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WO2003090811A2 - Distributeur de medicaments - Google Patents

Distributeur de medicaments Download PDF

Info

Publication number
WO2003090811A2
WO2003090811A2 PCT/EP2003/004404 EP0304404W WO03090811A2 WO 2003090811 A2 WO2003090811 A2 WO 2003090811A2 EP 0304404 W EP0304404 W EP 0304404W WO 03090811 A2 WO03090811 A2 WO 03090811A2
Authority
WO
WIPO (PCT)
Prior art keywords
medicament
dispenser according
medicament dispenser
primer
carrier
Prior art date
Application number
PCT/EP2003/004404
Other languages
English (en)
Other versions
WO2003090811A3 (fr
Inventor
Stephen James Harvey
Allen John Pearson
Paul Kenneth Rand
Original Assignee
Glaxo Group Limited
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 Glaxo Group Limited filed Critical Glaxo Group Limited
Priority to JP2003587436A priority Critical patent/JP2005523748A/ja
Priority to AU2003233083A priority patent/AU2003233083A1/en
Priority to EP03727384A priority patent/EP1499375A2/fr
Publication of WO2003090811A2 publication Critical patent/WO2003090811A2/fr
Publication of WO2003090811A3 publication Critical patent/WO2003090811A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0043—Non-destructive separation of the package, e.g. peeling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A61M15/0046—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier
    • A61M15/0051—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier the dosages being arranged on a tape, e.g. strips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A61M15/0053—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type or way of disposal
    • A61M15/0055—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type or way of disposal the used dosages being coiled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/007—Mechanical counters
    • A61M15/0071—Mechanical counters having a display or indicator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/008—Electronic counters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/0081—Locking means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/06—Packaging for specific medical equipment

Definitions

  • the present invention relates to a medicament dispenser for dispensing medicament.
  • the invention particularly relates to a device for use in dispensing medicament in powder or tablet form.
  • inhalation devices in the administration of medicaments, for example in bronchodilation therapy.
  • Such devices generally comprise a body or housing within which a medicament carrier is located.
  • Known inhalation devices include those in which the medicament carrier is a blister strip containing a number of discrete doses of powdered medicament.
  • Such devices usually contain a mechanism for accessing these doses, which usually comprises either piercing means or means to peel a lid sheet away from a base sheet. The powdered medicament can then be accessed and inhaled.
  • a mechanism may also be used for dispensing medicament in tablet form wherein peeling away the lid sheet from the base sheet reveals a tablet for removal and subsequent consumption.
  • emergency or rescue situations e.g. asthma attacks
  • a medicament dispenser for use with a medicament carrier having a plurality of pockets for containing medicament wherein said pockets are spaced along the length of and defined between two peelable sheets secured to each other, said dispenser having an internal mechanism for accessing said medicament contained within said medicament carrier, said mechanism comprising,
  • a peeler for peelably opening a pocket, said peeler including a lid driver for drivably peeling a lid sheet from a base sheet of said pocket;
  • an indexer for indexing pockets of a medicament carrier in use with said medicament dispenser
  • said mechanism additionally comprises a primer moveable between a primed position in which said primer stores mechanical energy and a release position in which the primer releases said mechanical energy to said lid driver and/or said indexer.
  • the medicament dispenser herein is suitable for dispensing medicament from a medicament carrier.
  • medicament carrier herein is used to define any suitable form of carrier.
  • the medicament carrier is in the form of an elongate strip or tape.
  • the medicament carrier has a plurality of pockets for containing medicament wherein said pockets are spaced along the length of and defined between two peelable sheets secured to each other.
  • the medicament carrier comprises a blister pack in laminate form.
  • the laminate comprises material selected from the group consisting of metal foil, organic polymeric material and paper.
  • metal foils include aluminium or tin foil having a thickness of from 5 to 100 ⁇ m, preferably from 10 to 50 ⁇ m, such as 20 to 30 ⁇ m.
  • Suitable organic polymeric materials include polyethylene, polypropylene, polyvinyl chloride and polyethylene terephthalate.
  • Access to the medicament dose portions comprised within the pockets of the elongate strip form carrier is by any suitable access means including tearing, piercing or peeling apart the relevant pockets.
  • the peelable blister strip comprises a base sheet in which blisters are formed to define pockets therein for containing distinct medicament dose portions and a lid sheet which is hermetically sealed to the base sheet except in the region of the blisters in such a manner that the lid sheet and the base sheet can be peeled apart.
  • the base and lid sheets are typically sealed to one another over their whole width except for the forward end portions where they are typically not sealed to one another at all. Thus, separate base and lid sheet forward end portions are presented at the end of the strip.
  • the respective base and lid sheets are peelably separable from each other to (e.g. separately) release the contents of each pocket.
  • the lid sheet comprises at least the following successive layers: (a) paper; adhesively bonded to (b) polyester; adhesively bonded to (c) aluminium foil; that is coated with a heat seal lacquer for bonding to the base sheet.
  • the thickness of each layer may be selected according to the desired properties but is typically of the order of from 5 to 200 micron, particularly from 10 to 50 micron.
  • the base sheet comprises at least the following successive layers: (a) oriented polyamide (OPA); adhesively bonded to (b) aluminium foil; adhesively bonded to (c) a third layer comprising a polymeric material (e.g. polyvinyl chloride).
  • OPA oriented polyamide
  • a polymeric material e.g. polyvinyl chloride
  • lid and base sheet can be joined to join the lid and base sheet and hence to seal the blisters of the peelable blister strip.
  • Such methods include adhesive bonding, hot metal bonding, hot metal welding, radio frequency welding, laser welding, ultrasonic welding and hot bar sealing.
  • the lid sheet and base sheet of the peelable blister strip are particularly sealable by 'cold form' sealing methods, which are conducted at lower temperatures than conventional heat sealing methods.
  • 'cold form' sealing methods are of particular utility where the medicament or medicament formulation for containment within the blister is heat sensitive (e.g. degrades or denatures on heating).
  • Suitable 'cold form' sealing methods are conducted at a temperature in the range of 150-250°C, more preferably, 210-240°C.
  • the medicament dispenser has an internal mechanism for accessing medicament carried by said medicament carrier.
