WO2013110107A1

WO2013110107A1 - Medicament packaging

Info

Publication number: WO2013110107A1
Application number: PCT/AT2013/050013
Authority: WO
Inventors: Gernot Schmid; Manfred Bammer
Original assignee: Ait Austrian Institute Of Technology Gmbh; Seibersdorf Labor Gmbh
Priority date: 2012-01-25
Filing date: 2013-01-16
Publication date: 2013-08-01
Also published as: AT512406A4; EP2806846A1; AT512406B1

Abstract

The invention relates to medicament packaging. The medicament packaging comprises at least one blister (1) which comprises a main part (2) with bulges (3) for receiving medicaments (5) and which comprises an electrically and/or magnetically conductive foil (4) that is attached face to face onto the main part (2) and closes the bulges (3) such that closed cavities (6) are formed between the bulges (3) and the foil (4) for the medicaments (5). The invention also relates to medicaments (5), in particular in the form of tablets, which can be found in the cavities (6), and to a packaging unit (7) for receiving the at least one blister (1), said packaging unit being made of a flat material and comprising a plurality of delimiting surfaces, in particular in the shape of a folded box, wherein an antenna (8) is arranged on a delimiting surface (9) of the packaging unit (7).

Description

drug packaging

The invention relates to a medicament pack according to the preamble of patent claim 1. Furthermore, the invention relates to a method for testing the authenticity of a medicament pack according to the preamble of patent claim 11.

Particularly with expensive medicines, there is the problem that the authenticity of medicines must be made comprehensible in order to ensure the proper treatment of patients with the respective medicaments, as well as the safe use of the respective medicaments by the patient.

The object of the invention is to provide a medicament pack with which a verification of the authenticity of the drug can be checked together with the pack,

Another object of the invention is to provide a method for easy authentication of such a drug package available.

The invention solves this problem in a drug package of the type mentioned above with the features of the characterizing part of claim 1. The invention relates to a drug package comprising

at least one blister comprising a base body with bulges for receiving medicaments and an electrically and / or magnetically conductive foil which is applied flatly to the base body and closes the bulges so that closed cavities for the medicaments are formed between the convexities and the foil,

- medicines in the cavities, in particular in the form of tablets,

- A packaging unit for receiving the at least one blister of sheet material comprising a number of boundary surfaces, in particular in the form of a carton. According to the invention, an antenna is arranged on a boundary surface of the packaging unit.

Such a drug package has a good interface for wireless communication with an external data communication device, with a secure and error-free data transmission is ensured with the external data communication device. Furthermore, it can be provided that the antenna is arranged on that boundary surface of the packaging unit which is furthest away from the foil. As a result, the data transmission between the antenna and an external data communication device is further improved.

Alternatively or additionally, it may be provided that the antenna is arranged along the peripheral edge of the boundary surface, which is furthest away from the film. As a result of this measure, a particularly large area is available for the data transmission, so that the specific position plays a rather subordinate role for the external data communication device.

In order to achieve a simple production of the packaging, it can be provided that the antenna is arranged on the inside of the boundary surface of the packaging unit, which is furthest away from the film, wherein the antenna is arranged in particular on an adhesive film or printed.

In order to create a particularly difficult to manipulate or fake medication package, it can be provided that the antenna embedded in the packaging unit, poured, integrated or printed by means of electrically conductive paste or paint on the packaging unit.

In order to easily ensure an authenticity check, a control chip may be provided which has connections for connection to the antenna. The control chip drives the antenna for communication with the external data communication device.

In order to achieve an improved transmission, provision can be made for an enclosed leaflet to bear against the boundary surface on which the antennas are arranged. The leaflet serves as a spacer between the boundary surface and the foil. The large distance between the boundary surface and the foil improves the communication between the antenna as well as the control chip and the external data communication device.

To facilitate handling of the respective drug package as well as to achieve a more stable data communication connection, a further antenna may be provided, which is arranged on the boundary surface opposite the antenna supporting the boundary surface. For this purpose, it can also be provided that a further control chip is provided and the further antenna is connected to the further control chip or that the antenna and the further antenna are connected to the control chip.

