Delivery device for oral dosage forms

Abstract

The present application provides a device for dispensing an oral dosage form. The device comprises a cartridge comprising one or more chambers for containing an oral dosage form, wherein each of the one or more chambers comprises at least one outlet for dispensing 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 contain a specific volume of an oral dosage form from one chamber of the cartridge through one outlet, wherein the member is movable to one or more intermediate positions in which the specific volume of oral dosage form is held and retained within the movable member such that the oral dosage form cannot be dispensed therefrom, and from the intermediate position to the second position in which the oral dosage form within the movable member can be dispensed therefrom.

Description

Technical Field

[0001] This disclosure (invention) generally relates to delivery devices for oral dosage forms, which may be solid, semi-solid, or liquid, such as granules and / or powders and / or liquids (e.g., drugs or pharmaceuticals in granule / powder / liquid form), and various aspects of such devices, such as those relating to dispensing granules / powders or liquids from the device, and the operation and mechanical properties of such devices. The invention aims to dispense reliable volume-based doses, for example, devices capable of dispensing different volume-based doses and / or different drugs. Background Technology

[0002] Solid oral dosage forms (“ODF”) of medicines can be formulated as tablets, granules, or even powders. Tablets or granules may contain different substances in which the main ingredient is an active pharmaceutical ingredient (“API”). Medicine granules can be administered to patients as pre-filled capsules or compressed with materials that facilitate filling. Dispensing mechanisms for various forms of ODF medicines are known and can be blister packs, where individual tablets can be held in a pocket using foil, or dispensing bottles. Various more complex mechanisms are also known, particularly for other types of pharmaceutical formulations, such as those present as granules, which are typically less than 10% of a specific dose per unit. An advantage of dispensing medicines in granule form is the ability to vary the dosage using the same dispensing device. Another advantage is that granules are easily swallowed by patients with swallowing difficulties who are currently crushing tablets for easier swallowing. Patients also now use methods of crushing or splitting tablets, such as obtaining half a dose from a prescription, which is not recommended and can be avoided if the device can dispense granules of varying elasticity. Compared to using larger dosage forms (such as tablets or capsules), the variable dosing of granules allows for more precise dosage adjustments. Furthermore, for modified release formulations, granules are generally more resistant to food interactions than larger dosage forms such as tablets.

[0003] Liquid dosage forms of pharmaceuticals are also known and generally correspond to liquid dosage forms of chemical compounds used as pharmaceuticals or intended for oral or consuming purposes. For example, liquid dosage forms can be prepared by dissolving the active pharmaceutical ingredient in water or a non-aqueous solvent, such as by suspending the drug in a suitable medium or by incorporating the drug into an oil or aqueous phase.

[0004] Various methods have been used to dispense precise doses of granular drugs, but dispensing specific doses of granules has been found to be challenging. Invention Overview

[0006] The following describes various aspects and embodiments of the dispensing apparatus that can be used in this invention, and any aspects and embodiments of the invention described herein, as they may be suitable.

[0007] In one aspect of the invention, an apparatus is provided for dispensing at least one oral dosage form (e.g., a drug or pharmaceutical agent in solid, semi-solid, or liquid form).

[0008] Oral dosage forms can be solid and may include one or more tablets, granules, and powders.

[0009] For example, oral dosage forms can be provided as solid units (e.g., particles), wherein the maximum size (e.g., width or diameter) of the unit (e.g., particle) can be as low as about 100 μm. The unit can be between about 150 μm and about 1200 μm (or even about 1500 μm), optionally between about 200 μm and about 300 μm. Other size ranges are also possible, such as between about 300 μm and about 500 μm, about 500 μm and about 700 μm, about 700 μm and about 900 μm, or about 800 μm and about 1100 μm.

[0010] A particularly preferred size range suitable for this invention has been found to be units (e.g., particles) with a maximum size (e.g., width or diameter) between about 100 μm and about 300 μm. Although larger sizes can still be used, using these smaller sizes avoids clogging and other adverse effects. Within this size range (about 100 μm to about 300 μm, for example, about 100 μm to about 250 μm and about 100 μm to about 200 μm), solid units of various materials have been found to have good performance.

[0011] The unit (e.g., granules) can be made of compressible and / or porous materials, which has been found to further prevent clogging / blockage, especially for the smaller sizes mentioned above. In further refinements, the compressibility index (Carl index) of the unit (e.g., granules) can be greater than 11% (e.g., 11-15%), or the compressibility index of the unit can be greater than 16% (e.g., 16-20%). As is known in the art, the Carl index is equal to 100 x (1 - (bulk density of the material / tap bulk density of the material)).

[0012] Typically, units (e.g., particles) can have inconsistent or non-spherical and / or irregular sizes. Particle sizes can be mixed within any specified range.

[0013] Oral dosage forms may be provided in powder form. The term "powder" as used herein should be considered as a normal definition in the art, such as fine, dry particles that may result from the disintegration of a solid substance. Therefore, in various embodiments, solid oral dosage forms may be in powder form with a maximum size (e.g., width or diameter) as low as about 40 μm, optionally up to about 250 μm or 300 μm. The compressibility index (Kal index) of the powder may be similar to that described above, i.e., above 11% (e.g., 11-15%) or above 16% (e.g., 16-20%).

[0014] Oral dosage forms can be liquid or semi-solid, which allows for the delivery of large quantities of drugs in liquid or semi-solid form (e.g., gels).

[0015] Turning now to the device, it includes at least one cartridge, wherein each cartridge may include one or more chambers configured to store an oral dosage form, such as multiple units and / or a volume of solid, semi-solid, or liquid oral dosage form. Each of the one or more chambers includes at least one outlet for dispensing the oral dosage form from the chamber.

[0016] The device further includes: a member movable between a first and a second position, wherein in the first position, the member is configured to receive and contain a specific volume of oral dosage form from a chamber of the cartridge via an outlet, wherein the member is movable to one or more intermediate positions in which the specific volume of oral dosage form is held and retained within the movable member, such that the oral dosage form cannot be dispensed therefrom (e.g., in the intermediate positions, the oral dosage form contained in the movable member in a specific volume can be substantially fixed, i.e., the volume remains substantially constant); and the member is movable from the intermediate positions to a second position in which the oral dosage form within the movable member can be dispensed therefrom.

[0017] This provides a device capable of repeatedly dispensing a specific volume of oral dosage form because it uses an intermediate position in which the oral dosage form (as a specific volume) contained within a movable member is substantially fixed. That is, in this intermediate position, the oral dosage form cannot be added to or lost / dispensed, for example, the oral dosage form cannot be dispensed into, through, or from the movable member.

[0018] This device is an improvement on conventional arrangements that involve dispensing a single unit of drug (i.e., pills one after another). This device is configured and optimized for volume-based dosing, rather than unit-based dosing. For example, oral dosage forms are typically much smaller than a single pill and can be provided in granule or powder form, where the device is configured to contain multiple solid particles (e.g., 10s, 100s, or even 1000s) in each chamber of a movable component (described below). Alternatively, as mentioned above, oral dosage forms can be semi-solid or liquid. In addition to these general considerations, as described above, it has been found that certain sizes of solid particles and certain types of materials offer optimized arrangements not envisioned by conventional single-unit mechanisms.

[0019] The component can slide or rotate between its first and second positions, which allows a chamber within the movable component to be configured to receive an oral dosage form, allowing it to slide or rotate as needed, for example, to move the chamber within the movable component to align and / or communicate with the chamber and / or outlet of the cartridge, and to misalign and / or not communicate with it. This provides a simple and efficient mechanism by which the component can be moved between first, intermediate, and second positions.

[0020] The movable member may include at least one chamber, wherein each chamber of the member is configured to receive and contain a single (specific) volume of oral dosage form from the cartridge. This means that the device can dispense different types of drugs using the same movable member. When the oral dosage form is solid, the chamber may be configured to contain multiple units (e.g., 10s, 100s, or even 1000s) to provide a reliable volumetric dose of a smaller unit type of drug. When the oral dosage form is semi-solid (e.g., gel) or liquid, the chamber is configured in an intermediate position to contain and retain the oral dosage form within the chamber, thus preventing it from being dispensed.

[0021] Typically, in the intermediate position, the chamber can be completely isolated (e.g., sealed) from any chamber of the cartridge, such that no part of any chamber aligns with or overlaps with a chamber of the cartridge. This differs from the conventional arrangement of transferring individual units (e.g., pills one after another), but uses only a slight misalignment, and cannot guarantee complete separation of the chamber of the movable component from the chamber of the cartridge when transferring the oral dosage form to be dispensed from the cartridge. This is especially important when the unit is small in size (e.g., in granule or powder form), semi-solid, or liquid, as conventional arrangements that are not isolated in this way would be completely unsuitable.

[0022] At least one chamber of the movable member may include a first chamber configured to receive and contain a first volume of oral dosage form from the cartridge, and a second separate chamber configured to receive and contain a second volume of oral dosage form from the cartridge. This allows the movable member to accommodate various volumes of oral dosage form contained in the cartridge.

[0023] Throughout the process of the component moving from the first position to the intermediate position, the first and second chambers of the component can receive and contain their respective first and second volumes.

[0024] The first volume of oral dosage form may differ from the second volume of oral dosage form, for example, different types (e.g., sizes) of oral dosage forms and / or different types of drugs. The first volume of oral dosage form may (optionally) be the same as the second volume of oral dosage form, for example, to provide greater flexibility when dispensing the same oral dosage form in different volumes.

[0025] The cartridge may include multiple chambers, such as a first chamber and a second separate chamber. Each chamber in the first and second chambers of the cartridge may be configured such that the oral dosage form in one chamber does not mix with the oral dosage form in the other chamber. Each chamber of the cartridge may include a separate outlet for dispensing the oral dosage form from the respective chamber. This allows the oral dosage forms in the chambers to be separated from each other during use.

[0026] The first chamber of the movable member is configured in its first position to receive and contain a first volume of oral dosage form from one of the first and second chambers of the cartridge via its respective outlet, and the second chamber of the movable member is configured in its first position to receive and contain a second volume of oral dosage form from the other chamber of the first and second chambers of the cartridge via its respective outlet.

[0027] In a first position of the component, its first and second chambers are configured to simultaneously receive and contain individual volumes of oral dosage forms from the cartridge, wherein in a second position of the component, its first and second chambers are configured to dispense their respective volumes of oral dosage forms from the cartridge.

[0028] In a first position of the component, its first chamber is configured to receive and contain a volume of oral dosage form from a cartridge, while the second chamber of the component is prevented from receiving the oral dosage form from the cartridge. In a second position of the component, its first chamber is configured to dispense the volume of the oral dosage form, and the second chamber of the component is configured to receive and contain a volume of oral dosage form from the cartridge.

[0029] In the first position, the second chamber can be configured as an oral dosage form for dispensing its volume.

[0030] The movable component may include a first portion having a first chamber and a second separate portion having a second chamber, wherein the first portion and the second portion are movable relative to each other. The first portion and the second portion may be separate workpieces connected together in a manner that allows one to move relative to the other.

[0031] The first and second parts can move relative to each other so that, in a first relative position, the first and second chambers of the component are aligned so that an oral dosage form can pass through them, and in a second relative position, the first and second chambers of the component are disaligned so that an oral dosage form cannot pass through them.

[0032] In a first position of the movable member, its first and second portions are movable to align with their first relative positions so that they are both configured to simultaneously receive and contain a volume of oral dosage form from the cartridge, wherein the first and second portions of the member are configured to remain aligned in their first relative positions throughout the movement of the member to the second position, thereby allowing the dispensing of an oral dosage form volume corresponding to the combined volume of the first and second chambers of the member.

[0033] In a first position of the movable member, its first and second portions are movable to a position not aligned with its second relative position, such that only one of the first and second chambers is configured to receive and contain an oral dosage volume from the cartridge, wherein the first and second portions of the member can be configured to move from its second relative position to its first relative position during the entire process of the member moving to the second position in order to align, thereby allowing the dispensing of an oral dosage volume corresponding to one of the first and second chambers of the member.

