WO2013164127A1 - Dispositif et procédé de préparation d'une capsule pharmaceutique remplie à la demande avec une quantité prédéterminée d'un principe pharmaceutique actif - Google Patents

Dispositif et procédé de préparation d'une capsule pharmaceutique remplie à la demande avec une quantité prédéterminée d'un principe pharmaceutique actif Download PDF

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Publication number
WO2013164127A1
WO2013164127A1 PCT/EP2013/055846 EP2013055846W WO2013164127A1 WO 2013164127 A1 WO2013164127 A1 WO 2013164127A1 EP 2013055846 W EP2013055846 W EP 2013055846W WO 2013164127 A1 WO2013164127 A1 WO 2013164127A1
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WO
WIPO (PCT)
Prior art keywords
pharmaceutical
container
capsule
filled
active pharmaceutical
Prior art date
Application number
PCT/EP2013/055846
Other languages
English (en)
Inventor
Thomas Klein
Johannes Khinast
Original Assignee
Research Center Pharmaceutical Engineering Gmbh
Technische Universität Graz
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 Research Center Pharmaceutical Engineering Gmbh, Technische Universität Graz filed Critical Research Center Pharmaceutical Engineering Gmbh
Publication of WO2013164127A1 publication Critical patent/WO2013164127A1/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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/074—Filling capsules; Related operations
    • 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
    • A61J2200/70—Device provided with specific sensor or indicating means
    • A61J2200/74—Device provided with specific sensor or indicating means for weight
    • 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
    • A61J2205/00—General identification or selection means
    • A61J2205/70—Audible labels, e.g. for pre-recorded info or messages
    • 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
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0445—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system for preventing drug dispensing during a predetermined time period

Definitions

  • the invention relates to a device for preparing a filled pharmaceutical capsule on demand with a predetermined amount of an active pharmaceutical ingredient.
  • the invention further relates to a pharmaceutical container.
  • the invention relates to a kit. Further, the invention relates to a method for preparing a filled pharmaceutical capsule on demand with a predetermined amount of an active pharmaceutical ingredient.
  • Medicines and active pharmaceutical ingredients and/or pharmaceutical substances are generally manufactured in pre-determined dosages chosen from a relatively limited range, based on the presumptions of the
  • a device for preparing a filled pharmaceutical capsule on demand with a predetermined amount of an active pharmaceutical ingredient comprises a container accommodation unit adapted for accommodating a pharmaceutical container, a filling unit adapted for filling the active pharmaceutical ingredient into the pharmaceutical capsule, and a controller adapted for controlling the amount of the active pharmaceutical ingredient filled into the pharmaceutical capsule.
  • the device may further comprise a monitoring unit adapted for monitoring that the predetermined amount of the active
  • pharmaceutical ingredient is filled into the pharmaceutical capsule. It may be a particular necessity that not more and not less than the predetermined amount of the active pharmaceutical ingredient is filled into the
  • a pharmaceutical container is provided, wherein the pharmaceutical container is adapted to be placed in a device according to an exemplary aspect.
  • kits comprising the device for preparing a filled pharmaceutical capsule on demand according to an exemplary aspect, and the pharmaceutical container according to an exemplary aspect, is provided.
  • a method for preparing a filled pharmaceutical capsule on demand with a predetermined amount of an active pharmaceutical ingredient comprises providing a pharmaceutical capsule, filling the active pharmaceutical ingredient from a pharmaceutical container comprising a reservoir of the active pharmaceutical ingredient into the pharmaceutical capsule, and controlling the amount of the active pharmaceutical ingredient filled into the pharmaceutical capsule.
  • the method may further comprise monitoring that only the predetermined amount of the active pharmaceutical ingredient is filled into the pharmaceutical capsule.
  • capsule may particularly denote a shell adapted to enclose or accommodate medicines and/or pharmaceuticals.
  • a capsule may allow for taking a pharmaceutical orally or using a pharmaceutical as a suppository.
