DEVICE FOR DISPENSING MEDICINES AND METHOD FOR CONTROLLING EXPIRATION DATES OF MEDICINE DISPENSER - Patent application

Abstract

The device for dispensing medicines comprises a dispenser and a portable electronic device. An application loaded on the portable electronic device or a remote location receives and optionally stores the dispenser data and the read date Tread when the reading device reads the machine-readable code on the read date Tread, and if the machine-readable code is read for the first time after the manufacture of the dispenser, the read date Tread and the usable period ΔT in_use From expiry date Texp in_use Calculate and store the expiration date Texp and / or start the expiration counter. in_use and / or usable period ΔT in_use It is configured to enable warnings depending on the expiration date Texp in_use or when the available period ΔT in_use When the time has elapsed or is about to elapse, the portable electronic device issues a warning.

Description

[Technical field]

[0001] The present invention relates to a device for administering medicine and a method for managing the expiry date of a medicine dispenser. In particular, the present invention relates to improving the safety features of handheld medicine dispensers such as (but not limited to) dry powder inhalers DPI or pressurized metered dose inhalers pMDI or soft mist inhalers SMI to assist patients in using their medicine correctly. [Background technology]

[0002] It is commonly known to dispense doses of a medicament from a dispenser containing multiple doses of the medicament, the dispenser comprising a dispensing device configured to dispense unit doses of the medicament when a metering device is actuated by a user.

[0003] For example, a multi-dose dry powder inhaler (DPI) is a widely used device available for delivering medicament to the lungs. The applicant's WO 2004 / 012801 discloses a dry powder inhaler comprising a container for containing multiple doses of powdered medicament, a metering member having a dosing recess into which the dose of powdered medicament is loaded, and a mouthpiece communicating with an inhalation channel of the dry powder inhaler. The dry powder inhaler further comprises an inhalation actuation mechanism by which medicament is dispensed for inhalation by the user if or when the user applies an inhalation force above a predetermined level.

[0004] Pressurized metered dose inhalers (pMDIs) are also widely used to deliver medicine to the lungs. European Patent Specification No. 2890437 by the same applicant discloses an aerosol inhalation device comprising a housing adapted to receive an aerosol canister containing a pressurized medicine formulation, a mouthpiece portion through which a user inhales, and a nozzle block having an orifice which serves to propel the aerosol formulation into the mouthpiece portion.

[0005] EP 3370810 discloses an example of a soft mist inhaler (SMI) that includes an atomizer for atomizing a fluid.

[0006] Another type of multi-dose dry powder inhaler is disclosed in WO2004011071 and comprises a blister strip containing a number of individual doses of powdered medicament and a mechanism for accessing these doses, either with piercing means or means for peeling the lid sheet from the base sheet.

[0007] Regardless of the type of dispenser known, the expiration date of the medication is typically printed on the packaging of the dispenser or included in a machine-readable code on a label or tag, such as a bar code or QR code. The expiration date may be printed or included in a machine-readable code when the dispenser is manufactured or packaged.

[0008] In some circumstances, the multiple doses of medicament in a dispenser may be affected by environmental conditions such as humidity and / or temperature and / or light and / or pressure and / or other contaminants that may affect the properties of the medicament (e.g., sterility) once the dispenser is in the hands of a user and first used. For example, a multiple dose of medicament in a housing of a DPI or a canister of a pMDI or SMI is a quantity of material sufficient to provide many unit doses, but which may not be divided into sealed individual doses when contained in the housing. The blisters of a multiple dose dry powder inhaler such as those disclosed in WO2004011071 are not made of suitable materials to protect each single dose from environmental conditions.

[0009] For example, once removed from the sealed packaging, moisture may affect the medication in a dry powder inhaler (DPI) and / or the medication may no longer be sterile, so the product may need to be discarded after a period of use, for example six months after removal from the sealed packaging, even if the dispenser is not empty and has not yet reached its expiration date.

[0010] Also, some types of MDIs are stored in sealed packaging after manufacture and before first use. Other types of MDIs are stored in a refrigerator during distribution and storage at the pharmacy, and when the patient begins using the device, they do not need to be stored in a refrigerator and are stored at room temperature. In that case, the product may have a usable life of three or four months (from removal from the refrigerator) after which it is discarded.

[0011] Therefore, these medications that may be affected by environmental conditions may have two expiration dates: the expiration date mentioned above, and a use-by date, which is calculated from the first use of the dispenser, i.e., the time the dispenser / medication is first exposed to normal environmental conditions, e.g., a DPI is removed from its sealed packaging or an MDI is removed from the refrigerator.

[0012] Because the time when a patient will first use the product is unknown at the time of manufacture, an expiration date cannot be printed on the dispenser or its packaging or included in a machine readable code.

[0013] Thus, known dispensers require the user to calculate the expiration date from the usable period listed in the instruction manual and must make note of when they first started using the product so that they can discard it after the expiration date.

[0014] There is a high risk that users will forget to take notes, and so there is a real risk that drugs will be used after they have lost their efficacy and / or safety, or will be discarded when they are still usable.

[0015] Also, if a user has multiple inhalers, the user must separately identify each inhaler, which can lead to confusion.

