DUST INHALER KIT.

Abstract

A powder inhaler assembly comprises a powder inhaler (2) comprising a metering device (10) having a dosing recess (11) and being movable, with respect to a container (8) and an inhalation channel (9), between an inactive state, in which the dosing recess (11) is in communication with an opening (12) of the container (8) to be filled with a dose of the powdered drug, and an active state, in which the dosing recess (11) is in communication with the inhalation channel (9) to allow inhalation of a dose of the powdered drug contained in the dosing recess (11) through a mouthpiece (6). An electronic module (3) may be attached to the powder inhaler (2) and comprises a contactless sensor (29) positioned and configured to detect the position or positions of at least part of the metering device (10) to detect at least when the metering device (10) is in the active state.

Description

The present invention relates to a powder inhaler assembly, i.e., a device for dispensing a powdered medicament preparation by inhalation. The device is, in particular, a portable, multi-dose, breath-activated, propellant-free dry powder inhaler equipped with a metering device that dispenses doses from a medication container. The device is, in particular, a portable, multi-dose dry powder inhaler equipped with a removable electronic module configured to detect activation of the metering device and, possibly, other related functions. Background Art The administration of a powdered drug preparation by inhalation from an inhaler is common knowledge. Multidose powder inhalers, comprising a powder container and a metering member that measures and dispenses a unit dose, are also known. Document WO 2004 / 012801, from the same Applicant, discloses a powder inhaler comprising a container for storing a powdered drug, a metering member having a dosing recess to be filled with a dose of the powdered drug, and a mouthpiece communicating with an inhalation channel of the powder inhaler. The powder inhaler comprises a protective member that is movable by sliding over the metering member between a closed position, in which the protective member covers the dosing recess of the metering member when the metering member is in an inhalation position, and an open position, in which the protective member exposes the dosing recess, thereby permitting inhalation of the dose of powdered drug contained in the dosing recess.The protective member is coupled to an inhalation-actuated mechanism such that the inhalation-actuated mechanism moves the protective member from its closed to its open position if the inhalation suction force exerted by a user exceeds a predetermined level. The mechanical structure of the powder inhaler described in WO 2004 / 012801 can provide a powder inhaler with improved dosing capacity, thus preventing unintentional dosing. Nowadays, every user possesses such an electronic device. QRnann / zznz / B / GALA, such as a computer, smartphone, or tablet, with applications that could be used in everyday life and that could be useful for managing medication administration. Document WO 2016 / 000983, from the same Applicant, discloses a powder inhaler similar to that in document WO 2004 / 012801. The powder inhaler of documents WO 2004 / 012801 and WO 2016 / 000983 does not comprise any electronic device that interacts with an external electronic device. Inhalers equipped with electronic devices configured to detect the activation of the inhaler itself and / or to collect data are also known. US patent 6182655 discloses a multi-dose inhaler for administering a dry powder medication. Externally, the inhaler consists of a cartridge and a removable protective cap attached to a mouthpiece. Internally, it includes a sliding rail, a dosing slide, a plug, a carriage, a funnel assembly, a counter, a valve protector, and a valve guide. Removing the protective cap initiates dosing, with the dosing slide delivering a dose from the dosing cavity to the mouthpiece. The inhaler can be equipped with a plug-in, reusable electronic module and a controllable mouthpiece to record inhalation-relevant data and regulate flow conditions.To measure the parameters, membrane / flex beam technology or a piezoresistive element in combination with a diaphragm or the Venturi measurement principle is used. To monitor the inhalation procedure, a mechanically and / or electronically generated acoustic and / or optical signal can be emitted at the end of a successful or failed inhalation. US patent 6182655 does not disclose in detail the structure of the reusable electronic module and how it monitors the inhalation procedure. Furthermore, the sensors used are configured to detect airflow and are neither reliable nor fail-safe. US patent 5505195 discloses a dry powder inhalation device adapted for mounting on a conventional dry powder medication dispenser that has a mouthpiece incorporated at one end of the dispenser. The QRnann / zznz / B / GALA device is designed to monitor prescribed doses of dry powder medication delivered through the mouthpiece, lips, and into the mouth, throat, and respiratory system of a device user. The device includes an electronic cartridge mounted in the dispenser to calculate and record when an appropriate amount of dry powder is released into the dispenser, when an appropriate amount of airflow is inhaled through the dispenser to mix it with the dry powder, and when each dispenser or dry powder container is removed and replaced in the electronic cartridge. US5505195 detects drug dispensing using a thermistor, a pressure device, or an audio element to detect the user's inhalation airflow. These sensors are neither reliable nor fail-safe. Furthermore, the dry powder inhalation device design described in US5505195 cannot prevent unintentional dosing as it does in WO 2004 / 01280. WO2015 / 133909 discloses a compliance monitor for monitoring patient use of a dry powder drug delivery device. The drug delivery device includes a drug reservoir housed within a main body portion and a base portion that can rotate relative to the main body portion. The drug delivery device also includes a drug dispensing means for dispensing a dose of drug into an inhalation chamber, a mouthpiece through which a user can inhale the dose of drug, and a replaceable cap. The compliance monitor includes a first portion for receiving and / or retaining the base portion of the drug delivery device and a second portion for releasably securing the drug delivery device to the first portion.The compliance monitor may also include an electronic control module, which is adapted to monitor, manipulate, store, and / or transmit all collected compliance data related to the patient's use of the medication delivery device. An optical dose detector may be used to detect rotation of the base portion relative to the main body portion. Furthermore, the structure of the dry powder inhalation device of document WO2015 / 133909 cannot prevent unintentional dosing as QRnann / zznz / Β / γΐΛΐ does so in document WO 2004 / 01280. Summary One objective of the present invention is to eliminate the previous drawbacks of powder inhalers known to date and to provide a powder inhaler with improved electronic detection of drug dosage. In particular, an objective of the present invention is to provide a powder inhaler assembly equipped with an electronic module capable of detecting the movement of the mechanical parts of the powder inhaler to infer the dosage of the drug in a safe and reliable manner. Another objective of the present invention is to provide an electronic module capable of reading the movements of such mechanical parts of the powder inhaler without making relevant structural modifications to existing powder inhalers, such as, for example, the one disclosed in document WO 2004 / 012801 or WO 2016 / 000983 of the same Applicant. At least one of the above objectives is substantially achieved by means of an assembly, of an electronic module and a powder inhaler according to one or more of the appended claims and / or the following aspects. The aspects of the invention are disclosed below. According to a first independent aspect, a powder inhaler assembly comprises: a powder inhaler comprising: a container for storing powdered medicine; a mouthpiece and an inhalation channel connected to the mouthpiece; A metering device having a dosage recess; wherein the metering device is movable, with respect to the container and the inhalation channel, between an inactive state, in which the dosage recess is in communication with an opening in the container to be filled with a dose of the powdered drug, and an active state, in which the dosage recess is in communication with the inhalation channel to allow inhalation of the dose of powdered drug contained in the dosage recess through the mouthpiece. QRnann / zznz / B / γΐΛΐ The powder inhaler assembly also includes: an electronic module attached or capable of being attached to the powder inhaler and comprising: a contactless sensor, optionally an optical proximity sensor, located and configured to detect the position or positions of at least part of the measuring device to detect at least when the measuring device is in the active state. In a second independent aspect, an electronic module is attached or can be attached to a powder inhaler. The powder inhaler comprises: a container for storing powdered medicine; a mouthpiece and an inhalation channel connected to the mouthpiece; A metering device having a dosage recess; wherein the metering device is movable, with respect to the container and the inhalation channel, between an inactive state, in which the dosage recess is in communication with an opening in the container to be filled with a dose of the powdered drug, and an active state, in which the dosage recess is in communication with the inhalation channel