INHALER AND METHOD AND ARRANGEMENT FOR ADMINISTERING AN ACTIVE SUBSTANCE

Abstract

An inhaler that includes a housing having a body configured to receive an active substance container containing an active substance, and an air channel extending within the housing; an administration element for nebulising or vaporising the active substance for mixing the active substance with air flowing in the air channel; an electronic control apparatus; an electronic data storage device; and a sensor system having a flow measuring apparatus for measuring a volume flow and a mass flow of the air and the active substance for storage as active substance delivery data; wherein: the electronic control apparatus is configured to convert active substance administration data into administration data to control the mixing of the active substance with the air; and the electronic control apparatus is configured to calculate a quantity of the active substance delivered from the active substance container and to compare the quantity with the active substance administration data.

Claims

1-21. (canceled)

22. An inhaler comprising: a housing having a main body, wherein the main body is configured to receive an active substance container containing an active substance, and an air channel extending within the housing between at least one air inlet opening of the housing and an inhalation opening of the housing; an administration element for nebulising or vaporising the active substance fed from the active substance container to the administration element for mixing the active substance with air flowing in the air channel; an electronic control apparatus; an electronic data storage device; and a sensor system having a flow measuring apparatus for measuring at least one of a volume flow and a mass flow of at least one of the air flowing through the air channel and the active substance flowing through the air channel for storage as active substance delivery data in the electronic data storage device; wherein: the electronic control apparatus is configured to convert active substance administration data, provided in the electronic data storage device for administering the active substance by the inhaler, into administration data in order to control the mixing, by the administration element, of the active substance with the air flowing in the air channel; and the electronic control apparatus is configured to calculate a quantity of the active substance delivered from the active substance container based on the active substance delivery data detected by means of the flow measuring apparatus and to compare the quantity with the active substance administration data.

23. The inhaler of claim 22, further comprising a communication device configured to either or both transmit or receive data.

24. The inhaler of claim 23, wherein data can be provided to the electronic data storage device by means of at least one of the communication device and a storage unit comprising the active substance container.

25. The inhaler of claim 23, wherein the communication device is configured to communicate with an external deployment source containing the active substance administration data in order to either or both receive the active substance administration data or transmit data.

26. The inhaler of claim 25, wherein the external deployment source comprises at least one of an application terminal, a cloud storage, and a mobile application to either or both receive the active substance administration data by means of the communication device or to transmit data.

27. The inhaler of claim 26, wherein the inhaler is configured to be linked to a mobile application of a communication terminal by means of the communication device to either or both transmit data or receive data, wherein the active substance administration data can be received from at least one of the cloud storage and the application terminal via the mobile application and can be transferred to the electronic data storage device of the inhaler.

28. The inhaler of claim 22, further comprising at least one motion sensor to detect specific movements of the inhaler at least one of before, during and after delivery of the active substance.

29. The inhaler of claim 22, further comprising a blocking element, wherein the blocking element blocks the administration element to disable the delivery of the active substance from the active substance container.

30. The inhaler of claim 29, wherein the blocking element is configured to be controlled by means of the electronic control apparatus, wherein the blocking element is configured to disable the administration element if the active substance administration data is not available to the electronic control apparatus.

31. The inhaler of claim 30, wherein, when the active substance delivery data at least substantially matches the active substance administration data, the electronic control apparatus is configured to take an action including at least one of: emitting a signal to at least one of a signaling device comprising the inhaler, a mobile application, an application terminal, and a cloud storage; blocking of the administration element by the blocking element; storing of an at least substantial match of the active substance delivery data with the active substance administration data with at least one of a place and a time stamp on or in at least one of the electronic data storage device, the application terminal, the cloud storage, and the mobile application.

32. The inhaler of claim 30, wherein, in the case of a defined deviation of the active substance delivery data from the active substance administration data, the electronic control apparatus takes an action including at least one of: emitting a signal to at least one of a signaling device comprising the inhaler, the mobile application, the application terminal, and the cloud storage; adjusting the administration data for delivering the quantity of the active substance for mixing with the air flowing in the air channel; blocking the administration element with the blocking element; receiving new active substance administration data by means of the communication device for generating new administration data; storing the defined deviation of the active substance delivery data from the active substance administration data with at least one of a place and time stamp on or in at least one of the electronic data storage device, the application terminal, the cloud storage, and the mobile application.

