Delivery devices for oral dosage forms

Abstract

The present application provides a device for expelling oral dosage forms. The device comprises a cartridge having one or more chambers for containing oral dosage forms, each of the one or more chambers having at least one outlet for expelling the oral dosage form from the chamber. The device further comprises a member movable between first and second positions, wherein in the first position, the member is configured to receive and retain a specific volume of the oral dosage form from one of the cartridge chambers via one of the outlets, the member is movable to one or more intermediate positions where the specific volume of the oral dosage form is retained and maintained within the movable member such that the oral dosage form cannot be expelled from the movable member, and the member is movable from the intermediate position to a second position from which the oral dosage form retained within the movable member can be expelled.

Description

[Technical Field]

[0001] The present disclosure (invention) generally relates to exemplary pellet and / or powder and / or liquid (e.g., drug or pharmaceutical products in pellet / powder / liquid form) delivery devices, and various aspects of such devices, e.g., relating to the ejection of pellets / powder / liquids from the device, as well as the operation and mechanics of such devices. The present invention is directed to devices capable of reliable volume-based dose ejection, e.g., ejection of different volume-based doses and / or different pharmaceutical products. [Background technology]

[0002] Solid oral dosage form ("ODF") drugs can be manufactured, for example, in tablet or pellet form, or even as a powder. The tablets or pellets can contain various substances, the main component of which is the active pharmaceutical ingredient ("API"). Drug pellets can be administered to patients as pre-filled capsules or compressed into tablets to aid in filling materials. Discharge mechanisms for various forms of ODF drugs are known and can range from transparent packaging-type devices in which individual tablets are held in pockets and can be retained therein by the use of foil to discharge bottles. More complex mechanisms are also known, particularly for other types of drug formulations, such as those in pellet form, which can usually be less than 10% of the specified dosage per unit. An advantage of discharging drugs in pellet form can be the ability to vary the dosage using the same discharge device. Another advantage can be that pellets can be easily swallowed by patients with swallowing difficulties who currently crush tablets to swallow them. Although crushing or splitting tablets is still used by patients today, for example, to obtain half the prescribed dose of a drug, this is a discouraged process that can be avoided if the device is capable of discharging different amounts of flexible pellets. The adjustable pellet dose allows for more precise dosage adjustment than can be achieved using larger dosage forms such as tablets or capsules. Furthermore, in the case of modified-release formulations, pellets are often more robust to food interactions than larger dosage forms such as tablets.

[0003] Liquid dosage forms are also known and typically correspond to liquid forms of doses of drugs or chemical compounds used as drugs intended for administration or consumption. Liquid dosage forms can be prepared, for example, by dissolving the active drug in an aqueous or non-aqueous solvent, for example, by suspending the drug in a suitable medium, or by incorporating the drug into an oily or aqueous phase.

[0004] Although various methods have been used to accurately expel pellet-type medications, expelling a specific dose of pellets has proven difficult. U.S. Patent Publication No. 2003 / 116157 discloses an inhaler, U.S. Patent Publication No. 2001 / 020147 discloses a device for delivering oral medication, WO 00 / 64520 discloses a powder inhaler for combined medication, and U.S. Patent Publication No. 2013 / 047986 discloses a storage system for powdered medication. . Summary of the Invention [Means for solving the problem]

[0005] There will now be described various aspects and embodiments of evacuation devices that may be used in the present invention and that relate to any of the aspects and embodiments of the invention described herein, insofar as they are suitable.

[0006] In an aspect of the present invention, a device for delivering at least one oral dosage form (eg, a drug or pharmaceutical agent in solid, semi-solid, or liquid form) is provided.

[0007] The oral dosage form may be solid and may include one or more of a tablet, pellet, and powder.

[0008] For example, the oral dosage form may be provided as a solid unit (e.g., a pellet), and the largest dimension (e.g., width or diameter) of the unit (e.g., pellet) may be as small as about 100 μm. The unit may be about 150 μm to about 1200 μm (or even about 1500 μm), optionally about 200 μm to about 300 μm. Other size ranges are possible, such as about 300 μm to about 500 μm, about 500 μm to about 700 μm, about 700 μm to about 900 μm, or about 800 μm to about 1100 μm.

[0009] A particularly preferred size range suitable for the present invention has been found to be building blocks (e.g., pellets) having a maximum dimension (e.g., width or diameter) of about 100 μm to about 300 μm. While larger sizes can still be used, using these smaller sizes can avoid clogging and other undesirable effects. This size range (about 100 μm to about 300 μm, e.g., about 100 μm to about 250 μm, and about 100 μm to about 200 μm) has been found to perform well for solid building blocks of various materials.

[0010] The building blocks (e.g., pellets) may be made of compressible and / or porous materials, which have been found to further avoid clogging / blockage, especially at the smaller sizes described above. In a further refinement, the building blocks (e.g., pellets) may have a compressibility index (Carr index) of greater than 11% (e.g., 11-15%), or the building blocks may have a compressibility index (Carr index) of greater than 16% (e.g., 16-20%). As known in the art, the Carr index is equal to 100 x (1 - (bulk density of material / tapped bulk density of material)).

[0011] In general, the building blocks (e.g., pellets) may have inconsistent or aspherical shapes and / or irregular sizes. The pellets may have a mixture of sizes within any of the specified ranges.

[0012] The oral dosage form may be provided in powder form. References to "powder" herein should be construed as the conventional definition in the art, e.g., fine dry particles that can be produced by some degree of disintegration of a solid substance. Thus, in various embodiments, the solid oral dosage form may be in the form of a powder having a maximum dimension (e.g., width or diameter) as small as about 40 μm, and optionally up to about 250 μm or 300 μm. The powder may have a compressibility index (Carr index) similar to that described above, i.e., greater than 11% (e.g., 11-15%) or greater than 16% (e.g., 16-20%).

[0013] Oral dosage forms can be liquid or semisolid, such that a volume of drug in liquid or semisolid (eg, gel) form can be delivered.

[0014] Moving now to the device, it may comprise at least one cartridge, each cartridge comprising one or more chambers configured to store a plurality of units and / or a volume of an oral dosage form, such as a solid, semi-solid, or liquid oral dosage form, each of the one or more chambers comprising at least one outlet for expelling the oral dosage form from the chamber.

[0015] The device further comprises a member movable between first and second positions, wherein in the first position the member is configured to receive and hold a specific volume of oral dosage forms from one of the chambers of the cartridge via one of the outlets, and the member is movable to one or more intermediate positions where the specific volume of oral dosage forms is held and maintained within the movable member such that the oral dosage forms cannot be expelled from the movable member (e.g., in the intermediate position the specific volume of oral dosage forms held within the movable member is substantially fixed, i.e., the volume remains substantially the same), and the member is movable from the intermediate position to a second position from which the oral dosage forms held within the movable member can be expelled.

[0016] This provides a device that can repeatedly dispense a specific volume of oral dosage forms due to the use of an intermediate position where the oral dosage forms (as a specific volume) held within the movable member are substantially fixed, i.e., in this intermediate position oral dosage forms cannot be added or lost / discharged, e.g., oral dosage forms cannot be dispensed into, through or from the movable member.

[0017] The device is an improvement over conventional dispensing, which involves expelling single units of medication (i.e., pill by pill). The device is configured and optimized for volume-based administration, rather than unit-based administration. For example, the size of the oral dosage form is generally much smaller than a single pill and may be provided in pellet or powder form, and the device is configured to hold multiple solid particles (e.g., 10s, 100s, or 1000s) within each chamber of the movable member (described below). Alternatively, as discussed above, the oral dosage form may be semi-solid or liquid. In addition to these general considerations, as discussed above, it has been found that solid pellets of certain sizes and certain types of materials provide optimized dispensing not contemplated by conventional single-unit mechanisms.

[0018] The member may be slidable or rotatable between its first and second positions, which may, for example, slide or rotate a chamber within the movable member configured to hold an oral dosage form, as needed to move the chamber within the movable member into and out of alignment and / or communication with the cartridge chamber and / or its outlet. This provides a simple and efficient mechanism for moving the member between its first, intermediate, and second positions.

[0019] The movable member may include at least one chamber, and each chamber of the member may be configured to receive and retain a distinct (specific) volume of the oral dosage form from the cartridge. This means that different types of medication can be dispensed by the device using the same movable member. If the oral dosage form is a solid, the chamber may be configured to accommodate multiple units thereof (e.g., 10s, 100s, or even 10,000s) to provide a reliable volume-based dose of the smaller unit type of medication. If the oral dosage form is a semi-solid (e.g., a gel) or liquid, the chamber is configured to retain and maintain the oral dosage form within the chamber in an intermediate position such that the oral dosage form cannot be dispensed therefrom.

[0020] Generally, in the intermediate position, the movable member chambers can be completely isolated (e.g., sealed) from any chambers of the cartridge such that no portion of any chamber is aligned with or overlaps with the chambers of the cartridge. This differs from conventional arrangements that transfer single units (e.g., individual pills) but use only slight misalignment and do not ensure that the movable member chambers are completely isolated from the cartridge chambers when transferring the oral dosage form from the cartridge being ejected. This is particularly important when the units are smaller in size (e.g., in pellet or powder form), semi-solid, or liquid, as conventional arrangements that are not isolated in this manner are completely unsuitable.

[0021] At least one chamber of the movable member may comprise a first chamber configured to receive and hold a first volume of oral dosage forms from the cartridge and a second separate chamber configured to receive and hold a second volume of oral dosage forms from the cartridge, providing the movable member with the ability to hold a variety of different volumes of oral dosage forms contained within the cartridge.

[0022] The first and second chambers of the member are capable of receiving and retaining respective first and second volumes throughout movement of the member from the first position to the intermediate position.

[0023] The first volume oral dosage form can be different from the second volume oral dosage form, e.g., a different type (e.g., size) of oral dosage form and / or a different type of drug. The first volume oral dosage form can (alternatively) be the same as the second volume oral dosage form, e.g., to provide greater flexibility in delivering the same oral dosage form at different volumes.

[0024] The cartridge may include multiple chambers, such as a first chamber and a second separate chamber. Each of the first and second chambers of the cartridge may be configured to prevent the oral dosage forms in one chamber from mixing with the oral dosage forms in the other chamber. Each chamber of the cartridge may include a separate outlet for discharging the oral dosage forms from the respective chamber. This may keep the oral dosage forms in the chambers separated from each other during use.

[0025] The first chamber of the movable member may be configured to receive and hold a first volume of oral dosage forms from one of the first and second chambers of the cartridge via its respective outlet, and the second chamber of the movable member may be configured, at its first position, to receive and hold a second volume of oral dosage forms from the other of the first and second chambers of the cartridge via its respective outlet.

[0026] In a first position of the member, its first and second chambers may both be configured to simultaneously receive and hold separate volumes of oral dosage forms from the cartridge, and in a second position of the member, its first and second chambers may both be configured to expel their respective volumes of oral dosage forms therefrom.

[0027] In a first position of the member, the first chamber may be configured to receive and hold a volume of oral dosage form from the cartridge while the second chamber of the member is prevented from receiving oral dosage form from the cartridge, and in a second position of the member, the first chamber may be configured to expel the volume of oral dosage form and the second chamber of the member may be configured to receive and hold a volume of oral dosage form from the cartridge.

[0028] In the first position, the second chamber can be configured to expel the volume of the oral dosage form.

[0029] The movable member may comprise a first portion having the first chamber and a second separate portion having the second chamber, the first and second portions being movable relative to one another. The first and second portions may be separate pieces connected together in a manner that allows one to move relative to the other.

[0030] The first and second portions may be movable relative to one another such that in a first relative position of the first and second portions, the first and second chambers of the member are aligned such that an oral dosage form can pass therebetween, and in a second relative position of the first and second portions, the first and second chambers of the member are moved out of alignment such that an oral dosage form cannot pass therebetween.

[0031] In a first position of the movable member, its first and second portions may be movable to align in their first relative positions so that they are both configured to simultaneously receive and hold a volume of oral dosage forms from the cartridge, and the first and second portions of the member may be configured to remain aligned in their first relative positions throughout movement of the member to its second position so that a volume of oral dosage forms corresponding to the combined volumes of the first and second chambers of the member can be expelled therefrom.