to allow inhalation of the dose of powdered drug contained in the dosage recess through the mouthpiece. The electronic module comprises: a contactless sensor located and configured to detect the position or positions of at least part of the measuring device to detect at least when the measuring device is in the active state; wherein the contactless sensor is an optical proximity sensor. In a third, independent aspect, a powder inhaler comprises: a container for storing powdered medicine; a mouthpiece and an inhalation channel connected to the mouthpiece; A metering device having a dosage recess; wherein the metering device is movable, with respect to the container and the inhalation channel, between an inactive state, in which the dosage recess is in communication with an opening in the container for filling with a dose of the powdered drug, and an active state, in which the dosage recess is in communication with the inhalation channel to allow the QRnann / zznz / Β / γΐΛΐ inhalation of the dose of the powdered medicine contained in the dosage recess through the mouthpiece; a housing having a respective window; wherein the measuring device and, optionally, the container and the inhalation channel are housed in the housing; wherein the measuring device is visible at least partially through the window; where the powder inhaler is configured to attach to an electronic module comprising an optical proximity sensor; wherein when the electronic module is attached to the powder inhaler, the window of the housing is oriented towards a window of a cartridge of the electronic module so that the optical proximity sensor is oriented towards at least part of the measuring device to detect the position or positions of at least said part of the measuring device to detect at least when the measuring device is in the active state. The Applicant has verified that the invention allows for the safe and reliable dispensing of a medication dose by reading the configuration, position, and actuation of the mechanical metering device of the powder inhaler via a contactless sensor. The powder inhaler incorporates a breath-actuated mechanism, which is activated when an inspiratory flow exceeds the minimum level required to move the balanced part of the mechanism. This, in turn, releases the metered dose present in the dosage recess. Actuation is achieved by releasing a spring component, the coupling member, which then moves a transparent plastic piece, called the dose shield, forward, thus exposing the formulation to the inhalation channel within the mouthpiece.The attached electronic module is configured to detect at least part of this activation of the mechanism, thereby inferring the release of the metered dose. The Applicant has verified that the invention allows this detection to be carried out without making relevant structural modifications to existing powder inhalers, such as, for example, those disclosed in WO 2004 / 012801 or WO 2016 / 000983. In fact, there is no direct access to the internal volume of the powder inhaler. In one respect, the electronic module can be detachably attached to the powder inhaler, optionally, via a snap-on coupling. QRnann / zznz / Β / γΐΛΐ coupling and uncoupling is easy and fast. In one respect, the electronic module, once detached from a powder inhaler, is reusable with another powder inhaler. The same electronic module can be used with a new powder inhaler once the medication in an old inhaler has run out. In one aspect, the container is filled or configured to be filled with an amount of powdered medicine corresponding to a plurality of doses, optionally 100-200 doses. In one respect, a contactless sensor is a proximity sensor. A proximity sensor is a sensor capable of detecting the presence of nearby objects without any physical contact. A proximity sensor emits an electromagnetic field or a beam of electromagnetic radiation and looks for changes in the field or the return signal. Examples of proximity sensors include capacitive sensors, inductive sensors, optical sensors, and photoelectric sensors. In one respect, the proximity sensor is an optical proximity sensor. In one respect, the optical proximity sensor operates in the near-infrared spectrum. In one aspect, the optical proximity sensor detects changes in reflected electromagnetic waves, optionally light, due to movements of at least part of the measuring device. In one respect, the powder inhaler comprises a housing, optionally a plastic housing, and the electronic module comprises a cartridge, optionally a plastic cartridge. In one respect, the cartridge can be attached removably to the housing, optionally by hooking the cartridge to the housing or hooking the housing to the cartridge. In one respect, the container, the inhalation channel, and the measuring device are housed in the casing. In one aspect, the casing has a respective window and the cartridge has a respective window. In one respect, when the electronic module is attached to the powder inhaler, the window in the housing is oriented towards the cartridge window so that the optical proximity sensor is oriented towards at least part of the measuring device. QRnann / zznz / B / γΐΛΐ In one respect, the optical proximity sensor is located in the cartridge. In one respect, the housing window and the cartridge window are optically transparent. These windows are transparent in the electromagnetic spectrum relevant to the optical proximity sensor. There is no relevant modification to existing inhalers, e.g., those disclosed in WO 2004 / 012801 or WO2016 / 000983, apart from a small, optically transparent window that forms part of the inhaler's outer cover. This window is located directly below the part of the mechanism that is activated by the user's inhalation. In one aspect, the optical proximity sensor comprises an emitter that emits light, optionally in the near-infrared spectrum, and an optical receiver with a photosensitive part; wherein an output signal from the optical receiver depends on electromagnetic waves, optionally light, reflected by at least said part of the measuring device. In one aspect, the emitter is an LED (light emitting diode) or a VCSEL (vertical cavity surface emitting laser). In one respect, the electronic module comprises an electronic control unit, optionally a microprocessor, which is operationally connected to the contactless sensor. In one respect, the optical proximity sensor or electronic control unit comprises a blocking amplifier configured to eliminate light noise, in particular to eliminate the contribution of outside light. In one respect, the shape and / or size of the housing window and / or cartridge window are configured to change the field of view (optical mask) of the optical proximity sensor to improve the detection of the position or positions of at least that part of the measuring device. In one aspect, a pinhole sensor cover is interposed between the optical proximity sensor and at least that part of the measuring device to change the field of view (optical mask) of the optical proximity sensor in order to improve the detection of the position or positions of at least that part of the measuring device. In one respect, at least one lens is interposed between the optical proximity sensor and at least that part of the measuring device to better redirect and / or regenerate an image of the emitted light and / or reflected light. QRnann / zznz / B / γΐΛΐ In one respect, the pinhole sensor cover and / or at least one lens is part of the electronic module and / or the powder inhaler. In one aspect, the electronic module comprises a printed circuit board (PCB). In one aspect, the electronic module comprises a storage memory. In one aspect, the electronic module comprises a communication interface, optionally a wireless communication interface, and optionally a Bluetooth communication interface. The communication interface is configured to connect the electronic module to an external device, such as a computer, smartphone, tablet, or similar device. All operating parameters and data of the powder inhaler detected by the electronic module can be transferred to the external device. In one respect, the electronic module comprises at least one battery to power the contactless sensor, the electronic control unit, and the communication interface. In one aspect, the contactless sensor, electronic control unit, communication interface, storage memory, and battery are mounted on the printed circuit board. In one respect, the electronic control unit is placed in the cartridge. In one respect, the electronic control unit is configured to carry out the execution of a task comprising at least the following steps: reading an output signal from the non-contact sensor at regular intervals; optionally, filtering and, optionally, normalizing the output; Compare the output to a threshold value and discern whether the measuring device is in the active state or not. In one aspect, the reading of the output signal of the non-contact sensor is carried out at a rate greater than 10 Hz, optionally greater than 100 Hz, optionally greater than 25 Hz (at regular intervals less than 100 ms, optionally less than 10 ms, optionally less than 40 ms). In one respect, the optical components of the proximity sensor are only activated for a fraction of a millisecond, optionally ranging from 100 to 300 ps, ​​or optionally from 125 ps, and can be considered that QRnann / zznz / Β / γΐΛΐ take a snapshot of the current position of the measuring device at regular intervals. In one aspect, a signal processing algorithm is implemented within the electronic control unit to filter the output. In one respect, the signal processing is carried out, at least in part, by the contactless sensor. In one aspect, the filtering of the output, optionally through the signal processing algorithm, comprises: apply a median