To check the authenticity of the drug can be provided that in the control chip a unique, exclusively for the respective control chip assigned code is stored, optionally on a control chip and on a further control chip arranged on the same control chip another code is stored.

Furthermore, the invention relates to a method for checking the authenticity of a drug package according to the invention, wherein a database with valid codes is stored on a server. According to the invention, the code stored on the control chip or the further control chip is read out with a data communication device and sent to the server, possibly encrypted, that the server checks whether the code transmitted to it is stored in the database, and that the result of the check is transmitted to the data communication device and displayed by the latter if necessary. As a result, a check of the authenticity can be carried out in a simple manner, wherein the code stored in the medicament pack is not visible to the user.

In order to ensure improved security, provision can be made for a further code, if appropriate in the form of a number or a barcode, to be printed on the medicament package, wherein the valid codes and the packaging units provided with these codes are contained in the database of the server further codes are stored. It is further provided that in addition to the code stored on the control chip and the printed on the packaging units code is determined by the data communication device that both the code and the other code are transmitted to the server, that is checked whether the code in the database the server is stored and the other code is associated with the code in the database, and that the result of the review is transmitted to the data communication device and displayed by the latter if necessary.

In order to exclude the authorization to obtain an authentication of the respective package to unauthorized persons, it can be provided that a person code identifying the patient and / or the pharmacist and / or the prescribing physician is determined during or before the dispensing of the medication package to the patient and transmitted to the server and assigned to the respective code stored on the control chip or the further control chip that prior to interrogation of the authenticity of a personal code queried by the data communication device and entered by the person in the data communication device that the person code together with the on the control chip or the further control chip stored code, and optionally with the other code is transmitted to the server that is checked before carrying out further checks, if the code is stored in the database of the server and the person code associated with the code in the database if not, a message of lack of authority is transmitted to the data communication device and another query is aborted.

For easy handling of an authentication by the respective user, it may be provided that the personal code characterizing the respective user is stored on a personalized chip card, and the personal code is read from the chip card.

A preferred embodiment of the invention is illustrated in more detail below with reference to the drawing figures. Fig. 1 shows the preferred embodiment of a drug package according to the invention obliquely from above. Fig. 2 shows the illustrated in Fig. 1 preferred embodiment of a drug package according to the invention from the side. Fig. 3 shows an adhesive label with an antenna and a control chip. Fig. 4 shows a detail of the embodiment shown in Fig. 1 and the arrangement of the adhesive label. Fig. 5 shows an alternative to the embodiment of the medicament pack shown in Fig. 4. Fig. 6 shows a further alternative embodiment of the invention with two antennas without the blisters. Fig. 7 shows the embodiment shown in Fig. 6 in side view with blisters. Fig. 8 shows schematically the transfer of data between the drug package, a data communication device and a server.

In Fig. 1, a drug package is shown containing two blisters 1 and a packaging unit 7 for receiving the two blisters 1. Of course, it is possible that only one or even more than two blisters 1 are located in the packaging unit 7. In addition, a folded leaflet 13 is also typically contained in the packaging unit 7 (FIG. 2). The two blisters 1 each comprise a main body 2 with bulges 3 for receiving medicaments 5. The main body 2 may consist of a molded plastic film or a plastic-metal composite foil. The medicaments 5 are in the concrete embodiment tablets or capsules. The blisters 1 are usually constructed equal to each other. Furthermore, each blister 1 in each case has an electrically and / or magnetically conductive foil 4. An advantage of such a blister 1 is a particularly good storage capacity of the medicaments and the guarantee of a high tightness of the cavities 6 formed by the bulges 3 and the film 4.

Also, the base body 2 of the blister 1 may itself consist of a metal-plastic composite film, said composite film is typically formed slightly thicker than the sealing film. This is mainly intended for packaging for medicines that require a special sunscreen.

The authenticity check is carried out in such a way that an antenna 8, which is connected to a control chip 12, is arranged on the medicament pack. In the control chip 12, a coded certificate is stored, this is in the present case a string or sequence of numbers, which is determined in the production of the control chip 12 and is known only to the manufacturer or a certifier instructed by the manufacturer. The string or sequence of numbers is read out via an external data communication device 17 (FIG. 8) and transmitted to the manufacturer or certifier, for example via the Internet, which possibly confirms the authenticity.