[0032] In a first position of the movable member, its first and second portions may be movable out of alignment to their second relative positions, whereby only one of the first and second chambers is configured to receive and hold a volume of oral dosage form from the cartridge, and the first and second portions of the member may be configured to move from their second relative positions to their first relative positions through movement of the member to its second position such that a volume of oral dosage form corresponding to one of the first and second chambers of the member can be expelled therefrom.

[0033] The first portion may include a first disk having a first chamber of the member, and the second portion may include a second disk having a second chamber of the member, the first and second disks being rotatable relative to each other and the cartridge.

[0034] The first disc may be rotatable between a first position in which the first chamber is configured to receive and retain a specific volume of oral dosage forms from the cartridge, one or more intermediate positions in which the specific volume of oral dosage forms retained in the first chamber is substantially fixed, and a second position from which the first disc may be rotatable to eject the oral dosage forms retained in the first chamber.

[0035] The second disc may be rotatable between a first position in which the second chamber is configured to receive and retain a specific volume of oral dosage forms from the cartridge, one or more intermediate positions in which the specific volume of oral dosage forms retained in the second chamber is substantially fixed, and a second position from which the oral dosage forms retained in the second chamber may be expelled.

[0036] The member may be configured such that upon rotation of the first disk in a first direction, the second disk also rotates, while upon rotation of the first disk in a second, opposite direction, the second disk remains stationary, such that rotating the first disk in the first direction allows only oral dosage forms held in its first chamber to be expelled therefrom, and rotating the first disk in the second direction allows oral dosage forms held in both the first and second chambers to be expelled therefrom.

[0037] The one-way bearing may be located between the first and second discs. Alternatively, the ratchet mechanism may be located between the first and second discs.

[0038] The device may include one or more exit passageways configured to receive oral dosage forms expelled from the movable member at its second position.

[0039] The device may include one or more rotating members extending through the cartridge. The rotating members may be configured to operate a plunger and / or actuate a respective screw pump, as described below, to assist in expelling the oral dosage form from each of the one or more chambers of the cartridge into the movable member. The device may include an actuator configured to rotate the rotating members, as described below.

[0040] The use of a screw pump is an optional feature and is not essential to the present invention. While it may have particular utility for the techniques described herein, any suitable method of expelling oral dosage forms may be used, and the present invention should not be considered limited to embodiments involving the use of a screw pump.

[0041] The cartridge may extend from a first end to a second discharge end, and each screw pump may be located at the second discharge end of the cartridge.

[0042] The device may be a handheld device.

[0043] The device may further comprise a plurality of pellets providing the oral dosage form contained within each of the one or more chambers.

[0044] Each chamber may include an ejection mechanism, e.g., a screw pump, e.g., an Archimedes screw, configured to receive multiple components of the oral dosage form from the respective chamber and transport the components of the oral dosage form from the respective chamber (e.g., upon rotation of the screw pump) and eject them from the device (and, e.g., cartridge and / or chamber) as described herein.

[0045] The rotating member described above may extend through each chamber and may be configured to actuate an ejection mechanism (e.g., rotate a screw pump) to eject multiple units of the oral dosage form therefrom.

[0046] The cartridge may include one or more outlet tubes extending from each chamber, each of which may contain a respective evacuation mechanism (e.g., a screw pump).

[0047] In aspects of the invention, methods are provided for using devices having ejection mechanisms (e.g., a screw pump as described above, or a plunger as described below), the methods comprising actuating one or more of the ejection mechanisms (e.g., rotating a rotating member) to eject dosage forms from their respective chambers.

[0048] This method is filling the chamber with an oral dosage form; determining an amount of actuation (rotation of the rotatable member) that will cause a predetermined amount of the oral dosage form to be expelled from the device; The method may further include actuating the ejection mechanism (e.g., rotating the rotating member) a predetermined amount to eject a predetermined amount of the oral dosage form from the device.

[0049] The chamber may extend from a first end of the device to a second discharge end of the device. The cartridge may extend from the first end to the second discharge end, and the actuation mechanism (e.g., a screw pump) may be at least partially located in the second discharge end of the cartridge.

[0050] The actuation mechanism can be gravity fed. In other words, the oral dosage form held in the chamber can be moved toward the second discharge end at least in part by gravity when the device is in a discharge orientation (e.g., with the discharge end pointing downward).

[0051] The device may be a handheld and / or portable device, in other words, the device may be capable of being held and transported with one hand and / or operable using one hand.

[0052] For example, the device may have a length (corresponding to its largest dimension) of about 250 mm or less (such as less than about 200 mm, about 150 mm, or about 100 mm), and a width or height (i.e., transverse to its length) of about 50 mm or less, optionally about 40 mm or less (and in some embodiments, less than 30 mm, or even less than 20 mm).

[0053] To optimize the handheld nature of the device, the length of the device can be about 150 mm to about 220 mm (e.g., about 160 mm to about 180 mm, optionally about 165 mm), the width (transverse to the length of the device) can be about 35 mm to about 45 mm (optionally about 40 mm), and the height (transverse to the width of the device) can be about 22 mm to about 32 mm (optionally about 28 mm).

[0054] The device may have a weight of about 500 g, about 400 g, about 300 g, about 200 g, or even about 100 g or less, which may ensure that the device is light enough to be carried in one hand.

[0055] In embodiments involving a screw pump and a rotating member as part of the actuation mechanism, each screw pump may be part of or include the respective rotating member. For example, a screw pump may include one or more threads formed around the rotating member. The term "one or more" is used herein due to the possibility that a screw pump may include one or more thread starts, each forming a separate thread. Hereinafter, for brevity, the term plural will be used, but it should be understood that a reference to multiple threads encompasses a singular thread.

[0056] The device may be configured such that when the rotating member and screw pump rotate during use, the oral dosage forms move along the threads of the screw pump from a portion of the thread extending into each respective chamber to the opposite end of the thread for ejection from the screw pump.

[0057] The screw threads may cooperate with the inner cylindrical surface of each respective cartridge to form a screw pump, such that when the rotating member rotates in use, the screw threads rotate within the inner cylindrical surface, forcing the oral dosage form contained in the chamber to enter the screw threads and move downwardly for ejection from the screw pump. Note that the cartridges themselves do not have to be generally cylindrical. Rather, to form a screw pump, the cartridges may have an inner cylindrical surface, although this should not be construed to necessarily mean that the cartridges themselves are wholly or partially cylindrical.

[0058] In any of the aspects and embodiments described herein, gravity (and / or a plunger device described below) may be used to move the oral dosage form to the discharge end of the chamber, at which point it may be output therefrom (e.g., via an outlet) and / or collected by a respective discharge mechanism (e.g., a screw pump).

[0059] The device may further comprise one or more devices (e.g., plungers) configured to urge the oral dosage forms contained in each chamber toward the respective outlets and / or ejection mechanisms (e.g., screw pumps). The devices may act in addition to gravity, such that a combination of gravity and the force provided by the device moves the oral dosage forms contained in the chambers toward the outlets. For example, the device may be or comprise a plunger (e.g., in the form of a weight) configured to rest on the oral dosage forms contained in the chambers when the device is in an orientation that allows ejection of the oral dosage forms.

[0060] The ejection mechanism may be provided by a combination of the plunger and rotating member described above, comprising a plunger configured to move along the or each rotating member automatically and / or as a result of rotation of the rotating member. For example, a portion of the rotating member in each respective chamber may be provided with a thread (e.g., plunger thread), and the plunger may form a nut around the rotating member that is configured to move along the thread of the rotating member in use, such that when the rotating member rotates, the plunger moves towards the outlet and / or ejection mechanism (e.g., a screw pump) to urge (press) the oral dosage form contained in the chamber towards its outlet / ejection end.

[0061] Particularly (though not exclusively) in the case of semi-solid or liquid dosage forms, the plunger may be sealed (e.g., fluidically) against the walls of the chamber and / or threads along which the plunger moves to help prevent undesired leakage from the various chambers and passageways of the device. Suitable fluid seals may be used between the various components of the device, particularly any components that move relative to one another, to help prevent undesired leakage.

[0062] The device may further comprise a valve configured to prevent the oral dosage form from being unintentionally expelled from the outlet of the chamber, for example, other than during an expelling operation (e.g., when the screw pump is not rotated) or before use. The valve may be configured to allow the oral dosage form to be expelled only during an expelling operation, for example, when the rotating member is rotated.

[0063] The valve may comprise an elastic portion, e.g., a rubber membrane, that is configured to flex open (when the rotating member is rotated during use) to allow the oral dosage form to be expelled, and then flex back (e.g., when the rotating member is not rotating) to stop or prevent the oral dosage form from falling out of the chamber and help seal the chamber and / or cartridge.

[0064] The device may include one or more actuators configured to operate each ejection mechanism (e.g., rotate each rotatable member). The actuators may be mechanical or electromechanical actuators. The actuators may be located at a first end of the device.

[0065] The actuator may be configured (in related embodiments) to rotate each rotating member, which may (in related embodiments) cause the plunger to move down the threaded portion of the rotating member and / or rotate the threaded portion, expelling the oral dosage form.

[0066] The actuator may be an electromechanical actuator (e.g., comprising one or more motors) or may comprise an electromechanical actuation mechanism such that the device can repeatedly expel precise doses or amounts (e.g., precise volumes) of oral dosage forms. The motor and control system may be powered by an integral battery (which may be user-replaceable), which may be held within the housing of the actuator.

[0067] The device may include a control system (e.g., as part of the actuator) that may be configured to expel a dose or amount (e.g., a precise volume) within a predetermined time (e.g., less than 2, 3, or 5 seconds) after receiving an actuation signal from an input device or mechanism. The actuation signal may be initiated, for example, by a user pressing a suitable button or other input mechanism located on the device, or optionally via a different controller, such as a wireless or wired external controller.

[0068] The actuator may include one or more electric (e.g., stepper) motors that may be configured to operate the ejection mechanism any suitable number of rotations (e.g., number of steps) based on the situation at hand, e.g., the type of oral dosage form / medication in the chamber, or the user. The control system may be provided, for example, in the form of a microcontroller on a printed circuit board ("PCB"), which may be located within the device housing within the actuator.

[0069] In an aspect of the present invention, there is provided a method of using the device in any of the aspects and embodiments described above. The method may include operating at least one of the ejection mechanisms to eject a predetermined amount of the oral dosage form from the device, for example, by rotating the rotatable member a predetermined amount of rotations.

[0070] The method may further include filling each chamber with an oral dosage form, determining an amount of rotation of the screw pump that will cause a predetermined amount of the oral dosage form to be expelled from the device, and operating at least one of the ejection mechanisms, for example, by rotating a rotating member a predetermined amount of rotation, to expel the predetermined amount of the oral dosage form from the device. As noted above, the oral dosage form may be solid, semi-solid, or liquid.

[0071] The method can include storing an oral dosage form in a cartridge (e.g., a chamber thereof). The oral dosage form can include storing pellets providing the oral dosage form in a cartridge (e.g., a chamber of the cartridge), which pellets can include drugs or compounds for the treatment of one or more of the following: attention deficit hyperactivity disorder ("ADHD" - drugs or compounds can include amphetamine and / or methylphenidate), general pain (drugs or compounds can include fentanyl, methadone, meperidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrochloride, hydroxybenzoates ... steroids, steroids, steroid drugs, steroid agonists ... and semaglutide), heart failure (drugs or compounds may include one or more of carvedilol, metoprolol, bisoprolol, and diuretics), Parkinson's disease ("PD" - drugs or compounds may include levodopa and / or carbidopa), epilepsy (drugs or compounds may include sodium valproate, carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, ethosuximide, and thrombus). therapies for the treatment of mental illness include: depression (drugs or compounds may include one or more of citalopram, amfebutamone, paroxetine, milnacipran, fluoxetine, duloxetine, fluvoxamine, and reboxetine); schizophrenia (drugs or compounds may include one or more of aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, and olanzapine); cancer; and animal health.