  • the mechanism comprises an opening station for receiving a pocket of the medicament carrier.
  • the mechanism further comprises a peeler for peeling apart a pocket of the medicament carrier.
  • each blister pocket is peeled apart about a defined beak, wedge or roller form feature of the dispenser.
  • An outlet is positioned to be in communication with the distinct medicament dose portions releasable by said a release to enable their dispensing to the patient.
  • the outlet may have any suitable form. In one aspect, it has the form of a mouthpiece. In another aspect, it has the form of a nozzle for insertion into the nasal cavity of a patient.
  • the internal mechanism includes a primer.
  • the primer comprises any suitable mechanical energy store, which may be primed to store mechanical energy, which is releasable there from to drive the lid driver and/or indexer.
  • the primer comprises a spring, such as a tension, compression or torsion spring or indeed any springy or elastic material, which can function in a manner that enables the required storage and release of mechanical energy.
  • a spring such as a tension, compression or torsion spring or indeed any springy or elastic material, which can function in a manner that enables the required storage and release of mechanical energy.
  • the primer comprises a lock (e.g. a latch mechanism) for releasably locking the primer in said primed position.
  • a lock e.g. a latch mechanism
  • the lock is releasable by a push button action.
  • the lock is releasable by a lever action.
  • the medicament dispenser additionally comprises a housing for the mechanism, wherein said housing includes
  • a feature which enables the user to reversibly open and close the mouthpiece cover (thereby moving the primer from unprimed to a nominal 'primed' position) without necessarily resulting in release of energy to the lid driver or indexer.
  • this feature comprises a coupling mechanism, to reversibly couple (and decouple) the primer to the indexer or lid driver.
  • the coupling mechanism is couplable by an actuation button, which typically includes a lock function (e.g. a latch mechanism).
  • actuation button typically includes a lock function (e.g. a latch mechanism).
  • the mouthpiece cover is opened, resulting in movement of the primer to the nominal 'primed' position and the coupling mechanism then engages (either automatically or as a result of direct user action) to couple the primer to the indexer and or lid driver, which corresponds to the (fully) primed position. Release of the primer is achievable as described hereinbefore.
  • the mouthpiece cover is in aspects, pivotally or rotationally mounted to the housing about which it is respectively pivotable or rotatable. Any suitable means of fixing the cover to the housing are envisaged including snap-fit type arrangements.
  • the indexer comprises an index ratchet which is moveable between a locked position whereby said ratchet engages a pocket on said medicament carrier and prevents further peeling thereof, and a release position allowing free movement of said medicament carrier, and release of the primer both actuates said lid driver and releases said index ratchet from the medicament carrier to allow peeling thereof.
  • the index ratchet is initially positioned ('locked position') such as to prevent travel of the medicament carrier.
  • the lid driving means is actuated and the index ratchet reversibly released ('release position') to enable a defined degree of travel of the medicament carrier to the opening station.
  • the defined degree of travel corresponds generally to that required to move one blister pocket to the opening station and open the pocket for release of a dose (generally, one pocket's worth) of medicament.
  • the index ratchet again locks ('locked position') and thereby acts such as to prevent further movement of the medicament carrier and hence further peeling thereof, until after the released dose of medicament has been dispensed to the patient.
  • the index ratchet may have any suitable form.
  • it comprises a ratchet arm that is suitably, pivotally mounted on the dispenser.
  • the ratchet arm is generally shaped (e.g. with a dog-leg end) to engage blister pockets of the medicament carrier and located within the medicament dispenser to ensure that such engagement occurs in ratchet fashion.
  • the index ratchet engages a pocket on said medicament carrier and in the release position said pocket is disengaged.
  • the medicament carrier is prevented from moving within the dispenser, but when dis-engaged the medicament carrier is movable within the dispenser for peelable opening of a pocket thereof.
  • the index ratchet is positioned to cam in and out of engagement with a blister pocket of the medicament carrier.
  • the index ratchet cams in and out to locate directly behind the blister pocket of a medicament carrier, thereby providing consistent (single) pocket feed to the opening station.
  • the medicament dispenser further comprises an indexing lever for actuating said dispenser (e.g. to actuate the lid driver and release the index ratchet from said medicament carrier to allow peeling thereof).
  • said indexing lever comprises moving means (e.g. cam-form) for moving said index ratchet between locked and release positions, such that actuation of said lever from a rest position releases said medicament carrier for peeling thereof.
  • the lid driver comprises an index gear and a drive gear which are interconnected so that the rotation of one correlates with the rotation of the other.
  • the medicament dispenser additionally comprises a counter wherein actuation of said counter is coupled to the actuation of the medicament dispenser.
  • actuation of the counter is coupled to the release of the primer.
  • actuation of the counter is coupled to the release of the index ratchet.
  • the counter may count the number of doses left to be taken or the number of doses taken.
  • the counter may be electronic or mechanical.
  • the lid driver comprises a mangle.
  • the lid sheet passes through two rotating wheels that act as a mangle and is gripped at the point of contact with the wheels.
  • the used portion of the lid sheet is collected in a chamber after it has passed through the mangle.
  • the lid driver comprises a roller.
  • said roller is composed of a polymeric rubber and is positioned next to a guide wall.
  • said roller has a smooth surface.
  • said roller has a knurled surface. The roller grips the lid sheet as it passes from the point at which it is separated from the base sheet through the space between the roller and the guide wall and the used portion of the lid sheet is then collected in a chamber.
  • the roller has the advantage over the mangle described above in that a greater degree of contact between the roller wheel and the lid sheet occurs- the lid sheet is squeezed through the roller and may pass around about 1/3 of the roller wheel. This provides a higher level of grip and pulling force than with a mangle.
  • the force required to turn the roller is constant throughout the use of the device and does not vary according to how much of the lid sheet has been peeled away from the base sheet.
  • the roller also has the advantage that the lid sheet does not have to be looped around or fixed to the roller before use of the device, therefore simplifying assembly of the device and reducing costs.
  • the internal mechanism additionally comprises a first chamber in which the strip is initially housed and from which it is dispensed and a second chamber to receive the used portion of the base sheet after it has been indexed and separated from the lid sheet.