  • the capsule may be a hard-shelled capsule, which may be suitable for dry, powdered ingredients or miniature pellets or miniature beads or miniature tablets, for example.
  • the capsules may be soft- shelled capsules, which may be suitable for liquids and for active ingredients that are dissolved or suspended in a liquid, particularly oil, for example.
  • the capsules may be produced from an aqueous solution of gelling agents such as animal protein, particularly gelatin, or plant
  • the capsules may comprise other ingredients such as plasticizers, particularly glycerin and/or sorbitol, coloring agents, preservatives, and/or lubricants.
  • the capsule may be a two part capsule which can be separated into two halves, filled with an active pharmaceutical ingredient, and subsequently closed by pressing the two halves together.
  • active pharmaceutical ingredient may particularly denote a substance which is physiologically and/or biologically active. More particularly the physiologically active substance may be a drug. Moreover, the physiologically active substance may be a drug. Moreover, the physiologically active substance may be a drug.
  • physiologically active substance may be a substance, for example a chemical which is intended for use in a medical and/or veterinary diagnosis, cure, treatment, and/or prevention of a disease.
  • on demand may particularly denote that a pharmaceutical capsule is only filled if a filled pharmaceutical capsule is requested, for example from a user of the device.
  • on demand has to be distinguished from a batchwise production of a pharmaceutical producer or a production in which a stock of filled pharmaceutical capsules is produced.
  • only a single pharmaceutical capsule may be filled at each point in time.
  • the single pharmaceutical capsule may be filled directly or
  • the device for preparing a filled pharmaceutical capsule on demand with a predetermined amount of an active pharmaceutical ingredient may be a portable device.
  • the term "portable" may denote that a size and a weight of an object is in a range that the object is portable by a human being, particularly a single human being .
  • the device may have a weight which is less than 10 kg, particularly less than 5 kg and/or may have a size which is smaller than 70 cm x 50 cm x 50 cm, particularly smaller than 40 cm x 40 cm x 40 cm.
  • the active pharmaceutical ingredient may be a liquid and/or a solid.
  • the active pharmaceutical ingredient may be provided as a powder, a bead, and/or a pellet, particularly a pellet having a standardized size.
  • a standardized single pellet may have a diameter of about 3 mm or less, particularly 1 mm.
  • the standardized pellet may comprise a defined or fixed amount of the active pharmaceutical ingredient or the physiologically active substance.
  • each standardized pellet may comprise the same defined amount of the active pharmaceutical ingredient.
  • the amount of active pharmaceutical ingredient may be proportional to a number of standardized pellets.
  • pellets having different defined amounts of active pharmaceutical ingredient and/or pellets having different sizes may be provided .
  • different types of pellets having different amounts of active pharmaceutical ingredient may be provided .
  • a size of the standardized pellet may be independent of the amount of active
  • a pellet having a larger amount of active pharmaceutical ingredient may comprise the same size as a pellet having a smaller amount of active of pharmaceutical ingredient.
  • the size of the standardized pellet may correlate with the amount of active pharmaceutical ingredient.
  • a pellet having a larger amount of active pharmaceutical ingredient may comprise a larger size than a pellet having a smaller amount of active pharmaceutical ingredient.
  • the size of a standardized pellet and/or the amount of active pharmaceutical ingredient per pellet may be adapted in such a manner that the number of standardized pellets filled into a single capsule and/or the amount of active pharmaceutical ingredient, in particular the overall amount of active pharmaceutical ingredient, filled into a single capsule is the same for each capsule.
  • the size to active pharmaceutical ingredient ratio for a particular pellet type may be chosen in such a manner that the same capsule type and/or capsule size may be employed independent of a
  • standardized pellets comprising no amount of an active pharmaceutical ingredient e.g . standardized placebo pellets
  • a capsule may be filled with placebo pellets and/or pellets comprising an active pharmaceutical ingredient. This may have the advantage that a patient may not know whether he or she is given a capsule comprising a placebo or a capsule comprising an active pharmaceutical ingredient.
