Medicament delivery device with vibrating means

Abstract

A device for dispensing a solid dosage form (e.g., a drug or medicament) comprises a receptacle for containing a plurality of units of the solid dosage form, means for vibrating the units of solid dosage form within the receptacle and dispensing means for dispensing the solid dosage form from the receptacle.

Description

[0001] MEDICAMENT DELIVERY DEVICE WITH VIBRATING MEANS

[0002] FIELD

[0003] The present disclosure relates generally to delivery devices for medication, in particular solid dosage form.

[0004] BACKGROUND

[0005] Medications can be manufactured as a solid oral dosage form, e.g., tablets or pellets. These could contain different substances where the main ingredient(s) is / are an active pharmaceutical ingredient (“API”). Dispensing mechanisms for these types of solid oral dosage form are known, and can range from blister-pack type devices, wherein individual tablets are retained within pockets and by the use of foil, through to dispensing bottles.

[0006] It is desired to improve the accuracy and flexibility of mechanisms by which solid dosage forms are dispensed, to allow an accurate and individualised dose of medication to be dispensed to a user. One example of a new and effective device for dispensing medication is disclosed in PCT publication number WO2019 / 115832, incorporated herein by reference in its entirety. This discloses a device in which pellet medication is contained within a cartridge, and dispensed accurately using a screw pump mechanism. The Applicant has developed this technology and optimised, for example, the geometry of such a device (which is the subject of co-pending patent applications). In doing so they also considered how solid dosage forms move through such devices (not limited to that specific type of device, or even to the type of solid dosage form) and the challenges involved in ensuring that they move smoothly. It is against this background that the present invention was devised.

[0007] SUMMARY

[0008] According to a first aspect, there is provided a device for dispensing a solid dosage form (e.g., a drug or medicament, e.g. a solid oral dosage form), the device comprising a receptacle for containing a plurality of units of the solid dosage form, means for vibrating the units of solid dosage form within the receptacle, and dispensing means for dispensing the solid dosage form from the receptacle. Such a device can help to ensure smooth movement of the medication as it travels through the device.

[0009] The receptacle may be substantially enclosed and the means for vibration may cause the solid dosage form within the enclosed receptacle to vibrate within the receptacle. Enclosing the dosage form means that it is retained within the receptacle during use, for example units of the dosage form cannot escape without activation of the dispensing means. The receptacle may be substantially sealed. The sealed receptacle may be air-tight, which helps to protect the solid dosage form (e.g., so that it is active for longer) and ensures that unwanted objects cannot enter the receptacle and contaminate the solid dosage form. By “substantially”, it is meant that the receptacle is sealed with perhaps the exception of an outlet through which the solid dosage form is dispensed from the receptacle. It may be that a valve is located at the outlet, meaning that the receptacle could be fully sealed (although this is not essential).

[0010] The dispensing means may be configured to transport the solid dosage form from the receptacle to at least one outlet of the device, wherein the means for vibrating the units of solid dosage form is configured to vibrate the solid dosage form being transported. The vibration can act to prevent jamming of the solid dosage form being transported, as well as reducing friction between the solid dosage form and the dispensing means to encourage smooth movement of the solid dosage form being transported. The vibration means also help to prevent interlocking of solid dosage form within the dispensing means, and can act to prevent voids in the solid dosage form, which can help to ensure that an accurate dose is dispensed.

[0011] The dispensing means may comprise a screw pump which is configured such that a dose being dispensed can be varied by varying the amount of rotation of the screw pump. The screw pump may be rotated by full or fractional amounts to fine-tune a dose.

[0012] The vibration means may be located adjacent to the dispensing means. This helps to provide more effective and targeted vibration to the solid dosage form within the dispensing means. The more targeted vibration can further aid to minimise the risk of jamming in the dispensing means, as well as providing an arrangement which is even more effective at reducing friction between the solid dosage form and the dispensing means to encourage smooth movement of the solid dosage form being through the dispensing means. Adjacent may mean that the vibration means (e.g., motor) is located at a dispensing end of the device, or more precisely in the same axial plane of the device as the dispensing means (relative to a longitudinal axis thereof).

[0013] Additionally, or alternatively, the vibration means may be located adjacent to the receptacle. This can help to provide more effective and targeted vibration to the solid dosage form within the receptacle to further aid in allowing the solid dosage form to move smoothly in the device. Similar to above, adjacent may mean that the vibration means (e.g., motor) in the same axial plane of the device as part of the receptacle (relative to a longitudinal axis thereof).

[0014] The device may be a hand-held device. A hand-held device may be a device that can be carried by a user in one hand. This provides a convenient device which is portable and convenient for a user. The size of the device may be no more than about 300 mm, 250 mm or 200 mm in length (the largest dimension of the device. The width of the device may be no more than about 100 mm, 75mm or 50mm. The device may have a weight of about 200g to 500g, for example 300g to 400g. The weight of the device may be no more than 400g. The dispensing means may be configured to dispense a number of units of the dosage form in a dispensing action, and such that the number of units being dispensed in one action can be adjusted / controlled (for example, using a screw pump as described herein).

[0015] The solid dosage form may comprise pellets, as defined herein. Pellets can be easier to swallow and it may be easier to provide more flexibility in terms of the dose dispensed compared with conventional tablets, to provide a more individualised dose for a user.

[0016] The solid dosage form may comprise mini-tablets, as defined herein. Mini-tablets can also provide more flexibility in terms of the dose dispensed compared with larger tablets, and can also be easier to swallow.

[0017] Where the dispensing means comprises a screw pump, this may comprise a screw thread, wherein the screw thread may cooperate with an inner cylindrical surface of the device to form the screw pump, such that, as the screw pump rotates in use, the screw thread rotates within the inner cylindrical surface, causing units of the solid dosage form contained within the receptacle to enter the screw thread, and travel down the screw thread for dispensing from the screw pump. The cylindrical surface may extend from the receptacle to an outlet of the device. The screw thread may be in sliding contact with the cylindrical surface to prevent solid dosage form from escaping around the sides of the screw pump. The screw pump provides simple and convenient means for accurately dispensing a dose, and allows the dose being dispensed to be conveniently continuously varied. As noted above, a unique mechanism for dispensing medication in this manner was described in PCT publication number WO2019 / 115832 (referred to above), which is incorporated herein by reference in its entirety.

[0018] Including a vibrating means in such a device (i.e. , employing a screw pump) has been found to aid the dispensing of the dosage form therefrom. The vibration helps to settle the units prior to their introduction into the screw pump, as well as avoid jamming throughout the device. Overall, the vibration helps to ensure a more accurate and reliable dose when using such a device. This is particularly the case for a hand-held or portable device, where the receptacle is likely to be quite small. The vibrating means may be configured to vibrate the units of the dosage form in the screw thread of the screw pump. This can further assist with avoiding jamming, specifically within the screw pump. The vibration means can also encourage smooth movement of the solid dosage form being transported. The vibration means also help to prevent interlocking of solid dosage form within the dispensing means, and can act to prevent voids in the solid dosage form, which can help to ensure that an accurate dose is dispensed.