filter to a plurality of samples where the output of the median filter selects an item after ranking the samples in ascending order; subtract the previous output of the median filter from the current output of the median filter. In one aspect, the metering device comprises: a shuttle having the dosing recess. In one aspect, the shuttle is movable between a filling position, corresponding to the inactive state of the metering device, in which the dosing recess is aligned with the opening of the container for filling with the dose of the powdered drug, and an inhalation position, corresponding at least to the active state of the metering device, in which the dosing recess is aligned with the inhalation channel. In one aspect, the shuttle is movable in a sliding manner between the filling position and the inhalation position. In one aspect, the measuring device comprises: a protective member provided between the shuttle and the inhalation channel. In one aspect, the movable protective member moves between a closed position, in which the protective member covers the dosage recess of the shuttle when the shuttle is in the inhalation position, thereby preventing the powdered drug contained in the dosage recess from entering the inhalation channel, and an open position, in which the protective member does not cover the dosage recess, thereby leaving the dosage recess exposed to the inhalation channel to allow inhalation of the dose of powdered drug contained in the dosage recess. In one aspect, the protective member is arranged on the movable shuttle in a sliding manner between the closed and open positions. QRnann / zznz / B / γΐΛΐ In one respect, the contactless sensor is positioned and configured to detect the position or positions of at least the shuttle and / or the protective member. In one aspect, in the active state, the shuttle is in the inhalation position and the protective limb is in the open position. In one respect, the measuring device is mobile, with respect to the container and the inhalation channel, in an armed state, in which the shuttle is in the inhalation position and the protective member is in the closed position. In one respect, the contactless sensor is positioned and configured to detect the transition between the armed state and the active state. In one aspect, the dust inhaler comprises an inhalation- or breath-actuated mechanism coupled to the protective member such that, if the protective member is in the closed position, the inhalation-actuated mechanism causes the protective member to move to the open position if an inhalation suction force produced by a user exceeds a predetermined value. In one aspect, the inhalation-actuated mechanism comprises an inhalation-actuated member, optionally a flap, which is movable between a first position and a second position; the inhalation-actuated member being coupled to the protective member so that, if there is an inhalation suction force that exceeds the predetermined value, the inhalation-actuated member moves from the first position to the second position, thereby causing the protective member to move from the closed position to the open position. In one respect, the contactless sensor is positioned and configured to detect the position of at least part of the inhalation-actuated mechanism. In one aspect, the optical proximity sensor detects changes in reflected electromagnetic waves, optionally light, due to the movements of at least part of the inhalation-driven mechanism. In one aspect, the inhalation-actuated mechanism comprises a coupling member, which couples the inhalation-actuated member to the protective member. In one aspect, the inhalation-driven mechanism comprises at least one elastic element, optionally arranged in the coupling member. QRnann / zznz / B / γΐΛΐ In one respect, the elastic element is arranged so that the elastic element keeps the inhalation-driven member in its first position when the lid is closed and the shuttle is in the filling position. In one respect, when the shuttle is pushed forward to the inhalation position by opening the lid, the elastic element releases the inhalation-driven member, to allow the inhalation-driven member to move from its first position to its second position by an inhalation suction force that exceeds the predetermined value. In one aspect, the coupling member comprises an extension that is assembled with an opening formed in the protective member. In one aspect, the extension of the coupling member is movably arranged in a longitudinal opening, which is formed in the shuttle along its longitudinal direction, so that the extension of the coupling member can move freely in the longitudinal opening of the shuttle from its initial position to its final position, while a movement of the shuttle from the inhalation position to the filling position causes the extension of the coupling member to abut against an edge of the longitudinal opening, thereby moving the coupling member back to its initial position. In one respect, the non-contact sensor is positioned and configured to detect the position of at least part of the coupling member, optionally, of the extension of the coupling member. In one respect, the contactless sensor is positioned and configured to detect the position of at least part of the measuring device and / or at least part of the inhalation-actuated mechanism. In one aspect, the optical proximity sensor detects changes in reflected electromagnetic waves, optionally light, due to the movements of the shuttle and / or the protective member and / or the coupling member, optionally, the extension of the coupling member. In one respect, the protective member has a surface that reflects light specularly, and the shuttle has a surface that reflects light diffusely. In one respect, the coupling member has a surface that diffusely reflects light. QRnann / zznz / B / γΐΛΐ In one respect, the shielding member has a smooth surface finish that reflects light specularly (mirror-like reflection), while the other two components, the shuttle and the docking member, reflect light more diffusely, also known as scattered reflection. In one respect, the shuttle and / or the protective member and / or the coupling member has or have at least one marker detectable by the optical proximity sensor. In one respect, the marker is part of the shuttle and / or the protective member and / or the coupling member or is an accessory attached to said shuttle and / or protective member and / or coupling member. In one respect, the marker is a diffuse reflection marker or a specular reflection marker. In one respect, the marker is a diffuse reflection marker placed on a specular reflection surface, e.g., the surface of the protective member or shuttle. In one respect, the marker is a specular reflection marker placed on a diffuse reflection surface, e.g., the surface of the coupling member. In one respect, the contactless sensor detects the transition to the active state when light is reflected primarily by the protective member. In one respect, the output signal of the optical receiver reaches a maximum when the light is reflected mainly by the protective member. In one respect, when the protective member is in the open position, said protective member is oriented towards the non-contact sensor. In one respect, the overall light received by the optical proximity sensor is governed by the combination of light reflected from the three parts (shield member, coupling member, and shuttle) and will be at its maximum level when the dominant reflecting source is the dose shield. Due to the position of the optical proximity sensor, this occurs when the inhalation-activated mechanism of the powder inhaler is triggered. In one respect, the powder inhaler comprises the housing and a lid rotatably attached to the housing. In one respect, the electronic module is attached or can be attached to a portion of the powder inhaler opposite the cap. QRnann / zznz / B / γΐΛΐ In one respect, the lid is movable between a closed position, in which it covers the nozzle, and an open position, in which it leaves the nozzle exposed. In one aspect, the electronic module comprises an open lid switch. In one respect, the open lid switch is operationally connected to the electronic control unit. In one respect, opening the lid beyond a range of rotary movement of the lid from the closed position of said lid causes the shuttle to move from the filling position to the inhalation position. In one respect, opening the lid beyond a certain range of rotational movement from the lid's closed position activates the open lid switch, which triggers the contactless sensor. In one respect, this range of rotary motion is approximately 80 degrees. In one respect, closing the lid causes the shuttle to move from the inhalation position to the filling position. In one respect, closing the lid releases the open lid switch, causing the contactless sensor to be deactivated. In one respect, the contactless sensor (and the detection of the measuring device's status) is only activated when the lid is open beyond that range of rotary movement. In one aspect, the open cover switch comprises a mechanical detector switch and a spring-loaded mechanical part, optionally, in the form of an arm. In one respect, the spring-loaded mechanical part is movable between a rest position, when the lid is in the closed position, in which it does not activate the mechanical detector switch, and an operating position, when the lid is in the open position, in which it presses the mechanical detector switch. In one respect, a spring is configured to move the spring-driven mechanical part to the rest position when the lid is in the closed position. In one aspect, the electronic module comprises a bonding detection switch that interacts with the powder inhaler when the electronic module is bonded to the powder