EP2170242A2

EP2170242A2 - System for controlling drug intake

Info

Publication number: EP2170242A2
Application number: EP08758928A
Authority: EP
Inventors: Michael Kiy; Hans Layer
Original assignee: Alcan Technology and Management Ltd
Current assignee: Amcor Flexibles Kreuzlingen AG
Priority date: 2007-06-22
Filing date: 2008-06-02
Publication date: 2010-04-07
Also published as: WO2009000383A3; WO2009000383A2

Abstract

The invention relates to a system for reminding a patient of drug intake and for monitoring whether a patient has taken his/her drugs from a blister package (10). Said system comprises a blister package (10) having a blister base (12) with at least one receptacle (14), molded out of a base film and containing a tablet (16) or a similar drug portion, and a cover film (18), which is sealed towards the blister base (12) and can be forced through, a communication means (42), associated with the patient, comprising an electronic camera for recording an image of the blister package (10) after every drug intake, software for evaluating every image and identifying the tablets (16) removed by comparison with earlier images of the same blister package (10), means for reading and storing data comprising the instructions for a patient regarding drug intake, and optionally input and output means interacting with the communication means (42) for receiving information and for transmitting information.

Description

System for controlling medication intake

The invention relates to a system for reminding a patient of a medi kamenteneinnahme and review of drug withdrawal by the patient from a blister pack.

Known push-through or blister packs consist of a blister base part and a cover foil which is sealed against the blister bottom part and closes the pack. A blister pack known for metered packaging of pharmaceutical products, such as tablets, usually has a multiplicity of individual small containers in the form of cup-shaped depressions formed in the bottom blister in the blister bottom part for receiving the tablets. To remove a single tablet from a blister pack, the corresponding recess is pressed in the bottom part and in this case the tablet pushed through the lid material. Typically, the cover sheet is an aluminum foil or a composite foil of an aluminum foil with further layers of plastic or paper. The aluminum foil is a preferred lidding material for blister packs, since at the selected thicknesses of the lid materials relatively low breaking forces are necessary, the required piercing energy is thus low and the aluminum has a low elongation. In general, the bottom part of the blister pack made of plastic, such as PVC, polyamide, polyolefin, polyethylene terephthalate and from at least one of these materials constructed, optionally also containing an aluminum foil composite films.

In the context of the development of unmixed blister packs plastic blister films have already been proposed, wherein the blistering property of the plastic film is achieved by embedding fillers in the matrix. The fillers are selected with regard to their composition and proportion in such a way that a weakening of the surrounding plastics occurs matrix, whereby the puncture resistance of the film is lowered so that the packaged goods can push through tearing or breaking the film through them. Due to the requirement that the selection of the fillers and in particular their proportions in the plastic matrix should ensure the puncture property of the film, opaque push-through films always resulted.

EP-A-0 613 832 discloses a metal foil-free cover sheet comprising at least one polyolefin or polyester-based thermoplastic film having a filler content of 5 to 50% by weight. Preferred plastic is polyethylene, fillers are, for example, chalk and talc.

From DE-A-196 13 960 a transparent push-through foil with a polyolefin-containing polymer phase is known. The polymer phase contains a hydrocarbon resin component in dissolved form with pendant cyclic groups on the polymer chain. Preferred polyolefins are polyethylene, polypropylene or a co- or terpolymer of ethylene and / or propylene. To set a desired push-through force, up to 35% by weight of filler, such as chalk or talc, may be embedded in the polymer composition.

The regular control of medication is critical to the success of most therapies. Various studies have shown that, especially with long-term therapies, the irregularity of taking medication increases over time and, in the end, in many cases no medication is taken at all. In case of negative treatment success, new therapies are often used that would be unnecessary with regular medication. If an irregular medication intake is detected, the regularity of the medication can be significantly improved by motivating the patient.

A control, memory and motivation of patients can significantly increase the success of a therapy and thus lead to a reduction in costs. All previous systems available on the market detect an opening of the packaging, which is also considered as taking the medication. If then the drug is really taken, can not be determined with most conventional systems. As a rule, however, a patient only bothers to open a package if he really wants to take the medication.

Some packages help the patient to take the medication by visibly displaying the time (e.g., days of the week) on the package from the outside.