[0019] The device may further comprise a plunger in the receptacle configured to press and compact the solid dosage form therein. The means for vibrating the dosage form can vibrate the solid dosage form at any point, but particularly after or during compacting by the plunger to help the solid dosage form to move smoothly within the device during or after the compacting by the plunger. As such, the combination of the vibration means and the plunger can help the device to dispense solid dosage form more effectively.

[0020] The device may comprise a replaceable cartridge, and the receptacle may be part of the replaceable cartridge.

[0021] The means for vibrating the units of solid dosage form may be located in a control apparatus configured to be attached to the replaceable cartridge, and the control apparatus may comprise means for actuating the dispensing means. The control apparatus may be configured to receive the replaceable cartridge in a receptacle of the control apparatus.

[0022] The control unit may comprise a main body, and an extension configured to form part of the attachment to the replaceable cartridge. The vibrating means may be located in the extension of the control unit attaching to the cartridge, so as to provide the means close / adjacent to the receptacle.

[0023] The cartridge may be formed from at least two parts which are connected to each other by a screw. The two parts may each have flanges which slot into each other, and the screw for attachment may connect the two flanges in order to connect the two parts of the cartridge. One flange may connect directly to the vibration means, whilst the other may connect directly to the receptacle. This can improve the effect of the vibrating means.

[0024] The cartridge may comprise at least one stiffening rib, for example two ribs, which may be configured to directly contact the control assembly. The ribs may be configured to contact a surface of the control assembly. The ribs may contact the control assembly adjacent to the vibration device therein (when the cartridge is assembled with the control assembly). The ribs may be disposed at or near the dispensing end of the cartridge. Placing the ribs proximate the vibration device and at the dispensing end of the cartridge can improve the effect of the vibrating means.

[0025] The means for vibrating the units of solid dosage form may comprises a vibration motor / vibrator e.g. a linear vibrator. For example, the means for vibrating the units of solid dosage form may be an eccentric rotating mass (“ERM”) or linear resonant actuator (“LRA”) motor. This provides simple means for generating the vibration.

[0026] In a further example, the device may further include a control unit configured to control the means for vibrating the units of solid dosage form. The control unit may be configured to cause the means for vibrating the units of solid dosage form to vibrate for a total of between 100 milliseconds and 20 seconds in total each time a dose of solid dosage form is dispensed, or even more optimally for between 2 and 6 seconds. A range of between 2 and 6 seconds has been found to allow the device to effectively prevent jamming during dispensing of solid dosage form (especially when the device comprises a screw pump) without the vibration being excessively long so as to be inconvenient for a user. The above control unit may be configured to progressively increase an amplitude and / or a frequency of vibration. For example, the control unit may be configured to cause the amplitude and / or the frequency of vibration to increase on start-up according to a ramp function. This helps to make the device more user-friendly (because a sudden change in the vibration may be less pleasant for a user, especially in a hand-held device) and has also been found to increase the effectiveness of the device at preventing solid dosage form from becoming jammed / stuck in the device. In some embodiments the above progressive increase is applied upon starting the vibration and / or at the beginning of a dispensing step. Advantageously, the ramp function may last between 2 and 6 seconds, and optionally between 3 and 5 seconds. These time periods have been found to be effective at preventing jamming in a dispensing device (particularly with a screw pump). The ramp function may be applied for the whole of the vibrating step, or may be applied before applying a different, for example constant vibration (in frequency and amplitude) for a period of time (which period may be between 2 and 6 seconds, optionally between 3 and 5 seconds).

[0027] The device may further comprise a sensor, for example an accelerometer, configured to measure a frequency and / or an amplitude of vibration. This allows the vibration to be measured and adjusted, to help to ensure that the device functions reliably regardless of external factors. In embodiments with a screw pump, the sensor may be adjacent to the screw pump. This helps to ensure that the sensor can provide an accurate picture of what vibrations the solid dosage form in the screw will be experiencing. In embodiments with the above control unit, the control unit may be configured to receive data from the sensor and to control the means for vibrating the units of solid dosage form based on the data from the sensor. In this way, the control unit can adjust the means for vibrating as necessary to ensure that the vibration experienced by the solid dosage form is as it should be even if there are other external factors which may otherwise affect the vibration. For example, in a hand-held device, the way in which the device is held may affect the vibration measured and the control unit can be used to adjust the means for vibrating the solid dosage form to account for this. The control unit may be configured to stabilise vibration of the device by controlling the means for vibrating the units of solid dosage form based on variations in the data received from the sensor. The control unit may comprise a proportional integral derivative ("PID") controller for controlling vibration of the means for vibrating the units of solid dosage form based on the data from the sensor. Such a controller is particularly effective at stabilising the vibration experienced by the solid dosage form in the device.

[0028] According to a further aspect, there is provided a method for dispensing solid dosage form (e.g., a drug or medicament, e.g. oral dosage form) from a device as described in any of the aspects and embodiments above. That is, a device comprising a receptacle for containing the solid dosage form and dispensing means for dispensing the solid dosage form from the receptacle, the method comprising vibrating the solid dosage form within the receptacle and then dispensing a dose of the solid dosage form from the device. The dose may comprise a particular number of units of solid dosage form and / or a particular volume of solid dosage form. Vibrating the solid dosage form in the receptacle, in particular before the dispensing step, helps to aid in distributing the solid dosage form within the receptacle, for example those units of the solid dosage form that may have become jammed or highly compacted.

[0029] The method may further comprise vibrating the solid dosage form within the receptacle during the dispensing step. This can help to avoid solid dosage form from becoming jammed within the device, and can help to provide smooth movement of the solid dosage form through the device. This helps to ensure that an accurate dose of solid dosage form is dispensed from the device. The vibration may occur throughout the whole of the dispensing step.

[0030] The dispensing step may include rotating a screw pump as described above, wherein rotating the screw pump comprises rotating a screw thread of the screw pump within an inner cylindrical surface of the device such that solid dosage form contained within the receptacle enters the screw thread, travels down the screw thread, and is dispensed from the device. Rotating the screw pump may include controlling or selecting the number of rotations and / or partial rotations of the screw pump to dispense a particular dose.

[0031] The method may comprise vibrating the solid dosage form within the screw thread of the screw pump during the dispensing step. This can help to avoid jamming of the solid dosage form within the screw pump, and can thereby help to ensure that an accurate number and / or volume of units of solid dosage form is dispensed.

[0032] The method may comprise compacting the solid dosage form within the receptacle using a plunger, for example before or after vibration. The plunger may translate within the receptacle to decrease the volume of the receptacle containing the solid dosage form as the solid dosage form is dispensed in order to compact the solid dosage in the receptacle. This can help to ensure that the device dispenses an accurate number of units and / or volume of solid dosage form during the dispensing step.

[0033] The step of vibrating the units of solid dosage form may comprise vibrating the units of solid dosage form for a total of between 100 milliseconds and 20 seconds in total each time a dose of solid dosage form is dispensed, and optionally for a total of between 2 and 6 seconds.

[0034] The step of vibrating the units of solid dosage form may further comprise progressively increasing an amplitude and / or a frequency of vibration. In one example, the amplitude and / or the frequency is progressively increased according to a ramp function, optionally the ramp function lasting between 2 and 6 seconds, optionally between 3 and 5 seconds.

