WO2020058520A1

WO2020058520A1 - Device and method for the patient-individual combination of solid, orally administered medicament units

Info

Publication number: WO2020058520A1
Application number: PCT/EP2019/075434
Authority: WO
Inventors: Michael Baehr
Original assignee: Universitätsklinikum Hamburg-Eppendorf
Priority date: 2018-09-23
Filing date: 2019-09-21
Publication date: 2020-03-26
Also published as: DE102018123360A1

Abstract

The invention relates to means for the patient-individual combination of solid, orally administered medicament units.

Description

DEVICE AND METHOD FOR THE PATIENT-INDIVIDUAL COMPILATION OF SOLID, ORAL-TAKABLE MEDICINAL UNITS

TECHNICAL AREA

The present invention relates to means for the patient-specific compilation of solid, orally ingestible drug units. In particular, the present invention relates to the removal of a number of drug units that can be predefined individually for a patient from one or more blisters.

STATE OF THE ART

Often, solid, orally ingestible drug units are not available as bulk goods, but are packed in blisters. The removal of drug units from a blister can be done manually or by means of a machine that unpacks the drug units located in the blister. The unpacked drug units can then (like bulk goods) be put together individually for each patient in a process step after unpacking (and often carried out on another machine).

BRIEF DESCRIPTION OF THE INVENTION

The invention enriches in this regard the prior art, as devices, systems and methods according to the invention combine the process step of unpacking and the process step of patient-specific compilation by automatically (from each blister) only as many drug units are removed as in the context of the patient-specific Compilation are needed. A device according to the invention for providing a patient-specific combination of solid, orally ingestible drug units comprises a storage unit, set up for receiving one or more blisters, a unpacking unit, set up for removing a predeterminable number of drug units from a blister, a control unit, set up for specifying a Time of withdrawal and / or the number of drug units to be withdrawn depending on the individual needs of a patient and an output unit for receiving the withdrawn drug units.

The term "solid, orally ingestible drug units" as used in the description and the claims are to be understood in particular tablets, coated tablets and capsules. In addition, the term “blister”, as used in the description and the claims, is to be understood in particular as a push-through pack which has a plastic body with a multiplicity of depressions which are closed by means of a film.

Furthermore, the term "patient-specific compilation", as used in the description and the claims, is to be understood in particular as a compilation of (often) different medicaments, the type and number of prescribed medicines typically varying from patient to patient , so that, for example, a first patient requires two drug units of drug A and a drug unit of drug B and a second patient requires two drug units of drug B and a drug unit of drug C.

[0007] In addition, the same patient can be administered or administered different compositions at different administration times (for example in the morning, at noon, in the evening). A “patient-specific compilation” is therefore in particular a compilation that is typically for exactly one patient for administration at a specific time or in a specific time Period is provided so that it is no longer necessary to differentiate between the pharmaceutical units of a compilation (except for control purposes).

The process step of compiling is thus typically (from a process safety point of view) irreversible, while unpacking only one type of drug would not be. In addition, when unpacking only one type of drug, the unpacking process is typically carried out at a constant speed, whereas in the case of a unpacking process which is aimed at patient-specific drug compositions, the unpacking typically does not take place constantly if compositions comprise, for example, only one or a few units of a drug and the drug units of a blister must be distributed over several compilations (unevenly).

By combining the process steps of unpacking and patient-specific assembly, the need to temporarily store the drug units can also be avoided. In this way it can be avoided, for example, that the shelf life of the pharmaceutical units has to be examined / proven or is not guaranteed. In addition, the security when assembling the pharmaceutical units can be increased, since the reduction in the number of process steps avoids sources of error which, for example, can lead to the mixing up of pharmaceutical units.

Devices according to the invention can be used both as independent devices and as modules of a pharmaceutical supply system which can be used, for example, in hospital pharmacies. E.g. Devices according to the invention that enable unpacking for individual patients can replace devices that convert pharmaceutical units packaged in drug blisters into bulk goods and divide the bulk goods into patient-specific combinations. The device may further comprise a conveyor unit arranged at an output opening of the storage unit, which is set up for pulling a blister out of the storage unit and placing the blister on a template of the unpacking unit. Furthermore, the unpacking unit can comprise a component for pressing out the number of pharmaceutical units to be removed, which are predetermined by the control unit, from the blister placed on the template.