[0016] EP 3349719 discloses a method for counting doses of medicament dispensed by an inhaler. WO 2012 / 004298 discloses a drug delivery system comprising a control means adapted to store information indicative of a recommended maximum period of use of the reservoir assembly. US 2014 / 0155827 discloses an emergency drug device, such as an epinephrine auto-injector, including a memory for storing and a display for displaying the expiration date of the drug. EP 3348295 discloses a drug injection device capable of controlling the expiration date of a drug formulation after the formulation has been used. Summary of the Invention

[0017] SUMMARY OF THE PRESENT EMBODIMENT An object of the present invention is to overcome the above-mentioned drawbacks of previously known dispensers.

[0018] A first object of the present invention is to provide a drug delivery system with improved safety.

[0019] It is also an object of the present invention to provide a system that allows users / patients to more easily take their medication.

[0020] It is also an object of the present invention to provide a system that allows a user / patient to order new prescriptions in a timely manner, thereby preventing the risk of drug shortages.

[0021] At least one of the above objects is substantially achieved by a device for administering medicines and a method for managing the expiry date of a medicine dispenser according to the appended claims and / or one or more of the following aspects.

[0022] Aspects of the present invention are disclosed below.

[0023] According to a first independent aspect, a device for administering a medicament comprises: a dispenser including a housing, a dispensing device connected to the housing, optionally a metering device, and a multi-dose amount of a medicament contained in the housing, the dispenser configured to dispense unit doses of the medicament when the dispensing device is actuated by a user; A label or tag including a machine-readable code containing or linked to dispenser data, affixed to the dispenser and / or included or attached to the dispenser packaging, wherein the dispenser data indicates the shelf life of the drug, ΔT in_use a label or tag comprising: a portable electronic device including an electronic control unit and a reader configured to read dispenser data from the machine readable code; an application loaded onto the electronic control unit or, optionally, at a remote location accessed via a network connection (e.g., a web-based application); Equipped with The application is When the reading device reads the machine-readable code on the reading date Tread, the dispenser data and said reading date are received and optionally stored, and if at least one of said data of the dispenser is new, indicating that the machine-readable code has been read for the first time since the manufacture of the dispenser, Reading date Tread and usable period ΔT in_use From expiry date Texp in_use , Texp in_use =Tread+ΔT in_use and / or start an expiration counter, Expiration date Texp in_use and / or usable period ΔT in_use Enable at least one warning depending on the expiration date Texp in_use When the usable period ΔT in_use the portable electronic device issuing said at least one alert when said at least one warning period has elapsed or is about to elapse; is configured to run

[0024] According to a second independent aspect, a method for managing an expiry date of a drug dispenser comprises: Reading and optionally storing dispenser data and a reading date from a machine-readable code of a label or tag fixed to the dispenser of the drug and / or included or attached to the packaging of the dispenser via a reader of the portable electronic device, wherein the dispenser data is used to determine the usable period ΔT in_use and If at least one of the data of the dispenser is new, indicating that the machine-readable code has been read for the first time since the manufacture of the dispenser, Reading date Tread and usable period ΔT in_use From expiry date Texp in_use , Texp in_use =Tread+ΔT in_use and / or starting an expiration counter; Expiration date Texp in_use and / or usable period ΔT in_use enabling at least one warning in response to Expiration date Texp in_use and / or when the usable period ΔT in_use issuing said at least one alert via the portable electronic device when said at least one warning period has elapsed or is about to elapse; Includes.

[0025] According to a third independent aspect, an application for managing the medicament dispenser is loaded or configured to be loaded onto an electronic control unit of the portable electronic device or, optionally, at a remote location accessed via a network connection (e.g. a web-based application), When the reader of the portable electronic device reads the machine-readable code on the reading date Tread, the dispenser data and the reading date are received and optionally stored, and the dispenser data is used to calculate the usable period ΔT of the drug contained in the dispenser. in_use and if at least one of the data of the dispenser is new, indicating that the machine-readable code has been read for the first time since the manufacture of the dispenser, Reading date Tread and usable period ΔT in_use From expiry date Texp in_use , Texp in_use =Tread+ΔT in_use and / or start an expiration counter, Expiration date Texp in_use and / or usable period ΔT in_use Enable at least one warning depending on the expiration date Texp in_use When the usable period ΔT in_use When the time has elapsed or is about to elapse, the portable electronic device issues the at least one warning.

[0026] The present invention helps to ensure that the user / patient does not use the medication after the expiration date. In fact, the expiration counter / clock and the countdown to the expiration date are only started when the dispenser is used for the first time (e.g., removed from the packaging). In this way, the present invention prevents the user / patient from taking the medication after it has passed its expiration date.

[0027] Indeed, after the expiration date, a drug may not be effective within its specifications, and patients may not receive a sufficient dose of the drug to treat their illness. Therefore, any product that has passed its expiration date should be discarded, even if there are doses remaining.

[0028] The present invention is particularly useful, but not limited to, when the medication is prescribed as a "relief" or "as needed" product to be used only when the patient feels short of breath. In such situations, it is very difficult for the patient to know how long the product will last. In such situations, it is much more likely that the device will reach its expiration date and still have a dose remaining.

[0029] The present invention also provides further benefits and technical advantages.

[0030] For example, the present invention may enable a user / patient to take medication more easily and / or allow the user / patient to order new prescriptions in a timely manner, thus preventing the risk of running out of medication.

[0031] Further aspects of the invention are disclosed below.

