Device for administration of medicines and a method for controlling the expiry date of a medicine dispenser

Abstract

FIELD: medicine.SUBSTANCE: group of inventions relates to medicine, namely to a device for administering drugs and a method for controlling the expiration date of a drug dispenser. The device comprises a dispenser, a label or tag, and a portable electronic device. The dispenser contains a dispensing device and a multi-dose quantity of medicinal product contained in the dispenser body. The machine-readable code on the label or tag contains dispenser data that includes the period of use of the medicinal product. The portable electronic device provides reading of dispenser data from machine-readable code. In this case, the dispenser data and the reading date are received and stored. The expiration date is calculated and stored upon use based on the reading date and period. A warning signal is provided so that the portable electronic device emits a signal when the expiration date is reached and / or approaching during use, or when the period of use has expired or is approaching expiration. A parameter reflecting the region or country in which it is located, and / or the time of year or season is obtained from the radio receiver of a portable electronic device. The period of use for a given region or country and / or a given time of year or season is selected from the dispenser data.EFFECT: safety of drug administration is improved with the ability to order a new prescription in a timely manner, which prevents the risk of running out of medication, and also takes into account the impact of climatic conditions on medications.17 cl, 6 dwg

Description

[0001] Field of technology to which the invention relates

[0002] The present invention relates to a device for administering medications and to a method for monitoring the expiration date of a medication dispenser. In particular, the present invention relates to improving the safety features of manual medication dispensers, such as, but not limited to, dry powder inhalers (DPIs) or pressurized metered-dose inhalers (pMDIs), or superfine mist inhalers (SMIs), to facilitate the correct use of medication by the patient.

[0003] State of the art of the invention

[0004] Administering doses of a medicinal product from a dispenser containing a multi-dose quantity of the medicinal product is a well-known method. The dispenser contains a dispensing device that is capable of dispensing uniform doses of the medicinal product when the user actuates the dispensing device.

[0005] For example, among existing devices for delivering drugs to the lungs, multi-dose dry powder inhalers (DPIs) are widely used. Document WO 2004 / 012801, filed by the applicant of the present application, discloses a dry powder inhaler comprising a container for storing a multi-dose amount of a powdered drug, a metering element having a metering recess to be filled with a dose of the powdered drug, and a mouthpiece communicating with an inhalation channel of the dry powder inhaler. The dry powder inhaler further comprises a breath-activated mechanism, such that the breath-activated mechanism allows the drug to be atomized and inhaled by the user if and when the user generates an inhalation suction force that exceeds a predetermined level.

[0006] Pressed metered dose inhalers (pMDIs) are also widely used for delivering drugs to the lungs. EP 2890437 B1, filed by the applicant of the present application, discloses an aerosol inhalation device comprising a housing designed to accommodate an aerosol canister containing a pressurized dosage form, a mouthpiece portion through which the user inhales, and a nozzle assembly having a passageway that serves to expel the aerosol composition into the mouthpiece portion.

[0007] Document EP 3370810 B1 discloses an example of an ultrafine mist inhaler (SMI) comprising a nebulizer for atomizing a fluid.

[0008] Another type of multi-dose dry powder inhaler is disclosed in WO 2004011071 A1 and comprises a blister strip containing a plurality of individual doses of a powdered medicinal product and a mechanism for selecting said doses comprising either a piercing means or a means for removing a coating layer from a backing.

[0009] Regardless of the type of dispenser used, the drug's expiration date is usually printed on the dispenser packaging or contained in a machine-readable code on the label or tag, such as a barcode or QR code. The expiration date can be printed on the machine-readable code or incorporated into it during the manufacture or packaging of the dispenser.

[0010] In some cases, the drug in a multi-dose form contained in a dispenser may be exposed to environmental conditions such as moisture and / or temperature and / or light and / or pressure and / or foreign impurities that may degrade the properties (e.g., sterility) of the drug after the dispenser is picked up by the user and used for the first time. For example, the drug in a multi-dose form in the housing of a DPI inhaler or in the canister of a pMDI or SMI inhaler is present in an amount of material sufficient to deliver multiple unit doses, but said amount of material may not be divided into individual sealed doses when contained in the housing. Blisters of multi-dose dry powder inhalers, such as the one disclosed in WO 2004011071 A1, are not made of a material suitable for protecting each unit dose from environmental conditions.

[0011] For example, after being removed from the sealed packaging, moisture may have affected the medication in the dry powder inhaler (DPI) and / or the medication is no longer sterile, and therefore the product may need to be discarded after a certain period of use, such as six months after being removed from the sealed packaging, even if the dispenser has not been emptied and the expiration date has not yet been reached.

[0012] Some types of metered-dose inhalers (MDIs) are also stored in sealed packaging after manufacture and until first use. Other types of MDIs are refrigerated during shipment and storage at the pharmacy. Once the patient begins using the device, refrigeration is not required; room temperature is sufficient. In this case, the device may have a three- to four-month usable life (from the time it is removed from the refrigerator) before it should be discarded.

[0013] Such medicinal products that may be exposed to environmental conditions may therefore have two expiration dates: the above-mentioned expiration date and the expiration date on use, which is calculated from the start of use of the dispenser, i.e., from the moment the dispenser / medicinal product is first exposed to normal environmental conditions, such as when a DPI is removed from its sealed packaging, or when an MDI is removed from the refrigerator.

[0014] The expiration date upon use cannot be printed on the dispenser packaging or printed on the dispenser, or included in the machine-readable code, since it is not known during the manufacturing process when the patient will start using the product.