[0035] The method may further comprise measuring a frequency and / or an amplitude of vibration using a sensor, wherein the sensor is optionally adjacent to a or the screw pump. For example, the method may further comprise receiving data from the sensor at a control unit, and using the control unit to control the vibration of the units of solid dosage form based on the data from the sensor. The method may further comprise using the above control unit to stabilise vibration of the device by controlling the vibration of the units of solid dosage form based on variations in the data received from the sensor. For example, the method may comprise using a proportional integral derivative ("PID") controller to control vibration of the units of solid dosage form based on the data from the sensor.

[0036] According to a further aspect, there is provided a method for filling a device for dispensing a solid dosage form (e.g., a drug or medicament), the device as described in any of the aspects and embodiments described above. That is, comprising a receptacle for containing the solid dosage form and dispensing means for dispensing the solid dosage form from the receptacle, the method comprising filling the receptacle with a plurality of units of the solid dosage form, and while carrying out the step of filling, vibrating the units of solid dosage form within the receptacle. This can help to ensure that the solid dosage form is packed tightly within the receptacle during the filling step, and can mean that the receptacle can be filled with a greater number of solid dosage form (compared with an arrangement which does not have a vibration step).

[0037] The above method may further comprise providing a funnel for guiding the solid dosage form into the receptacle, and vibrating the funnel during the filling step. This can help to ensure that the solid dosage form flows smoothly from the funnel into the receptacle in a predictable manner.

[0038] For any of the above, the solid dosage form may be solid oral dosage form as defined below.

[0039] Definitions

[0040] Solid dosage form - a medicament, drug or medication in solid form. This includes (but is not limited to) tablets, mini-tablets, pellets. Solid dosage for may comprise multiple units of medicament, drug or medication in solid form. The units may be generally uniform in size, or may include a range of unit sizes.

[0041] Solid oral dosage form - a solid dosage form which is designed or intended to be consumed by a patient orally.

[0042] Mini-tablet - a solid dosage form (e.g., a medicament, drug, medication, etc.) in the form of a tablet, each with a dimension smaller than that of conventional medicament tablets, optionally having a maximum dimension (e.g., a diameter, if the solid dosage form has a circular cross-section) of between about 1 mm and 7 mm, optionally between about 1 mm and 5 mm, optionally between about 1 mm and 4 mm, optionally between about 2 mm to 5 mm, optionally between about 2 mm and 4 mm, optionally between about 1 mm and 3 mm, optionally between about 3 mm and 4 mm. A height (which is a dimension of the tablet perpendicular to the width) of the mini-tablet may be between about 1 mm and 7 mm, optionally between about 1 mm and 5 mm, optionally between about 2 mm to 5 mm, optionally between about 2 mm and 4 mm, optionally between about 1 mm and 3 mm, optionally between about 3 mm and 4 mm. The width to height ratio may be between 0.8 and 1 .2. By “diameter” it is meant that the mini-tablets are assumed to be roughly spherical, although they could be irregular shaped. For example, the mini-tablets may have an ovoid shape. Each mini-tablet may typically be shaped as a cylinder with domed caps. The diameter or width / dimension could correspond to a largest width of the mini-tablets. Mini-tablets may or may not have a surface coating. Mini-tablets may be manufactured by a die stamping process.

[0043] Pellet - A single granule of a solid oral dosage form (e.g., a medicament, drug, medication, etc.), optionally having a dimension (e.g., width, diameter or largest dimension) of less than 2000 pm, optionally having a dimension (e.g., a largest dimension, width or diameter) between about 150 pm and about 1200 pm (or even about 1500 pm, optionally between about 200 pm and about 300 pm, between about 300 pm and about 900 pm, between about 500 pm and about 700 pm, between about 50 pm and 2000 pm, or between about 250 pm and 1000 pm). By “diameter” it is meant that the pellets are assumed to be roughly spherical, although they could be irregular shaped. The diameter could correspond to a largest width of the pellets, if they are not assumed to be spherical. Pellets may or may not have a surface coating. Where a surface coating is provided, the dimensions provided herein correspond to the pellets with any surface coating.

[0044] In various embodiments the pellets may have a dimension (e.g., a largest dimension, width or diameter) within one or more of the following ranges: 150-300 pm; 150-400 pm; 200-400 pm; 200-500 pm; 300-500 pm; 400-600 pm; 300-700 pm 500-700 pm; 200-800 pm; 600-800 pm; 700- 900 pm; 700-1200 pm; 800-1000 pm; 800-1100 pm; 900-1100 pm; 900-1200 pm; and 1000-1200 pm.

[0045] Dose - A single measurement (e.g., volume, weight or number of units e.g. number of units of mini-tablets) of solid dosage form, for example totalling between about 0.01 ml to about 5 ml (such as about 0.1 ml to about 0.6 ml) by volume, for example about 0.3 ml by volume (although sometimes such solid dosage form is measured by weight).

[0046] Dispensing Mechanism - A system, e.g., an electromechanical system that converts a user’s action into the dispensing of a dose.

[0047] Cartridge - A component, e.g., a replaceable component used to store and dispense solid dosage form, optionally containing features of the device such as a rotating member in the form of, e.g., a central threaded bar, a moving plunger and the solid dosage form.

[0048] Plunger - A component that can ensures the solid dosage form stay packed together toward the dispensing end of the cartridge.

[0049] It will be appreciated that references to “a” drug or medicament as referred to herein may be taken as “one or more” drugs or medicaments. For example, the solid dosage form could comprise several drugs or medicaments. This could be achieved by mixing solid dosage form, each comprising a different drug or medicament, and / or mixing drugs or medicaments within each unit of solid dosage form.

[0050] BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Various embodiments will now be described, by way of example only, and with reference to the accompanying drawings in which: Figure 1 illustrates a perspective view of a device capable of dispensing a drug or medicament (e.g., a solid dosage form);

[0052] Figure 2 illustrates a cutaway view of a cartridge suitable for use in the device shown in Figure 1 ;

[0053] Figure 3 schematically illustrates a cutaway view of a screw and an exit tube of the cartridge shown in Figure 2;

[0054] Figure 4 illustrates a cross-sectional view of a portion of a cartridge and a plunger suitable for use in the device and cartridge of Figures 1 to 3;

[0055] Figure 5 illustrates a perspective view of the plunger shown in Figure 4;

[0056] Figure 6 illustrates a cross sectional view of a first end of the device shown in Figure 1 ;

[0057] Figure 7 illustrates a perspective view of the first end of the device shown in Figure 6;

[0058] Figure 8 illustrates a cross sectional view of a first end of another device capable of dispensing a drug or medicament (e.g., a solid dosage form).

[0059] DETAILED DESCRIPTION

[0060] Figure 1 illustrates a perspective cutaway view of a delivery device 100 capable of dispensing a solid dosage form. The device 100 has the aim of making the dispensing of dosages of solid dosage form, e.g. solid oral dosage form, more reliable and efficient.