Other systems actively determine when the medicine packages were opened and store the opening hours, which are then read out at a later date. The detection is usually carried out electrically, in the case of bottles as medicament containers by means of a small switch or in blister packs or blister packs by destruction of conductor tracks either directly on the blister pack or in the repacking.

Printed conductors arranged directly on the blister pack are disclosed, for example, in US Pat. No. 4,616,316, US Pat. No. 4,617,557, EP 0 972 507 A1, EP 0 129 785 A1 and US2007 / 0084746 A1. The blister pack with the tracks are connected to dataloggers, which record every change of the contacts and record the time of the change. The data is usually read out at the end, thus controlling the time of taking it. Even systems without data output are known; they will issue warnings and instructions when not taking proper medication via a display.

A major disadvantage of the known systems are the required electronic components and batteries, which are usually for reasons of cost and lack of environmental compatibility no disposable items. The use of mobile telephones for the memory of a medicament intake is disclosed in DE 100 46 762 A1.

The invention has for its object to provide a system of the type mentioned, which allows reliable control of the drug intake without costly adaptation of the blister packs to the system and requires no electronic components and batteries to the blister pack.

To solve this problem according to the invention, a system is provided which comprises:

a blister pack comprising a blister bottom portion having at least one container formed from a bottom sheet, containing a tablet or like medication portion and a push-through cover sheet sealed against the blister sheet portion,

- A means of communication associated with the patient with an electronic camera for receiving the blister pack after each done

Drug withdrawal, with software for evaluating each shot and recognizing the removed tablets by comparison with previous shots of the same blister pack,

a means for reading and storing data with instructions for a patient to take medication, and optionally

input and output means cooperating with the communication means for receiving information and for transmitting information.

The software for displaying reminder messages through the communication Onsmittel is configured to take medication, with each withdrawn tablet recorded as the time of ingestion and the next reminder message is displayed according to a given timely intake rule.

The communication means is preferably a mobile phone with integrated camera.

For installation or activation of and / or for identification and verification of the authenticity of the blister pack, an RFID tag may be arranged on the blister pack, and the communication means is preferably a mobile phone with integrated camera and is equipped with NFC (Near Field Communication). fitted.

For scaling the image recordings, a pattern may be printed on the blister pack, preferably circumferentially on the edge of the blister base part or the cover film.

The cover film and the blister base part are preferably designed so that they can be distinguished by a brightness or color contrast. Depending on the contrast difference, the picture can be taken from the side of the cover foil or from the side of the bottom foil.

The image recognition on the side of the cover sheet may be e.g. become safer if a light area on otherwise dark background is printed over the containers with the tablets. A white frame on the cover foil helps to orient the software.

The image can also be taken from the side of the Blisterbodenteils, with particularly white tablets stand out well against a dark cover sheet. When the tablet is ejected, it is possible to see residues of the cover foil or a non-white background through the resulting hole. Depending on the frequency of the RFID different types of antennas can be realized. LF (low frequency, 125kHz) RFID antennas are hardly suitable for this application, since they usually consist of a wound coil with ferrite core. HF (13.56 MHz) RFID antennas are well suited if the antenna is very compact. UHF RFID antennas are usually very small dipoles and also very well suited. The removal of medicines from the blister package usually already causes the destruction of a very small part of the RFID antenna, which drastically alters its resonance frequency.

RFID tags are mostly passive systems, that is, they are only active if there is enough electromagnetic radiation above the RFID antenna to build up a sufficiently high operating voltage. Passive RFID tags therefore do not require a battery and are available on demand. Upon activation, the RFID tags return information in the form of a number as an individual identification code to the RFI D reader.

When using NFC (Near Field CommunicationJ technology), which works in the HF range, the RFID antennas can not be applied directly to a metal surface, as this would dampen the electromagnetic radiation too much, and spacers would have to be used when using conventional aluminum foil as a cover foil However, the problem can be solved by using a nonmetallic cover film, as known from DE 196 13 960 A1, for example, although the known metal foil-free cover films have the disadvantage that However, without these additives, the brittleness of these films is too low for use as printable cover films.

The invention is therefore based on the further object of providing a non-metallic cover film which is suitable for sealing against all common floor materials, which is transparent and at the same time has a brittleness which has comparable through-pressure properties with a conventional push-through foil containing aluminum foil.