[0072] The oral dosage form may include a drug or compound for treating one or more of the following: riociguat or selexipag for pulmonary arterial hypertension, perampanel or cenobamate for epilepsy, siponimod for multiple sclerosis, vortioxetine, aripiprazole, brexpiprazole or cariprazine for depression / schizophrenia, lenalidomide for myeloma, memantine for Alzheimer's, deflazacort or ataluren for Duchenne muscular dystrophy, deutetrabenazine for tardive dyskinesia, osilodrostat for Cushing's disease, cisnatovir for respiratory syncytial virus, peanut allergy medication for peanut allergy, fenfluramine for Dravet's syndrome.

[0073] The method may include using the device in the treatment of one or more of attention deficit hyperactivity disorder ("ADHD"), general pain, immunosuppression after organ transplantation, diabetes, heart failure, Parkinson's disease ("PD"), epilepsy, depression, schizophrenia, cancer, and animal health. The oral dosage form in the cartridge (e.g., the chamber of the cartridge), when used in a particular treatment, may include one or more of the drugs or compounds mentioned above with respect to that particular treatment.

[0074] definition Pellet—A single granule / unit of a solid oral dosage form (e.g., a pharmaceutical product, drug, or medication) having a largest dimension (e.g., width or diameter) as small as about 100 μm. The unit can be about 150 μm to about 1200 μm (or even about 1500 μm), optionally about 200 μm to about 300 μm. Other size ranges are possible, such as about 300 μm to about 500 μm, about 500 μm to about 700 μm, about 700 μm to about 900 μm, or about 800 μm to about 1100 μm.

[0075] A particularly preferred size range suitable for the present invention has been found to be building blocks (e.g., pellets) having a maximum dimension (e.g., width or diameter) of about 100 μm to about 300 μm. While larger sizes can still be used, using these smaller sizes can avoid clogging and other undesirable effects. This size range (about 100 μm to about 300 μm, e.g., about 100 μm to about 250 μm, and about 100 μm to about 200 μm) has been found to perform well for solid building blocks of various materials.

[0076] Powder - fine dry particles produced by breaking down (e.g., crushing, grinding) a solid substance, each particle having a maximum dimension (e.g., width / diameter) as low as about 40 μm, and optionally up to about 250 μm or 300 μm.

[0077] Dose - a single measurement (e.g., volume or weight) of an oral dosage form, for example, a total volume of about 0.05 mL to about 0.8 mL (such as about 0.1 mL to about 0.6 mL), e.g., a volume of about 0.3 mL (note, however, that in some cases oral dosage forms are measured by weight).

[0078] Ejection mechanism - a system, for example an electromechanical system that converts user action into dose ejection.

[0079] Cartridge - a component, e.g., a replaceable component used to store and expel oral dosage forms, optionally containing device features such as a rotating member in the form of a central threaded bar, a moving plunger, and the oral dosage forms.

[0080] Plunger - a plate (although other types of plungers are envisioned) that may ensure that the oral dosage form moves toward the discharge end of the cartridge (and where the solid oral dosage form stays packaged together). The plate may be substantially rigid, although portions of the plate, for example, those portions that interact with other parts of the cartridge, may be flexible.

[0081] Discharge opening - the open end of a cartridge or chamber that allows the oral dosage form to be discharged for consumption.

[0082] Cap - a container or tray that covers a delivery opening to collect doses and protect the stored oral dosage form from moisture.

[0083] Press - the action that the user performs on the device when they want to expel a specified dosage, which can be a rotary or linear movement.

[0084] It should be understood that, as referred to herein, reference to "one" drug or pharmaceutical may be considered "one or more" drugs or pharmaceuticals. For example, an oral dosage form may contain several drugs or pharmaceuticals. This may be achieved by blending solid oral dosage forms, each containing a different drug or pharmaceutical (e.g., each unit oral dosage form may contain a different drug or pharmaceutical from the other units), and / or by blending drugs or pharmaceuticals within each solid oral dosage form (e.g., each unit may itself contain a different type of drug or pharmaceutical). [Brief explanation of the drawings]

[0085] Various embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1] 1 shows a cross-sectional view of a portion of device 100, which is a delivery device capable of ejecting a drug or pharmaceutical agent. [Figure 2] 2 illustrates an embodiment of a device that may incorporate features of the device illustrated with respect to FIG. [Figure 3A] 1 illustrates an embodiment of a device comprising a cartridge having a single chamber configured to store an oral dosage form. [Figure 3B] 1 illustrates an embodiment of a device comprising a cartridge having a single chamber configured to store an oral dosage form. [Figure 3C]1 illustrates an embodiment of a device comprising a cartridge having a single chamber configured to store an oral dosage form. [Figure 4A] 3A-3C, but in which the movable member slides between its first and second positions in a manner similar to that described with respect to FIG. [Figure 4B] 3A-3C, but in which the movable member slides between its first and second positions in a manner similar to that described with respect to FIG. [Figure 4C] 3A-3C, but in which the movable member slides between its first and second positions in a manner similar to that described with respect to FIG. [Figure 5A] 1 illustrates an embodiment with a movable member that is divided into separate parts that are movable relative to each other. [Figure 5B] 1 illustrates an embodiment with a movable member that is divided into separate parts that are movable relative to each other. [Figure 5C] 1 illustrates an embodiment with a movable member that is divided into separate parts that are movable relative to each other. [Figure 5D] 1 illustrates an embodiment with a movable member that is divided into separate parts that are movable relative to each other. [Figure 5E] 1 illustrates an embodiment with a movable member that is divided into separate parts that are movable relative to each other. [Figure 5F] 1 illustrates an embodiment with a movable member that is divided into separate parts that are movable relative to each other. [Figure 5G] 1 illustrates an embodiment with a movable member that is divided into separate parts that are movable relative to each other. [Figure 5H] 1 illustrates an embodiment with a movable member that is divided into separate parts that are movable relative to each other. [Figure 5I] 1 illustrates an embodiment with a movable member that is divided into separate parts that are movable relative to each other. [Figure 6A] 5B illustrates an embodiment similar to that of FIG. 5A, but in which the first and second portions comprise movable members that are not rotatable but are slidable relative to one another. [Figure 6B] 5B illustrates an embodiment similar to that of FIG. 5B, but in which the first and second portions comprise movable members that are not rotatable but are slidable relative to one another. [Figure 6C] 5C, but in which the first and second portions comprise movable members that are not rotatable but are slidable relative to one another. [Figure 6D] 5D, but in which the first and second portions comprise movable members that are not rotatable but are slidable relative to one another. [Figure 6E] 5C illustrates an embodiment similar to that of FIG. 5E, but in which the first and second portions comprise movable members that are not rotatable but are slidable relative to one another. [Figure 6F] 5F illustrates an embodiment similar to that of FIG. 5F, but in which the first and second portions comprise movable members that are not rotatable but are slidable relative to one another. [Figure 6G] 5G illustrates an embodiment similar to that of FIG. 5G, but in which the first and second portions comprise movable members that are not rotatable but are slidable relative to one another. [Figure 6H] 5H illustrates an embodiment similar to that of FIG. 5H, but in which the first and second portions comprise movable members that are not rotatable but are slidable relative to one another. [Figure 6I] 5I illustrates an embodiment similar to the embodiment of FIG. 5I, but in which the first and second portions comprise movable members that are not rotatable but are slidable relative to one another. [Figure 7] 1 illustrates an embodiment of a device in which the movable member is divided into multiple component parts. [Figure 8A] 8 illustrates (schematically) the embodiment of FIG. 7 and a series of rotations that may be used to expel an oral dosage form from the device. [Figure 8B] 8 illustrates (schematically) the embodiment of FIG. 7 and a series of rotations that may be used to expel an oral dosage form from the device. [Figure 8C] 8 illustrates (schematically) the embodiment of FIG. 7 and a series of rotations that may be used to expel an oral dosage form from the device. [Figure 8D] 8 illustrates (schematically) the embodiment of FIG. 7 and a series of rotations that may be used to expel an oral dosage form from the device. [Figure 8E] 8 illustrates (schematically) the embodiment of FIG. 7 and a series of rotations that may be used to expel an oral dosage form from the device. [Figure 8F] 8 illustrates (schematically) the embodiment of FIG. 7 and a series of rotations that may be used to expel an oral dosage form from the device. [Figure 9] 8A and 8B illustrate schematically an alternative embodiment similar to that of FIG. 7, in which one or more ratchet mechanisms are used in place of one-way bearings. [Figure 10] 1 shows an embodiment of a device capable of delivering a drug or medication. DETAILED DESCRIPTION OF THE INVENTION

[0086] FIG. 1 shows a cross-sectional view of a portion of device 100, a delivery device capable of expelling a drug or pharmaceutical agent (e.g., an oral dosage form). This is but one example of a device that may be suitable for use with the present invention, as defined in its broadest terms by the claims. Various examples of such devices are described, for example, in PCT Application Nos. PCT / EP2018 / 085320 and PCT / EP2019 / 079999, the contents of which are incorporated by reference in their entireties. For the sake of brevity, different types of devices will not be described in detail herein; it will be understood that any suitable device for expelling an oral dosage form (e.g., solid or liquid) may be used, and the present invention should not be considered limited to use with any particular type of device or mechanism for expelling an oral dosage form.

[0087] It will be further understood that the present invention, in various embodiments, relates to devices for dispensing volume-based doses of drugs or pharmaceuticals (e.g., oral dosage forms), as discussed in more detail below. As such, the embodiments discussed below are suitable for use of the device in connection with solid oral dosage forms such as tablets and pellets, but also smaller types such as powders, and even semi-solid or liquid dosage forms.

[0088] For purposes of brevity, the various embodiments and figures may depict or describe solid oral dosage forms (e.g., pellets), but this should not be construed as limiting the disclosure to the use of such dosage forms. In other words, and generally, the present invention and its various embodiments should not be construed as limited to any particular type of dosage form.

[0089] The device 100 comprises a first end 102 for connection to an actuator 300 or other drive mechanism (e.g., a motor), and a second end 104 (opposite the first end 102) that comprises the discharge end of the device 100. During use, a medication (e.g., an oral dosage form) will be expelled out the second end 104 as a result of operation of the drive mechanism (e.g., a motor).

[0090] The device 100 includes a cartridge 200 configured to attach to an actuator 300 or drive mechanism (eg, a motor) at a first end 102 of the device 100 .

[0091] Device 100 includes one or more rotating members 250 extending through cartridge 200. At a first end 102 of device 100, rotating members 250 connect to actuators 300 that are configured to rotate rotating members 250 (e.g., separately and / or independently) to cause oral dosage forms to be ejected from a second end 104 of device 100, as described in further detail below.

[0092] The device 100 includes one or more outlet conduits 212 at its second end 104 through which oral dosage forms (drugs, medications, etc.) can be discharged.

[0093] 1 shows in more detail the interior of cartridge 200 and some features of rotating member 250. Cartridge 200 is hollow and includes one or more chambers 220 for holding multiple units of an oral dosage form (e.g., pellets), through which rotating member 250 extends from first end 102 of device 100 to second end 104 of device 100.

[0094] The chamber 220 and / or cartridge 200 may be substantially fluid- and / or gas-tight sealed (e.g., except for the flow path through which the pellets are ejected). For example, at the first end 102, the connection between the rotating member 250 and the cartridge 200 may comprise a seal, such as an elastomeric packing or a valve (not shown). Similarly, at the second ejection end 104 of the device 100, a suitable seal (not shown) may be provided between the rotating member 250 and the outlet tube 212.

[0095] Additionally or alternatively, a valve (not shown) may be used to at least partially seal the second discharge end of device 100. A valve may be connected to each outlet tube 212 and configured to prevent the oral dosage form from being unintentionally discharged from the outlet tube other than during the discharge operation, for example, when the discharge mechanism is not operating (e.g., rotatable member 250 is not rotating) or prior to use. The valve may be configured to allow the oral dosage form to be discharged from the discharge mechanism only during the discharge operation, for example, when rotatable member 250 is rotating. The valve may comprise an elastic and / or deformable material, for example, a rubber membrane, configured to flex open (when rotatable member 250 rotates during use) to allow the oral dosage form to be discharged from outlet tube 212, and then flex back (e.g., when rotatable member 250 is not rotating) to stop the oral dosage form from falling / dripping out of outlet tube 212 and help seal chamber 220.