[0061] The device 100 comprises a cartridge 101 and a control assembly 103. The cartridge 101 is configured to mate with the control assembly 103 such and the cartridge 101 is attachable to and removable from the control assembly 103. The cartridge 101 is configured for storing and dispensing a solid dosage form, as described below in relation to Figures 2 and 3. The control assembly 103 is configured to operate the cartridge 101 to dispense a drug or medicament from the cartridge 101 .

[0062] The control assembly 103 comprises an actuator or driving mechanism 105. In this embodiment the actuator 105 is in the form of an electric motor 105, and the control assembly 103 may further comprise a battery 107 for powering the electric motor 105. The actuator 105 is configured to engage with and rotate a rotating member 150 of the cartridge 101 in order to dispense solid dosage form from the cartridge 101. The control assembly 103 may also comprise a control unit for controlling the actuator 105.

[0063] In this embodiment, the cartridge 101 is formed from at least two parts which are connected to each other by a screw 109. The two parts each have flanges 111 , 113 which slot into each other, and the attachment screw 109 connects the two flanges 111 , 113 in order to connect the two parts of the cartridge 101. This arrangement is not essential, however, and in other embodiments (e.g., such as that shown in Figure 8) the cartridge may be formed as an integral unit, for example. The cartridge 101 is attached to the control assembly 103 by any suitable means, for example the cartridge 101 may comprise rails which slide along and slot into elongate slots in the control assembly 103. The cartridge 101 may also be retained in its attached position in the control assembly 103 by any suitable means, for example the cartridge 101 may provide a flange which clicks into a corresponding slot when the cartridge 101 reaches its attached position.

[0064] In the illustrated embodiment, the device 100 has a generally oblong shape having a generally flat upper surface 112 and a curved lower surface 114 opposite the upper surface 112. Although such a shape is visually and ergonomically appealing, the device 100 is not limited to this particular arrangement, and other suitable shapes may be provided whilst achieving the functionality set out herein.

[0065] The device 100 is configured as a handheld unit, and is sized appropriately. For example, the size of the device 100 may be no more than about 300 mm, 250 mm or 200 mm in length (the largest dimension of the device. The width (second largest dimension) may be no more than about 100 mm, 75mm or 50mm.

[0066] The device 100 may also be light enough that it can be easily carried and operated by a user with one hand. In various embodiments, the device 100 may have a weight of about 200g to 500g, for example 300g to 400g. The weight of the device 100 may be no more than 400g.

[0067] The control assembly 103 extends from a first end 120 to a second end 122. The control assembly 103 comprises a first portion 110 located towards the first end 120, and a second portion 120 located towards the second end 22. The first portion 110 comprises a pocket or cavity 121 shaped to receive and hold the cartridge 101. The first portion further comprises a battery 107 and a vibration device 131 (described below). The second portion 120 is configured to contain various control electronics and the actuator 105 to control the dispensing of medication from the cartridge 101 . This can help to distribute the weight of the device 100 evenly and make it more comfortable to hold and / or easier to operate. In other embodiments, the components may be distributed differently, for example at least some of the control electronics may be located in the first portion 110, or the battery 107 may be located in the second portion 120.

[0068] The control assembly 103 comprises an interface 132 at the junction between the first portion 110 and the second portion 120, wherein the interface 132 is configured to mate with the cartridge 101 . When the cartridge 101 is received in the control assembly 103, an end of the rotating member 150 of the cartridge 101 mates with a rotating member 151 of the actuator 105 of the control assembly 103 located at the interface 132, such that when the rotating member 151 of the actuator 105 rotates, this causes rotation of the rotating member 150 of the cartridge 101 to dispense the drug or medicament from the cartridge 101 , as described further below. The mating may be achieved in any suitable manner, for example using complementary teeth which engage with each other.

[0069] As mentioned above, the device 100 may include a control unit which may be configured to dispense a dose of the solid dosage form contained within the cartridge 101 , for example after receiving an actuating signal from an input device or mechanism. The actuating signal may be initiated, for example, by a user pressing a suitable button or other input mechanism located on the control assembly or via a different control such as a wireless or wired external control.

[0070] By using an electromechanical actuating mechanism, the device 100 may be able to dispense a precise number of units and / or volume of the solid dosage form repeatedly. The motor 105 and the control unit may be powered by the battery 107, which may be an integrated battery and which may be user replaceable.

[0071] The motor 105 may comprise a stepper motor, which could be configured to rotate the rotating member 150 by any suitable number of rotations based on the situation at hand, e.g., based on the type of medicament within the cartridge 101 , or the user. The control unit may be provided in the form of a computer, processor, processing device or microcontroller, e.g., on a PCB.

[0072] Although this device 100 has one motor 105 and one cartridge 101 , in embodiments there may be more than one motor 105 and / or cartridge 101 .

[0073] The device 100 may also include a removable cap 140 at the first end 120. The cap 140 may be configured to hold or store units of the solid dosage form once they have been dispensed from the cartridge 101. The user can then remove the cap 140 in order to gain access to the solid dosage form. The cap 140 illustrated is generally cup-shaped and shaped such that units of the solid dosage form will pool into a particular region of the cap 140, although other shapes may be provided. In other embodiments, the cap 140 may be omitted.

[0074] The first portion 110 of the control assembly 103 further comprises means for vibrating the solid dosage form within the cartridge 101 . The means are in the form of a vibration device 131 , as explained in more detail below.

[0075] Figure 2 shows a perspective cutaway view of an embodiment of a cartridge 201 suitable for use in the device of Figure 1 .

[0076] The cartridge 201 comprises a first end 217 for connecting to the control assembly 103, and a second end 218 (opposite the first end 217) that comprises the dispensing end of the cartridge 201. In use, units of the solid dosage form will be dispensed out of the second end 218 as a result of the operation of the driving mechanism (e.g., motor).

[0077] The rotating member 250 extends through the whole length of the cartridge 201 . The rotating member 250 is configured to connect to the rotating member 151 of the actuator or driving mechanism (e.g., motor) at the first end 217 of the cartridge 201. As described below, rotation of the rotating member 250 will cause units of the solid dosage form to be dispensed from the second end 218 of the cartridge 201 .

[0078] The cartridge 201 comprises an exit tube 212 at the second end 218 thereof, through which the units of the solid dosage form are dispensed. The cartridge 201 is hollow and comprises a chamber 220 for holding a plurality of units of a solid dosage form (e.g., solid oral dosage form), and through which the rotating member 250 extends from the first end 217 of the cartridge 201 to the second end 218 of the cartridge 201 .

[0079] The chamber 220 and / or the cartridge 201 may be substantially hermetically sealed (e.g., with the exception of the passage through which the units of the solid dosage form are dispensed). For example, at the first end 217 the connection between the rotating member 250 and the cartridge 201 may comprise a seal, for example an elastomeric gasket or valve (not shown). Similarly, at the second, dispensing end 218 of the device a suitable seal (not shown) may be provided between the rotating member 250 and exit tube 212. For example, a packaging seal may be provided that covers and seals the outlet of the device (e.g., the exit tube 212), which a user can remove (e.g., peel off) when they wish to begin use. Additionally, or alternatively a valve may be used to at least partly seal the second, dispensing end of the device 100. These features can help prevent air and / or moisture from entering the chamber 220 and interacting with the units of the solid oral dosage form undesirably.