  • the pellets being placebo pellets, e.g. comprising no amount of an active
  • a pharmaceutical ingredient may have the same size and/or appearance, for example the same color and/or texture, as the pellets comprising the active pharmaceutical ingredient.
  • a patient may not be able to detect whether a single pellet comprises an active pharmaceutical ingredient or not, particularly when the pellet is filled into the capsule.
  • a patient may not be able to obtain any information with respect to the overall amount of an active pharmaceutical ingredient filled into a single capsule.
  • the standardized pellets may comprise or may have a coating .
  • a coating may provide a form of passivation of the pellets, e.g. inhibit or at least reduce chemical interactions between the pellets. Chemical interactions of the ingredients of the pellets may otherwise occur in the pharmaceutical container or in the capsule in case more than one pellet is filled into a single capsule. This interaction may particularly occur if different pellets comprising different active pharmaceutical ingredient are filled into a single capsule. The chemical interaction may be reduced or even prevented by coating the pellet.
  • stability in particular a chemical stability, of the
  • ingredients of the pellets may be increased .
  • the standardized pellets may not comprise a coating or may be coatingfree.
  • the active pharmaceutical ingredient, particularly a pellet or bead comprising the active pharmaceutical ingredient may be
  • the device may be adapted to prepare not more than 5 capsules at a time, particularly not more the 3 capsules at a time, more particularly 1 capsule at a time. Moreover, the device may not prepare two capsules or more simultaneously.
  • the device may include a timing mechanism similar to a time lock, which may disable the filling or removing of a second pharmaceutical capsule for a predetermined or pre-settable time span. The active pharmaceutical ingredient which is filled into the
  • the pharmaceutical capsule may be provided in a pharmaceutical container.
  • the pharmaceutical container may be adapted to be inserted and/or
  • the pharmaceutical container may comprise a reservoir of the active
  • the pharmaceutical container may be replaceable, for example if the reserve of the active pharmaceutical ingredient is depleted or used up.
  • the filling procedure of the capsules may be configured accordingly. For example, a liquid may be filled in a capsule in a different manner compared to a solid .
  • the active pharmaceutical ingredient may be filled into a capsule by filling single pellets or beads one by one into the capsule. This may in particular allow to count the pellets which have been already filled into the capsule.
  • the capsules may be empty capsules or capsules which are already partly filled. Depending on whether the capsules are empty or already filled, the filling of the capsules with the active pharmaceutical ingredient may be adapted accordingly. Furthermore, a controller of the device may be adapted to control the filling unit.
  • a predetermined amount of the active pharmaceutical ingredient may be specified by a physician or medical practitioner medicating or treating a user of the device.
  • the physician may prescribe a certain dosage and may further specify a certain schedule. Since it may be important that only that amount of the active pharmaceutical ingredient which is prescribed is filled into the pharmaceutical capsule, the amount of the active pharmaceutical ingredient which is filled into the capsule may have to be monitored .
  • the device, the container, the kit and the method according to an exemplary aspect may provide the advantage that all allow preparing a pharmaceutical capsule filled with a predetermined amount of an active pharmaceutical ingredient.
  • the device is arranged within a housing .
  • the housing may be made of a suitable material or a combination of suitable materials.
  • the housing may be made of plastics and/or metal.
  • a housing may prevent an unauthorized opening of the device and/or an unauthorized manipulation of the device. Further, the housing may prevent that dust, humidity, and/or dirt may enter the device. Additionally, the housing may make a handling of the device easier. For example, the housing may have the additional advantage that a transport of the device may be easier.
  • the container accommodation unit is adapted for checking a security feature of the pharmaceutical container.
  • the pharmaceutical container may be a replaceable container which may be replaced if the active pharmaceutical ingredient comprised in the pharmaceutical container is depleted or used up. Moreover, the
  • the pharmaceutical container may be sealed so that the pharmaceutical container may not be easily openable.