The invention is therefore based on the further object of providing a metal foil-free cover film which is suitable for sealing against all common floor materials, which is transparent and at the same time has a brittleness which has comparable through-pressure properties with a conventional push-through film containing aluminum foil, and suitable for printing on RFID antennas with electrically conductive colors.

For the novel solution of this further object, the cover film contains at least one layer of cycloolefin copolymer (COC).

Cycloolefin copolymer (COC) is a highly transparent material with excellent barrier to water vapor transmission, can be coextruded with other materials such as polyethylene or polypropylene and is also very brittle. These properties provide ideal conditions for the use of cycloolefin copolymer (COC) for the production of push-through films. It is possible with this material Durchdrückfolien with Durchdrückeigen- shafts similar to the produced in large quantities mainly made of aluminum foil of a thickness of 20 microns Durchdrückfolien.

The cover film is preferably provided in layers on the side facing against the blister side with a hot-sealing lacquer layer or a coextruded heat seal, the seal to blister base made of PVC, ACLAR ^®, PP, PE, PS, Formpack ^® or PA.

On the side facing away from the Blisterbodenteil side the cover sheet with a thermally stable at sealing temperature lacquer layer or with a coextruded, at sealing temperature thermally stable plastic layer, preferably from COC, PP, PA or PET, be provided. The cover film has a preferred thickness of 5 to 60 .mu.m, in particular 10 to 30 .mu.m.

In the case of a blister pack with a blister bottom part and a cover foil sealed against the bottom part of the blister, at least on the side sealed against the cover foil, the blister bottom part consists of a material whose chemical structure is compatible with that of the plastic film sealed against the blister bottom part.

Examples of materials used to make blister sheet parts are films of PVC, PVDC, PP, PET, PE, PS; PA and composite films such as PVC / ACLAR® (PCTFE), PVC / PVDC and COC or FORMPACK® (AI-AI BIister).

It should be mentioned here that both the cover foil and the bottom foil can be printed.

In the system according to the invention, an image-based evaluation method is used by using an electronic camera installed in a mobile telephone. Image-recognizing software evaluates a blister pack image to be taken by the patient with the camera and thereby detects one or more tablet samples by comparison with previous evaluations. The blister pack is advantageously sealed with a sealed film foil printed in relation to the tablets with high brightness or color contrast, so that the tablets are clearly distinguishable by the transparent containers. The distinction can also be achieved by patterns, colors or structures on the tablets and / or on the sealing film.

Another software supports the control of the patient's medication intake by recording the withdrawn tablets as time of taking and according to the Pharograms maherstellers is reminiscent of the further intake. If necessary, the software may initiate further actions if, for example, the medication is not taken, too late or too early, and, if necessary, indicate instructions and measures for the patient.

The software may be implemented by known methods, e.g. via an SMS link, download to a personal computer, input of an Internet address, etc. transferred to the mobile phone.

Another possibility of software installation or activation is the integration of an RFID tag in the blister pack. A mobile telephone equipped with NFC (Near Field Communication) reads the individual identification code stored in the RFID chip when approaching the blister pack. This one-to-one ID number is automatically matched by the mobile phone with NFC technology to a central database and thus leads to a feedback from the pharmaceutical manufacturer to the mobile phone. Thus, first of all, the authenticity of the blister pack can be reconfirmed by the manufacturer. At the same time corresponding programs or program modules can be loaded on the mobile phone. Optionally, the software may include enhanced functionality by detecting additional RFID tag blister packs that are specifically tailored to the combination of drugs for a patient. Other features include including data collected by other devices and transmitted via NFC or Bluetooth, such as blood pressure, heart rate, temperature and more. to be triggered.

In order for a tablet removal to be recognizable, the software first calculates the distance from the camera and the rotation in space with respect to the central optical acquisition axis by means of a pattern advantageously printed around the edge of the blister pack on the sealing side of the cover foil , This correction is possible via the software known width / length ratio of the blister pack on which the image is first scaled. The position of the tablets in the blister is then interrogated on this normalized image basis, free from the environment. On the basis of the resulting contrast, it is recognized whether a tablet is still present at a location known to the software or has already been removed. In this case, once recognized as a removed tablet may not be available again later. An indication of the recognized, withdrawn tablet for reconfirmation by the patient protects against in principle not absolutely avoidable misrecognitions of the software.