[0032] In a fourth aspect according to at least one of the first to third aspects, if said data of the dispenser is new, indicating that the machine readable code is read for the first time after the manufacture of the dispenser, the read date Tread is recorded and / or labelled as the date of first use after the manufacture of the dispenser (i.e. when the dispenser / medication is exposed for the first time to normal environmental conditions, such as room temperature and / or moisture and / or light and / or pressure and / or other contamination). Optionally, the read date Tread or the date of first use is used for commercial reasons to know how long it takes from manufacture to reach patients in a particular country to get a better understanding of the supply chain.

[0033] In a fifth aspect related to at least one of the first to fourth aspects, enabling at least one warning includes enabling a final warning.

[0034] In a sixth aspect according to the fifth aspect, the issuing of the at least one warning is performed by an expiration date Texp in_use and / or when the usable period ΔTin_use This includes issuing a final warning when the

[0035] In a seventh aspect related to at least one of the first to sixth aspects, enabling the at least one warning includes enabling at least one pre-warning.

[0036] In an eighth aspect according to the seventh aspect, issuing the at least one warning includes issuing an alert when the expiration date Texp in_use and / or before the usable period ΔT in_use The method includes providing at least one advance warning before the expiration of the period.

[0037] This allows a warning to be given to the user / patient when the product is nearing the end of its useful life.

[0038] In a ninth aspect according to at least one of the first to eighth aspects, the dispenser data further comprises an expiration date Texp.

[0039] In a tenth aspect according to the ninth aspect, the method further comprises: in_use Compared with the expiration date Texp in_use occurs after the expiration date Texp and / or the usable period ΔT in_use elapses after the expiry date Texp, issuing a further warning, or the application is configured to perform said step.

[0040] In this case, the user / patient can immediately return the dispenser to the pharmacy and obtain another dispenser.

[0041] In an eleventh aspect related to at least one of the first to tenth aspects, the dispenser data includes a unique identifier of the dispenser.

[0042] In a twelfth embodiment according to the eleventh embodiment, the method further comprises: in_use and / or usable period ΔT in_use The method includes, or the application is configured to perform, a step of enabling management of a plurality of dispensers in association with the

[0043] In a thirteenth aspect relating to at least one of the first to twelfth aspects, the method is configured to display, or have the application execute, a status indicating that the machine-readable code has already been read via an output device of the portable electronic device if the dispenser data is not new (i.e., identified as having already been read by the portable electronic device and, e.g., already present in the electronic control unit or at a remote location),

[0044] If the patient owns more than one dispenser, the machine readable code can be read again to verify that the dispenser that should be discarded has been discarded (i.e., recognizing that the first use date for that dispenser has already been stored / labeled).

[0045] In a fourteenth aspect according to at least one of the first to thirteenth aspects, the dispenser data comprises further information regarding the dispenser and the medicament, such as drug, dosage, manufacturing location or batch number.

[0046] In a fifteenth aspect according to at least one of the first to fourteenth aspects, the method further comprises the steps of: if the dispenser data is not new (i.e., is identified as having already been read by the portable electronic device and is, for example, already present in the electronic control unit or in a remote location), outputting, via an output device of the portable electronic device, a remaining usable time ΔT remain or the application is configured to perform the steps of:

[0047] In a sixteenth aspect relating to at least one of the first to fifteenth aspects, the method includes, in addition to the step of enabling at least one warning, a step of enabling further notifications and / or links, such as a notification informing the patient when to take the medicine, a notification informing the patient that the product is empty when all the prescribed doses have been taken (this allows the patient to know how well they have complied with the prescription), instructions for use, a video on how to use the device and a link to disposal instructions, etc., or the application is configured to perform the above steps.

[0048] In a seventeenth aspect according to at least one of the first to sixteenth aspects, the method comprises: receiving or selecting parameters that reflect the region or country in which the portable electronic device is located and / or in which the dispenser user / patient resides, and / or the time of year or season; From the dispenser data, the available period ΔT corresponding to the region or country and / or the time or season in_use selecting or the application is configured to perform these steps.

[0049] In an eighteenth aspect according to at least one of the first to seventeenth aspects, the portable electronic device includes a wireless receiver, and the method includes: receiving from the wireless receiver parameters reflecting a region or country and / or a time or season in which the portable electronic device is located; From the dispenser data, the available period ΔT corresponding to the region or country and / or the time or season in_use selecting or the application is configured to perform these steps.

[0050] In a nineteenth aspect relating to the eighteenth aspect, the wireless receiver is a GPS receiver, or a mobile network (e.g., 3G, 4G, 5G) receiver, or a Bluetooth (registered trademark) receiver, or a Wi-Fi receiver.

[0051] Since the usable period may depend on the region or country and / or time or season (e.g. some countries / regions are very hot in the summer and very cold in the winter due to differences in temperature and / or humidity), this further function ensures that the expiration date is appropriate for the region or country and / or time or season of use.

[0052] In a twentieth aspect relating to at least one of the first to nineteenth aspects, the reading is performed after the dispenser is removed from the sealed packaging (optionally, the sealed packaging is a moisture-proof pouch) or the controlled atmosphere environment for the first time.

[0053] In a twenty-first aspect according to at least one of the first to twentieth aspects, the dispenser is a handheld or portable dispenser, optionally an inhaler.

[0054] In a twenty-second aspect relating to the twenty-first aspect, the inhaler is a dry powder inhaler, the medicament is a powdered medicament, and optionally the multiple doses of medicament contained in the housing are a single amount of material not divided into sealed individual doses, or optionally the multiple doses of medicament contained in the housing include a number of individual doses of powdered medicament contained in blisters.