  • a wall separates said first chamber and said second chamber.
  • said wall is movable to adjust the size of said first and second chambers.
  • the wall is pivotally mountable.
  • the wall is slidably mountable.
  • the wall is flexible to allow changes in the relative size of said first and second chambers.
  • the internal mechanism further comprises a third chamber to receive the used portion of the lid sheet and a fourth chamber that houses the index ratchet.
  • the fourth chamber may communicate via a slit, which in turn extends upwardly within a mouthpiece and communicates with air inlets.
  • the medicament dispenser is configured to be refillable.
  • the refillable medicament dispenser comprises
  • 'base station' is used herein, simply to denote the part of the dispenser that receives the refill. It may, in practice be configured to outwardly adopt the general form of a medicament dispenser.
  • the individual components of the internal mechanism may be located in either the refill cassette or base station.
  • the majority of the components are located in the base station such that the refill cassette is as simple in form (and therefore also cheaper) as possible.
  • the refill cassette includes, in communication with said outlet, a mouthpiece; and said base station includes a movable cover for said mouthpiece, and wherein in use, movement of said cover from a first position, in which the mouthpiece is covered to a second position, in which the mouthpiece is uncovered results in movement of the primer to the primed position.
  • the cover is pivotally movable relative about the base station. In another aspect, the cover is rotationally movable relative to the base station.
  • the base station additionally comprises a catch to retain the cassette.
  • the catch may for example comprise a sprung pin that fits into a hole or an integral catch that deforms when pressed allowing removal of the cassette.
  • the catch is child resistant.
  • Child resistance may be realised by having a system that forces the user to perform two actions at once to remove the cassette.
  • Other features of the catch may include shock or impact resistance, the ability to lock the catch and orientation features to ensure that the cassette can only be inserted one way.
  • the catch should also be easy to manufacture and assemble, be robust, be composed of a minimal number of components and intrude minimally into the space into which the cassette is inserted.
  • the base station includes guide means to guide the cassette into the receiving part of the base station.
  • said guide means comprise guide rails.
  • the guide means comprise grooves, indentations or other shaping or surface details to define a 'lock and key' relationship between the holder and the cassette. Colour guides, arrows and any other surface markings may also be employed.
  • the cassette additionally comprises an indexing lever.
  • the indexing lever has a finger tab located outside the body of the cassette. The rest of the indexing lever is located within the cassette.
  • the indexing lever may have teeth at its tail end and/or teeth along its mid portion.
  • the cassette additionally comprises a mouthpiece.
  • the medicament dispenser may also be designed for nasal inhalation of a powdered medicament and may therefore incorporate a nosepiece as an alternative to a mouthpiece. If the medicament is in solid form, the dispenser may incorporate an exit channel for tablet release.
  • the cassette additionally comprises a raised portion to fit against the base station.
  • the raised portion is located at the opposite end of the cassette to the mouthpiece/nosepiece/exit and indexing lever and prevents the incorrect insertion of the cassette into the holder since it is too wide to fit into the holder.
  • the raised portion is shaped such that it fits against a cut away part of the holder.
  • said raised portion includes a section that is raised to define a grip portion.
  • At least a portion of the base station and/or cassette is shaped for ease of grip by the user.
  • operation of the device may be performed with one hand.
  • the refillable device may be assembled as follows.
  • the base station and cassette are assembled separately.
  • the body of the cassette is formed, preferably in two sections with any necessary spindles or integral components formed into the base. Individual components such as the indexer, lid drive mechanism, guide portions etc are then assembled into the base.
  • the medicament containing blister strip (or other suitable medicament carrier) may be inserted into the cassette. This may be wound into the device before the lid is attached to the cassette and the cassette sealed.
  • the cassette may be formed completely apart from a hole left in its side for insertion of the blister strip or medicament carrier. The hole may then be sealed to complete the cassette. This second method of inserting the medicament carrier into the device has the advantage that it is much simpler.
  • the medicament dispenser additionally comprises an electronic data management system.
  • the electronic data management system has input/output capability and comprises a memory for storage of data; a microprocessor for performing operations on said data; and a transmitter for transmitting a signal relating to the data or the outcome of an operation on the data.
  • the electronic data management system is arranged to be responsive to or activated by the voice of a user.
  • the system may be switched on or off in response to a voice command.
  • the electronic data management system may be integral with the body.
  • the electronic data management system forms part of a base unit that is reversibly associable with the body.
  • the medicament dispenser additionally comprises a data input system for user input of data to the electronic data management system.
  • the data input system comprises a man machine interface (MMI) preferably selected from a keypad, voice recognition interface, graphical user interface (GUI) or biometrics interface.
  • MMI man machine interface
  • GUI graphical user interface
  • Energy may be conserved by a variety of means to enable the device to operate for longer on a given source of energy, such as a battery. Energy conservation or saving methods have additional advantages in terms of reducing the size requirements of the power source (e.g. battery) and thus the weight and portability of the medicament dispenser.
  • a battery e.g. battery
  • a variety of energy saving methods is available which generally involve reducing power consumption.
  • One such method is to use a clock or timer circuit to switch the power on and off at regular or predetermined intervals.
  • the system can selectively switch on/off specific electronic devices, such as visual display units or sensors, in order to power these devices only when they are required to perform a particular sequence of events.
  • different electronic devices may be switched on and off at varying intervals and for varying periods under control of the system.
  • the power sequencing system may also respond to a sensor, such as a motion or breath sensor, which is activated on use of the device.
  • Low power or "micropower” components should be used within the electronics where possible and if a high power device is required for a particular function this should be put into a low power standby mode or switched off when not required. Similar considerations apply in the selection of transducers. Operation at low voltage is desirable since power dissipation generally increases with voltage.
  • CMOS complementary metal oxide semi-conductor
  • Clock speeds of processors and other logic circuits should be reduced to the minimum required for computational throughput as power consumption increases with frequency.
  • Supply voltages should also be kept at minimal values consistent with reliable operation because power dissipation in charging internal capacitance's during switching is proportional to the square of the voltage. Where possible, supply voltages should be approximately the same throughout the circuit to prevent current flowing through input protection circuits.
