another aspect, a dose collection device is provided, the device comprising: (a) a first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) a second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) a movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose, wherein the first catheter and / or the second catheter includes a pressure sensor.

[0010] In another aspect, a dose collection device is provided, the device comprising: (a) a first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) a second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) a movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose, wherein the device includes a plurality of flow control valves configured to independently control or regulate flow through each of the plurality of catheters, wherein the plurality of catheters includes at least the first catheter and the second catheter.

[0011] In another aspect, a dose collection device is provided, the device comprising: (a) a first conduit including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) a second conduit including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with a second inlet segment port and a second dose collector module; (c) a movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first conduit or the second conduit, wherein the dose includes a sample dose or a waste dose; and (e) a matching plane sensor configured to obtain positioning information for the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or the inhaler relative to the first input port or the second input port.

[0012] In another aspect, a dose collection device is provided, the device comprising: (a) a first conduit including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) a second conduit including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) a movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first conduit or the second conduit, wherein the dose includes a sample dose or a waste dose, wherein at least one or both of the first conduit or the second conduit include at least one, two, or three of a laminar flow regulator, a flow tube, or a flow detector.

[0013] In some cases, in any of the foregoing, the first dose collector module is a dose unit sampling instrument (DUSA). In some cases, in any of the foregoing, the first dose collector module includes a low-resistance filter configured to capture the dose delivered by the inhaler. In some cases, in any of the foregoing, the low-resistance filter is configured to retain aerosol particles with a particle size range of about 0.1 micrometers (μm) to about 10 μm. In some cases, in any of the foregoing, the low-resistance filter has a flow resistance of about 150 Pascals at a flow rate of about 90 liters of air per minute. In some cases, in any of the foregoing, the first dose collector module is a cascade impactor. In some cases, in any of the foregoing, the first dose collector module is an optical nebulizer or an aerosol analyzer. In some cases, in any of the foregoing, the second dose collector module is a waste collector. In some cases, in any of the foregoing, a first inlet port is located at one end of a first conduit, and the first dose collector module is located at the opposite end of the first conduit. In some cases, in any of the foregoing embodiments, the second inlet port is located at one end of the second catheter, and the second dose collector module is located at the opposite end of the second catheter. In some cases, in any of the foregoing embodiments, the instrument includes a manifold configured to converge the first and second catheters into an outlet catheter, wherein the outlet catheter includes an outlet port in fluid communication with a vacuum source. In some cases, in any of the foregoing embodiments, at most one of the first and second catheters is operable at a given time. In some cases, in any of the foregoing embodiments, the vacuum source includes a breathing simulator configured to induce (i) flow from one end of the first or second catheter to the opposite end of the respective first or second catheter to simulate inhalation, and (ii) flow in the opposite direction from the opposite end to one end to simulate exhalation. In some cases, in any of the foregoing embodiments, the breathing simulator is configured to induce flow through at most one of the first and second catheters at a given time. In some cases, in any of the foregoing embodiments, the breathing simulator is configured to generate a user-programmable output trigger signal. In some cases, in any of the foregoing, the output trigger signal is programmed to trigger at a user-specified time, which is within the time period required for the respiratory simulator to perform a respiratory profile. In some cases, in any of the foregoing, the actuator is configured to (i) shake the inhaler and / or (ii) actuate the inhaler to deliver a dose to at least one of the first and second catheters. In some cases, in any of the foregoing, the actuator is configured to receive the output trigger signal described in any of the foregoing. In some cases, in any of the foregoing, the actuator is configured to actuate the device upon receiving the output trigger signal described in any of the foregoing. In some cases, in any of the foregoing, the first catheter includes a pressure sensor. In some cases, in any of the foregoing, the pressure sensor is a differential pressure sensor.In some cases, in any of the foregoing embodiments, the first conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the first conduit. In some cases, in any of the foregoing embodiments, the instrument includes a plurality of flow regulating valves configured to independently control or regulate flow through each of a plurality of conduits, wherein the plurality of conduits includes at least a first conduit and a second conduit. In some cases, in any of the foregoing embodiments, the first conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the first conduit. In some cases, in any of the foregoing embodiments, the instrument further includes an electric motor operatively coupled to the flow regulating valve, wherein the electric motor is configured to control the flow regulating valve. In some cases, in any of the foregoing embodiments, the flow regulating valve includes a control valve, gate valve, check valve, ball valve, globe valve, butterfly valve, diaphragm valve, needle valve, pinch valve, proportional valve, or stepper motor valve. In some cases, in any of the foregoing embodiments, the instrument further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor. In some cases, in any of the foregoing embodiments, the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through the first conduit. In some cases, in any of the foregoing embodiments, the flow control valve includes a triple-biased butterfly valve or a proportional valve. In some cases, in any of the foregoing embodiments, the instrument further includes a controller configured to provide at least one command to the electric motor to progressively open and close the flow control valve to a predetermined position or orientation. In some cases, in any of the foregoing embodiments, at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from the first pressure sensor. In some cases, in any of the foregoing embodiments, the second conduit includes a pressure sensor. In some cases, in any of the foregoing embodiments, the pressure sensor is a differential pressure sensor. In some cases, in any of the foregoing embodiments, the second conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the second conduit. In some cases, in any of the foregoing embodiments, the second conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the second conduit. In some cases, in any of the foregoing embodiments, the instrument further includes an electric motor operatively coupled to the flow regulating valve, wherein the electric motor is configured to control the flow regulating valve. In some cases, in any of the foregoing embodiments, the instrument further includes an electric motor operatively coupled to the flow regulating valve, wherein the electric motor is configured to control the flow regulating valve based on at least one measurement obtained from the pressure sensor. In some cases, in any of the foregoing embodiments, the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through the second conduit.In some cases, in any of the foregoing, the flow control valve includes a triple-biased butterfly valve or a proportional valve. In some cases, the instrument also includes a controller configured to provide at least one command to an electric motor to progressively open and close the flow control valve to a predetermined position or orientation. In some cases, in any of the foregoing, at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from a first pressure sensor. In some cases, in any of the foregoing, the instrument also includes a controller. In some cases, in any of the foregoing, the instrument also includes a mating plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or inhaler relative to a first input port or a second input port. In some cases, in any of the foregoing, the mating plane sensor is configured to detect the position of the first input port or the second input port relative to the movable platform. In some cases, in any of the foregoing, the mating plane sensor is configured to detect when the inhaler is aligned with the first input port or the second input port. In some cases, in any of the foregoing, the mating plane sensor is configured to detect an offset between the position or orientation of the inhaler and the position or orientation of the first input port or the second input port. In some cases, in any of the foregoing, the mating plane sensor is configured to (i) obtain positioning information associated with the inhaler, the movable platform, or at least one of the first and second input ports, and (ii) provide the positioning information to a controller to adjust the position, orientation, movement, or path of movement of the movable platform relative to the first or second input port. In some cases, in any of the foregoing, the instrument further includes a controller configured to receive multiple inputs from the mating plane sensor and adjust the position or orientation of the movable platform based at least in part on the multiple inputs, including (i) positioning information of the movable platform and (ii) user input corresponding to a desired selection of an input port. In some cases, in any of the foregoing, the first and second inlet ports include mating rings configured to be releasably coupled to the inhaler to form a seal. In some cases, in any of the foregoing, the inhaler includes a mating ring fitted onto a portion of the inhaler. In some cases, in any of the foregoing embodiments, the mating ring is configured to form a seal between the inhaler and the first or second inhalation port when the inhaler is positioned adjacent to the first or second inhalation port. In some cases, in any of the foregoing embodiments, the mating ring comprises a soft silicone rubber or a soft flexible material configured to form a reliable seal between the inhaler and the first or second inhalation port.In some cases, in any of the foregoing embodiments, at least one or two of the first or second tubing include at least one, two, or three of a laminar flow regulator, a flow tube, or a flow tester. In some cases, in any of the foregoing embodiments, the instrument further includes a third tubing including a third inlet port and a third fluid flow path, wherein the third fluid flow path is in fluid communication with the third inlet port. In some cases, in any of the foregoing embodiments, the movable platform is configured to match the inhaler to at least one of the first, second, or third inlet ports in response to user input corresponding to the selection of a desired input port. In some cases, in any of the foregoing embodiments, the flow tester is configured to obtain one or more measurements corresponding to the flow rate or mass flow rate through the first or second tubing. In some cases, in any of the foregoing embodiments, the flow tester is configured to provide one or more measurements to a mass flow controller, which is configured to adjust the operation of the breathing simulator.

[0014] In another aspect, a dose collection device is provided, the device comprising: (a) a first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) a second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) a movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose, wherein the first catheter and / or the second catheter includes a flow regulating valve configured to regulate the flow rate of fluid through the first catheter and / or the second catheter, and wherein the flow regulating valve is a proportional valve.

[0015] In another aspect, a dose collection device is provided, the device comprising: (a) a first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) a second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) a movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose, wherein the inhaler includes a matching ring fitted onto a portion of the inhaler.

[0016] In some cases, in any of the foregoing, the first dose collector module is a dose unit sampling instrument (DUSA). In some cases, in any of the foregoing, the first dose collector module includes a low-resistance filter configured to capture the dose delivered by the inhaler. In some cases, in any of the foregoing, the low-resistance filter is configured to retain aerosol particles with a particle size range of about 0.1 micrometers (μm) to about 10 μm. In some cases, in any of the foregoing, the low-resistance filter has a flow resistance of about 150 Pascals at a flow rate of about 90 liters of air per minute. In some cases, in any of the foregoing, the first dose collector module is a cascade impactor. In some cases, in any of the foregoing, the first dose collector module is an optical nebulizer or an aerosol analyzer. In some cases, in any of the foregoing, the second dose collector module is a waste collector. In some cases, in any of the foregoing, a first inlet port is located at one end of a first conduit, and the first dose collector module is located at the opposite end of the first conduit. In some cases, in any of the foregoing embodiments, the second inlet port is located at one end of the second catheter, and the second dose collector module is located at the opposite end of the second catheter. In some cases, in any of the foregoing embodiments, the instrument includes a manifold configured to converge the first and second catheters into an outlet catheter, wherein the outlet catheter includes an outlet port in fluid communication with a vacuum source. In some cases, in any of the foregoing embodiments, at most one of the first and second catheters is operable at a given time. In some cases, in any of the foregoing embodiments, the vacuum source includes a breathing simulator configured to induce (i) flow from one end of the first or second catheter to the opposite end of the respective first or second catheter to simulate inhalation, and (ii) flow in the opposite direction from the opposite end to one end to simulate exhalation. In some cases, in any of the foregoing embodiments, the breathing simulator is configured to induce flow through at most one of the first and second catheters at a given time. In some cases, in any of the foregoing embodiments, the breathing simulator is configured to generate a user-programmable output trigger signal. In some cases, in any of the foregoing, the output trigger signal is programmed to trigger at a user-specified time, which is within the time period required for the respiratory simulator to perform a respiratory profile. In some cases, in any of the foregoing, the actuator is configured to (i) shake the inhaler and / or (ii) actuate the inhaler to deliver a dose to at least one of the first and second catheters. In some cases, in any of the foregoing, the actuator is configured to receive the output trigger signal described in any of the foregoing. In some cases, in any of the foregoing, the actuator is configured to actuate the device upon receiving the output trigger signal described in any of the foregoing. In some cases, in any of the foregoing, the first catheter includes a pressure sensor. In some cases, in any of the foregoing, the pressure sensor is a differential pressure sensor.In some cases, in any of the foregoing embodiments, the first conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the first conduit. In some cases, in any of the foregoing embodiments, the instrument includes a plurality of flow regulating valves configured to independently control or regulate flow through each of a plurality of conduits, wherein the plurality of conduits includes at least a first conduit and a second conduit. In some cases, in any of the foregoing embodiments, the first conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the first conduit. In some cases, in any of the foregoing embodiments, the instrument further includes an electric motor operatively coupled to the flow regulating valve, wherein the electric motor is configured to control the flow regulating valve. In some cases, in any of the foregoing embodiments, the flow regulating valve includes a control valve, gate valve, check valve, ball valve, globe valve, butterfly valve, diaphragm valve, needle valve, pinch valve, proportional valve, or stepper motor valve. In some cases, in any of the foregoing embodiments, the instrument further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor. In some cases, in any of the foregoing embodiments, the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through the first conduit. In some cases, in any of the foregoing embodiments, the flow control valve includes a triple-biased butterfly valve or a proportional valve. In some cases, in any of the foregoing embodiments, the instrument further includes a controller configured to provide at least one command to the electric motor to progressively open and close the flow control valve to a predetermined position or orientation. In some cases, in any of the foregoing embodiments, at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from the first pressure sensor. In some cases, in any of the foregoing embodiments, the second conduit includes a pressure sensor. In some cases, in any of the foregoing embodiments, the pressure sensor is a differential pressure sensor. In some cases, in any of the foregoing embodiments, the second conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the second conduit. In some cases, in any of the foregoing embodiments, the second conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the second conduit. In some cases, in any of the foregoing embodiments, the instrument further includes an electric motor operatively coupled to the flow regulating valve, wherein the electric motor is configured to control the flow regulating valve. In some cases, in any of the foregoing embodiments, the instrument further includes an electric motor operatively coupled to the flow regulating valve, wherein the electric motor is configured to control the flow regulating valve based on at least one measurement obtained from the pressure sensor. In some cases, in any of the foregoing embodiments, the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through the second conduit.In some cases, in any of the foregoing, the flow control valve includes a triple-biased butterfly valve or a proportional valve. In some cases, the instrument also includes a controller configured to provide at least one command to an electric motor to progressively open and close the flow control valve to a predetermined position or orientation. In some cases, in any of the foregoing, at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from a first pressure sensor. In some cases, in any of the foregoing, the instrument also includes a controller. In some cases, in any of the foregoing, the instrument also includes a mating plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or inhaler relative to a first input port or a second input port. In some cases, in any of the foregoing, the mating plane sensor is configured to detect the position of the first input port or the second input port relative to the movable platform. In some cases, in any of the foregoing, the mating plane sensor is configured to detect when the inhaler is aligned with the first input port or the second input port. In some cases, in any of the foregoing, the mating plane sensor is configured to detect an offset between the position or orientation of the inhaler and the position or orientation of the first input port or the second input port. In some cases, in any of the foregoing, the mating plane sensor is configured to (i) obtain positioning information associated with the inhaler, the movable platform, or at least one of the first and second input ports, and (ii) provide the positioning information to a controller to adjust the position, orientation, movement, or path of movement of the movable platform relative to the first or second input port. In some cases, in any of the foregoing, the instrument further includes a controller configured to receive multiple inputs from the mating plane sensor and adjust the position or orientation of the movable platform based at least in part on the multiple inputs, including (i) positioning information of the movable platform and (ii) user input corresponding to a desired selection of an input port. In some cases, in any of the foregoing, the first and second inlet ports include mating rings configured to be releasably coupled to the inhaler to form a seal. In some cases, in any of the foregoing, the inhaler includes a mating ring fitted onto a portion of the inhaler. In some cases, in any of the foregoing embodiments, the mating ring is configured to form a seal between the inhaler and the first or second inhalation port when the inhaler is positioned adjacent to the first or second inhalation port. In some cases, in any of the foregoing embodiments, the mating ring comprises a soft silicone rubber or a soft flexible material configured to form a reliable seal between the inhaler and the first or second inhalation port.In some cases, in any of the foregoing embodiments, at least one or two of the first or second tubing include at least one, two, or three of a laminar flow regulator, a flow tube, or a flow tester. In some cases, in any of the foregoing embodiments, the instrument further includes a third tubing including a third inlet port and a third fluid flow path, wherein the third fluid flow path is in fluid communication with the third inlet port. In some cases, in any of the foregoing embodiments, the movable platform is configured to match the inhaler to at least one of the first, second, or third inlet ports in response to user input corresponding to the selection of a desired input port. In some cases, in any of the foregoing embodiments, the flow tester is configured to obtain one or more measurements corresponding to the flow rate or mass flow rate through the first or second tubing. In some cases, in any of the foregoing embodiments, the flow tester is configured to provide one or more measurements to a mass flow controller, which is configured to adjust the operation of the breathing simulator.