[0034] The first part may include a first disk having a first chamber with components, and the second part may include a second disk having a second chamber with components, wherein the first and second disks may rotate relative to each other and the cartridge.

[0035] A first disc can rotate between first positions, wherein the first chamber is configured to receive and contain a specific volume of oral dosage form from the cartridge. The first disc can then rotate to one or more intermediate positions, wherein the oral dosage form contained in the first chamber in a specific volume is substantially fixed. The first disc can then rotate from the intermediate position to a second position, in which the oral dosage form contained in the first chamber can be dispensed.

[0036] The second disc is rotatable between first positions, wherein the second chamber is configured to receive and contain a specific volume of oral dosage form from the cartridge. The second disc is rotatable to one or more intermediate positions, wherein the oral dosage form contained in the second chamber in a specific volume is substantially fixed. The second disc can then be rotatable from the intermediate position to a second position, in which the oral dosage form contained in the second chamber can be dispensed.

[0037] The component can be configured such that when the first disk rotates in a first direction, the second disk is also configured to rotate, and when the first disk rotates in a second opposite direction, the second disk is configured to remain stationary. This allows the first disk to be rotated in the first direction to dispense only oral dosage forms contained in the first chamber, and the first disk to be rotated in the second direction to dispense oral dosage forms contained in both the first and second chambers.

[0038] A one-way bearing may be located between the first and second disks. Alternatively, a ratchet mechanism may be located between the first and second disks.

[0039] The device may include one or more outlet channels configured to receive oral dosage forms dispensed from a movable component in its second location.

[0040] The device may include one or more rotating members extending through the cartridge. The rotating members may be configured to operate a plunger, as described below, and / or be configured to drive a corresponding screw pump to assist in dispensing the oral dosage form from one or more chambers of the cartridge into a movable member. The device may include an actuator configured to rotate the rotating members as described below.

[0041] The use of a screw pump is an optional feature and is not required for this invention. While the invention may have a particular use with the techniques described herein, any suitable method of dispensing oral dosage forms may be used, and the invention should not be considered limited to embodiments involving the use of a screw pump.

[0042] The cartridge can extend from the first end to the second dispensing end, and each screw pump can be located at the second dispensing end of the cartridge.

[0043] This device is a handheld device.

[0044] The device may also include multiple particles to provide an oral dosage form contained in each of the one or more chambers.

[0045] Each chamber may include a dispensing mechanism, such as a screw pump, such as an Archimedes screw, wherein each dispensing mechanism is configured to receive multiple oral dosage units from the respective chambers and (e.g., while the screw pump is rotating) deliver oral dosage units from the respective chambers for dispensing from the device described herein (and, for example, cartridges and / or chambers).

[0046] The rotating member described above can extend through each chamber and can be configured to drive a dispensing mechanism (e.g., a rotary screw pump) to dispense multiple oral dosage units therefrom.

[0047] The cartridge may include one or more outlet tubes extending from each chamber. Each outlet tube may contain its own dispensing mechanism (e.g., a screw pump).

[0048] In one aspect of the invention, a method is provided using an apparatus having a dispensing mechanism (e.g., a screw pump described above or a plunger described below), the method comprising driving one or more dispensing mechanisms (e.g., rotation of a rotating member) to dispense a dosage form from various chambers.

[0049] The method may also include:

[0050] Use oral dosage forms to fill the chamber;

[0051] Determine the driving amount (e.g., rotation of a rotating component) that will result in the dispensing of a predetermined amount of oral dosage form from the device; and

[0052] A predetermined amount of oral dosage form is dispensed from the device by driving the dispensing mechanism (e.g., rotating the rotating member) to dispense the predetermined amount of oral dosage form.

[0053] The chamber can extend from the first end of the device to the second dispensing end. The cartridge can extend from the first end to the second dispensing end, and the drive mechanism (e.g., a screw pump) can be located at least partially at the second dispensing end of the chamber.

[0054] The drive mechanism can be gravity-driven. In other words, when the device is in the dispensing direction (e.g., dispensing end facing down), the oral dosage form contained in the chamber can be moved at least partially by gravity toward the second dispensing end.

[0055] The device can be handheld and / or portable. In other words, the device can be held and transported with one hand, and / or operated with one palm.

[0056] For example, the length of the device (corresponding to its longest dimension) does not exceed about 250 mm (e.g., less than about 200 mm, about 150 mm, or about 100 mm), and the width or height (i.e., transverse to its length) does not exceed about 50 mm, and optionally does not exceed about 40 mm (in some embodiments less than 30 mm or even less than 20 mm).

[0057] To optimize its handheld nature, the device may have a length of about 150 mm to about 220 mm (e.g., about 160 mm to about 180 mm, and optionally about 165 mm), a width of about 35 mm to about 45 mm (optionally about 40 mm) (lateral to its length), and a height of about 22 mm to about 32 mm (optionally about 28 mm) (lateral to its width).

[0058] The device can weigh no more than approximately 500 grams, 400 grams, 300 grams, 200 grams, or even 100 grams. This ensures that the device is light enough to be carried with one hand.

[0059] In embodiments involving screw pumps and rotating components as part of an actuator, each screw pump may be or include part of a respective rotating component. For example, a screw pump may include one or more threads formed around the rotating component. The term "one or more" is used here because a screw pump may include one or more threaded ends, each forming a separate thread. Although the plural form of the term is used below for brevity, it is worth noting that the reference to a thread includes a single thread.

[0060] The device can be configured such that, as the rotating component and the screw pump rotate in use, the oral dosage form moves along the threads of the screw pump from the threaded portion extending to each corresponding chamber to the other end of the thread for dispensing from the screw pump.

[0061] The thread can mate with the inner cylindrical surface of each corresponding cartridge to form a screw pump, so that as the rotating component rotates in use, the thread rotates within the inner cylindrical surface, thereby allowing the oral dosage form contained in the chamber to enter the thread and move downward along the thread for dispensing from the screw pump. It should be noted that the cartridge itself is not typically cylindrical. Rather, to form a screw pump, the cartridge may include an inner cylindrical surface, although this does not necessarily mean that the cartridge itself is integrally or partially cylindrical.

[0062] In any aspect and embodiment described herein, gravity (and / or the plunger device described below) may be used to move the oral dosage form to the dispensing end of the chamber from which it may be dispensed (e.g., through an outlet) and / or collected by a corresponding dispensing mechanism (e.g., a screw pump).

[0063] The device may also include one or more means (e.g., plungers) configured to force the oral dosage form contained in each chamber toward its respective outlet and / or dispensing mechanism (e.g., a screw pump). In addition to gravity, the device may function to move the oral dosage form in the chamber toward the outlet using a combination of gravity and forces provided by the device. For example, the device may be or include a plunger (e.g., in the form of a weight) configured to remain stationary on top of the oral dosage form contained in the chamber when the device is in the orientation allowing dispensing of the oral dosage form.

[0064] As described above, a dispensing mechanism can be provided by a combination of a plunger and a rotating member, wherein the dispensing mechanism includes a plunger configured to move automatically along or to each rotating member and / or due to rotation of the rotating members. For example, a portion of the rotating member in each respective chamber may include threads (e.g., plunger threads), and the plunger may form a nut around the rotating member, configured to move along the threads of the rotating member in use, such that as the rotating member rotates, the plunger moves toward the outlet and / or the dispensing mechanism (e.g., a screw pump) to force (push) the oral dosage form contained in the chamber toward its outlet / dispensing end.

[0065] In particular (though not limited to) in the case of semi-solid or liquid formulations, a plunger can seal (e.g., the fluid) against the chamber wall and / or along the threads or grooves along which the plunger moves to help prevent unwanted leaks in the various chambers and passages of the device. Suitable fluid seals can be used between the various components of the device, especially any components that move relatively, to help prevent accidental leaks.

[0066] The device may also include a valve configured to prevent the oral dosage form from being unintentionally dispensed from the outlet of the chamber, for example, outside of a dispensing operation (e.g., when the screw pump is not rotating) or before use. The valve may be configured to allow dispensing of the oral dosage form only during a dispensing operation (e.g., while the rotating member is rotating).

[0067] The valve may include a resilient portion, such as a rubber diaphragm, configured to bend open to allow dispensing of oral dosage forms (e.g., when the rotating part is rotating in use), and then bend back (e.g., when the rotating part is not rotating) to prevent or stop the oral dosage form from falling out of the chamber and to help seal the chamber and / or cartridge.

[0068] The device may include one or more actuators configured to operate each dispensing mechanism (e.g., rotate each rotating member). The actuators may be mechanical or electromechanical. The actuators may be located at a first end of the device.

[0069] The actuator may be configured to rotate each rotating member (in a relevant embodiment). This may cause (also in a relevant embodiment) the plunger to move downwards along the helical portion of the rotating member, and / or the helical portion to rotate, thereby resulting in the dispensing of an oral dosage form.

[0070] The actuator may be an electromechanical actuator (e.g., including one or more motors) or may include an electromechanical drive mechanism so that the device can repeatedly dispense precise doses or quantities (e.g., precise volumes) of oral dosage forms. The motors and control system may be powered by an integrated battery (which may be replaced by the user), and the battery may be fixed within the actuator housing.

[0071] The device may include a control system (e.g., as part of an actuator) configured to dispense a dose or amount (e.g., a precise amount) within a predetermined time period (e.g., less than 2, 3, or 5 seconds) upon receiving a drive signal from an input device or mechanism. For example, the activation signal may be initiated by a user pressing an appropriate button or other input mechanism located on the device, or by various control devices (optionally) such as wireless or wired external controls.

[0072] The actuator may include one or more electric (e.g., stepper motor) motors that can be configured to operate the dispensing mechanism at any suitable number of revolutions (e.g., steps) depending on available resources, such as the type of oral dosage form / drug in the chamber, or according to the user. The control system may be provided in the form of a microcontroller, for example, on a printed circuit board (“PCB”), which may be located within a device housing within the actuator.

[0073] In aspects of the invention, methods of using the device in any of the foregoing aspects and embodiments are provided. The method may include operating at least one of the dispensing mechanisms, for example, by rotating a rotating member by a predetermined amount to dispense a predetermined amount of oral dosage form from the device.

[0074] The method may further include filling each chamber with an oral dosage form, determining the amount of rotation of the screw pump that will cause a predetermined amount of oral dosage form to be dispensed from the device, and operating at least one of the dispensing mechanisms, for example, by rotating the rotating member by a predetermined amount to dispense the predetermined amount of oral dosage form from the device. As mentioned above, the oral dosage form may be solid, semi-solid, or liquid.

[0075] The method may include storing an oral dosage form within a cartridge (e.g., its chamber). The oral dosage form may include a drug or compound for treating one or more attention deficit hyperactivity disorder (“ADHD”), wherein the drug or compound may include amphetamines and / or methylphenidate, general pain (wherein the drug or compound may include one or more of fentanyl, methadone, piperidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrocortisone, oxycodone, hydromorphone, naltrexone, buprenorphine, and methadone), post-organ transplant immunosuppression (wherein the drug or compound may include one or more of tacrolimus, sirolimus, everolimus, corticosteroids, cyclosporine, mycophenolate mofetil, and azathioprine), diabetes (wherein the drug or compound may include one or more of sitagliptin, vidagliptin, saxagliptin, linagliptin, metformin, cargglitazone, dapagliptin, enpagglitazone, and cemaglutide). Multiple diseases, heart failure (where the drug or compound may contain one or more of carvedilol, metoprolol, bisoprolol, and diuretics), Parkinson's disease (“PD”, where the drug or compound may include levodopa and / or carbidopa), epilepsy (where the drug or compound may include one or more of sodium valproate, carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, ethioxime, and topiramate), depression (where the drug or compound may include one or more of citalopram, bupropion, paroxetine, mirinacipram, fluoxetine, duloxetine, fluvoxamine, and reboxetine), schizophrenia (where the drug or compound may include one or more of aripiprazole, asenapine, buripiprazole, carrezine, clozapine, ilopridone, fluprazole, and olanzapine), cancer, and animal health.