inhaler. QRnann / zznz / B / γΐΛΐ In one aspect, the junction detection switch is a mechanical detector switch. In one respect, the junction detection switch is operationally connected to the electronic control unit. In one respect, the attachment of the electronic module to the powder inhaler activates the attachment detection switch, which triggers the open lid switch. In one respect, separating the electronic module from the powder inhaler releases the bond detection switch, causing the open lid switch to be deactivated. In one respect, the closed or open state of the lid is only monitored when the electronic module is attached. In one respect, the electronic module used mechanical switches to determine, a) when it is attached to the inhaler, and b) when the inhaler cap is open and, therefore, an actuation of the internal mechanism can occur. In one respect, the electronic module is configured to differentiate three states: The inactive state in which the electronic module is attached to the powder inhaler, the attachment detection switch is active, the lid is closed and the lid open switch is released and no inhalation can occur; the armed state in which the lid is open, the lid open switch is active and the metering device can be activated; the active state in which an inspiratory flow has released the protective member and a metered dose can be dispensed. In one aspect, the electronic control unit is configured to store in the storage memory and / or send to the external device, via the communication interface, data related to events of the powder inhaler, such as, for example, the activation of the measuring device and / or the joining / separation of the electronic module to / from the powder inhaler and / or the opening / closing of the lid. In one respect, the electronic control unit is configured first to store such data in the storage memory and then, after a delay time, send said data to the external device. QRnann / zznz / B / γΐΛΐ In one respect, the electronic control unit is configured to send this data to the external device on demand. The data can only be stored in the electronic control unit while no connection to an external device is available. Therefore, the electronic control unit does not require an external device to function correctly and store data. Description of the drawings Figure 1 shows an isometric view of a powder inhaler assembly according to the present invention in a closed configuration; Figure 2 shows an isometric view of a powder inhaler assembly according to the present invention in an open configuration; Figure 3 shows an isometric view of an electronic module of the powder inhaler assembly of Figures 1 and 2; Figure 4 shows another isometric view of the electronic module from Figure 3; Figure 5 is a cross-sectional view of the powder inhaler assembly of the previous figures in a first state; Figure 6 is an enlarged portion of Figure 5; Figure 7 is a cross-sectional view of the powder inhaler assembly of the previous figures in a second state; Figure 8 is an enlarged portion of Figure 7; Figure 9 is a cross-sectional view of the powder inhaler assembly of the previous figures in a third state; Figure 10 is an enlarged portion of Figure 9; Figure 11 shows an isometric view of some internal elements of the powder inhaler; Figure 12 shows another isometric view of the internal elements of Figure 11; Figure 13 shows an additional isometric view of the internal elements of Figure 11; Figure 14 is a portion of the electronic module in a respective configuration; Figure 15 shows the portion of Figure 14 in another configuration; Figure 16 shows diagrams of a signal related to the powder inhaler assembly of the previous figures. QRnann / zznz / B / γΐΛΐ Detailed description With reference to the accompanying drawings, Figures 1 and 2 show a powder inhaler assembly 1 according to the present invention. The powder inhaler assembly 1 comprises a powder inhaler 2 and an electronic module 3. The powder inhaler 2 may be substantially the same as that disclosed in WO 2004 / 012801 or WO 2016 / 000983 of the same Applicant. Therefore, the following description will only detail the main parts and the differences with respect to WO 2004 / 012801 or WO 2016 / 000983. Powder inhaler The powder inhaler 2 shown in Figure 1 comprises a housing 4 and a cap 5 pivotally or rotatably attached to the housing 4. As can be seen in Figure 2, the cap 5 can be opened to reveal a mouthpiece 6 through which a user can inhale a powdered medication. On the upper front side of the mouthpiece 6, slots 7 are formed in the housing 4 to allow air to enter. The powder inhaler 2 comprises a container 8 for storing a powdered medication, an inhalation channel 9 connected to the mouthpiece 6, and a metering device 10. The inhalation channel 9 has a first opening connected to the mouthpiece and a second opening, opposite the first opening. As shown in Figures 5, 7, and 9, all these elements are housed inside the casing 4. Container 8 is filled or configured to be filled with an amount of powdered medicine corresponding to a plurality of doses, e.g., up to 100-200 doses. The metering device 10 is movable, with respect to the container 8 and with respect to the inhalation channel 9, between an inactive state, in which a dosage recess 11 is in communication with an opening 12 of the container 8 to be filled with a dose of the powdered drug, and an active state, in which the dosage recess 11 is in communication with the inhalation channel 9 to allow inhalation of a dose of the powdered drug contained in the dosage recess 11 through the mouthpiece 6. The metering device 10 comprises a shuttle 13 having the dosing recess 11 formed on an upper face as a cup-shaped recess. QRnann / zznz / B / YiAi The shuttle 13 slides between a filling position (Figure 5) and an inhalation position (Figures 7 and 9). The filling position corresponds to the inactive state (Figure 5) of the metering device 10, in which the dosage recess is aligned with the opening 12 of the container 8 for filling with the dose of powdered medication. The inhalation position corresponds to an armed state (Figure 7), which will be described later, and to the active state (Figure 9) of the metering device 10, in which the dosage recess 11 is aligned with the inhalation channel 9. Shuttle 13 is mechanically coupled to cap 5 such that opening cap 5 beyond a certain range of rotational movement from the closed position causes shuttle 13 to move from the filling position to the inhalation position. Closing cap 5 causes shuttle 13 to move from the inhalation position back to the filling position. Figure 5 shows cap 5 in the closed position and shuttle 13 in the filling position. Figures 7 and 9 show cap 5 in the open position and shuttle 13 in the inhalation position. For example, the range of rotational movement that causes the shuttle to slide from the filling position to the inhalation position is eighty degrees. The measuring device 10 further comprises a protective member 14 provided between the shuttle 13 and the inhalation channel 9. The protective member 14 is a transparent or semi-transparent plate disposed between the second opening of the inhalation channel 9 and the shuttle 13. The protective member 14 has a smooth surface finish that reflects light specularly (mirror-like reflection). The protective member 14 is parallel to the shuttle 13 and slides along the shuttle 13 between a closed and an open position. In the closed position, the protective member 14 moves rearward toward the second inhalation channel opening 9 and the canister 8. In the closed position, a rear portion of the protective member 14 may at least partially close the second inhalation channel opening 9. In the open position, the protective member 14 moves forward toward a wall of the housing 4. In the open position, a rear portion of the protective member 14 leaves the second inhalation channel opening 9 open. The protective member 14 is in the closed position when the shuttle 13 QRnann / zznz / B / GALA is in the filling position. The protective member 14 can move between the closed and open positions when the shuttle 13 is in the inhalation position. Therefore, the measuring device 10 is configured to adopt the three different states mentioned above (inactive, armed, active), and these states are determined by the positions of the shuttle 13 and the protective member 14, as disclosed in Table 1 below. QRnann / zznz / B / γΐΛΐ Table 1 Measuring device status Shuttle position Protective member position Figures Inactive Filling Closed 5 and 6 Arming Inhalation Closed 7 and 8 Active Inhalation Open 9 and 10 In the inactive state of Figures 5 and 6, the shuttle 13 is in the filling position and the protective member 14 is in the closed position. The protective member 14 does not cover the dosing recess 11. The dosing recess 11 is in communication with the opening 12 of the container 8 to receive the drug dose. In the armed state of Figures 7 and 8, the shuttle 13 is in the inhalation position and the protective member 14 is in the closed position. The protective member 14 covers the dosage recess 11. The protective member 14 prevents the powdered medication contained in the dosage recess 11 from entering the inhalation channel 9 and being lost if the inhaler is turned or moved to an oblique position before the inhalation maneuver or if the user blows into the mouthpiece. In the active state of Figures 9 and 10, the shuttle 13 is in the inhalation position and the protective member 14 is in the open position. The protective member 14 does not cover the dosage recess 11, thereby leaving the dosage recess 11 exposed to the inhalation channel 9 to allow a user to inhale the dose of powdered medication contained in the dosage recess 11. The powder inhaler 2 comprises an inhalation- or breath-actuated mechanism 15 