The problem, however, is that the electrically and / or magnetically conductive foil 4 or optionally also the electrically and / or magnetically conductive base body 2 weakens or shields electrical and / or magnetic fields and thus a simple authenticity check by means of electromagnetic radio waves or magnetic and / or or electrical coupling between antenna 8 and external data communication device 17, such as in NFC, makes it difficult or impossible. Electromagnetic waves emitted by an external data communication device 17 or electric and / or magnetic fields generated by an external data communication device 17 are shielded or weakened by the film 4 of the blister 1 or blisters 1, so that a test for authenticity impossible or difficult. The power supply of the control chip 12 via the radiated from the external data communication device 17 electromagnetic energy. In order nevertheless to obtain a good reception, as shown in FIGS. 1 and 2, an antenna 8 is arranged on a boundary surface 9 of the packaging unit 7. In the present case, it is ensured by the special insertion of the blister 1 into the packaging unit 7 that the antenna 8 is arranged on the boundary surface 9 of the packaging unit 7, which is furthest away from the film 4. As a result, an electromagnetic data transmission between the antenna 8 and an external data communication device 17 is possible without the electromagnetic waves or electrical and / or magnetic fields used for communication being shielded or excessively weakened by the foils 4 of the blisters 1. The antenna 8 comprises one or more windings which run along the outer peripheral edge 10 of a boundary surface 9 of the packaging unit 7.

The distance between the film 4 and the antenna 8 is further increased by the leaflet 13 shown in Fig. 2, so that the transmission of data between the antenna 8 and the external data communication device 17 is further improved by the arrangement shown in Fig. 2. The leaflet 13 is applied to the boundary surface 9 of the packaging unit 7, on which the antenna 8 is arranged.

Fig. 3 shows an adhesive film 1 1 on which an antenna 8 and the control chip 12 are applied. The adhesive film 1 1 is glued in the preparation of the drug package, as shown in Fig. 4, on the inside of the boundary surface 9, wherein the antenna 8 extends in the region of the inner peripheral edge 10 of the packaging unit 7. The arrangement of the adhesive film 1 1 inside the packaging unit 7, the risk of destruction of the antenna 8 or the control chip 12 and the risk of detachment of the adhesive film 1 1 is largely avoided.

As an alternative to the embodiment shown in FIG. 4, as shown in FIG. 5, provision may also be made for the antenna 8 to be embedded, cast in or integrated into the packaging unit 7. In this embodiment case, the packaging unit 7 is formed of plastic, wherein the antenna 8 and the control chip 12 are molded into the body of the packaging unit 7. Alternatively, the antenna 8 and the control chip 12 can also be integrated directly into the carton during the production of a packaging unit 7 made as a carton. Furthermore, the antenna 8 can be printed on the packaging unit 7 by means of electrically conductive paste or paint. FIG. 6 shows a further alternative embodiment of the invention, with a view to achieving as little error-prone robust communication between the control chip 12 and the external data communication device.

At the boundary surface 9 opposite another boundary surface 14, a further antenna 15 is arranged. This further antenna 15 is connected to a further control chip 16. Each antenna 8, 15 is thus each connected to a control chip 12, 16. The antenna 8 is connected to the control chip 12, the further antenna 15 is connected to the further control chip 16. In the present case, the control chip 12 and the further control chip 16 are identical and provided with a different code, which is transmitted to the external data communication device 17 on request. But it is also possible that each control chip is provided with its own code.

By virtue of this measure, it is thus possible to apply the external data communication device 17 to each of the boundary surfaces 9, 14 provided with antennas 8, 15 and to one of the two antennas 8, 15 and to the control chips 12, 16 connected to the antennas 8, 15 to connect in data connection and to read the respective code.

If the foil 4 or the basic body 2 of a blister 1 located in the packaging unit 7 completely shields the flux penetrating one of the antennas 8, 15, a data communication connection can optionally be achieved with the respective other antenna 15, 8 and data from the respective control chip 12, 16 are transmitted to the external data communication device 17. Of considerable advantage here is further that the use of two opposing antennas 8, 15 causes the blisters 1 does not have to be "inserted in a special way" or arranged to an advantageous data communication connection between the data communication device 17 and at least one of the antennas 8, 15th to reach.