[0076] Oral dosage forms may include a drug or compound for the treatment of one or more of the following: Leo watermelon or celecoxib for pulmonary hypertension; pirenpoxetine or cefenobarbital for epilepsy; ciponimo for multiple sclerosis; votizoxetine, aripiprazole, buripiperazole, or caripirizine for depression / schizophrenia; lenalidomide for myeloma; memantine for Alzheimer's disease; deflazacort or ataluren for Duchenne muscular dystrophy; deterbunazine for tardive dyskinesia; osimertin for Cushing's disease; cezonatovir for respiratory syncytial virus; peanut allergen powder; fenfluramine for Dravet syndrome.

[0077] This method may include using the device in the treatment of one or more types of attention deficit hyperactivity disorder (“ADHD”), generalized pain, post-organ transplant immunosuppression, diabetes, heart failure, Parkinson’s disease (“PD”), epilepsy, depression, schizophrenia, cancer, and animal health. When used in a particular treatment, the oral dosage form (e.g., a chamber) within the cartridge may include one or more of the drugs or compounds described above for that particular treatment.

[0078] definition

[0079] Particles – Single particles / units of solid oral dosage forms (such as pharmaceuticals, drugs, preparations, etc.) with a maximum size (such as width or diameter) as low as about 100 μm. The unit may be between about 150 μm and about 1200 μm (or even about 1500 μm), optionally between about 200 μm and about 300 μm. Other size ranges are also possible, for example, between about 300 μm and about 500 μm, about 500 μm and about 700 μm, about 700 μm and about 900 μm, or about 800 μm and about 1100 μm.

[0080] A particularly preferred size range suitable for this invention has been found to be units (e.g., particles) with a maximum size (e.g., width or diameter) between about 100 μm and about 300 μm. Although larger sizes can still be used, using these smaller sizes avoids clogging and other adverse effects. Within this size range (about 100 μm to about 300 μm, for example, about 100 μm to about 250 μm and about 100 μm to about 200 μm), solid units of various materials have been found to have good performance.

[0081] Powder - Fine, dry particles produced by the decomposition of solid matter (e.g., crushing, grinding), with the maximum size (e.g., width / diameter) of each particle as low as about 40 μm, optionally up to about 250 μm or 300 μm.

[0082] Dosage – A single measurement (e.g., volume or weight) of an oral dosage form (e.g., solid, semi-solid, or liquid), for example, a total volume between about 0.05 ml and about 0.8 ml (e.g., about 0.1 ml to about 0.6 ml), or a volume of about 0.3 ml (although it should be noted that oral dosage forms are sometimes measured by weight).

[0083] Dispensing mechanism – a system, for example, an electromechanical system that translates user behavior into dose dispensing.

[0084] Drug cartridge – a component for storing and dispensing oral dosage forms, such as a replaceable component, optionally including features of a device, such as a rotating member in the form of a central threaded rod, a movable plunger, and an oral dosage form.

[0085] A plunger – a plate that ensures the oral dosage form moves toward the dispensing end of the cartridge (or remains packaged together if it is a solid oral dosage form) (although other types of plungers are envisioned). The plate can be substantially rigid, but portions of the plate can be flexible, such as those that interact with other parts of the cartridge.

[0086] Dispensing port – the open end of the cartridge or chamber that allows dispensing of oral dosage forms for consumption.

[0087] A lid is a container or tray that covers the delivery port to collect the dose and protect stored oral dosage forms from moisture.

[0088] Press – An operation performed on the device when a user wishes to administer their specified dose; this can be a rotation or a linear motion.

[0089] It is important to note that the term "one" drug or agent as used herein can be considered as "one or more" drugs or agents. For example, an oral dosage form may contain several drugs or agents. This can be achieved by mixing solid oral dosage forms, each containing a different drug or agent (e.g., each oral dosage form unit may contain a drug different from the other units), and / or by mixing drugs or agents within each solid oral dosage form (e.g., each unit itself may contain a different type of drug or agent). Brief description of the attached diagram

[0091] Various embodiments will now be described by way of example and with reference to the accompanying drawings, wherein:

[0092] Figure 1 A cross-sectional view of a portion of the display device 100, which is a delivery device capable of dispensing drugs or agents;

[0093] Figure 2 Embodiments of a display device, the device may include Figure 1 Features of the device shown;

[0094] Figure 3A - An embodiment of the C display device includes a cartridge having a separate chamber configured to store an oral dosage form;

[0095] Figure 4A -C displays Figure 3A -C is an embodiment, but in which the movable component is similar to Figure 2 The manner described is to slide between its first and second positions;

[0096] Figure 5A -C, 5D-F, and 5G-I illustrate embodiments including a movable component that is divided into individual workpieces that are movable relative to each other;

[0097] Figure 6A-C, 6D-F, and 6G-I are similar to... Figure 5A -C, 5D-F and 5G-I embodiments, but including movable members, wherein the first part and the second part are slidable relative to each other rather than rotatable;

[0098] Figure 7 An embodiment of the display device, wherein the movable component is divided into multiple parts;

[0099] Figure 8A -F Diagrammatic Explanation (Illustrative) Figure 7 Examples of embodiments and rotation sequences that can be used to dispense oral dosage forms from a device;

[0100] Figure 9 Schematic display with Figure 7 Similar but alternative embodiments, wherein one or more ratchet mechanisms are used instead of one-way bearings; and

[0101] Figure 10 Examples of devices capable of dispensing drugs or pharmaceuticals are shown. Invention Details

[0103] Figure 1 A cross-sectional view of a portion of device 100 is shown, which is a delivery device capable of dispensing drugs or pharmaceutical preparations (e.g., oral dosage forms). This is merely an example of a device that may be suitable for use with the invention as defined in the broadest terms of the claims. For example, various examples of such devices are described in PCT applications PCT / EP2018 / 085320 and PCT / EP209 / 079999, the contents of which are incorporated herein by reference in their entirety. For simplicity, different types of devices are not described in detail herein, and it should be understood that any suitable device for dispensing oral dosage forms (e.g., solids or liquids) can be used, and the invention should not be considered as limited to use with any particular type of device or mechanism for dispensing oral dosage forms.

[0104] It is further recognized that, as discussed in more detail below, the present invention relates in various embodiments to a device for dispensing volume-based doses of drugs or pharmaceutical agents (e.g., oral dosage forms). Therefore, the embodiments discussed below are well-suited for use in conjunction with devices for solid oral dosage forms (e.g., tablets and granules), as well as smaller types (e.g., powders), and even semi-solid or liquid dosage forms.

[0105] For the sake of brevity, various embodiments and figures may show or describe solid oral dosage forms (e.g., granules), but this should not be construed as limiting the use of this invention to such dosage forms. In other words, in general, this invention and its various embodiments should not be considered as limited to a particular type of dosage form.

[0106] The device 100 includes a first end 102 for connecting an actuator 300 or other drive mechanism (e.g., a motor), and a second end 104 (opposite to the first end 102) including a dispensing end of the device 100. In use, a drug (e.g., an oral dosage form) is dispensed from the second end 104 due to the operation of the drive mechanism (e.g., a motor).

[0107] The device 100 includes a cartridge 200 and is configured to be connected to an actuator 300 or a drive mechanism (e.g., a motor) at a first end 102 of the device 100.

[0108] The device 100 includes one or more rotating members 250 extending through the cartridge 200. As described below, at a first end 102 of the device 100, the rotating member 250 is connected to an actuator 300, which is configured to rotate the rotating member 250 (e.g., individually and / or independently) to dispense an oral dosage form from a second end 104 of the device 100.

[0109] The device 100 includes one or more outlet tubes 212 located at its second end 104, through which oral dosage forms (drugs, pharmaceuticals, etc.) can be dispensed.

[0110] Figure 1 The interior of the cartridge 200 and some features of the rotating member 250 are shown in more detail. The cartridge 200 is hollow and includes one or more chambers 220 for containing multiple oral dosage form units (e.g., granules), and the rotating member 250 extends from a first end 102 of the device 100 to a second end 104 of the device 100.

[0111] The chamber 220 and / or cartridge 200 can be substantially fluid-tight and / or gas-tight (e.g., except for the channel for dispensing the granules). For example, at the first end 102, the connection between the rotating member 250 and the cartridge 200 may include a seal, such as a resilient gasket or a valve (not shown). Similarly, at the second dispensing end 104 of the device 100, a suitable seal (not shown) may be provided between the rotating member 250 and the outlet tube 212.

[0112] Alternatively, a valve (not shown) may be used to at least partially seal the second dispensing end of device 100. This valve may be connected to each outlet tube 212 and configured to prevent unintentional dispensing of oral dosage form from the outlet tube, for example, when the dispensing mechanism is not operated (e.g., the rotating member 250 is not rotated) or before use, outside of dispensing operations. The valve may be configured to allow dispensing of oral dosage form from the dispensing mechanism only during dispensing operations (e.g., when the rotating member 250 is rotated). The valve may include a resilient and / or deformable material, such as a rubber membrane, configured to bend open to allow dispensing of oral dosage form from outlet tube 212 (e.g., when the rotating member 250 is rotated in use), and then bend back (e.g., when the rotating member 250 is not rotating) to prevent oral dosage form from falling / dripping from outlet tube 212 and to help seal chamber 220.

[0113] As one or more rotating members 250 rotate, the oral dosage form is pushed toward the end of the outlet tube 212 for dispensing from the device 100. Upon encountering an elastic material, the oral dosage form is pressed against the elastic material, causing it to deform and create a gap through which the oral dosage form can be dispensed. At the end of the dispensing operation, once the rotating members 250 stop rotating, the oral dosage form is no longer pressed against the deformable material, and the deformable material can spring back to its resting sealed position.

[0114] The valve helps prevent air and / or moisture from entering chamber 220 and interacting undesirably with the oral dosage form unit.

[0115] Each rotating member 250 may extend into a corresponding outlet tube 212 at the second end 104 of the device 100 and may include a helical portion 240. The outlet tube 212 and the helical portion 240 may be combined to form a screw pump 210, configured to dispense oral dosage forms from the second end 104 of the device 100. That is, the oral dosage form will enter the threads 242 of the helical portion 240 and, as the rotating member 250 rotates, will be extruded through the threads 242 into the outlet tube 212 and dispensed from the device 100. A screw pump 210 is not necessary, and the chamber may simply be included at the outlet at the dispensing end through which the dispensing unit (particles) is dispensed (e.g., by gravity alone). For example, the outlet tube 212 may be hollow or not used (in which case a simple hole may exist in the end face 234 of the chamber 220).

[0116] Each rotating component 250 may have a longitudinal axis A about which it rotates, which may also be the rotation axis of the screw pump 210.

[0117] The device 100 may also include one or more plungers 230 configured to move automatically or due to rotation of the rotating member 250 along the respective rotating member 250.

[0118] As described above, each cartridge 200 stores an oral dosage form within one or more chambers 220. In embodiments involving one or more plungers 230, the volume of each chamber 220 varies due to the action of the plungers 230 during operation of the device 100 and throughout its service life, as will be described in more detail below.

[0119] At one end, each chamber 220 is at least partially closed by its respective plunger 230, more specifically, the radially extending surface 232 of the plunger 230 faces the chamber 220. The other end of the chamber 220 is at least partially closed by a corresponding surface 234 of the cartridge 200. Each rotating member 250 extends along its longitudinal axis A through its corresponding chamber 220.

[0120] When the rotating member 250 rotates during use, the plunger 230 rests on top of the oral dosage form (not shown) located in the chamber 220.

