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WO2009008811A1 - Conditionnement pour le contrôle ou la surveillance de la prise de médicaments - Google Patents

Conditionnement pour le contrôle ou la surveillance de la prise de médicaments Download PDF

Info

Publication number
WO2009008811A1
WO2009008811A1 PCT/SE2008/050739 SE2008050739W WO2009008811A1 WO 2009008811 A1 WO2009008811 A1 WO 2009008811A1 SE 2008050739 W SE2008050739 W SE 2008050739W WO 2009008811 A1 WO2009008811 A1 WO 2009008811A1
Authority
WO
WIPO (PCT)
Prior art keywords
package
compartment
conductive
weakable adhesive
electrically weakable
Prior art date
Application number
PCT/SE2008/050739
Other languages
English (en)
Inventor
Ingrid Rokahr
Kaj Backfolk
Marcus Dehlin
Ismo Saarinen
Lars Sandberg
Risto Vesanto
Original Assignee
Stora Enso Oyj
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 Stora Enso Oyj filed Critical Stora Enso Oyj
Publication of WO2009008811A1 publication Critical patent/WO2009008811A1/fr

Links

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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/30—Compliance analysis for taking medication

Definitions

  • the present invention relates to the field of pharmaceutical packaging, and to compliance monitoring. More specifically, the present invention relates to a package comprising a first and second portion, an electrical circuitry and a sensor.
  • the first and second portions have conductive surface portions being adhesively bonded together by an electrically weakable adhesive and are adapted to be separated from each other by application of electrical power thereby forming an opening providing access to a compartment of the package.
  • a patient's compliance with prescription schemes is one critical factor for the effect and efficiency of certain drug treatments. Examples are treatments of depression, HIV, and hypertension, among many others.
  • Solutions are already available on the market, which supports a patient's compliance. Some of the solutions are, for example, a blister pack containing one dose of a drug in each blister. In that way, it is easier to see how many doses have been taken, compared with bottles or other bulk packages. Another solution is a blister pack having printed symbols or text that indicate day and night, weekdays, or dates, or similar guidance in order to see when the last drug has been taken, or whether it has been forgotten. Special compartment packages have been made available to re-pack drugs in compartments. This is especially suitable for bottled drugs. Each compartment corresponds to one point of time when the content of the compartment should be taken by a patient or administered to a patient. The compartments can be marked for example with weekdays and daytimes like morning, noon, and evening, as an example.
  • Compliance monitoring solutions have been disclosed, which automatically record the time when a bottle is opened, or when a blister is opened.
  • the log of opening events provides valuable information to the healthcare provider about the compliance.
  • the opening of a blister or a bottle is interpreted as the patient has taken the medication .
  • One method for monitoring the intake of drug doses is to record a log of opening events of a blister pack, for example as it has been presented in US4616316.
  • a grid of conductive lines is aligned on the backside of blister cavities so that a conductive line breaks and becomes disconnected when a blister cavity is opened, i.e. when the pill is pushed through the backing foil to remove the pill from the blister pack.
  • the disconnected line will change the conductive properties of the grid.
  • the conductivity or resistance of the grid is measured by an electronic module. A significant deviation from previously measured resistance values indicates an opening event, i.e. that a blister cavity has been opened.
  • the electronic module usually consists of a clock, a sensing device and a processor for storing information and for performing data analysis.
  • the external communication with the device can be done via an antenna for wireless communication means or via contact points for connection with external devices.
  • US 6244462, US 6628199 and US 6839304 are giving further examples of compliance monitoring packages.
  • US 6244462 discloses a device adapted to register the dispensing of medicaments, comprising sensing devices located at the medicament side to detect the dispensing thereof.
  • a response form containing a means of input, which on manual influence can switch a conducting electrical circuit connected to an electronic unit incorporated into the response form, for registration of the manual influence is disclosed.
  • the response form may be used as a patient's journal and may be integrated with a pharmaceutical response package.
  • US 6839304 discloses a system for managing delivery of pharmaceutical drugs formed of a blister package including a plurality of cells arranged In a grid.
  • a computer chip, electrically connected to severable conductors senses the puncturing of each cell in the grid by monitoring the rupturing of each of the severable conductors .