[0080] The rotating member 250 extends into the exit tube 212 at the second end 218 of the device 100, and comprises a screw 240. Together, the exit tube 212 and screw 240 form a type of screw pump configured to dispense units of the solid dosage form from the second end 218 of the device 100. That is, the units will enter or feed into a channel 233 defined by a screw thread 242 of the screw 240 and, upon rotation of the rotating member 250, will be forced out of the exit tube 212 via the channel 233 and be dispensed from the device 100.

[0081] The rotating member 250 and the cartridge 201 may have a common longitudinal axis, which may also be the axis of rotation of the rotating member 250. However, in various embodiments the longitudinal axis of the cartridge 201 may be offset from that of the rotating member 250 and / or the axis of rotation of the rotating member 250.

[0082] Figure 2 shows the cartridge 201 having an oblong shape. This shape may have advantages in terms of ergonomics, although this shape is not essential, and the cartridge 201 could have any suitable shape.

[0083] Figure 3 shows the second, dispensing end 218 of the cartridge 201 in more detail, at which end there is located the exit tube 212, with the screw 240 of the rotating member 250 extending through the exit tube 212 as discussed above.

[0084] A radially outer surface 241 of the screw 240 may substantially contact (and / or abut) a radially inner surface 214 of the exit tube 212. That is, the outer surface 241 of the screw 240 and the radially inner surface 214 of the exit tube 212 may substantially contact each other or abut (e.g., continuously or intermittently), but not to the extent that they have an interference or friction fit relative to each other, to ensure that they can move smoothly past each another and ensure reliable dispensing as the radially outer surface 241 of the screw 240 rotates past the radially inner surface 214 of the exit tube 212. It is envisioned that any tolerances between the outer surface 241 of the screw 240 and the inner surface 214 of the exit tube 212 are as tight as possible whilst still allowing the screw 240 to rotate within the exit tube 212.

[0085] For example, a small tolerance or gap may be present between the outer surface 241 of the screw 240 and the inner surface 214 of the exit tube 212, e.g., due to manufacturing tolerances. If the surfaces are configured to contact each other (e.g., continuously or intermittently), the surfaces may be manufactured from low friction materials (e.g., a non-stick coating on or an additive applied to one or both of the opposing surfaces, using, e.g., Teflon), which may lead to a tight (e.g., contact fit) but without a friction or interference fit. In various embodiments (e.g., those including a cartridge 201 containing the solid dosage form therein), a tolerance or gap between the outer surface 241 of the screw 240 and the inner surface 214 of the exit tube 212 may be present, and may be large enough to allow free rotation of the shaft 250, but small enough to prevent any individual units of the solid dosage form (and / or solid dosage form debris) from sliding between the gap, adding friction and inhibiting the free rotation.

[0086] The screw 240 defines at least one channel 233 defined by the screw thread 242, the screw 240 configured to receive units of the solid dosage form contained within the chamber 220 and transport them, upon rotation of the rotating member 250, along the channel 233 to be dispensed out of the exit tube 212. The screw thread 242 defines one or more channel starts (not shown), each channel 233 forming a continuous helix that the units of the solid dosage form fill during operation of the device, for example due (at least in part) to the action of the plunger 230 pressing on the units within the chamber 220, which forces them into the channel 233.

[0087] The screw 240 contacts the inner radial surface 214 of the exit tube 212 so as to form a screw pump (e.g., an “Archimedes” screw) with the exit tube 212 of the cartridge 201 . That is, as the rotating member 250 rotates, the screw 240 will also rotate, causing units of the solid dosage form contained within the chamber 220 to enter the channel 233 of the screw 240, travel down the channel 233 of the screw thread 242 and exit the cartridge 201 . The screw pump may comprise an outlet 243 through which the units are dispensed.

[0088] As mentioned above, in order to dispense the solid dosage form from the cartridge 201 , the actuator may rotate the rotating member 250. This causes (in relevant embodiments) the plunger 230 to move down the screw thread 252 of the rotating member 250, and / or the screw 240 to rotate, causing the solid dosage form to be dispensed via the screw pump. In embodiments, there may not be a plunger present, and the solid dosage form may be contained within the chamber 220 by an end surface of the cartridge 201 . In such an embodiment, gravity may be relied upon to ensure that the solid dosage form stays at the bottom of the device to feed into the screw pump during dispensing.

[0089] The cartridge 201 may be made from a rigid material, for example polycarbonate or polyamide, although any suitable material may be used. The inner diameter of the cartridge 201 (i.e. , forming the chamber 220) may be between about 5 mm to about 200 mm, optionally about 10 mm to about 20 mm. The cartridge 201 may have a length (corresponding to its longest dimension) of between about 80 mm and about 120 mm, a width (transverse to its length) between about 30 mm and about 50 mm, and a height (transverse to its width) of between about 10 mm and about 25 mm.

[0090] The exit tube 212 may have an internal diameter that substantially equals the diameter of the rotating member 250, and specifically at (and optionally only at) the location of the screw 240 thereof. Outside of the screw, the diameter of the rotating member 250 may be different, for example substantially less than that of the exit tube 212 internal diameter. In such embodiments, the screw 240 may start within the exit tube 212 itself and the units of the dosage form may enter the screw thread within the exit tube 212. This internal diameter may be less than 10 mm, for example less than about 6 mm. The length of the exit tube 212 along the longitudinal axis A of the device 100 may be less than about 20 mm (such as about 15 mm or about 10 mm).

[0091] The volume of the chamber 220 (i.e., prior to operation or a maximum volume) may be less than about 75mL, for example less than 20 mL or approximately 14 mL.

[0092] The cartridge 201 may comprise a tapered portion 204 at the second end 218 of the device 100, which tapered portion 204 may be configured to guide or direct units of the solid dosage form contained within the chamber 220 into the channel 233 of the screw 240. In other words, the surface 210 may be tapered or angled such that it is not perpendicular to the longitudinal axis A, but is oriented at an angle with respect thereto, for example an angle of about 30°, 60° or more. The tapered portion 204 may be frustoconical or trumpet shaped. In embodiments, the tapered portion 204 is omitted and the second end 218 of the cartridge 201 may be perpendicular to the longitudinal axis A, for example.

[0093] The outer surface 241 of the screw 240 may be made from a low friction material, for example nylon, polyethylene (“PE”), polyethylene terephthalate (“PET”), polypropylene, polybutylene terephthalate, optionally containing friction reducing additives. The cartridge 201 and portions thereof that abut, oppose or contact the screw 240, plunger 230 or other moving parts of the device 100 may also be made from a low friction material, for example nylon, polyethylene (“PE”), polyethylene terephthalate (“PET”), polypropylene, polybutylene terephthalate, optionally containing friction reducing additives.

[0094] In this embodiment, the screw 240 is configured such that the height of the screw thread 242 extends above the exit tube 212 (towards the chamber 220) by at least one complete turn. In other embodiments, the screw 240 may not extend above the exit tube 212, and could for example start at the top, or even within the exit tube 212 (with the diameter of the rotating member 250 modified accordingly to allow the units of the dosage form to enter the screw thread 242).