  • the pharmaceutical container may be provided with a security feature.
  • the container may be sealed so that the pharmaceutical container may not be easily openable.
  • the pharmaceutical container may be provided with a security feature.
  • accommodation unit may be adapted in such a way that it interacts with the pharmaceutical container, for example with a security feature of the
  • the container accommodation unit may be adapted that the pharmaceutical container interacts with a security feature of the container accommodation unit.
  • the security feature may be a mechanical security feature, such as a tongue and groove feature.
  • the container accommodation unit may comprise a tongue which is adapted to fit into a respective groove at the pharmaceutical container or vice versa. This may prevent that a false container is inserted into the container accommodation unit.
  • the security feature may be an electronic security feature, such as a ID bar code, a 2D barcode, a hologram, an RFID chip or an electronic circuit.
  • the container accommodation unit may be adapted to check whether the electronic security feature is a valid security feature.
  • the container accommodation unit may comprise a reader device for checking a security feature of the pharmaceutical container. If the electronic security feature is not valid, the container accommodation unit may be adapted to prevent a filling of the active pharmaceutical ingredient comprised in the invalid pharmaceutical container into the
  • the container accommodation unit may also be adapted to check more than one security feature.
  • the container accommodation unit may be adapted to check a mechanical security feature and an electronic security feature.
  • the container accommodation unit may be adapted that render a pharmaceutical container invalid if a security feature of the pharmaceutical container is not present any more, e.g . is removed and/or broken.
  • an advantage of checking a mechanical security feature may be that an inserting of an invalid
  • An advantage of checking an electronic security feature may be that the container accommodation unit may prevent that an inserted pharmaceutical container having a valid mechanical security feature but the wrong electronic security feature is used for filling the pharmaceutical capsule.
  • the device further comprises a capsule accommodation unit adapted for accommodating reserve
  • the reserve pharmaceutical capsules may be contained in a capsule container.
  • the capsule container may be also replaceable, for example if a reserve of the pharmaceutical capsules is depleted.
  • the capsule container may be refillable with reserve pharmaceutical capsules.
  • the capsule accommodation unit may be adapted for checking a security feature.
  • the amount of the active pharmaceutical ingredient filled into the pharmaceutical capsule is determined by a weighing device.
  • the weighing device may be adapted to perform a differential measurement. Determining the amount of the active pharmaceutical ingredient filled into the pharmaceutical capsule using a weighing device may provide the advantage, that weighing allows for an accurate and efficient measuring of an amount of a liquid or a solid.
  • the amount of the active pharmaceutical ingredient filled into the pharmaceutical capsule may be determined by a weighing device.
  • the weighing device may be adapted to perform a differential measurement. Determining the amount of the active pharmaceutical ingredient filled into the pharmaceutical capsule using a weighing device may provide the advantage, that weighing allows for an accurate and efficient measuring of an amount of a liquid or a solid.
  • pharmaceutical ingredient filled into the pharmaceutical capsule may be determined by an optical measuring device, for example a device which measures a depth of filling of the pharmaceutical capsule.
  • the active pharmaceutical ingredient is provided in form of standardized pellets.
  • a standardized single pellet may have a diameter of about 3 mm or less, particularly 1 mm.
  • the standardized pellet may comprise a defined or fixed amount of the active pharmaceutical ingredient.
  • the amount of the active pharmaceutical ingredient filled into the pharmaceutical capsule is determined by a counting device or a counting unit.
  • the amount of the active pharmaceutical ingredient may be determined by the number of standardized pellets filled into the capsules. If each standardized pellets comprises a defined amount of active pharmaceutical ingredient, a particular dosage may be determined by a particular number of pellets. In particular, determining the amount of active pharmaceutical ingredient by counting may provide a simple and efficient way for determining the amount of the filled active
  • the device further comprises an alarm unit adapted for activating an alarm.
  • the alarm may be an acoustic alarm and/or an optical alarm and/or a haptic alarm.