[0096] Upon rotation of one or more of the rotating members 250, the oral dosage form may be urged toward the end of the exit conduit 212 for ejection from the device 100, and upon encountering the resilient material, the oral dosage form will be forced against the resilient material, which may cause deformation and create a gap through which the oral dosage form may be ejected. At the end of the ejection operation, when the rotating members 250 stop rotating, the oral dosage form will no longer be urged against the deformable material, and the deformable material may spring back to its resting, sealed position.

[0097] The valve may help prevent air and / or moisture from entering the chamber 220 and undesirably interfering with the components of the oral dosage form.

[0098] Each rotating member 250 extends into a respective outlet tube 212 at the second end 104 of the device 100 and may include a threaded portion 240. Together, the outlet tubes 212 and the threaded portions 240 may combine to form a screw pump 210 configured to expel an oral dosage form from the second end 104 of the device 100. That is, the oral dosage form will enter the threads 242 of the threaded portions 240 and, upon rotation of the rotating member 250, will be forced out the outlet tubes 212 via the threads 242 and expelled from the device 100. The use of a screw pump 210 is not required; the chamber may simply include an outlet at the discharge end through which the building blocks (pellets) are expelled (e.g., by gravity alone). For example, the outlet tubes 212 may be hollow or not used (in which case there may be a simple opening in the end face 234 of the chamber 220).

[0099] Each rotating member 250 may have a longitudinal axis A about which it rotates, which may also be the axis of rotation of the screw pump 210 .

[0100] The device 100 may further comprise one or more plungers 230 configured to move along the respective rotating member 250 automatically or as a result of rotation of the rotating member 250 .

[0101] As explained above, each cartridge 200 holds an oral dosage form within its one or more chambers 220. In embodiments with one or more plungers 230, the volume of each chamber 220 varies during operation of, and throughout the life of, the device 100 by action of the plungers 230, which are described in more detail below.

[0102] At one end, each chamber 220 is at least partially sealed by its respective plunger 230, more specifically, by a radially extending surface 232 of the plunger 230 that faces the chamber 220. At the other end, the chamber 220 is at least partially sealed by a respective surface 234 of the cartridge 200. Each rotating member 250 extends through its respective chamber 220 along its longitudinal axis A.

[0103] As the rotating member 250 rotates during use, the plunger 230 rests on top of an oral dosage form (not shown) located within the chamber 220 .

[0104] Plunger 230 may act by gravity to move the oral dosage form contained within chamber 220 toward screw pump 210 (or the outlet if screw pump 210 is not used). For example, plunger 230 may be a weight configured to rest on an oral dosage form contained within the chamber when device 100 is in an orientation that allows for expulsion of the oral dosage form.

[0105] Each plunger 230 may be configured to move along its respective rotating member 250 automatically or as a result of rotation of the rotating member 250. For example, a portion of the rotating member 250 within the chamber may include threads 252 (e.g., plunger threads that may be different from any threads 242 of the screw pump 210, if provided), and the plunger 230 may form a nut around the rotating member 250 that is configured to move along the threads 252 of the rotating member 250, such that when the rotating member 250 rotates, the plunger 230 moves toward the screw pump and forces pellets contained within the chamber 220 toward the screw pump 210 (or the outlet, if the screw pump 210 is not used).

[0106] Particularly (though not exclusively) for liquid dosage forms, plunger 230 may be sealed (e.g., fluidly) against the walls of chamber 220 and / or threads 250 along which it travels to prevent undesired leakage. For example, a suitable elastomeric seal may be provided that is configured to fluidly seal against the walls of chamber 220 and / or threads 250.

[0107] As plunger 230 translates along rotating member 250, the volume of chamber 220 gradually decreases. Furthermore, the oral dosage forms contained within chamber 220 will be urged (forced) by plunger 230 toward second end 104 of cartridge 200 throughout the operation and service life of device 100. During use, radially extending surface 232 of plunger 230 may pressurize the oral dosage forms and force them toward second discharge end 104 of device 100, helping to compact them tightly within chamber 220.

[0108] However, it should be noted that the use of plunger 230, while useful, is not considered essential to the broadest aspects of the invention described herein.

[0109] At the second discharge end 104 of the cartridge 200 , the rotating member 250 includes a threaded portion 240 that is axially separated from a thread 252 that cooperates with the plunger 230 .

[0110] FIG. 1 shows the second discharge end 104 of the cartridge 200, at which the optional outlet tube 212 is located, and as discussed above, the optional threaded portion 240 of each rotating member 250 extends through the outlet tube 212.

[0111] Each threaded portion 240 includes threads 242 configured to receive an oral dosage form contained within a respective chamber 220 and, upon rotation of rotating member 250, transport the oral dosage form along threads 242 for ejection out of outlet conduit 212. Threads 242 are comprised of one or more initiations, each of which may, for example, press onto the oral dosage form in chamber 220, forming a continuous spiral that the oral dosage form fills into during operation of device 100 due (at least in part) to the action of plunger 230, which may force the oral dosage form onto threads 242, if provided.

[0112] The screw portion 240 and its threads 242 contact the inner radial surface of the outlet tube 212 of the cartridge 200 to form a screw pump 210 (e.g., an "Archimedes" screw) with the outlet tube 212. That is, when the rotating member 250 rotates, the screw portion 240 and its threads 242 also rotate, causing the oral dosage form contained in the chamber 220 to enter the voids of the threads 242, move down the threads 242, and out of the cartridge 200. The screw pump 210 may include an outlet 243 through which the oral dosage form is expelled.

[0113] An actuator 300 or drive mechanism (e.g., one or more motors 302) may be configured to rotate each respective rotating member 250 (e.g., separately and / or independently) and may be connected to the rotating members 250 at the first end 102 of the device 100 as described above.

[0114] The actuator 300 may be configured to provide a rotational force to the rotating member 250 and, in turn, the threads 242, 252 of the rotating member 250. The actuator 300 may be either mechanical (e.g., manually operated) or electromechanical (e.g., electrically operated, e.g., an electric motor). The actuator 300 (or a control unit comprising the actuator) may be detachable from the cartridge 200 such that different cartridges 200 may be connected to the same actuator 300 or control unit.

[0115] To eject the oral dosage form from the cartridge 200, the actuator 300 may rotate one or more of the rotating members 250, which rotates the rotating members 250 and ejects the oral dosage form (e.g., via the screw pump 210).

[0116] Device 100 may include a control system (e.g., as part of actuator 300 or a control unit) that may be configured to expel a dose of the oral dosage form contained within chamber 220, for example, after receiving an actuation signal from an input device or mechanism. The actuation signal may optionally be initiated, for example, by a user pressing a suitable button or other input mechanism located on the control unit, or via another control, such as a wireless or wired external control.

[0117] By using an electromechanical actuation mechanism, device 100 may be able to repeatedly expel precise doses or amounts (e.g., volumes) of oral dosage forms. The motor 302 and control system may be powered by an integral battery (which may be user-replaceable), which may be held within the housing of actuator 300.

[0118] The actuator 300 may include one or more motors 302. The actuator 300 (e.g., its motors 302) may be configured to rotate the rotating member 250 an amount corresponding to a predetermined dose or fraction of a dose (which may correspond to a particular volume of an oral dosage form).

[0119] Motor 302 may be a stepper motor, which may be configured to rotate each rotatable member 250 any suitable number of steps based on the situation at hand, for example, based on the type of medication in cartridge 200 or the user. The control system may be provided in the form of, for example, a computer, processor, processing device, circuitry, or microcontroller on a PCB, which may be located within the housing of device 100, in actuator 300, or in a control unit.

[0120] The volume (ie, pre-operational or maximum volume) of each chamber 220 can be less than about 50 mL, for example, less than 20 mL or approximately 11 mL.

[0121] In various embodiments, threads 242 (if provided) may extend into chamber 220 a distance of about 1 to 2 times the diameter of rotating member 250, e.g., about 1, 1.5, or 2 times the diameter of rotating member 250. This may help prevent certain undesirable effects, such as "doming" of pellets within chamber 220, or constriction of other types of dosage forms, such as in the case of pellets. The length of threads 240 may be defined by the length of threads 242, which may be about 10 mm to about 30 mm, e.g., about 10 mm to 20 mm.

[0122] Each outlet tube 212 (if provided) may have a length of about 5 mm to about 20 mm (optionally, about 10 mm to about 15 mm), and the length of the thread 242 in a direction along the longitudinal axis A of the chamber 220 may be at least the length of the outlet tube 212 in the same direction, for example, about 1 to about 10 times the length of the outlet tube 212, or about 1 to about 5 times the length of the outlet tube 212, for example, about 1.2, 1.3, 1.4, 1.5, or 2 times the length of the outlet tube 212 (this is applicable to all aspects and embodiments including an outlet tube 212).

[0123] The depth of each thread 242 can be from about 1 mm to about 3 mm. Alternatively, the depth of thread 242 can be matched to the diameter, such as the diameter of a pellet, in the case of a solid oral dosage form. For example, the depth of thread 242 can be greater than the diameter of the pellet (or the smallest pellet contained within chamber 220). Similarly, the height of thread 242 can range from about 1 mm to about 10 mm, for example, from about 1 mm to about 4 mm.

[0124] The actuator 300, when provided with an electromechanical motor 302, may be configured to rotate each rotating member 250 at a speed of between about 50 rpm and about 500 rpm, optionally between about 90 rpm and about 150 rpm.

[0125] 1 shows an embodiment including two chambers 220 positioned side-by-side, more or fewer chambers 220 may be provided. As explained above, a single chamber 220 may be used. The two chambers 220 may abut, as shown, or may not abut, and may be operated by a common actuator 300.

[0126] Actuator 300 may form part of a control unit (in any of the aspects or embodiments described herein) that may include an input device or user interface, which may include one or more buttons for operating device 100. The control unit may comprise a control system configured to operate various electrical and mechanical components of device 100, such as the user interface, display, and ejection mechanism.

[0127] Aspects of the present invention are now described in connection with various embodiments of devices capable of controlling the discharge of oral dosage forms from one or more chambers, where the oral dosage forms can be solid, semi-solid, or liquid oral dosage forms held within the chambers. The chambers can be part of device 100 as described above (e.g., as shown in FIG. 1 ), with a discharge mechanism incorporated into each chamber 220. However, the chambers can simply be hollow cavities without an active discharge mechanism therein, such that the oral dosage forms simply fall, drip, or otherwise discharge from the chamber due to, for example, gravity. It should be noted that semi-solid and / or liquid oral dosage forms can be held within the chambers and discharged using any suitable mechanism, for example, by capillary force.

[0128] Figure 2 shows an embodiment of device 100 that may incorporate features of device 100 shown with respect to Figure 1, with like features being designated with like reference numerals. Note that Figure 2 is highly schematic in order to illustrate the operation of the device, as will become apparent from the discussion below.

[0129] The device 100 of FIG. 2 comprises a cartridge 200 incorporating two separate chambers 220A, 220B, each configured to store an oral dosage form. Each of the chambers 220A, 220B comprises a longitudinal axis A. The oral dosage forms may be loaded into the chambers 220A, 220B at a first end 202 of the cartridge 200. A suitable cap (not shown) may be placed over the first end 202 to seal the chambers 220A, 220B. The oral dosage forms may then be configured to move to a second discharge end 204 of the cartridge 200 and may be ejected therefrom by gravity. Alternatively, an ejection mechanism comprising, for example, an actuator 300 having a rotating member 250 and a plunger 230 and / or a screw pump 210 may be incorporated into the cartridge 200 for each chamber 220A, 220B to move the oral dosage form toward the discharge end 204 from which it is ejected.

[0130] The device 100 comprises a movable member, shown in FIG. 2 as 400, which is operably connected to the discharge end 204 of the cartridge 200 and configured to control the movement of the oral dosage form discharged from the cartridge 200 through the chambers 220A, 220B.

[0131] To do this, member 400 comprises a first chamber 402 configured to selectively communicate with a first one of chambers 220A of cartridge 200 and an exit passageway 502 of device 100, wherein in its first position, member 400 is configured such that first chamber 402 receives the oral dosage form from the first one of chambers 220A and in its second position, first chamber 402 is configured to expel the oral dosage form to exit passageway 502. In the first position, first chamber 402 may not be in communication with exit passageway 502; similarly, in the second position, first chamber 402 may not be in communication with the first one of chambers 220A.