[0095] The exit tube 212 may have a length of between about 5 mm and about 20 mm (optionally between about 10 mm and about 15 mm), wherein the length of the screw thread 242 in a direction along the longitudinal axis A of the cartridge 201 may be at least the length of the exit tube 212 in the same direction, for example between about 1 to about 5 times the length of the exit tube 212, for example about 1 .2, 1 .3, 1 .4, 1 .5 or 2 times the length of the exit tube 212. It should be noted that, in some embodiments, there may not be an exit tube 212, or the internal diameter of the exit tube 212 could correspond to that of the chamber 220.

[0096] The rotating member 250 may comprise a high stiffness and / or rigid material, for example polycarbonate or polyamide. The diameter of the rotating member 250 can vary from about 3 mm to about 10 mm, for example about 3 mm to about 6 mm. The diameter of the rotating member 250 may be equal to the diameter of the outer surface 241 of the screw 240, e.g., along its entire length (along the longitudinal axis A).

[0097] The actuator, if provided with an electromechanical motor, may be configured to rotate the rotating member 250 at a rate of between about 0 rpm and about 1000 rpm, optionally between about 50 rpm and about 500 rpm, optionally between about 90 rpm and about 150 rpm.

[0098] Generally, the screw pump disclosed herein may be aimed at providing an accurate dose of medication by weight, and also providing a simple mechanism by which to administer a dosage and / or titrate a medication.

[0099] The device 100 may further comprise a plunger 230 that is configured to move along the rotating member 250 as a result of the rotation of the rotating member 250.

[0100] The cartridge 201 holds a solid dosage form within the chamber 220 thereof, as described above. The plunger 230 causes the volume of the chamber 220 to vary during operation of the device 100, as described in more detail below.

[0101] At one end, the chamber 220 is enclosed at least in part by the plunger 230. The other end of the chamber 220 is enclosed at least in part by a surface 210 of the cartridge 201. The rotating member 250 extends through the chamber 220 along the longitudinal axis A of the cartridge 201 .

[0102] The use of a screw pump as described above is advantageous when used to dispense any type of solid dosage form. However, the screw pump may be particularly advantageous when used to dispense small units of a solid dosage form, such as in the form of pellets. The screw pump has been found to be particularly accurate at dispensing a dose of pellet medication. The screw pump is also able to provide accurate dose adjustments (by varying the number of turns of the screw pump during dispensing) so that the dose can be easily and continuously varied using the same dispensing device. This means that an individualised dose can be applied and dispensed more easily, and depending on an individual user’s needs.

[0103] Figure 4 shows a cross-sectional view of a portion of a cartridge 301 comprising a preferred embodiment of the plunger 330, and Figure 5 shows a side view of the plunger 330 in isolation of the rest of the cartridge 301 . The plunger 330 is suitable for use in the cartridge shown in Figure 2, and the device shown in Figure 1 .

[0104] As the rotating member 350 is rotated in use, the plunger 330 rests on top of the solid dosage form (not shown) located within the chamber 320 (below the plunger 330). The plunger 330 is configured to move along the rotating member 350 as a result of the rotation of the rotating member 350. A portion of the rotating member 350 within the chamber 320 comprises a screw thread 352 (which may be distinct from any screw thread of the screw pump).

[0105] As will be described in more detail below, the plunger 330 in one embodiment comprises flanges 345 which are configured to fit into channels of the screw thread 352 of the rotating member 350 such that the plunger 330 forms a nut around the rotating member 350. The screw thread 352 of the rotating member 350 and the flanges 345 of the plunger 330 are configured such that when the rotating member 350 rotates to dispense units of the solid dosage form (as described below), the plunger 330 moves or translates axially along the screw thread 352 of the rotating member 350 towards the screw pump (not shown).

[0106] As the plunger 330 translates along the rotating member 350, the volume of the chamber 320 containing the solid dosage form gradually decreases. Units of the solid dosage form contained within the chamber 320 will be forced towards the second end of the cartridge 301 by the plunger 330 throughout the operation and lifetime of the device.

[0107] The plunger 330 may comprise a plurality of members 344 for releasing overpressure of the solid dosage form within the chamber 320. The members 344 may be elongate and circumferentially distributed around the rotating member 350, and may extend in an axial direction.

[0108] As shown in Figure 4, the members 344 extend from a radially inner surface 334 of the plunger 330 (described below) in a direction away from the dispensing end. At the end of each elongate member 344 is a respective one of the flanges 345. As explained above, each flange 345 is configured to fit within a channel of the screw thread 352 of the rotating member 350 such that the flanges 345 engage with the screw thread 352 of the rotating member 350 of the cartridge 301 . If enough pressure builds within the chamber 320, the elongate members 344 (which are flexible) are configured to bend outwards and snap onto the next screw thread in order to avoid excessive pressure within the chamber (which may result from overpacking of the solid dosage form or jamming of solid dosage form during the dispensing step).

[0109] The plunger 330 may be configured to abut and / or contact an inner surface 335 of the chamber 320, and a friction fit may exist between the plunger 330 and the inner surface 335 of the chamber 320, to help prevent the plunger 330 from rotating with the rotating member 350. In this embodiment, the inner surface 335 of the chamber 320 has a generally square cross-section (such that the chamber 320 has a cuboid shape), and the perimeter or radially outer surface 353 of the plunger 330 has a corresponding generally square cross section as shown in Figure 5. A square cross-sectional chamber 320 will help to prevent the plunger 330 from rotating within the chamber 320. However, any suitable chamber 320 cross-sectional shape may be provided, for example a chamber 320 with a circular cross-sectional shape (e.g. a cylindrical chamber 320).

[0110] The cartridge 301 may include features that provide a driving force to the plunger 330 that acts in a direction towards the solid dosage form located within the chamber 320, for example other than relying on the weight of the plunger 330 and / or the corresponding screw threads described above. For example, a ratchet mechanism may be used to ensure that the plunger 330 can only move in a single direction, namely towards the solid dosage form located within the chamber 320. A resilient member (e.g., a spring) may be provided to force the plunger 330 towards the solid dosage form located within the chamber 320. A source of pneumatic air may be provided, which may pressurise the plunger 330 towards the solid dosage form located within the chamber 320.

[0111] In use, a surface 332 of the plunger 330 presses onto the units of the solid dosage form and forces them towards the dispensing end of the cartridge 301 , which assists in packing the units tightly within the chamber 320. The surface 332 may be slanted at an angle relative to a radial direction (the radial direction defined relative to a longitudinal axis X of the rotating member 350 of the cartridge 301) with a radially innermost portion of the surface 332 being axially closer to the screw pump or bottom of the cartridge 301 than a radially outermost portion of the surface 332. In other words, the surface 332 may generally follow a conical frustum shape, as shown in Figure 4.

[0112] As shown in Figure 4, the plunger 330 may also provide a radially inner surface 334 which is adjacent to the surface 332 pressing onto the solid dosage form. The radially inner surface 334 rests on top of and slides along radially outer surfaces of the screw thread 352 of the rotating member 350 to provide stability to the plunger 330 as it moves along the rotating member 350.