  • Compliance monitoring is especially important for people who have care-taking assistance, for example elderly patients or children, for monitoring their intake of prescribed drugs. In case their ability is deficient to remember whether a drug has been taken recently or not, and when it was taken, they may use the stored monitoring information to improve the reliability of their drug intake. For their care-taking assistants, drug intake monitoring is beneficial to ensure that drugs have been taken, but also to ensure that drugs are not overdosed. Drug removal is in those cases interpreted as drug intake, unless trustworthy information given by the patient is suggesting something else.
  • the resistivity of a line or a grid is measured by applying a voltage and measuring the current. This resistivity measurement has to be done regularly In certain time intervals to determine if the blister was opened and at what time of the event when a blister was opened.
  • a further object is to provide a solution for compliance monitoring that does not depend on regular measurements.
  • a further object is to detect an opening event of a compartment of a package.
  • a package comprising a first and second portion.
  • the first and second portions have conductive surface portions being adhesively bonded together by an electrically weakable adhesive and are adapted to be separated from each other by application of electrical power thereby forming an opening providing access to a compartment of the package.
  • the package further comprises an electrical circuitry adapted to apply electrical power to the conductive surface portions via the electrically weakable adhesive, and a sensor adapted to monitor when electrical power is applied to the electrically weakable adhesive.
  • An advantage of the present invention is that it is possible to monitor opening of a compartment .
  • the opening of the compartment may be used as an indication of a patient's intake of a drug contained in the compartment.
  • the electrical circuitry applies electrical power which is adapted to be connected to the conductive surface portions to, in a closed electrical circuit, apply a voltage to the electrically weakable adhesive.
  • a voltage is applied to the electrically weakable adhesive, e.g. by the closure of a switch, current will flow between the conductive surface portions. This will cause the bonds m the weakable adhesive or between the weakable adhesive and one or both of the conductive surface portions to break or to weaken.
  • the sensor is activated by the current which flows through the closed circuit when electrical power is applied to the electrically weakable adhesive. There is thus no need for regular measurement, for example resistivity measurement, performed by the sensor for discovering whether a compartment is opened or not.
  • the senor is activated when the electrical circuitry is closed.
  • the electrical circuitry is closed by, for example the patient, or a care-taking assistant, when it is time to take the drug.
  • the sensor requires less electrical power as it is only activated during a short period of time and this substantially increases the lifetime of the package.
  • Another advantage is that the compartment of the package only is openable once electrical power has been applied to the conductive surface portions such that they separate from each other due to the electrical weakable properties of the adhesive.
  • An active input may be required to activate the electrical circuitry such that electrical power is applied to the conductive surfaces. The active input prevents unintended or accidental opening of the compartment.
  • the package may comprise a plurality of compartments. In this way, it is possible to package a plurality of doses, pills, or the like m one package.
  • the electrical circuitry is then adapted to apply electrical power to first and second portions having conductive surfaces which surround each compartment such that the compartments are individually openable after application of electrical power.
  • the sensor as then adapted to monitor opening of any one of the compartments .
  • the compartments may be formed of blisters. The doses, pills, etc, are contained within the blister.
  • the sensor may be adapted to register information associated with the compartment being opened and/or point of time of opening. If the sensor registers information associated with point of time of opening, a care-taking assistant may monitor that drugs have been taken m compliance with a patient's prescription. In this way, care-takmg assistants may ensure that the patient does not overdose the drug, that the patient has not forgotten to take their drugs, or that the drug has been taken at the right point of time.
  • the sensor may also register information associated with the compartment being opened, such that which compartment of the package being opened, if the package comprises more than one compartment. For example, if the package comprises more than one type of drug, the sensor may register which compartment that has been opened such that it is possible to monitor which drug that has been taken by the patient.
  • the electrical circuitry may comprise an internal power source, such as a battery and/or a solar cell.
  • the electrical circuitry may comprise an antenna adapted to receive electrical power from an external sender.
  • the package does not have to include the power source, but the package is adapted to receive electrical power from an external power source via the sender.
  • the power source is arranged outside the package, the components that have to be arranged m the package are reduced.