[0121] The plunger 230 can move the oral dosage form within the chamber 220 toward the screw pump 210 (or outlet if the screw pump 210 is not used) by gravity. For example, the plunger 230 can be a weight configured to remain on top of the oral dosage form contained within the chamber when the device 100 is in the orientation that allows dispensing the oral dosage form.

[0122] Each plunger 230 may be configured to move automatically along its respective rotating member 250, or to move due to rotation of the rotating member 250. For example, a portion of the rotating member 250 within the chamber 220 may include a thread 252 (e.g., a plunger thread, which may differ from any thread 242 of the screw pump 210, if provided), and the plunger 230 may have a nut formed around the rotating member 250, which is configured to move along the thread 252 of the rotating member 250 such that as the rotating member 250 rotates, the plunger 230 moves toward the screw pump, thereby forcing the particles contained within the chamber 220 toward the screw pump 210 (or, if the screw pump 210 is not used, toward the outlet).

[0123] In particular (though not limited to) for liquid dosage forms, the plunger 230 can be sealed (e.g., fluid-sealed) against the walls of the chamber 220 and / or its threaded 250 along which it moves to prevent accidental leakage. For example, suitable resilient seals configured for fluid sealing can be provided against the walls of the chamber 220 and / or the threaded 250.

[0124] As the plunger 230 translates along the rotating member 250, the volume of the chamber 220 gradually decreases. Furthermore, throughout the operation and lifespan of the device 100, the plunger 230 will force (push) the oral dosage form contained within the chamber 220 toward the second end 104 of the cartridge 200. During use, the radially extending surface 232 of the plunger 230 presses against the oral dosage form and towards the second dispensing end 104 of the device 100, which, in the case of solid oral dosage forms, especially granules, helps to tightly package them within the chamber 220.

[0125] However, it should be noted that while the use of plunger 230 is useful, it is not important for the broadest aspects of the invention described herein.

[0126] At the second dispensing end 104 of the cartridge 200, the rotating member 250 includes a helical portion 240 that is axially separated from the thread 252 that mates with the plunger 230.

[0127] Figure 1 The second dispensing end 104 of the cartridge 200 is shown, at which there is an optional outlet tube 212, through which an optional spiral portion 240 of each rotating member 250 extends, as described above.

[0128] Each helical portion 240 includes a thread 242 configured to receive an oral dosage form contained within its respective chamber 220 and, as the rotating member 250 rotates, dispense it from the outlet tube 212 along the thread 242. The thread 242 includes one or more starting points, each forming a continuous helix of oral dosage form filling during operation of the device 100, for example, due to the action of the plunger 230, if provided, pressing the oral dosage form within the chamber 220 can force it into the thread 242.

[0129] The helical portion 240 and its thread 242 contact the inner radial surface of the outlet tube 212, thereby forming a screw pump 210 (e.g., an "Archimedes" screw) with the outlet tube 212 of the cartridge 200. That is, when the rotating member 250 rotates, the helical portion 240 and the thread 242 also rotate, causing the oral dosage form contained in the chamber 220 to enter the gap of the thread 242, move downward along the thread 242, and exit the cartridge 200. The screw pump 210 may include an outlet 243 through which the oral dosage form is dispensed.

[0130] The actuator 300 or drive mechanism (e.g., one or more motors 302) may be configured to rotate the respective rotating members 250 (e.g., individually and / or independently) and may be connected to the rotating members 250 at the first end 102 of the device 100 as described above.

[0131] Actuator 300 may be configured to provide rotational force to rotating member 250, and thereby to threads 242, 252 of rotating member 250. Actuator 300 may be mechanical (e.g., manually operated) or electromechanical (e.g., electrically operated, such as an electric motor). Actuator 300 (or control unit containing actuator) may be detached from cartridge 200 so that different cartridges 200 may be connected to the same actuator 300 or control unit.

[0132] To dispense an oral dosage form from cartridge 200, actuator 300 may rotate one or more rotating members 250. This causes the rotating members 250 to rotate, thereby dispensing the oral dosage form (e.g., via screw pump 210).

[0133] The device 100 may include a control system (e.g., as part of the actuator 300 or control unit) configured to dispense an oral dosage form contained in the chamber 220, for example, upon receiving a drive signal from an input device or mechanism. The activation signal may be initiated, for example, by a user pressing an appropriate button or other input mechanism located on the control unit, or via various control devices (optional), such as wireless or wired external control.

[0134] By using an electromechanical drive mechanism, device 100 can repeatedly dispense precise doses or quantities (e.g., volumes) of oral dosage forms. Motor 302 and control system can be powered by an integrated battery (replaceable by the user) that is secured within the housing of actuator 300.

[0135] Actuator 300 may include one or more motors 302. Actuator 300 (e.g., its motors 302) may be configured to rotate each rotating member 250 by an amount corresponding to a prescribed dose or partial dose (which may correspond to a specific volume of an oral dosage form).

[0136] Motor 302 may be a stepper motor, which may be configured to rotate the corresponding rotating member 250 in any suitable number of steps, depending on the available resources, such as the type of drug within cartridge 200 or the user. The control system may be provided in the form of a computer, processor, processing device, circuit, or microcontroller, for example on a PCB, which may be located within the housing of device 100 within actuator 300 or control unit.

[0137] The volume of each chamber 220 (i.e., before operation or at maximum volume) may be less than about 50 mL, for example less than 20 mL or about 11 mL.

[0138] In various embodiments, the thread 242 (if provided) may extend into the chamber 220 by a distance approximately one or two times the diameter of the rotating member 250, for example, approximately one, 1.5, or two times the diameter of the rotating element 250. This can help prevent certain adverse effects, such as “bulging” of particles within the chamber 220 or shrinkage of other dosage forms in the case of re-granulation. The length of the helical portion 240 may be determined by the length of the thread 242, which may be between approximately 10 mm and approximately 30 mm, for example, between approximately 10 mm and 20 mm.

[0139] The length of each outlet pipe 212 (if provided) may be between about 5 mm and about 20 mm (optionally between about 10 mm and about 15 mm), wherein the length of the thread 242 along the longitudinal axis A of the chamber 220 may be at least the length of the outlet pipe 212 in the same direction, for example, between about 1 and about 10 times the length of the outlet pipe 2121, or about 1 to about 5 times the length of the outlet pipe 212, for example, about 1.2, 1.3, 1.4, 1.5 or 2 times the length of the outlet pipe 212 (this applies to all aspects and embodiments including the outlet pipe 212).

[0140] The depth of each thread 242 can be between approximately 1 mm and approximately 3 mm. Alternatively, for solid oral dosage forms, the depth of the thread 242 can be adjusted according to its diameter (e.g., the diameter of the granule). For example, the depth of the thread 242 can be greater than the diameter of the granule (or the smallest granule contained in the chamber 220). Similarly, the height of the thread 242 can range from approximately 1 mm to approximately 10 mm, for example, from approximately 1 mm to approximately 4 mm.

[0141] The actuator 300 (if equipped with an electric motor 302) can be configured to rotate the corresponding rotating member 250 at a rate of about 50 rpm to about 500 rpm, optionally between about 90 rpm and about 150 rpm.

[0142] although Figure 1 The illustration shows an embodiment comprising two chambers 220 placed side-by-side, but more or fewer chambers 220 may be provided. As described above, a single chamber 220 may be used. The two chambers 220 may be adjacent as shown or not adjacent, and may be operated by a universal actuator 300.

[0143] Actuator 300 may form part of a control unit (in any aspect or embodiment described herein), which may include input devices or user interfaces, including one or more buttons for operating device 100. The control unit may include control systems configured to operate various electrical and mechanical components of device 100, such as user interfaces, display and distribution mechanisms.

[0144] Various aspects of the invention will now be described with respect to various embodiments of a device capable of controlling the dispensing of an oral dosage form from one or more chambers, wherein the oral dosage form may be a solid, semi-solid, or liquid oral dosage form stored in a chamber. These chambers may be as described above (e.g., such as...). Figure 1 As shown, this is part of a device 100, in which each chamber 220 contains a dispensing mechanism. However, these chambers may simply be chambers without an active dispensing mechanism, so that oral dosage forms are dispensed from the chambers simply by dropping, dripping, or otherwise due to gravity or other reasons. It should be noted that semi-solid and / or liquid oral dosage forms may be retained within the chambers and dispensed using any suitable mechanism, such as by capillary force.

[0145] Figure 2 One embodiment of the display device 100 may include Figure 1 The features of the illustrated device 100, wherein similar features are indicated by similar reference numerals. It should be noted that... Figure 2 This is a height diagram to indicate the operation of the device, as can be clearly seen from the discussion below.

[0146] Figure 2 The illustrated device 100 includes a cartridge 200 containing two separate chambers 220A and 220B, each configured to store an oral dosage form. Each chamber 220A and 220B includes a longitudinal axis A. The oral dosage form can be loaded into chambers 220A and 220B located at a first end 202 of the cartridge 200. A suitable cap (not shown) can be placed over the first end 202 to seal chambers 220A and 220B. The oral dosage form can then be configured to move to a second dispensing end 204 of the cartridge 200 and be dispensed therefrom by gravity. Alternatively, a dispensing mechanism, such as an actuator 300 including a rotating member 250, and a plunger 230 and / or a screw pump 210, can be incorporated into the cartridge 200 relative to each chamber 220A and 220B to move the oral dosage form toward the dispensing end 204 from which it is dispensed.

[0147] Device 100 includes Figure 2 The movable member 400 shown is operatively connected to the dispensing end 204 of the cartridge 200 and is configured to control the movement of an oral dosage form to be dispensed from the cartridge 200 through chambers 220A, 220B.

[0148] For this purpose, component 400 includes a first chamber 402 configured to selectively communicate with the first chamber 220A of cartridge 200 and the outlet channel 502 of device 100, wherein component 400 is movable so that in a first position, the first chamber 402 is configured to receive an oral dosage form from the first chamber 220A, and in a second position, the first chamber 402 is configured to dispense the oral dosage form into the outlet channel 502. In the first position, the first chamber 402 may not be in communication with the outlet channel 501, and similarly, in the second position, the first chamber 402 may not be in communication with the first chamber 220A within the first chamber 220A.

[0149] The component 400 also includes a second chamber 404 configured to selectively communicate with a second chamber in chamber 220B of the cartridge 200 and an outlet channel 502 of the device 100. The component 400 is movable such that, in a first position, the second chamber 404 is configured to dispense an oral dosage form into the outlet channel 503, and in a second position, the second chamber 404 is configured to receive an oral dosage form from the second chamber in chamber 220B. In the second position, the second chamber 404 may not be in communication with the outlet channel 502; similarly, in the first position, the second chamber 404 may not be in communication with the second chamber 220B.

[0150] The outlet channel 502 may have a longitudinal axis X, which is offset from the two axes A of the chambers 220A and 220B.

[0151] Figure 2 The component 400 is shown in its first position, wherein the component 400 is movable (in this case, slidable) between its first and second positions, for example, it can slide along track 504, as shown. Note that for simplicity, parts of component 400 may not be shown. Figure 2 For example, component 400 may include a baffle that is configured to cover the outlet of one of the chambers 220A, 220B when an oral dosage form is dispensed from another chamber of chambers 220A, 220B.

[0152] The outlet channel 502 and optional track 504 may form part of the cap 500. The outlet channel 503 may be introduced into the collection area 506 in the form of a cavity within the cap 500. The device 100 may also include a housing (not shown) that holds each of the cartridge 200, member 400, and cap 500 in relative positions such that member 400 can slide between its first and second positions as described above, while cartridge 200 and cap 500 remain stationary. The housing may be configured to selectively close the collection area 506 to retain the oral dosage form dispensed into the collection area until it needs to be dispensed from. Various selective closure mechanisms may be used, such as caps, stoppers, plugs, etc.