  • Logic inputs should not be left floating and circuits should be arranged so that power consumption is minimised in the most usual logic output state. Slow logic transitions are undesirable because they can result in relatively large class-A currents flowing.
  • Resistors may be incorporated in the power supply to individual devices in order to minimise current in the event of failure.
  • devices that switch between on and off states are preferred to those that allow analog (e.g. linear) control because less power is dissipated in low resistance on states and low current off states.
  • linear components e.g. certain types of voltage regulators
  • types with low quiescent currents should be selected.
  • appropriate reactive components i.e. inductors and capacitors
  • the system additionally comprises a visual display unit for display of data from the electronic data management system to the user.
  • the display may for example, comprise a screen such as an LED or LCD screen. More preferably the visual display unit is associable with the body of the medicament dispenser.
  • the medicament dispenser additionally comprises a datalink for linking to a local data store to enable communication of data between the local data store and the electronic data management system.
  • the datastore may also comprise data management, data analysis and data communication capability.
  • the datastore may itself form part of a portable device (e.g. a handheld device) or it may be sized and shaped to be accommodated within the patient's home.
  • the datastore may also comprise a physical storage area for storage of replacement cassettes.
  • the datastore may further comprise a system for refilling medicament from a reservoir of medicament product stored therewithin.
  • the datastore may further comprise an electrical recharging system for recharging any electrical energy store on the medicament dispenser, particularly a battery recharging system.
  • the datalink may for example enable linking with a docking station, a personal computer, a network computer system or a set-top box by any suitable method including a hard-wired link, an infrared link or any other suitable wireless communications link.
  • the medicament dispenser additionally comprises an actuation detector for detecting actuation of the dispensing mechanism wherein said actuation detector transmits actuation data to the electronic data management system.
  • the medicament dispenser may additionally comprise a safety mechanism to prevent unintended multiple actuations of the dispensing mechanism.
  • the patient is thereby protected from inadvertently receiving multiple doses of medicament in a situation where they take a number of short rapid breaths.
  • the safety mechanism imposes a time delay between successive actuations of the release means.
  • the time delay is typically of the order of from three to thirty seconds.
  • the medicament dispenser additionally comprises a release detector for detecting release of medicament from the cassette, wherein said release detector transmits release data to the electronic data management system.
  • the medicament dispenser additionally comprises a shake detector for detecting shaking of the medicament container (e.g. prior to actuation of the dispensing mechanism), wherein said shake detector transmits shake data to the electronic data management system.
  • any actuation detector, release detector, or shake detector comprises a sensor for detecting any suitable parameter such as movement. Any suitable sensors are envisaged including the use of optical sensors.
  • the release detector may sense any parameter affected by release of the medicament such as pressure, temperature, sound, moisture, carbon dioxide concentration and oxygen concentration.
  • the medicament dispenser additionally comprises a breath trigger for triggering the dispensing mechanism, said breath trigger being actuable in response to a trigger signal from the electronic data management system.
  • the electronic data management system includes a predictive algorithm or look-up table for deriving from the breath data when to transmit the trigger signal. For example, a real-time analysis of the patient breath waveform may be made and the trigger point derived by reference to that analysed waveform.
  • the electronic data management system includes a predictive algorithm or look-up table for calculating the optimum amount of medicament to dispense.
  • the memory on the electronic data management system includes a dose memory for storing dosage data and reference is made to the dose memory in calculating the optimum amount of medicament to dispense.
  • the medicament dispenser additionally comprises a selector for selecting the amount of medicament to dispense from said dispensing mechanism.
  • the selector is manually operable.
  • the selector is operable in response to a signal from the transmitter on the electronic data management system.
  • the medicament dispenser comprises in association with a body or housing thereof, a first transceiver for transmitting and receiving data and in association with the medicament container, a second transceiver for transmitting and receiving data, wherein data is transferable in two-way fashion from the first transceiver to the second transceiver.
  • the data is preferably in digital form and suitable for transfer by electronic or optical means.
  • the information is furthermore stored in a form that is readily and accurately transferable.
  • the information could for example, include manufacturing and distribution compliance information written to the memory at various points in the manufacturing or distribution process, thereby providing a detailed and readily accessible product history of the dispenser. Such product history information may, for example, be referred to in the event of a product recall.
  • the compliance information could, for example, include date and time stamps.
  • the information could also include a unique serial number stored in encrypted form or in a password protectable part of the memory that uniquely identifies the product and therefore may assist in the detection and prevention of counterfeiting.
  • the information could also include basic product information such as the nature of the medicament and dosing information, customer information such as the name of the intended customer, and distribution information such as the intended product destination.
  • the second transceiver On loading or reloading the medicament dispenser with a cassette the second transceiver may, for example, read the unique serial number, batch code and expiry date of the medicament and any other information on the second transceiver. In this way the nature and concentration of the medicament, together with the number of doses used or remaining within the cassette, may be determined. This information can be displayed to the patient on a visual display unit. Other information, such as the number of times the medicament dispenser has been reloaded with a cassette, may also be displayed.
  • the same data can be read from the second transceiver and the number of doses remaining or used determined.
  • Other information such as the date and time of administration of the drug, or environmental exposure data such as the minimum / maximum temperatures or levels of humidity the cassette has been exposed to, may also be read and displayed to the user.
  • activation of the dispenser may be prevented to safeguard the user. Activation may also be prevented if the medicament has been exposed to extreme environmental conditions for periods outwith the manufacturer's guidelines.
  • the medicament dispenser may include an electronic data management system having various sensors associated therewith. Any data collected by the sensors or from any data collection system associated with the electronic data management system including a clock or other date/time recorder is transferable.
  • Data may be transferred each time the patient uses the device.
  • data may be stored in a database memory of the electronic data management system and periodically downloaded to any transceiver. In either case, a history of the usage of the device may be built up in the memory of a transceiver.
  • a history of the usage of the medicament dispenser is transferred to the second transceiver.
  • the blister strip in the cassette is exhausted it is exchanged by the patient for a new refill cassette.
  • data may be transferred from the exhausted cassette to the refill and vice-versa.
  • usage history data may be read from the refill and transferred to a healthcare data management system for example comprising a network computer system under the control of a healthcare data manager.