coupled to the protective member 14. The inhalation-actuated mechanism 15 comprises a flap-shaped inhalation-actuated member 16, a coupling member 17, and an elastic element 18 disposed on the coupling member 17 (see Figures 11, 12, and 13). An additional elastic element, not shown in the accompanying drawings, can be mounted on the coupling member 17 on a side opposite the elastic element 18 (as in WO 2016 / 000983). The flap 16 is coupled to the protective member 14 via the coupling member 17 such that, if there is an inhalation suction force exceeding a predetermined value, the flap 16 moves from a first position to a second position, thereby moving the protective member 14 from the closed position to the open position.The flap 16 is positioned inside the housing 4 and near the slots 7. In the first position (Figure 5), the flap 16 separates the slots 7 from the inhalation channel 9 and sits in a primary airflow path. The flap 16 offers resistance if the user blows into the device, providing a positive response. In the second position (Figure 9), the flap 16 rotates relative to the first position to open the slots 7 and allow air to flow through the slots 7 into the inhalation channel 9 and out through the mouthpiece 6. The elastic element 18 is arranged so that it holds the flap 16 in its first position. When the shuttle 13 is pushed forward, upon opening the lid 5, the elastic element 18 is compressed and loaded, releasing the restoring force exerted on the flap 16. This allows the flap 16 to pivot or rotate from the first position to the second position; that is, it pivots downwards from the first position if there is a sufficiently high inhalation suction force in the inhalation channel 9. The additional elastic element imparts a suitable force on the coupling member 17, which is released during inhalation. The downward movement of the flap 16 during inhalation releases some of the force exerted by the additional elastic element on the coupling member 17, while closing the lid 5 tensions the additional elastic element. With reference to Figures 11 to 13, flap 16 is hinged to housing 4 to rotate between the first and second positions about a respective pivot axis XX, which is substantially perpendicular to a main axis ZZ of the inhalation channel 9 (Figures 5, 7, and 9). The coupling member 17 is also hinged to housing 4 to rotate between a first and second position about a respective pivot axis YY, which is substantially perpendicular to the main axis ZZ of the inhalation channel 9. QRnann / zznz / Β / γΐΛΐ parallel to the axis of rotation XX. The coupling member 17 comprises an arm 19 projecting into the flap 16 and assembled with the flap 16 such that (with reference to Figures 5, 7, 9, 11, 12 and 13) counterclockwise rotation of the flap 16 from the first position to the second position causes clockwise rotation of the coupling member 17 from its respective first position to its respective second position. The coupling member 17 comprises an extension 20 that is assembled with an opening 21 formed in the protective member 14 to move the protective member 14 from the closed position to the open position when the coupling member 17 is moved from its respective first position to its respective second position and vice versa. The extension 20 of the coupling member 17 is also movably arranged in a longitudinal opening 22 formed in the shuttle 13 along its longitudinal direction, such that said extension 20 can move freely in the longitudinal opening 22, while a movement of the shuttle 13 from the inhalation position to the filling position causes the extension 20 of the coupling member 17 to abut against an edge of the longitudinal opening 22, thereby moving the coupling member 20 back to its first initial position. The housing 4 has an optically transparent window 23 positioned near the measuring device 10 such that the measuring device 10 is at least partially visible through the window 23 from outside the housing 4. In particular, the shuttle 13, the protective member 14, and a terminal end of the extension 20 are visible through the window 23. While the protective member 14 has a smooth surface finish that reflects light specularly (mirror-like reflection), the shuttle 13 and the extension 20 reflect light more diffusely (scattered reflection). All elements of the powder inhaler 2 can be made of a plastic material. Electronic module The electronic module 3 is configured to be detachably attached to the powder inhaler 2 so that the same electronic module 3 can be used with a new powder inhaler 2 once the medication in the old inhaler has been used up. In the embodiment shown in the accompanying Figures, the QRnann / zznz / B / γΐΛΐ electronic module 3 is attached or can be attached to a portion of the powder inhaler 2 opposite the cap 5. The electronic module 3 comprises a plastic cartridge 24 that can be removably attached to the powder inhaler housing 4 via a snap-on coupling. The non-limiting embodiment of the cartridge 24 of the electronic module 3 shown in the accompanying Figures comprises a rigid snap-on 25 and a flexible snap-on 26 shaped to engage in respective recesses in the powder inhaler housing 4. The cartridge 24 has an upper face configured to be oriented, when the electronic module 3 is attached to the powder inhaler 2, towards a lower face of the powder inhaler 2 that has the optically transparent window 23. Likewise, the upper face of the electronic module 3 is provided with a respective optically transparent window 27, and, when the electronic module 3 is attached to the powder inhaler 2, the window 23 of the housing 4 is oriented towards the window 27 of the cartridge 24. A printed circuit board (PCB) 28 is housed inside the cartridge 24. The PCB 28 contains a microprocessor, a wireless communication interface (e.g., Bluetooth), and a storage memory electronically connected to each other. The communication interface is configured to connect the electronic module to an external device, such as a computer, smartphone, tablet, or similar device. All operating parameters and data of the powder inhaler 2 detected by the electronic module 3 can be stored in the storage memory and / or transferred to the external device. A contactless sensor 29 is mounted on the printed circuit board (PCB) 28 and is operatively connected to the microprocessor. The contactless sensor 29 shown in the accompanying figures is an optical proximity sensor and comprises a side-by-side emitter and receiver. The emitter emits light, e.g., in the near-infrared spectrum, and the receiver is an optical receiver with a photosensitive element. The emitter can be an LED (light-emitting diode) or a VCSEL (vertical cavity surface-emitting laser). The position of the optical proximity sensor 29 on the printed circuit board (PCB) 28 and the position of the printed circuit board (PCB) 28 in the cartridge 24 are such that the optical proximity sensor 29 is located in the cartridge 24 and is oriented toward the window. QRnann / zznz / Β / γΐΛΐ optically transparent 27 of said cartridge 24. The emitted and reflected light from the optical proximity sensor 29 passes through the optically transparent window 27 of the cartridge 24. When the electronic module 3 is attached to the powder inhaler 2, the optical proximity sensor 29 is oriented towards the shuttle 13, the protective member 14, and one end of the extension 20. The output signal of the optical receiver depends on the amount of light reflected by these parts. The optical proximity sensor 29 is positioned and configured to detect the position(s) of at least part of the measuring device 10 when the measuring device 10 is in the active state. In particular, the optical proximity sensor 29 is positioned and configured to detect the position(s) of the shuttle 13, the protective member 14, and the extension 20 of the coupling member 17. To ensure adequate optical detection of the measuring device (in order to better detect signal changes due to movement of the measuring device 10), the shape and / or size of the window 23 of the housing 4 of the powder inhaler 2 and / or the window 27 of the plastic housing 24 of the electronic module 3 can be configured to change the original field of view (optical mask) of the optical proximity sensor 29. The electronic module 3 further comprises a junction detection switch 30 that interacts with the powder inhaler 2 when the electronic module 3 is attached to the powder inhaler 2.The junction detection switch 30 is a mechanical detector switch mounted on the printed circuit board (PCB) 28, operatively connected to the microprocessor and comprising a pin 31 that protrudes from the top face of the cartridge 24 through a respective opening (Figures 3, 4, 14 and 15) to mechanically interact with the powder inhaler 2 when the electronic module 3 is attached to the powder inhaler 2. The electronic module 3 further comprises an open-cap switch 32 operatively connected to the microprocessor. The open-cap switch 32 comprises (Figures 4, 14, and 15) a mechanical sensor switch 33 mounted on the printed circuit board (PCB) 28 and operatively connected to the microprocessor, and a spring-loaded mechanical arm 34. A portion of this arm 34 is positioned outside the cartridge 24 of the electronic module 3 to mechanically interact with the cap 5 of the powder inhaler 2 when the cap 5 QRnann / zznz / B / GALA opens beyond a certain range of rotational movement of said lid 5 from the closed position. When the lid 5 is closed, the arm 34 is in a rest position in which it does not activate the mechanical detector switch 33. When the lid 5 opens beyond this range of rotational movement, the arm 34 is in an operating position in which it presses the mechanical detector switch 33. A spring is configured to move the spring-loaded arm 34 back to the rest position when the lid 5 is again in