33. A method for administering an active substance with an inhaler, the inhaler comprising: a housing having a main body, wherein the main body is configured to receive an active substance container containing an active substance, and an air channel extending within the housing between at least one air inlet opening of the housing and an inhalation opening of the housing; an administration element for nebulising or vaporising the active substance fed from the active substance container to the administration element for mixing the active substance with air flowing in the air channel; an electronic control apparatus; an electronic data storage device; and a sensor system having a flow measuring apparatus for measuring at least one of a volume flow and a mass flow of at least one of the air flowing through the air channel and the active substance flowing through the air channel for storage as active substance delivery data in the electronic data storage device; wherein the method comprises: providing active substance administration data in the electronic data storage device of the inhaler; converting the active substance administration data into administration data by means of the electronic control apparatus of the inhaler; controlling the mixing of the active substance, by the administration element, with the air flowing in the air channel using the administration data; calculating a quantity of the active substance delivered from the active substance container based on the active substance delivery data detected by means of the flow measuring device; and comparing the active substance administration data with the active substance delivery data.

34. The method of claim 33, wherein the inhaler further comprises a communication device configured to either or both transmit data or receive data.

35. The method of claim 34, wherein data is provided to the electronic data storage device by means of at least one of the communication device and a storage unit comprising the active substance container.

36. The method of claim 35, wherein the communication device communicates with an external deployment source containing the active substance administration data to either or both receive the active substance administration data or transmit data.

37. The method of claim 34, wherein the inhaler is linked to a mobile application of a communication terminal by means of the communication device before a first time of either or both of transmitting data or receiving data.

38. The method of claim 37, wherein the active substance administration data is received from at least one of a cloud storage, an application terminal, and the mobile application by means of the communication device of the inhaler and is transferred to the electronic data storage device of the inhaler.

39. The method of claim 38, wherein data is transmitted to at least one of the mobile application, the application terminal, and the cloud storage by means of the inhaler.

40. The method of claim 38, wherein, when the active substance delivery data at least substantially matches the active substance administration data the electronic control apparatus is configured to take an action including at least one of: emitting a signal to at least one of a signaling device comprising the inhaler, the mobile application, the application terminal, and the cloud storage; blocking the administration element with the blocking element; storing of an at least substantial match of the active substance delivery data with the active substance administration data with at least one of a place and time stamp on or in at least one of the electronic data storage device, the application terminal, the cloud storage, and the mobile application.

41. The method of claim 38, wherein, in the case of a defined deviation of the active substance delivery data from the active substance administration data, the electronic control apparatus is configured to take an action including at least one of: emitting a signal to at least one of a signaling device comprising the inhaler, the mobile application, the application terminal, and the cloud storage; adjusting the administration data for delivering the quantity of the active substance for mixing with the air flowing in the air channel; blocking the administration element with the blocking element; receiving new active substance administration data by means of the communication device for generating new administration data; storing the defined deviation of the active substance delivery data from the active substance administration data with at least one of a place and time stamp on or in at least one of the electronic data storage device, the application terminal, the cloud storage, and the mobile application.

42. An arrangement for administering an active substance, the arrangement comprising a communication terminal comprising at least one of a mobile application, an application terminal, and cloud storage, the arrangement further comprising an inhaler comprising: a housing having a main body, wherein the main body is configured to receive an active substance container containing an active substance, and an air channel extending within the housing between at least one air inlet opening of the housing and an inhalation opening of the housing; an administration element for nebulising or vaporising the active substance fed from the active substance container to the administration element for mixing the active substance with air flowing in the air channel; an electronic control apparatus; an electronic data storage device; and a sensor system having a flow measuring apparatus for measuring at least one of a volume flow and a mass flow of at least one of the air flowing through the air channel and the active substance flowing through the air channel for storage as active substance delivery data in the electronic data storage device; wherein: the electronic control apparatus is configured to convert active substance administration data, provided in the electronic data storage device for administering the active substance by the inhaler, into administration data in order to control the mixing, by the administration element, of the active substance with the air flowing in the air channel; the electronic control apparatus is configured to calculate a quantity of the active substance delivered from the active substance container based on the active substance delivery data detected by means of the flow measuring apparatus and to compare the quantity with the active substance administration data; and at least one of the communication terminal, the application terminal, and the cloud storage are configured to either or both transmit data to or receive data from the inhaler.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0075] Further expedient and/or advantageous features and developments of the inhaler as well as the arrangement and the method emerge from the dependent claims and the description. Particularly preferred embodiments are explained in greater detail with reference to the attached drawings. The drawings show:

[0076] FIG. 1 a schematic view of an inhaler according to the invention in longitudinal section;

[0077] FIG. 2 a schematic illustration of the inhaler in conjunction with an external deployment source;

[0078] FIG. 3 a flow chart for use of an inhaler;

[0079] FIG. 4 a flow chart for successful use of an inhaler;

[0080] FIG. 5 a flow chart for unsuccessful use of an inhaler; and

[0081] FIG. 6 a schematic illustration of the use of an arrangement according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0082] The inhaler according to the invention, the method according to the invention and the arrangement according to the invention are described with reference to the aforementioned figures. To avoid repetition, the statements made about the inhaler also apply to the method according to the invention and to the arrangement according to the invention, so that statements are made below only on selected aspects of the method according to the invention and the arrangement according to the invention, detached from the inhaler according to the invention.

[0083] The inhaler shown in the drawing is configured and adapted for administering an active substance. The invention relates in the same way to comparable products for administering active substances with which other substances, for example luxury goods/stimulant substances or medical preparations, are to be administered. In particular, this explicitly includes electronic cigarette products and medical inhalers which have a similar construction.

[0084] The inhaler 10 shown in FIG. 1, comprises a housing 11 having a main body 12, the main body 12 being configured and adapted to receive an active substance container 13 containing an active substance 14, an air channel 17 extending between at least one air inlet opening 15 and an inhalation opening 16 within the housing 11, an administration element 18 for nebulising or vaporising the active substance 14 supplied to the administration element 18 from the active substance container 13 for mixing with air 23 flowing in the air channel 17, an electronic control apparatus 19, an electronic data storage device 20 and a sensor system 21 having a flow measuring apparatus 22 for measuring the volume flow and/or mass flow of the air 23 flowing through the air channel 17 and/or of the active substance 14 flowing through the air channel 17 for storage as active substance delivery data in the electronic data storage device 20. The inhaler 10 preferably comprises at least one energy source 27, for example for supplying the electronic control apparatus 19 as well as the administration element 18 and the further electrical or electronic components with energy.

[0085] This inhaler 10 is characterised according to the invention in that the electronic control apparatus 19 of the inhaler 10 is configured and adapted to convert active substance administration data, provided in the electronic data storage device 20, for administering the active substance 14 by the inhaler 10 into administration data in order to control mixing of the active substance 14, by the administration element 18, with air 23 flowing in the air channel 17, and the electronic control apparatus 19 being adapted to calculate the active substance 14 delivered from the active substance container 13 based on the active substance delivery data detected by means of the flow measuring device 22 and to compare same with the active substance administration data.

[0086] The air 23 flowing in the air channel 17 is shown in stylised form in FIG. 1, whereby the air 23 flowing in the air channel 17 is not usually visible, or the flowing air 23 is regularly formed, for example, as vapour or aerosol. The air 23 flowing in the air channel 17 includes the active substance 14 during use of the inhaler 10, i.e. during the inhalation process, provided that the user sucks on the inhalation opening 16. In the process, the active substance 14 is transported by the air 23 flowing in the air channel 17.

[0087] The housing 11 of the inhaler 10 can basically have any colours and shapes and is not limited in design and choice of material. In this respect, the housing 11 is structured so that it includes a region for receiving and/or enclosing the active substance container 13 within the housing 11 of the inhaler 10. The inhaler 10 shown in FIG. 1 corresponds to the schematic construction of a medical inhaler, although a more elongated construction, comparable to that of an electronic cigarette, for example, is also conceivable. For the inhaler 10 according to the invention, it is not relevant whether the inhaler 10 or parts thereof are configured as disposable or reusable items. The active substance container 13 can preferably be configured as a disposable item and can have a further electronic data storage device/a storage unit, not shown in the figures, on which, for example, active substance administration data and/or administration data for controlling the inhaler 10 are stored.

[0088] The active substance 14 to be administered, which is located in the active substance container 13, is preferably dissolved in a liquid and is present as a mixture. Furthermore, the active substance 14 can be present in the active substance container 13 as a gas, or can be a compressed liquid or can be dissolved in a compressed liquid. If the active substance 14 is dissolved in a liquid, the mixture comprises, for example, one or a plurality of the following constituents: 1,2-propylene glycol, glycerin, water, at least one flavouring, and one or a plurality of active substances 14. The composition of the liquid, however, depends on the active substance 14 to be administered and can be designed according to the pharmacological requirements.