[0132] Member 400 further comprises a second chamber 404 configured to selectively communicate with a second one of chambers 220B of cartridge 200 and an exit passageway 502 of device 100, member 400 being movable such that in its first position, second chamber 404 is configured to eject the oral dosage form into exit passageway 502 and in its second position, second chamber 404 is configured to receive the oral dosage form from the second one of chambers 220B. In the second position, second chamber 404 may not be in communication with exit passageway 502; similarly, in the first position, second chamber 404 may not be in communication with the second one of chambers 220B.

[0133] The outlet passage 502 may have a longitudinal axis X that is offset from the axis A of both chambers 220A, 220B.

[0134] 2 shows member 400 in its first position, and member 400 may be movable (in this case, slidable) between its first and second positions, for example, slidable along track 504 as shown. It will be understood that for simplicity, portions of member 400 may not be shown in FIG. 2. For example, member 400 may include a closure plate configured to cover an outlet of one of chambers 220A, 220B when an oral dosage form is expelled from the other of chambers 220A, 220B.

[0135] The exit passage 502 and optional track 504 may form part of the cap 500. The exit passage 502 may lead to a collection area 506 in the form of a cavity within the cap 500. The device 100 may further include a housing (not shown) that holds each of the cartridge 200, member 400, and cap 500 in a fixed position relative to one another, such that the member 400 may slide between its first and second positions as described above, while the cartridge 200 and cap 500 remain stationary. The housing may be configured to selectively seal the collection area 506, so that an oral dosage form ejected into the collection area is maintained therein until it is required to be ejected therefrom. A variety of selective sealing mechanisms may be used, such as lids, plugs, stoppers, etc.

[0136] Device 100 may have a simpler mechanism than shown in Figures 1 and 2. For example, as shown in Figures 3A-3C, device 100 may include cartridge 200 having a single chamber 220 configured to store an oral dosage form (although multiple chambers may alternatively be provided). For convenience, this is shown as multiple pellets in these figures, but as noted above, the oral dosage form may be of different types, such as different types of solid dosage forms, or semi-solid or liquid dosage forms. The concepts are substantially the same regardless of which type of dosage form is used, and are similar to those described with respect to Figure 2.

[0137] In the case of semi-solid or liquid dosage forms, suitable fluid seals may be used between the various components, particularly moving components, to prevent unwanted leakage from the various chambers and passages of the device 100.

[0138] The device 100 comprises a movable (in this case, rotating) member 400 comprising first and second chambers 402, 404. The single chamber 220 of the cartridge 200 comprises two separate outlets (e.g., outlet tubes) 212, and the pellets contained in the single chamber 220 of the cartridge 200 are configured to enter the outlet tube 212, e.g., via gravity.

[0139] The first and second chambers 402, 404 of the rotating member 400 are configured to move in alignment and out of alignment with the exit conduit 212 so that at some point during rotation of the rotating member 400, the first and second chambers 402, 404 are aligned with the exit conduit 212 such that oral dosage forms contained within chamber 220 move through the exit conduit 212 and into the first and second chambers 402, 404. This position is shown in FIG.

[0140] The device 100 further comprises a substantially solid cap 500 having a pair of exit passages 502 that are also configured to align with the first and second chambers 402, 404, but at a different rotational position of the rotatable member 400 than the rotational position in which the rotatable member 400 is aligned with the exit conduit 212. This means that upon rotation of the rotatable member 400 from the position of the rotatable member 400 shown in FIG. 3A, oral dosage forms contained within the first and second chambers 402, 404 will be maintained therein, while the cap 500 will occlude the exit conduit 212, preventing the oral dosage forms from being expelled from the chamber 220. This position is shown in FIG. 3B.

[0141] Upon further rotation of the rotating member 400, the first and second chambers 402, 404 will eventually align with the exit passageway 502, which causes the oral dosage forms to fall or otherwise move out of the first and second chambers 402, 404 and out of the device 100. This position is shown in Figure 3C.

[0142] 4A-4C show an embodiment similar to that of FIGS. 3A-3C, but in which movable member 400 slides between its first and second positions in a manner similar to that described with respect to FIG. 2.

[0143] In this embodiment, cartridge 200 is substantially the same as the cartridge of Figures 3A-3C, with a single chamber 220 and a pair of outlets (e.g., outlet tubes) 212. Cap 500 includes a single outlet passageway 502 instead of dual outlet passageways as shown in the previous embodiment.

[0144] The sliding member 400 comprises a first chamber 402 configured to selectively communicate with a first one of the outlet conduits 212A of the cartridge 200 and an outlet passage 502 of the cap 500, wherein in its first position, the first chamber 402 is configured to receive the oral dosage form from the first one of the outlet conduits 212A and in its second position, the first chamber 402 is configured to expel the oral dosage form into the outlet passage 502. In the first position, the first chamber 402 may not be in communication with the outlet passage 502; similarly, in the second position, the first chamber 402 may not be in communication with the first one of the outlet conduits 212A.

[0145] The member 400 further comprises a second chamber 404 configured to selectively communicate with a second one of the outlet conduits 212B of the cartridge 200 and an outlet passage 502 of the device 100, the member 400 being movable such that in its first position, the second chamber 404 is configured to eject the oral dosage form into the outlet passage 502 and in its second position, the second chamber 404 is configured to receive the oral dosage form from the second one of the outlet conduits 212B. In the second position, the second chamber 404 may not be in communication with the outlet passage 502; similarly, in the first position, the second chamber 404 may not be in communication with the second one of the outlet conduits 212B.

[0146] 4A shows sliding member 400 in its first position so that the oral dosage form can be expelled from chamber 220 of cartridge 200 through first exit conduit 212A into first chamber 402. Second exit conduit 212B is blocked by member 400, so that the oral dosage form cannot be expelled therefrom.

[0147] 4B, the sliding member 400 may be movable to an intermediate position between the first and second positions, in which neither the first chamber 402 nor the second chamber 404 is aligned with either the outlet conduit 212A, 212B or the outlet passage 502. Thus, an oral dosage form maintained within the first chamber 402 remains within the first chamber 402, while the oral dosage form is not permitted to pass from the chamber 220 of the cartridge 200 to the outlet passage 502.

[0148] 4C shows sliding member 400 in its second position such that the oral dosage form can be expelled from first chamber 402 via exit passage 502. Also, in this position, the oral dosage form will not be expelled from chamber 220 of cartridge 200 into second chamber 404 via second exit conduit 212B. First exit conduit 212A is blocked by member 400, so that the oral dosage form cannot be expelled therefrom.

[0149] The sliding member 400 can be returned to its first position, via an intermediate position, to continue to allow the oral dosage form to be expelled from the device 100 in a controlled manner.

[0150] 2 and 4A-4C show similar arrangements, however, the embodiment shown with respect to Figure 2 uses separate chambers 220A, 220B to supply each of the first and second chambers 402, 404 of the movable member 400, whereas the embodiment of Figures 4A-4C uses a common chamber 222 to supply both the first and second chambers 402, 404 of the movable member 400 (although separate chambers could be provided if desired). The overall principle in both arrangements is the same, namely, to provide a manner of controlling the discharge of an oral dosage form from the cartridge 200 to a user.

[0151] 2 may be used to provide different / separate medications in each respective chamber 220A, 220B, such that each different / separate medication may be expelled sequentially and in controlled amounts corresponding to the volumes of the first and second chambers 402, 404 of the movable member 400. In this manner, the device 100 may be configured to control the expulsion of two different medications in specific amounts. The volumes of the first and / or second chambers 402, 404 may correspond to a specific dose of medication held in either chamber.

[0152] 4A-4C may be used to provide a simple mechanism for expelling an oral dosage form from a single chamber 220 in a controlled amount corresponding to the volumes of the first and second chambers 402, 404 of the movable member 400. That is, the combined volumes of the first and second chambers 402, 404 may correspond to a particular dose of medication held within the common chamber.

[0153] It will be appreciated that the embodiment of Figures 3A-3C operates in a manner substantially similar to the embodiment of Figures 4A-4C, except that the movable member 400 is configured to rotate rather than slide between its first and second positions. It is further envisioned that the embodiment of Figures 3A-3C may be used with a cartridge 200 having separate chambers 220A, 220B to supply each of the first and second chambers 402, 404 of the movable member 400 in a manner similar to the embodiment described with respect to Figures 4A-4C.

[0154] It is envisioned that different dose sizes can be ejected using the embodiment of Figures 3A-3C or 4A-4C by rotating or sliding the movable member 400 multiple times. For example, rotating the member 400 of Figures 3A-3C 720 degrees would mean that a dose having a volume twice the combined volume of the first and second chambers 402, 404 can be ejected.

[0155] 5A-5C, 5D-5F and 5G-5I illustrate embodiments with a movable member 400 that is divided into separate parts that are movable relative to one another, allowing the same device 100 to eject different dose sizes (e.g., without having to rotate or slide the member multiple times), as described in more detail below.

[0156] Referring first to Figure 5A, this shows device 100 comprising cartridge 200 configured to hold an oral dosage form and chamber 220. Chamber 220 comprises first and second outlet conduits 212A, 212B and a cap 500 comprising a single outlet passageway 502. In this manner, device 100 is similar to the device described with respect to Figures 4A-4C.

[0157] 5A , however, comprises a movable member 400 having a first rotatable portion 410 and a second rotatable portion 420, the first and second portions 410, 420 being rotatable relative to one another. The first portion 410 comprises a first chamber 412 configured to align with one or the other of the first and second outlet conduits 212A, 212B depending on the rotational position of the first portion 410. The second portion 420 comprises a second chamber 422 configured to align with the first chamber 412 at a given point in its rotation. The second chamber 422 is also configured to align with one or the other of the first and second outlet conduits 212A, 212B depending on the rotational position of the second portion 420.

[0158] The first and second portions 410 may be aligned with the first outlet conduit 212A or the second outlet conduit 212B as desired, for example, if the first outlet conduit 212A is associated with a different chamber of the cartridge 200 than the second outlet conduit 212B, as is possible in various embodiments described herein.

[0159] 5A-5C illustrate a first sequence, with FIG. 5A showing the movable member 400 configured such that the first chamber 412 is aligned with the second outlet conduit 212B such that the oral dosage form enters the first chamber 412 from the chamber 220 of the cartridge 200 via the second outlet conduit 212B. In this position, the second chamber 422 is not aligned with the first chamber 412 such that the oral dosage form is not further transported.

[0160] 5A to the position shown in FIG. 5B, the first chamber 412 is no longer aligned with the second exit conduit 212B, and oral dosage forms cannot enter the first chamber 412 from the chamber 220 of the cartridge 200. Additionally, the first chamber 412 is still not aligned with the second chamber 422, such that oral dosage forms cannot be transported from the first chamber 412. It will be understood that the first chamber 412 has a given volume, and the oral dosage forms in the first chamber 412 may correspond to a first volume-based dose.

[0161] To expel the oral dosage form from the first chamber 412, the first portion 410 can be rotated from its position shown in Figure 5B to the position shown in Figure 5C, where the first chamber 412 is aligned with the second chamber 422 such that the oral dosage form passes from the first chamber 412 to the second chamber 422. When the second chamber 422 is aligned with the exit passageway 502, the oral dosage form is conveyed linearly through the second chamber 422 and expelled from the device 100 to the user.

[0162] Thus, using the first sequence of FIGS. 5A-5C, a first dose may be expelled from the device 100 corresponding to the volume of the first chamber 412.

[0163] Figures 5D-5F illustrate a second sequence, with Figure 5D showing both the first and second chambers 412, 422 of the movable member 400 aligned with the first outlet tube 212A so that the oral dosage form is expelled from the chamber 220 of the cartridge 200 via the first outlet tube 212A into both the first and second chambers 412, 422 simultaneously.

[0164] 5E, the second chamber 422 is no longer aligned with the first chamber 412 or the first exit conduit 212A such that the oral dosage form cannot enter the second chamber 422 from the chamber 220 of the cartridge 200 or the first chamber 412 of the movable member 400. Additionally, the second chamber 422 is still not aligned with the exit passageway 502 such that the oral dosage form cannot be expelled from the device 100. It will be understood that the second chamber 422 has a given volume and the oral dosage form in the second chamber 422 may correspond to a second volume-based dose.