[0017] Another aspect of this disclosure provides a non-transitory computer-readable medium containing machine-executable code that, when executed by one or more computer processors, implements any of the methods described above or elsewhere.

[0018] Another aspect of this disclosure provides a system comprising one or more computer processors and computer memory coupled thereto. The computer memory includes machine-executable code that, when executed by the one or more computer processors, implements any of the methods described above or elsewhere.

[0019] Other aspects and advantages of this disclosure will be readily apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the disclosure are shown and described. As will be appreciated, other and different embodiments of the disclosure are possible, and certain details thereof can be modified in various obvious ways without departing from the scope of the disclosure. Therefore, the drawings and descriptions should be considered illustrative in nature and not restrictive.

[0020] Incorporation

[0021] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the extent that each individual publication, patent, or patent application is specifically and individually cited and incorporated herein by reference. Where a publication, patent, or patent application incorporated by reference contradicts the disclosure contained herein, this specification is intended to supersede and / or give precedence to any such contradictory material. Attached Figure Description

[0022] The novel features of this disclosure are set forth in detail in the appended claims. A better understanding of the features and advantages of this disclosure will be obtained by referring to the following detailed description and accompanying drawings, which illustrate illustrative embodiments utilizing the principles of this disclosure, and the drawings (also referred to herein as “Figures” and “Drawings”), wherein:

[0023] Figure 1A and Figure 1B An instrument for testing drug delivery devices according to some embodiments described herein is illustrated schematically.

[0024] Figure 2 A dose collection instrument comprising multiple catheters according to some embodiments described herein is illustrated schematically.

[0025] Figure 3 A computer system that is programmed or otherwise configured to implement the methods described herein is illustrated schematically. Detailed Implementation

[0026] While various embodiments of this disclosure have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions will occur to those skilled in the art without departing from this disclosure. It should be understood that various alternatives to the embodiments of this disclosure described herein may be employed.

[0027] Whenever the terms "at least," "greater than," or "greater than or equal to" precede the first value in a series of two or more values, the terms "at least," "greater than," or "greater than or equal to" apply to each value in that series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0028] When the terms "not greater than", "less than", or "less than or equal to" precede the first value in a series of two or more values, the terms "not greater than", "less than", or "less than or equal to" apply to each value in the series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0029] As used herein, the terms “delivered dose” or “emitted dose” or “sample dose” or “aerosol sample” are used interchangeably herein and generally refer to the total amount of drug emitted from a drug delivery device (e.g., an MDI or pMDI or DPI) and available to a user when the drug delivery device is actuated.

[0030] The terms "real-time" or "real-time" are used interchangeably herein and generally refer to the simultaneous or substantially simultaneous occurrence of a first event or action with respect to a second event or action. A real-time action or event can be executed within a response time of less than one or more of the following relative to at least another event or action: ten seconds, five seconds, one second, one-tenth of a second, one-hundredth of a second, one millisecond, or less. In some cases, a real-time event can be executed almost immediately or over a sufficiently short time span, such as within a time of at most 1 second, 0.5 seconds, 0.1 seconds, 0.05 seconds, 0.01 seconds, 5 milliseconds, 1 millisecond, 0.5 milliseconds, 0.1 milliseconds, 0.05 milliseconds, 0.01 milliseconds, 0.005 milliseconds, 0.001 milliseconds, 0.0005 milliseconds, 0.0001 milliseconds, or less. Real-time actions can be executed using one or more sensors or computer processors.

[0031] Dose collection instruments

[0032] In one aspect, this disclosure provides a dose collection instrument. The dose collection instrument can be configured to test the performance of one or more drug delivery devices configured to deliver one or more doses of a drug or substance. The dose collection instrument can be configured to test the capability of one or more drug delivery devices to consistently deliver one or more doses of a drug or substance. The dose collection instrument can be configured to collect and / or analyze one or more doses delivered by one or more drug delivery devices. The one or more doses may include a drug or substance that can be delivered by operation or actuation of the one or more drug delivery devices. In some cases, the one or more doses may be provided as an aerosol spray. The aerosol spray may include a drug or substance that is released as a fine spray using a propellant gas. In some cases, the one or more doses may be provided as a dry powder. In some cases, the one or more doses may be provided as a testable sample dose. In some cases, the one or more doses may be provided as a discard dose that may not be tested or does not require testing.

[0033] One or more drug delivery devices may include inhaler devices. Inhaler devices may include formulations of, for example, drugs or active ingredients. In some cases, the formulation may include one or more excipients. In some cases, the formulation may not include or need not include any excipients. In some cases, the formulation includes one or more propellants. The formulation may be a suspension, solution, or dry powder. In some cases, the inhaler device may include a pressurized metered-dose inhaler (pMDI), a metered-dose inhaler (MDI), a soft fog inhaler (SMI), a small-volume nebulizer (SVN), and / or a dry powder inhaler.

[0034] Inhaler devices can be used to deliver drugs or substances directly to the lungs of a subject. The systems and methods described herein are applicable to any drug delivery device or inhaler device that requires shaking and / or actuation. In some cases, the inhaler device may include a metered-dose inhaler (MDI) or a pressurized metered-dose inhaler (pMDI). Non-limiting examples of MDIs may include and In some cases, an MDI may include a spacer or an aerosol holding chamber. The inhaler device may be a dry powder inhaler, and non-limiting examples include: Ellipta TM , Neohaler TM Pressair TM Twisthaler TM , and

[0035] In some cases, one or more drug delivery devices may include a nasal device. The nasal device may be configured to deliver a drug locally to the nose or paranasal sinuses. Non-limiting examples of nasal devices may include mechanical spray pumps (e.g., squeeze bottles, multi-dose metering spray pumps, single / dual-dose spray pumps, bidirectional multi-dose spray pumps), gas-driven spray systems / nebulizers, mechanical powder nebulizers, respiratory-actuated inhalers, and blowpipes.

[0036] In some cases, one or more drug delivery devices may include oral inhalation or nasal medication products (OINDPs). Non-limiting examples of OINDPs suitable for the systems and methods described herein may include: adecyl bromide inhalation powder. Ipratropium inhalation aerosol ( HFA, tiotropium inhalation powder Tiotropium inhalation solution Wudi bromide inhalation powder Salbutamol / Ipratropium Inhalation Solution Salbutamol / Ipratropium bromide inhalation spray Budesonide / Formoterol fumarate dihydrate inhalation aerosol Fluticasone / Sameterol Inhalation Powder Fluticasone / salmeterol inhalation aerosol ( HFA), fluticasone furoate / vilanterol inhalation powder Mometasone furoate / formoterol fumarate inhalation aerosol Tiotropium bromide / Oudaterol inhalation spray TM ), Uredemol / Vilanterol Inhalation Powder Beclomethasone propionate HFA inhalation aerosol Budesonide inhalation powder Budesonide inhalation suspension Cyclosone Inhalation Aerosol Flunisolone inhalation aerosol Fluticasone furoate inhalation powder (Arnuity) TM Fluticasone propionate inhalation aerosol ( HFA), fluticasone propionate inhalation powder Mometasone furoate inhalation powder Mometasone furoate inhalation aerosol ( HFA), formoterol tartrate inhalation solution Formoterol fumarate inhalation powder Formoterol fumarate inhalation solution Indacaterol inhalation powder (Arcapta) TM Neohaler TM Olodaterol inhalation spray Salmeterol inhalation powder Salbutamol Sulfate Inhalation Powder Salbutamol sulfate inhalation aerosol ( HFA), salbutamol inhalation solution Salbutamol sulfate inhalation aerosol ( HFA), salbutamol sulfate inhalation aerosol ( HFA) or levanobutanol tartrate inhalation aerosol ( HFA).

[0037] Dose collection instruments can be configured to evaluate and / or test the performance of one or more drug delivery devices. Evaluating and / or testing the performance of one or more drug delivery devices may include determining the amount and uniformity of the delivered dose.

[0038] In some cases, evaluating and / or testing the performance of one or more drug delivery devices may include determining delivery dose uniformity (DDU). Delivery dose uniformity may correspond to the uniformity of the delivered dose of drug emitted from the drug delivery device over multiple uses.

[0039] In some cases, evaluating and / or testing the performance of one or more drug delivery devices may include determining or evaluating dose content uniformity (DCU) and / or aerodynamic particle size distribution (APSD) in relation to one or more doses delivered by one or more drug delivery devices. DCU may refer to the uniformity of the drug emitted with each actuation, consistent with the labeling requirements of the drug product. APSD may correspond to the spatial distribution of particles in a drug dose delivered by a drug delivery device and inhaled by a subject. The drug dose may be delivered as an aerosol cloud or as dry powder comprising one or more particles. The spatial distribution may indicate multiple locations where particles in the aerosol cloud or dry powder may deposit after inhalation. APSD can depend on particle size. If the particles are too large, they may deposit in the back of the subject's throat instead of the desired target area. If the particles are too small, they may be exhaled instead of deposited on the desired target area.

[0040] In some cases, evaluating and / or testing the performance of one or more drug delivery devices may include determining or evaluating injection weight performance, spray pattern, plume geometry, and / or droplet or particle size distribution in relation to one or more doses delivered using one or more drug delivery devices or using one or more drug delivery devices. Injection weight may correspond to the weight of a single dose. Spray pattern may correspond to a pattern generated by one or more particles released from a pressurized source. Spray pattern may refer to any characterization of the spray, including, for example, the spray divergence angle (e.g., plume geometry) as the spray exits the device, the cross-sectional ellipticity of the spray, uniformity, and / or particle / droplet distribution. Spray pattern may include optical spray patterns or impact-based spray patterns. Plume geometry may include one or more physical characteristics of the size and / or shape of the plume generated when one or more particles are released from a pressurized source.

[0041] In some cases, spray patterns can be measured or analyzed by illuminating the spray plume with an illumination device (e.g., a laser) and then capturing an image of the spray plume with an imaging device (e.g., a camera). In other cases, an impact-based method can be used to analyze spray patterns. In a non-limiting example, spray pattern analysis may include igniting a spray pump at a solid, thin-layer chromatography (TLC) surface having a coating that fluoresces in response to incident ultraviolet (“UV”) radiation. The pattern of the spray deposited on the surface can then be analyzed. In some cases, dose-content uniformity (DCU) performance of an inhaler or drug delivery device can be determined based on the spray pattern. Optionally, spray pattern measurements can be associated with DCU. In some cases, spray pattern measurements can be used to determine, for example, the optimal set of shaking parameters for a particular drug formulation and / or a particular drug delivery device. In some cases, spray pattern measurements can be used to verify the desired performance and / or performance consistency of a drug delivery device (e.g., an oral inhaler) after shaking.

[0042] In some cases, evaluating and / or testing the performance of one or more drug delivery devices may involve comparing the performance of one or more drug delivery devices to target performance levels specified by regulatory or industry guidance (e.g., the U.S. Food and Drug Administration).

[0043] In some cases, evaluating and / or testing the performance of one or more drug delivery devices may include full-life testing. Full-life testing of one or more drug delivery devices may include testing the performance of one or more drug delivery devices at the start of life (BoL), mid-life (MoL), and / or end-of-life (EoL). BoL dosing may refer to actuation of the drug delivery device at the start of a marked number of sprays (after any desired starting spray has been wasted as a discard dose, and typically within approximately the first 5% of the marked number of sprays). MoL dosing may refer to actuation of the drug delivery device at the middle of a marked number of sprays (within approximately 45-55% of the marked number of sprays). EoL dosing may refer to actuation of the drug delivery device at the end of a marked number of sprays (within approximately the last 95% of the marked number of sprays).

[0044] In some cases, evaluating and / or testing the performance of one or more drug delivery devices may involve actuating the drug delivery device to emit and / or deliver one or more doses to a dose collection instrument. The dose collection instrument may include a catheter, a dose collector module, and / or a container containing a filter configured to capture one or more doses provided by one or more drug delivery devices. In some cases, the catheter, dose collector module, and / or container may be connected to a negative pressure source during testing to broadly simulate inhalation.

[0045] In some embodiments, the dose collection device may include (a) a first conduit including a first inlet port and a first fluid flow path. The first fluid flow path may be in fluid communication with the first inlet port and the first dose collector module.

[0046] In some embodiments, the dose collection device may include (b) a second conduit including a second inlet port and a second fluid flow path. The second fluid flow path may be in fluid communication with the second inlet port and the second dose collector module.

[0047] The first and second catheters may include a hollow region through which one or more doses provided by a drug delivery device can travel. The one or more doses can travel along a fluid flow path corresponding to the size and / or shape of the hollow region. The fluid flow path can guide one or more doses provided by one or more drug delivery devices from a first end of the first / second catheter to a second end of the first / second catheter.

[0048] In some embodiments, the dose collection device may include (c) a movable platform configured to mate a drug delivery device to at least one of a first inlet port or a second inlet port. In some cases, the drug delivery device may include an inhaler as described above.

[0049] In some embodiments, the dose collection instrument may include (d) an actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter. In some cases, the dose may include a sample dose or a waste dose.

[0050] In some embodiments, at least one of the first dose collector module or the second dose collector module may include a dose unit sampling instrument (DUSA), a cascade impactor, an optical spray or aerosol analyzer, and / or a waste collector.

[0051] In some cases, at least one of the first or second dose collector modules may include a low-resistance filter to capture aerosols. The low-resistance filter may be configured to retain nebulized drug with particle sizes ranging from 0.1 μm to 10 μm. The low-resistance filter may be configured to allow flow rates ranging from about 1 liter of air per minute to about 200 liters of air per minute. The low-resistance filter may include a plurality of pores with apertures greater than about 0.01 μm and less than about 10 μm. The low-resistance filter may have a flow resistance of about 150 Pascals at a flow rate of about 90 liters of air per minute. The low-resistance filter may have a thickness ranging from about 0.1 mm to about 1 mm (in a flat or flat form). The low-resistance filter may have one or more dimensions (e.g., height, width, diameter, etc.) ranging from about 1 mm to about 10 cm.

[0052] In some embodiments, the low-resistance filter may include a low-resistance, pleated filter media. The low-resistance, pleated filter media may be formed from a sheet (e.g., nylon, polypropylene, polystyrene, polyester, paper, cotton, or any other suitable filter material) folded into pleats to increase the surface area of ​​the filter available for capturing airborne particles. Pleats may include multiple folds held together by stitching or adhesive. Low-resistance, pleated filter media can be configured to capture more airborne particles compared to low-resistance filter media without pleats. In some cases, the low-resistance filter media may include a nonwoven, electrostatically charged filter media. Nonwoven electrostatically charged filter media may include nonwoven synthetic fibers. In some cases, nonwoven electrostatically charged filter media may include, for example, polypropylene, polystyrene, or nylon. In some embodiments, nonwoven electrostatically charged filter media may include charged polypropylene, charged polystyrene, or charged nylon. In some embodiments, nonwoven electrostatically charged filter media may include an electrostatic filter having a first set of positively charged fibers and a second set of negatively charged fibers. In some cases, approximately 50% of the fibers may be positively charged, and approximately 50% of the fibers may be negatively charged. In some embodiments, the electrostatic filter medium of the nonwoven tape may include a hydrophobic material.