If the tablet removal is clearly recognized, it is provided with a time stamp and stored in the mobile phone using the RFID identification of the blister pack and the mobile phone ID. This is a one-to-one assignment of removal of a special tablet by a special patient, who is also the owner of the phone, at a unique time possible.

Further advantages, features and details of the invention will become apparent from the following description of preferred embodiments and with reference to the drawing; this shows schematically in

- Figure 1 is a plan view of the Blisterbodenteil a blister pack.

FIG. 2 shows a cross section through the blister pack of FIG. 1 along the line I-I; FIG. - Fig. 3 is a plan view of the cover sheet of the blister pack of

Fig.1;

FIG. 4 shows a cross section through a first cover sheet; FIG.

FIG. 5 shows a cross section through a second cover film; FIG.

FIG. 6 shows a system for controlling a medication intake. FIG.

A blister pack 10 shown in FIGS. 1 to 3 consists of a blister base part 12 with a cup-shaped shape formed out of a bottom film Containers 14. In the containers 14 are tablets 16. As a closure for the containers 14, a cover film 18 spanning the openings of the containers 14 is sealed against the blister base part 12. To increase the contrast difference for an image evaluation, the cover sheet 18 is printed with a pattern (FIG. 3).

To remove the individual tablets 16 from the blister pack 10, pressure is exerted on the corresponding container 14 from the side of the blister bottom part 12 with the thumb or a finger and the tablet 16 is pushed out of the container 14 through the cover film 18. In this case, the thickness of the cover sheet is adjusted so that the cover sheet 18 tears when ejecting the tablet 16 from the container 14 without excessive force.

In the example shown in FIGS. 1 to 3, one of the tablets 16 has already been ejected from its container 14 through the cover film 18. In FIG. 3, the contrast difference between the open container with the cover sheet removed and the cover sheet 18 printed with a pattern is clearly recognizable for image evaluation.

In addition, a reference RFID tag 70 a with an RFID chip 72 a and an RFID antenna 74 a is arranged in a non-destructible area on the cover film 18.

A first cover film 18 shown by way of example in FIG. 4 consists of a core film 20 of mLLDPE (metallocene-based linear polyethylene lower

Density) of a thickness of 10 .mu.m with COC films 22, 24 coextruded on both sides, each having a thickness of 5 .mu.m. The later to be sealed against a Blisterbodenteil 12

Side of the cover sheet 18 is coated with a Heisssiegellackschicht 26 has a thickness of 2 microns, optionally provided with an imprinted outside with a transparent protective lacquer layer 28 of a thickness of 2 microns.

A second embodiment of a cover film 18 shown by way of example in FIG. 5 consists of a core film 30 of COC a thickness of 10 microns with coextruded films on both sides of a thickness of 5 microns. The film of cover sheet 18, which is later to be sealed against a blister base part 12 made of PVC, is a heat-sealable layer 32; the film on the outside of the other cover sheet 18 is a thermal protection layer 34.

An exemplary system shown in FIG. 6 for controlling the taking of a medication or withdrawing a tablet 16 from a blister pack 10 comprises a mobile telephone 42 for receiving and transmitting information, e.g. in the form of SMS (Short Message Service) short messages, via a mobile radio network 44, for example a GSM (Global System for Mobile Communications) or a UMTS (Universal Mobile Telecommunications System) mobile radio network or another mobile radio network, for example a satellite-based mobile radio network or a wireless local area network (WLAN). The system further comprises a computer system 46 having a transceiver unit 48 for transmitting and receiving information over the cellular network 44, a computer unit 50, and a database 52 associated with the computer unit 50 with the stored data including instructions for a patient to take the medication Identification 40 of the blister packs 10th

The computer system 46 or the database 52 stores the retrievable software for the mobile telephone 42. This is requested by the mobile telephone 42 and then runs autonomously, for example with a Java program, on the mobile telephone 42. The mobile telephone 42 optionally communicates with it the database 52 and optionally sends medication extraction data or receives additional information from there. LIST OF REFERENCE NUMBERS