[0015] Therefore, in the known dispensers, the expiration date upon use should be calculated by the user according to the use period recorded in the instructions for use, and the user should keep a time stamp when he started to use the product, so that he can throw away the product after the expiration date upon use.

[0016] The risk that the user will forget to keep the label is high and therefore there is a real risk that the medicinal product will be used after it has lost potency and / or safety, or that it may be discarded while still fit for use.

[0017] Furthermore, if the user has several inhalers, he must be able to identify each one individually and may confuse them with each other.

[0018] Document EP 3349719 B1 discloses a method for counting doses of a drug metered by an inhaler. Document WO 2012 / 004298 discloses a drug delivery system comprising a control means configured to store information representing the recommended maximum service life of a reservoir assembly. Document US 2014 / 0155827 discloses a device for emergency drug delivery, such as an adrenaline autoinjector, containing a memory and a display for storing and displaying the expiration date of the drug. Document EP 3348295 A1 discloses a device for injecting a drug substance capable of monitoring the expiration date of a composition from the start of use of the composition.

[0019] The essence of the invention

[0020] The purpose of the present invention is to eliminate the above-mentioned disadvantages of previously known dispensers.

[0021] Firstly, the object of the present invention is to provide a drug administration system with greater safety.

[0022] An object of the present invention is also to provide a system that makes it easier for a user / patient to take a medicine.

[0023] An object of the present invention is also to provide a system that allows a user / patient to order a new prescription in a timely manner, which prevents the risk of running out of a drug.

[0024] At least one of the above-mentioned objects is essentially achieved by a device for administering medicinal preparations and by a method for monitoring the expiration dates of a medicinal preparation dispenser in accordance with one or more of the claims of the attached invention and / or the following aspects.

[0025] Aspects of the invention are disclosed below.

[0026] In accordance with the 1st independent aspect, the drug administration device comprises:

[0027] a dispenser comprising a housing, a dispensing device, possibly a dosing device connected to the housing, and a multi-dose quantity of a medicinal product contained in the housing, wherein the dispensing device is configured to dispense unitized doses of said medicinal product when actuated by a user;

[0028] a label or tag containing a machine-readable code containing or associated with dispenser data, wherein the label or tag is attached to the dispenser and / or contained in or secured to packaging for the dispenser, wherein the dispenser data contains a period ΔT in_use use of a medicinal product;

[0029] a portable electronic device comprising an electronic control unit and reading devices designed to read dispenser data from a machine-readable code;

[0030] An application loaded into the ECU or a remote node that may be accessed via a network connection (such as a web application) and configured to perform the following procedure:

[0031] - receiving and possibly storing the dispenser data and the Tread reading date when the reading devices read the machine-readable code on the said Tread reading date, and if at least some of the said dispenser data is new data indicating that the machine-readable code has been read for the first time since the dispenser was manufactured, then:

[0032] - Calculate and save the Texp term in_use shelf life based on the Tread reading date and ΔT period in_use use, according to the Texp formula in_use =Tread+ΔT in_use and / or starting the expiration counter upon use;

[0033] - Providing at least one warning signal depending on the Texp term in_useshelf life and / or ΔT period in_use use, so that the portable electronic device emits said at least one warning signal when the Texp period is reached and / or approaching in_use shelf life when used, or when the period ΔT in_use the use is about to expire or is about to expire.

[0034] In the 2nd independent aspect, the method for monitoring the expiration date of a medicinal product dispenser comprises the following steps:

[0035] - reading and possibly storing the dispenser data and the Tread reading date by means of the reading devices of the portable electronic device and from the machine-readable code of the label or tag attached to the medicinal product dispenser and / or contained in or attached to the packaging for the dispenser; wherein the dispenser data contains the period ΔT in_useuse of the medicinal product; and if at least some of the said dispenser data is new, indicating that the machine-readable code has been read for the first time since the manufacture of the dispenser, then:

[0036] - Calculate and save the Texp term in_use shelf life based on the Tread reading date and ΔT period in_use use, according to the Texp formula in_use =Tread+ΔT in_use and / or starting the expiration counter upon use;

[0037] - Providing at least one warning signal depending on the Texp term in_use shelf life and / or ΔT period in_use use;

[0038] - issuing, by means of a portable electronic device, said at least one warning signal when the Texp period is reached and / or approaching in_use shelf life when used, and / or when the period of use ΔT in_useis expiring or is approaching expiration.

[0039] In the 3rd independent aspect, the drug dispenser control application is loaded or configured to be loaded into the electronic control unit of the portable electronic device or into a remote node that may be accessed via a network connection (for example, a web application); and said application is configured to perform the following procedure:

[0040] - receiving and possibly storing the dispenser data and the Tread reading date when the reading devices of the portable electronic device read the machine-readable code on said Tread reading date, wherein the dispenser data contains the period ΔT in_use use of the medicinal product contained in the dispenser; and if at least some of the said dispenser data is new, indicating that the machine-readable code has been read for the first time since the manufacture of the dispenser, then:

[0041] - Calculate and save the Texp term in_use shelf life based on the Tread reading date and ΔT period in_use use, according to the Texp formula in_use =Tread+ΔT in_use and / or starting the expiration counter upon use;

[0042] - Providing at least one warning signal depending on the Texp term in_use shelf life and / or ΔT period in_use use, so that the portable electronic device emits said at least one warning signal when the Texp period is reached and / or approaching in_use shelf life when used, or when the period of use ΔT in_use is expiring or is approaching expiration.

[0043] The invention helps ensure that the user / patient does not use the medicinal product after its expiration date. Indeed, only when the dispenser is used for the first time (e.g., removed from the packaging) will the expiration date / clock start counting down to the expiration date and the countdown to the expiration date. Thus, the invention prevents the user / patient from taking the medicinal product after its expiration date.