[0089] The schematically illustrated inhaler 10 serves the purpose of administering the active substance 14 via the inhalation opening 16 to the respective user of the inhaler 10, who is not shown in the drawings. For this purpose, the active substance 14 is present in the active substance container 13 and is administered by means of the administration element 18 to air 23 flowing in the air channel 17, as a result of which this air 23 is in turn orally ingested by the user. The administration element 18 can be configured as required depending on the active substance 14 to be administered, whereby in each case administration of the active substance 14 from the active substance container 13 is provided for. The administration element 18 is controlled by means of the electronic control apparatus 19 in order to administer the active substance 14 in accordance with the active substance administration data provided. The active substance administration data are provided in the electronic data storage device 20 and can be converted into administration data by means of the electronic control apparatus 19. The administration data form the data for administering the active substance 14 by means of the administration element 18 which is controlled by means of the electronic control apparatus 19. The active substance 14 generated by the administration element 18 in vapour or aerosol form escapes from the administration element 18 and is mixed with the air 23 flowing in the air channel 17, see FIG. 1. The flow measuring apparatus 22 uses the sensor system 21 to determine the quantity of active substance 14 administered and uses the electronic control apparatus 19 to calculate the active substance delivery data in order to compare them with the active substance administration data.

[0090] The electronic data storage device 20 is advantageously non-volatile and is used, for example, to store the active substance administration data, the administration data, the active substance delivery data, the data of the sensor system and further general information or parameters about operation of the inhaler 10. The data storage device 20 can be part of the electronic control apparatus 19. Advantageously, the data storage device 20 stores information on the composition of the liquid or active substance 14 stored in the active substance container 13, information on the operating principle of the administration element 18, in particular on power/temperature control, etc., data on condition monitoring or system testing, for example leak testing, data relating to copy protection and counterfeit protection, an ID for unique identification, serial number, date of manufacture, expiry date, number of inhalation processes and/or usage time.

[0091] The sensor system 21 comprises a flow measuring apparatus 22 which is configured here as a differential pressure measuring apparatus. For this purpose, the flow measuring apparatus 22 comprises a first pressure sensor, not shown in detail in the figures, which is arranged such that it is adapted for measuring the atmospheric air pressure outside the housing 11 of the inhaler 10. For example, a measuring opening in the housing 11 can be provided to connect the first pressure sensor to the atmosphere in a flow-conducting manner. The flow measuring apparatus 22 further comprises a second pressure sensor, not shown in detail in the figures, which is arranged such that it is adapted for measuring the air pressure prevailing in the air channel 17. By knowing the cross-section of the air channel 17 at the measuring location of the second pressure sensor and the pressure difference measured between the first and second pressure sensor, the electronic control apparatus 19 can calculate the air volume flow through the inhaler 10 and, by repeatedly measuring, the air flow volume over time.

[0092] The sensor system 21 can have a vapour quantity sensor to detect the quantity of active substance, liquid or vapour administered by the administration element 18 during an inhalation process. The vapour quantity sensor, for example, can be an air humidity sensor, not shown in detail.

[0093] The inhaler 10 preferably comprises a communication device 24, configured and adapted to transmit and/or receive data. Preferably, data can be provided to the electronic data storage device 20 by means of the communication device 24 and/or by means of a storage unit, not shown in the figures, which comprises the active substance container 13. In this case, the data are determined in particular for operating the inhaler 10 or for administering the active substance 14 and/or data during the inhalation process. The communication device 24 is configured and adapted to communicate with an external deployment source 25 (see FIG. 2) which contains the active substance administration data in order to receive the active substance administration data and/or to transmit data. The transmitting and receiving of data is indicated in FIG. 2 by the double arrow between inhaler 10 and the deployment source 25. The inhaler 10 and the deployment source 25 are shown in simplified schematic form, with the ability to communicate with each other apparent from FIG. 2. The communication device 24 of the inhaler 10 preferably comprises means for wirelessly transmitting data, e.g. based on Bluetooth, WLAN, ZigBee, NFC, RFID, Wibree, WiMAX, mobile radio, optically; alternatively, wired data transmission or communication is also possible. The external deployment source 25 preferably also comprises at least one of the aforementioned means or communication options to configure and adapt a connection or communication with the inhaler 10.