[0165] To expel the oral dosage form from the second chamber 422, the second portion 420 can be rotated from its position shown in FIG. 5E to the position shown in FIG. 5F, where the second chamber 422 is now aligned with the exit passage 502, thereby causing the oral dosage form to be transported from the second chamber 422 and expelled from the device 100 to the user.

[0166] 5D-5F, a second dose can be expelled from device 100 corresponding to the volume of second chamber 422. Because the volume of second chamber 422 is greater than the volume of first chamber 412, the second dose will be greater than the first dose (which corresponds to the volume of first chamber 412).

[0167] Figures 5G-5I illustrate a third sequence, with Figure 5G (similar to Figure 5D) showing both the first and second chambers 412, 422 of the movable member 400 aligned with the first outlet tube 212A so that the oral dosage form is expelled from the chamber 220 of the cartridge 200 via the first outlet tube 212A into both the first and second chambers 412, 422 simultaneously.

[0168] 5G to the position shown in FIG. 5H, the first and second chambers 412, 422 remain aligned with one another but are no longer aligned with the first exit conduit 212A, such that oral dosage forms cannot enter the combined volume of the first and second chambers 412, 422 from the chamber 220 of the cartridge 200. In addition, the first and second chambers 412, 422 are not aligned with the exit passage 502, such that oral dosage forms cannot be expelled from the device 100. It will be understood that the first and second chambers 412, 422 have a given combined volume and the oral dosage forms within the first and second chambers 412, 422 may correspond to a third volume-based dose.

[0169] To expel the oral dosage form from the first and second chambers 412, 422, the first and second portions 410, 420 can be rotated from their position shown in FIG. 5H to the position shown in FIG. 5I, with the first and second chambers 412, 422 remaining aligned with one another, where both are aligned with the exit passage 502, so that the oral dosage form is transported from both the first and second chambers 412, 422 and expelled from the device 100 to the user.

[0170] 5G-5I, a third dose may be expelled from device 100 corresponding to the volumes of both first and second chambers 412, 422. Because the volumes of both first and second chambers 412, 422 are greater than the volumes of either the first or second chambers 412, 422, separately, the third dose is greater than both the first and second doses (corresponding to the volumes of the first and second chambers 412, 422, respectively).

[0171] Figures 6A-6C, 6D-6F, and 6G-6I illustrate an embodiment similar to that of Figures 5A-5C, 5D-5F, and 5G-5I, respectively, but comprising a movable member 400 in which first and second portions are slidable relative to one another rather than rotatable. That is, movable member 400 is divided into separate portions 410, 420 that are movable (in this case, slidable) relative to one another, which allows the same device 100 to eject different dose sizes in a manner similar to the devices described above with respect to Figures 5A-5C, 5D-5F, and 5G-5I.

[0172] Referring initially to Figure 6A, this shows device 100 comprising cartridge 200 configured to hold an oral dosage form and chamber 220. Chamber 220 comprises first and second outlet conduits 212A, 212B and cap 500 comprising a single outlet passageway 502. In this manner, device 100 is similar to the devices described with respect to Figures 4A-4C and 5A-5I.

[0173] 6A , however, comprises a movable member 400 having a first slidable portion 410 and a second slidable portion 420, the first and second portions 410, 420 being slidable / translatable relative to one another. The first portion 410 comprises a first chamber 412 configured to align with one or the other of the first and second outlet conduits 212A, 212B depending on the position of the first portion 410 along its sliding axis. The second portion 420 comprises a second chamber 422 configured to align with the first chamber 412 at a given point in its translation. The second chamber 422 is also configured to align with one or the other of the first and second outlet conduits 212A, 212B depending on the position of the second portion 420 along its sliding axis.

[0174] The first and second portions 410, 420 may be aligned with either the first outlet conduit 212A or the second outlet conduit 212B, as desired. For example, if the first outlet conduit 212A is associated with a different chamber of the cartridge 200 than the second outlet conduit 212B, as is possible in various embodiments described herein, a user may desire to align the first and / or second portions 410, 420 with the first outlet conduit 212B rather than the second outlet conduit 212B.

[0175] 6A-6C illustrate a first sequence, with FIG. 6A showing the movable member 400 configured such that the first chamber 412 is aligned with the second outlet conduit 212B such that the oral dosage form enters the first chamber 412 from the chamber 220 of the cartridge 200 via the second outlet conduit 212B. In this position, the second chamber 422 is not aligned with the first chamber 412 such that the oral dosage form is not further transported.

[0176] 6A to the position shown in FIG. 6B, the first chamber 412 is no longer aligned with the second exit conduit 212B, and oral dosage forms cannot enter the first chamber 412 from the chamber 220 of the cartridge 200. Additionally, the first chamber 412 is still not aligned with the second chamber 422, such that oral dosage forms cannot be transported from the first chamber 412. It will be understood that the first chamber 412 has a given volume, and the oral dosage forms in the first chamber 412 may correspond to a first volume-based dose.

[0177] To expel the oral dosage form from the first chamber 412, the first portion 410 can be translated from its position shown in Figure 6B to the position shown in Figure 6C, where the first chamber 412 is aligned with the second chamber 422 such that the oral dosage form passes from the first chamber 412 to the second chamber 422. Once the second chamber 422 is aligned with the exit passageway 502, the oral dosage form is conveyed linearly through the second chamber 422 and expelled from the device 100 to the user.

[0178] Thus, using the first sequence of FIGS. 6A-6C, a first dose may be expelled from the device 100 corresponding to the volume of the first chamber 412.

[0179] Figures 6D-6F illustrate a second sequence, with Figure 6D showing both the first and second chambers 412, 422 of the movable member 400 aligned with the first outlet tube 212A so that the oral dosage form is expelled from the chamber 220 of the cartridge 200 via the first outlet tube 212A into both the first and second chambers 412, 422 simultaneously.

[0180] 6E, the second chamber 422 is no longer aligned with the first chamber 412 or the first exit conduit 212A such that the oral dosage form cannot enter the second chamber 422 from the chamber 220 of the cartridge 200 or the first chamber 412 of the movable member 400. Additionally, the second chamber 422 is still not aligned with the exit passageway 502 such that the oral dosage form cannot be expelled from the device 100. It will be understood that the second chamber 422 has a given volume and the oral dosage form in the second chamber 422 may correspond to a second volume-based dose.

[0181] To expel the oral dosage form from the second chamber 422, the second portion 420 can be translated from its position shown in FIG. 6E to the position shown in FIG. 6F, where the second chamber 422 is now aligned with the exit passage 502, thereby causing the oral dosage form to be transported from the second chamber 422 and expelled from the device 100 to the user.

[0182] 6D-6F, a second dose may be expelled from device 100 corresponding to the volume of second chamber 422. Because the volume of second chamber 422 is greater than the volume of first chamber 412, the second dose will be greater than the first dose (which corresponds to the volume of first chamber 412).

[0183] Figures 6G-6I illustrate a third sequence, with Figure 6G (similar to Figure 6D) showing both the first and second chambers 412, 422 of the movable member 400 aligned with the first outlet tube 212A so that the oral dosage form is expelled from the chamber 220 of the cartridge 200 via the first outlet tube 212A into both the first and second chambers 412, 422 simultaneously.

[0184] 6H, the first and second chambers 412, 422 remain aligned with one another but are no longer aligned with the first exit conduit 212A, such that oral dosage forms cannot enter the combined volume of the first and second chambers 412, 422 from the chamber 220 of the cartridge 200. In addition, the first and second chambers 412, 422 are no longer aligned with the exit passage 502, such that oral dosage forms cannot be expelled from the device 100. It will be understood that the first and second chambers 412, 422 have a given combined volume and the oral dosage forms within the first and second chambers 412, 422 may correspond to a third volume-based dose.

[0185] To expel the oral dosage form from the first and second chambers 412, 422, the first and second portions 410, 420 can be translated from their position shown in FIG. 6H to the position shown in FIG. 6I, with the first and second chambers 412, 422 remaining aligned with one another, where both are aligned with the exit passage 502, so that the oral dosage form is transported from both the first and second chambers 412, 422 and expelled from the device 100 to the user.

[0186] 6G-6I, a third dose may be expelled from device 100 corresponding to the volumes of both first and second chambers 412, 422. Because the volumes of both first and second chambers 412, 422 are greater than the volumes of either the first or second chambers 412, 422, separately, the third dose is greater than both the first and second doses (corresponding to the volumes of the first and second chambers 412, 422, respectively).

[0187] It will be understood that various modifications may be made to the above-described embodiments while still falling within the broadest aspects of the present disclosure. For example, although two separate outlet conduits 212A, 212B are shown, which may provide greater flexibility and redundancy, a single outlet conduit may be provided that still allows different dosage amounts to be discharged from device 100. Similarly, and as noted above, single chamber 220 may be divided into multiple chambers, e.g., two separate chambers, each with an outlet conduit configured to convey an oral dosage form from the respective chamber to either or both of first and second chambers 412, 402 of movable member 400.

[0188] References herein to various tubes, chambers, or passageways being "aligned" with one another may be interpreted as being in communication with one another so that oral dosage forms may be transported from one to the other, for example, via gravity or using a suitable discharge mechanism.

[0189] The cap 500 (or an additional cap disposed over the cap 500) may comprise a collection area, for example, in the form of a cavity within the cap 500. The device 100 may further comprise a housing (not shown) that holds each of the cartridge 200, member 400, and cap 500 (and additional caps, if provided) in a fixed position relative to one another, such that the portions 410, 420 of the member 400 may rotate or slide between their described positions as described above, while the cartridge 200 and cap 500 (and additional caps, if provided) remain stationary. The housing may be configured to selectively seal the collection area, so that an oral dosage form ejected into the collection area is maintained therein until required to be ejected therefrom. Alternatively, or additionally, a cover, lid, plug, or the like may be disposed over the exit passage 502, configured to maintain the oral dosage form in the exit passage 502 until required to be ejected therefrom.

[0190] Movement of the movable member 400 in any of the above-described embodiments may be controlled and effected by an actuator, which may form part of a control system and / or control unit as described elsewhere herein. The actuator may be configured to slide or rotate the movable member 400, or portions 410, 420 thereof, as described above, to expel doses of one or more pharmaceutical agents contained within the cartridge 200. The actuator may be electrically driven using one or more electric motors.

[0191] FIG. 7 shows an embodiment of the device 100 in which the movable member 400 is divided into multiple component parts such that when rotated in a first direction, the member 400 ejects the drug from a first outlet tube 212A, and when rotated in a second, opposite direction, the member 400 ejects the drug from a second, different outlet tube 212B.

[0192] Device 100 may incorporate features of device 100 shown with respect to Figure 1, and like features are indicated with like reference numerals. Note that Figure 7 is highly schematic and is intended merely to illustrate the operation of the device, as will become apparent from the discussion below.

[0193] The device 100 comprises a cartridge 200 having a chamber 220 for storing an oral dosage form, the chamber 220 comprising a first outlet (e.g., outlet tube) 212A and a second outlet (e.g., outlet tube) 212B. The first outlet tube 212A is located at a position that is radially inward of the second outlet tube 212B relative to the longitudinal axis Y of the device 100.

[0194] The device 100 further comprises a movable (in this case, rotatable) member 400 having a first rotatable plate 450 configured to rotate during use. The first plate 450 comprises a first chamber 452 configured to align with the first outlet conduit 212A at a particular rotational position thereof. The member 400 may be rotatable about a longitudinal axis Y of the device 100, as shown in FIG. 7.

[0195] The member 400 further comprises a second rotatable plate 460 configured to rotate during use, the second plate 460 comprising a second chamber 462 configured to align with the second outlet tube 212B at a particular rotational position thereof.

[0196] The member 400 further comprises a third plate 470 configured to rotate with the second plate 460. The third plate 470 comprises an opening 472, and the first chamber 452 of the first plate 450 is configured to align with the opening 472 at a particular rotational position of the first plate 450. Upon alignment of the first chamber 452 with the opening 472, an oral dosage form may be ejected from the first chamber 452 from the device 100 through the opening 472 of the third plate 470. To ensure that the third plate 470 rotates with the second plate 460, the teeth 474 of the third plate 470 may enter into the cavities 464 of the second plate 460, and cooperation of the teeth 474 and the cavities 464 locks the third plate 470 in place relative to the second plate 460.