[0044] Indeed, after the expiration date, the medicinal product's potency may no longer meet specifications, and therefore patients may not receive the appropriate dose for their condition. Therefore, the product should be discarded at the end of its expiration date, even if there are still doses remaining.

[0045] The invention is also useful if the medication is prescribed as a "relief" or "on-demand" medication, used only when short of breath. In this case, it is difficult for the patient to know how long the product should last. In these circumstances, it is more likely that the device will last until its expiration date and still contain remaining doses.

[0046] The invention also provides additional advantages and technical effects.

[0047] For example, the invention makes it easier for a user / patient to take a medication and / or allows the user / patient to order a new prescription in a timely manner, which prevents the risk of running out of medication.

[0048] Additional aspects of the invention are disclosed below.

[0049] In the 4th aspect corresponding to at least one of the previous aspects, if said doser data is new data indicating that the machine-readable code was read for the first time after the manufacture of the doser, the Tread reading date is recorded and / or designated as the start date of use of the doser after manufacture (i.e., when the doser / drug is first exposed to normal environmental conditions, such as room temperature and / or moisture and / or light and / or pressure and / or foreign matter). Possibly, the Tread reading date or the start date of use is used for commercial reasons to better understand the logistics chain by understanding the time elapsed from manufacture to delivery to a patient in a specific country.

[0050] In a 5th aspect corresponding to at least one of the previous aspects, providing at least one warning signal comprises: providing a final warning signal.

[0051] In a 6th aspect corresponding to the previous aspect, issuing said at least one warning signal comprises: issuing a final warning signal when the Texp time limit is reached in_use shelf life when used and / or when the ΔT period expires in_use use.

[0052] In a 7th aspect corresponding to at least one of the previous aspects, providing at least one warning signal comprises: providing at least one preliminary warning signal.

[0053] In an 8th aspect corresponding to the previous aspect, issuing said at least one warning signal comprises: issuing at least one preliminary warning signal before reaching the Texp time in_use shelf life upon use and / or before the ΔT period expires in_use use.

[0054] This allows warning signals to be issued to the user / patient when the product's use period is approaching the end.

[0055] In the 9th aspect corresponding to at least one of the previous aspects, the dispenser data further comprises an expiration date Texp.

[0056] In the 10th aspect corresponding to the previous aspect, the method comprises the steps of, or the application is configured to compare the expiration date Texp with the expiration date Texp in_use expiration date and issuance of an additional warning signal if the Texp period in_usethe shelf life when used expires at the end of the shelf life Texp, and / or if the period ΔT in_use The use period expires upon expiration of the Texp.

[0057] In this case, the user / patient can immediately return the dispenser to the pharmacy and get another one.

[0058] In the 11th aspect corresponding to at least one of the previous aspects, the dispenser data comprises a unique identifier of the dispenser.

[0059] In the 12th aspect corresponding to the previous aspect, the method comprises the step, or the application is configured with the possibility, of linking the unique identifier to the reading date Tread and / or to the expiration date Texp in_use shelf life and / or ΔT period in_use use to ensure handling of multiple dispensers.

[0060] In the 13th aspect, corresponding to at least one of the previous aspects, the method comprises the step, or the application is configured to perform the following procedure: if the dispenser data is not new (i.e., is identified as already read by the portable electronic device, for example, already located in the electronic control unit or remote node), then presenting, by means of the output devices of the portable electronic device, a state indicating that the machine-readable code has already been read.

[0061] If the patient has more than one dispenser, the machine readable code can be read again to ensure that the correct dispenser is discarded (i.e. it will be clear that the start date has already been stored / designated for this dispenser).

[0062] In the 14th aspect corresponding to at least one of the previous aspects, the doser data contains additional information regarding the doser and the drug, such as the drug, the dose, the manufacturing location, the batch number.

[0063] In a 15th aspect corresponding to at least one of the previous aspects, the method comprises the step, or the application is configured to perform the following procedure: if the dispenser data is not new (i.e., is identified as already read by the portable electronic device, for example, already located in the electronic control unit or remote node), then presenting, by the output devices of the portable electronic device, the remaining period ΔT remain use.

[0064] In the 16th aspect corresponding to at least one of the previous aspects, in addition to providing at least one warning signal, the method comprises the step, or the application is configured to perform the following procedure: providing additional notification and / or links, such as notifications about when to take the medicine, notifications about when the product should be empty if the patient has taken all of the prescribed doses (this function can give the patient the opportunity to understand how accurately he / she is following the prescription instructions), instructions for use, links to a video on how to use the device, disposal instructions, etc.

[0065] In the 17th aspect corresponding to at least one of the previous aspects, the method comprises the following steps, or the application is configured to perform the following procedure:

[0066] - obtaining or selecting a parameter reflecting the region or country in which the portable electronic device is located, and / or in which the user / patient of the dispenser resides, and / or the time of year or season;

[0067] - selection of the ΔT period from the dispenser data in_use use for a given region or country and / or a given time of year or season.

[0068] In the 18th aspect corresponding to at least one of the previous aspects, the portable electronic device comprises a radio receiver, and the method comprises the following steps, or the application is configured to perform the following procedure:

[0069] - receiving, from the radio receiver, a parameter reflecting the region or country in which the portable electronic device is located, and / or the time of year or season;

[0070] - selection of the ΔT period from the dispenser data in_use use for a given region or country and / or a given time of year or season.

[0071] In the 19th aspect corresponding to the previous aspect, the radio receiver is a GPS receiver or a mobile network receiver (for example, 3G, 4G, 5G), or a Bluetooth receiver, or a Wi-Fi receiver.