[0053] In some embodiments, the low-resistance filter may conform to one or more test specifications set by the user. For example, in one embodiment, the low-resistance filter may be inert and may not react with the drug. In another embodiment, the filter may be inert and may not react with one or more solvents used to prepare the test sample. In one embodiment, the filter may include a glass fiber filter. In one embodiment, the filter may have an aerosol holding force of about 0.3 micrometers. In one embodiment, the filter may enable the collection of a dose at a flow rate of up to about 100 L / min. In one embodiment, the filter may include a material sufficient to retain the sample dose while allowing fluid or gas (e.g., air) to flow through the filter. In one embodiment, the filter may have an aerosol sufficient to retain one or more sample doses provided by a drug delivery device such as an MDI, pMDI, or DPI. In one embodiment, the filter may be configured to collect aerosol samples at a flow rate sufficient to perform one or more tests using the instrument. In one embodiment, the filter may be able to capture, trap, or absorb an aerosol sample corresponding to a single dose of the contents of the drug delivery device. In one embodiment, the filter may be able to capture, trap, or absorb an aerosol sample corresponding to the entire contents of the drug delivery device. In one embodiment, the filter may be capable of capturing, trapping, or absorbing about 100%, or about 90%, or about 80%, or about 70%, or about 60%, or about 50%, or about 40%, or about 30%, or about 20%, or about 10% or less of the contents of a drug delivery device from a single actuated dose. In some embodiments, the filter may be configured to degrade or dissolve upon the addition of a solvent. In one embodiment, degradation of the filter may facilitate the collection of aerosol samples captured, trapped, or absorbed by the filter. In one embodiment, the filter may include an open mesh filter support. In one embodiment, the open mesh filter support may include a stainless steel mesh. In one embodiment, the open mesh filter support may include a plastic material. In one embodiment, the filter support may include an inert material. The filter support may include a shape. In some cases, the shape may be circular or elliptical. In other cases, the shape may be a polygon with three or more sides. The polygon may include two or more sides of the same length. Alternatively, the polygon may include two or more sides of different lengths. In some implementations, the filter support may be shaped as a hexagonal honeycomb to provide an optimal ratio of high airflow cross-sectional area to mechanical support.

[0054] In some embodiments, the first dose collector module may include a dose unit sampling instrument (DUSA). In some embodiments, the first dose collector module may include a cascaded impactor. In some embodiments, the first dose collector module may include an optical spray or aerosol analyzer. In some embodiments, the second dose collector module may include a waste collector.

[0055] In some cases, the instrument may include three or more catheters. In some cases, the instrument may include three or more dose collector modules. In this case, at least one of the three or more dose collector modules may include a unit dose sampling instrument (DUSA), a cascade impactor, an optical spray or aerosol analyzer, and / or a waste collector. In some cases, the three or more dose collector modules may include different groups of components. For example, the first dose collector module may include a DUSA, the second dose collector module may include a cascade impactor, the third dose collector module may include an optical spray or aerosol analyzer, and the fourth dose collector may include a waste collector.

[0056] In some implementations, the instrument may include two or more catheters in fluid communication with two or more dose collector modules. In some cases, the two or more catheters may be parallel to each other. In some cases, the two or more catheters may not be parallel to each other or do not need to be parallel to each other.

[0057] Two or more conduits may include two or more inlets. The two or more inlets may be arranged laterally or side-by-side. The two or more inlets may be arranged in a circular configuration such that the respective center of each inlet is equidistant from the center point around which the two or more inlets are arranged.

[0058] In some embodiments, the first inlet port of the first catheter may be located at one end of the first catheter, and the first dose collector module may be located at the opposite end of the first catheter. In some embodiments, the second inlet port of the second catheter may be located at one end of the second catheter, and the second dose collector module may be located at the opposite end of the second catheter.

[0059] In some cases, the instrument may also include a third conduit, which includes a third inlet port and a third fluid flow path. The third fluid flow path may be in fluid communication with the third inlet port.

[0060] In some embodiments, the instrument may include a manifold configured to converge a first conduit and a second conduit into an outlet conduit. The outlet conduit may include an outlet port in fluid communication with a vacuum source.

[0061] In some cases, the vacuum source may include a negative pressure source. In one embodiment, the negative pressure source may be configured to induce a stable flow rate through one or more conduits. In one embodiment, the negative pressure source may include a flow regulator and / or a flow meter. The negative pressure source may be configured to draw gas or fluid (e.g., air) or one or more sample doses through the conduit at a desired flow rate.

[0062] In some cases, the vacuum source may include a breathing simulator configured to guide flow from one end of a first or second conduit to the opposite end of that respective first or second conduit to simulate inhalation. Alternatively, flow may be guided in the opposite direction from the opposite end to the first end to simulate exhalation. In some cases, the breathing simulator may be configured to generate a user-programmable output trigger signal. In some cases, the breathing simulator may be configured to provide a user-programmable output trigger signal to another component of the instrument (e.g., an actuator or breathing simulator). The output trigger signal may be programmed to trigger another event (e.g., shaking and / or actuation of a drug delivery device) at a user-specified time, within the time required to perform the breathing profile.

[0063] In any of the embodiments described herein, at most one catheter may be operated at a time. For example, when the first catheter is in operation, the second catheter may be inoperable (e.g., the instrument may be configured to inhibit or limit the movement of one or more doses through the second catheter). In some cases, the second catheter may be configured to be inoperable when a flow regulator (e.g., a valve) in the second catheter restricts flow through the second catheter, or when a vacuum source does not guide flow from one end of the second catheter to the other.

[0064] The instrument may include an actuator. The actuator may be configured to (i) shake the inhaler and / or (ii) actuate the inhaler to deliver a dose to at least one of a first or second catheter. In some cases, the actuator may be configured to receive an output trigger signal. In some cases, the actuator may be configured to actuate one or more drug delivery devices upon receiving an output trigger signal generated and / or provided by a breathing simulator. The output trigger signal may be configured to achieve a predetermined delay between operation of the breathing simulator and actuation of the drug delivery device.

[0065] The actuator may be configured to shake the inhaler. The actuator may be configured to shake the inhaler according to one or more shaking protocols. One or more shaking protocols may be specific to a particular drug delivery device or inhaler and may depend at least in part on the formulation of the drug, one or more features of the drug delivery device or inhaler, the volume of the metering valve of the drug delivery device or inhaler, the relative mixing efficiency of drug particles with excipients and / or propellants in the formulation, or any combination thereof. One or more shaking protocols may be tailored according to the components of the formulation contained in the container (e.g., the amount of excipients contained in the drug in the formulation or the specific components of the excipients contained in the formulation). Therefore, different products or drug delivery devices containing the same drug may require different shaking protocols to deliver the intended dose range. In some embodiments, the systems and methods provided herein may allow a user or tester of an inhaler or other drug delivery device to identify a specific set of shaking parameters (e.g., a shaking protocol) required to deliver a drug of the intended dose range from a particular inhaler or drug delivery device.

[0066] One or more rocking schemes can be generated, at least in part, based on one or more rocking parameters. The one or more rocking parameters may include rocking duration, rocking frequency, rocking angle, rocking-to-start interval, and / or rocking orientation.

[0067] As used herein, the term "shaking duration" may refer to the length of time during which an inhaler or nasal device is shaken. In some cases, shaking duration may refer to the expected length of time the device should be shaken, such as that determined during a shaking study. The required shaking duration may vary for different pharmaceutical formulations (e.g., those comprising different active ingredients and / or excipients). In some cases, the expected shaking duration may vary for different devices. Shaking duration may range from about 1 second to about 30 seconds. In some cases, shaking duration may be equal to or greater than about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 6 seconds, about 7 seconds, about 8 seconds, about 9 seconds, about 10 seconds, about 11 seconds, about 12 seconds, about 13 seconds, about 14 seconds, about 15 seconds, about 20 seconds, about 25 seconds, about 30 seconds, about 35 seconds, about 40 seconds, about 45 seconds, about 50 seconds, about 55 seconds, or about 60 seconds.

[0068] As used herein, the term "shaking angle" can refer to the angle of a can of a device measured from its vertical axis during shaking. For example, a shaking angle of 90 degrees would involve shaking the can horizontally. In some cases, the shaking angle can refer to the desired angle at which the device or the can of the device should be shaken, such as that determined during shaking studies described in this disclosure. The required shaking angle may differ for different pharmaceutical formulations (e.g., comprising different active ingredients and / or excipients). In some cases, the desired shaking angle may differ for different devices. The shaking angle can range from about 30 degrees to about 180 degrees. In some cases, the sway angle may be equal to or greater than approximately 0 degrees, approximately 10 degrees, approximately 20 degrees, approximately 30 degrees, approximately 40 degrees, approximately 50 degrees, approximately 60 degrees, approximately 70 degrees, approximately 80 degrees, approximately 90 degrees, approximately 100 degrees, approximately 110 degrees, approximately 120 degrees, approximately 130 degrees, approximately 140 degrees, approximately 150 degrees, approximately 160 degrees, approximately 170 degrees, or approximately 180 degrees.

[0069] As used herein, the term "shaking frequency" can refer to the number of times (cycles) the device is shaken within a given time period. In some cases, shaking frequency can refer to the desired frequency at which the device should be shaken within a given time period, such as that determined during a shaking study. The required shaking frequency may differ for different pharmaceutical formulations (e.g., comprising different active ingredients and / or excipients). In some cases, the desired shaking frequency may differ for different devices. Shaking frequency can be measured in Hertz (Hz), which is defined as the number of cycles per second. Shaking frequency can range from about 1.0 Hz to about 5.0 Hz. In some cases, shaking frequency may be equal to or greater than about 0.5 Hz, about 1.0 Hz, about 1.5 Hz, about 2.0 Hz, about 2.5 Hz, about 3.0 Hz, about 3.5 Hz, about 4.0 Hz, about 4.5 Hz, about 5.0 Hz, about 6.0 Hz, about 7.0 Hz, about 8.0 Hz, or about 9.0 Hz or about 10.0 Hz.

[0070] As used herein, the term "shake-to-start interval" refers to the length of time between the end of a shaking program and the actuation of the device. In some cases, the shake-to-start interval may refer to the desired length of time between the end of a shaking program and the actuation of the device, for example, as determined during a shaking study. The desired shake-to-start interval may differ for different pharmaceutical formulations (e.g., comprising different active ingredients and / or excipients). In some cases, the desired shake-to-start interval may differ for different devices. The shake-to-start interval can range from about 0 seconds to about 30 seconds. In some cases, the shake-to-start interval may be equal to or greater than about 0 seconds (e.g., actuation immediately after shaking), about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 6 seconds, about 7 seconds, about 8 seconds, about 9 seconds, about 10 seconds, about 11 seconds, about 12 seconds, about 15 seconds, about 20 seconds, about 25 seconds, about 30 seconds, about 40 seconds, about 50 seconds, or about 60 seconds.

[0071] As used herein, the term "shaking orientation" can refer to the range of angles experienced by the device during shaking. For example, if the device or can is shaken at an angle rather than up-and-down or left-and-right, the shaking orientation of the device may be relevant. In some cases, shaking orientation can refer to the expected range of angles that the device should experience during shaking. In some cases, shaking orientation can refer to the desired shaking orientation of the device, such as that determined during a shaking study. The desired shaking orientation may differ for different pharmaceutical formulations (e.g., those comprising different active ingredients and / or excipients). In some cases, the desired shaking orientation may differ for different devices. Shaking orientation can range from about 0 to about 359 degrees. In some cases, the rocking orientation can be equal to or greater than approximately 0 degrees, approximately 10 degrees, approximately 20 degrees, approximately 30 degrees, approximately 40 degrees, approximately 50 degrees, approximately 60 degrees, approximately 70 degrees, approximately 80 degrees, approximately 90 degrees, approximately 100 degrees, approximately 110 degrees, approximately 120 degrees, approximately 130 degrees, approximately 140 degrees, approximately 150 degrees, approximately 160 degrees, approximately 170 degrees, approximately 180 degrees, approximately 190 degrees, approximately 200 degrees, approximately 210 degrees, approximately 220 degrees, approximately 230 degrees, approximately 240 degrees, approximately 250 degrees, approximately 260 degrees, approximately 270 degrees, approximately 280 degrees, approximately 290 degrees, approximately 300 degrees, approximately 310 degrees, approximately 320 degrees, approximately 330 degrees, approximately 340 degrees, approximately 350 degrees, or approximately 360 degrees.

[0072] In some cases, the actuator may determine one or more shaking parameters of the inhaler or drug delivery device based on the type of inhaler or drug delivery device. In other cases, the actuator may be configured to determine one or more shaking parameters based on user input.

[0073] As described above, one or more rocking parameters may include one or more of the following: rocking frequency, rocking angle, rocking duration, rocking-to-start interval, and rocking orientation. In some cases, the rocking frequency may be from about 1.0 Hz to about 4.0 Hz. In some cases, the rocking angle may be from about 30 degrees to about 180 degrees. In some cases, the rocking duration may be from about 2 seconds to about 15 seconds. In some cases, the rocking-to-start interval may be from about 0 seconds to about 10 seconds. In some cases, the rocking orientation may include from about 0 degrees to about 359 degrees.

[0074] Actuators can be configured to actuate one or more drug delivery devices after a shaking program has been executed to release a quantity of formulation. In some cases, the formulation released from the inhaler may be emitted as a spray. The spray may contain a dose of the drug. The term "actuation" can refer to the action of compressing a portion of the canister of an inhaler or drug delivery device for a period of time to release the drug or substance contained within the canister or device's retainer. Actuation can include, for example, automated actuation by robotic equipment or manual actuation by a human operator.

[0075] An actuated inhaler or drug delivery device can release a single dose of the formulation contained therein. Proper actuation of the device may be required to release the target dose of drug from the device. For example, an inhaler or drug delivery device that has been properly shaken according to a prescribed shaking protocol may deliver an unintended dose of drug if the device is not properly actuated. Therefore, the instruments described herein can be configured to measure and / or monitor the actuation of inhalers or drug delivery devices.

[0076] Actuating an inhaler or drug delivery device may involve actuating the inhaler or drug delivery device according to one or more actuation parameters. One or more actuation parameters may include, but are not limited to, compression rate, compression acceleration, actuation hold time, decompression rate, decompression acceleration, actuation stroke length, and any combination thereof. In some cases, measuring or monitoring the actuation of an inhaler or nasal device may involve measuring or monitoring one or more actuation parameters.

[0077] As used herein, “compression speed” can refer to the speed at which the device is compressed (e.g., the speed at which a user pushes or compresses the canister of a drug delivery device during actuation). Compression speeds can range from about 10 mm / s to about 100 mm / s. For example, compression speeds can be about 10 mm / s, about 15 mm / s, about 20 mm / s, about 25 mm / s, about 30 mm / s, about 35 mm / s, 40 mm / s, about 45 mm / s, about 50 mm / s, about 55 mm / s, about 60 mm / s, about 65 mm / s, about 70 mm / s, about 75 mm / s, about 80 mm / s, about 85 mm / s, about 90 mm / s, about 95 mm / s, about 100 mm / s, or greater than about 100 mm / s.