The term “template” as used in the description and the claims is to be understood in particular as a support provided with recesses / openings. In addition, the term “storage unit”, as used in the description and the claims, is to be understood in particular as an arrangement which is set up to hold a blister stack.

The device can also be set up to place the template for pulling out the blister below the blister, to fix the blister to the template placed below the blister and to move the template together with the blister attached to the template out of the storage unit.

For example. the template can be provided with a clamping mechanism which is set up to clamp the blister onto the template during the pulling out.

The template may further have a number of recesses or openings and the device may be arranged to move the blister relative to the template when there are no more drug units above the recesses or openings.

The component can be designed as a stamp or eccentric and the device can be configured to guide the stamp against the blister for pushing out a drug unit from the blister or to drive a shaft connected to the eccentric and after pressing out the drug unit a relative movement between of the Effect template and the stamp or between the template and the eccentric.

The device can comprise a component for severing a blister film, the component having a tip or cutting edge and being designed to guide it through one of the cutouts or openings against the blister film before a medication unit is pressed out.

[0018] This makes it easier to push out the drug units or prevent damage to the drug units when they are pushed out.

The unpacking unit can be set up to pull off a part of a blister film that can be predetermined by the control unit from a blister, wherein the pulling off of the predetermined part enables the removal of exactly the predetermined number of drug units from a blister.

[0020] As a result, the number of drug units (for example one, two, three, etc.) that a patient requires can be taken from the blister.

The unpacking unit can be set up to attach a traction means to the blister film and to pull off the predeterminable part of the blister film by pulling the traction means from the blister.

By pulling off the blister film, the exertion of pressure on the pharmaceutical units during unpacking can be avoided or the pressure exerted on the pharmaceutical units during unpacking can be reduced.

For example. the traction means can comprise a film and the unpacking unit can be set up to glue the film onto the blister film.

The unpacking unit can also be set up to pull off the predefinable part of the blister film from the blister by pulling in a strip of material arranged between the blister film and a pharmaceutical unit. A system according to the invention for providing a patient-specific combination of solid, orally ingestible pharmaceutical units comprises a first storage unit, set up to hold one or more first blisters, a second storage unit, set up to hold one or more second blisters, a first unpacking unit, set up for removal a predeterminable number of drug units from one of the first blisters, a second unpacking unit, set up for withdrawing a predeterminable number of drug units from one of the second blisters, a control unit, set up for specifying a point in time of the withdrawal and / or the number of drug units to be withdrawn as a function of it an individual need of a patient and an output unit for receiving the removed drug units.

The system may further comprise a first container, the first unpacking unit being arranged in the first container and the first container having an opening through which the medicament units removed from the first blister are fed to the dispensing unit.

The system may further comprise a second container, the second unpacking unit being arranged in the second container and the second container having an opening through which the medicament units removed from the second blister are fed to the dispensing unit, the openings in a slide , open a tube or hose that leads into the output unit.

The system may further comprise a monitoring unit, the monitoring unit being set up to monitor the chute, the tube or the tube with regard to the passage of medicament units and to issue an error message if fewer or more medicament units pass than specified by the control unit. It goes without saying that the storage units and the unpacking units of the system can have the same features as the storage unit and the unpacking unit of the device.

A method according to the invention comprises specifying a time of removal and / or a number of drug units to be removed from a plurality of blisters filled with different drug units, removing the drug units to be removed from the blisters and outputting the removed drug units as a patient-specific compilation.

The method can also provide a storage unit filled with a blister stack, pulling out a single blister from the storage unit, placing the blister on a stencil and pressing out a patient-specific amount of medication units, which is specified by a control unit, from that placed on the stencil Include blisters.

Pulling out the blister can include placing the template underneath the blister, attaching the blister to the template placed below the blister, and moving the template together with the blister attached to the template from the storage unit.

The number of recesses or openings of the template can be less than a number of drug units in a blister and the method can also cause a relative displacement between the blister and the template after a drug unit has been pressed out of the blister.

[0034] The method can further comprise pulling off a part of a blister film from a blister, the part of the blister film to be removed corresponding to the number of medicament units required for the patient-specific combination. [0035] The method can further include packaging the removed pharmaceutical units and providing the packaging with a unique patient-specific identification.