Furthermore, it can alternatively be provided that only one control chip 12 is provided, which is connected to both antennas 8, 15.

In Fig. 7 the illustrated in Fig. 6 further embodiment of the invention with two blisters 1 is shown in side view. The two blisters 1 lie with the films 4 to each other. In the present case, they are arranged so that the foils 4 are as far away as possible from the respectively nearest antenna 8, 15. It is also possible that the position and arrangement of the blisters 1 in the interior of the packaging unit 7 is different, whereby one of the two antennas 8, 15 can be shielded by a foil 4 of one of the blisters 1. In such a case, there is the possibility that the external data communication device 17 enters data communication with the unshielded antenna 8, 15.

FIG. 8 shows the examination of the authenticity of the packaging unit 7 with a data communication device 17 which is connected to a server 18. The data communication device 17 itself is either authorized by the drug manufacturer or is a standard data communication device 17, for example a mobile phone, on which runs a software application authorized by the drug manufacturer.

In the control chip 12 or in the control chips 12, 16, the manufacturer stores a unique, in particular secret, code known only to the manufacturer. Alternatively, different codes for each control chip 12 can be stored separately on this.

In addition, a further code 20 can be visibly printed on the packaging unit 7. The unambiguous assignment of packaging unit 7 and control chip 12 also results in a clear association between the secret and the code printed on the box, which is only known to the manufacturer.

The user brings the data communication device 17 in the vicinity of the packaging unit 7, whereby the code stored in the control chip 12, 16 is automatically read by the data communication device 17, in particular the software application running thereon. This code is encrypted by the data communication device 17, in particular on the software application running thereon, transmitted to the server 18 under control of the manufacturer or a trusted third party. If appropriate, the user is prompted by the data communication device 17, in particular the software application running on it, to enter the additional code that is visibly printed on the packaging unit 7.

It can be provided, for example as a further code 20, a bar code, which is digitally photographed by means of the data communication device 17 and then decoded and transmitted together with the stored on the memory chip 12, 16 code to the server 18.

According to another alternative, instead of the manual input, the transmission of a code printed in the form of numbers can take place in that these numbers are digitally photographed by means of the data communication device 17 and subsequently determined by character recognition.

The server 18 determines whether the code stored on the control chip 12, 16 is valid and, if appropriate, whether the association between code stored on the control chip 12, 16 and the code printed on the packaging unit 7 is correct. The additional use of a printed on the packaging unit 7 or otherwise supplied with the drug package codes increases the security against counterfeiting. The result of the check is returned by the server 18 to the data communication device 17.

In order to enable the above-mentioned review only a limited circle of authorized users, such as only the doctor, pharmacist or the patient, it can also be provided that authenticate the respective user before initializing the check on the data communication device 17 and / or the server 18 got to. This can be done for example via a wirelessly readable chip card, such as the e-card. On this chip card, a personal code assigned to the respective user is stored, which is transmitted to the server 18 together with the code of the medicament pack during the first authentication and is assigned to the code of the respective medicament pack in the database 19 of the server 18. For example, when dispensing the medicine pack, the pharmacist may transmit his or her own personal code, the personal code of the prescribing physician, and the personal code of the particular patient to the server so that only the prescribing physician, the pharmacist himself and the patient perform an authenticity check allowed to.

If an authenticity check is now carried out, for example by the patient, then his data communication device 17 transmits the code stored on the control chip 12 or the further control chip 12, optionally the further code 20 printed on the medicament pack, and finally his personal code to the server 18.

If the personal code is assigned to the respective code of the control chip 12 or of the further control chip 16, the patient is entitled to the result of the authenticity check to learn, it is now checked by the server 18, if the code of the control chip 12 or the other control chip 16 is assigned to the other code 20. The patient is sent a certificate of the authenticity of the drug package.

On the other hand, if the personal code is not associated with the respective code of the control chip 12 or the further control chip 16, then it only receives the notification that it is not authorized to check the authenticity of the medication package.