[0197] Member 400 further comprises a fourth plate 480 that is fixed in position relative to cartridge 200 and may not rotate during use. Fourth plate 480 comprises an opening 482, and second chamber 462 of second plate 460 is configured to align with opening 482 at a particular rotational position of second plate 460. Upon alignment of second chamber 462 with opening 482, oral dosage forms may be expelled from second chamber 462 (and potentially from device 100 or into a cap / collection area) through opening 482 in fourth plate 480.

[0198] The first plate 450 may be positioned radially within the second plate 460, and a one-way bearing, indicated at 490, may be positioned between (e.g., radially between) the first and second plates 450, 460. The one-way bearing 490 may be configured to allow the first plate 450 to rotate relative to and independently of the second plate 460 when the first plate 450 is rotated in a first rotational direction (e.g., one of clockwise and counterclockwise), and the one-way bearing 490 is further configured to lock the first plate 450 in position relative to the second plate 460 so that the first plate 450 does not rotate relative to and independently of the second plate 460 when the first plate 450 and / or the second plate 460 are rotated in a second, opposite rotational direction (e.g., the other of clockwise and counterclockwise).

[0199] Thus, device 100 can be operated such that a first volumetric dose can be ejected from first chamber 452 of first plate 450 via first outlet conduit 212A and opening 472 in third plate 470. The first dose can correspond in volume to the size of first chamber 452 of first plate 450 and can be ejected by rotating only first plate 450 relative to the other parts of member 400.

[0200] The device 100 can be further operated such that a second volumetric dose can then be expelled from the second chamber 462 of the second plate 460 via the second outlet conduit 212B and the opening 482 of the fourth plate 480. The second dose can correspond in volume to the size of the second chamber 462 of the second plate 460 and can be expelled by rotating both the first plate 450 and the second plate 460 in a configuration in which the first plate 450 is locked in place relative to the second plate 460. In this configuration, the first plate 450 will rotate at the same speed as the third plate 470, such that the first chamber 452 cannot align with the opening 472 of the third plate 470. This means that the oral dosage form cannot be expelled from the first chamber 452.

[0201] It will be appreciated that the sizes of the first and second chambers 452, 462 may be configured such that the first and second volume-based doses may differ. In embodiments where the chamber 220 is a single chamber that services both the first and second outlet conduits 212A, 212B, this may allow for different volume-based doses of the same medication contained within the single chamber 220.

[0202] 2 described above, it is envisioned that chamber 220 may be divided into first chamber 220A and second outlet tube 220B, each serving a respective first and second outlet tube 212A, 212B. In this situation, first and second chambers 452, 462 of movable member 400 may be of the same volume and configured to eject different medications contained within first and second chambers 220A, 220B. First and second chambers 452, 462 of movable member 400 may still be of different volumes and configured to eject different medications at different volumes.

[0203] A cap, lid, or plug (which may be removable / replaceable) may be placed on the fourth plate 480, for example, comprising a collection area in the form of a cavity. The device 100 may further comprise a housing (not shown) that holds the cartridge 200, the member 400, and each of the caps, lids, or plugs in place relative to one another, so that the various parts of the member 400 may rotate, as described above, while the cartridge 200 and caps, lids, or plugs remain stationary. The housing may be configured to selectively seal the collection area, so that oral dosage forms ejected into the collection area are retained therein until required to be ejected therefrom. Alternatively, or additionally, covers or plugs may be placed over the openings 472, 482 of the third and fourth plates 470, 480, configured to retain the oral dosage forms within the exit passage 502 until required to be ejected therefrom.

[0204] The rotational movements described above in connection with FIG. 7 may be controlled and implemented by an actuator, which may form part of a control system and / or control unit, as described elsewhere herein. The actuator may be configured to rotate the first plate 450 such that rotation of the first plate 450 in a first rotational direction causes rotation of only the first plate 450 (due to the one-way bearing 490), as described above, and rotation of the first plate 450 in a second rotational direction causes rotation of both the first plate 450, the bearing 490, the second plate 460, and the third plate 470. To enable this, a shaft (not shown) may extend through the cartridge 200 and may be configured to rotate the first plate 450 in this manner. The shaft may be operably connected to the actuator, which may comprise, for example, an electric motor configured to rotate the shaft.

[0205] It is envisioned that several layers of similar plates may be provided on the movable member 400 of this embodiment so that different dosage volumes may be provided.

[0206] 8A-8F illustrate (schematically) the embodiment of FIG. 7 and a series of rotations that may be used to expel an oral dosage form from device 100. FIG.

[0207] 8A-8C show a first sequence that may be used to rotate a first plate 450 and eject a first dose of a pharmaceutical agent. The device 100 is shown to include a cartridge 200 having a chamber 220 that services first and second outlets (e.g., outlet tubes) 212A, 212B, as described above. A movable member 400 is also provided having a first plate 450 having a first chamber 452, shown in FIGS. 8A-8C in solid lines to distinguish it from the rest of its components.

[0208] 8A-8C further show in dotted lines second plate 460, third plate 470, and fourth plate 480, and their respective second chambers 462, openings 472, and openings 482.

[0209] 8A shows the first plate 450 in a first rotational position, with its first chamber 452 aligned with the first exit conduit 212A, thereby discharging the oral dosage form from the chamber 220 of the cartridge 200 through the first exit conduit 212A and into the first chamber 452 of the member 400. Because the first chamber 452 is not aligned with the opening 472 of the third plate 470 in this position, the oral dosage form is not further discharged from the first chamber 452 but remains therein.

[0210] 8B, the first chamber 452 is no longer aligned with the first outlet conduit 212A and the oral dosage form cannot enter the first chamber 452 from the chamber 220 of the cartridge 200. In addition, the first chamber 452 is still not aligned with the opening 472 of the third plate 470 such that the oral dosage form cannot be transferred from the first chamber 452.

[0211] To expel the oral dosage form from the first chamber 452, the first plate 450 can be further rotated in the same direction from its position shown in FIG. 8B to the position shown in FIG. 8C, so that the first chamber 452 is aligned with the opening 472 of the third plate 470, causing the oral dosage form to pass from the first chamber 452 and be transported through the opening 472 of the third plate 470 and expelled from the device 100 to the user.

[0212] Thus, using the sequence of FIGS. 8A-8C, a first dose may be expelled from the device 100 corresponding to the volume of the first chamber 412.

[0213] 8D-8F show a second sequence that may be used to rotate both the first plate 450 and the second plate 460 to eject a second dose of pharmaceutical agent. In these figures, for illustrative purposes, the second plate 460 and its chamber 462 are shown in solid lines, while the first plate 450, third plate 470, and fourth plate 480 and their respective first chambers 452, openings 472, and openings 482 are shown in dashed lines.

[0214] 8D shows the first and second plates 450, 460 in a first rotational position (similar to that of FIG. 8A ), with the first chamber 452 aligned with the first outlet conduit 212A and the second chamber 462 aligned with the second outlet conduit 212B, thereby expelling the oral dosage form from the chamber 220 of the cartridge 200 through the second outlet conduit 212B and into the second chamber 462 of the member 400. Because the second chamber 452 is not aligned with the opening 482 of the fourth plate 470 in this position, the oral dosage form is not further expelled from the second chamber 462 but remains therein.

[0215] 8E, which also causes rotation of second plate 460 and second chamber 462, and third plate 470 and its opening 472. Thus, second chamber 462 is no longer aligned with second outlet conduit 212B, and oral dosage forms cannot enter second chamber 462 from chamber 220 of cartridge 200. In addition, second chamber 462 is still not aligned with opening 482 of fourth plate 480, thereby preventing oral dosage forms from being transferred from second chamber 462.

[0216] Furthermore, the first chamber 452 is not aligned due to the opening 472 in the third plate 470 and the one-way bearing 490 (not shown in these figures for simplicity) rotating together in the second rotational direction, so that the oral dosage form cannot be transported from the first chamber 452 either.

[0217] 8F , which causes the second plate 460 to rotate so that the second chamber 462 is aligned with the opening 482 of the fourth plate 480. This means that the oral dosage form passes from the second chamber 462, is transported through the opening 482 of the fourth plate 480, and is ejected from the device 100 to the user. At the same time, the third plate 472 will continue to rotate with the first plate 450, so that the first chamber 452 still cannot be aligned with the opening 472 of the third plate 470, and therefore the oral dosage form cannot be transported from the first chamber 452.

[0218] Thus, using the sequence of FIGS. 8D-8F, a second dose can be expelled from device 100 corresponding to the volume of second chamber 462.

[0219] 9, which is highly schematic, shows an alternative arrangement similar to that of FIG. 7 in which one or more ratchet mechanisms are used in place of one-way bearings 490. In this arrangement, a first plate 450 includes a plurality of ratchet teeth 456 around its outer periphery (e.g., radially) that are configured to cooperate with a plurality of ratchet teeth 466 located on the inner periphery of a second plate 460.

[0220] The ratchet teeth 456, 466 located on the first and second plates 450, 460 may be configured to cooperate to allow the first plate 450 to rotate in a first rotational direction (as indicated by arrow 600) without causing rotation of the second plate 460. Additionally, the ratchet teeth 456, 466 located on the first and second plates 450, 460 may be further configured to cooperate such that rotation of the first plate 450 in a second, opposite rotational direction (as indicated by arrow 602) causes rotation of the second plate 460 in the same direction.

[0221] The second plate 460 may be further configured with additional ratchet teeth 468 located on its outer periphery configured to cooperate with the ratchet teeth 268 located on the inner periphery of the cartridge 200. The additional ratchet teeth 468 of the cartridge 200 and the ratchet teeth 268 may be cooperatively configured such that their engagement prevents the second plate 460 from rotating in a first direction while allowing the second plate 460 to rotate.

[0222] The arrangement of Figure 9 is considered a modification of the embodiment of Figure 7, with the remaining features disclosed with respect to Figure 7 remaining the same. Thus, the arrangement of Figure 9 may be configured in the same manner as described above, such that oral dosage forms may be expelled from one or the other of the first and second chambers 452, 462 of the first and second plates 450, 460.

[0223] FIG. 10 shows an exploded view of a device 100 that is functionally similar to, and incorporates some of the features of, the devices described above.

[0224] The device 100 comprises a first end 102 located at an actuator 300 (a drive mechanism, e.g., a motor) and a second end 104 (opposite the first end 102) that comprises the discharge end of the device 100. During use, a medication (e.g., an oral dosage form) will be discharged out of the second end 104 as a result of operation of the drive mechanism. The actuator 300 can be either mechanical (e.g., manually operated) or electromechanical (e.g., electrically operated, e.g., an electric motor).

[0225] The device 100 includes a cartridge 200 configured to attach to an actuator 300, which may be achieved using latches 201, 301, fasteners 209, or other suitable attachment mechanisms.

[0226] The device 100 includes a rotating member 250 extending through the cartridge 200. The rotating member 250 connects at a first end 102 to an actuator 300, which is configured to rotate the rotating member 250. Each rotating member 250 may have a longitudinal axis A about which it rotates.

[0227] Cartridge 200 includes a chamber 220 for holding multiple units of an oral dosage form (e.g., pellets), through which a rotating member 250 extends. Chamber 220 includes an outlet 212 at second end 104, through which the oral dosage form (drug, medication, etc.) can be ejected from chamber 220. Exit 212 is shown as an arcuate opening, which aids in the ejection of the oral dosage form from the chamber (although any suitable shaped opening may be used).

[0228] Rotating member 250 includes a lance 251 at its end distal to the end attached to actuator 300. Lance 251 is configured to extend through opening 213 in chamber 220 and engage rotating member 400, as described in more detail below.

[0229] The device 100 further comprises a plunger 230 configured to automatically move along the rotating member 250 as it rotates. That is, a portion of the rotating member 250 within the chamber 220 comprises a screw thread 252, and the plunger 230 forms a nut around the rotating member 250 and is configured to move along the screw thread 252 of the rotating member 250 as it rotates. In doing so, the plunger 230 pushes the oral dosage form towards the outlet 212 of the chamber 220.