  • the electrical circuitry may comprise one or more electrical connections adapted to be connected to an external power source.
  • the package only comprises said connections and no internal power source. Electrical power is supplied to the electrical circuitry from the external power source via said connections.
  • the package may be connected to an adapter comprising the external power source, which may be reused for a plurality of different packages. In this way, the components that have to be arranged in the package are reduced.
  • the electrical circuitry may be adapted to be closed, such as by a switch, a conductive tool or a human finger, in order to provide electrical power to the conductive surfaces and via the electrically weakable adhesive.
  • the electrical circuitry only applies electrical power to the conductive surfaces when the patient, or a care-taking assistant, closes the electrical circuitry. Consequently, the electrical circuitry is only closed when it is time to open the compartment for gaining access to the drug. In order to gain access to the drug, the patient or the care-taking assistance performs the active input of closing the electrical circuitry. Thus, accidental or unintended opening of the compartment is prevented.
  • the electrically weakable adhesive may be applied to the conductive surface portions within an area extending adjacent and at least partly surrounding the compartment which is to be opened. In this way it is possible to selectively open one compartment if the package contains more than one compartment.
  • the electrically weakable adhesive may be applied m a cut-out formed m the second portion of the package, extending along at least a portion of the compartment.
  • the conductive surface portion of the first portion is preferably a conductive foil, for example an aluminium foil.
  • the foil works both as a conductive surface and as a protection for the drug or pill contained within the compartment.
  • the foil may be covering the whole surface of the first portion of the package.
  • the conductive surface portion of the second portion is preferably o
  • Fig. 1 shows a package comprising an electrical circuitry according to the present invention.
  • Fig. 2 shows a cross section of the package shown in fig. 1.
  • the package 1 is especially suitable for pharmaceutical packaging.
  • the package 1 comprises a blister card 10 comprising one or more compartments in form of blister cavities 2.
  • Each blister cavity 2 is adapted to contain a dose of a drug in form of a pill, or the like.
  • the blister cavity 2 has a blister opening 20.
  • the package 1 further comprises an electrical circuitry 3, power supply such as a power source 4, a sensor 5 and a switch 6 adapted to close the electrical circuitry 3.
  • a cross section of the blister card 10 is shown.
  • the blister card 10 comprises a plastic foil 11 in which the blister cavity 2 is formed.
  • the blister card 10 further comprises a backing laminate having conductive properties.
  • the backing laminate comprises a backing foil 12 and a board laminate 13.
  • the backing foil 12 may be formed of an aluminium foil.
  • the backing foil 12 in form of an aluminium foil, is used as electrical ground and is connected to the electrical circuitry 3.
  • the backing foil 12 is arranged between the plastic foil 11 and the board laminate 13.
  • a first portion of the package 1 is formed of the plastic foil 11 having a conductive surface portion in form of the backing foil 12.
  • the board laminate 13 is attached to the backing foil 12.
  • the board laminate 13 comprises a first board layer 14 and a second board layer 17.
  • a second portion of the package 1 is formed of the first and second board layers 14, 17.
  • the first board layer 14 comprises a cut-out 19. If the package 1 comprises more than one blister cavity 2, the first board layer 14 comprises one cut-out 19 for each blister cavity 2.
  • the cut-out 19 may be shaped like a horseshoe, extending along the blister opening 20. Alternatively, the cut-out 19 is circular, elliptical, or quadrangular, having a form essentially corresponding to the blister opening 20.
  • the first board layer 14 is adapted to insulate the various cut-outs 19 such that not all electrically weakable adhesive 16 arranged in different cut-outs 19 associated with different blister cavities 2 debond at the same time.
  • the cut-out 19 is filled with an electrically weakable adhesive 16.
  • the electrically weakable adhesive 16 is composed of a composition possessing both matrix functionality and electrolyte functionality.
  • the matrix and the electrolyte functionalities may be formed by a single phase or several separate phases.
  • the matrix functionality provides the adhesive properties necessary to bind surfaces to one another mechanically or chemically.
  • the matrix functionality may be provided by polymers, polymer resins or fibres that possess adhesive properties.
  • the electrolyte functionality provides the ion conductivity necessary to support a faradic reaction, i.e. an electrochemical reaction in which a material is oxidized or reduced, or some other chemical/physical reaction.
  • the materials are preferably chosen and designed such that the reaction occurs at the interface between one or both of the active surfaces and the electrically weakable adhesive 16.