the closed position. Connecting the electronic module 3 to the powder inhaler 2 activates the connection detection switch 30, which in turn activates the open lid switch 32. The open or closed state of the lid 5 is only monitored when the electronic module 3 is connected. Opening the lid 5 beyond a certain rotational range, e.g., to 80 degrees, activates the open lid switch 32, which in turn activates the optical proximity sensor 29. Closing the lid 5 releases the open lid switch 32, which in turn deactivates the optical proximity sensor 29. Separating the electronic module 3 from the powder inhaler 2 releases the connection detection switch 30, which in turn deactivates the open lid switch 32. The electronic module 3 uses the bonding detection switch 30 and the open lid switch 32 to determine, a) when the electronic module 3 is bonded to the powder inhaler 2, and b) when the lid of the powder inhaler 5 is open and, therefore, an actuation of the internal mechanism can occur. The electronic module 3 further comprises a battery 35 mounted on the printed circuit board (PCB) 28 and configured to power the electronic components, such as the optical proximity sensor 29, the microprocessor, the communication interface, the storage memory, the junction detection switch 30, and the open lid switch 32. Figures 5 and 6 show the electronic module 3 attached to the powder inhaler 2 to form the powder inhaler assembly 1 with the measuring device 10 in the inactive state, where the lid 5 is closed. In the inactive state, the junction detection switch 30 is active, the open lid switch 32 is activated, and the optical proximity sensor 29 is deactivated. The emitter of the optical proximity sensor 29 does not emit any light. Figures 7 and 8 show the powder inhaler assembly with the measuring device 10 in the armed state, where the cover 5 is open. In the In the armed state, the open cover switch 32 is active and the optical proximity sensor 29 is activated. The emitter emits light towards the shuttle 13, the protective member 14, and the terminal end of the extension 20. The light is reflected by the shuttle 13, the protective member 14, and the terminal end of the extension 20 (reflecting the light in a scattered manner) and captured by the optical receiver. The microprocessor reads an output signal from the optical receiver at regular intervals, e.g., at a frequency of 25 Hz (every 40 ms). The optical receiver is only active for a fraction of a millisecond, e.g., 125 ps, and can be considered to take a snapshot of the current position of the measuring device at regular intervals. Inhalation by the user causes the measuring device 10 to move to the active state shown in Figures 9 and 10, in which the emitted light strikes and is reflected primarily by the protective member 14 (which reflects light specularly) and is then captured by the optical receiver. Once the inhalation-activated mechanism 15 is triggered, the measuring device 10 takes approximately 4 ms to transition from its armed to its active state. This transition is detected by the optical proximity sensor 29, when the light is reflected primarily by the protective member 14, thus indicating the activation of the inhalation-activated mechanism 15. The top graph in Figure 16 shows an example of a time series output from the optical proximity sensor 29 during activation of the inhaler's internal mechanism. The optical proximity sensor 29 counts, starting around 1140 (baseline reading), suddenly increase around 2.5 s, reaching over 1160, resulting in a difference in signal levels (contrast) of more than 20. Variations in the sensor output can also be observed at 1.2 s and 3.8 s in the graphs due to mechanical forces resulting from manual handling of the powder inhaler assembly, as well as the movement of the mouthpiece cap 5, which is directly linked to the position of the shuttle 13. To differentiate between these signals and the signal caused by the state transition of the measuring device 10 and the inhalation-actuated mechanism 15, a signal processing algorithm is implemented within the microprocessor. This algorithm can be considered a type of edge detector, as it is tuned to respond to the rapid increase in the positive signal caused by the QRnann / zznz / Β / γΐΛΐ transition movement of extension 20 of coupling member 17 and of protective member 14 when the powder inhaler 2 is activated to release a metered dose. The algorithm performs the following task: applies a median filter to the last seven samples where the output of the median filter selects the fourth element after ranking the samples in ascending order; subtracts the previous output of the median filter from the current output of the median filter; this requires a valid previous output of the median filter to produce a value; It compares the previously obtained value with a threshold and decides that it is active if the value is higher than the threshold, and not active otherwise. Figure 16 shows the filtered signal (center graph) as well as the algorithm's output signal over time (bottom graph) as a function of the received reflected light. As shown in the bottom graph of Figure 16, activation of the inhalation-actuated mechanism 15 and the measuring device 10 at approximately 2.5 s in the graph results in a sharp peak of more than 20 counts in the algorithm's output, which is detected as a successful activation. The behavior described above means that the electronic module 3 can infer successful release of the metered dose drug formulation if it is correctly attached to the powder inhaler 2 and is actively monitoring the position of the internal mechanisms, mainly the shuttle 13, extension 20 and protective member 14, so that it can capture the rapid transition that occurs when inspiratory flow triggers drug release. The electronic module 3 may be provided with indicators 36, such as LEDs, operatively connected to the printed circuit board (RGB) 28 and located on the cartridge 24 so that they are visible to the user. These indicators may provide information on the status of the powder inhaler 2. For example, the indicators may show whether the electronic module 3 is correctly attached to the powder inhaler 2 and / or the successful release of the metered dose of medication and / or whether the electronic module 3 is wirelessly connected to the external device and / or whether the cap 5 is open or closed. QRnann / zznz / B / γΐΛΐ Some embodiments, not shown, for improving the optical detection of moving parts and configurations of the measuring device 10, the shuttle 13 and / or the protective member 14 and / or the coupling member 17 have or have at least one diffuse reflection marker or a specular reflection marker easily detectable by the optical proximity sensor 29. For example, a diffuse reflection marker can be attached to the specular reflection surface of the protective member 14 so that it is oriented towards the optical proximity sensor 29. In some other embodiments, not shown, the position of the optical proximity sensor 29 with respect to the measuring device 10 may differ from that shown in Figures 5 to 10, so that the detected parts or parts of the measuring device 10 may also differ. With reference to Figures 6, 8, and 10, the optical proximity sensor 29 may be positioned slightly further to the left on the printed circuit board (RGB) 28. In one embodiment, when the measuring device 10 is in the armed state, the emitted light is incident upon and reflected primarily by the transparent protective member 14 (which reflects light specularly), and when the measuring device 10 is in the active state, the emitted light is incident upon and reflected primarily by the diffuse reflection marker of the protective member 14.In one embodiment, when the measuring device 10 is in the armed state, the emitted light is incident upon and reflected primarily by the transparent protective member 14 (which reflects the light specularly), and when the measuring device 10 is in the active state, the emitted light is incident upon and reflected primarily by the coupling member 17 (which reflects the light diffusely). In another embodiment, when the measuring device 10 is in the armed state, the emitted light is not incident upon anything, and when the measuring device 10 is in the active state, the emitted light is incident upon and reflected primarily by the diffuse reflection marker of the protective member 14. In some other embodiments, not shown, a pinhole sensor cover (a cover with a small opening) and / or at least one lens, not shown, may be interposed between the optical proximity sensor 29 and at least that part of the measuring device 10. The pinhole sensor cover and / or the lens may be located in the plastic cartridge 24 of the electronic module 3 or in the housing 4 of the powder inhaler 2. These elements may be useful for better detecting signal changes due to movement of the measuring device 10. QRnann / zznz / B / γΐΛΐ The pinhole sensor cover is adapted to change the original field of view (optical mask) of the proximity optical sensor 29 (in addition to or instead of the shape and / or size of the window 23 of the housing 4 and / or the window 27 of the plastic cartridge 24). The lens is used to redirect and / or reproduce the emitted and / or reflected light. The emitted light can be better focused on the objective part of the measuring device 10. The reflected light can be better reproduced in the optical receiver. The optical proximity sensor 29 or the electronic control unit of other embodiments may comprise a blocking amplifier configured to eliminate noise, in particular, to eliminate noise due to the contribution of light signals from outside the housing (e.g., ambient light). A blocking amplifier is a well-known type of amplifier that can extract a signal with a known carrier wave from a noisy environment.