[0094] Preferably, the external deployment source 25 (see FIG. 2) comprises an application terminal and/or cloud storage and/or a mobile application, not shown in the figures, in order to receive the active substance administration data by means of the communication device 24 and/or to transmit data. In this case, the external deployment source 25 is selected depending on the application purpose or configuration of the inhaler 10, the active substance 14 to be administered or the relevant authorised person.

[0095] Advantageously, the inhaler 10 can be linked by means of the communication device 24 to a mobile application of a communication terminal, shown schematically in FIG. 2 as external deployment source 25, in order to transmit and/or receive data, it being possible to receive the active substance administration data from the cloud storage and/or from the application terminal via the mobile application and to transmit them to the electronic data storage device 20 of the inhaler 10. Transmission of the data is shown schematically in FIG. 2 as a double arrow. The external deployment source 25 can be divided into a plurality of separate components which fulfil different sub-functions of the overall functionality of the external deployment source 25. For example, the mobile application can be used to display supplementary information or to emit signals, while data are being provided in the cloud storage, in order to retrieve them by means of the communication terminal.

[0096] Optionally, the inhaler 10 comprises at least one motion sensor 26 to detect specific movements of the inhaler 10 before, during and/or after delivery of the active substance. The motion sensor 26 can be a separate component, or the motion sensor 26 can be integrated into the electronic control apparatus 19, for example.

[0097] Preferably, the inhaler 10 further comprises a blocking element 28, the blocking element 28 in particular disabling the administration element 18 to block the delivery of the active substance 14 from the active substance container 13. In FIG. 1, the blocking element 28 is configured as an object, however, electronic control components which stop the administration element 18 from administering the active substance 14 from the active substance container 13 are also conceivable as an alternative. It is additionally possible for the blocking element 28 to be arranged directly at the outlet opening of the active substance container 13 in order to block administration of the active substance 14. The blocking element 28 is preferably controllable by means of the electronic control apparatus 19, the blocking element 28 disabling the administration element 18 if no active substance administration data are available to the electronic control apparatus 19.

[0098] The inhaler 10 preferably comprises a signalling device 29. For example, the signalling device 29 comprises visual, acoustic and/or haptic signalling elements, for example one or a plurality of LEDs, a digital display, a display, a haptic signal transmitter and/or an acoustic signal transmitter.

[0099] A preferred method is explained below in greater detail with the aid of FIG. 3.

[0100] The method is described for administering an active substance 14 with an inhaler 10. The method comprises the steps S1 to S5. In step S1, active substance administration data are provided in an electronic data storage device 20 of the inhaler 10. The data can be provided to the electronic data storage device 20 in a variety of ways. For example, the active substance administration data are provided via a storage unit of the active substance container 13 or can be received by means of a communication device 24.

[0101] In step S2, the active substance administration data are converted into administration data by means of an electronic control apparatus 19 of the inhaler 10. The administration data can be used to control administration of the active substance 14 via an administration element 18. The administration data are based on the active substance administration data and convert the data into control signals in order to adjust the active substance administration data to a respective administration element 18.

[0102] In step S3, mixing of the active substance 14, by the administration element 18, with air 23 flowing in an air channel 17 is controlled by means of the administration data. The inhaler 10 is activated by the administration data as a function of its comprehensive components, so that the active substance 14 to be administered matches the active substance administration data.

[0103] In the following step S4, the active substance 14 delivered from the active substance container 13 is calculated based on the active substance delivery data detected by means of a flow measuring apparatus 22 of the inhaler 10. For this purpose, the air components in particular of the air 23 flowing through the air channel 17 are calculated out during delivery of the active substance and the quantity of the active substance 14 actually administered can be determined and stored in the active substance delivery data. The active substance delivery data thus represent the active substance 14 actually delivered which has been absorbed by the user of the inhaler 10 while carrying out the previous steps S1 to S3.

[0104] In step S5, the active substance administration data are compared with the active substance delivery data. Basically, a successful inhalation process is when the active substance delivery data match the active substance administration data. The electronic control apparatus 19 is used to calculate how the inhalation process has gone as a function of the active substance administration data with the active substance delivery data. The comparison can be based on both absolute data and relative data.

[0105] The data provided and/or generated while carrying out steps S1 to S5 can be transmitted via a communication device 24 of the inhaler 10 to an external deployment source 25, the external deployment source 25 comprising in particular a mobile application, an application terminal and/or cloud storage.