  • the electrically weakable adhesive 16 may be designed such that the reaction will occur within the electrically weakable adhesive 16. This may, e.g., be accomplished by providing islands of a material with electrolyte functionality within the matrix material.
  • the electrolyte functionality may be provided by adding a salt to the material or by modifying the polymer so that it includes ion-coordinating moieties.
  • the electrically weakable adhesive 16 used in the inventive packages may be the electrochemically disbondable composition ElectRelease TM supplied by EIC laboratories and disclosed in more detail in US 6,620, 308.
  • the electrically weakable adhesive 16 bonds the board laminate 13 to the backing foil 12.
  • the backing laminate comprising the backing foil 12 and the board laminate 13 is too strong for easily pushing out the pill. Thereby, a user can not easily (or not at all) gain access to the pill.
  • Conductive lines 15 are arranged on the first board layer 14 or on the second board layer 17.
  • the conductive lines 15 form a conductive surface portion of the second portion.
  • the conductive lines 15 belong to a conductive grid connected to the electrical circuitry 3.
  • the conductive lines 15 may be printed on the first or second board layer 14, 17.
  • the conductive line 15 may have a horseshoe shape, essentially corresponding to a horseshoe shape of the cut-out 19, extending along the blister opening 20.
  • the second board layer 17 has a perforation or removed portion 18 extending along the blister opening 20.
  • the perforation or removed portion 18 may have an extension formed as a horseshoe shape.
  • the perforation or removed portion 18 preferably defines a portion of the backing laminate having an equal or a smaller extension than a portion of the backing laminate defined by the cut-out 19.
  • the portion defined by the perforation or removed portion 18 being smaller than the portion defined by the cut-out 19 makes it even more difficult to push the pill through the backing laminate before the electrically weakable adhesive 16 has debonded.
  • the electrically weakable adhesive 16 When electrical power is applied to the conductive line 15 and the backing foil 12, the electrically weakable adhesive 16 will debond.
  • the blister cavity 2 can then be opened by pushing the pill through the backing laminate.
  • the perforation or removed portion 18 of the second board layer 17 facilitates pushing the pill through the backing laminate for gaining access to the pill. As long as the electrically weakable adhesive 16 still is bonding, the backing laminate is too strong for easily pushing out the pill.
  • the electrical circuitry 3 of the package 1 comprises a switch 6, the electrical circuitry 3 is only closed when the switch 6 is closed. Thereby, electrical power is only applied to the electrically weakable adhesive 16 when the switch 6 is closed. Consequently, the patient, or the care-taking assistant, must initialize the opening of the blister cavity 2 by closing the switch 6.
  • the switch 6 closing the electrical circuitry 3 may be in form of a conventional switch, a conductive tool, or a human finger pushing on a certain portion of the package 1, thereby closing the electrical circuitry 3.
  • An individual switch 6 may be provided for each blister cavity 2 making it possible to choose which blister cavity 2 to open.
  • each blister cavity 2 may have its own identifying switch 6 for closing the electrical circuitry 3 or an individual conductive line could be addressed by the electrical circuitry 3.
  • the sensor 5 is adapted to monitor when electrical power is applied to the electrically weakable adhesive 16, i.e. when the electrical circuitry 3 is closed. As the electrical circuitry 3 only is closed when it is time to open the blister cavity 2, the electrical circuitry 3 being closed is taken as an indication of intake of the pill contained within the blister cavity 2. Further, the sensor b is adapted to register information associated with the opening of the blister cavity 2. Such information may be point of time of the opening of the blister cavity 2, which blister cavity 2 being opened, if the blister card 10 comprises more than one blister cavities, etc. A clock may be provided for registering the point of time of the opening of the blister cavity 2.
  • the power source 4 is arranged in the package 1.
  • the internal power source 4 may be in form of a battery, a solar cell, or a combination thereof.
  • the power source may be arranged outside the package 1 in form of an external power source.
  • the package 1 may be provided with an antenna adapted to receive electrical power from an external sender of the external power source.
  • the package 1 may be provided with a connection adapted to be connected to the external power source.
  • the package 1 may be adapted to be connected to a reusable unit comprising the external power source, and other electrical devices. The reusable unit may then be used for a plurality of different packages comprising varying drugs.
  • the information monitored and stored by the sensor 5 may be communicated to a computer, PDA or mobile phone.
  • the communication is preferably done wireless by for example WiFi, NFC, Bluetooth or IR.
  • the printed conductive lines could be applied by other means or be formed of a conductive foil.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)