[0072] Since the period of use may vary depending on the region or country and / or time of year or season (for example, due to differences in temperature and / or humidity; some countries / regions are very hot in summer and much colder in winter), the mentioned additional function ensures the appropriate shelf life for the region or country of use and / or time of year or season.

[0073] In the 20th aspect corresponding to at least one of the previous aspects, the reading is performed after the dispenser is removed for the first time from the sealed package or from the controlled environment; possibly, the sealed package is a moisture-proof bag.

[0074] In a 21st aspect corresponding to at least one of the previous aspects, the dispenser is a hand-held or portable dispenser, possibly an inhaler.

[0075] In the 22nd aspect corresponding to the previous aspect, the inhaler is a dry powder inhaler, and the drug is a powder drug; possibly, the multi-dose amount of drug contained in the housing is a single amount of material that is not divided into individual sealed doses; or possibly, the multi-dose amount of drug contained in the housing contains multiple individual doses of powder drug contained in blisters.

[0076] In the 23rd aspect, corresponding to the previous aspect, the reading is performed after the dispenser is removed from the sealed package for the first time.

[0077] In the 24th aspect, corresponding to the previous aspect 22 or 23, the period ΔT in_useThe shelf life is five to seven months, possibly six months.

[0078] In the 25th aspect corresponding to aspect 20, the inhaler is a metered dose inhaler (MDI), possibly a pressurized metered dose inhaler (pMDI), or a super fine mist inhaler (SMI), and the drug is a suspension or solution composition, preferably a solution.

[0079] In the 26th aspect corresponding to the previous aspect, the reading is performed after the dispenser is removed from the refrigerator for the first time.

[0080] In the 27th aspect, corresponding to the previous aspect, the period ΔT in_use The shelf life is two to five months, possibly three or four months.

[0081] In the 28th aspect corresponding to any of the previous aspects, the medicinal product is a single-component or multi-component composition.

[0082] In the 29th aspect corresponding to at least one of the previous aspects, the label or mark comprises an optical code such as a QR code or a barcode, and the reading devices comprise an optical reading device such as a camera.

[0083] In the 30th aspect corresponding to any of the previous aspects 1-28, the label or tag is an RFID tag (radio frequency identification tag), and the reading devices include an RFID reader (a device for reading RFID tags), or the label or tag is a BLE (Bluetooth Low Energy) beacon, and the reading devices include a BLE reader; possibly, said label or tag also includes a "recording function", and the portable electronic device includes recording devices configured to record on said label or tag.

[0084] In the 31st aspect corresponding to any of the previous aspects, the portable electronic device is a smartphone.

[0085] In the 32nd aspect corresponding to any of the previous aspects, the dispenser data is contained in a machine-readable code and / or in a portable electronic device.

[0086] In the 33rd aspect, corresponding to the previous aspect, when the reading devices read the machine-readable code on said reading date Tread, the method comprises a step, or the application is configured to perform the following procedure: reading the dispenser data from the machine-readable code.

[0087] In the 34th aspect corresponding to any one of the preceding aspects 1-31, the dispenser data is contained in a remote node that may be accessed via a network connection (for example, in a remote database).

[0088] In the 35th aspect, corresponding to the previous aspect, when the reading devices read the machine-readable code on said reading date Tread, the method comprises the following steps, or the application is configured to perform the following procedure:

[0089] - reading the address of the remote node from the machine-readable code;

[0090] - connect to the remote node and retrieve the mentioned dispenser data from the remote node;

[0091] - possibly storing the said dispenser data in a portable electronic device or on a label or tag, if the said label or tag also includes a "recording function", such as an RFID tag or a BLE beacon.

[0092] In the 36th aspect corresponding to any of the previous aspects, in order to recognize whether the dispenser data is new data, the method comprises the step, or the application is configured to perform the following procedure: comparing at least some of the dispenser data with at least some of the previously read, already stored data of other dispensers.

[0093] In the 37th aspect, corresponding to the previous aspect and aspect 11 or 12, it is provided to compare the unique identifier of the dispenser with previously read, already stored unique identifiers of other dispensers.

[0094] In the 38th aspect corresponding to any of the previous aspects, the dispenser comprises a dose counter unit configured to count the number of dispensed unit doses. The dose counter unit is configured to activate and increment the value each time the dispensing device is activated.

[0095] In the 39th aspect corresponding to any of the previous aspects, the method comprises the following steps, or the application is configured to perform the following procedure:

[0096] - receiving a medical prescription containing the number of doses per unit of time to be taken by the user and the total time ΔT assum doses or the total number of doses to be taken by the user;

[0097] - accounting or calculation of the total time ΔT assum reception and comparison of the mentioned total time ΔT assum admission with a Texp term in_use shelf life and / or ΔT period in_use use;

[0098] - issue an additional warning signal if the Texp period in_use the shelf life when used expires before the end of the full time ΔT assum reception, and / or if the period ΔT in_use use expires before the end of the total time ΔT assum reception.

[0099] In the 40th aspect, corresponding to any of the previous aspects, the Texp term in_use the usability is stored in a portable electronic device or in a remote location, possibly accessible via a network connection (e.g. a remote database), or on a label or tag if the said label or tag also includes a "recording function", such as an RFID tag or a BLE beacon.

[0100] In the 41st aspect, corresponding to any of the previous aspects, if the label or tag is a beacon (e.g., BLE), it can automatically emit a signal when first used. This signal can be received in the home environment or home central station, which can maintain the Texp period. in_use suitability for use at a remote site.