[0106] One or a plurality of the following steps are preferably performed if the comparison carried out in step S5 by means of the electronic control apparatus 19 results in at least a substantial match between the active substance delivery data and the active substance administration data. In step SE1, emitting of a signal to a signalling device 29 comprising the inhaler 10 and/or to the mobile application and/or to the application terminal and/or to the cloud storage. The signal is emitted after the inhalation process has been completed and the comparison of the active substance administration data with the active substance delivery data has ended. In particular, the signal informs the user of the inhaler 10 that the inhalation process has been successfully carried out, i.e. that the active substance administration data match the active substance delivery data. The signal is preferably represented visually, haptically and/or acoustically by means of a signalling device 29. As a result of the signal, further actions concerning the inhaler 10 can be performed by means of the electronic control apparatus 19. In step SE2, for example, blocking of the administration element 18 or the inhaler 10 by the blocking element 28 takes place subsequently or alternatively to SE1. This step is preferably configured to be reversible.

[0107] In addition or alternatively to step SE1 or SE2, in step SE3 the at least substantial match of the active substance delivery data with the active substance administration data is stored with a place and/or date stamp on the electronic data storage device 20 and/or on the application terminal and/or in the cloud storage and/or in the mobile application.

[0108] One or a plurality of the following steps are preferably performed if the comparison carried out in step S5 by means of the electronic control apparatus 19 results in a defined deviation of the active substance delivery data from the active substance administration data. In step SU1, emitting of a signal to a signalling device 29 comprising the inhaler 10 and/or to the mobile application and/or to the application terminal and/or to the cloud storage. The signal is emitted after the inhalation process has been completed and the comparison of the active substance administration data with the active substance delivery data has ended. In particular, the signal informs the user of the inhaler 10 that the inhalation process has been unsuccessfully carried out, i.e. that the active substance delivery data deviate from the active substance administration data. As a result of the signal, further actions concerning the inhaler 10 can be performed by means of the electronic control apparatus 19, in which case the signal is in particular a control signal.

[0109] Additionally or alternatively to step SUL adjusting the administration data for delivering the quantity of the active substance 14 for mixing with the air 23 flowing in the air channel 17 takes place in step SU2. The administration data are carried out based on the comparison between the active substance administration data and the active substance delivery data performed in step S5. In particular, the administration data are adjusted to the effect that delivery of the active substance 14 to air 23 flowing in the air channel 17 is modified by means of the administration element 18. For example, the administration data can be adjusted to the effect that the duration of the delivery of the active substance 14 to air 23 flowing in the air channel 17 is varied by means of the administration element 18; for example, in that the quantity of the active substance 14 to be absorbed previously in an inhalation process is divided over two inhalation processes in order to achieve complete administration of the active substance 14. The administration data are thus adjusted but the active substance administration data are retained. When the active substance administration data are compared with the active substance delivery data, the active substance 14 delivered to the user by the inhaler 10 are compared with each other again.

[0110] In step SU3, blocking of the administration element 18 or the inhaler 10 by the blocking element 28 takes place subsequently or alternatively to steps SU1 and/or SU2. This step is preferably configured to be reversible.

[0111] In addition and/or alternatively, in step SU4, new active substance administration data are received from the inhaler 10 by means of the communication device 24 for generating new administration data. The new active substance administration data preferably have a modified specification for administering the active substance 14. Preferably, steps SU2 and/or SU4 in particular are repeated as often as desired until there is at least a substantial match between the active substance delivery data and the active substance administration data in the further inhalation processes carried out.

[0112] In addition or alternatively to steps SU1 to SU4, in step SU5, the defined deviations of the active substance delivery data from the active substance administration data are stored with a place and/or time stamp on the electronic data storage device 20 and/or on the application terminal and/or in the cloud storage and/or in the mobile application. The process is preferably repeated as often as desired until there is at least a substantial match between the active substance delivery data and the active substance administration data.

[0113] Steps SE1 and/or SE2 or steps SU3 and/or SU5 take place if there is an at least substantial match between the active substance delivery data and the active substance administration data after the inhalation process is repeated with modified active substance administration data.

[0114] FIG. 6 shows an inhaler 10 preferably as a component of an arrangement 30 which is configured and adapted for administering an active substance 14. The arrangement 30 comprises an inhaler 10 and a communication terminal 32 comprising a mobile application 31 and/or an application terminal and/or a cloud storage 33, the inhaler 10 being configured and adapted according to one or more of claims 1 to 11 and the communication terminal and/or the application terminal and/or the cloud storage being configured and adapted for transmitting and/or receiving data with the inhaler 10.