  • Methods are envisaged herein whereby the patient is given some sort of reward for returning the refill and making available the data comprised within the second transceiver.
  • Methods are also envisaged herein whereby the healthcare data manager is charged for either receipt of the data from the second transceiver or for its use for commercial purposes. Any rewards or charging may be arranged electronically.
  • the methods may be enabled by distributed or web-based computer network systems in which any collected data is accessible through a hub on the network.
  • the hub may incorporate various security features to ensure patient confidentiality and to allow selective access to information collected dependent upon level of authorisation.
  • the level of user authorisation may be allocated primarily to safeguard patient confidentiality. Beyond this the level of user authorisation may also be allocated on commercial terms with for example broader access to the database being authorised in return for larger commercial payments.
  • the first and second transceiver each comprise an antenna or equivalent for transmitting or receiving data and connecting thereto a memory.
  • the memory will typically comprise an integrated circuit chip.
  • Either transceiver may be configured to have a memory structure that allows for large amounts of information to be stored thereon.
  • the memory structure can be arranged such that parts of the memory are read-only, being programmed during/after manufacture, other parts are read/write and further parts are password protectable.
  • Initial transfer of information (e.g. on manufacture or one dispensing) to or from any transceiver can be arranged to be readily achievable by the use of a reader which is remote from the medicament dispenser, thereby minimising the need for direct product handling.
  • the reader can be arranged to simultaneously read or write to the memory of multiple transceivers on multiple medicament dispensers.
  • a suitable power source such as a battery, clockwork energy store, solar cell, fuel cell or kinetics-driven cell will be provided as required to any electronic component herein.
  • the power source may be arranged to be rechargeable or reloadable.
  • data is transferable in two-way fashion between the first and second transceiver without the need for direct physical contact therebetween.
  • data is transferable wirelessly between the first and second transceiver.
  • the first transceiver is an active transceiver and the second transceiver is a passive transceiver.
  • active is used to mean directly powered and the term passive is used to mean indirectly powered.
  • the second transceiver comprises a label or tag comprising an antenna for transmitting or receiving energy; and an integrated circuit chip connecting with said antenna
  • the first transceiver comprises a reader for said label or tag.
  • the label or tag is a passive transceiver and the reader is an active transceiver.
  • the reader will not need to be in direct contact with the tag or label to enable the tag or label to be read.
  • the tag may be used in combination and/or integrated with other traditional product labelling methods including visual text, machine-readable text, bar codes and dot codes.
  • the integrated circuit chip has a read only memory area, a write only memory area, a read/write memory area or combinations thereof.
  • the integrated circuit chip has a one-time programmable memory area. More preferably, the one-time programmable memory area contains a unique serial number.
  • the integrated circuit chip has a preset memory area containing a factory preset, non-changeable, unique data item. The preset memory item is most preferably in encrypted form.
  • the integrated circuit chip has plural memory areas thereon.
  • any memory area is password protected.
  • any memory area contains data in encrypted form.
  • Electronic methods of checking identity, error detection and data transfer may also be employed.
  • the integrated circuit has plural memory areas thereon including a read only memory area containing a unique serial number, which may for example be embedded at the time of manufacture; a read/write memory area which can be made read only once information has been written thereto; and a password protected memory area containing data in encrypted form which data may be of anti- counterfeiting utility.
  • the tag is on a carrier and the carrier is mountable on the body or holder of the medicament dispenser or on the cassette.
  • the carrier is a flexible label. In another aspect, the carrier is a rigid disc. In a further aspect, the carrier is a rectangular block. In a further aspect, the carrier is a collar ring suitable for mounting to the neck of an aerosol container. Other shapes of carrier are also envisaged.
  • the carrier is mouldable or weldable to the cassette or housing.
  • the carrier encases the tag. More preferably, the carrier forms a hermetic seal for the tag.
  • the carrier comprises an insulating material such as a glass material or, a paper material or an organic polymeric material such as polypropylene.
  • the carrier comprises a ferrite material.
  • the energy may be in any suitable form including ultrasonic, infrared, radio frequency, magnetic, optical and laser form. Any suitable channels may be used to channel the energy including fibre optic channels.
  • the second transceiver comprises a radio frequency identifier comprising an antenna for transmitting or receiving radio frequency energy; and an integrated circuit chip connecting with said antenna
  • the first transceiver comprises a reader for said radio frequency identifier.
  • the radio frequency identifier is a passive transceiver and the reader is an active transceiver.
  • the radio frequency identifier can be any known radio frequency identifier. Such identifiers are sometimes known as radio frequency transponders or radio frequency identification (RFID) tags or labels. Suitable radio frequency identifiers include those sold by Phillips Semiconductors of the Netherlands under the trade marks Hitag and lcode, those sold by Amtech Systems Corporation of the United States of America under the trade mark Intellitag, and those sold by Texas Instruments of the United States of America under the trade mark Tagit.
  • the antenna of the RFID tag is capable of transmitting or receiving radio frequency energy having a frequency of from 100 kHz to 2.5 GHz.
  • Preferred operating frequencies are selected from 125 kHz, 13.56 MHz and 2.4 GHz.
  • the second transceiver comprises a magnetic label or tag comprising an antenna for transmitting or receiving magnetic field energy; and an integrated circuit chip connecting with said antenna, and the first transceiver comprises a reader for said magnetic label or tag.
  • the magnetic label or tag is a passive transceiver and the reader is an active transceiver.
  • a suitable magnetic label or tag comprises plural magnetic elements in mutual association whereby the magnetic elements move relative to each other in response to an interrogating magnetic field.
  • a magnetic label or tag of this type is described in U.S. Patent No. 4,940,966.
  • Another suitable magnetic label or tag comprises a magneto restrictive element which is readable by application of an interrogating alternating magnetic field in the presence of a magnetic bias field which results in resonance of the magneto restrictive elements at different predetermined frequencies.
  • a magnetic label of this type is described in PCT Patent Application No. WO92/12402.
  • Another suitable magnetic label or tag comprising plural discrete magnetically active regions in a linear array is described in PCT Patent Application No. WO96/31790.
  • Suitable magnetic labels and tags include those making use of Programmable Magnetic Resonance (PMR) (trade name) technology.
