WO2020058520A1 - Dispositif et procédé pour préparer des doses d'unités médicamenteuses solides à prise orale de manière spécifique au patient - Google Patents

Dispositif et procédé pour préparer des doses d'unités médicamenteuses solides à prise orale de manière spécifique au patient Download PDF

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Publication number
WO2020058520A1
WO2020058520A1 PCT/EP2019/075434 EP2019075434W WO2020058520A1 WO 2020058520 A1 WO2020058520 A1 WO 2020058520A1 EP 2019075434 W EP2019075434 W EP 2019075434W WO 2020058520 A1 WO2020058520 A1 WO 2020058520A1
Authority
WO
WIPO (PCT)
Prior art keywords
blister
unit
template
units
patient
Prior art date
Application number
PCT/EP2019/075434
Other languages
German (de)
English (en)
Inventor
Michael Baehr
Original Assignee
Universitätsklinikum Hamburg-Eppendorf
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universitätsklinikum Hamburg-Eppendorf filed Critical Universitätsklinikum Hamburg-Eppendorf
Publication of WO2020058520A1 publication Critical patent/WO2020058520A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076—Medicament distribution means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B69/00—Unpacking of articles or materials, not otherwise provided for
    • B65B69/005—Unpacking of articles or materials, not otherwise provided for by expelling contents, e.g. by squeezing the container
    • B65B69/0058—Solid contents
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers

Definitions

  • the present invention relates to means for the patient-specific compilation of solid, orally ingestible drug units.
  • 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.
  • 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).
  • 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.
  • solid, orally ingestible drug units as used in the description and the claims are to be understood in particular tablets, coated tablets and capsules.
  • 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.
  • patient-specific compilation 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • template as used in the description and the claims is to be understood in particular as a support provided with recesses / openings.
  • 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.
  • 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.
  • 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.
  • 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.
  • the traction means can comprise a film and the unpacking unit can be set up to glue the film onto the blister film.
  • 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 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.
  • a 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.
  • 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.
  • 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.
  • the method can further include packaging the removed pharmaceutical units and providing the packaging with a unique patient-specific identification.
  • FIG. 3 shows a schematic top view of a template
  • 3a and 3b show further possible embodiments of a template
  • 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
  • FIG. 14 shows a flow chart of a method according to the invention.
  • FIG. 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.
  • the plastic body 12 is provided with a film 18 which closes the cavities formed by the depressions 14.
  • FIG. 2 several (identical) blisters 10 in the form of a blister stack 20 can be arranged in a storage unit 22.
  • a plurality of stacks of different blisters 10 i.e. blisters with different drugs and / or different dimensions
  • 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.
  • 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.
  • the embodiments shown in FIGS. 3 and 3b can be combined by providing both the cutouts 28 and openings 30 shown.
  • instead of the openings 30 shown in FIG. 3b only cutouts 28 can also be provided.
  • the template 26 can be used to pull a blister 10 out of the blister stack 20.
  • the template 26 (for example, through an opening in the storage unit 22) can be moved under the blister stack 20.
  • 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.
  • 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.
  • FIG. 8a, 8b and 8c illustrate the pushing out of a medicament unit 16 from the blister 10 placed on the template 26.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • the compilation can be taken directly from the dispensing unit 34 and taken / administered.
  • the blister film 18 can be scratched before being pressed out, as illustrated in FIG. 9.
  • 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.
  • 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.
  • the material strip 40 (already on the manufacturer's side) can be arranged between the plastic body 12 and 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.
  • the components required for pressing out (such as the eccentric 32a and the punch 32b) can be omitted. As shown in FIG.
  • 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.
  • 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.
  • 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.
  • step 54 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.
  • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)

Abstract

L'invention concerne des moyens permettant de préparer des doses d'unités médicamenteuses solides à prise orale de manière spécifique au patient.
PCT/EP2019/075434 2018-09-23 2019-09-21 Dispositif et procédé pour préparer des doses d'unités médicamenteuses solides à prise orale de manière spécifique au patient WO2020058520A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102018123360.4A DE102018123360A1 (de) 2018-09-23 2018-09-23 Vorrichtung und verfahren zur patientenindividuellen zusammenstellung fester, oral einnehmbarer arzneimitteleinheiten
DE102018123360.4 2018-09-23

Publications (1)

Publication Number Publication Date
WO2020058520A1 true WO2020058520A1 (fr) 2020-03-26

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PCT/EP2019/075434 WO2020058520A1 (fr) 2018-09-23 2019-09-21 Dispositif et procédé pour préparer des doses d'unités médicamenteuses solides à prise orale de manière spécifique au patient

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WO (1) WO2020058520A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2838047A1 (fr) * 2002-04-08 2003-10-10 Tam Telesante Sarl Systeme d'observance et d'aide a la prise de medicaments conditionnees en plaquettes
WO2011023941A2 (fr) * 2009-08-24 2011-03-03 Sanjeet Pakrasi Distributeur motorisé à ouverture d'emballage-coque et dispositif d'ouverture d'emballage-coque pour celui-ci
US20150191268A1 (en) * 2012-07-05 2015-07-09 P.C.O.A. Devices Ltd. Medication dispenser

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0948306A1 (fr) * 1996-12-30 1999-10-13 P+P MATERIALFLUSS-SYSTEME GmbH Procede et dispositif de distribution automatique d'objets individuels, notamment d'une pilule individuelle

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2838047A1 (fr) * 2002-04-08 2003-10-10 Tam Telesante Sarl Systeme d'observance et d'aide a la prise de medicaments conditionnees en plaquettes
WO2011023941A2 (fr) * 2009-08-24 2011-03-03 Sanjeet Pakrasi Distributeur motorisé à ouverture d'emballage-coque et dispositif d'ouverture d'emballage-coque pour celui-ci
US20150191268A1 (en) * 2012-07-05 2015-07-09 P.C.O.A. Devices Ltd. Medication dispenser

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