Claims

1. Powder inhaler assembly, comprising: a powder inhaler (2) comprising: a container (8) for storing a powdered drug; a mouthpiece (6) and an inhalation channel (9) connected to the mouthpiece (6); a metering device (10) having a dosing recess (11); wherein the metering device (10) is movable, with respect to the container (8) and the inhalation channel (9), between an inactive state, in which the dosing recess (11) is in communication with an opening (12) of the container (8) to be filled with a dose of the powdered drug, and an active state, in which the dosing recess (11) is in communication with the inhalation channel (9) to permit inhalation of a dose of the powdered drug contained in the dosing recess (11) through the mouthpiece (6);an electronic module (3) attached or capable of being attached to the powder inhaler (2) and comprising: a contactless sensor (29) located and configured to detect the position or positions of at least part of the measuring device (10) to detect at least when the measuring device (10) is in the active state.; 2. Assembly according to claim 1, wherein the powder inhaler (2) comprises a housing (4) and the electronic module (3) comprises a cartridge (24); wherein the measuring device (10) and, optionally, the canister (8) and the inhalation channel (9) are housed in the housing (4); wherein the housing (4) has a respective window (23) and the cartridge (24) has a respective window (27); wherein, when the electronic module (3) is attached to the powder inhaler (2), the window (23) of the housing (4) is oriented towards the window (27) of the cartridge (24) such that the contactless sensor (29) is at least partially oriented towards the measuring member (10). QRnann / zznz / B / GALA 3. Assembly according to claim 2, wherein the contactless sensor (29) is an optical proximity sensor, which, optionally, operates in the near infrared spectrum, and the window (23) of the housing (4) and the window (27) of the cartridge (24) are optically transparent windows.