[0153] Device 100 may have a ratio Figure 1 and 2 The simpler mechanism shown is an example. Figure 3A As shown in Figure C, the device 100 may include a cartridge 200 having a separate chamber 220 configured to store an oral dosage form (although multiple chambers may be provided). For convenience, this is shown as multiple granules in these figures, but as mentioned above, the oral dosage form can be of different types, such as different types of solid dosage forms, or semi-solid or liquid dosage forms. Regardless of the dosage form used, the concept is essentially the same. Figure 2 The concepts described are similar.

[0154] In the case of semi-solid or liquid formulations, suitable fluid seals can be used between various components, especially between moving parts, to prevent unwanted leakage from the various chambers and channels of the device 100.

[0155] The device 100 includes a movable (rotatable in this case) member 400, which includes first and second chambers 402, 404. The individual chamber 220 of the cartridge 200 includes two separate outlets (e.g., outlet pipes) 212, wherein the particles contained in the individual chamber 220 of the cartridge 200 are configured to enter the outlet pipes 212 by gravity.

[0156] The first and second chambers 402 and 404 of the rotating member 400 are configured to align with and exit the outlet tube 212, such that at a point during rotation of the rotating member 400, the first and second chambers 402 and 404 are aligned with the outlet tube 212, thereby allowing the oral dosage form contained within the chamber 220 to move through the outlet tube 212 into the first and second chambers 402 and 404. This position is as follows: Figure 3A As shown.

[0157] The device 100 also includes a generally solid cover 500 having a pair of outlet channels 502, which are also configured to align with the first and second chambers 402, 404, but the rotational position of the rotating member 400 differs from its rotational position aligned with the outlet pipe 212. This means that the rotating member 400... Figure 3A After rotation to the indicated position, the oral dosage form contained in the first and second chambers 402, 404 will remain therein, while the cap 500 will block the outlet tube 212 and prevent the oral dosage form from being dispensed from chamber 220. This position is as follows... Figure 3B As shown.

[0158] After the rotating member 400 rotates further, the first and second chambers 402, 404 will eventually align with the outlet channel 502, which will cause the oral dosage form to fall out or otherwise be removed from the first and second chambers 402, 404 for dispensing from the device 100. This position is as follows: Figure 3C As shown.

[0159] Figure 4A -C displays something similar to Figure 3A -C, but in which movable component 400 is similar to Figure 2 The method described is to slide between its first and second positions.

[0160] In this embodiment, the cartridge 200 and Figure 3A -C is essentially the same, including a separate chamber 220 and a pair of outlets (e.g., outlet tubes) 212. Cover 500 includes a single outlet channel 502 instead of the dual outlet channels shown in the previous embodiment.

[0161] The sliding member 400 includes a first chamber 402 configured to selectively communicate with a first outlet tube 212A of the cartridge 200 and an outlet channel 502 of the cap 500. The member 400 is movable such that, in a first position, the first chamber 402 is configured to receive an oral dosage form from the first outlet tube 212A, and in a second position, the first chamber 402 is configured to dispense an oral dosage form into the outlet channel 502. In the first position, the first chamber 402 may not be in communication with the outlet channel 501; similarly, in the second position, the first chamber 402 may not be in communication with the first chamber in the outlet tube 212A.

[0162] The component 400 also includes a second chamber 404 configured to selectively communicate with the second outlet tube 212B of the cartridge 200 and the outlet channel 502 of the device 100, wherein the component 400 is movable such that, in a first position, the second chamber 404 is configured to dispense an oral dosage form into the outlet channel 502, and in a second position, the second chamber 404 is configured to receive an oral dosage form from the second outlet tube 212B. In the second position, the second chamber 404 may not be in communication with the outlet channel 502, and similarly, in the first position, the second chamber 404 may not be in communication with the second outlet tube 212B.

[0163] Figure 4A The sliding member 400 is positioned such that the oral dosage form can be dispensed from chamber 220 of cartridge 200 into first chamber 402 via first outlet tube 212A. Second outlet tube 212B is blocked by member 400, thus preventing the dispensing of the oral dosage form.

[0164] The sliding member 400 can be moved to an intermediate position between the first and second positions, such as... Figure 4B As shown. In this position, neither the first chamber 402 nor the second chamber 404 is aligned with the outlet tubes 212A, 212B or the outlet channel 502. Therefore, the oral dosage form retained in the first chamber 403 remains in the first chamber 402, and the oral dosage form is not allowed to pass through the outlet channel 502 from the chamber 220 of the cartridge 200.

[0165] Figure 4C The sliding member 400 is shown in its second position so that the oral dosage form can be dispensed from the first chamber 402 through the outlet channel 502. Also in this position, the oral dosage form is not dispensed from chamber 220 of the cartridge 200 into the second chamber 404 through the second outlet tube 212B. The first outlet tube 212A is blocked by the member 400, thus preventing the dispensing of the oral dosage form from it.

[0166] The sliding member 400 can be moved back to its first position from the intermediate position to continue to allow the controlled dispensing of oral dosage forms from the device 100.

[0167] Will realize, Figure 2 and 4A -C displays a similar layout, but Figure 2 The illustrated embodiment uses separate chambers 220A, 220B to power each of the first and second chambers 402, 404 of the movable member 400. Figure 4A -C uses a shared chamber 222 to feed the first chamber 402 and the second chamber 404 of the movable member 400 (although separate chambers may be provided if needed). The general principle of both arrangements is the same, namely, to provide a method for controlling the dispensing of oral dosage forms from the cartridge 200 to the user.

[0168] Figure 2 The embodiments can be used to provide different / individual drugs in each corresponding chamber 220A, 220B, thereby allowing for the sequential dispensing of each different / individual drug and for dispensing in a controlled amount corresponding to the volume of the first and second chambers 402, 404 of the movable member 400. In this way, the device 100 can be configured to control the dispensing of specific amounts of two different drugs. The volume of the first and / or second chambers 402, 404 may correspond to a specific dose of drug held in either chamber.

[0169] Figure 4A -C can be used to provide a simple mechanism for dispensing an oral dosage form from a single chamber 220 to a controlled amount corresponding to the volume of the first and second chambers 402, 404 of the movable member 400. That is, the combined volume of the first and second chambers 402, 404 can correspond to a specific dose of the drug held in a common chamber.

[0170] Will realize, Figure 3A -C's implementation examples are shown in the figure. Figure 4A -C operates in a similar manner, although the movable member 400 is configured to rotate rather than slide between its first and second positions. Further envisioning, Figure 3A -C can be used with cartridge 200 having separate chambers 220A, 220B, to be compatible with Figure 4AIn a similar manner as shown in -C, each of the first and second chambers 402, 404 of the movable member 400 is powered.

[0171] It is conceivable that using Figure 3A -C or Figure 4A -C embodiments can dispense different dose sizes, or rotate or slide the movable member more than 400 times. For example, rotation Figure 3A The component 400 720 degrees in -C means that a dose with a volume twice that of the combined volume of the first and second chambers 402, 404 can be dispensed.

[0172] Figure 5A -C, 5D-F, and 5G-I illustrate embodiments including a movable member 400 that is divided into individual blocks that are movable relative to each other, which allows the same device 100 to dispense different dose sizes (e.g., without having to rotate or slide the member multiple times), as will be described in more detail below.

[0173] First refer to Figure 5A This display device 100 includes a cartridge 200 and a chamber 220 configured to receive an oral dosage form. The chamber 220 includes first and second outlet tubes 212A, 212B, and a cap 500 including a single outlet channel 502. Thus, device 100 is similar to... Figure 4A The apparatus described in -C.

[0174] However, Figure 5A The device includes a movable member 400 having a first rotatable portion 410 and a second rotatable portion 420, wherein the first and second portions 410 and 420 are rotatable relative to each other. The first portion 410 includes a first chamber 412 configured to align with one or the other of the first and second outlet pipes 212A and 212B, depending on the rotational position of the first portion 410. The second portion 420 includes a second chamber 422 configured to align with the first chamber 412 at a given point of rotation. The second chamber 422 is also configured to align with one or the other of the first and second outlet pipes 212A and 212B depending on the rotational position of the second portion 420.

[0175] The first and second portions 410 may be aligned with either the first outlet tube 212A or the second outlet tube 212B as needed. For example, the first outlet tube 212A may be associated with a different chamber of the cartridge 200 rather than with the second outlet tube 212B, as described herein in various embodiments.

[0176] Figure 5A -C indicates the first sequence, where Figure 5AThe movable component 400 is configured such that the first chamber 412 is aligned with the second outlet tube 212B, allowing the oral dosage form to enter the first chamber 412 from the chamber 220 of the cartridge 200 through the second outlet tube 212B. In this position, the second chamber 422 is not aligned with the first chamber 412, thus preventing further delivery of the oral dosage form.

[0177] The first part 410 of the movable component 400 can be from Figure 5A Rotate to the position shown Figure 5B As shown, the first chamber 412 is no longer aligned with the second outlet tube 212B, and the oral dosage form cannot enter the first chamber 412 from the chamber 220 of the cartridge 200. Furthermore, the first chamber 412 is still not aligned with the second chamber 422, preventing the oral dosage form from being delivered from the first chamber 412. It should be understood that the first chamber 422 has a given volume, and the oral dosage form within the first chamber can correspond to a dose based on the first volume.

[0178] In order to dispense an oral dosage form from the first chamber 412, the first portion 410 can be dispensed from... Figure 5B Rotate to the position shown Figure 5C As shown, the first chamber 412 is aligned with the second chamber 422, such that an oral dosage form is transferred from the first chamber 412 to the second chamber 422. When the second chamber 422 is aligned with the outlet channel 502, the oral dosage form is directly delivered through the second chamber 422 for distribution from the device 100 to the user.

[0179] Therefore, use Figure 5A -C can dispense a first dose from a device 100 corresponding to the volume of the first chamber 412.

[0180] Figure 5D -F indicates the second sequence, where Figure 5D The movable member 400, aligned with the first outlet tube 212A, displays the first and second chambers 412, 422, thereby dispensing an oral dosage form simultaneously from chamber 220 of cartridge 200 into the first and second chambers 412, 422 via the first outlet tube 121A.

[0181] The second part 420 of the movable component 400 can be drawn from... Figure 5D Rotate to the position shown Figure 5EAs shown, the second chamber 422 is no longer aligned with the first chamber 412 or the first outlet tube 212A, thus preventing the oral dosage form from entering the second chamber 422 from the chamber 220 of the cartridge 200 or the first chamber 412 of the movable member 400. Furthermore, the second chamber 422 is still not aligned with the outlet channel 502, thus preventing the dispensing of the oral dosage form from the device 100. It should be understood that the second chamber 422 has a given volume, and the oral dosage form within the second chamber may correspond to a second volumetric dose.

[0182] In order to dispense the oral dosage form from the second chamber 422, the second part 420 can be dispensed from... Figure 5E Rotate to the position shown Figure 5F As shown in the diagram, the second chamber 422 is now aligned with the outlet channel 502, thereby delivering the oral dosage form from the second chamber 422 to the user via the device 100.

[0183] Therefore, use Figure 5D The second sequence of -F can dispense a second dose from the device 100 corresponding to the volume of the second chamber 422. Since the volume of the second chamber 422 is larger than the volume of the first chamber 412, the second dose will be greater than the first dose (corresponding to the volume of the first chamber 412).

[0184] Figure 5G -I indicates the third sequence, where Figure 5G Display (similar to) Figure 5D The first and second chambers 412, 422 of the movable member 400 aligned with the first outlet tube 212A allow the oral dosage form to be dispensed simultaneously from chamber 220 of cartridge 200 into the first and second chambers 412, 422 via the first outlet tube 21A.