[0055] In a twenty-third aspect relating to the twenty-second aspect, the reading is performed after the dispenser is removed from the sealed packaging for the first time.

[0056] In the twenty-fourth aspect relating to the twenty-second aspect or the twenty-third aspect, the usable period ΔT in_use is between 5 and 7 months, optionally 6 months.

[0057] In a twenty-fifth aspect relating to the twentieth aspect, the inhaler is a metered dose inhaler (MDI), optionally a pressurized metered dose inhaler (pMDI), or a soft mist inhaler (SMI), and the medicament is a suspension or solution formulation, preferably a solution.

[0058] In a twenty-sixth aspect relating to the twenty-fifth aspect, the reading is performed after the dispenser is removed from the refrigerator for the first time.

[0059] In the twenty-seventh aspect relating to the twenty-sixth aspect, the usable period ΔT in_use is between 2 and 5 months, optionally 3 or 4 months.

[0060] In a twenty-eighth embodiment relating to any of the first to twenty-seventh embodiments, the medicament is a single component formulation or a multi-component formulation.

[0061] In a 29th embodiment relating to at least one of the 1st to 28th embodiments, the label or tag comprises an optical code such as a QR code or a barcode, and the reader comprises an optical reader such as a camera.

[0062] In a 30th aspect relating to any of the 1st to 28th aspects, the label or tag is an RFID (Radio Frequency Identification) tag and the reading device comprises an RFID reader, or the label or tag is a BLE (Bluetooth Low Energy) beacon and the reading device comprises a BLE reader, and optionally, the label or tag also incorporates a "writing function" and the portable electronic device comprises a writing device configured to write to the label or tag.

[0063] In a thirty-first aspect relating to any one of the first to thirtieth aspects, the portable electronic device is a smartphone.

[0064] In a thirty-second aspect relating to any of the first to thirty-first aspects, the dispenser data is contained in a machine-readable code and / or a portable electronic device.

[0065] In a thirty-third aspect relating to the thirty-second aspect, when a reading device reads the machine-readable code on the reading date Tread, the method includes a step of reading dispenser data from the machine-readable code, or the application is configured to perform the above step.

[0066] In a thirty-fourth aspect relating to any of the first to thirty-first aspects, the dispenser data is contained in a remote location (e.g., a remote database) that is optionally accessed via a network connection.

[0067] In a thirty-fifth aspect according to the thirty-fourth aspect, when a reading device reads a machine-readable code on the reading date Tread, the method further comprises: reading an address of the remote location from the machine readable code; connecting to a remote location and obtaining said data for the dispenser from the remote location; Optionally, storing said dispenser data on a portable electronic device or on a label or tag, if said label or tag also incorporates a "write function" such as an RFID tag or BLE beacon; or the application is configured to perform these steps.

[0068] In a thirty-sixth aspect relating to any of the first to thirty-fifth aspects, in order to identify whether the dispenser data is new data, the method includes a step of comparing at least one of the dispenser data with at least one of other dispenser data previously read and already stored, or the application is configured to perform the above steps.

[0069] In the thirty-sixth aspect and in a thirty-seventh aspect relating to the eleventh aspect or the twelfth aspect, there is provided a step of comparing the unique identifier of the dispenser with unique identifiers of other dispensers that have previously been read and already stored.

[0070] In a thirty-eighth aspect relating to any of the first to thirty-seventh aspects, the dispenser comprises a dose counting unit configured to count the number of dispensed unit doses, the dose counting unit being configured to be activated and incremented each time the dispensing device is activated.

[0071] In a thirty-ninth aspect of any one of the first to thirty-eighth aspects, the method comprises: The number of doses per unit time that the user should take and the overall expected time ΔT assum or a total number of doses to be taken by the user; Overall expected time ΔT assum Consider or calculate the total expected time ΔT assum Use Expiry Date Texp in_use and / or usable period ΔT in_use and comparing Expiration date Texp in_use is the total expected time ΔT assum and / or before the end of the available period ΔT in_use is the total expected time ΔT assum issuing an additional warning if the time elapses before or the application is configured to perform these steps.

[0072] In a fortieth aspect according to any one of the first to thirty-ninth aspects, the expiration date Texp in_use is stored on the portable electronic device or optionally at a remote location (e.g., a remote database) accessed via a network connection, or on the label or tag if said label or tag also incorporates a "write capability" such as an RFID tag or BLE beacon.

[0073] In a forty-first embodiment according to any one of the first to fortieth embodiments, if the label or tag is a beacon (e.g. BLE), it can automatically emit a signal on first use. This signal can be an expiration date Texpin_use The device can be stored remotely in the home environment or picked up by a home hub.

[0074] In a forty-second aspect according to any of the first to forty-first aspects, the method includes a step of adjusting and / or manually inputting the read date Tread or the first use date via the portable electronic device or an application is configured to perform said step, which may be useful if the user forgets to read the machine-readable code when using the dispenser for the first time.

[0075] Further features are presented in more detail in the detailed description of preferred, but not exclusive, embodiments of the device for administering medicaments and the method for managing the expiry date of a medicament dispenser according to the invention.