[0101] In the 42nd aspect, corresponding to any of the previous aspects, the method comprises a step or application configured to adjust the Tread reading date or the start date of use and / or manually input the reading date or start date via a portable electronic device. This may be useful if the user forgets to read the machine-readable code when using the dispenser for the first time.

[0102] Additional features will be presented in more detail in the detailed description of preferred, but not exclusive, embodiments of the drug administration device and the method for monitoring the expiration dates of the drug dispenser of the present invention.

[0103] Description of drawings

[0104] The present description will be set forth below with reference to the accompanying drawings, which are provided by way of example and without limitation, and in which:

[0105] Fig. 1 is a view of the device for administering drugs according to the present invention;

[0106] Fig. 2 - schematic section of one element of the device shown in Figure 1;

[0107] Fig. 3 is another embodiment of the element shown in Fig. 2;

[0108] Fig. 4 is a schematic section of the element shown in Figure 3;

[0109] Fig. 5 is a schematic representation of a part of the device shown in Figure 1; and

[0110] Fig. 6 - flow chart of the sequence of operations of the method according to the invention.

[0111] Detailed description

[0112] Referring to the accompanying drawings, Figure 1 depicts a device for administering medications. Device 1 comprises a pressurized metered-dose inhaler 2 (pMDI), i.e., a portable or manual medication dispenser, and a smartphone 3, i.e., a portable electronic device.

[0113] A pressurized metered dose inhaler 2 is known to date and comprises a housing 4 provided with a metering device 5 secured or located in the housing 4. As shown more clearly in Figure 2, a reservoir 6 containing a suitable medicinal preparation M (for example, a single-component or multi-component composition) and containing a valve 7 is placed in the housing 4 through a window 8 of the housing 4. The reservoir 6 can be disposable. The housing 4 is also provided with a mouthpiece 9 defining an outlet opening 10 for dispensing the medicinal preparation M expelled through the passage opening of the metering device 5.

[0114] The medicinal product M in the reservoir 6 constitutes a multi-dose amount of the medicinal product M, and the dosing device 5 is capable of dispensing a unit dose of said medicinal product M each time the user presses the reservoir 6 against the body 4.

[0115] The pressurized metered dose inhaler 2 may also comprise a dose counter unit, not shown in the drawings, which is configured to be switched on and to increase or decrease a value each time the dosing device 5 is actuated to count the number of unit doses dispensed.

[0116] A pressurized metered dose inhaler 2 of the type shown is disclosed, for example, in document EP 2890437 B1 filed by the applicant of the present application.

[0117] A label 11 containing a QR code 12 (i.e., a machine-readable code) is attached to the outer surface of the housing 4. The QR code contains data of the pressurized metered dose inhaler 2 or is associated with them, as explained below.

[0118] The smartphone 3 is also known to date and comprises a housing 13 with a display 14, and contains (Figure 5) a camera 15 (reading device), a memory 16, an electronic control unit 17, a radio receiver 18, a radio transmitter 19 and a GPS receiver 20. The electronic control unit 17 is functionally connected to the camera 15, the memory 16, the radio receiver 18, the radio transmitter 19 and the GPS receiver 20, in order to properly control the operations of the smartphone 3.

[0119] The radio receiver 18 and the radio transmitter 19 are configured to communicate with a cellular communication network or a mobile communication network (for example, a 3G, 4G or 5G network).

[0120] The GPS receiver is designed to receive signals from GPS satellites.

[0121] The smartphone 3 may also be equipped with a Bluetooth receiver / transmitter and a Wi-Fi receiver / transmitter, which are not shown in the accompanying figures.

[0122] The device 1 further comprises a software application (application) downloaded to the smartphone 3, for example, recorded in the memory 16 of the smartphone 3, and the electronic control unit 17 is configured to execute the said application, as well as to execute the method according to the invention.

[0123] As shown in the flow chart shown in Figure 6, the application is configured to read the QR code 12 with the camera 15 and obtain and store the pressurized metered dose inhaler 2 (pMDI) data contained in or associated with the QR code.

[0124] For example, in one embodiment, data related to the pMDI may be contained in a QR code, or in another embodiment, said data may be contained in a remote database 100 accessible in a web system, and the QR code contains a web address of said remote database 100, so that when the user points the camera of the smartphone 3 at the QR code while the application is running, the application selects said data from the remote database 100 and can store them in the memory 16.

[0125] Data related to pMDI contains ΔT period in_useuse of medicinal product M, i.e., the period beginning with the hypothetical start of pMDI use, when medicinal product M is first exposed to normal environmental conditions, such as room temperature and / or moisture and / or light and / or pressure and / or non-sterile conditions. Since pMDI inhalers are kept refrigerated (i.e., in a controlled environment) during transport and storage in the pharmacy, the period ΔT in_use The period of use will typically begin from the moment the product is removed from the refrigerator when it is received from the pharmacy. The ΔT period in_use The ΔT period for using a pMDI is known to the manufacturer, depends on the composition of the drug M, and can be, for example, three or four months, or even longer. The ΔT period in_use use is guaranteed, of course, only if the user follows the recommendations for use and storage of the product. The ΔT period in_useuse is known and is included in the data related to pMDI, but the Texp in_use The shelf life calculated from a hypothetical start of use is not known when the pMDI is manufactured and cannot be included in the data relating to the pMDI.

[0126] Data related to the pMDI usually additionally includes a unique identifier for the pMDI, such as a serial number.

[0127] Data related to a pMDI typically additionally includes the expiration date Texp, i.e., the expiration date calculated from the pMDI's manufacturing date. Since the manufacturing date is known, the expiration date Texp is included in the pMDI's data in the QR code or remote database 100. The expiration date Texp typically corresponds to the expiration date of the medicinal product M if said medicinal product M is stored protected from exposure to normal environmental conditions, for example, if the pMDI is refrigerated or sealed in a package or bag during transportation and storage in a pharmacy. Furthermore, this expiration date Texp is known to the manufacturer and depends on the composition of the medicinal product M.