  • the activated alarm may indicate an irregularity of the device and/or an irregularity of a functionality of the device.
  • the alarm unit may be adapted to activate different alarm signals depending on the detected irregularity.
  • the alarm may indicate that a filled pharmaceutical capsule is not removed from the device, a pharmaceutical capsule which is scheduled to be filled is not filled, a remaining amount of an active pharmaceutical ingredient in a pharmaceutical container is less than a set point value, a number of reserve pharmaceutical capsules is smaller than a reference number, and/or a failure in one or more units of the device are detected.
  • the alarm unit may be adapted to activate an alarm also at a different location.
  • the alarm unit may additionally comprise a transmit unit and/or receive unit for transmitting and/or receiving an alarm signal to and/or from a different location.
  • an alarm may be activated at a medical practitioner's office if a user of the device fails to fill a predetermined number of scheduled pharmaceutical capsules.
  • the device may be adapted to be connected to a telephone line and/or to the Internet, e.g . via a LAN or WLAN connection.
  • the alarm unit is adapted for activating an alarm if a capsule filled with the predetermined amount of the active pharmaceutical ingredient is not removed from the device.
  • the device may indicate that a filled pharmaceutical capsule is not removed from the device by activating an alarm.
  • a non-removal of a filled capsule may particularly indicate that a user of the device may have forgotten to remove the filled capsule.
  • the activated alarm may be an acoustic alarm and/or an optical alarm and/or a haptic alarm which may be designed to inform a user that he or she may have forgotten to remove a filled
  • a non-removal may also indicate that a user is not able to remove a filled pharmaceutical capsule from the device, for example due to a medical emergency.
  • the device may also be designed not only to activate an alarm to inform the user but also to activate an alarm to inform a third person such as an emergency contact person and/or a physician and/or a nurse and/or a carer.
  • the device further comprises a security unit adapted for preventing that a filled pharmaceutical capsule is removable from the device.
  • the security unit may be adapted to prevent a filling of a pharmaceutical capsule.
  • the security unit may be adapted to prevent a removing of a filled pharmaceutical capsule from the device.
  • the security unit may provide the advantage that an unauthorized filling of a pharmaceutical capsule may be prevented . It may be particularly important to prevent an unauthorized utilization of the device, if for example the active pharmaceutical ingredient is a controlled substance such as a narcotic.
  • the security unit may be coupled to an alarm unit for activating an alarm.
  • the security unit is adapted for preventing that a filled pharmaceutical capsule is removable from the device based upon a predetermined filling condition.
  • the predetermined filling condition is one of:
  • the using of the device may be limited to a certain person.
  • the identity of a user of the device may be recognized by a numerical user identity code, a password, a gesture, a finger print recognition, a voice recognition, and/or a retina recognition.
  • the device may accordingly comprise a respective detection unit which may be adapted to recognize a user identity.
  • the detection unit may be a finger print reader, a retina reader, a gesture recognition device, a voice recognition device, and/or device which may be adapted to recognize a password or a numerical identity code.
  • the container accommodation unit is further adapted to allow a replacing of a pharmaceutical container based upon a predetermined replacing condition.
  • a replacing of a pharmaceutical container may be allowed if the pharmaceutical container is empty or almost empty. Further, the predetermined replacing condition may take into account that an active pharmaceutical ingredient comprised in the pharmaceutical container may expire.
  • the predetermined replacing condition is one of:
  • the person who is replacing the pharmaceutical container may be different from a person who is preparing the filled pharmaceutical capsules.
  • the person who is replacing the pharmaceutical container may be an authorized person, particularly a person who is certified to replace the pharmaceutical container. In particular, this may increase a safety of a user of the device, since an unauthorized replacement of a pharmaceutical container may be prevented .