[0185] In this sequence, the first and second portions 410, 420 of the movable member 400 can be from... Figure 5G Rotate to the position shown Figure 5H As shown, the first and second chambers 412, 422 remain aligned with each other but are no longer aligned with the first outlet tube 212A, preventing oral dosage forms from entering the combined volume of the first and second chambers 412, 422 from the chamber 220 of the cartridge 200. Furthermore, the first and second chambers 412, 422 are not aligned with the outlet channel 502, thus preventing the dispensing of oral dosage forms from the device 100. It should 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 can correspond to a dose based on a third volume.

[0186] In order to dispense oral dosage forms from the first and second chambers 412, 422, the first portion and the second portion 410, 420 can be dispensed from... Figure 5HRotate to the position shown Figure 5I The positions shown are such that the first and second chambers 412, 422 are kept aligned with each other and are now aligned with the outlet channel 502, so that oral dosage forms are delivered from both the first and second chambers 412, 422 for distribution to the user from the device 100.

[0187] Therefore, use Figure 5G The third sequence of -I can dispense a third dose from the device 100, corresponding to the volumes of the first and second chambers 412, 422. Since the volumes of the first and second chambers 412 and 422 are larger than the volumes of the first or second chambers 412, 422, the third dose will be greater than the first dose and the second dose (corresponding to the volumes of the first and second chambers 412, 422, respectively).

[0188] Figure 6A -C, 6D-F, and 6G-I descriptions are respectively related to Figure 5A Embodiments similar to -C, 5D-F, and 5G-I, but including a movable member 400, wherein the first and second portions 410, 420 are slidable relative to each other, rather than rotatable. That is, the movable member 400 is divided into individual parts 410, 420 that are relatively movable (in this case, slidable) relative to each other, allowing the same device 100 to be used in conjunction with the aforementioned... Figure 5A Different dose sizes are allocated in a manner similar to that described in -C, 5D-F, and 5G-I.

[0189] First refer to Figure 6A This display device 100 includes a cartridge 200 and a chamber 220 configured to receive an oral dosage form. The chamber 220 includes first and second outlet tubes 212A, 212B, and a cap 500 including a single outlet channel 502. Thus, device 100 is... Figure 4A The devices described in -C and 5A-I are similar.

[0190] However, Figure 6A The device includes a movable member 400 having a first slidable portion 410 and a second slidable portion 420, wherein the first and second portions 410 and 420 are relatively slidable / translatable. The first portion 410 includes a first chamber 412 configured to align with one or the other of the first and second outlet pipes 212A and 212B, depending on the position of the first portion 410 along its sliding axis. The second portion 420 includes a second chamber 422 configured to align with the first chamber 412 at a given point of its translation. The second chamber 422 is also configured to align with one or the other of the first and second outlet pipes 212A and 212B according to the position of the second portion 420 along its sliding axis.

[0191] The first and second portions 410, 420 may be aligned with either the first outlet tube 212A or the second outlet tube 212B as needed. For example, if the first outlet tube 212A is associated with a chamber of a cartridge 200 that is different from the second outlet tube 212B, as in the various embodiments described herein, the user may wish to align the first and / or second portions 410, 420 with the first outlet tube 21A instead of the second outlet tube 212B.

[0192] Figure 6A -C indicates the first sequence, where Figure 6A The movable component 400 is configured such that the first chamber 412 is aligned with the second outlet tube 212B, allowing the oral dosage form to enter the first chamber 412 from the chamber 220 of the cartridge 200 through the second outlet tube 212B. In this position, the second chamber 422 is not aligned with the first chamber 412, thus preventing further delivery of the oral dosage form.

[0193] The first part 410 of the movable component 400 can be from Figure 6A The position shown is translated to Figure 6B In the position shown, the first chamber 412 is no longer aligned with the second outlet tube 212B, and the oral dosage form cannot enter the first chamber 412 from the chamber 220 of the cartridge 200. Furthermore, the first chamber 412 is still not aligned with the second chamber 422, preventing the oral dosage form from being delivered from the first chamber 412. It should be understood that the first chamber 422 has a given volume, and the oral dosage form within the first chamber can correspond to a dose based on the first volume.

[0194] In order to dispense an oral dosage form from the first chamber 412, the first portion 410 can be dispensed from... Figure 6B The position shown is translated to Figure 6C As shown in the diagram, the first chamber 412 is aligned with the second chamber 422 such that the oral dosage form is transferred from the first chamber 412 to the second chamber 422. When the second chamber 422 is aligned with the outlet channel 502, the oral dosage form is directly delivered through the second chamber 422 for distribution from the device 100 to the user.

[0195] Therefore, use Figure 6A -C can dispense a first dose from a device 100 corresponding to the volume of the first chamber 412.

[0196] Figure 6D -F indicates the second sequence, where Figure 6D The movable member 400, aligned with the first outlet tube 212A, displays the first and second chambers 412 and 422, thereby dispensing an oral dosage form simultaneously from chamber 220 of cartridge 200 into the first and second chambers 412 and 422 via the first outlet tube 121A.

[0197] The second part 420 of the movable component 400 can be drawn from... Figure 6D The position shown is translated to Figure 6E As shown, the second chamber 422 is no longer aligned with the first chamber 412 or the first outlet tube 212A, thus preventing the oral dosage form from entering the second chamber 422 from the chamber 220 of the cartridge 200 or the first chamber 412 of the movable member 400. Furthermore, the second chamber 422 is still not aligned with the outlet channel 502, thus preventing the dispensing of the oral dosage form from the device 100. It should be understood that the second chamber 422 has a given volume, and the oral dosage form within the second chamber may correspond to a second volumetric dose.

[0198] In order to dispense the oral dosage form from the second chamber 422, the second part 420 can be dispensed from... Figure 6E The position shown is translated to Figure 6F As shown in the diagram, the second chamber 422 is now aligned with the outlet channel 502, thereby delivering the oral dosage form from the second chamber 422 to the user from the device 100.

[0199] Therefore, use Figure 6D The second sequence of -F can dispense a second dose from the device 100 corresponding to the volume of the second chamber 422. Since the volume of the second chamber 422 is larger than the volume of the first chamber 412, the second dose will be greater than the first dose (corresponding to the volume of the first chamber 412).

[0200] Figure 6G -I indicates the third sequence, where Figure 6G Display (similar to) Figure 6D The first and second chambers 412 and 422 of the movable member 400 aligned with the first outlet tube 212A are such that an oral dosage form is simultaneously dispensed from chamber 220 of cartridge 200 into the first and second chambers 412 and 422 via the first outlet tube 21A.

[0201] In this sequence, the first and second parts 410 and 420 of the movable member 400 can both be... Figure 6G The position shown is translated to Figure 6H As shown in the diagram, the first and second chambers 412, 422 remain aligned with each other but are no longer aligned with the first outlet tube 212A, preventing oral dosage forms from entering the combined volume of the first and second chambers 412, 422 from the chamber 220 of the cartridge 200. Furthermore, the first and second chambers 412, 422 are not aligned with the outlet channel 502, thus preventing the dispensing of oral dosage forms from the device 100. It should 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 can correspond to a dose based on a third volume.

[0202] In order to dispense oral dosage forms from the first and second chambers 412, 422, the first and second portions 410, 420 can be dispensed from... Figure 6H The position shown is translated to Figure 6I The positions shown are such that the first chamber and the second chambers 412, 422 are aligned with each other and now both are aligned with the outlet channel 502, so that oral dosage forms are delivered from both the first and second chambers 412, 422 for distribution from the device 100 to the user.

[0203] Therefore, using the third sequence of Figure 3G-I, a third dose can be dispensed from device 100, corresponding to the volumes of the first and second chambers 412, 422. Since the volumes of the first and second chambers 412 and 422 are larger than the volumes of the first or second chambers 412, 422, the third dose will be greater than the first dose and the second dose (corresponding to the volumes of the first and second chambers 412, 422, respectively).

[0204] It should be understood that various modifications can be made to the above embodiments while still remaining within the broadest aspects of the invention. For example, although two separate outlet tubes 212A, 212B are shown, which may provide a greater degree of flexibility and redundancy, a single outlet tube can be provided while still allowing different doses to be dispensed from device 100. Similarly, as previously described, the individual chamber 220 can be divided into multiple chambers, for example, two separate chambers, wherein each of the multiple chambers includes an outlet tube configured to deliver an oral dosage form from the respective chamber to one or both of the first and second chambers 412, 402 of the movable member 400.

[0205] The references in this article to various tubes, lumens, or channels that are “aligned” with each other can be interpreted as mutual communication so that oral dosage forms can be delivered from one to another by gravity or by using a suitable dispensing mechanism.

[0206] The cap 500 (or an additional cap placed on the cap 500) may include a collection area, for example, in the form of a cavity within the cap 500. The device 100 may also include a housing (not shown) that holds each of the cartridge 200, member 400, and cap 500 (and additional caps, if provided) in a relative position, such that portions 410, 420 of member 400 can rotate or slide between the aforementioned positions, while the cartridge 200 and cap 500 (and additional caps, if provided) remain stationary. The housing may be configured to selectively close the collection area, such that the oral dosage form dispensed into the collection area is retained therein until dispensing is required. Alternatively, a cap, lid, stopper, etc., may be additionally placed above the outlet channel 402, configured to retain the oral dosage form within the outlet channel 402 until dispensing is required.

[0207] In any of the above embodiments, movement of the movable member 400 may be controlled and achieved by an actuator, which may form part of the control system and / or control unit 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 dispense a dose of one or more drugs contained in the cartridge 200. The actuator may be electrically driven using one or more electric motors.

[0208] Figure 7 In an embodiment of the display device 100, the movable member 400 is divided into multiple parts so that when rotated in a first direction, the member 400 dispenses a drug from a first outlet pipe 212A, and when rotated in a second opposite direction, it dispenses a drug from a second different outlet pipe 212B.

[0209] Device 100 may include Figure 1 The features of the illustrated device 100, wherein similar features are indicated by similar reference numerals. It should be noted that... Figure 7 It is highly illustrative and is intended only to indicate the operation of the equipment, as will be evident from the discussion below.

[0210] The device 100 includes a cartridge 200 having a chamber 220 for storing an oral dosage form. The chamber 220 includes a first outlet (e.g., an outlet tube) 212A and a second outlet (e.g., an outlet tube) 212B. The first outlet tube 212A is located radially inward of the second outlet tube 212B relative to the longitudinal axis Y of the device 100.

[0211] The device 100 also includes a movable (in this case, rotatable) member 400 having a first rotatable plate 450 configured to rotate in use. The first plate 450 includes a first chamber 452 configured to align with the first outlet pipe 21A at a specific rotational position. The member 400 is rotatable about the longitudinal axis Y of the device 100, such as... Figure 7 As shown.

[0212] The component 400 also includes a second rotatable plate 460 configured to rotate in use, wherein the second plate 460 includes a second chamber 462 configured to align with the second outlet pipe 212B at a specific rotational position of the second outlet pipe 212B.

[0213] Component 400 also includes a third plate 470 configured to rotate together with the second plate 460. The third plate 470 includes a hole 472, wherein a first chamber 452 of the first plate 450 is configured to align with the hole 472 at a specific rotational position of the first plate 450. When the first chamber 442 is aligned with the hole 472, an oral dosage form can be dispensed from the first chamber 452 of the device 100 through the hole 472 of the third plate 470. To ensure that the third plate 470 rotates together with the second plate 460, teeth 474 of the third plate 470 are slotted within a cavity 464 of the second plate 464, wherein the engagement of the teeth 474 and the cavity 464 locks the third plate 470 in a position relative to the second plate 460.

[0214] Component 400 also includes a fourth plate 480, which is fixed in position relative to the cartridge 200 and cannot be rotated during use. The fourth plate 480 includes an orifice 482, wherein a second chamber 462 of the second plate 460 is configured to align with the orifice 482 at a specific rotational position of the second plate 460. After the second chamber 462 is aligned with the orifice 482, the oral dosage form can be dispensed from the second chamber 462 (and possibly from device 100, or into the cap / collection area) via the orifice 482 of the fourth plate 480.