  • PMR Programmable Magnetic Resonance
  • the second transceiver comprises a microelectronic memory chip and the first transceiver comprises a reader for said microelectronic memory chip.
  • the microelectronic memory chip may comprise an Electrically Erasable Programmable Read Only Memory (EEPROM) chip or a SIM card-type memory chip.
  • EEPROM Electrically Erasable Programmable Read Only Memory
  • SIM card-type memory chip In this case the microelectronic memory chip is a passive transceiver and the reader is an active transceiver.
  • Any transceiver herein, particularly a passive transceiver may be mounted on or encased within any suitable inert carrier.
  • the carrier may comprise a flexible sheet, which may in embodiments be capable of receiving printed text thereon.
  • the first transceiver is integral with the body such that a single unit is comprised.
  • the first transceiver may for example be encased within or moulded to the body.
  • the first transceiver forms part of a base unit, which is reversibly associable with the body.
  • the base unit may for example, form a module receivable by the body such as a snap-in module.
  • the medicament dispenser additionally comprises a communicator for wireless communication with a network computer system to enable transfer of data between the network computer system and the electronic data management system.
  • the communicator enables two-way transfer of data between the network computer system and the electronic data management system.
  • the data is communicable between the network computer system and the electronic data management system in encrypted form. All suitable methods of encryption or partial encryption are envisaged. Password protection may also be employed.
  • the communicator employs radio frequency or optical signals.
  • the communicator communicates via a gateway to the network computer system.
  • the communicator includes a network server (e.g. a web server) such that it may directly communicate with the network.
  • the communicator communicates with the gateway via a second communications device.
  • the second communications device is a telecommunications device, more preferably a cellular phone or pager.
  • the communicator communicates with the second communications device using spread spectrum radio frequency signals.
  • a suitable spread spectrum protocol is the Bluetooth (trade mark) standard which employs rapid (e.g. 1600 times a second) hopping between plural frequencies (e.g. 79 different frequencies).
  • the protocol may further employ multiple sending of data bits (e.g. sending in triplicate) to reduce interference.
  • the network computer system comprises a public access network computer system.
  • the Internet is one suitable example of a public access network computer system, wherein the point of access thereto can be any suitable entry point including an entry point managed by an Internet service provider.
  • the public access network computer system may also form part of a telecommunications system, which may itself be either a traditional copper wire system, a cellular system or an optical network.
  • the network computer system comprises a private access network computer system.
  • the private access network system may for example, comprise an Intranet or Extranet that may for example, be maintained by a health service provider or medicament manufacturer.
  • the network may for example include password protection; a firewall; and suitable encryption means.
  • the communicator enables communication with a user-specific network address in the network computer system.
  • the user-specific network address may be selected from the group consisting of a web-site address, an e-mail address and a file transfer protocol address.
  • the user-specific network address is accessible to a remote information source such that information from said remote information source can be made available thereto. More preferably, information from the user-specific network address can be made available to the remote information source.
  • the remote information source is a medicament prescriber, for example a doctor's practice.
  • Information transferred from the medicament prescriber may thus, comprise changes to prescription details, automatic prescription updates or training information.
  • Information transferred to the medicament prescriber may comprise compliance information, that is to say information relating to the patient's compliance with a set prescribing programme.
  • Patient performance information relating for example, to patient-collected diagnostic data may also be transferred to the medicament prescriber.
  • the dispenser is an inhaler for dispensing medicament for the relief of respiratory disorders examples of such diagnostic data would include breath cycle data or peak flow data.
  • the remote information source is a pharmacy.
  • Information transferred from the pharmacy may thus, comprise information relating to the medicament product.
  • Information sent to the pharmacy may thus include prescription requests that have been remotely pre-authorised by the medicament prescriber.
  • the remote information source is an emergency assistance provider, for example a hospital accident and emergency service or an emergency helpline or switchboard.
  • the information may thus, comprise a distress or emergency assist signal which requests emergency assistance.
  • the remote information source is a manufacturer of medicament or medicament delivery systems.
  • Information transferred to the system may thus, comprise product update information.
  • the system may also be configured to feed information back to the manufacturer relating to system performance.
  • the remote information source is a research establishment.
  • information may thus be transferred relating to the trial protocol and information relating to patient compliance fed back to the research establishment.
  • the remote information source is an environmental monitoring station. Information relating to weather, pollen counts and pollution levels may thus be made accessible to the system.
  • the medicament dispenser additionally comprises a geographic positioning system such as a global positioning system or a system that relies on the use of multiple communications signals and a triangulation algorithm.
  • the medicament dispenser additionally comprises a medicament carrier that carries medicament.
  • the medicament may comprise a capsule, pellet or tablet.
  • the medicament may be in powdered form.
  • the medicament comprises a drug.
  • the drug is selected from the group consisting of albuterol, salmeterol, fluticasone propionate and beclomethasone dipropionate and salts or solvates thereof and any combination thereof.
  • said combination comprises salmeterol xinafoate and fluticasone propionate.
  • the powdered medicament additionally comprises an excipient.
  • said excipient is a sugar.
  • the invention provides a kit of parts comprising a cassette and base station as described supra.
  • the invention provides a cassette for use in the medicament dispenser described supra.
  • the invention provides the use of a medicament dispenser as described supra.
  • Figure 1 shows a perspective view of a medicament carrier for use in accordance with the present invention
  • Figure 2 shows a sectional view of refill cassette for containing a medicament carrier for use in accordance with the present invention
  • Figure 3 shows a base station for use in accordance with the refill cassette of Figure 2;
  • Figure 4a shows a sectional view of a second base station for use in accordance with the refill cassette of Figure 2 in a primed position
  • Figure 4b shows a sectional view of the second base station of Figure 4a in a released position.
  • FIG. 1 shows a medicament carrier 1 in accord with the present invention.
  • the medicament carrier comprises a flexible strip 2 defining a plurality of pockets 4, 6, 8 each of which contains a dose of medicament which can be inhaled, in the form of powder.
  • the strip comprises a base sheet 10 in which blisters are formed to define the pockets 4, 6, 8 and a lid sheet 12 which is hermetically sealed to the base sheet except in the region of the blisters in such a manner that the lid sheet 12 and the base sheet 10 can be peeled apart.