4. Assembly according to any of claims 1 to 3, wherein the metering device (10) comprises: a shuttle (13) having the dosing recess (11), wherein the shuttle (13) is movable between a filling position, corresponding to the inactive state of the metering device (10), in which the dosing recess (11) is aligned with the opening (12) of the container (8) to be filled with the dose of the powdered drug, and an inhalation position, corresponding at least to the active state of the metering device (10), in which the dosing recess (11) is aligned with the inhalation channel (9);a protective member (14) provided between the shuttle (13) and the inhalation channel (9), the protective member (14) being movable between a closed position, in which the protective member (14) covers the dosage recess (11) of the shuttle (13) when the shuttle (13) is in the inhalation position, thereby preventing the powdered drug contained in the dosage recess (11) from entering the inhalation channel (9), and an open position, in which the protective member (14) does not cover the dosage recess (11), thereby leaving the dosage recess (11) uncovered opposite the inhalation channel (9) to allow inhalation of the dose of powdered drug contained in the dosage recess (11); wherein the contactless sensor (29) is located and configured to detect the position or positions of the shuttle (13) and / or the protective member (14).

5. Assembly according to claim 4, wherein the measuring device (10) is movable with respect to the container (8) and the inhalation channel (9) in an armed state, wherein the shuttle (13) is in the inhalation position and the protective member (14) is in the closed position; wherein the contactless sensor (29) is positioned and configured to detect the transition between the armed state and the active state. QRnann / zznz / B / γΐΛΐ 6. Assembly according to claim 4 or 5, wherein the powder inhaler (2) comprises an inhalation-actuated mechanism (15) coupled to the protective member (14) such that, if the protective member (14) is in the closed position, the inhalation-actuated mechanism (15) causes the protective member (14) to move to the open position if an inhalation suction force being produced by a user exceeds a predetermined value; wherein the contactless sensor (29) is positioned and configured to detect the position or positions of at least part of the inhalation-actuated mechanism (15).

7. Assembly according to claim 6, wherein the inhalation-actuated mechanism (15) comprises an inhalation-actuated member (15) and a coupling member (17) coupling the inhalation-actuated member (15) to the protective member (14), the contactless sensor (29) being positioned and configured to detect the position of at least part of the coupling member (17).

8. Assembly according to claim 7, wherein claim 4 depends on claim 3, wherein the optical proximity sensor (29) is configured to detect changes in reflected electromagnetic waves, optionally light, due to movements of the shuttle (13) and / or the protective member (14) and / or the coupling member (17).

9. Assembly according to any of claims 4 to 8, wherein, when the protective member (14) is in the open position, said protective member (14) is oriented towards the non-contact sensor (29).

10. Assembly according to any of claims 1 to 9, wherein the electronic module (3) comprises an electronic control unit operatively connected to the contactless sensor (29), wherein the electronic control unit and / or the contactless sensor (29) are configured to perform a task comprising at least the following steps: reading an output signal from the contactless sensor (29), optionally at regular intervals; optionally, filtering the output; comparing the output with a threshold value and discerning whether the measuring device (10) is in the active state or not.

11. Assembly according to any one of claims 1 to 10, wherein the powder inhaler (2) comprises a housing (4) and a cap (5) rotatably coupled to the housing (4) such that the cap (5) is movable between a closed position, in which it covers the mouthpiece (6), and an open position, in which it leaves the mouthpiece (6) uncovered; wherein the electronic module (3) comprises an open cap switch (32); wherein an opening of the cap (5) beyond a range of rotary movement of the cap (5) from the closed position of said cap (5) causes the shuttle (13) to move from the filling position to the inhalation position and activates the open cap switch (32), thereby activating the contactless sensor (29);where closing the lid (5) causes the shuttle (13) to move from the inhalation position to the filling position and releases the lid open switch (32), which causes the contactless sensor (29) to be deactivated.

12. Assembly according to claim 11, wherein the electronic module (3) comprises a bonding detection switch (30) that interacts with the powder inhaler (2) when the electronic module (3) is bonded to the powder inhaler (2); wherein bonding the electronic module (3) to the powder inhaler (2) activates the bonding detection switch (30), causing the open lid switch (32) to be activated; wherein separating the electronic module (3) from the powder inhaler (2) releases the bonding detection switch (30), causing the open lid switch (32) to be deactivated.

13. Assembly according to any of claims 1 to 12, wherein the electronic module (3) can be removably attached to the powder inhaler (2), optionally, via a snap-on coupling.

14. Assembly according to any of claims 1 to 13, wherein the electronic module (3) comprises an electronic control unit and a storage memory, wherein the electronic control unit is configured first to store data in the storage memory and then, after a delay time, to send said data to an external device.

15. Electronic module attached or capable of being attached to a powder inhaler, wherein the powder inhaler (2) comprises: a container (8) for storing a powdered drug; a mouthpiece (6) and an inhalation channel (9) connected to the mouthpiece (6); a metering device (10) having a dosing recess (11); wherein the metering device (10) is movable, with respect to the container (8) and the inhalation channel (9), between an inactive state, wherein the dosing recess (11) is in communication with an opening in the container (8) to be filled with a dose of the powdered drug, and an active state, wherein the dosing recess (11) is in communication with the inhalation channel (9) to permit inhalation of a dose of the powdered drug contained in the dosing recess (11) through the mouthpiece (6);wherein the electronic module (3) comprises: a contactless sensor (29) located and configured to detect the position or positions of at least part of the measuring device (10) to detect at least when the measuring device (10) is in the active state; wherein the contactless sensor (29) is an optical proximity sensor, which, optionally, operates in the near-infrared spectrum.

16. Electronic module according to claim 15, comprising a storage memory, wherein the electronic control unit is configured first to store data in the storage memory and then, after a delay time, send said data to an external device.

17. A powder inhaler comprising: a container (8) for storing a powdered drug; a mouthpiece (6) and an inhalation channel (9) connected to the mouthpiece (6); a metering device (10) having a dosing recess (11); wherein the metering device (10) is movable, with respect to the container (8) and the inhalation channel (9), between an inactive state, in which the dosing recess (11) is in communication with an opening (12) of the container (8) to be filled with a dose of the powdered drug, and an active state, in which the dosing recess (11) is in communication with the inhalation channel (9) to permit the inhalation of a dose of the powdered drug contained in the dosing recess (11) through the mouthpiece (6); a housing (4) having a respective window (23); wherein the container (8), the inhalation channel (9) and the measuring device (10) are housed in the casing (4);wherein the measuring device (10) is visible at least partially through the window (23); wherein the powder inhaler (2) is configured to be attached to an electronic module (3) comprising an optical proximity sensor (29); wherein when the electronic module (3) is attached to the powder inhaler (2), the window (23) of the housing (4) is oriented towards a window (27) of a cartridge (24) of the electronic module (3) such that the optical proximity sensor (29) is oriented at least partially towards the measuring device (10) to detect the position or positions of at least said part of the measuring device (10) to detect at least when the measuring device (10) is in the active state.

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