[0215] The first plate 450 may be radially positioned within the second plate 460, and the one-way bearing 490 shown may be positioned between the first and second plates 450, 460 (e.g., radially between the second plates). The one-way bearing 490 may be configured to allow the first plate 450 to rotate relative to, independently of the second plate 460, when the first plate 450 rotates in a first direction of rotation (e.g., one of clockwise and counterclockwise), wherein the one-way bearing 490 is further configured to lock the first plate 450 in a position relative to the second plate 460 such that it does not rotate relative to, or independently of, the first plate 450 and / or the second plate 460 when they rotate in a second opposite direction of rotation (e.g., another of clockwise and counterclockwise).

[0216] Therefore, the operation of the device 100 allows a first volume-based dose to be dispensed from the first chamber 452 of the first plate 450 through the first outlet tube 212A and the hole 472 of the third plate 470. The volume of the first dose can correspond to the volume of the first chamber 452 of the first plate 45, and can be dispensed by rotating the first plate 450 only relative to the other parts of the member 400.

[0217] The device 100 can be further operated such that a second volume-based dose can be dispensed from the second chamber 462 of the second plate 460 through the second outlet tube 212B and the orifice 482 of the fourth plate 480. The volume of the second dose corresponds to the volume of the second chamber 462 of the second plate 462 and can be dispensed by rotating the first plate 450 and the second plate 450 in a configuration in which the first plate 450 is locked in position relative to the second plate 460. In this configuration, the first plate 450 will rotate at the same rate as the third plate 470, such that the first chamber 452 cannot be aligned with the orifice 472 of the third plate 470. This means that oral dosage forms cannot be dispensed from the first chamber 452.

[0218] It should be understood that the sizes of the first and second chambers 452, 462 can be configured such that the volumetric doses of the first and second phases can be different. In embodiments where chamber 220 is a separate chamber serving the first and second outlet tubes 212A, 212B, this can allow for different volumetric doses of the same drug contained in the separate chamber 220.

[0219] Imagine that chamber 220 can be divided into a first chamber and second chambers 220A and 220B, each chamber serving its respective first and second outlet pipes 212A and 212B, similar to the above. Figure 2 In this embodiment, the first and second chambers 452, 462 of the movable member 400 may have the same volume and be configured to dispense different drugs contained in the first and second chambers 220A, 220B. Alternatively, the first and second chambers 452, 462 of the movable member 400 may still have different volumes and be configured to dispense different drugs in different volumes.

[0220] A cap, lid, or plug (removable / replaceable) may be placed on a fourth plate 480, which includes a collection area, for example, in the form of a cavity. The device 100 may also include a housing (not shown) that holds the cylinder 200, component 400, and cap in place, with the caps or plugs facing each other, such that the various parts of component 400 can rotate as described above, while the cylinder 200 and the cap, lid, or plug (if provided) remain stationary. The housing may be configured to selectively close the collection area, such that the oral dosage form dispensed into the collection area is retained therein until dispensing is required. Alternatively, caps or plugs may also be placed on orifices 472, 482 of the third and fourth plates 470, 480, configured to retain the oral dosage form within the outlet channel 502 until dispensing is required.

[0221] The above regarding Figure 7The rotational motion can be controlled and achieved by an actuator, which may form part of a control system and / or control unit as described elsewhere herein. The actuator can be configured to rotate a first plate 450 such that rotation of the first plate 450 in a first rotational direction as described above results only in rotation of the first plate 450 (due to the one-way bearing 490), and rotation of the first plate 450 in a second rotational direction results in rotation of the first plate 45, bearing 490, second plate 460, and third plate 470. To achieve this, a shaft (not shown) can extend through the cartridge 200, which can be configured to rotate the first plate 450 in this manner. The shaft is operatively connected to the actuator, which may include a motor configured to rotate the shaft.

[0222] It is conceivable that several similar plates can be provided in the active component 400 of this embodiment in order to provide different doses.

[0223] Figure 8A -F diagram (illustrative) Figure 7 Examples of embodiments and rotation sequences that can be used to dispense oral dosage forms from device 100.

[0224] Figure 8A -C shows a first sequence that can be used to rotate the first plate 450 and dispense a first dose of drug. The illustrated device 100 includes a cartridge 200 having a chamber 220 for the first and second outlets (e.g., outlet tubes) 212A, 212B as described above. A movable member 400 is also provided, disposed on the first plate 450, having a first chamber 452 as described above. Figure 8A -C is indicated by a solid line to distinguish it from other components.

[0225] Figure 8A -C further shows the second plate 460, the third plate 470 and the fourth plate 480 in dashed lines, as well as the second chamber 462, the hole 472 and the hole 482 therein.

[0226] Figure 8A The diagram shows the first plate 450 at the first rotational position, where the first chamber 452 is aligned with the first outlet pipe 212A, thereby dispensing the oral dosage form from the chamber 220 of the cartridge 200 into the first chamber 452 of the component 400 through the first outlet pipe 21A. Since the first chamber 452 is not aligned with the hole 472 of the third plate 470 at this position, the oral dosage form is not dispensed from a more distant position but remains within the first chamber 442.

[0227] The first plate 450 can rotate along the first rotation direction to Figure 8BAs shown, the first chamber 452 is no longer aligned with the first outlet tube 212A, and the oral dosage form cannot enter the first chamber 45 from the chamber 220 of the cartridge 200. Furthermore, the first chamber 452 is still not aligned with the hole 472 of the third plate 470, preventing the oral dosage form from being conveyed from the first chamber 452.

[0228] In order to dispense oral dosage forms from the first chamber 452, the first chamber 450 can be dispensed from... Figure 8B The position shown is further rotated in the same direction to Figure 8C As shown, the first chamber 45 is aligned with the orifice 472 of the third chamber 470, such that the oral dosage form passes through the first chamber 452 and is delivered through the orifice 472 of the third chamber 470 for dispensing from the device 100 to the user.

[0229] Therefore, use Figure 8A -C can dispense a first dose from a device 100 corresponding to the volume of the first chamber 412.

[0230] Figure 8D -F indicates a second sequence that can be used to rotate the first plate 450 and the second plate 460 to dispense a second dose of drug. In these figures, for ease of illustration, the second plate 460 and its chamber 462 are shown in solid lines, while the first plate 450, the third plate 470, and the fourth plate 480, as well as the corresponding first chamber 452, orifice 472, and orifice 482, are shown in dashed lines.

[0231] Figure 8D The image shows the first and second plates 450 and 460 at the first rotation position (similar to...). Figure 8A The first chamber 452 is aligned with the first outlet pipe 212A, and the second chamber 462 is aligned with the second outlet pipe 212B, such that the oral dosage form is dispensed from the chamber 220 of the cartridge 200 into the second chamber 462 of the component 400 through the second outlet pipe 212B. Since the second chamber 452 is not aligned with the hole 482 of the fourth plate 470 at this position, the oral dosage form is not dispensed from a more distant location but remains within the second chamber 462.

[0232] The first plate 450 can rotate in the second rotation direction (opposite to the first rotation direction) to... Figure 8E As shown, this also causes rotation of the second plate 460 and the second chamber 462, as well as the third plate 470 and its orifice 472. Therefore, the second chamber 462 is no longer aligned with the second outlet tube 212B, and the oral dosage form cannot enter the second chamber 462 from the chamber 220 of the cartridge 200. Furthermore, the second chamber 462 is still not aligned with the orifice 482 of the fourth plate 480, thus preventing the oral dosage form from being delivered from the second chamber 462.

[0233] Furthermore, the first chamber 452 is misaligned with the hole 472 of the third plate 470 because the one-way bearing 490 (not shown in these figures for simplicity) causes them to rotate together in the second rotational direction, thus preventing the oral dosage form from being delivered from the first chamber 452.

[0234] To dispense the oral dosage form from the second compartment 462, the first plate 450 can be dispensed from... Figure 8E Rotate further in the same direction to the position shown. Figure 8F As shown, this causes the second plate 460 to rotate, aligning the second chamber 462 with the hole 482 of the fourth plate 480. This means that the oral dosage form passes through the second chamber 462 and is delivered through the hole 4802 of the fourth plate 430 for dispensing from the device 100 to the user. Simultaneously, the third plate 472 continues to rotate with the first plate 450, preventing the first chamber 452 from aligning with the hole 472 of the third plate 470, thus preventing the delivery of the oral dosage form from the first chamber 452.

[0235] Therefore, use Figure 8D -F can dispense a second dose from a device 100 corresponding to the volume of the second chamber 462.

[0236] Figure 9 This is a height diagram, showing the relationship between... Figure 7 A similar but alternative arrangement is used in which one or more ratchet mechanisms are used instead of the one-way bearing 490. In this arrangement, the first plate 450 includes a plurality of ratchet teeth 456 surrounding its outer (e.g., radial) periphery, which are configured to engage with a plurality of ratchet teeth 466 located on the inner periphery of the second plate 460.

[0237] The ratchet teeth 456 and 466 located on the first and second plates 450 and 460 can be configured to engage with each other so that the first plate 450 can rotate in a first rotational direction (as shown by arrow 600) without causing the second plate 460 to rotate. 460 can also be configured to engage so that the first plate 450 rotates in a second opposite rotational direction (as shown by arrow 602), causing the second plate 460 to rotate in the same direction.

[0238] The second plate 460 may be further configured with additional ratchet teeth 468 located on its outer periphery, which are configured to engage with ratchet teeth 268 located on the inner periphery of the cartridge 200. The additional ratchet teeth 468 and ratchet teeth 268 of the cartridge 200 may be configured to engage to prevent the second plate 460 from rotating in the first plate by means of their engagement, while allowing the second plate 460 to rotate.

[0239] Figure 9 The arrangement is considered Figure 7 Modifications to the embodiments, wherein regarding Figure 7The remaining publicly disclosed features remain unchanged. Therefore, Figure 9 The arrangement can be configured in the same way so that oral dosage forms can be dispensed from one or the other of the first and second chambers 452, 462 of the first and second plates 450, 460 as described above.

[0240] Figure 10 The diagram shown is an exploded view of device 100, which functions similarly to the above-described device and includes some additional features.

[0241] The device 100 includes a first end 102 located at an actuator 300 (drive mechanism, such as a motor) and a second end 104 (opposite to the first end 102), the second end 102 comprising the dispensing end of the device 100. In use, a drug (e.g., an oral dosage form) is dispensed from the second end 103 due to operation of the drive mechanism. The actuator 300 may be mechanical (e.g., manually operated) or electromechanical (e.g., electrically operated, such as a motor).

[0242] The device 100 includes a cartridge valve 200 configured to be connected to an actuator 300, which may be implemented using latches 201, 301, fasteners 209 or other suitable connection mechanisms.

[0243] The device 100 includes a rotating member 250 extending through the cylinder 200. The rotating member 250 is connected to an actuator 300 at a first end 102, wherein the actuator 300 is configured to rotate the rotating member 250, and each rotating member 250 may have a longitudinal axis A about which it rotates.

[0244] The cartridge 200 includes a chamber 220 for receiving multiple units of an oral dosage form (e.g., granules), through which a rotating member 250 extends. The chamber 220 includes an outlet 212 located at a second end 104 through which the oral dosage form (medication, pharmaceuticals, etc.) can be dispensed from the chamber 220. The outlet 212 is shown as an arcuate orifice, which facilitates dispensing the oral dosage form from the chamber (although any suitable orifice shape may be used).

[0245] The rotating member 250 includes a nozzle 251 located at the distal end of the end connected to the actuator 300. The nozzle 251 is configured to extend through a hole 213 in the chamber 220 and engage with the rotating member 400, as detailed below.

[0246] The device 100 also includes a plunger 230 configured to move automatically along the rotating member 250 as the rotating member 250 rotates. Specifically, a portion of the rotating member 250 within the chamber 220 includes a thread 252, and the plunger 230 forms a nut around the rotating member 250 and is configured to move along its thread 252 as the rotating member 250 rotates. In this way, the plunger 230 pushes the oral dosage form toward the outlet 212 of the chamber 220.