  • the device comprises a further container accommodation unit adapted for accommodating a further pharmaceutical container comprising a reservoir of a further active
  • a further pharmaceutical container comprising a reservoir of a further active pharmaceutical ingredient
  • several active pharmaceutical ingredients may be filled in one pharmaceutical capsule and/or with one single device. This may allow preparing a filled pharmaceutical capsule which is specially tailored for an individual patient. In particular, a number of capsules which have to be prepared may be reduced .
  • the pharmaceutical container comprises a security feature.
  • the security feature of the pharmaceutical container may be adapted in such a way that it interacts with a container accommodation unit, for example with a checking device of the container accommodation unit.
  • the security feature may be a mechanical security feature, such as a tongue and groove feature.
  • the pharmaceutical container may comprise a tongue which is adapted to fit into a respective groove at the container accommodation unit or vice versa. This may prevent that a false container is inserted into the container accommodation unit.
  • the security feature may be an electronic security feature, such as a I D bar code, a 2D barcode, a hologram, an RFID chip or an electronic circuit.
  • the electronic security feature may be adapted to be checked by a container accommodation unit whether the electronic security feature is a valid security feature.
  • the pharmaceutical container may comprise more than one security feature.
  • the pharmaceutical container may comprise a mechanical security feature and an electronic security feature.
  • the security feature may be adapted to render the pharmaceutical container invalid if the security feature is removed and/or broken.
  • an advantage of checking a mechanical security feature may be that an inserting of an invalid pharmaceutical container may be prevented .
  • An advantage of checking an electronic security feature may be that the container
  • accommodation unit may prevent that an inserted pharmaceutical container having a valid mechanical security feature but the wrong electronic security feature is used for filling the pharmaceutical capsule.
  • the pharmaceutical container is sealed.
  • the pharmaceutical container may be sealed so that the pharmaceutical container may not be easily openable. Further, a sealed pharmaceutical container may indicate whether an unauthorized opening of the
  • the method further comprises checking a security feature of the pharmaceutical container.
  • Checking the security feature of a pharmaceutical container may allow for a validation of the pharmaceutical container.
  • the checking of the security feature may validate whether a pharmaceutical container has been opened unauthorized and/or whether an active pharmaceutical ingredient comprised in the pharmaceutical container is consistent with a prescribed pharmaceutical ingredient.
  • the method further comprises activating an alarm based on predetermined alarm conditions.
  • an alarm may be activated when a deviation from an expectation value may be detected .
  • an expectation value may be an identity of a user, a security feature of a pharmaceutical container, a person who is replacing a pharmaceutical container, an amount of the active pharmaceutical ingredient in the container, a time which has elapsed after a previous replacing of the pharmaceutical container, a number of filled capsule in a given time interval, a time interval between two fillings of a
  • pharmaceutical capsule an amount of active pharmaceutical ingredient filled in one or more pharmaceutical capsules during a given time interval.
  • a program element which, when being executed by a processor, is adapted to control and/or carry out a method according to an exemplary aspect of the invention. Further the program element may be adapted, when being executed by a processor, to control an amount of an active pharmaceutical ingredient filled into a
  • the program element may be implemented as a computer readable command code in any suitable programming language such as JAVA, C++ etc.
  • the program element may be stored on a computer readable medium such as CD-ROM, DVD, Blue-ray Disk, removable drive, volatile and non-volatile memory etc. Further, the program element may be provided in a network, for example the Internet, and may be downloaded from a user on demand.
  • a computer-readable medium in which a computer program is stored which, when being executed by a processor, is adapted to control and/or carry out a method according to an exemplary aspect of the invention.
  • Fig. 1 shows a device for preparing a filled pharmaceutical capsule on demand with a predetermined amount of an active pharmaceutical ingredient according to an exemplary embodiment.
  • Fig. 2 shows a pharmaceutical container according to an exemplary embodiment.
  • Fig . 3 shows a method for preparing a filled pharmaceutical capsule on demand with a predetermined amount of an active pharmaceutical ingredient according to an exemplary embodiment.
  • the illustration in the drawing is schematically. In different drawings, similar or identical elements are provided with the same reference signs.