  • the sheets 10, 12 are sealed to one another over their whole width except for the leading end portions 14, 16 where they are preferably not sealed to one another at all.
  • the lid 12 and base 10 sheets are each preferably formed of a plastics/aluminium laminate and are preferably adhered to one another by heat sealing.
  • the strip 2 is shown as having elongate pockets 4, 6, 8 that run transversely with respect to the length of the strip 2. This is convenient in that it enables a large number of pockets 4, 6, 8 to be provided in a given strip length.
  • the strip may, for example, be provided with sixty or one hundred pockets but it will be understood that the strip may have any suitable number of pockets.
  • Figures 2 and 3 respectively show a refill cassette and base station, which when combined form a medicament dispenser herein.
  • FIG 2 shows a refill cassette, in which medicament carrier blister strip 102 (see also Figure 1 ) is coiled in a chamber 104 and fed about guide wall 106 to opening station 108 and beak 110.
  • the lid sheet 112 is fed to a lid spool 116 in the lid spool chamber 116a, and the base sheet 114 to a base spool 118 in the base spool chamber 118a.
  • An index ratchet 120 prevents non-driven movement of the blister strip 102.
  • a nose 122 on the index ratchet 120 rests adjacent a medicament pocket 124 on the strip 102 hence halting further progression of the strip 102 through the mechanism.
  • FIG. 3 shows the base station 130, which is shaped to receive the cassette of Figure 2.
  • the base station houses a primable drive mechanism, which is arranged for engagement with the mechanism of the refill cassette.
  • lid spool driver 132 which engages idle gear 134, which in turn engages the geared end 135 of drive arm 136.
  • the lollipop end 137 of the drive arm 136 is mounted to spring 138, which in turn is mounted to spring mounting 139.
  • the geared end 135 of the drive arm 136 engages coupling arm 140 whose nib end 142 latches onto pivot 145 mounted priming arm 144.
  • the apparatus is in the unprimed position with the spring 138 untensioned, and the nib end 142 of the coupling arm 140 in a latched relation with the priming arm 144.
  • the base station houses a primable drive mechanism, which is arranged for engagement with the mechanism of the refill cassette.
  • lid spool driver 132 which engages idle gear 134, which in turn engages the
  • Figures 4a and 4b shows a base station 230 similar to that of Figure 3, which is also suitable for receiving the cassette of Figure 2.
  • the base station 230 is shown in the 'cover open, primed' position and in Figure 4b the base station 230 is shown in the 'cover open, primer released' position.
  • Figures 4a and 4b show a drive/latching mechanism in which lid spool driver 232 engages idle gear 234, which in turn engages the geared end 235 of drive arm 236. It may also be seen that the lollipop end 237 of the drive arm 236 is mounted to long extension spring 238, which loops about roller 231 and then is mounted to spring mounting 239. The geared end 235 of the drive arm 236 engages coupling arm 240. In Figure 4a ('primed' position), the extension spring 238 is tensioned and the nib end 242 of the coupling arm 240 latches onto pivot 245 mounted priming arm 244.
  • lid spool driver 132, 232 In use (i.e. when the refill cassette of Figure 2 is received by the base station of Figure 3, 4a or 4b) anti-clockwise movement of the lid spool driver 132, 232 results in the opening of a pocket of the medicament carrier of the refill cassette.
  • rotation of the lid spool driver 132, 232 acts such as rotate the lid spool 116 (of Figure 2) to pull apart the lid sheet 112 and the base sheet 114.
  • Drive of the medicament carrier is not prevented by the index ratchet 120 because the coupling arm 140, 240 is also coupled to the index ratchet such that delatching of the coupling arm 140, 240 results in indexing (i.e. one ratchet release) of the index ratchet 120.
  • the roller 231 (of Figures 4a and 4b) may be configured to couple to the base spool 118 such that when the roller 231 is rotated in response to the release of the energy stored by the long extension spring 238, the base spool 118 is also rotated, thereby resulting in winding up of the base sheet 114.
  • each medicament carrier may be associated with a separate driver and/or indexer and/or primer or alternatively, each medicament carrier may be associated with a common driver and/or indexer and/or primer.
  • any of the parts of the dispenser or cassette, which contact the medicament suspension may be coated with materials such as fluoropolymer materials (e.g. PTFE or FEP) that reduce the tendency of medicament to adhere thereto.
  • fluoropolymer materials e.g. PTFE or FEP
  • Any movable parts may also have coatings applied thereto that enhance their desired movement characteristics. Frictional coatings may therefore be applied to enhance frictional contact and lubricants (e.g. silicone oil) used to reduce frictional contact as necessary.
  • the medicament dispenser of the invention is suitable for dispensing medicament, particularly for the treatment of respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD), bronchitis and chest infections.
  • Appropriate medicaments may thus be selected from, for example, analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, e.g., diltiazem; antiallergics, e.g., cromoglycate (e.g. as the sodium salt), ketotifen or nedocromil (e.g.
  • antiinfectives e.g., cephalosporins, penicillins, streptomycin, sulphonamides, tetracyclines and pentamidine
  • antihistamines e.g., methapyrilene
  • anti- inflammatories e.g., beclomethasone (e.g. as the dipropionate ester), fluticasone (e.g. as the propionate ester), flunisolide, budesonide, rofleponide, mometasone e.g. as the furoate ester), ciclesonide, triamcinolone (e.g.
  • antitussives e.g., noscapine
  • bronchodilators e.g., albuterol (e.g. as free base or sulphate), salmeterol (e.g. as xinafoate), ephedrine, adrenaline, fenoterol (e.g. as hydrobromide), formoterol (e.g.
  • bromide as bromide
  • tiotropium as bromide
  • atropine or oxitropium hormones, e.g., cortisone, hydrocortisone or prednisolone
  • xanthines e.g., aminophylline, choline theophyllinate, lysine theophyllinate or theophylline
  • therapeutic proteins and peptides e.g., insulin or glucagon
  • vaccines, diagnostics, and gene therapies as bromide
  • hormones e.g., cortisone, hydrocortisone or prednisolone
  • xanthines e.g., aminophylline, choline theophyllinate, lysine theophyllinate or theophylline
  • therapeutic proteins and peptides e.g., insulin or glucagon
  • vaccines diagnostics, and gene therapies.