[0247] The chamber 220 is at least partially closed by the plunger 230, and more specifically, the radially extending surface of the plunger 230 faces the chamber 220. The volume of the chamber 220 (i.e., before operation or at its maximum volume) may be less than about 50 mL, for example less than 20 mL or about 11 mL.

[0248] In particular (though not limited to) for liquid dosage forms, the plunger 230 can be sealed (e.g., fluid-sealed) against the walls of the chamber 220 and / or its threaded 250 along which it moves to prevent accidental leakage. For example, suitable resilient seals configured for fluid sealing can be provided against the walls of the chamber 220 and / or the threaded 250.

[0249] As the plunger 230 translates along the rotating member 250, the volume of the chamber 220 gradually decreases. In use, the radially extending surface 232 of the plunger 230 presses against the oral dosage form and pushes it toward the second dispensing end 104 of the device 100, which, for solid oral dosage forms, especially granules, helps to tightly pack them within the chamber 220.

[0250] Figure 10 The second dispensing end 104 of the cartridge 200 is located at the outlet 212 of the chamber 220, and the mechanism 400', funnel 501 and cap 500 for providing volume-based doses are shown.

[0251] The mechanism 400' for providing volume-based doses uses a rotating disk 400 (similar to a rotating member 400) as described above, which includes an aperture 401 located at its center and a (rotating) chamber 402 extending through the disk 400. Figure 10 The image shows four rotating disks 400a-d for illustration, as will be described in more detail below, each configured to deliver a dose of a different volume.

[0252] The mechanism 400 also includes a first plate 406 configured to receive the disk 400, which is located within an aperture 407 passing through the first plate 406. The aperture 407 is sized to accommodate the disk 400 and allows it to rotate within the first plate 407. A first plate 409 is fixed to the lower wall 224 of the cartridge 200 (and chamber 220), through which the outlet 212 and the aperture 213 pass. Therefore, the disk 400 within the first plate 406 can contact the lower wall 224 during its rotational movement.

[0253] The nozzle 251 of the rotating member 250 is configured to pass through a hole 213 in the lower wall 224 of the cartridge 200 and is mounted in a hole 401 of the disk 400. The nozzle 252 is configured to rotate the disk 400 when the rotating member 250 rotates. In the illustrated embodiment, the nozzle 251 has a cuboid shape that matches the cuboid form of the hole 401 in the disk 400. Alternatively, the nozzle 252 may be a press / interference type, etc., mounted into the hole 401 so that rotation of the nozzle 251 causes a corresponding rotation of the disk 400.

[0254] Mechanism 400' also includes a second plate 408 configured to be located on top of the first plate 406 and the disk 400, and to enclose the disk 400 within a hole 407 between the second disk 408 and the lower wall 224 of the cartridge 200. Thus, as the disk 400 rotates within the hole 407, the chamber 402 of the disk is pressed against the surface of the lower wall 227 on one side and the second plate 408 on the other. It is worth noting that for solid oral dosage forms, the disk 400 need not be sealed to the wall 224 or the second plate 208, and a minimal gap may exist (as long as it is in the intermediate position defined herein, to prevent the oral dosage form from leaving the chamber 402).

[0255] The second plate 408 includes a hole 409 through which an oral dosage form can pass from the chamber 402 of the disc 400, as described below. The hole 409 is shown in an arc shape, which facilitates the dispensing of the oral dosage form from the chamber 402 (although any suitable orifice shape can be used).

[0256] The chamber 402 of the disk 400 is configured to align with the outlet 212 of the chamber 220 during rotation, such that at a certain point during the rotation of the disk 400, the chamber 401 is aligned with the outlet 212. At this time, the oral dosage form contained in the chamber 220 can be moved into the rotating chamber 402 through the outlet 212.

[0257] Similarly, the chamber 402 of the disc 400 is configured to align with the orifice 409 as it rotates. The chamber 402 is configured to align with the orifice 409 at different points during its rotation, rather than at different points where it aligns with the outlet 212. The chamber 403, outlet 212, and orifice 409 are all configured such that the oral dosage form is dispensed into the chamber 402 through the outlet 212, but not simultaneously through the orifice 409. This is similar to the embodiment described above.

[0258] In other words, chamber 402 is configured to selectively communicate with outlet 212 of chamber 220 and aperture 409 of second plate 408. Specifically, mechanism 400' is configured such that in a first position of disk 400, oral dosage form is received from outlet 212 into chamber 402, and in a second position, oral dosage form is dispensed from chamber 402 through aperture 409. In other words, in the first position, chamber 403 does not communicate with aperture 409, and in the second position, chamber 422 does not communicate with outlet 212.

[0259] The disc 400 includes an intermediate position between the first and second positions, wherein the chamber 402 is not aligned with the outlet 212 or the orifice 409. Therefore, the oral dosage form retained in the chamber 403 remains within the chamber 402, and the oral dosage form is not permitted to pass from the chamber 220 of the cartridge 200 to the orifice 409.

[0260] The disc 400 can be rotated between its first and second positions via an intermediate position to allow for controlled dispensing of oral dosage forms from the device 100.

[0261] The device 100 may include a control system (e.g., as part of the actuator 300 or control unit) configured to dispense an oral dosage form contained in the chamber 220, for example, upon receiving a drive signal from an input device or mechanism. The activation signal may be initiated, for example, by a user pressing an appropriate button or other input mechanism located on the control unit, or via various control devices (optional), such as wireless or wired external control.

[0262] By using an electromechanical drive mechanism, device 100 can repeatedly dispense precise doses or quantities (e.g., volumes) of oral dosage forms. Motor 302 and control system can be powered by an integrated battery (replaceable by the user) that is secured within the housing of actuator 300.

[0263] Actuator 300 may include one or more motors 302. Actuator 300 (e.g., its motors 302) may be configured to rotate each rotating member 250 by an amount corresponding to a prescribed dose or partial dose (possibly corresponding to a specific volume of an oral dosage form).

[0264] Motor 302 may be a stepper motor, which may be configured to rotate the corresponding rotating component 250 in any suitable number of steps, depending on the available resources, such as the type of drug within cartridge 200 or the user. The control system may be provided in the form of a computer, processor, processing device, circuit, or microcontroller, for example on a PCB, which may be located within the housing of device 100 within actuator 300 or control unit.

[0265] The actuator 300 (if equipped with an electric motor 302) can be configured to rotate the corresponding rotating member 250 at a rate of about 50 rpm to about 500 rpm, or can be selected to rotate between about 90 rpm and about 150 rpm.

[0266] However, an actuator 300 is provided so that the dose dispensed from device 100 corresponds to the volume of chamber 402 of disk 400. To dispense doses of different volumes, different disks 400 can be used, such as... Figure 10 As shown, disks 400a-d. Each disk 400a-d includes chambers 402 of different sizes, such that each disk is configured to dispense a dose of a different volume by a single rotation. It is also possible to dispense a dose of a different volume by rotating the disk 400 multiple times. The actuator 300 can be configured to control the volume of the dose by controlling the number of rotations of the disk 400 in this manner.

[0267] The device 100 also includes a funnel 501 configured to be mounted on the surface 224 of the cartridge 200. The funnel 501 can be secured to the cartridge 200 using any suitable means, such as a fastener 509 (or a clamp, or even molded onto the chamber 220). A mechanism 400' for providing a volume-based dose can be contained within the funnel 501, which can be configured to hold various parts of the mechanism 400' in place. For example, the funnel 501 can be configured to press a second plate 408 against a first plate 406, which in turn presses the first plate 406 against the lower wall 224 of the cartridge 200. Thus, the hole 407 where the disc 400 is located can be configured as a substantially closed / sealed cavity, with its inlet formed by the outlet 212 of the chamber 220 and its outlet formed by the hole 409 of the second plate 408.

[0268] The device 100 also includes a cap 500, which may include a collection area in the form of a cavity within the cap 500. The cap 500 may be configured to be mounted above the funnel 501 and the cartridge 200 so that the oral dosage form dispensed into the collection area is retained in the cavity within the cap 500. For access to the oral dosage form, the cap 500 is configured to be removable from the remainder of the device 100 (e.g., by snap-fit ​​engagement) so that a user can expose the collection area and access the oral dosage form.

[0269] The methods, method steps, or functional features disclosed herein, such as those related to the control system of the aforementioned control unit, can be implemented at least in part using software, such as a computer program. They may reside on a processor or circuitry that forms part of the control unit itself. It can be seen, then, that the present invention provides computer software, when mounted on a data processing device, particularly suitable for performing the methods, method steps, or functional features described herein. The computer program elements include computer software code portions for performing the methods or method steps, or the functional features described herein that, when run on a data processing device, and a computer program containing code means adapted to perform all steps of the methods, method steps, or functional features described herein when the program is run on a data processing system. The data processor may be a microprocessor system, a programmable FPGA (Field-Programmable Gate Array), etc.

[0270] While the invention has been described with reference to preferred embodiments, those skilled in the art will understand that various changes in form and detail may be made without departing from the scope of the invention as set forth in the appended claims.

Claims

1. A device for dispensing oral dosage forms, comprising: A cartridge includes one or more chambers for containing an oral dosage form, wherein each of the one or more chambers includes at least one outlet for dispensing the oral dosage form from the chamber; A movable member movable between a first and a second position, wherein in the first position, the movable member is configured to receive and contain a specific volume of oral dosage form from a chamber of the cartridge via an outlet, wherein the movable member is movable to one or more intermediate positions in which the specific volume of oral dosage form is held and retained within the movable member so that the oral dosage form cannot be dispensed therefrom, and the movable member is movable from the intermediate positions to the second position in which the oral dosage form within the movable member can be dispensed therefrom; The movable component is a rotatable disk, including a chamber for receiving and maintaining the oral dosage form of the specific volume described above; The chambers of the movable member include a first chamber and a second chamber; and The device is configured such that, when the device is used, the one or more chambers of the cartridge are arranged above the rotatable disk, and the rotatable disk is arranged generally horizontally. The movable member includes a first portion having the first chamber and a separate second portion having the second chamber; The first and second portions are movable relative to each other such that, at a first relative position of the first and second portions, the first and second chambers of the movable member are aligned so that the oral dosage form can pass through therein, and at a second relative position of the first and second portions, the first and second chambers of the movable member are displaced so that the oral dosage form cannot pass through therein.

2. The apparatus of claim 1, wherein in the intermediate position, the chamber of the movable member is sealed and isolated from one or more chambers of the cartridge.

3. The apparatus of claim 1 or 2, wherein at least one chamber of the component includes a first chamber configured to receive and contain a first volume of an oral dosage form from the cartridge, and a second separate chamber configured to receive and contain a second volume of an oral dosage form from the cartridge.

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

5. The apparatus of claim 3, wherein in the first position of the movable member, both its first and second chambers are configured to simultaneously receive and contain individual volumes of oral dosage forms from the cartridge, and wherein in the second position of the movable member, both its first and second chambers are configured to dispense their respective volumes of oral dosage forms.

6. The apparatus of claim 5, wherein the first portion includes a first disk having a first chamber of the member, and the second portion includes a second disk having a second chamber of the member, wherein the first and second disks are rotatable relative to each other and the cartridge.

7. The apparatus of claim 6, wherein the apparatus includes one or more outlet channels configured to receive an oral dosage form dispensed from the movable member at a second location.

8. The apparatus of claim 7, further comprising: A rotating member that extends through the cartridge and is configured as a rotating disk.

9. The apparatus of claim 8, further comprising an actuator configured to rotate the rotating member.

10. The apparatus of claim 9, wherein the actuator comprises an electric motor.

11. The apparatus of claim 10, further comprising a plunger configured to automatically move along the rotating member as the rotating member rotates and push the oral dosage form toward the outlet of the chamber in use.

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