10 blister pack

12 blister bottom part

14 container

16 tablet

18 cover sheet

20 mLLDPE core film

22, 24 coextruded COC films

26 heat sealing lacquer layer

28 thermal protective lacquer layer

30 COC core film

32 Polymeric heat-sealable layer

34 Polymer thermal protection layer

40 ldentifikationskennung

42 mobile phone

44 Mobile network

46 computer system

48 transmitter / receiver unit

50 computer unit

52 data memory

70 a RFI D day

72 a RFID chip

74 a RFI D antenna

Claims

claims

A system for reminding a patient of a medication intake and checking the withdrawal of medication by the patient from a blister pack (10), the system comprising:

- A blister pack (10) having a Blisterbodenteil (12) with at least one formed from a bottom foil, a tablet (16) or the like drug portion containing container (14) and sealed against the Blisterbodenteil (12), push-through cover sheet (18), and

a communication means (42) associated with the patient having an electronic camera for receiving the blister pack (10) after each withdrawal of medication, with software for evaluating each shot and recognizing the removed tablets (16) by comparison with previous images of the same blister pack (10) .

input and output means cooperating with the communication means (42) for receiving information and transmitting information.

2. System according to claim 1, characterized in that the software for displaying reminder messages by the communication means (42) is configured for taking medication, each removed tablet (16) detected as taking time and the next reminder message is displayed according to a predetermined temporal revenue.

3. System according to claim 1 or 2, characterized in that the Communication means (42) is a mobile phone with integrated camera.

4. System according to claim 1 or 2, characterized in that for installing or activating the software and / or for identifying and verifying the authenticity of the blister pack (10) an RFID tag (70 a) with RFID chip (72 a) and RFID antenna (74 a) on the push-through pack (10) is arranged, and the communication means (42) is a mobile phone with integrated camera and equipped with NFC (Near Field CommunicationJ technology.

5. System according to one of claims 1 to 4, characterized in that for scaling the image recordings on the blister pack (10), preferably circumferentially at the edge of Blisterbodenteils (12) or the cover sheet (18), a pattern is printed.

6. System according to one of claims 1 to 5, characterized in that the cover film (18) and the Blisterbodenteil (12) are distinguishable by a brightness or color contrast.

7. cover film for a blister pack (10) in a system according to one of the preceding claims, comprising at least one on the blister pack (10) arranged RFID tag (70 a), characterized in that on the blister pack (10) at least one RFID Antenna (74 a) is printed.

8. cover sheet according to claim 7, characterized in that the at least one RFID antenna (74 a) in the form of a printed conductor imprint on the cover sheet (18) is printed.

9. Deckfoiie according to claim 8, characterized in that the conductor track overprint is made of a coating containing at least one electrically conductive material.

10. cover sheet according to claim 9, characterized in that the electrically conductive material is a powder of metal and / or graphite or an intrinsically conductive polymer.

11. Covering film according to one of claims 7 to 10, characterized in that the cover film (18) contains at least one layer of cycloolefin copolymer (COC).

12. Covering film according to claim 11, characterized in that the cover film (18) is provided on the side facing the blister base part (12) side with a Heisssiegellackschicht (26).

13. cover film claim 11, characterized in that the cover film (18) on the side facing the blister (12) facing side with a co-extruded Heisssiegelschicht (32) is provided.

14. cover film according to claim 12 or 13, characterized in that the Heisssiegellackschicht (26) or the coextruded Heisssiegelschicht (32) against Blisterbodenteile (12) made of PVC, ACLAR ^® , PP, PE, PS, Formpack ^® or PA is sealable.

15. cover film according to one of claims 11 to 14, characterized in that the cover film (18) on the Blisterbodenteil (12) facing away side with a thermally stable at sealing temperature lacquer layer (28) is provided.

16. Covering film according to one of claims 11 to 14, characterized in that the cover film (18) on the Blisterbodenteil (12) facing away side with a coextruded, at sealing temperature thermally stable plastic layer (34) is provided.

17. Covering film according to claim 16, characterized in that the coextruded, at sealing temperature thermally stable plastic layer (34) consists of COC, PP, PA or PET.

18. Covering film according to one of claims 11 to 17, characterized in that the cover film (18) has a thickness of 5 to 60 microns, preferably 10 to 30 microns.