[0076] The present specification will hereinafter be described with reference to the accompanying drawings, which are provided for illustrative and non-limiting purposes. [Brief description of the drawings]

[0077] [Figure 1] FIG. 1 shows a device for administering a medicament according to the present invention. [Diagram 2] FIG. 2 is a schematic cross-sectional view of one element of the apparatus of FIG. 1. [Diagram 3] 4A-4C show different embodiments of the elements of FIG. 3. [Figure 4] FIG. 4 is a schematic cross-sectional view of the element of FIG. 3. [Diagram 5] FIG. 2 is a schematic diagram of a portion of the apparatus of FIG. 1. [Figure 6] 2 is a flow chart of a method according to the present invention; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0078] With reference to the accompanying drawings, Figure 1 shows an apparatus for administering medication. The apparatus 1 comprises a pressurized metered dose inhaler (pMDI) 2, i.e. a portable or handheld medication dispenser, and a smartphone 3, i.e. a portable electronic device.

[0079] The pressurized metered dose inhaler 2 is known per se and comprises a housing 4 comprising a metering device 5 attached to or arranged within the housing 4. As better shown in Figure 2, a reservoir 6 containing a suitable medicament M (e.g. a mono- or multi-component formulation) and provided with a valve 7 is arranged within the housing 4 through an opening 8 in the housing 4. The reservoir 6 may be disposable. The housing 4 also comprises a mouthpiece 9 defining a mouth 10 for dispensing the medicament M released through the orifice of the metering device 5.

[0080] The medication M in the reservoir 6 is a multi-dose medication M, and the metering device 5 enables a user to dispense a unit dose of said medication M each time the reservoir 6 is pressed towards the housing 4.

[0081] The pressurized metered dose inhaler 2 may also be provided with a dose counting unit (not shown) which is configured to operate each time the metering device 5 is actuated and to count, increment or decrement, the number of unit doses dispensed.

[0082] A pressurized metered dose inhaler 2 of this kind is disclosed, for example, in EP 2 890 437 by the same applicant.

[0083] A tag 11 containing a QR code 12 (i.e. a machine-readable code) is affixed to the exterior of the housing 4. As will be described later in this specification, the QR code contains or is linked to data of the pressurized metered dose inhaler 2.

[0084] The smartphone 3 is also known per se and comprises a casing 13 with a display 14 and includes a camera 15 (reader), a memory 16, an electronic control unit 17, a radio receiver 18, a radio transmitter 19 and a GPS receiver 20 (Figure 5). The electronic control unit 17 is operatively connected to the camera 15, the memory 16, the radio receiver 18, the radio transmitter 19 and the GPS receiver 20 for properly managing the operation of the smartphone 3.

[0085] The wireless receiver 18 and the wireless transmitter 19 are configured to communicate with a cellular or mobile network (e.g., a 3G, 4G, or 5G network).

[0086] A GPS receiver is configured to receive signals from satellites of the GPS system.

[0087] The smartphone 3 may also include a Bluetooth transmitter / receiver and a Wi-Fi transmitter / receiver, not shown.

[0088] The device 1 further comprises a software application (App) loaded onto the smartphone 3 and stored, for example in a memory 16 of the smartphone 3, the electronic control unit 17 being configured to execute said application and to carry out the method according to the invention.

[0089] Please refer to the flow chart in Figure 6. The application is configured to read the QR code 12 via the camera 15 and receive and store the pressurized metered dose inhaler (pMDI) 2 data contained in or linked to the QR code.

[0090] For example, in one embodiment, the pMDI data may be contained in a QR code, while in another embodiment, the data may be contained in a web-accessible remote database 100. The QR code may contain a web address for the remote database 100, such that when the user points the camera of the smartphone 3 at the QR code while the application is running, the application may retrieve the data from the remote database 100 and store it in memory 16.

[0091] The data for the pMDI are based on the time period ΔT in_use The hypothetical time of first use is the time when the drug M is first exposed to normal environmental conditions, e.g., room temperature and / or moisture and / or light and / or pressure and / or non-sterile conditions. pMDIs are stored in a refrigerator (i.e., in a controlled atmosphere environment) during distribution and storage in the pharmacy, so the usable period ΔT in_use The usable life of a pMDI, ΔT, typically begins when the product is removed from the refrigerator when it is transported from the pharmacy. in_use is known to the manufacturer and depends on the formulation of drug M and may be, for example, 3 or 4 months or more. in_use is only guaranteed if the user adheres to the product's use and storage recommendations. in_use is known and is part of the pMDI data, but is the expiration date Texp calculated from a hypothetical first use. in_use is not known when the pMDI is manufactured and cannot be part of the pMDI data.

[0092] The pMDI data will typically further include a unique identifier for the pMDI, for example a serial number.

[0093] The data of the pMDI typically further comprises an expiration date Texp, i.e. the expiration date calculated from the date of manufacture of the pMDI. Since the date of manufacture is known, the expiration date Texp is part of the data of the pMDI in the QR code or in the remote database 100. If the drug M is kept safe from normal environmental conditions, for example if the pMDI is stored in a refrigerator or sealed in a package or pouch during distribution and storage in the pharmacy, the expiration date Texp is typically the expiration date of said drug M. This expiration date Texp is also known to the manufacturer and varies depending on the formulation of drug M.

[0094] According to an embodiment, the database 100 stores a number of expiration dates Texp and / or usable periods ΔT in_use Includes the expiration date Texp and the usable period ΔT in_use may vary from one region or country to another, for example due to temperature and humidity differences, and are therefore each linked to one or more geographic regions or countries.