Furthermore, it goes without saying that all the features (preferred embodiments) of the devices according to the invention can also be features (preferred embodiments) of the method according to the invention, which relates to a (possible) use of the devices according to the invention.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

The invention is explained below in the detailed description with reference to exemplary embodiments, reference being made to drawing figures in which:

1 shows a schematic sectional view of a blister;

Fig. 2 shows a schematic sectional view of a blister stack;

3 shows a schematic top view of a template;

3a and 3b show further possible embodiments of a template;

Figures 4 to 7 illustrate pulling a blister out of the blister stack and placing the blister on the template;

8a, 8b and 8c illustrate the pushing out of drug units from the blister;

9 illustrates scoring of the blister film;

10a and 10b illustrate a sticking of a material strip onto the blister film and a peeling off of the blister film;

11 illustrates a further possible procedure for pulling off the blister film; 12 shows a container with a storage unit and an unpacking unit;

13 shows a system with several containers; and

14 shows a flow chart of a method according to the invention.

The same and functionally similar elements are identified by the same reference numerals in the drawing figures. However, it should be understood that not all elements are necessarily shown in all drawing figures and that the elements shown are not necessarily shown to scale.

DESCRIPTION OF EMBODIMENTS

1 shows a schematic sectional view of a blister 10. The blister 10 has a plastic body 12 with a multiplicity of depressions 14, in which medicament units 16 are arranged. In order to prevent the medicament units 16 from falling out of the depressions 14, the plastic body 12 is provided with a film 18 which closes the cavities formed by the depressions 14. As shown in FIG. 2, several (identical) blisters 10 in the form of a blister stack 20 can be arranged in a storage unit 22. In addition, a plurality of stacks of different blisters 10 (i.e. blisters with different drugs and / or different dimensions) can be arranged in a storage unit 22

To unpack the drug units 16, as shown in FIG. 3, a unpacking unit 24 with a template 26 can be provided. The template 26 can have one or more cutouts 28 through which the medicament units 16 can be pressed out of the blister 16. It goes without saying that the template 26 shown in FIG. 3 shows only one possible embodiment and the template 26, as shown in FIG. 3a, can also have openings 30 instead of the cutouts 28 shown, and, as indicated in FIG. 3b , the number of openings 30 of the number Medicament units 16 in a blister 10 can correspond. In addition, the embodiments shown in FIGS. 3 and 3b can be combined by providing both the cutouts 28 and openings 30 shown. In addition, instead of the openings 30 shown in FIG. 3b, only cutouts 28 can also be provided.

As illustrated in FIGS. 4 to 7, the template 26 can be used to pull a blister 10 out of the blister stack 20. E.g. As indicated in FIG. 4 by the arrows, the template 26 (for example, through an opening in the storage unit 22) can be moved under the blister stack 20. Then, as shown in FIGS. 5 and 6, the blister 10 can be attached (for example clamped) to the template 26 placed below the blister stack 20 and, as indicated in FIG. 7 by means of the arrows, the template 26 together with the Blisters 10 attached to the template 26 are pulled out of the blister stack 20. It goes without saying that the relative movement between the template 26 and the storage unit 22 can be realized both by a method of the template 26 and by a method of the storage unit 22.

8a, 8b and 8c illustrate the pushing out of a medicament unit 16 from the blister 10 placed on the template 26. In FIG. 8a, an eccentric 32a is rotated and in FIG. 8b, a linear movement of a Stamp 32b exerted pressure on the medicament unit 16, by means of which the blister film 18 is torn and the medicament unit 16 is pressed out of the blister 10 and conveyed into an output unit 34. After the medicament unit 16 has been pushed out, the blister 10, as illustrated in FIG. 8c, can be displaced relative to the template 26, so that the next medicament unit (s) 16 can be pressed out of the blister 10. It goes without saying that there is no need to move the blister 10 relative to the template 26 if the template 26 has a recess 28 or an opening 30 for each medicament unit 16.

[0043] The time of withdrawal and the number of pharmaceutical units 16 withdrawn can depend on an individual need of a patient can be specified by a control unit 36 which controls the movement of the template 26 and the eccentric 32a or the stamp 32b. E.g. The control unit 36 can store data relating to the patient and the pharmaceutical composition which the patient is taking or which is to be administered to the patient, and can control the (elements of the) unpacking unit 24 in such a way that a corresponding number (possibly different) pharmaceutical units 16 are incorporated into the Output unit 34 are transported.