[0078] The term "compression acceleration" as used in this article refers to the rate of change of velocity within a unit time during compression. The compression acceleration can be approximately 500 mm / s². 2 Approximately 4000 mm / s 2 For example, the compressive acceleration can be approximately 500 mm / s². 2 Approximately 600 mm / s 2 Approximately 700 mm / s 2 Approximately 800 mm / s 2 Approximately 900 mm / s 2 Approximately 1000 mm / s 2 Approximately 1100 mm / s 2 Approximately 1200 mm / s 2 Approximately 1300 mm / s 2 Approximately 1400 mm / s 2 Approximately 1500 mm / s 2 Approximately 1600 mm / s 2 Approximately 1700 mm / s 2 Approximately 1800 mm / s 2 Approximately 1900 mm / s 2 Approximately 2000 mm / s 2 Approximately 2100 mm / s 2 Approximately 2200 mm / s 2 Approximately 2300 mm / s 2 Approximately 2400 mm / s 2 Approximately 2500 mm / s 2 Approximately 2600 mm / s 2 Approximately 2700 mm / s 2 Approximately 2800 mm / s 2 2900mm / s 2 3000mm / s 2 3100mm / s 2 Approximately 3200 mm / s 2 Approximately 3300 mm / s 2 Approximately 3400 mm / s 2 Approximately 3500 mm / s 2 Approximately 3600 mm / s 2 Approximately 3700 mm / s 2 Approximately 3800 mm / s 2 Approximately 3900 mm / s 2 Approximately 4000 mm / s 2 or greater than approximately 4000 mm / s 2 .

[0079] As used herein, “actuated hold time” can refer to the amount of time a device remains fully actuated. “Fully actuated” can refer to the maximum compression of the canister of an inhaler or drug delivery device. Actuation of the device can include compression of the device and can include an “actuated hold time window,” such as the period of time during which the device remains in its fully actuated state. The actuated hold time window can range from about 0 seconds to about 30 seconds. For example, the actuated hold time window can be about 0 seconds (immediate release), about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 6 seconds, about 7 seconds, about 8 seconds, about 9 seconds, about 10 seconds, about 11 seconds, about 12 seconds, about 13 seconds, about 14 seconds, about 15 seconds, about 16 seconds, about 17 seconds, about 18 seconds, about 19 seconds, about 20 seconds, about 21 seconds, about 22 seconds, about 23 seconds, about 24 seconds, about 25 seconds, about 26 seconds, about 27 seconds, about 28 seconds, about 29 seconds, about 30 seconds, or greater than 30 seconds.

[0080] As used herein, “decompression speed” can refer to the speed at which the device decompresses (e.g., the speed at which a user releases or decompresses the canister of a drug delivery device or inhaler after activation). Decompression speeds can range from approximately 10 mm / s to approximately 100 mm / s. For example, decompression speeds can be approximately 10 mm / s, approximately 15 mm / s, approximately 20 mm / s, approximately 25 mm / s, approximately 30 mm / s, approximately 35 mm / s, approximately 40 mm / s, approximately 45 mm / s, approximately 50 mm / s, approximately 75 mm / s, approximately 80 mm / s, approximately 85 mm / s, approximately 90 mm / s, approximately 95 mm / s, approximately 100 mm / s, or greater than approximately 100 mm / s.

[0081] The term "decompression acceleration" as used in this article refers to the rate of change of velocity of the tank in the drug delivery equipment per unit time during decompression. The decompression acceleration can be approximately 500 mm / s². 2 Approximately 4000 mm / s 2 For example, the decompression acceleration can be approximately 500 mm / s². 2 Approximately 600 mm / s 2 Approximately 700 mm / s 2 Approximately 800 mm / s 2 Approximately 900 mm / s 2 Approximately 1000 mm / s 2 Approximately 1100 mm / s 2 Approximately 1200 mm / s 2 1300mm / s 2 Approximately 1400 mm / s 2 1500mm / s 2 Approximately 1600 mm / s 2 Approximately 1700 mm / s 2 Approximately 1800 mm / s 2 Approximately 1900 mm / s2 Approximately 2000 mm / s 2 Approximately 2100 mm / s 2 Approximately 2200 mm / s 2 Approximately 2300 mm / s 2 Approximately 2400 mm / s 2 Approximately 2500 mm / s 2 Approximately 2600 mm / s 2 Approximately 2700 mm / s 2 Approximately 2800 mm / s 2 Approximately 3200 mm / s 2 Approximately 3300 mm / s 2 Approximately 3400 mm / s 2 Approximately 3500 mm / s 2 Approximately 3600 mm / s 2 Approximately 3700 mm / s 2 Approximately 3800 mm / s 2 Approximately 3900 mm / s 2 Approximately 4000 mm / s 2 or greater than approximately 4000 mm / s 2 .

[0082] As used herein, "actuation stroke length" refers to the maximum compression of the device during actuation. In some cases, the actuation stroke length is the mechanical compression limit of the device. The actuation stroke length can range from approximately 3 mm to approximately 20 mm. For example, the actuation stroke length can be approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, approximately 11 mm, approximately 12 mm, approximately 13 mm, approximately 14 mm, approximately 15 mm, approximately 16 mm, approximately 17 mm, approximately 18 mm, approximately 19 mm, or greater than approximately 20 mm.

[0083] In some cases, the actuator may determine one or more actuation parameters of the inhaler or drug delivery device based on the type of inhaler or drug delivery device. In other cases, the actuator may be configured to determine one or more actuation parameters based on user input. User input may include one or more settings for force, speed, acceleration, stroke length, and / or other relevant actuation parameters.

[0084] In some cases, the actuator may be configured to actuate the inhaler or device according to a predetermined actuation profile. The actuation profile may include, for example, actuation speed, actuation acceleration, initial actuation delay, actuation hold time, post-actuation delay, and / or a predetermined number of actuations. In some cases, a single actuation profile may be used for the upstroke (e.g., from the rest position to the fully actuated position), while another single actuation profile is used for the downstroke (e.g., from the fully actuated position to the rest position). In some cases, the device may include a controller configured to measure and record multiple pump stroke statistics, including but not limited to the distance required to reach maximum speed, the distance at maximum speed, the distance required to stop from maximum speed, the time required to reach maximum speed, the time spent at maximum speed, the time required to stop from maximum speed, the time required to reach the fully actuated position, the total time required for overall actuation, and so on.

[0085] In some embodiments, the actuator may be configured to adjust one or more shaking parameters or one or more actuation parameters based on user input. In other embodiments, the actuator may be configured to adjust one or more shaking parameters or one or more actuation parameters based on the manufacturer of the inhaler or drug delivery device, the type of drug or substance contained in the inhaler or drug delivery device, the amount of remaining dose in the inhaler or drug delivery device, a previous set of shaking parameters for shaking the inhaler or drug delivery device, a previous set of actuation parameters for actuating the inhaler or drug delivery device, or the number of times the inhaler or drug delivery device has been used.

[0086] In some cases, the actuator may be configured to monitor one or more shaking parameters and / or one or more actuation parameters, and adjust these parameters when one or more parameters reach or exceed a predetermined threshold. In some cases, the predetermined threshold may be based at least in part on the composition of the pharmaceutical formulation.

[0087] In some cases, the first conduit may include a pressure sensor. The pressure sensor may be configured to obtain one or more pressure measurements at different portions of the first conduit. The pressure sensor may be a differential pressure sensor.

[0088] In some cases, the first conduit may include a flow control valve configured to regulate the flow rate of fluid through the first conduit. The flow control valve may include a control valve, gate valve, check valve, ball valve, globe valve, butterfly valve, diaphragm valve, needle valve, pinch valve, proportional valve, or stepper motor valve. In some cases, the flow control valve may include a triple-biased butterfly valve or a proportional valve. Each conduit may include a separate and independently controllable flow control valve.

[0089] In some cases, the first conduit may include a pressure sensor and a flow regulating valve, which are configured to regulate the flow rate of fluid through the first conduit.

[0090] In some embodiments, the second conduit may include a pressure sensor. The pressure sensor may be configured to obtain one or more pressure measurements at different portions of the second conduit. The pressure sensor may be a differential pressure sensor. In some cases, the second conduit may include a flow regulating valve configured to regulate the flow rate of fluid through the second conduit. In some cases, the second conduit may include both a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the second conduit. The flow regulating valve may include a control valve, gate valve, check valve, ball valve, globe valve, butterfly valve, diaphragm valve, needle valve, pinch valve, proportional valve, or stepper motor valve. In some cases, the flow regulating valve includes a triple-biased butterfly valve or a proportional valve.

[0091] In some cases, at least one or two of the first or second conduit may include at least one, two, or three of a laminar flow regulator, a flow tube, or a flow checker. A laminar flow regulator may include a device configured to adjust the flow distribution of one or more doses or atomized particles flowing through the first or second conduit. A laminar flow regulator may be configured to reduce one or more disturbances in the flow through the first or second conduit. A laminar flow regulator may be configured to maintain laminar flow through the first or second conduit. Laminar flow may correspond to a fluid flow characterized by multiple minimal parallel layers, where there are no interruptions between the parallel layers (e.g., eddies, vortices, or flow perpendicular to the flow itself). Laminar flow is characterized by momentum diffusion and minimal momentum convection, such that the viscous forces associated with the fluid flow are higher than the inertial forces associated with the fluid flow. A flow regulator may be configured to eliminate eddies, asymmetry in the flow profile, and / or generate pseudo-fully developed flow. A flow regulator may include one or more folded blades, tubes, fins, or orifices configured to adjust the flow profile. A flow tube may include one or more tubes through which doses or atomized particles can flow. The tube may include multiple sections with different cross-sectional dimensions to adjust the flow path of one or more doses or atomized particles. The tube may include multiple bends to adjust the pressure drop across the flow tube. The flow tube may include multiple features (e.g., blades, fins, grooves, protrusions, etc.) to adjust the flow profile associated with the flow of one or more doses or atomized particles through the flow tube. A flow detector may be configured to obtain one or more measurements corresponding to the flow rate or mass flow rate of one or more doses or atomized particles through a first or second conduit. In some cases, the flow detector may be configured to provide one or more measurements to a mass flow controller configured to adjust the operation of a breathing simulator. For example, the mass flow controller may be configured to adjust the negative pressure volume guided by the breathing simulator, the frequency of the breathing simulator, and / or the timing associated with one or more breaths simulated using the breathing simulator.

[0092] In some cases, the instrument may include an electric motor operatively coupled to a flow control valve in the first and / or second conduit. The electric motor may be configured to control the flow control valve. Specifically, the electric motor may be configured to control the position, orientation, wafer angle, and / or movement of the flow control valve.

[0093] The electric motor can be configured to control the flow regulating valves of the first and / or second conduits based on at least one measurement obtained from a pressure sensor and / or a flow sensor. In some cases, the at least one measurement may include a real-time pressure measurement of one or more regions in the first and / or second conduits. In some cases, the at least one measurement may include a real-time flow rate measurement of one or more doses or one or more particles passing through the first and / or second conduits.

[0094] In some cases, the instrument may further include a controller configured to provide at least one command to an electric motor to gradually open and close the flow regulating valve to a predetermined position, orientation, or angle. The at least one command may be generated in part based on (i) a user input corresponding to a desired pressure drop across the first conduit and / or (ii) one or more measurements obtained from a first pressure sensor.

[0095] In any of the embodiments described herein, the electric motor may be configured to receive a power input from an external power source and a control input from a system controller, and may generate a rotary drive output based on the power and control inputs. In one embodiment, the rotary drive output may consist of a cylindrical shaft rotating about a rotation axis, and may be characterized instantaneously by angular position, angular velocity, angular acceleration, and torque. The rotary drive output may include rotation in any direction (e.g., clockwise or counterclockwise). The rotary drive output may be configured to control the position, orientation, angle, and / or movement of one or more flow control valves.

[0096] The device may include a movable platform. The movable platform may include an adapter unit configured to secure or attach an inhaler or drug delivery device to a portion of the movable platform. The adapter unit may be configured to fix the position and / or orientation of the inhaler or drug delivery device relative to the movable platform. In some cases, the adapter unit may include an attachment unit. The attachment unit may include hooks, clips, latches, retainers, straps, and / or strips.

[0097] In some cases, the movable platform may be configured to move relative to one or more catheters of the instrument or one or more inlets of one or more catheters. The movable platform may be configured to adjust the position and / or orientation of the inhaler or drug delivery device relative to one or more catheters or one or more inlets of one or more catheters.

[0098] The movable platform can be configured to move along the XY plane. The XY plane can be parallel to the longitudinal axis of one or more catheters. The XY plane can be orthogonal to a matching plane corresponding to the location and / or orientation of one or more inlets of one or more catheters. The movable platform can be configured to move along a Z-axis perpendicular to the XY plane.

[0099] The movable platform is operatively coupled to a motor assembly including one or more drive motors. The one or more drive motors may be configured to move the movable platform forward, backward, or laterally relative to the one or more conduits or one or more inlets of the one or more conduits. In some cases, the motor assembly may include one or more voltage or current drive amplifiers configured to control the one or more drive motors.

[0100] In some embodiments, the instrument may also include a mating plane sensor. The mating plane sensor may be configured to obtain positioning information of the movable platform. This positioning information may correspond to the position or orientation of the movable platform or inhaler relative to the first or second input port.

[0101] The alignment plane sensor can be configured to detect the position of one or more input ports. The alignment plane sensor can be configured to detect when the inhaler is aligned with one or more input ports. The alignment plane sensor can be configured to detect the offset between the position and / or orientation of the inhaler and the position and / or orientation of the input ports. The alignment plane sensor can be configured to provide the controller with positioning information related to the inhaler, the movable platform, and / or one or more input ports to adjust the position, orientation, movement, or path of the movable plate relative to one or more input ports. The alignment plane sensor and the controller can operate as part of a closed-loop control system.

[0102] In some embodiments, the instrument may include a controller configured to receive multiple inputs and adjust the position or orientation of the mobile platform based at least in part on the multiple inputs. The multiple inputs may include (i) positioning information associated with the mobile platform and (ii) user input corresponding to the selection of a desired input port.

[0103] In some cases, the portable platform can be configured to match the inhaler to at least one of a first inlet port, a second inlet port, or a third inlet port in response to user input corresponding to the selection of a desired inlet port.

[0104] In some cases, the first and second inlet ports may include mating rings configured to releasably couple to the inhaler to form a seal. The mating rings may be adequately designed to form a seal between the inhaler tube and the mouthpiece of an MDI, pMDI, DPI, or similar device. In some cases, the inhaler may include a mating ring fitted to a portion of the inhaler and / or the tube interface. In this case, the mating ring may be configured to form a seal between the inhaler and the first, second, or third inlet port. The mating ring may include a soft and flexible material configured to form a reliable seal. This material may include, for example, soft silicone rubber.

[0105] Figure 1A An exemplary instrument 100 for inhaler testing is shown. Instrument 100 may include one or more dose collector modules 110, which may include a dose unit sampling instrument (DUSA), a cascaded impactor, an optical spray or aerosol analyzer, and / or a waste collector. Instrument 100 may include a dose collection flow chamber 120. The dose collection flow chamber 120 may include a manifold. The dose collection flow chamber 120 may be in fluid communication with a vacuum source 130. Instrument 100 may include an actuator 140. The actuator 140 may be a Vereo SFMDX autoactor. The actuator 140 may be configured to agitate and / or actuate an inhaler 145 for testing. Instrument 100 may include a movable platform 150 including an automated stage configured to move relative to one or more dose collector modules 110 in the X-axis, Y-axis, and / or Z-axis directions to mate the inhaler 145 with one or more dose collector modules 110. In some cases, the automated stage can be configured to rotate around the XY plane, XZ plane, and / or YZ plane to align the inhaler 145 with one or more dose collector modules 110.