[0095] The application receives parameters reflecting the region or country in which the smartphone 3 is located and / or in which the user resides, and determines the expiration date Texp and / or the usable period ΔT corresponding to that region or country. in_use The parameters reflecting the region or country may be entered by a user or may be obtained by the application from a cellular or mobile network and / or a GPS system.

[0096] As climatic conditions may greatly affect the medication in some countries / regions by being very hot in the summer and very cold in the winter, the application may be configured to receive parameters that reflect the time of year or season in which the dispenser is used.

[0097] The pMDI data may include links via further information and / or applications (e.g., web addresses) to obtain information such as the drug, dosage, place of manufacture, batch number, instructions for use, a video on how to use the device, or disposal instructions.

[0098] The application further: receiving and optionally storing the read date Tread, i.e. the date the QR code was read; comparing the unique identifier of the pMDI with other unique identifiers of pMDIs that may have been previously read and are present in memory 16; It is structured as follows.

[0099] If the unique identifier that has just been read is the first time it has been read or is different from other unique identifiers, i.e. it is a new unique identifier indicating that this is the first time the QR code has been read since the manufacture of the pMDI, storing the read date Tread as the date of first use of the pMDI after manufacture in association with the unique identifier and labelling it; Reading date Tread and usable period ΔT in_use From expiry date Texp in_use "Texp in_use =Tread+ΔT in_use " and / or a use-by-date counter, i.e., a usable period ΔT in_use Start a timer with a length of time equal to Use expiry date Texp in_use Compared with the expiration date Texp in_use occurs after the expiration date Texp and / or the usable period ΔT in_use elapses after the expiry date Texp, issue a warning (e.g., an audible or visual signal or vibration) via the smartphone 3, allowing the user to immediately return the pMDI to a pharmacy to obtain another one, otherwise Enable advance warning and expiry date Texp in_use and / or the usable period ΔT in_usea pre-warning (e.g., a message, an audible or visual signal, or a vibration) is issued via the smartphone 3 before the expiration date of the product (e.g., a few weeks or days in advance to alert the user when the product is nearing the end of its useful life, so that a new product can be prescribed by a doctor and obtained at a pharmacy before the expiration date of the old product); Enable Final Warning and Expiration Date Texp in_use and / or when the usable period ΔT in_use The final warning is issued when the time has elapsed.

[0100] The application may also be configured to adjust the Tread or first use date and / or to manually enter the Tread or first use date via the portable electronic device 3, which is useful if the user forgets to read the machine-readable code 12 when the dispenser 2 is used for the first time and / or removed from its packaging.

[0101] The application may be configured to allow for further notifications and / or links.

[0102] The application may be further configured to receive a medical prescription for a user / patient, said medical prescription including the number of doses per unit time that the user should take (e.g., two doses per day) and an overall expected time ΔT assum (e.g., 90 days) or the total number of doses the user should take (e.g., 180 doses).

[0103] The application also estimates the overall expected time ΔT assum Consider or calculate the total expected time ΔT assum Use Expiry Date Texp in_use and / or usable period ΔT in_use It is designed to be compared with

[0104] The application also displays the expiry date Texp in_use is the total expected time ΔT assumand / or before the end of the available period ΔT in_use is the total expected time ΔT assum In this way, it is possible to detect whether a pMDI contains a large number of unit doses and the usable period ΔT in_use If the time is too short, the user may be informed that they cannot use the drug at all.

[0105] The application may optionally provide notifications when the user should use the product, which may be input by the user so that notifications occur at preferred times when the patient is instructed to take their medication, for example 8:00 am and 6:00 pm.

[0106] If the unique identifier that has just been read is identical to one of the other unique identifiers in memory 16, i.e., it is not a new unique identifier, which indicates that the QR code has already been read; Via the display 14 of the smartphone 3, a status (message, image, etc.) is displayed indicating that the QR code has been read and the remaining usable period ΔT remain is displayed.

[0107] Thus, the application allows for the management of multiple pMDIs or other inhalers or dispensers and ensures that the appropriate inhaler is discarded when the final warning is given.

[0108] Figures 3 and 4 show another type of inhaler, namely a dry powder inhaler (DPI) 21. This may for example be the dry powder inhaler disclosed in the applicant's WO 2004 / 012801, and this dry powder inhaler 21 may be used in a similar manner to that described above, together with the application and smartphone 3.

[0109] The dry powder inhaler 21 shown in Figures 3 and 4 comprises a housing 22 defining a mouthpiece 23 and a mouthpiece cover 24 configured to open and close the mouthpiece 23. A container 25 within the housing 22 contains multiple doses of a powdered medicament M (e.g. a single-component or multi-component formulation). A metering member 26 having a dosing recess into which a dose of the powdered medicament M is loaded may be provided in communication with the inhalation channel 27 and the mouthpiece 23. The dry powder inhaler 21 further comprises an inhalation actuation mechanism configured to dispense the medicament M for inhalation by the user if or when the user applies an inhalation force above a predetermined level.

[0110] During distribution and storage at the pharmacy, the dry powder inhaler 21 is typically contained in a sealed package 28 (FIG. 4) to protect it from environmental conditions. The sealed package may be a moisture-proof foil laminate pouch and may, for example, contain a desiccant that is disposed of when the pouch is opened.