In the output unit 34, the patient-specific compilation can then be packaged (for example a plastic film welded) and provided with a unique identification (for example a patient name or a patient identification number - for example in the form of a bar code or an RFID chip). Alternatively, the compilation can be taken directly from the dispensing unit 34 and taken / administered.

In order to prevent damage to the medicament units 16 when they are pressed out, the blister film 18 can be scratched before being pressed out, as illustrated in FIG. 9. For this purpose, for example, a component 38 with a tip or cutting edge can be guided through the cutouts 28 against the blister film 18 before being pressed out.

In an alternative embodiment, as illustrated in FIGS. 10a and 10b, a material strip 40 (for example a film) can be glued to the blister film 18 and the blister film by pulling in the material strip 40 (for example by rolling up the material strip 40) a coil 42) are withdrawn from the plastic body 12. Furthermore, as shown in FIG. 11, the material strip 40 (already on the manufacturer's side) can be arranged between the plastic body 12 and the blister film 18. By pulling off the blister film 18, a mechanical load on the drug units 16 can be reduced even further, as a result of which even very sensitive drug units can be unpacked without damage. In addition, the components required for pressing out (such as the eccentric 32a and the punch 32b) can be omitted. As shown in FIG. 12, the storage unit 22 and the unpacking unit 24 can be arranged in a container 44 which has an opening 46 through which the medicament units 16 removed from a blister 10 can be fed to the dispensing unit 34. Furthermore, as shown in FIG. 13, a system 48 can be provided with a plurality of the containers 44 shown in FIG. 12, the openings 46 opening into supply devices 50 such as a slide, a tube or a hose which the medicament units 16 into the Route output unit 34.

Along the feeder 50, a monitoring unit 52 consisting of one or more networked components can also be provided, which monitors the feeder 50 for the passage of drug units 16 and issues an error message when fewer or more drug units 16 pass through the feeder 50 than through the control unit 36 predefined. The monitoring unit 52 can, for example, be provided with one or more optical sensors which register when a medicament unit 16 passes a sensor. The error message can be output locally in the form of an optical or acoustic signal and / or displayed on a host computer.

14 shows a flowchart of a method according to the invention. The method begins in step 54 with the specification of the time (for example morning, noon, evening) and the number of drug units 16 to be removed from the respective blisters 10. After step 56 the drug units 16 have been removed from the blisters 10, they are output in step 58 as a patient-specific compilation. The described device and the method can be used both when unpacking large quantities of pharmaceutical units (for example in a hospital pharmacy) and in a private environment (within the scope of a patient-specific dispenser) LIST OF REFERENCES Blister

Plastic body

Indentations

Drug unit

foil

Blister pack

Storage unit

Unpacking unit

template

Recess

opening

a eccentric

b stamp

Output unit

Control unit

Component

Strips of material

Kitchen sink

container

opening

system

Feeder device

Monitoring unit

Process step

Claims

EXPECTATIONS

l. Device for providing a patient-specific

A combination of solid, orally ingestible medicament units (16), comprising: a storage unit (22), arranged to hold one or more blisters (10); a unpacking unit (24), configured to remove a predeterminable number of drug units (16) from a blister (10); a control unit (36) set up for specifying a time of the withdrawal and / or the number of drug units (16) to be withdrawn as a function of an individual need of a patient; and an output unit (34) for receiving the removed drug units (16).

2. The apparatus of claim 1, further comprising: a conveyor unit arranged at an output opening of the storage unit (22), arranged to pull a blister (10) out of the storage unit (22) and place the blister (10) on a template (26) Unpacking unit (24); and a component for pressing out the number of medicament units (16), which are predetermined by the control unit (36), from the blister (10) placed on the template (26).

3. The device according to claim 2, wherein the device is set up, the template (26) for pulling out the blister (10) below the blister (10) to place the blister (10) on the template (26) placed below the blister (10) and to move the template (26) together with the blister (10) attached to the template (26) out of the storage unit (22).

4. The device according to claim 3, wherein the template (26) is provided with a clamping mechanism which is adapted to clamp the blister (10) to the template (26) during the extraction.

5. Device according to one of claims 2 to 4, wherein the template (26) has a series of recesses (28) or openings (30) and the device is set up to move the blister (10) relative to the template (26), if there are no more drug units (16) above the cutouts (28) or openings (30).