  • a device 100 for preparing a filled pharmaceutical capsule 106 on demand with a predetermined amount of an active pharmaceutical ingredient 101 will be explained .
  • the device 100 for preparing a filled pharmaceutical capsule 106 on demand with a predetermined amount of an active pharmaceutical ingredient 101 shown in Fig. 1 comprises a container accommodation unit 102 adapted for accommodating a pharmaceutical container 103.
  • the device 100 further comprises a filling unit 104 adapted for filling the active pharmaceutical ingredient into the pharmaceutical capsule 106.
  • the device 100 comprises a controller 108 adapted for controlling the amount of the active pharmaceutical ingredient filled into the pharmaceutical capsule.
  • the device 100 comprises a monitoring unit 110 adapted for monitoring that only the predetermined amount of the active pharmaceutical ingredient 101 is filled into the
  • the device 110 is arranged within a housing 112. Further, the housing 112 prevents that dust, humidity, and/or dirt may enter the device 100.
  • the device 100 further comprises a capsule accommodation unit 114 adapted for accommodating reserve pharmaceutical capsules 107.
  • the reserve pharmaceutical capsules 107 are contained in a capsule container 115.
  • the capsule container 115 may be configured to be replaceable, for example if a reserve of the pharmaceutical capsules 107 is depleted .
  • the capsule container 115 may be refillable with reserve pharmaceutical capsules 107.
  • the device 100 also comprises an alarm unit 116 adapted for activating an alarm.
  • the alarm may be an acoustic alarm and/or an optical alarm and/or a haptic alarm. Further, the alarm unit 116 is adapted to activate different alarm signals depending on a detected irregularity.
  • the alarm may indicate that a filled pharmaceutical capsule 106 is not removed from the device, a pharmaceutical capsule 106 which is scheduled to be filled is not filled, a remaining amount of an active pharmaceutical ingredient in a pharmaceutical container is less than a set point value, a number of reserve pharmaceutical capsules 107 is smaller than a reference number, and/or a failure in one or more units of the device 100 is detected.
  • the alarm unit 116 may be adapted to activate an alarm also at a different location, e.g . via a connection via the Internet.
  • the device 100 comprises a weighing device 118 for determining an amount of the active pharmaceutical ingredient 101 filled into the
  • the weighing device 118 may be a precision balance.
  • the device 100 may alternatively comprise a counting device.
  • the device 100 may comprise both a weighing device 118 and a counting device.
  • the container accommodation unit 102 is adapted for checking a security feature of a pharmaceutical container 103.
  • the pharmaceutical container 103 is a replaceable container which is replaced if the active pharmaceutical ingredient comprised in the pharmaceutical container 103 is depleted. Moreover, the pharmaceutical container 103 is sealed so that the pharmaceutical container 103 may not be opened. Further, the pharmaceutical container 103 is provided with a security feature which interacts with the container accommodation unit 102.
  • the pharmaceutical container 103 comprises a mechanical security feature 200 in form of a tongue 200 which is adapted to fit into a respective groove at the container accommodation unit 102.
  • a mechanical security feature may particularly prevent that a false container is inserted into the container accommodation unit 102.
  • the pharmaceutical container 103 may comprise a bar code 202 which may be readable by the container accommodation unit 102, for example.
  • the bar code 202 may comprise also additional information about the active pharmaceutical ingredient comprised in the pharmaceutical container 103.
  • the bar code 202 may contain an expiration date of the active pharmaceutical ingredient.
  • the pharmaceutical container 103 may comprise a further security feature in form of an electronic circuit 204.
  • the electronic circuit 204 may be adapted that the pharmaceutical container 103 becomes invalid if a sealing of the pharmaceutical container 103 is removed and/or broken.