[0111] 4, the tag 11 containing the QR code 12 is attached to the sealed packaging 28, and the user reads the QR code via the camera 15 of the smartphone 3 when removing the dry powder inhaler 21 from the sealed packaging 28 upon first use. In another embodiment, the QR code may be printed on the housing 22 of the dry powder inhaler 21.

[0112] Dry Powder Inhaler 21 Shelf Life Date Texp shelf varies by formulation and can be 18 months.

[0113] Also, the expiration date Texp in_use varies by formulation and can be 6 months.

[0114] According to other embodiments of the invention, the device 1 may comprise other types of dispensers including a housing, a dispensing device connected to the housing, and a multi-dose medicament contained in the housing (i.e., the multi-dose medicament in the housing is a quantity of material sufficient to provide a number of unit doses, but which quantity of material is not necessarily divided into sealed individual doses when contained in the housing), the dispensing device configured to dispense unit doses of the medicament when actuated by a user. For example, the dispenser may be an MDI with pre-filled blisters as disclosed in WO2004011071, or a soft mist inhaler (SMI) as disclosed in EP3370810.

[0115] According to an embodiment, the application may not be loaded onto the electronic control unit, but may instead be a web-based application accessed via a network connection.

[0116] Instead of a QR code, other tags or labels with machine-readable codes may be employed, for example bar codes or RFID (Radio Frequency Identification) tags or BLE (Bluetooth Low Energy) beacons. The reader is therefore an optical reader (like the camera 15) or an RFID reader or a BLE reader. These kinds of tags (RFID or BLE readers) may incorporate a "write function" so that the data of the dispenser 2 and / or the expiry date Texp in_use For this purpose, the portable control unit 3 stores the data of the dispenser 2 and / or the expiry date Texp in_use A writing device is provided for writing the expiration date Texp to the tag. If the label or tag is a BLE beacon, it can automatically emit a signal when used for the first time. This signal is the expiration date Texp in_use can be picked up by the home environment (e.g., Alexa®) or home hub, which can store the information in the cloud.

[0117] A tag or label containing the machine readable code may be attached to the housing of a dispenser such as the pMDI 2 disclosed above, or to a package such as the DPI 21 disclosed above, or may be attached to a sheet inserted into the dispenser package 28 or secured to the disposable reservoir 6 of the pMDI 2. If the components of the DPI are to be reused, the machine readable code is attached to the disposable drug containing housing. [Explanation of symbols]

[0118] 1 device 2. Pressurized Metered Dose Inhaler (pMDI) 3. Smartphone 4. Chassis 5 Weighing device 6. Storage section 7 Valve 8 aperture 9 Mouthpiece 10 Mouth 11 Tags 12 QR Code 13 Casing 14 Display 15 Camera 16 Memory 17 Electronic Control Unit 18 Radio Receiver 19 Radio transmitter 20 GPS receiver 21 Dry powder inhaler (DPI) 22 Case 23 Mouthpiece 24 Mouthpiece cover 23 Mouthpiece 25 Container 26 Measuring elements 27 Intake Channel 28 Sealed packaging

Claims

1. 1. A device for administering a medicament, comprising: a dispenser (2, 21) including a housing (4, 22), a dispensing device (5, 26) connected to the housing (4, 22), and a multi-dose medicament (M) contained in the housing (4, 22), the dispenser (2, 21) configured to dispense unit doses of the medicament (M) when the dispensing device (5, 26) is actuated by a user; a label or tag (11) containing a machine-readable code (12) containing or linked to data of the dispenser (2, 21), said label or tag (11) being fixed to said dispenser (2, 21) and / or contained or attached to the packaging (28) of said dispenser (21), said data of said dispenser (2, 21) being used to determine the shelf life (ΔT ｉｎ＿ｕｓｅ a label or tag (11) comprising a portable electronic device (3) including an electronic control unit (17) and a reader (15) configured to read the data of the dispenser (2, 21) from the machine-readable code (12); an application loaded on said electronic control unit (17) or remotely; Equipped with The application receiving and optionally storing the data of the dispenser (2, 21) and the reading date (Tread) when the reading device (15) reads the machine-readable code (12) on a reading date (Tread), and if at least one of the data of the dispenser (2, 21) is new, indicating that the machine-readable code (12) has been read for the first time since the manufacture of the dispenser (2, 21); The read date (Tread) and the usable period (ΔT ｉｎ＿ｕｓｅ ) to the expiration date (Texp ｉｎ＿ｕｓｅ ) to Texp ｉｎ＿ｕｓｅ = Tread + ΔT ｉｎ＿ｕｓｅ and / or start an expiration counter; The expiration date (Texp ｉｎ＿ｕｓｅ ) and / or the usable period (ΔT ｉｎ＿ｕｓｅ ), thereby enabling at least one warning in response to the expiration date (Texp ｉｎ＿ｕｓｅ ) is reached and / or approached, or the usable period (ΔT ｉｎ＿ｕｓｅ ) has elapsed or is about to elapse, the portable electronic device (3) issues the at least one warning; 20. An apparatus configured to:

2. The data of the dispenser (2, 21) further includes an expiration date (Texp), and the application converts the expiration date (Texp) into the use-by date (Texp ｉｎ＿ｕｓｅ ) and compare it with the expiration date (Texp ｉｎ＿ｕｓｅ ) occurs after the expiration date (Texp), and / or the usable period (ΔT ｉｎ＿ｕｓｅ 2. The device of claim 1, wherein the device is configured to issue a further warning if a timestamp (Texp) elapses after the expiration date (Texp).