Abstract

La présente invention concerne un conditionnement comprenant des première et une seconde parties (11, 14 ; 17). Les première et seconde parties (11, 14 ; 17) présentent des parties de surface conductrices (11, 15) collées ensemble de manière adhésive par un adhésif pouvant être électriquement affaibli (16) et adaptées de manière à être séparées l'une de l'autre par l'application d'énergie électrique formant ainsi une ouverture donnant accès à un compartiment (2) du conditionnement. Le conditionnement comprend en outre des circuits électriques (3) adaptés de manière à appliquer une énergie électrique aux parties de surface conductrices (11, 15) via l'adhésif pouvant être électriquement affaibli (16), et un capteur (5) adapté de manière à effectuer une surveillance lorsque l'énergie électrique est appliquée à l'adhésif pouvant être électriquement affaibli (16).
PCT/SE2008/050739 2007-07-06 2008-06-19 Conditionnement pour le contrôle ou la surveillance de la prise de médicaments WO2009008811A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US95865707P 2007-07-06 2007-07-06
US60/958,657 2007-07-06

Publications (1)

Publication Number Publication Date
WO2009008811A1 true WO2009008811A1 (fr) 2009-01-15

Family

ID=40228830

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE2008/050739 WO2009008811A1 (fr) 2007-07-06 2008-06-19 Conditionnement pour le contrôle ou la surveillance de la prise de médicaments

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011018199A1 (de) * 2011-04-19 2012-10-25 Schreiner Group Gmbh & Co. Kg Detektionselement für eine Blisterverpackung und Blisterverpackungseinheit
DE102021123227A1 (de) 2021-09-08 2023-03-09 medentis medical GmbH Sterilgutverpackung, insbesondere Dentalvorrichtungsverpackung, und Verpackungssystem

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4616316A (en) * 1982-07-01 1986-10-07 The United States Of America As Represented By The Administrator Of Veterans Affairs Medication compliance monitoring device having conductive traces upon a frangible backing of a medication compartment
US6244462B1 (en) * 1997-02-19 2001-06-12 Cypak Ab Medicament dispense sensing device
US6628199B1 (en) * 1998-09-25 2003-09-30 Cypak Ab Integrated pharmaceutical package and questionnaire
US6839304B2 (en) * 2000-07-07 2005-01-04 Ddms Holdings, L.L.C. Drug delivery management system
WO2007015672A1 (fr) * 2005-08-01 2007-02-08 Stora Enso Ab Emballage et procédé de fermeture et d’ouverture d’emballage
WO2007015674A1 (fr) * 2005-08-01 2007-02-08 Stora Enso Ab Emballage

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4616316A (en) * 1982-07-01 1986-10-07 The United States Of America As Represented By The Administrator Of Veterans Affairs Medication compliance monitoring device having conductive traces upon a frangible backing of a medication compartment
US6244462B1 (en) * 1997-02-19 2001-06-12 Cypak Ab Medicament dispense sensing device
US6628199B1 (en) * 1998-09-25 2003-09-30 Cypak Ab Integrated pharmaceutical package and questionnaire
US6839304B2 (en) * 2000-07-07 2005-01-04 Ddms Holdings, L.L.C. Drug delivery management system
WO2007015672A1 (fr) * 2005-08-01 2007-02-08 Stora Enso Ab Emballage et procédé de fermeture et d’ouverture d’emballage
WO2007015674A1 (fr) * 2005-08-01 2007-02-08 Stora Enso Ab Emballage

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011018199A1 (de) * 2011-04-19 2012-10-25 Schreiner Group Gmbh & Co. Kg Detektionselement für eine Blisterverpackung und Blisterverpackungseinheit
DE102021123227A1 (de) 2021-09-08 2023-03-09 medentis medical GmbH Sterilgutverpackung, insbesondere Dentalvorrichtungsverpackung, und Verpackungssystem

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