  • the method 300 comprises providing a pharmaceutical capsule 106 as indicated by reference numeral 302. Before a predetermined amount 101 of an active pharmaceutical ingredient is filled into the pharmaceutical capsule 106, the method may optionally check a security feature 200, 202, 204 of a pharmaceutical container 103 as indicated by reference numeral 304. After the provided security features 200, 202, 204 of the pharmaceutical container 103 may have been checked and validated, the active pharmaceutical ingredient is filled as indicated by reference numeral 306 from the pharmaceutical container 103 comprising a reservoir of the active pharmaceutical ingredient into the pharmaceutical capsule 106. The method further comprises a controlling, as indicated by reference numeral 308, of the amount of the active
  • predetermined amount of the active pharmaceutical ingredient is filled into the pharmaceutical capsule.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (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)

Abstract

La présente invention concerne un dispositif de préparation à la demande d'une capsule pharmaceutique remplie d'une quantité prédéterminée d'un principe pharmaceutique actif. Le dispositif comprend une unité de réception de récipient conçue pour recevoir un récipient pharmaceutique, une unité de remplissage conçue pour remplir le principe pharmaceutique actif dans la capsule pharmaceutique, et un organe de commande conçu pour réguler la quantité de principe pharmaceutique actif remplie dans la capsule pharmaceutique. L'invention concerne également un récipient pharmaceutique. L'invention concerne en outre un kit comprenant le dispositif de préparation à la demande d'une capsule pharmaceutique remplie ainsi que le récipient pharmaceutique. L'invention concerne finalement un procédé de préparation à la demande d'une capsule pharmaceutique remplie d'une quantité prédéterminée d'un principe pharmaceutique actif.
PCT/EP2013/055846 2012-05-04 2013-03-20 Dispositif et procédé de préparation d'une capsule pharmaceutique remplie à la demande avec une quantité prédéterminée d'un principe pharmaceutique actif WO2013164127A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1207893.7 2012-05-04
GB201207893A GB201207893D0 (en) 2012-05-04 2012-05-04 A device and a method for preparing a filled pharmaceutical capsule on demand with a predetermined amount of an active pharmaceutical ingredient

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EP3241540A1 (fr) * 2016-05-02 2017-11-08 Miteshkumar Ishwarbhai Patel Système et procédés pour des dosages de médicament personnalisé dans une capsule

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EP1413434A1 (fr) * 2002-10-24 2004-04-28 Hewlett-Packard Development Company, L.P. Forme pharmaceutique et procédé de préparation
US20040172169A1 (en) * 2001-03-02 2004-09-02 Curtis Wright Method and apparatus for compouding individualized dosege forms
US20070068959A1 (en) * 2003-11-26 2007-03-29 D Silva Joe Preparing for individualized dosage forms of medicaments
US20080127609A1 (en) * 2004-09-27 2008-06-05 Mg 2-S.R.L. Machine and Process for Filing Capsules or Similar
WO2010070592A1 (fr) * 2008-12-18 2010-06-24 I.M.A. Industria Macchine Automatiche S.P.A. Machine et procédé de remplissage et vérification de capsules
US20120003928A1 (en) * 2008-12-12 2012-01-05 Dsm Ip Assets B.V. Dispenser

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EP1413434A1 (fr) * 2002-10-24 2004-04-28 Hewlett-Packard Development Company, L.P. Forme pharmaceutique et procédé de préparation
US20070068959A1 (en) * 2003-11-26 2007-03-29 D Silva Joe Preparing for individualized dosage forms of medicaments
US20080127609A1 (en) * 2004-09-27 2008-06-05 Mg 2-S.R.L. Machine and Process for Filing Capsules or Similar
US20120003928A1 (en) * 2008-12-12 2012-01-05 Dsm Ip Assets B.V. Dispenser
WO2010070592A1 (fr) * 2008-12-18 2010-06-24 I.M.A. Industria Macchine Automatiche S.P.A. Machine et procédé de remplissage et vérification de capsules

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3241540A1 (fr) * 2016-05-02 2017-11-08 Miteshkumar Ishwarbhai Patel Système et procédés pour des dosages de médicament personnalisé dans une capsule

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