[0106] Figure 1BAnother exemplary instrument 100 for inhaler testing is shown. Instrument 100 may include one or more dose collector modules 110. The one or more dose collector modules 110 may include a dose unit sampling instrument (DUSA), a cascaded impactor, an optical nebulizer or aerosol analyzer and / or a waste collector. Instrument 100 may include a dose collection flow chamber 120. The dose collection flow chamber 120 may include a manifold. The dose collection flow chamber 120 may be in fluid communication with a vacuum source 130. Instrument 100 may include an actuator 140. The actuator 140 may be a Vereo SFMDx autoacter. The actuator 140 may be configured to agitate and / or actuate an inhaler 145 for testing. Instrument 100 may include a movable platform 150 including an automated stage configured to move relative to one or more dose collector modules 110 in the X-axis and / or Y-axis directions to mate the inhaler 145 with one or more dose collector modules 110.

[0107] Figure 2 An exemplary instrument 200 for inhaler testing is shown. Instrument 200 may include a first conduit 210 having a first port or inlet 310. The first conduit 210 may include a first fluid flow path 211 through the first conduit 210. Instrument 200 may include a second conduit 220 having a second port or inlet 320. The second conduit 220 may include a second fluid flow path 221 through the second conduit 220.

[0108] Instrument 200 may include a first dose collector module 410. The first dose collector module 410 may include a quick disconnect cartridge. The quick disconnect cartridge may include waste, DUSA, flow tube, and / or flow meter.

[0109] The first conduit 210 may include a quick-disconnect matching inlet 411. The first conduit 210 may include a laminar flow regulator 412 and / or a laminar flow sensor. The first conduit 210 may include a flow control valve 413. The flow control valve 413 may include a triple-biased butterfly valve, a proportional valve, or a stepper motor valve.

[0110] Instrument 200 may include a second dose collector module 420. The second dose collector module 420 may include a quick disconnect cartridge. The quick disconnect cartridge may include waste, DUSA, flow tube, and / or flow meter.

[0111] The second conduit 220 may include a quick-disconnect matching inlet 421. The second conduit 220 may include a laminar flow regulator 422 and / or a laminar flow sensor. The second conduit 220 may include a flow control valve 423. The flow control valve 423 may include a triple-biased butterfly valve, a proportional valve, or a stepper motor valve.

[0112] In some embodiments, the instrument may include a manifold 430. The manifold 430 may be configured to converge at least a first conduit 210 and a second conduit 220 into an outlet conduit. The outlet conduit may be in fluid communication with a vacuum source 440. The vacuum source 440 may include a breathing simulator as described elsewhere herein.

[0113] Each catheter may include an inlet or port. For example, the first catheter 210 may include a first inlet 310, and the second catheter 220 may include a second inlet 320. A mating ring 401 may be provided at or near inlets 310 and 320. In some cases, the instrument 200 may include a third catheter having a third fluid flow path 231. The third catheter may include a third inlet 330. In some cases, a throat collar 402 may be provided at the third inlet 330.

[0114] In some cases, instrument 200 may include three or more catheters. In some cases, instrument 200 may include a third catheter. In some cases, the third catheter may include a USP (United States Pharmacopeia) inlet tube 460. The third catheter may be in fluid communication with a cascade impactor 470. The cascade impactor 470 may be in fluid communication with a flow tube 480.

[0115] Instrument 200 may include an automated stage configured to move the drug delivery device 600 and adjust its position and / or orientation relative to one or more inlet ports 310, 320, and 330. The drug delivery device 600 may include an inhaler. The automated stage may include a movable platform as described elsewhere herein. The automated stage may be configured to move along a port selection axis 510 and / or a mating axis 520. The port selection axis 510 may span one or more inlet ports 310, 320, and 330. The automated stage may be configured to move along the port selection axis 510 to align the drug delivery device 600 with one or more inlet ports 310, 320, and / or 330, depending on user selection or specification of a specific catheter for testing a particular drug delivery device 600. Once the desired inlet port is selected or specified, the automated stage may be configured to move along the mating axis 520 to mate the drug delivery device 600 with one or more inlet ports 310, 320, and / or 330. In some cases, the drug delivery device 600 may include another mating ring 401 configured to mate with inlets 310, 320, and 330, the mating ring 401 of the inlets, or the laryngeal collar 402 of the inlets. In some cases, the automated stage may be configured to move the drug delivery device 600 to align a portion of the drug delivery device 600 with a mating plane 530 corresponding to the position and / or orientation of inlets 310, 320, and 330. In some cases, the automated stage may be configured to adjust the position and / or orientation of the drug delivery device 600 based on one or more position measurements obtained using a mating plane detection sensor 540. The mating plane detection sensor 540 may be configured to detect the position of one or more input ports. The mating plane detection sensor 540 may be configured to detect when the inhaler 600 is aligned with one or more input ports 310, 320, and 330. The mating plane detection sensor 540 may be configured to detect the offset between the position and / or orientation of the inhaler 600 and the position and / or orientation of the input ports 310, 320, and 330. The mating plane detection sensor 540 can be configured to provide the controller with positioning information related to the inhaler 600, the movable platform, and / or one or more input ports 310, 320, and 330 to adjust the position, orientation, movement, or path of the movable plate relative to one or more input ports 310, 320, and 330. The mating plane detection sensor 540 and the controller can operate as part of a closed-loop control system.

[0116] In any of the embodiments described herein, one or more components of the dose collection instrument may include an inert material. The inert material may include a material that does not react with the sample dose. In one embodiment, the inert material may include plastic. In one embodiment, the inert material may include polypropylene. In one embodiment, the inert material may include glass.

[0117] On the other hand, this disclosure provides an inhaler testing method. The method may include providing an instrument for inhaler testing. The instrument may include: (a) a first catheter including a first inlet port and a first fluid flow path; (b) a second catheter including a second inlet port and a second fluid flow path; (c) a movable platform configured to match an inhaler to at least one of the first or second inlet ports; and (d) an actuator configured to operate the inhaler to deliver a dose to at least one of the first or second catheters. The first fluid flow path may be in fluid communication with the first inlet port and a first dose collector module. The second fluid flow path may be in fluid communication with the second inlet port and the second dose collector module. The dose delivered by the inhaler may include a sample dose or a waste dose. In some cases, the instrument may include a third catheter including a third inlet port and a third fluid flow path. The method may also include using an actuator to shake the inhaler. The method may further include, in response to user input corresponding to the selection of a desired input port, using a movable platform to adjust the position and / or orientation of the inhaler relative to a first inlet port, a second inlet port, or a third inlet port, so that the inhaler is matched to at least one of the first, second, or third inlet ports. The method may also include using an actuator to actuate the inhaler to deliver one or more doses to the selected or desired inlet port for testing.

[0118] Computer System

[0119] In one aspect, this disclosure provides a computer system that is programmed or otherwise configured to implement the methods of this disclosure, such as any subject method for testing drug delivery devices. Figure 3A computer system 1001 is illustrated, which is programmed or otherwise configured to implement a method for testing a drug delivery device. The computer system 1001 may be configured to, for example, control the operation of one or more components of a dose collection instrument. The computer system 1001 may be configured to control actuators to agitate the drug delivery device. The computer system 1001 may be configured to control a movable platform to adjust the position and / or orientation of the drug delivery device relative to a first inlet port, a second inlet port, or a third inlet port in response to user input corresponding to the selection of a desired input port, such that the drug delivery device is aligned with at least one of the first, second, or third inlet ports. The computer system 1001 may be configured to control actuators to actuate the drug delivery device to provide one or more sample doses or waste doses to the selected or desired inlet port for testing. The computer system 1001 may be a user's electronic device or a computer system remotely positioned relative to an electronic device. The electronic device may be a mobile electronic device.

[0120] Computer system 1001 may include a central processing unit (CPU, also referred to herein as a “processor” and “computer processor”) 1005, which may be a single-core or multi-core processor, or multiple processors for parallel processing. Computer system 1001 also includes memory or memory location 1010 (e.g., random access memory, read-only memory, flash memory), electronic storage unit 1015 (e.g., hard disk), communication interface 1020 for communicating with one or more other systems (e.g., network adapter), and peripheral devices 1025, such as cache, other memory, data storage, and / or electronic display adapters. Memory 1010, storage unit 1015, interface 1020, and peripheral devices 1025 communicate with CPU 1005 via a communication bus (solid line) (e.g., motherboard). Storage unit 1015 may be a data storage unit (or data repository) for storing data. Computer system 1001 may be operatively coupled to computer network (“network”) 1030 with the aid of communication interface 1020. Network 1030 may be the Internet, the Internet and / or an extranet, or an intranet and / or extranet communicating with the Internet. In some cases, network 1030 is a telecommunications and / or data network. Network 1030 may include one or more computer servers that can enable distributed computing, such as cloud computing. In some cases, with the assistance of computer system 1001, network 1030 can implement a peer-to-peer network that enables devices coupled to computer system 1001 to act as clients or servers.

[0121] CPU 1005 can execute a series of machine-readable instructions, which can be contained in a program or software. The instructions can be stored in a memory location such as memory 1010. The instructions can point to CPU 1005, which can then be programmed or otherwise configured to implement the methods of this disclosure. Examples of operations performed by CPU 1005 can include fetching, decoding, executing, and writing back.

[0122] CPU 1005 may be part of a circuit, such as an integrated circuit. One or more other components of system 1001 may be included in the circuit. In some cases, the circuit is an application-specific integrated circuit (ASIC).

[0123] Storage unit 1015 may store files such as drivers, libraries, and save programs. Storage unit 1015 may store user data, such as user preferences and user programs. In some cases, computer system 1001 may include one or more additional data storage units located outside computer system 1001 (e.g., on a remote server communicating with computer system 1001 via an intranet or the Internet).

[0124] Computer system 1001 can communicate with one or more remote computer systems via network 1030. For example, computer system 1001 can communicate with a user's remote computer system (e.g., a drug delivery equipment manufacturer, drug delivery equipment tester, consumer, healthcare provider, patient, etc.). Examples of remote computer systems include personal computers (e.g., portable PCs), tablets, or tablet computers (e.g., [missing information]). iPad Galaxy Tab), telephone, smartphone (e.g., iPhone, Android-compatible devices (or personal digital assistant). Users can access computer system 1001 via network 1030.

[0125] The methods described herein can be implemented via machine-executable code (e.g., a computer processor) stored in an electronic storage location (e.g., memory 1010 or electronic storage unit 1015) of computer system 1001. The machine-executable or machine-readable code may be provided in software form. During use, the code can be executed by processor 1005. In some cases, the code can be retrieved from storage unit 1015 and stored in memory 1010 so that processor 1005 can access it at any time. In some cases, electronic storage unit 1015 can be excluded, and machine-executable instructions are stored on memory 1010.

[0126] The code can be pre-compiled and configured for use with a machine having a processor suitable for executing the code, or it can be compiled at runtime. The code can be provided in a programming language, which can be selected to enable the code to be executed either pre-compiled or compiled.

[0127] Various aspects of the systems and methods provided herein, such as computer system 1001, can be embodied in programming. These aspects of the technology can be considered "products" or "manufactured articles," typically in the form of machine (or processor) executable code and / or related data carried or contained on a machine-readable medium. Machine-executable code can be stored on electronic storage units, such as memory (e.g., read-only memory, random access memory, flash memory) or hard disks. "Storage" type media can include any or all tangible memory of a computer, processor, etc., or related modules thereof, such as various semiconductor memories, tape drives, disk drives, etc., which can provide non-transient storage for software programming at any time. All or part of the software can sometimes be communicated via the Internet or various other telecommunications networks. Such communication, for example, enables the loading of software from one computer or processor to another, such as from a management server or host computer to a computer platform for an application server. Therefore, another type of medium that can carry software elements includes light waves, radio waves, and electromagnetic waves, such as physical interfaces between local devices, via wired and fiber optic terrestrial networks, and via various air links. The physical elements that carry such waves, such as wired or wireless links, optical links, etc., can also be considered as the medium carrying software. As used herein, unless limited to non-transitory tangible "storage" media, terms such as "computer or machine-readable medium" refer to any medium that participates in providing instructions to the processor for execution.

[0128] Therefore, machine-readable media (such as computer-executable code) can take many forms, including but not limited to tangible storage media, carrier media, or physical transmission media. Non-volatile storage media, including, for example, optical discs or disks, or any storage device in any computer, can be used to implement databases, etc., as shown in the figure. Volatile storage media include dynamic memory, such as the main memory of such a computer platform. Tangible transmission media include coaxial cables; copper wires and optical fibers, including wires that form the bus within a computer system. Carrier transmission media can take the form of electrical or electromagnetic signals, or they can take the form of sound waves or light waves, such as sound waves or light waves generated during radio frequency (RF) and infrared (IR) data communication. Therefore, common forms of computer-readable media include, for example: floppy disks, flexible disks, hard disks, magnetic tape, any other magnetic media, CD-ROMs, DVDs or DVD-ROMs, any other optical media, punched cards, paper tape, any other physical storage media with a perforated pattern, RAM, ROM, PROM and EPROM, FLASH-EPROM, any other memory chips or cassette tapes, carrier waves for transmitting data or instructions, cables or links for transmitting such carrier waves, or any other medium from which a computer can read program code and / or data. Many of these forms of computer-readable media may involve carrying one or more sequences of one or more instructions to a processor for execution.

[0129] Computer system 1001 may include or communicate with an electronic display 1035, which includes a user interface (UI) 1040 for providing a portal to a user to monitor or track testing of one or more drug delivery devices. The portal may be provided via an application programming interface (API). Users or entities may also interact with various elements within the portal through the UI. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces.

[0130] The methods and systems disclosed herein can be implemented via one or more algorithms. When executed by the central processing unit 1005, the algorithms can be implemented via software. The algorithm can be configured to control the actuator of the dose collection instrument to agitate the inhaler according to one or more agitation parameters. The algorithm can also be configured to control a movable platform to adjust the position and / or orientation of the inhaler relative to a first, second, or third inlet port of the dose collection instrument in response to user input corresponding to the selection of a desired input port, such that the inhaler is aligned with at least one of the first, second, or third inlet ports. The algorithm can also be configured to control the actuator to agitate the inhaler according to one or more actuation parameters to provide one or more sample doses or waste doses to the selected or desired inlet port for testing.

[0131] Non-limiting examples of exemplary embodiments

[0132] In addition to the aspects and implementations described and provided elsewhere in this disclosure, the following non-limiting enumeration of specific implementations is particularly contemplated.

[0133] 1. A dose collection instrument, the instrument comprising:

[0134] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module;

[0135] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module;

[0136] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port; and

[0137] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose.

[0138] 2. The instrument as described in Embodiment 1, wherein the first dose collector module is a dose unit sampling instrument (DUSA).

[0139] 3. The instrument as described in Embodiment 1, wherein the first dose collector module includes a low-resistance filter configured to capture the dose provided by the inhaler.

[0140] 4. The instrument as described in Embodiment 3, wherein the low-resistance filter is configured to retain aerosol particles with a particle size range of about 0.1 micrometers (μm) to about 10 μm.

[0141] 5. The instrument as described in embodiment 3, wherein the low-resistance filter has a flow resistance of about 150 Pascals at a flow rate of about 90 liters of air per minute.