6. The device according to claim 5, wherein the component is designed as a stamp (32b) or eccentric (32a) and the device is set up to push a medicament unit (16) out of the blister (10), the stamp (32b) against the blister (10) or to drive a shaft connected to the eccentric (32a) and after the medication unit (16) has been pressed out, a relative movement between the template (26) and the stamp (32b) or between the template (26) and the eccentric ( 32a) to effect.

7. The device according to claim 5 or 6, wherein the device comprises a component (38) for severing a blister film (18), wherein the component (38) has a tip or cutting edge and is arranged, this before Pushing out a medicament unit (16) through one of the cutouts (28) or openings (30) against the blister film (18).

8. The device according to claim 1, wherein the unpacking unit (24) is set up to pull off a part of a blister film (18) which can be predetermined by the control unit (36) from a blister (10), the pulling off of the predetermined part being the removal of exactly the predetermined number on drug units (16) from a blister (10).

9. The device according to claim 8, wherein the unpacking unit (24) is set up to fasten a traction means to the blister film (18) and to pull off the predefinable part of the blister film (18) by pulling the traction means from the blister (10).

10. The device according to claim 9, wherein the traction means comprises a film and the unpacking unit (24) is set up to glue the film onto the blister film (18).

11. The device according to claim 8, wherein the unpacking unit (24) is set up to pull off the predeterminable part of the blister film (18) from the blister (10) by pulling in a material strip (40) arranged between the blister film (18) and a medicament unit.

12. A system for providing a patient-specific compilation of solid, orally ingestible pharmaceutical units (16), comprising: a first storage unit (22) set up to receive one or more first blisters (10); a second storage unit (22) designed to hold one or more second blisters (10); a first unpacking unit (24), configured to remove a predeterminable number of medicament units (16) from one of the first blisters (10); a second unpacking unit (24), configured to remove a predeterminable number of medicament units (16) from one of the second blisters (10); a control unit (36) set up for specifying a time of the withdrawal and / or the number of drug units (16) to be withdrawn as a function of an individual need of a patient; and an output unit (34) for receiving the removed

Pharmaceutical units (16).

The system of claim 12, further comprising: a first container (44), the first unpacking unit (24) being disposed in the first container (44) and the first container (44) having an opening (46) through which the drug units (16) removed from the first blister (10) are fed to the dispensing unit (34).

The system of claim 13, further comprising: a second container (44), wherein the second unpacking unit (24) is arranged in the second container (44) and the second container (44) has an opening (46), through which the drug units (16) removed from the second blister (10) are fed to the output unit (34); the openings (46) opening into a chute, a tube or a hose which leads into the dispensing unit (34).

15. The system of claim 14, further comprising a monitoring unit (52), wherein the monitoring unit (52) is configured to monitor the chute, tube or tube for the passage of medicament units (16) and to issue an error message if less or more drug units (16) pass than specified by the control unit (36).

16. A method of providing a compilation

Pharmaceutical units comprising:

Specifying (54) a time of removal and / or a number of drug units (16) to be removed from a plurality of blisters (10) filled with different drug units (16);

Removing (56) the drug units (16) to be removed from the blisters (10); and

Output (58) of the removed drug units (16) as a patient-specific compilation.

17. The method of claim 16, further comprising:

Providing a storage unit (22) filled with a blister stack (20); Withdrawing a single blister (10) from the storage unit (22) and placing the blister (10) on a template (26); and

Pushing out a quantity of medicament units (16), which is predetermined individually for each patient by a control unit (36), from the blister (10) placed on the template (26).

18. The method according to claim 17, wherein the pulling out of the blister (10) comprises the following substeps:

Placing the template (26) below the blister (10);

Attaching the blister (10) to the template (26) placed below the blister (10); and

Moving the template (26) together with the blister (10) attached to the template (26) from the storage unit (22).

19. The method of claim 16 or 17, wherein a number of recesses or openings of the template (26) is smaller than a number of drug units (16) in a blister (10) and the method further comprises:

Effect a relative displacement between the blister (10) and the template (26) after a drug unit (16) has been pressed out of the blister (10).

20. The method of claim 16, further comprising:

Peeling off a part of a blister film (18) from a blister (10), the part of the blister film (18) to be peeled off being the number for the patient-specific compilation required drug units (16) corresponds.

21. The method according to any one of claims 16 to 20, further comprising:

Packaging the withdrawn drug units (16); and

Provide the packaging with a unique patient-specific identification.