[0128] According to embodiments, the database 100 includes a plurality of expiration dates Texp and / or periods ΔT in_useuse, each of which is associated with one or more geographic regions or countries, since the shelf life Texp and the period ΔT in_use usage may vary by region or country due to, for example, differences in temperature and / or humidity.

[0129] The application is configured to receive a parameter reflecting the region or country in which the smartphone 3 is located and / or the user lives, and selects the expiration date Texp and / or the period ΔT in_use for a given region or country. The region or country parameter may be entered by the user or selected by the application from the cellular or mobile phone network and / or GPS system.

[0130] The APP can also be set to get the parameter reflecting the time of year or season when the dispenser is used, since some countries / regions are very hot in summer and much colder in winter, and the climate conditions will greatly affect the medicine.

[0131] Data related to the pMDI may also include additional information and / or links through the application (e.g., web addresses) to retrieve information such as the drug, dose, place of manufacture, lot number, instructions for use, video on how to use the device, disposal instructions, etc.

[0132] The application is additionally configured to:

[0133] - receiving and, possibly, storing the Tread reading date, i.e. the date when the QR code was read;

[0134] - compare the pMDI unique identifier with other pMDI unique identifiers read earlier and possibly present in memory 16.

[0135] If the newly read unique identifier is read for the first time or is different from other unique identifiers, i.e., it is a new unique identifier, indicating that the QR code has been read for the first time since the pMDI was manufactured, then:

[0136] - designation and storage of the Tread date as the start date of use of the pMDI after manufacture, associated with a unique identifier;

[0137] - Calculation and storage of the Texp term in_use shelf life based on the Tread reading date and ΔT period in_use use, according to the formula "Texp in_use =Tread+ΔT in_use » and / or starting the expiration counter upon use, i.e. a time interval timer equal to the period ΔT in_use use;

[0138] - comparison of the expiration date Texp with the expiration date Texp in_use shelf life when used and if the Texp period in_use the shelf life when used expires at the end of the shelf life Texp, and / or if the period ΔT in_useIf the pMDI expires after its Texp expiration date, the smartphone will issue a warning signal (e.g., an audible or visual signal or vibration) so that the user can immediately return the pMDI to the pharmacy and get another one, or otherwise:

[0139] - providing a pre-warning signal so that said pre-warning signal can be issued via the smartphone 3 (for example, in the form of a message, an audible or visual signal, or vibration) before the Texp period is reached in_use shelf life upon use and / or until the ΔT period has expired in_use use (e.g. a few weeks or days earlier to alert the user when the product's use period is approaching its end and so that a new product can be prescribed by a doctor and obtained from a pharmacy before the expiry date of the previous product);

[0140] - Providing a final warning signal so that the said final warning signal can be issued when the Texp period is reached in_use shelf life when used, and / or when the ΔT period expires in_use use.

[0141] The application can also be configured to correct the Tread reading date or the date of first use and / or manually input, via the portable electronic device 3, the Tread reading date or the date of first use, and this function can be useful if the user forgets to read the machine-readable code 12 when the dispenser 2 is used for the first time and / or from its packaging.

[0142] The app may also be configured to provide additional notification and / or link.

[0143] The application can be further configured to obtain a medical prescription for the user / patient, wherein said medical prescription contains the number of doses per unit of time to be taken by the user (e.g. 2 doses per day) and the total time ΔT assum intake (e.g. 90 days) or the total number of doses to be taken by the user (e.g. 180 doses).

[0144] The app is also configured to account for or calculate the total time ΔT assum reception and comparison of the total time ΔT assum admission with a Texp term in_use shelf life and / or with ΔT period in_use use.

[0145] The application is also additionally configured to issue an additional warning signal by smartphone 3 if the Texp period in_use the shelf life when used expires before the end of the full time ΔT assum reception, and / or if the period ΔT in_use use expires before the end of the total time ΔT assumreception. Thus, if a pMDI contains a very large number of unit doses, and the ΔT period in_use If the period of use is very short, the user may be warned that he / she will not be able to use the entire medication.

[0146] The app can also optionally provide notifications for when the user should use their device. These notifications will be configured by the user to appear at the patient's preferred times of day when they are scheduled to take their medication: 8:00 AM and 6:00 PM.

[0147] If the unique identifier just read is the same as one of the other unique identifiers in memory 16, i.e. it is not a new unique identifier and indicates that the QR code has already been read, then:

[0148] - a representation, on display 14 of smartphone 3, of a state (message, image, etc.) indicating that the QR code has already been read and the remaining period ΔT remainusing pMDI.

[0149] Therefore, the app allows you to manage multiple pMDIs or other inhalers or dispensers and ensures that the correct inhaler is discarded when the final warning signal is triggered.

[0150] Figures 3 and 4 show another type of inhaler, i.e., a dry powder inhaler (DPI) 21, which may be, for example, the dry powder inhaler disclosed in document WO 2004 / 012801 filed by the applicant of the present application. This dry powder inhaler 21 can also be used with the above-described application and smartphone 3 in the same manner as described above.