[0142] 6. The instrument as described in Embodiment 1, wherein the first dose collector module is a cascaded impactor.

[0143] 7. The instrument as described in Embodiment 1, wherein the first dose collector module is an optical nebulizer or an aerosol analyzer.

[0144] 8. The instrument as described in any of the foregoing embodiments, wherein the second dose collector module is a waste collector.

[0145] 9. The instrument as described in any of the preceding embodiments, wherein the first inlet port is located at one end of the first catheter, and wherein the first dose collector module is located at the opposite end of the first catheter.

[0146] 10. The instrument as described in any of the preceding embodiments, wherein the second inlet port is located at one end of the second catheter, and wherein the second dose collector module is located at the opposite end of the second catheter.

[0147] 11. The instrument as described in any of the preceding embodiments, wherein the instrument includes a manifold configured to converge a first conduit and a second conduit into an outlet conduit, wherein the outlet conduit includes an outlet port in fluid communication with a vacuum source.

[0148] 12. The instrument as described in any of the foregoing embodiments, wherein at most one of the first catheter and the second catheter is operable at a given time.

[0149] 13. The instrument as described in embodiment 11, wherein the vacuum source includes a breathing simulator configured to guide (i) a flow from one end of a first or second catheter to the opposite end of the respective first or second catheter to simulate inhalation, and (ii) a flow in the opposite direction from the opposite end to one end to simulate exhalation.

[0150] 14. The instrument as described in embodiment 13, wherein the breathing simulator is configured to guide flow through at most one of the first conduit and the second conduit at a given time.

[0151] 15. The instrument as described in embodiment 13, wherein the breathing simulator is configured to generate a user-programmable output trigger signal.

[0152] 16. The instrument as described in embodiment 15, wherein the output trigger signal is programmed to trigger at a user-specified time, which is within the time period required for the respiratory simulator to perform a respiratory profile.

[0153] 17. The instrument as described in any of the foregoing embodiments, wherein the actuator is configured to (i) shake the inhaler and / or (ii) actuate the inhaler to deliver a dose to at least one of the first catheter and the second catheter.

[0154] 18. The instrument as described in embodiment 17, wherein the actuator is configured to receive the output trigger signal of any of the preceding claims.

[0155] 19. The instrument as described in embodiment 18, wherein the actuator is configured to actuate the device upon receiving an output trigger signal as described in any of the preceding claims.

[0156] 20. The instrument as described in any of the foregoing embodiments, wherein the first conduit includes a pressure sensor.

[0157] 21. The instrument as described in embodiment 20, wherein the pressure sensor is a differential pressure sensor.

[0158] 22. The instrument as described in any of the preceding embodiments, wherein the first conduit includes a flow regulating valve configured to regulate the flow rate of fluid passing through the first conduit.

[0159] 23. The instrument as described in any of the preceding embodiments, wherein the instrument includes a plurality of flow regulating valves configured to independently control or regulate flow through each of a plurality of conduits, wherein the plurality of conduits includes at least a first conduit and a second conduit.

[0160] 24. The instrument as described in any of the preceding embodiments, wherein the first conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid passing through the conduit.

[0161] 25. The instrument as described in embodiment 22 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

[0162] 26. The instrument as described in embodiment 22, wherein the flow regulating valve includes a control valve, gate valve, check valve, ball valve, stop valve, butterfly valve, diaphragm valve, needle valve, pinch valve, proportional valve, or stepper motor valve.

[0163] 27. The instrument as described in embodiment 22 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor.

[0164] 28. The instrument as described in embodiment 27, wherein the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through the first conduit.

[0165] 29. The instrument as described in any one of embodiments 22-28, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

[0166] 30. The instrument as described in any one of embodiments 25-28 further includes a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

[0167] 31. The instrument as described in embodiment 30, wherein at least one command is generated in part based on (i) user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from the first pressure sensor.

[0168] 32. The instrument as described in any of the foregoing embodiments, wherein the second conduit includes a pressure sensor.

[0169] 33. The instrument as described in embodiment 32, wherein the pressure sensor is a differential pressure sensor.

[0170] 34. The instrument as described in any of the preceding embodiments, wherein the second conduit includes a flow regulating valve configured to regulate the flow rate of fluid passing through the second conduit.

[0171] 35. The instrument as described in any of the preceding embodiments, wherein the second conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the second conduit.

[0172] 36. The instrument as described in embodiment 34 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

[0173] 37. The instrument as described in embodiment 34 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor.

[0174] 38. The instrument as described in embodiment 37, wherein the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through a second conduit.

[0175] 39. The instrument as described in any one of embodiments 34-38, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

[0176] 40. The instrument as described in any one of embodiments 36-38 further includes a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

[0177] 41. The instrument as described in embodiment 40, wherein at least one command is generated in part based on (i) user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from the first pressure sensor.

[0178] 42. The instrument as described in any of the foregoing embodiments further includes a controller.

[0179] 43. The instrument as described in any of the preceding embodiments further includes a mating plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or inhaler relative to the first input port or the second input port.

[0180] 44. The instrument as described in embodiment 43, wherein the matching plane sensor is configured to detect the position of the first input port or the second input port relative to the movable platform.

[0181] 45. The instrument as described in embodiment 43, wherein the mating plane sensor is configured to detect when the inhaler is aligned with the first input port or the second input port.

[0182] 46. ​​The instrument as described in embodiment 43, wherein the matching plane sensor is configured to detect the offset between the position or orientation of the inhaler and the position or orientation of the first input port or the second input port.

[0183] 47. The instrument as described in embodiment 43, wherein the matching plane sensor is configured to (i) obtain positioning information associated with at least one of the inhaler, the movable platform, or the first input port and the second input port, and (ii) provide the positioning information to the controller to adjust the position, orientation, movement, or movement path of the movable plate relative to the first input port or the second input port.

[0184] 48. The instrument of embodiment 43 further includes a controller configured to receive multiple inputs from a mating plane sensor and to adjust the position or orientation of the movable platform based at least in part on the multiple inputs, the multiple inputs including (i) positioning information of the movable platform and (ii) user input corresponding to the selection of a desired input port.

[0185] 49. The instrument as described in any of the preceding embodiments, wherein the first inlet port and the second inlet port include a mating ring configured to be releasably coupled to the inhaler to form a seal.

[0186] 50. The instrument as described in any of the preceding embodiments, wherein the inhaler includes a matching ring fitted to a portion of the inhaler.

[0187] 51. The instrument as described in embodiment 49 or 50, wherein the matching ring is configured to form a seal between the inhaler and the first or second inhaler when the inhaler is positioned adjacent to the first or second inhaler port.

[0188] 52. The instrument as described in embodiment 49 or 50, wherein the mating ring comprises a soft silicone rubber or a soft flexible material configured to form a reliable seal between the inhaler and the first inlet port or the second inlet port.

[0189] 53. The instrument as described in any of the foregoing embodiments, wherein at least one or two of the first or second conduit includes at least one, two or three of a laminar flow regulator, a flow tube or a flow tester.

[0190] 54. The instrument as described in any of the foregoing embodiments further includes a third conduit, the third conduit including a third inlet port and a third fluid flow path, wherein the third fluid flow path is in fluid communication with the third inlet port.

[0191] 55. The instrument as described in embodiment 54, wherein the movable platform is configured to match the inhaler to at least one of a first inlet port, a second inlet port, or a third inlet port in response to user input corresponding to the selection of a desired input port.

[0192] 56. The instrument as described in embodiment 53, wherein the flow tester is configured to obtain one or more measurements corresponding to the flow rate or mass flow rate through the first conduit or the second conduit.

[0193] 57. The instrument as described in embodiment 53, wherein the flow tester is configured to provide one or more measurements to a mass flow controller, which is configured to adjust the operation of the breathing simulator.

[0194] 58. A dose collection instrument, the instrument comprising:

[0195] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module;

[0196] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module;

[0197] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port; and

[0198] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose.

[0199] The first dose collector module includes a low-resistance filter configured to capture the dose delivered by the inhaler.

[0200] 59. A dose collection instrument, the instrument comprising:

[0201] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module;

[0202] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module;

[0203] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port; and

[0204] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose.

[0205] The first dose collector module is either an optical nebulizer or an aerosol analyzer.

[0206] 60. A dose collection instrument, the instrument comprising:

[0207] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module;

[0208] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module;

[0209] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port; and

[0210] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose.

[0211] The instrument includes a manifold configured to converge a first conduit and a second conduit into an outlet conduit, wherein the outlet conduit includes an outlet port in fluid communication with a vacuum source.

[0212] 61. A dose collection instrument, the instrument comprising:

[0213] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module;

[0214] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module;

[0215] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port; and

[0216] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose.

[0217] The first conduit and / or the second conduit include a pressure sensor.

[0218] 62. A dose collection instrument, the instrument comprising:

[0219] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module;

[0220] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module;

[0221] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port; and

[0222] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose.

[0223] The instrument includes multiple flow control valves configured to independently control or regulate flow through each of a plurality of conduits, wherein the plurality of conduits includes at least a first conduit and a second conduit.

[0224] 63. A dose collection instrument, the instrument comprising:

[0225] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module;

[0226] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with a second inlet segment and a second dose collector module;

[0227] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port;

[0228] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose; and

[0229] (e) Matching a plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or inhaler relative to the first input port or the second input port.

[0230] 64. A dose collection instrument, the instrument comprising:

[0231] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and the first dose collector module;

[0232] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module;

[0233] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port; and

[0234] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose.

[0235] At least one or two of the first or second conduits include at least one, two or three of a laminar flow regulator, a flow tube or a flow tester.

[0236] 65. The instrument as described in any one of embodiments 58-64, wherein the first dose collector module is a dose unit sampling instrument (DUSA).

[0237] 66. The instrument as described in any one of embodiments 58-65, wherein the first dose collector module includes a low-resistance filter configured to capture the dose provided by the inhaler.

[0238] 67. The instrument as described in embodiment 66, wherein the low-resistance filter is configured to retain aerosol particles with a particle size range of about 0.1 micrometers (μm) to about 10 μm.

[0239] 68. The instrument as described in embodiment 66, wherein the low-resistance filter has a flow resistance of about 150 Pascals at a flow rate of about 90 liters of air per minute.

[0240] 69. The instrument as described in any one of embodiments 58-68, wherein the first dose collector module is a cascaded impactor.

[0241] 70. The instrument as described in any one of embodiments 58-69, wherein the first dose collector module is an optical nebulizer or an aerosol analyzer.

[0242] 71. The instrument as described in any one of embodiments 58-70, wherein the second dose collector module is a waste collector.

[0243] 72. The instrument as described in any one of embodiments 58-71, wherein the first inlet port is located at one end of the first catheter, and wherein the first dose collector module is located at the opposite end of the first catheter.

[0244] 73. The instrument as described in any one of embodiments 58-72, wherein the second inlet port is located at one end of the second catheter, and wherein the second dose collector module is located at the opposite end of the second catheter.

[0245] 74. The instrument as described in any one of embodiments 58-73, wherein the instrument includes a manifold configured to converge a first conduit and a second conduit into an outlet conduit, wherein the outlet conduit includes an outlet port in fluid communication with a vacuum source.

[0246] 75. The instrument as described in any one of embodiments 58-74, wherein at most one of the first catheter and the second catheter is operable at a given time.

[0247] 76. The instrument as described in embodiment 74, wherein the vacuum source includes a breathing simulator configured to guide (i) a flow from one end of a first or second catheter to the opposite end of the respective first or second catheter to simulate inhalation, and (ii) a flow in the opposite direction from the opposite end to one end to simulate exhalation.

[0248] 77. The instrument as described in embodiment 76, wherein the breathing simulator is configured to guide flow through at most one of the first and second conduits at a given time.

[0249] 78. The instrument as described in embodiment 76, wherein the breathing simulator is configured to generate a user-programmable output trigger signal.

[0250] 79. The instrument as described in embodiment 78, wherein the output trigger signal is programmed to trigger at a user-specified time, which is within the time period required for the respiratory simulator to perform a respiratory profile.

[0251] 80. The instrument as described in any one of embodiments 58-79, wherein the actuator is configured to (i) shake the inhaler and / or (ii) actuate the inhaler to deliver a dose to at least one of the first catheter and the second catheter.

[0252] 81. The instrument as described in embodiment 80, wherein the actuator is configured to receive the output trigger signal of any of the preceding claims.

[0253] 82. The instrument as described in embodiment 81, wherein the actuator is configured to actuate the device upon receiving an output trigger signal as described in any of the preceding claims.

[0254] 83. The instrument as described in any one of embodiments 58-82, wherein the first conduit includes a pressure sensor.

[0255] 84. The instrument as described in embodiment 83, wherein the pressure sensor is a differential pressure sensor.

[0256] 85. The instrument as described in any one of embodiments 58-84, wherein the first conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the first conduit.

[0257] 86. The instrument as described in any one of embodiments 58-85, wherein the instrument includes a plurality of flow regulating valves configured to independently control or regulate flow through each of a plurality of conduits, wherein the plurality of conduits includes at least a first conduit and a second conduit.

[0258] 87. The instrument as described in any one of embodiments 58-86, wherein the first conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the conduit.

[0259] 88. The instrument as described in embodiment 85 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

[0260] 89. The instrument as described in embodiment 85, wherein the flow regulating valve includes a control valve, gate valve, check valve, ball valve, stop valve, butterfly valve, diaphragm valve, needle valve, pinch valve, proportional valve, or stepper motor valve.

[0261] 90. The instrument as described in embodiment 85 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor.

[0262] 91. The instrument as described in embodiment 90, wherein the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through the first conduit.

[0263] 92. The instrument as described in any one of embodiments 85-91, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

[0264] 93. The instrument as described in any one of embodiments 88-91 further includes a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

[0265] 94. The instrument as described in embodiment 93, wherein at least one command is generated in part based on (i) user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from the first pressure sensor.

[0266] 95. The instrument as described in any one of embodiments 58-94, wherein the second conduit includes a pressure sensor.

[0267] 96. The instrument as described in embodiment 95, wherein the pressure sensor is a differential pressure sensor.

[0268] 97. The instrument as described in any one of embodiments 58-96, wherein the second conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the second conduit.

[0269] 98. The instrument as described in any one of embodiments 58-97, wherein the second conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the second conduit.

[0270] 99. The instrument as described in embodiment 97 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

[0271] 100. The instrument as described in embodiment 97 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor.

[0272] 101. The instrument as described in embodiment 100, wherein the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through a second conduit.

[0273] 102. The instrument as described in any one of embodiments 97-101, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

[0274] 103. The instrument as described in any one of embodiments 99-101 further includes a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

[0275] 104. The instrument as described in embodiment 103, wherein at least one command is generated in part based on (i) user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from the first pressure sensor.

[0276] 105. The instrument as described in any one of embodiments 58-104 further includes a controller.

[0277] 106. The instrument as described in any one of embodiments 58-105 further includes a mating plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or inhaler relative to the first input port or the second input port.

[0278] 107. The instrument as described in embodiment 106, wherein the matching plane sensor is configured to detect the position of the first input port or the second input port relative to the movable platform.

[0279] 108. The instrument as described in embodiment 106, wherein the mating plane sensor is configured to detect when the inhaler is aligned with the first input port or the second input port.

[0280] 109. The instrument as described in embodiment 106, wherein the matching plane sensor is configured to detect the offset between the position or orientation of the inhaler and the position or orientation of the first input port or the second input port.