Claims

claims:

1 . Comprehensive drug package

- At least one blister (1) comprising a base body (2) with bulges (3) for receiving medicaments (5) and an electrically and / or magnetically conductive foil (4), which is applied flat on the base body (2) and the Bulges (3) closes, so that between the bulges (3) and the film (4) closed cavities (6) are formed for the drugs (5),

in the cavities (6) located drugs (5), in particular in the form of tablets,

- A packaging unit (7) for receiving the at least one blister (1) of sheet material comprising a number of boundary surfaces, in particular in the form of a carton,

characterized in that an antenna (8) is arranged on a boundary surface (9) of the packaging unit (7).

2. medicament packaging according to claim 1, characterized in that the antenna (8) on that boundary surface (9) of the packaging unit (7) is arranged, which is furthest away from the film (4).

3. medicament pack according to claim 1 or 2, characterized in that the antenna (8) along the peripheral edge (10) of the boundary surface (9) is arranged, which is the furthest away from the film (4).

4. medicament packaging according to one of the preceding claims, characterized in that the antenna (8) on the inside of the boundary surface (9) of the packaging unit (7) is arranged, which is furthest away from the film (4), wherein the antenna ( 8) is arranged in particular on an adhesive film (1 1) or on the adhesive film (1 1) is printed.

5. medicament pack according to one of the preceding claims, characterized in that the antenna (8) embedded in the packaging unit (7), poured, integrated or printed by means of electrically conductive paste or paint on the packaging unit.

6. medicament pack according to one of the preceding claims, characterized by a control chip (12) having connections for connection to the antenna (8).

7. medicament pack according to one of the preceding claims, characterized in that a leaflet (13) on the inside abuts the boundary surface (9) on which the antenna (8) is arranged.

8. medicament pack according to one of the preceding claims, characterized in that a further antenna is provided, which is arranged on the said antenna (8) carrying the boundary surface (9) opposite boundary surface.

9. medicament pack according to claim 8, characterized in that a further control chip (16) is provided and the further antenna is connected to the further control chip (16) or that the antenna (8) and the further antenna connected to the control chip (12) are.

10. medicament pack according to one of the preceding claims, characterized in that for verifying the authenticity of the drug in the control chip (12) a unique, exclusively for the respective control chip (12) assigned code is stored, optionally on a control chip (12) and on a further control chip (16) arranged on the medicament pack stores a further unique code.

1 1. Method for checking the authenticity of a medicament pack according to one of Claims 6 to 10, a database (19) having valid codes being stored on a server (18), characterized

- That the stored on the control chip (12) or the further control chip (16) code is read out with a data communication device (17) and to the server (18), optionally encrypted, is transmitted,

- Is checked by the server (18), whether the transmitted to him code in the database (19) is stored, and

- That the result of the review to the data communication device (17) is transmitted and displayed by this if necessary.

12. The method of claim 1 1, wherein on the drug package (7) another code (20), optionally in the form of a number or a bar code, is printed, wherein in the database (19) of the server (18) the valid codes and which are stored on the further provided with these codes packing units (7) associated additional codes, characterized in that

that in addition to the code stored on the control chip (12, 16) also the code printed on the packaging unit (7) is determined by the data communication device (17),

that both the code and the further code are transmitted to the server (18),

that it is checked whether the code is stored in the database (19) of the server (18) and the further code is associated with the code in the database (19), and

13. The method according to any one of claims 1 1 or 12, characterized

- That during or before the dispensing of the drug package to the patient a person identifying the patient and / or the pharmacist and / or the prescriber physician code and transmitted to the server (18) and the respective on the control chip (12) or the other control chip (16) the drug package is associated with stored code,

that prior to the request for authenticity, a personal code is requested from the data communication device (17) and entered by the respective person at the data communication device (17),

- That the personal code is transmitted together with the on the control chip (12) or the further control chip (16) stored code, and optionally with the other code to the server,

in that, before carrying out further checks, it is checked whether the code is stored in the database (19) of the server (18) and the personal code is associated with the code in the database (19), and otherwise a message of lack of authorization to the data communication device ( 17) is transmitted and another query is canceled.

14. The method according to any one of claims 1 1 to 13, characterized in that the person identifying the respective user code is stored on a personalized smart card, and the personal code is read from the smart card