[0151] The dry powder inhaler 21 shown in Figures 3 and 4 comprises a housing 22 defining a mouthpiece 23 and provided with a mouthpiece cap 24 configured to open or close the mouthpiece 23. A container 25 inside the housing 22 contains a multi-dose amount of a powdered medicinal product M (for example, a single-component or multi-component composition). The dosing element 26, having a dosing recess to be filled with a dose of powdered medicinal product M, may be in a position of communication with the inhalation channel 27 and the mouthpiece 23. The dry powder inhaler 21 further comprises an inhalation-activated mechanism designed in such a way that the inhalation-activated mechanism ensures that the medicinal product M is dosed and inhaled by the user in the case and at the time when the user creates an inhalation suction force that exceeds a predetermined level.

[0152] During transportation and storage in the pharmacy, the dry powder inhaler 21 is typically enclosed in a sealed package 28 (Figure 4) to prevent exposure to environmental conditions. The sealed package may be, for example, a moisture-proof foil pouch containing a desiccant, which should be discarded when the package is opened.

[0153] As shown in Figure 4, a label 11 containing a QR code 12 is attached to a sealed package 28, and the user scans the QR code with a camera 15 of a smartphone 3 when removing the dry powder inhaler 21 from the sealed package 28 at the beginning of use. In another embodiment, the QR code can be printed on the body 22 of the dry powder inhaler 21.

[0154] Texp term shelf The shelf life of the 21 dry powder inhaler depends on the composition and can be eighteen months.

[0155] Texp term in_use The shelf life depends on the composition and can be six months.

[0156] According to other embodiments of the invention, the device 1 may comprise other types of dispensers comprising a housing, a dispensing device connected to the housing, and a multi-dose amount of a drug contained in the housing (i.e., the drug in the form for multiple doses in the housing constitutes an amount of material sufficient to deliver a plurality of unit doses, but said amount of material is not necessarily divided into separate sealed doses when enclosed in the housing), wherein the dispensing device is configured to spray unit doses of said drug when activated by the user. For example, the dispenser may be an MDI provided with pre-filled blisters, similar to that disclosed in document WO 2004011071 A1, or an ultrafine mist inhaler (SMI), similar to that disclosed in document EP 3370810 B1.

[0157] According to embodiments, the application may not be downloaded to the electronic control unit, but may be a web application accessible over a network connection.

[0158] Instead of a QR code, other tags or labels equipped with a machine-readable code can be used, such as a barcode or RFID (radio frequency identification) tag, or a BLE (Bluetooth Low Energy) tag. Accordingly, the reader will be an optical reader (similar to camera 15) or an RFID reader or a BLE reader. Since tags of the mentioned types (for an RFID reader or a BLE reader) may include a "writing function," the dispenser 2 data and / or the Texp period in_use expiration dates can be stored on the labels. For this purpose, the portable control unit 3 contains recording devices to record the dispenser 2 data and / or the expiration date in_useexpiration date on tags. If the label or tag is a BLE tag, it can automatically emit a signal when first used. This signal can be received in the home environment (e.g., by Alexa™) or by a home central station, which can maintain the expiration date. in_use suitability for use in a cloud environment.

[0159] A label or tag with a machine-readable code may be attached to the body of the dispenser, similar to the pMDI 2 disclosed above, to the packaging, similar to the DPI 21 disclosed above, as well as to a sheet inserted into the packaging 28 of the dispenser, or attached to the disposable reservoir 6 related to the pMDI 2. If the components of the DPI are reused, the machine-readable code will be attached to the disposable body containing the drug.

[0160] List of elements

[0161] device 1

[0162] Pressed Metered Dose Inhaler (pMDI) 2

[0163] smartphone 3

[0164] Case 4

[0165] dispensing device 5

[0166] tank 6

[0167] valve 7

[0168] window 8

[0169] Mouthpiece 9

[0170] outlet 10

[0171] label 11

[0172] QR code 12

[0173] Case 13

[0174] Display 14

[0175] Camera 15

[0176] memory 16

[0177] Electronic control unit 17

[0178] Radio Receiver 18

[0179] Radio Transmitter 19

[0180] GPS Receiver 20

[0181] Dry Powder Inhaler (DPI) 21

[0182] Case 22

[0183] Mouthpiece 23

[0184] Mouthpiece cap 24

[0185] container 25

[0186] dosing element 26

[0187] Inhalation channel 27

[0188] sealed packaging 28.

Claims

1. A device for administering medicinal preparations, comprising: a dispenser (2, 21) comprising a housing (4, 22), a dispenser (5, 26) connected to the housing (4, 22), and a multi-dose quantity of a medicinal product (M) contained in the housing (4, 22), wherein the dispenser (5, 26) is configured to dispense standardized doses of said medicinal product (M) when activated by the user; a label or mark (11) containing a machine-readable code (12) containing data of the dispenser (2, 21) or associated with them, wherein the label or mark (11) is attached to the dispenser (2, 21) and / or contained in or secured to the packaging (28) for the dispenser (21), wherein the data of the dispenser (2, 21) contains the period of use (ΔT in_use ) medicinal product (M); a portable electronic device (3) containing an electronic control unit (17) and reading devices (15) designed to read dispenser data (2, 21) from machine-readable code (12); an application loaded into the electronic control unit (17) or into a remote node and configured to perform the following procedure: - receiving and storing the data of the dispenser (2, 21) and the date (Tread) of reading, when the reading devices (15) read the machine-readable code (12) on the said date (Tread) of reading and, if at least one of the said data of the dispenser (2, 21) is new, indicating that the machine-readable code (12) was read for the first time after the manufacture of the dispenser (2, 21), then: - calculation and storage of the term (Texp in_use ) shelf life based on the reading date (Tread) and period (ΔT in_use ) use, according to the formula Texp in_use =Tread+ΔT in_useand / or starting the expiration counter upon use; - providing at least one warning signal as a function of the time limit (Texp in_use ) shelf life and / or shelf life (ΔT in_usr ) of use, so that the portable electronic device (3) emits said at least one warning signal when the time limit (Texp) is reached and / or approaches in_use ) shelf life when used, or when the period (ΔT in_use ) the term of use is about to expire, wherein the portable electronic device (3) comprises a radio receiver (18, 20), and the application is configured to perform the following procedure: - receiving from the radio receiver (18, 20) a parameter reflecting the region or country in which the portable electronic device (3) is located, and / or the time of year or season; selection, from the dispenser data (2, 21), of the period (ΔT in_use) use for a given region or country and / or a given time of year or season.