[0281] 110. The instrument as described in embodiment 106, wherein the matching plane sensor is configured to (i) obtain positioning information associated with at least one of the inhaler, the movable platform, or the first input port and the second input port, and (ii) provide the positioning information to the controller to adjust the position, orientation, movement, or movement path of the movable plate relative to the first input port or the second input port.

[0282] 111. The instrument as described in embodiment 106 further includes a controller configured to receive multiple inputs from a mating plane sensor and to adjust the position or orientation of the movable platform based at least in part on the multiple inputs, the multiple inputs including (i) positioning information of the movable platform and (ii) user input corresponding to the selection of a desired input port.

[0283] 112. The instrument as described in any one of embodiments 58-111, wherein the first inlet port and the second inlet port include a mating ring configured to be releasably coupled to the inhaler to form a seal.

[0284] 113. The instrument as described in any one of embodiments 58-112, wherein the inhaler includes a matching ring fitted to a portion of the inhaler.

[0285] 114. The instrument as described in embodiment 112 or 113, wherein the matching ring is configured to form a seal between the inhaler and the first or second inhaler when the inhaler is positioned adjacent to the first or second inhaler port.

[0286] 115. The instrument as described in embodiment 112 or 113, wherein the mating ring comprises a soft silicone rubber or a soft flexible material configured to form a reliable seal between the inhaler and the first inlet port or the second inlet port.

[0287] 116. The instrument as described in any one of embodiments 58-115, wherein at least one or two of the first or second conduit includes at least one, two or three of a laminar flow regulator, a flow tube or a flow tester.

[0288] 117. The instrument as described in any one of embodiments 58-116 further includes a third conduit, the third conduit including a third inlet port and a third fluid flow path, wherein the third fluid flow path is in fluid communication with the third inlet port.

[0289] 118. The instrument as described in embodiment 117, wherein the movable platform is configured to match the inhaler to at least one of a first inlet port, a second inlet port, or a third inlet port in response to user input corresponding to the selection of a desired input port.

[0290] 119. The instrument as described in embodiment 116, wherein the flow tester is configured to obtain one or more measurements corresponding to the flow rate or mass flow rate through the first conduit or the second conduit.

[0291] 120. The instrument as described in embodiment 116, wherein the flow tester is configured to provide one or more measurements to a mass flow controller, which is configured to adjust the operation of the breathing simulator.

[0292] 121. A dose collection instrument, the instrument comprising:

[0293] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module;

[0294] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module;

[0295] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port; and

[0296] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose.

[0297] The first conduit and / or the second conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the first conduit and / or the second conduit, and wherein the flow regulating valve is a proportional valve.

[0298] 122. A dose collection instrument, the instrument comprising:

[0299] (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module;

[0300] (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module;

[0301] (c) A movable platform configured to match an inhaler to at least one of a first inlet port or a second inlet port; and

[0302] (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose.

[0303] The inhaler includes a matching ring that is fitted onto a part of the inhaler.

[0304] 123. The instrument as described in embodiment 121 or 122, wherein the first dose collector module is a dose unit sampling instrument (DUSA).

[0305] 124. The instrument as described in embodiment 121 or 122, wherein the first dose collector module includes a low-resistance filter configured to capture the dose provided by the inhaler.

[0306] 125. The instrument as described in embodiment 124, wherein the low-resistance filter is configured to retain aerosol particles with a particle size range of about 0.1 micrometers (μm) to about 10 μm.

[0307] 126. The instrument as described in embodiment 124, wherein the low-resistance filter has a flow resistance of about 150 Pascals at a flow rate of about 90 liters of air per minute.

[0308] 127. The instrument as described in embodiment 121 or 122, wherein the first dose collector module is a cascaded impactor.

[0309] 128. The instrument as described in embodiment 121 or 122, wherein the first dose collector module is an optical nebulizer or an aerosol analyzer.

[0310] 129. The instrument as described in any one of embodiments 121-128, wherein the second dose collector module is a waste collector.

[0311] 130. The instrument as described in any one of embodiments 121-129, wherein the first inlet port is located at one end of the first catheter, and wherein the first dose collector module is located at the opposite end of the first catheter.

[0312] 131. The instrument as described in any one of embodiments 121-130, wherein the second inlet port is located at one end of the second catheter, and wherein the second dose collector module is located at the opposite end of the second catheter.

[0313] 132. The instrument as described in any one of embodiments 121-131, wherein the instrument includes a manifold configured to converge a first conduit and a second conduit into an outlet conduit, wherein the outlet conduit includes an outlet port in fluid communication with a vacuum source.

[0314] 133. The instrument as described in any one of embodiments 121-132, wherein at most one of the first catheter and the second catheter is operable at a given time.

[0315] 134. The instrument as described in embodiment 132, wherein the vacuum source includes a breathing simulator configured to guide (i) a flow from one end of a first or second catheter to the opposite end of the respective first or second catheter to simulate inhalation, and (ii) a flow in the opposite direction from the opposite end to one end to simulate exhalation.

[0316] 135. The instrument as described in embodiment 134, wherein the breathing simulator is configured to guide flow through at most one of the first and second conduits at a given time.

[0317] 136. The instrument as described in embodiment 134, wherein the breathing simulator is configured to generate a user-programmable output trigger signal.

[0318] 137. The instrument as described in embodiment 136, wherein the output trigger signal is programmed to trigger at a user-specified time, which is within the time period required for the respiratory simulator to perform a respiratory profile.

[0319] 138. The instrument as described in any one of embodiments 121-137, wherein the actuator is configured to (i) shake the inhaler and / or (ii) actuate the inhaler to deliver a dose to at least one of the first catheter and the second catheter.

[0320] 139. The instrument as described in embodiment 138, wherein the actuator is configured to receive the output trigger signal of any of the preceding claims.

[0321] 140. The instrument as described in embodiment 139, wherein the actuator is configured to actuate the device upon receiving an output trigger signal as described in any of the preceding claims.

[0322] 141. The instrument as described in any one of embodiments 121-140, wherein the first conduit includes a pressure sensor.

[0323] 142. The instrument as described in embodiment 141, wherein the pressure sensor is a differential pressure sensor.

[0324] 143. The instrument as described in any one of embodiments 121-142, wherein the first conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the first conduit.

[0325] 144. The instrument as described in any one of embodiments 121-143, wherein the instrument includes a plurality of flow regulating valves configured to independently control or regulate flow through each of a plurality of conduits, wherein the plurality of conduits includes at least a first conduit and a second conduit.

[0326] 145. The instrument as described in any one of embodiments 121-144, wherein the first conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the conduit.

[0327] 146. The instrument as described in embodiment 143 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

[0328] 147. The instrument as described in embodiment 143, wherein the flow regulating valve includes a control valve, gate valve, check valve, ball valve, stop valve, butterfly valve, diaphragm valve, needle valve, pinch valve, proportional valve, or stepper motor valve.

[0329] 148. The instrument as described in embodiment 143 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor.

[0330] 149. The instrument as described in embodiment 148, wherein the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through the first conduit.

[0331] 150. The instrument as described in any one of embodiments 143-149, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

[0332] 151. The instrument as described in any one of embodiments 146-149 further includes a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

[0333] 152. The instrument as described in embodiment 151, wherein at least one command is generated in part based on (i) user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from the first pressure sensor.

[0334] 153. The instrument as described in any one of embodiments 121-152, wherein the second conduit includes a pressure sensor.

[0335] 154. The instrument as described in embodiment 153, wherein the pressure sensor is a differential pressure sensor.

[0336] 155. The instrument as described in any one of embodiments 121-154, wherein the second conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the second conduit.

[0337] 156. The instrument as described in any one of embodiments 121-155, wherein the second conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the second conduit.

[0338] 157. The instrument as described in embodiment 155 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

[0339] 158. The instrument as described in embodiment 155 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from a pressure sensor.

[0340] 159. The instrument as described in embodiment 158, wherein the pressure sensor includes a differential pressure sensor, and wherein at least one measurement includes a real-time flow rate measurement through a second conduit.

[0341] 160. The instrument as described in any one of embodiments 155-159, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

[0342] 161. The instrument as described in any one of embodiments 157-159 further includes a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

[0343] 162. The instrument as described in embodiment 161, wherein at least one command is generated in part based on (i) user input corresponding to a desired pressure drop across the first conduit and (ii) one or more measurements obtained from the first pressure sensor.

[0344] 163. The instrument as described in any one of embodiments 121-162 further includes a controller.

[0345] 164. The instrument according to any one of embodiments 121-163 further includes a mating plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or inhaler relative to the first input port or the second input port.

[0346] 165. The instrument as described in embodiment 164, wherein the matching plane sensor is configured to detect the position of the first input port or the second input port relative to the movable platform.

[0347] 166. The instrument as described in embodiment 164, wherein the mating plane sensor is configured to detect when the inhaler is aligned with the first input port or the second input port.

[0348] 167. The instrument as described in embodiment 164, wherein the matching plane sensor is configured to detect the offset between the position or orientation of the inhaler and the position or orientation of the first input port or the second input port.

[0349] 168. The instrument as described in embodiment 164, wherein the matching plane sensor is configured to (i) obtain positioning information associated with at least one of the inhaler, the movable platform, or the first input port and the second input port, and (ii) provide the positioning information to the controller to adjust the position, orientation, movement, or movement path of the movable plate relative to the first input port or the second input port.

[0350] 169. The instrument as described in embodiment 164 further includes a controller configured to receive a plurality of inputs from a mating plane sensor and to adjust the position or orientation of a movable platform based at least in part on the plurality of inputs, the plurality of inputs including (i) positioning information of the movable platform and (ii) user input corresponding to the selection of a desired input port.

[0351] 170. The instrument as described in any one of embodiments 121-169, wherein the first inlet port and the second inlet port include a mating ring configured to be releasably coupled to the inhaler to form a seal.

[0352] 171. The instrument as described in any one of embodiments 121-170, wherein the inhaler includes a matching ring fitted to a portion of the inhaler.

[0353] 172. The instrument as described in embodiment 170 or 171, wherein the matching ring is configured to form a seal between the inhaler and the first or second inhaler when the inhaler is positioned adjacent to the first or second inhaler port.

[0354] 173. The instrument as described in embodiment 170 or 171, wherein the mating ring comprises a soft silicone rubber or a soft flexible material configured to form a reliable seal between the inhaler and the first inlet port or the second inlet port.

[0355] 174. The instrument as described in any one of embodiments 121-173, wherein at least one or two of the first or second conduit includes at least one, two or three of a laminar flow regulator, a flow tube or a flow tester.

[0356] 175. The instrument as described in any one of embodiments 121-174 further includes a third conduit, the third conduit including a third inlet port and a third fluid flow path, wherein the third fluid flow path is in fluid communication with the third inlet port.

[0357] 176. The instrument as described in embodiment 175, wherein the movable platform is configured to match the inhaler to at least one of a first inlet port, a second inlet port, or a third inlet port in response to user input corresponding to the selection of a desired input port.

[0358] 177. The instrument as described in embodiment 174, wherein the flow tester is configured to obtain one or more measurements corresponding to the flow rate or mass flow rate through the first conduit or the second conduit.

[0359] 178. The instrument as described in embodiment 174, wherein the flow tester is configured to provide one or more measurements to a mass flow controller, which is configured to adjust the operation of the breathing simulator.

[0360] While preferred embodiments of this disclosure have been shown and described herein, these embodiments will be apparent to those skilled in the art only by way of example. This disclosure is not limited to the specific examples provided in the specification. Although this disclosure has been described with reference to the foregoing specification, the description and illustration of embodiments herein are not intended to be construed as limiting. Many variations, alterations, and substitutions will now occur to those skilled in the art without departing from this disclosure. Furthermore, it should be understood that all aspects of this disclosure are not limited to the specific descriptions, configurations, or relative proportions described herein, and depend on various conditions and variables. It should be understood that various alternatives to the embodiments of this disclosure described herein may be employed in practice. Therefore, this disclosure is also intended to cover any such substitutions, modifications, variations, or equivalents. The following claims are intended to define the scope of this disclosure, and methods and structures within the scope of these claims and their equivalents are thereby covered.

Claims

1. A dose collection device, the dose collection device comprising: (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) A movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) An actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose. The first dose collector module includes a low-resistance filter configured to capture the dose provided by the inhaler.

2. A dose collection device, the dose collection device comprising: (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) A movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) An actuator configured to operate the inhaler to deliver a dose to at least one of a first catheter or a second catheter, wherein the dose includes a sample dose or a waste dose. The first dose collector module is an optical nebulizer or an aerosol analyzer.

3. A dose collection device, the dose collection device comprising: (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) A movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) An actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose. The dose collection instrument includes a manifold configured to converge the first conduit and the second conduit into an outlet conduit, wherein the outlet conduit includes an outlet port in fluid communication with a vacuum source.

4. A dose collection device, the dose collection device comprising: (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) A movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) An actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose. The first catheter and / or the second catheter include a pressure sensor.

5. A dose collection device, the dose collection device comprising: (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) A movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) An actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose. The dose collection instrument includes multiple flow control valves configured to independently control or regulate flow through each of a plurality of catheters, wherein the plurality of catheters includes at least the first catheter and the second catheter.

6. A dose collection device, the dose collection device comprising: (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) A movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; (d) An actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose; and (e) Matching a plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or the inhaler relative to the first inlet port or the second inlet port.

7. A dose collection device, the dose collection device comprising: (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) A movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) An actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose. At least one or two of the first conduit or the second conduit include at least one, two or three of a laminar flow regulator, a flow tube or a flow tester.

8. The dose collection instrument according to any one of claims 1-7, wherein the first dose collector module is a dose unit sampling instrument (DUSA).

9. The dose collection device of any one of claims 1-7, wherein the first dose collector module includes a low-resistance filter configured to capture the dose provided by the inhaler.

10. The dose collection instrument of claim 9, wherein the low-resistance filter is configured to retain aerosol particles with a particle size range of 0.1 micrometers to 10 micrometers.

11. The instrument of claim 9, wherein the low-resistance filter has a flow resistance of 150 Pascals at a flow rate of 90 liters of air per minute.

12. The dose collection instrument according to any one of claims 1-7, wherein the first dose collector module is a cascaded impactor.

13. The dose collection instrument according to any one of claims 1-7, wherein the first dose collector module is an optical nebulizer or an aerosol analyzer.

14. The dose collection instrument according to any one of claims 1-7, wherein the second dose collector module is a waste collector.

15. The dose collection instrument according to any one of claims 1-7, wherein the first inlet port is located at one end of the first catheter, and wherein the first dose collector module is located at the opposite end of the first catheter.

16. The dose collection instrument according to any one of claims 1-7, wherein the second inlet port is located at one end of the second catheter, and wherein the second dose collector module is located at the opposite end of the second catheter.

17. The dose collection instrument of any one of claims 1, 2, and 4-7, wherein the dose collection instrument includes a manifold configured to converge the first conduit and the second conduit into an outlet conduit, wherein the outlet conduit includes an outlet port in fluid communication with a vacuum source.

18. The dose collection device according to any one of claims 1-7, wherein at most one of the first catheter and the second catheter is operable at a given time.

19. The dose collection device of claim 17, wherein the vacuum source comprises a breathing simulator configured to guide (i) a flow from one end of the first or second catheter to the opposite end of the respective first or second catheter to simulate inhalation, and (ii) a flow in the opposite direction from the opposite end to the one end to simulate exhalation.