[0113] Although the above described plunger 330 is a preferred embodiment which is particularly advantageous, other plunger 330 shapes and configurations may be provided. For example, a simple radially extending plunger 330 such as that illustrated in Figure 2 may be provided in order to compact the solid dosage form.

[0114] As explained, the plunger 330 acts to compact the solid dosage form within the chamber 320 and to push the units of the solid dosage form towards the screw pump. This helps to ensure that the density of the solid dosage form within the chamber 320 is high enough throughout the dispensing process, and that the units thereof are fed consistently and predictably into the screw pump. This helps to ensure that when the screw pump rotates to dispense the units, a uniform number of the units are dispensed per turn of the screw pump. This is of particular importance in a medication context, because accurate and predictable dispensing of a medicament is of critical importance. Otherwise, an incorrect or inaccurate dose may be dispensed, having significant health or safety implications.

[0115] Figure 6 shows a cross sectional view of the first end 120 of the device 100 shown in Figure 1 , and Figure 7 illustrates a top view of the first end 120 of the device 100 with the cartridge 101 partially removed from the control assembly 103 in order to illustrate certain features of the cartridge 101.

[0116] As shown in Figure 6, the first portion 110 of the control assembly 103 comprises a vibration device 131. The vibration device 131 may be a motor, such as an eccentric rotating mass (“ERM”) or linear resonant actuator (“LRA”) motor. The device 131 may be placed adjacent to or close to the cartridge 101 such that the vibration motor 131 is configured to vibrate the units of the solid dosage form within the cartridge 101.

[0117] In the illustrated embodiment, the vibration motor 131 is located at the first end 120 of the first portion 110 of the control assembly 103 such that the vibration motor 131 is close to the dispensing end (e.g., screw pump) of the cartridge 101 . In other embodiments, the vibration device 131 may be placed in another portion of the device 100, for example in the second portion 120 of the control assembly 103.

[0118] Importantly, the vibration device 131 should be configured to vibrate the units of the dosage form within the cartridge 101 . The skilled person will appreciate that this is dependent on many factors specific to a particular application, such as the size of the dispensing device, location of the vibration device, etc. As such the present invention is not limited to a specific size, location, etc. of the vibration device.

[0119] The vibration device 131 may be powered by the same battery that powers the motor for rotating the screw pump. Alternatively, the vibration device 131 may be powered by a dedicated battery, or it could have its own battery.

[0120] As shown in Figures 6 and 7, the cartridge 101 comprises two ribs 123 (although greater than or fewer than two ribs may be provided). The ribs 123 are disposed on an outer surface of the cartridge 101 . The ribs 123 are configured to contact a surface of the control assembly 103 when the cartridge 101 is assembled or attached to the control assembly 103. As shown in Figure 6, the ribs 123 are adjacent to the vibration device 131 in the control assembly 103 when the cartridge 101 is assembled in the control assembly 103. As shown, the ribs 123 are also adjacent the screw 109 of the cartridge and are disposed at or near the dispensing end 118 of the cartridge 101 . The placement of the ribs 123 proximate both the vibration device 131 and the dispensing end 118 of the cartridge 101 may help the vibration device 131 to vibrate solid dosage form being dispensed at the dispensing end 118 of the cartridge 101 more effectively than if the ribs were not present. This is because kinetic energy generated by the vibration device 131 will be transferred effectively to the ribs 123 (since they are in direct contact with the portion of the control assembly 103 containing the vibration device 131). Since the ribs 123 are at or near the dispensing end 118 of the cartridge 101 , the kinetic energy experienced by the ribs 123 will also be effectively transferred to the dispensing end 118 of the cartridge 101 , and thereby to the solid dosage form located in the dispensing end 118 of the cartridge 101 . In other words, the placement of the ribs 123 helps to ensure that a smaller proportion of the kinetic energy generated by the vibration device 131 is absorbed or dissipated before it reaches the pellets located in the dispensing end 118 of the cartridge 101 .

[0121] The flanges 111 , 113 and the screw 109 of the cartridge 101 may also aid in transferring kinetic energy / vibration generated by the vibration device 131 to the solid dosage form located in the dispensing end 118 of the cartridge 101 (for example solid dosage form located in the dispenser of the cartridge or in the end of the receptacle near the dispenser of the cartridge). This is because the screw 109 helps to ensure that the two flanges 111 , 113 are attached securely and tightly, such that the vibration can be effectively transferred through the flanges 111 , 113 to the solid dosage form adjacent to the flanges in the dispensing end 118 of the cartridge 101 whilst minimising kinetic energy absorbed by the flanges 111 , 113. The proximity of the screw 109 and flanges 111 , 113 to each other will also contribute towards minimising the amount of kinetic energy absorbed before it reaches the solid dosage form within the dispensing end of the cartridge 101 .

[0122] As illustrated, the cartridge 101 further comprises a funnel portion 119 which is tapered towards an exit aperture 126 of the cartridge 101. This helps to gather and direct solid dosage form dispensed from the screw pump (for example into a cap as described in relation to Figure 1). The funnel portion 119 is not essential and may be omitted in other embodiments.

[0123] Figure 8 illustrates another embodiment of a device 400. The device 400 illustrated in Figure 8 is similar to the device 100 illustrated in Figures 1 , 6 and 7, except that the cartridge 401 is formed as an integral unit instead of having a screw connecting two parts of the cartridge together. In this embodiment, the cartridge 401 has a flange 411 which is configured to convey vibration energy from the vibration motor 431 to the solid dosage form.

[0124] Vibrating the units of the solid dosage form in the cartridge has been found to significantly improve the reliability of the device when dispensing a dose or number of units of the solid dosage form.

[0125] In particular, as described below, vibrating the units before rotating the screw pump to dispense them can ensure that the units of the solid dosage form are at a consistent or desired density within the cartridge before dispensing occurs. For example, a vibration action can help to de-compact or spread out the units of the solid dosage form if conditions have caused them to become too compacted within the cartridge.

[0126] A vibration action can additionally, or alternatively help to increase the density of the solid dosage form if the units thereof are packed too loosely within the cartridge. In other words, vibration can help to ensure that the density of the units within the device is at a desired value, for example before the step of dispensing of a dose. This can help to ensure that a consistent number of units of the solid dosage form are dispensed per turn of the screw pump, thus improving consistency and reliability. As explained above, it is particularly important that a device for dispensing medication can dispense this accurately and predictably.

[0127] The plunger and vibrating means are advantageous in their own right. That is, although the vibrating means have been described in relation to the specific arrangement of a dispenser with a screw pump, the vibrating means could advantageously be used on a different device. For example, any dispensing mechanism configured to dispense units of medication from a chamber or receptacle may benefit from a vibration means as described herein. Similarly, any dispensing mechanism comprising a rotating member will also benefit from the vibration means and corresponding methods as described below.