[0230] Chamber 220 is at least partially enclosed by plunger 230, more specifically, by the radially extending surface of plunger 230 that faces chamber 220. The volume of chamber 220 (i.e., pre-actuation or maximum volume) can be less than about 50 mL, for example, less than 20 mL or approximately 11 mL.

[0231] Particularly (though not exclusively) for liquid dosage forms, plunger 230 may be sealed (e.g., fluidly) against the walls of chamber 220 and / or threads 250 along which it travels to prevent undesired leakage. For example, a suitable elastomeric seal may be provided that is configured to fluidly seal against the walls of chamber 220 and / or threads 250.

[0232] As plunger 230 translates along rotating member 250, the volume of chamber 220 gradually decreases. During use, radially extending surface 232 of plunger 230 may pressurize the oral dosage forms, urging them toward second discharge end 104 of device 100 and helping to compact them tightly within chamber 220.

[0233] FIG. 10 shows the second discharge end 104 of the cartridge 200 where the outlet 212 of the chamber 220 is located, as well as a mechanism 400 ′ for providing a volumetric dose, a funnel 501 , and a cap 500 .

[0234] The mechanism 400' for providing a volume-based dose uses the rotating disc 400 (similar to rotating member 400) described above, which has a central opening 401 and a (rotating) chamber 402 extending through the disc 400. Four rotating discs 400a-d are shown in Figure 10 for illustrative purposes, each configured to deliver a different volumetric dose, as described in more detail below.

[0235] The mechanism 400′ further includes a first plate 406 configured to receive the disc 400 located within an opening 407 extending through the first plate 406. The opening 407 is sized to receive the disc 400 and allow the disc 400 to rotate within the first plate 406. The first plate 406 is fixedly mounted to the bottom wall 224 of the cartridge 200 (and chamber 220) through which the outlet 212 and opening 213 extend. Thus, the disc 400 within the first plate 406 can contact the bottom wall 224 through its rotational movement.

[0236] The lance 251 of the rotating member 250 is configured to extend through the opening 213 in the bottom wall 224 of the cartridge 200 and fit within the opening 401 in the disk 400. The lance 251 is configured to rotate the disk 400 when the rotating member 250 rotates. In the illustrated embodiment, the lance 251 has a cubic shape that matches the cubic shape of the opening 401 in the disk 400. Additionally or alternatively, the lance 251 may press / interfere / etc. fit within the opening 401 such that rotation of the lance 251 causes a corresponding rotation of the disk 400.

[0237] The mechanism 400′ further comprises a second plate 408 overlying the first plate 406 and the disk 400 and configured to seal the disk 400 within an opening 407 between the second plate 408 and the bottom wall 224 of the cartridge 200. Thus, as the disk 400 rotates within the opening 407, the chamber 402 of the disk is pressed against the surface of the bottom wall 224 on one side and against the second plate 408 on the other side. It will be understood that in the case of a solid oral dosage form, the disk 400 need not be sealed against either the wall 224 or the second plate 208, and that a minimal gap may exist (as long as the oral dosage form is in the intermediate position defined herein, it will be prevented from leaving the chamber 402).

[0238] The second plate 408 includes an opening 409 through which the oral dosage form may pass from the chamber 402 of the disk 400, as will be described in more detail below. The opening 409 is shown as arcuate, which aids in the egress of the oral dosage form from the chamber 402 (although any suitable shaped opening may be used).

[0239] Chamber 402 of disk 400 is configured to move in and out of alignment with outlet 212 of chamber 220 as disk 400 rotates, such that at some point during the rotation of disk 400, chamber 402 will be aligned with outlet 212. At this point, an oral dosage form contained within chamber 220 may move into rotating chamber 402 via outlet 212.

[0240] Similarly, chamber 402 of disk 400 is configured to move in and out of alignment with opening 409 as disk 400 rotates. Chamber 402 is configured to align with opening 409 at a point in its rotation that is different from its alignment with outlet 212. Chamber 402, outlet 212, and opening 409 are all configured such that an oral dosage form will be ejected through outlet 212 into chamber 402, but will not simultaneously pass through opening 409. This is similar to the embodiment described above.

[0241] That is, chamber 402 is configured to selectively communicate with outlet 212 of chamber 220 and opening 409 of second plate 408. That is, mechanism 400′ is configured such that in a first position of disk 400, an oral dosage form is received into chamber 402 from outlet 212, and in its second position, the oral dosage form is expelled from chamber 402 through opening 409. In other words, in the first position, chamber 402 is not in communication with opening 409, and in the second position, chamber 402 is not in communication with outlet 212.

[0242] The disk 400 includes an intermediate position between the first and second positions in which the chamber 402 is not aligned with either the outlet 212 or the opening 409. Thus, an oral dosage form maintained within the chamber 402 remains within the chamber 402, while the oral dosage form is not allowed to pass from the chamber 220 of the cartridge 200 to the opening 409.

[0243] The disk 400 can be rotated between its first position to its second position, via intermediate positions, to allow the oral dosage form to be expelled from the device 100 in a controlled manner.

[0244] Device 100 may include a control system (e.g., as part of actuator 300 or a control unit) that may be configured to expel a dose of the oral dosage form contained within chamber 220, for example, after receiving an actuation signal from an input device or mechanism. The actuation signal may optionally be initiated, for example, by a user pressing a suitable button or other input mechanism located on the control unit, or via another control, such as a wireless or wired external control.

[0245] By using an electromechanical actuation mechanism, device 100 may be able to repeatedly expel precise doses or amounts (e.g., volumes) of oral dosage forms. The motor 302 and control system may be powered by an integral battery (which may be user-replaceable), which may be held within the housing of actuator 300.

[0246] The actuator 300 may include one or more motors 302. The actuator 300 (e.g., its motors 302) may be configured to rotate the rotating member 250 an amount corresponding to a predetermined dose or fraction of a dose (which may correspond to a particular volume of an oral dosage form).

[0247] Motor 302 may be a stepper motor, which may be configured to rotate each rotatable member 250 any suitable number of steps based on the situation at hand, for example, based on the type of medication in cartridge 200 or the user. The control system may be provided in the form of, for example, a computer, processor, processing device, circuitry, or microcontroller on a PCB, which may be located within the housing of device 100, in actuator 300, or in a control unit.

[0248] The actuator 300, when provided with an electromechanical motor 302, may be configured to rotate each rotating member 250 at a speed of between about 50 rpm and about 500 rpm, optionally between about 90 rpm and about 150 rpm.

[0249] However, when an actuator 300 is provided, the dose expelled from the device 100 corresponds to the volume of the chamber 402 of the disk 400. To expel doses of different volumes, different disks 400 may be used, as shown by disks 400a-d in FIG. 10. Each of the disks 400a-d includes a chamber 402 of a different size, such that each disk is configured to expel a dose of a different volume in one rotation thereof. It is also possible that doses of different volumes may be expelled by rotating the disk 400 multiple times. The actuator 300 may be configured to control the dose volume by controlling the number of rotations of the disk 400 in this manner.

[0250] The device 100 further comprises a funnel 501 configured to fit over the surface 224 of the cartridge 200. The funnel 501 may be secured to the cartridge 200 using any suitable device, for example, a fastener 509 (or clip, or may be molded onto the chamber 220). The mechanism 400′ for providing a volumetric dose may be housed within the funnel 501, which may be configured to secure various components of the mechanism 400′ in place. For example, the funnel 501 may be configured to force the second plate 408 against the first plate 406, which in turn forces the first plate 406 against the bottom wall 224 of the cartridge 200. In this manner, the opening 407 in which the disk 400 seats may be configured as a substantially closed / sealed cavity, having an entrance formed by the outlet 212 of the chamber 220 and an exit formed by the opening 409 of the second plate 408.

[0251] Device 100 may further comprise cap 500, which may comprise a collection area in the form of a cavity within cap 500. Cap 500 may be configured to fit over funnel 501 and over cartridge 200 such that oral dosage forms dispensed into the collection area are retained within the cavity within cap 500. To access the oral dosage forms, cap 500 is configured to be removable (e.g., via a snap fit) from the rest of device 100, such that a user can expose the collection area and access the oral dosage forms.

[0252] The methods, method steps, or functional features disclosed herein may be implemented, at least in part, using software, e.g., computer programs, in connection with, for example, the control system of the control unit described above. These may be located in the processor or circuitry of the control unit itself. Viewed from a further aspect, it will therefore be seen that the present invention provides computer software specifically adapted to perform the methods, method steps, or functional features described herein when implemented on a data processing means; computer program elements comprising computer software code portions for performing the methods, method steps, or functional features described herein when the program elements are executed on a data processing means; and computer programs comprising code means adapted to perform all steps of the methods, method steps, or functional features described herein when the program is executed on a data processing system. The data processor may be a microprocessor system, a programmable FPGA (Field Programmable Gate Array), etc.

[0253] Although the present invention has been described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the scope of the invention as set forth in the appended claims.

Claims

1. 1. A device for expelling an oral dosage form, comprising: a cartridge (200) comprising one or more chambers (220) for containing oral dosage forms, each of said one or more chambers (220) comprising at least one outlet for expelling said oral dosage forms from said chamber; a member (400) movable between first and second positions, wherein in the first position, the member (400) is configured to receive and retain a specific volume of the oral dosage forms from one of the chambers (220) of the cartridge (200) via one of the outlets, the member (400) being movable to one or more intermediate positions where the specific volume of the oral dosage forms is retained and maintained within the movable member (400) such that the oral dosage forms cannot be expelled from the movable member, and the member (400) being movable from the intermediate positions to a second position where the oral dosage forms retained within the movable member can be expelled; The movable member (400) is a rotatable disk (400) having chambers (412, 422) for holding and maintaining a specific volume of oral dosage form, as previously described; the chambers (412, 422) of the movable member (400) comprise a first chamber (412) and a second chamber (422); the movable member (400) comprises a first portion (410) having the first chamber (412) thereof and a second separate portion (420) having the second chamber (422) thereof, the first and second portions (410, 420) being movable relative to one another; As a result, in a first relative position of the first and second portions (410, 420), the first and second chambers (412, 422) of the movable member (400) are aligned so that the oral dosage form can pass therebetween, and in a second relative position of the first and second portions (410, 420), the first and second chambers (412, 422) of the movable member (400) are moved out of alignment so that the oral dosage form cannot pass therebetween.

2. 2. The device of claim 1, wherein in the intermediate position, the chambers (412, 422) of the movable member (400) are sealed and isolated from the one or more chambers of the cartridge.

3. 3. The device of claim 1, wherein the first chamber (412) is configured to receive and hold a first volume of the oral dosage form from the cartridge (200), and the second chamber (422) is configured to receive and hold a second volume of the oral dosage form from the cartridge (200).

4. 4. The device of claim 3, wherein the size of the first volume of oral dosage form is different from the size of the second volume of oral dosage form.

5. 5. The device of claim 3, wherein in the first position of the movable member (400), the first and second chambers (412, 422) are both configured to simultaneously receive and hold separate volumes of oral dosage forms from the cartridge (200), and in the second position of the movable member (400), the first and second chambers (412, 422) are both configured to expel their respective volumes of oral dosage forms therefrom.

6. 6. The device of claim 1, wherein the first portion (410) comprises a first disk having the first chamber (412) of the member, and the second portion (420) comprises a second disk having the second chamber (422) of the member, and the first and second disks are rotatable relative to each other and to the cartridge (200).

7. 7. The device of claim 1, wherein the device comprises one or more outlet passages configured to receive the oral dosage forms expelled from the movable member at the second position.

8. 8. The device of any one of claims 1 to 7, further comprising a rotating member (250) extending through the cartridge (200) and configured to rotate the disc.

9. 9. The device of claim 8, further comprising an actuator (300) configured to rotate the rotating member (250).

10. 10. The device of claim 9, wherein the actuator (300) comprises an electric motor.

11. 11. The device of claim 8, further comprising a plunger (230) configured to automatically move along the rotating member (250) as the rotating member (250) rotates and to push the oral dosage form towards the outlet of the chamber (220) during use.

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