20. The dose collection device of claim 19, wherein the breathing simulator is configured to guide flow through at most one of the first conduit and the second conduit at a given time.

21. The dose collection instrument of claim 19, wherein the breathing simulator is configured to generate a user-programmable output trigger signal.

22. The dose collection instrument of claim 21, wherein the user-programmable output trigger signal is programmed to trigger at a user-specified time, which is within the time period required for the respiratory simulator to execute the respiratory curve.

23. The dose collection device according to any one of claims 1-7, wherein the actuator is configured to (i) shake the inhaler and / or (ii) actuate the inhaler to deliver the dose to at least one of the first catheter and the second catheter.

24. The dose collection instrument of claim 21, wherein the actuator is configured to receive the user-programmable output trigger signal.

25. The dose collection device of claim 24, wherein the actuator is configured to actuate the inhaler upon receiving the user-programmable output trigger signal.

26. The dose collection instrument according to any one of claims 1-7, wherein the first catheter includes a pressure sensor.

27. The dose collection instrument of claim 26, wherein the pressure sensor is a differential pressure sensor.

28. The dose collection instrument of any one of claims 1-7, wherein the first conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the first conduit.

29. The dose collection instrument of any one of claims 1-7, wherein the dose collection instrument comprises a plurality of flow regulating valves configured to independently control or regulate flow through each of a plurality of catheters, wherein the plurality of catheters comprises at least the first catheter and the second catheter.

30. The dose collection instrument according to any one of claims 1-7, wherein the first conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the first conduit.

31. The dose collection instrument of claim 28, further comprising an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

32. The dose collection instrument of claim 28, wherein the flow regulating valve includes a control valve.

33. The dose collection instrument of claim 28, wherein the flow regulating valve comprises: Gate valves, check valves, ball valves, globe valves, butterfly valves, diaphragm valves, needle valves, pinch valves, proportional valves, or stepper motor valves.

34. The dose collection instrument of claim 30, further comprising an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from the pressure sensor.

35. The dose collection instrument of claim 34, wherein the pressure sensor comprises a differential pressure sensor, and wherein the at least one measurement comprises a real-time flow rate measurement through the first conduit.

36. The dose collection instrument of claim 28, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

37. The dose collection instrument of claim 31, further comprising a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

38. The dose collection instrument of claim 37, wherein the at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the first catheter and (ii) one or more measurements obtained from a pressure sensor of the first catheter.

39. The dose collection instrument according to any one of claims 1-7, wherein the second catheter includes a pressure sensor.

40. The dose collection instrument of claim 39, wherein the pressure sensor is a differential pressure sensor.

41. The dose collection instrument according to any one of claims 1-7, wherein the second conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the second conduit.

42. The dose collection instrument according to any one of claims 1-7, wherein the second conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the second conduit.

43. The dose collection instrument of claim 41 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

44. The dose collection instrument of claim 42, further comprising an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from the pressure sensor.

45. The dose collection instrument of claim 44, wherein the pressure sensor comprises a differential pressure sensor, and wherein the at least one measurement comprises a real-time flow rate measurement through the second conduit.

46. ​​The dose collection instrument of claim 41, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

47. The dose collection instrument of claim 43 further includes a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

48. The dose collection instrument of claim 47, wherein at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the second catheter and (ii) one or more measurements obtained from a pressure sensor of the second catheter.

49. The dose collection instrument according to any one of claims 1-7, further comprising a controller.

50. The dose collection device of any one of claims 1-7, further comprising a mating plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or the inhaler relative to the first inlet port or the second inlet port.

51. The dose collection instrument of claim 50, wherein the matching plane sensor is configured to detect the position of the first inlet port or the second inlet port relative to the movable platform.

52. The dose collection instrument of claim 50, wherein the matching plane sensor is configured to detect when the inhaler is aligned with the first inlet port or the second inlet port.

53. The dose collection instrument of claim 50, wherein the matching plane sensor is configured to detect an offset between the position or orientation of the inhaler and the position or orientation of the first inlet port or the second inlet port.

54. The dose collection instrument of claim 50, wherein the matching plane sensor is configured to (i) obtain positioning information associated with the inhaler, the movable platform, or at least one of the first inlet port and the second inlet port, and (ii) provide the positioning information to a controller to adjust the position, orientation, movement, or movement path of the movable platform relative to the first inlet port or the second inlet port.

55. The dose collection instrument of claim 50 further includes a controller configured to receive a plurality of inputs from the mating plane sensor and to adjust the position or orientation of the movable platform based at least in part on the plurality of inputs, the plurality of inputs including (i) positioning information of the movable platform and (ii) user input corresponding to the selection of a desired inlet port.

56. The dose collection device of any one of claims 1-7, wherein the first inlet port and the second inlet port include a matching ring configured to be releasably coupled to the inhaler to form a seal.

57. The dose collection device of any one of claims 1-7, wherein the inhaler includes a matching ring fitted to a portion of the inhaler.

58. The dose collection device of claim 56, wherein the matching ring is configured to form a seal between the inhaler and the first inlet port or the second inlet port when the inhaler is positioned adjacent to the first inlet port or the second inlet port.

59. The dose collection device of claim 56, wherein the matching ring comprises soft silicone rubber or a soft flexible material configured to form a reliable seal between the inhaler and the first inlet port or the second inlet port.

60. The dose collection instrument according to any one of claims 1-7, wherein at least one or two of the first catheter or the second catheter comprises at least one, two or three of a laminar flow regulator, a flow tube or a flow detector.

61. The dose collection device according to any one of claims 1-7, further comprising a third conduit, the third conduit including a third inlet port and a third fluid flow path, wherein the third fluid flow path is in fluid communication with the third inlet port.

62. The dose collection device of claim 61, wherein the movable platform is configured to match the inhaler to at least one of the first inlet port, the second inlet port, or the third inlet port in response to user input corresponding to the selection of a desired inlet port.

63. The dose collection instrument of claim 60, wherein the flow detector is configured to obtain one or more measurements corresponding to the flow rate or mass flow rate through the first conduit or the second conduit.

64. The dose collection instrument of claim 63, wherein the flow detector is configured to provide the one or more measurements to a mass flow controller, the mass flow controller being configured to adjust the operation of the respiratory simulator.

65. A dose collection device, the dose collection device comprising: (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) A movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) An actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose. The first conduit and / or the second conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the first conduit and / or the second conduit, and wherein the flow regulating valve is a proportional valve.

66. A dose collection device, the dose collection device comprising: (a) A first catheter, the first catheter including a first inlet port and a first fluid flow path, wherein the first fluid flow path is in fluid communication with the first inlet port and a first dose collector module; (b) A second catheter, the second catheter including a second inlet port and a second fluid flow path, wherein the second fluid flow path is in fluid communication with the second inlet port and the second dose collector module; (c) A movable platform configured to match an inhaler to at least one of the first inlet port or the second inlet port; and (d) An actuator configured to operate the inhaler to deliver a dose to at least one of the first catheter or the second catheter, wherein the dose includes a sample dose or a waste dose. The inhaler includes a matching ring fitted onto a portion of the inhaler.

67. The dose collection instrument of claim 65 or 66, wherein the first dose collector module is a dose unit sampling instrument (DUSA).

68. The dose collection device of claim 65 or 66, wherein the first dose collector module includes a low-resistance filter configured to capture the dose provided by the inhaler.

69. The dose collection instrument of claim 68, wherein the low-resistance filter is configured to retain aerosol particles with a particle size range of 0.1 micrometers to 10 micrometers.

70. The dose collection instrument of claim 68, wherein the low-resistance filter has a flow resistance of 150 Pascals at a flow rate of 90 liters of air per minute.

71. The dose collection instrument of claim 65 or 66, wherein the first dose collector module is a cascaded impactor.

72. The dose collection instrument of claim 65 or 66, wherein the first dose collector module is an optical nebulizer or an aerosol analyzer.

73. The dose collection instrument of claim 65 or 66, wherein the second dose collector module is a waste collector.

74. The dose collection instrument of claim 65 or 66, wherein the first inlet port is located at one end of the first catheter, and wherein the first dose collector module is located at the opposite end of the first catheter.

75. The dose collection instrument of claim 65 or 66, wherein the second inlet port is located at one end of the second catheter, and wherein the second dose collector module is located at the opposite end of the second catheter.

76. The dose collection device of claim 65 or 66, wherein the dose collection device includes a manifold configured to converge the first conduit and the second conduit into an outlet conduit, wherein the outlet conduit includes an outlet port in fluid communication with a vacuum source.

77. The dose collection device of claim 65 or 66, wherein at most one of the first catheter and the second catheter is operable at a given time.

78. The dose collection device of claim 76, wherein the vacuum source comprises a breathing simulator configured to guide (i) a flow from one end of the first or second catheter to the opposite end of the corresponding first or second catheter to simulate inhalation, and (ii) a flow in the opposite direction from the opposite end to the one end to simulate exhalation.

79. The dose collection device of claim 78, wherein the breathing simulator is configured to guide flow through at most one of the first conduit and the second conduit at a given time.

80. The dose collection instrument of claim 78, wherein the breathing simulator is configured to generate a user-programmable output trigger signal.

81. The dose collection instrument of claim 80, wherein the user-programmable output trigger signal is programmed to trigger at a user-specified time, the user-specified time being within the time period required for the respiratory simulator to execute the respiratory curve.

82. The dose collection device of claim 65 or 66, wherein the actuator is configured to (i) shake the inhaler and / or (ii) actuate the inhaler to deliver the dose to at least one of the first catheter and the second catheter.

83. The dose collection instrument of claim 80, wherein the actuator is configured to receive the user-programmable output trigger signal.

84. The dose collection device of claim 83, wherein the actuator is configured to actuate the inhaler upon receiving the user-programmable output trigger signal.

85. The dose collection instrument of claim 65 or 66, wherein the first catheter includes a pressure sensor.

86. The dose collection instrument of claim 85, wherein the pressure sensor is a differential pressure sensor.

87. The dose collection instrument of claim 65 or 66, wherein the first conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the first conduit.

88. The dose collection instrument of claim 65 or 66, wherein the dose collection instrument includes a plurality of flow regulating valves configured to independently control or regulate flow through each of a plurality of catheters, wherein the plurality of catheters includes at least the first catheter and the second catheter.

89. The dose collection instrument of claim 65 or 66, wherein the first conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the first conduit.

90. The dose collection instrument of claim 87 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

91. The dose collection instrument of claim 87, wherein the flow regulating valve includes a control valve.

92. The dose collection instrument of claim 87, wherein the flow regulating valve comprises: Gate valves, check valves, ball valves, globe valves, butterfly valves, diaphragm valves, needle valves, pinch valves, proportional valves, or stepper motor valves.

93. The dose collection instrument of claim 89 further includes an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from the pressure sensor.

94. The dose collection instrument of claim 93, wherein the pressure sensor comprises a differential pressure sensor, and wherein the at least one measurement comprises a real-time flow rate measurement through the first conduit.

95. The dose collection instrument of claim 87, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

96. The dose collection instrument of claim 93, further comprising a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

97. The dose collection instrument of claim 96, wherein the at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the first catheter and (ii) one or more measurements obtained from the pressure sensor of the first catheter.

98. The dose collection instrument of claim 65 or 66, wherein the second catheter includes a pressure sensor.

99. The dose collection instrument of claim 98, wherein the pressure sensor is a differential pressure sensor.

100. The dose collection instrument of claim 65 or 66, wherein the second conduit includes a flow regulating valve configured to regulate the flow rate of fluid through the second conduit.

101. The dose collection instrument of claim 65 or 66, wherein the second conduit includes a pressure sensor and a flow regulating valve configured to regulate the flow rate of fluid through the second conduit.

102. The dose collection instrument of claim 100, further comprising an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve.

103. The dose collection instrument of claim 101, further comprising an electric motor operatively coupled to the flow control valve, wherein the electric motor is configured to control the flow control valve based on at least one measurement obtained from the pressure sensor.

104. The dose collection instrument of claim 103, wherein the pressure sensor comprises a differential pressure sensor, and wherein the at least one measurement comprises a real-time flow rate measurement through the second conduit.

105. The dose collection instrument of claim 100, wherein the flow regulating valve comprises a triple-biased butterfly valve or a proportional valve.

106. The dose collection instrument of claim 103, further comprising a controller configured to provide at least one command to the electric motor to gradually open and close the flow regulating valve to a predetermined position or orientation.

107. The dose collection instrument of claim 106, wherein the at least one command is generated in part based on (i) a user input corresponding to a desired pressure drop across the second catheter and (ii) one or more measurements obtained from the pressure sensor of the second catheter.

108. The dose collection instrument as claimed in claim 65 or 66, further comprising a controller.

109. The dose collection device of claim 65 or 66, further comprising a matching plane sensor configured to obtain positioning information of the movable platform, wherein the positioning information corresponds to the position or orientation of the movable platform or the inhaler relative to the first inlet port or the second inlet port.

110. The dose collection instrument of claim 109, wherein the matching plane sensor is configured to detect the position of the first inlet port or the second inlet port relative to the movable platform.

111. The dose collection instrument of claim 109, wherein the matching plane sensor is configured to detect when the inhaler is aligned with the first inlet port or the second inlet port.

112. The dose collection instrument of claim 109, wherein the matching plane sensor is configured to detect an offset between the position or orientation of the inhaler and the position or orientation of the first inlet port or the second inlet port.

113. The dose collection instrument of claim 109, wherein the matching plane sensor is configured to (i) obtain positioning information associated with the inhaler, the movable platform, or at least one of the first inlet port and the second inlet port, and (ii) provide the positioning information to a controller to adjust the position, orientation, movement, or movement path of the movable platform relative to the first inlet port or the second inlet port.

114. The dose collection instrument of claim 109 further includes a controller configured to receive a plurality of inputs from the mating plane sensor and to adjust the position or orientation of the movable platform based at least in part on the plurality of inputs, the plurality of inputs including (i) positioning information of the movable platform and (ii) user input corresponding to the selection of a desired inlet port.

115. The dose collection device of claim 65 or 66, wherein the first inlet port and the second inlet port include a matching ring configured to be releasably coupled to the inhaler to form a seal.

116. The dose collection device of claim 65 or 66, wherein the inhaler includes a matching ring fitted to a portion of the inhaler.

117. The dose collection device of claim 115, wherein the matching ring is configured to form a seal between the inhaler and the first inlet port or the second inlet port when the inhaler is positioned adjacent to the first inlet port or the second inlet port.

118. The dose collection device of claim 115, wherein the matching ring comprises soft silicone rubber or a soft flexible material configured to form a reliable seal between the inhaler and the first inlet port or the second inlet port.

119. The dose collection instrument of claim 65 or 66, wherein at least one or two of the first catheter or the second catheter comprises at least one, two or three of a laminar flow regulator, a flow tube or a flow detector.

120. The dose collection device of claim 65 or 66 further includes a third conduit, the third conduit including a third inlet port and a third fluid flow path, wherein the third fluid flow path is in fluid communication with the third inlet port.

121. The dose collection device of claim 120, wherein the movable platform is configured to match the inhaler to at least one of the first inlet port, the second inlet port, or the third inlet port in response to user input corresponding to the selection of a desired inlet port.

122. The dose collection instrument of claim 119, wherein the flow detector is configured to obtain one or more measurements corresponding to the flow rate or mass flow rate through the first conduit or the second conduit.

123. The dose collection instrument of claim 122, wherein the flow detector is configured to provide the one or more measurements to a mass flow controller, the mass flow controller being configured to adjust the operation of the respiratory simulator.

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