  • the medicaments may be used in the form of salts, (e.g., as alkali metal or amine salts or as acid addition salts) or as esters (e.g., lower alkyl esters) or as solvates (e.g., hydrates) to optimise the activity and/or stability of the medicament.
  • salts e.g., as alkali metal or amine salts or as acid addition salts
  • esters e.g., lower alkyl esters
  • solvates e.g., hydrates
  • Preferred medicaments are selected from albuterol, salmeterol, fluticasone propionate and beclomethasone dipropionate and salts or solvates thereof, e.g., the sulphate of albuterol and the xinafoate of salmeterol.
  • Medicaments can also be delivered in combinations.
  • Preferred formulations containing combinations of active ingredients contain salbutamol (e.g., as the free base or the sulphate salt) or salmeterol (e.g., as the xinafoate salt) or formoterol (eg as the fumarate salt) in combination with an anti-inflammatory steroid such as a beclomethasone ester (e.g., the dipropionate) or a fluticasone ester (e.g., the propionate) or budesonide.
  • a particularly preferred combination is a combination of fluticasone propionate and salmeterol, or a salt thereof (particularly the xinafoate salt).
  • a further combination of particular interest is budesonide and formoterol (e.g. as the fumarate salt).
  • powdered medicament particles suitable for delivery to the bronchial or alveolar region of the lung have an aerodynamic diameter of less than 10 micrometers, preferably less than 6 micrometers. Other sized particles may be used if delivery to other portions of the respiratory tract is desired, such as the nasal cavity, mouth or throat.
  • the medicament may be delivered as pure drug, but more appropriately, it is preferred that medicaments are delivered together with excipients (carriers) which are suitable for inhalation.
  • excipients include organic excipients such as polysaccharides (i.e.
  • lactose is a preferred excipient.
  • Particles of the powdered medicament and/or excipient may be produced by conventional techniques, for example by micronisation, milling or sieving. Additionally, medicament and/or excipient powders may be engineered with particular densities, size ranges, or characteristics. Particles may comprise active agents, surfactants, wall forming materials, or other components considered desirable by those of ordinary skill.
  • the excipient may be included with the medicament via well known methods, such as by admixing, co-precipitating and the like.
  • Blends of excipients and drugs are typically formulated to allow the precise metering and dispersion of the blend into doses.
  • a standard blend for example, contains 13000 micrograms lactose mixed with 50 micrograms drug, yielding an excipient to drug ratio of 260:1.
  • Dosage blends with excipient to drug ratios of from 100:1 to 1 :1 may be used. At very low ratios of excipient to drug, however, the drug dose reproducibility may become more variable.

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Abstract

L'invention concerne un distributeur de médicaments associé à un support de médicaments présentant plusieurs logements destinés à recevoir des médicaments. Ces logements sont délimités par et disposés de manière espacée le long de deux feuilles pelables fixées l'une à l'autre. Le distributeur comprend un mécanisme d'ouverture qui ouvre les logements reçus du support de médicaments; une peleuse équipée d'un dispositif d'entraînement d'opercule, qui ouvre un logement en détachant par entraînement un film d'operculage d'une feuille de support du logement. Le mécanisme comprend également un diviseur qui, pendant l'utilisation, divise les logements d'un support de médicaments associé au distributeur de médicaments. Le mécanisme comprend en outre un amorceur qui se déplace entre une position amorcée dans laquelle il stocke de l'énergie mécanique et une position de libération dans laquelle il libère cette énergie mécanique pour ledit dispositif d'entraînement d'opercule et/ou ledit diviseur.
PCT/EP2003/004404 2002-04-26 2003-04-24 Distributeur de medicaments WO2003090811A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2003587436A JP2005523748A (ja) 2002-04-26 2003-04-24 薬物分配器
AU2003233083A AU2003233083A1 (en) 2002-04-26 2003-04-24 Medicament dispenser
EP03727384A EP1499375A2 (fr) 2002-04-26 2003-04-24 Distributeur de medicaments

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0209528.9A GB0209528D0 (en) 2002-04-26 2002-04-26 Medicament dispenser
GB0209528.9 2002-04-26

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WO2003090811A2 true WO2003090811A2 (fr) 2003-11-06
WO2003090811A3 WO2003090811A3 (fr) 2004-07-29

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JP (1) JP2005523748A (fr)
AU (1) AU2003233083A1 (fr)
GB (1) GB0209528D0 (fr)
WO (1) WO2003090811A2 (fr)

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EP1890753A2 (fr) * 2005-01-25 2008-02-27 Valois SAS Dispositif de distribution de produit fluide
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WO2010042035A1 (fr) 2008-10-08 2010-04-15 Astrazeneca Ab Inhalateur doté d'un avancement pas-à-pas lié au déplacement d'un couvercle
US8201556B2 (en) 2004-08-16 2012-06-19 Glaxo Group Limited Medicament dispenser
JP2014513608A (ja) * 2011-03-21 2014-06-05 シムプリフィード ソリューションズ スウェーデン エービー 粉末形態の物質用の吸入器
US8776788B2 (en) 2006-11-15 2014-07-15 Glaxo Group Limited Sheet driver for use in a drug dispenser
WO2017139259A1 (fr) * 2016-02-08 2017-08-17 Becton, Dickinson And Company Produit préparé pour milieux, sous forme de plaques
US10188810B2 (en) 2010-11-26 2019-01-29 Vectura Delivery Devices Limited Inhaler
US10258752B2 (en) 2013-10-01 2019-04-16 Novartis Ag Blister track inhaler device having a separate end path and methods of use thereof
CN114728137A (zh) * 2019-11-18 2022-07-08 维克多瑞传送设备有限公司 具有依从性监视器的干粉吸入器

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AU2003233083A1 (en) 2003-11-10
JP2005523748A (ja) 2005-08-11
WO2003090811A3 (fr) 2004-07-29
GB0209528D0 (en) 2002-06-05
AU2003233083A8 (en) 2003-11-10

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