3. The data of the dispenser (2, 21) includes a unique identifier of the dispenser (2, 21), and the application associates the unique identifier with the read date (Tread) and / or the expiry date (Texp ｉｎ＿ｕｓｅ ) and / or the usable period (ΔT ｉｎ＿ｕｓｅ 2. The device according to claim 1, wherein the device is configured to associate a plurality of dispensers (2, 21) with each other, thereby enabling the device to manage a plurality of dispensers (2, 21).

4. If the data in the dispenser (2, 21) is not new, the application outputs via an output device (14) of the portable electronic device (3) a status indicating that the machine-readable code (12) has already been read and / or a remaining usable period (ΔT ｒｅｍａｉｎ 10. The device of claim 1, configured to display a

5. The portable electronic device (3) includes a radio receiver (18, 20), and the application is receiving from said wireless receiver (18, 20) parameters reflecting the region or country and / or time of year or season in which said portable electronic device (3) is located; The available period (ΔT ｉｎ＿ｕｓｅ ) and The apparatus of claim 1 configured to perform:

6. 2. The device of claim 1, wherein the dispenser (2, 21) is an inhaler, optionally wherein the inhaler is a dry powder inhaler (21), and wherein the medicament (M) is a powdered medicament, and optionally wherein the inhaler is a metered dose inhaler (2), optionally a pressurized metered dose inhaler, or a soft mist inhaler, and wherein the medicament (M) is a suspension or solution formulation.

7. 7. The apparatus of any one of claims 1 to 6, wherein the label or tag (11) comprises a QR code (12), the portable electronic device is a smartphone (3), and the reader (15) comprises a camera.

8. 1. A method for managing expiration dates of a medication dispenser, comprising: reading and optionally storing, via a reader (15) of the portable electronic device (3), data of the dispenser (2, 21) and a read date (Tread) from a machine-readable code (12) of a label or tag (11) fixed to the dispenser (2, 21) of the drug (M) and / or contained in or attached to the packaging (28) of the dispenser (2, 21), wherein said data of the dispenser (2, 21) is used to determine the usable period (ΔT ｉｎ＿ｕｓｅ ) and If at least one of the data of the dispenser (2, 21) is new, indicating that the machine-readable code (12) has been read for the first time since the manufacture of the dispenser (2, 21), The read date (Tread) and the usable period (ΔT ｉｎ＿ｕｓｅ ) to the expiration date (Texp ｉｎ＿ｕｓｅ ) to Texp ｉｎ＿ｕｓｅ = Tread + ΔT ｉｎ＿ｕｓｅ and / or starting an expiration counter; The expiration date (Texp ｉｎ＿ｕｓｅ ) and / or the usable period (ΔT ｉｎ＿ｕｓｅ enabling at least one alert in response to the The expiration date (Texp ｉｎ＿ｕｓｅ ) is reached or approaches the usable period (ΔT ｉｎ＿ｕｓｅ issuing said at least one warning via said portable electronic device (3) when a predetermined time has elapsed or is about to elapse; A method comprising:

9. The expiration date (Texp) of the dispenser (2, 21) is set to the expiration date (Texp) ｉｎ＿ｕｓｅ ) and / or the usable period (ΔT ｉｎ＿ｕｓｅ ) and compare it with the expiration date (Texp ｉｎ＿ｕｓｅ ) occurs after the expiration date (Texp), and / or the usable period (ΔT ｉｎ＿ｕｓｅ 9. The method of claim 8, further comprising issuing a further warning if a time (Texp) has elapsed after the expiration date (Texp).

10. The unique identifier of the dispenser (2, 21) is stored in the Tread and / or Texp ｉｎ＿ｕｓｅ ) and / or the usable period (ΔT ｉｎ＿ｕｓｅ 9. The method of claim 8, further comprising the step of associating a plurality of dispensers (2, 21) with a plurality of dispensers (2, 21) to enable management of the dispensers (2, 21).

11. 9. The method of claim 8, further comprising displaying, via an output device (14) of the portable electronic device (3), a status indicating that the machine-readable code (12) has already been read, if the data in the dispenser (2, 21) is not new.

12. If the data of the dispenser (2, 21) is not new, the remaining usable period (ΔT ｒｅｍａｉｎ 9. The method of claim 8, wherein the display includes:

13. receiving or selecting parameters reflecting the region or country in which said portable electronic device (3) is located and / or in which the user of said dispenser (2, 21) resides, and / or the time of year or season; The available period (ΔT ｉｎ＿ｕｓｅ ) and The method of any one of claims 8 to 12, further comprising:

14. 9. The method according to claim 8, wherein the dispenser (2, 21) is a dry powder inhaler (21), the medicament (M) is a powdered medicament, and the reading is carried out after the dry powder inhaler (21) is removed from the sealed packaging (28) for the first time.

15. 9. The method of claim 8, wherein the dispenser (2, 21) is a metered dose inhaler (2), optionally a pressurized metered dose inhaler, or a soft mist inhaler, the medicament (M) is a suspension or solution formulation, and the reading is performed after the metered dose inhaler (2) or the soft mist inhaler is removed for the first time from a refrigerator or from a sealed packaging.

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