2. The device according to item 1, in which the dispenser data (2, 21) additionally contain the expiration date (Techn), and the application is configured to compare the expiration date (Techn) with the expiration date (Texp in_use ) expiration date and issuance of an additional warning signal if the expiration date (Texp in_use ) the shelf life when used expires at the end of the shelf life (Technical) and / or if the period (ΔT in_use ) the use expires upon expiration of the expiration date (Technical).

3. The device according to claim 1 or 2, in which the dispenser data (2, 21) contains a unique identifier of the dispenser (2, 21), and the application is configured to link the unique identifier to the date (Tread) of reading and / or to the expiration date (Texp in_use ) shelf life and / or shelf life (ΔT in_use ) use to ensure handling of dispensers (2, 21).

4. The device according to any one of claims 1 to 3, in which the application is configured to perform the following procedure: if the data of the dispenser (2, 21) is not new, then presenting, via the output devices (14) of the portable electronic device (3), a state indicating that the machine-readable code (12) has already been read, and / or the remaining period (ΔT remain ) use.

5. A device according to any one of claims 1-4, wherein the dispenser (2, 21) is an inhaler.

6. The device according to claim 5, wherein the inhaler is a dry powder inhaler (21) and the medicinal product (M) is a powder medicinal product.

7. The device according to claim 5, wherein the inhaler is a metered dose inhaler (2) or an ultra-fine mist inhaler, and the medicinal product (M) is a suspension or solution composition.

8. A device according to any one of paragraphs 1-7, in which the label or mark (11) contains a QR code (12), wherein the portable electronic device is a smartphone (3), and the reading devices (15) contain a camera.

9. A method for monitoring the expiration date of a drug dispenser, comprising the following steps: - reading and storing the data of the dispenser (2, 21) and the date (Tread) read by means of the reading devices (15) of the portable electronic device (3) and from the machine-readable code (12) of the label or mark (11) attached to the dispenser (2, 21) of the medicinal product (M) and / or contained in or secured to the packaging (28) for the dispenser (2, 21); wherein the data of the dispenser (2, 21) contain the period (ΔT in_use ) use of the medicinal product (M); and if at least one of the mentioned data of the dispenser (2, 21) is new, indicating that the machine-readable code (12) was read for the first time after the manufacture of the dispenser (2, 21), then: - calculation and storage of the term (Texp in_use ) shelf life based on the reading date (Tread) and period (ΔT in_use ) use, according to the formula Texp in_use =Tread+ΔT in_use and / or starting the expiration date counter upon use; - providing at least one warning signal as a function of the time limit (Texp in_use ) shelf life and / or shelf life (ΔT in_use ) use; - issuing, by means of a portable electronic device (3), said at least one warning signal when the time limit (Texp) is reached and / or approaches in_use ) shelf life when used, and / or when the period (ΔT in_use ) the term of use is expiring or is approaching expiration, and the method additionally contains the following steps: - obtaining or selecting a parameter reflecting the region or country in which the portable electronic device (3) is located, and / or in which the user of the dispenser (2, 21) resides, and / or the time of year or season; - selection, from the dispenser data (2, 21), of the period (ΔT in_use ) use for a given region or country and / or a given time of year or season.

10. The method according to item 9, comprising the following steps: comparing the expiration date (Techr), which is part of the dispenser data (2, 21), with the expiration date (Texp in_use ) shelf life and / or with a period (ΔT in_use ) use and issue of an additional warning signal if the period (Texp in_use ) the shelf life when used expires at the end of the shelf life (Technical) and / or if the period (ΔT in_use ) the use expires upon expiration of the expiration date (Technical).

11. The method according to item 9 or 10, comprising the step of: linking the unique identifier of the dispenser (2, 21) to the date (Tread) of reading and / or to the deadline (Texp in_use ) shelf life and / or shelf life (ΔT in_use ) use to ensure handling of dispensers (2, 21).

12. The method according to any one of claims 9-11, wherein, if the data of the dispenser (2, 21) is not new, then presenting, by means of the output devices (14) of the portable electronic device (3), a state indicating that the machine-readable code (12) has already been read.

13. The method according to any one of paragraphs 9-12, in which, if the data of the dispenser (2, 21) is not new, then the presentation, by means of the output devices (14) of the portable electronic device (3), of the remaining period of use (ΔT remain ).

14. The method according to any one of claims 9 to 13, wherein the dispenser (2, 21) is a dry powder inhaler (21) and the medicinal product (M) is a powder medicinal product; wherein the reading is performed after the dry powder inhaler (21) is removed for the first time from the sealed packaging (28).

15. The method according to any one of claims 9-13, wherein the dispenser (2, 21) is a metered dose inhaler (2).

16. The method according to any one of claims 9-13, wherein the dispenser (2, 21) is a pressurized metered dose inhaler or an ultrafine mist inhaler, and the medicinal product (M) is a suspension or solution composition.

17. The method according to claim 16, wherein the reading is performed after removing the metered dose inhaler (2) or the ultra fine mist inhaler for the first time from the refrigerator or from the sealed packaging.

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