[0128] Additionally, the combination of a device with a plunger as described above with means for applying vibration to the solid dosage form results in a device which is particularly reliable and accurate. This is because the plunger will act to ensure that the units of the solid dosage form are packed into the cartridge at a sufficient density (which may be pre-set depending on the type and dimensions of the solid dosage form being dispensed). The vibration will ensure that the units of the solid dosage form do not become over-compacted by the plunger and flow effectively within the device. The vibration can also ensure that the units of the solid dosage form are urged towards the dispensing end (e.g., screw pump) in order to allow the plunger to move laterally towards the dispensing end during a dispensing step. As such, the plunger and the vibration means can act together to ensure a consistent density of the solid dosage form units within the cartridge before and during the dispensing thereof.

[0129] The use of vibration means may be particularly advantageous when used in a device configured to dispense small units of a dosage form, such as pellets. Use of a medication formulated as pellets can support accurate dose adjustment and help paediatrics with swallowing issues. An advantage of dispensing drugs in pellet form is that the dose can be varied more easily, often using the same dispensing device (e.g., as described herein). Another advantage is that the pellets could be easy to swallow by patients having difficulty swallowing, who might alternatively crush tablets in order to swallow. Crushing or dividing of tablets is also used today by patients to get, e.g., half a dose from a prescribed drug, a process which is not recommended and can be avoided if a device can dispense flexible amounts. Variable dosing of pellets allows for a more exact tuning of a dose than what may be achieved using larger dosage forms such as tablets or capsules (which can typically only be cut along predetermined lines of weakness). Furthermore, for modified release formulations, pellets are often more robust against food interactions than larger dosage forms such as tablets. The device described is particularly effective at dispensing accurate doses of pellet-type medicaments. For example, the density of pellets stored within the device has been found to vary depending on the conditions of the device, and pellets have been found to be particularly susceptible to becoming over-compacted or to be packed too loosely within the device, which can affect how accurately the device can dispense pellets.

[0130] The use of vibration means, therefore, is particularly advantageous when used in a device configured to dispense small units of a solid dosage form. This is equally applicable to mini tablets (as defined herein). Mini-tablets are smaller than conventionally sized tablets. Use of a medication formulated as mini-tablets can also support accurate dose adjustment and help with difficulties with swallowing. The use of vibration in a device for dispensing mini-tablets can also help to ensure that the density of the mini-tablets is consistent. Mini-tablets can also be prone to becoming jammed, and the vibration means can also help to avoid such jamming.

[0131] A method of using the device and cartridges illustrated above will now be described.

[0132] When it is desired to dispense a dose of solid dosage form from the device, a user may activate the device (e.g., input the desired dose into the device, or press an initiating button), for example using buttons on the device which can communicate with the control system in the device. In embodiments, the device may be configured to dispense a pre-set dose, for example a doctor or pharmacist may have inputted the desired dose into the device. The control system then sends an instruction or signal to the vibration motor to activate (start vibrating), which causes the units of the solid dosage form to vibrate within the cartridge. The frequency, amplitude and duration of vibration may be pre-set and may depend on the particular dose, device and type of solid dosage form at hand. For example, a vibration with a frequency of between 1 and 500 Hz may be used. In examples, a vibration amplitude of between 0.2 and 7 G may be used.

[0133] In use, the vibration may be applied gradually, such that the amplitude of vibration is increased progressively and then maintained at a maximum amplitude. This can help to improve the user experience of the device.

[0134] The step of vibrating the solid dosage form is complete when the vibration motor stops vibrating. The control assembly may then send a signal to activate the dispensing mechanism.

[0135] In the illustrated example, the rotating element of the cartridge is caused to rotate, causing rotation of the screw pump. This causes the device to dispense units of the solid dosage form. The control assembly may calculate the number of rotations of the actuator (and thus the screw pump) depending on the particular dose being dispensed.

[0136] In some embodiments, the vibrating step may continue whilst the control assembly sends a signal to activate the dispensing mechanism. That is, the vibration motor may continue to vibrate whilst the dispensing mechanism is activated (e.g., the screw pump is rotating). This can aid in dispensing the units of the dosage form, for example in order to aid the feeding of the units into the mechanism (e.g., screw pump) and avoid jamming thereof.

[0137] As explained above, the rotation of the rotating member may cause a plunger (if provided) to automatically translate axially towards the screw pump, thereby reducing the volume of the chamber as the solid dosage form is dispensed.

[0138] The step of vibrating the solid dosage form before dispensing units thereof can help to ‘reset’ or re-order the units into a desired density before dispensing occurs. Additionally, if any units of the solid dosage form have become overly compressed or compacted, the vibration can help to dislodge units of the solid dosage form before dispensing.

[0139] The vibration, therefore, helps to ensure that throughout the life of the device a consistent dose (i.e., number of units of solid dosage form) is dispensed.

[0140] A vibrating step may also be carried out when the cartridge is being filled (including re-filled) with solid dosage form. When the cartridge is being filled, the cartridge may be separated from the control assembly and access to the chamber is provided, for example by removing the second end of the cartridge. The cartridge may be filled with the units of solid dosage form using a funnel (that is distinct from the funnel of the cartridge), or by other means. During the filling step, the cartridge and / or the funnel (if present) may be vibrated. Vibration of the solid dosage form during filling or refilling can help to ensure that the solid dosage form is packed into the cartridge at a higher density than if the vibration step was not applied. This helps to maximise the number of units of solid dosage form that will fit into the cartridge and to ensure that the density of solid dosage form within the cartridge is sufficient before a first dose is dispensed from the device after filling or re-filling (which can help to ensure that the first dose is correct). If present, after the filling step the plunger can be used to compact the solid dosage form in the receptacle such that the device is then ready for dispensing.

[0141] A further aspect of the invention is a method of avoiding jamming when dispensing solid dosage form from any of the devices described above (which may or may not include vibrating means or a vibration step). This is advantageous in its own right, and may be claimed independently of any aspect involving vibration means.

[0142] The method of this aspect comprises rotating the rotating member in a first direction in order to dispense the solid dosage form. The method then comprises detecting that jamming of the rotating member has occurred. Jamming may occur due to the solid dosage form becoming lodged or stuck or causing an obstruction in or around a portion of the screw of the screw pump. The detecting step may include using a sensor for sensing a resistance torque applied to the screw, the resistance torque being the torque being experienced by the screw in an opposite direction to the driving torque (the driving torque being applied by the motor to actuate dispensing movement of the screw / rotating member). The detecting step may then comprise sensing that the resistance torque has exceeded a certain value, indicating that jamming has occurred, and sending a signal to the control unit indicating that a jamming event has occurred. The control unit then sends a signal to the motor to reverse the direction of rotation of the rotating member, such that the screw rotates in an opposite direction. The screw / rotating member may be rotated in a reversed / opposite direction for a small, pre-set amount of time / rotation of the screw. In other embodiments, the screw-rotating member may be rotated in the opposite direction until the torque sensor senses that the blockage has been cleared. Once the step of rotating the screw / rotating member in the opposite direction is complete, the control unit sends a signal to the motor to continue the dispensing of the solid dosage form by rotation of the rotating member in the first dispensing direction.

[0143] In an embodiment, the method of avoiding jamming may also include a step of vibrating (e.g., using the above-described vibration means) the units of the solid dosage form being dispensed. For example, this step of vibrating could be after the step of reversing the rotation of the rotating member / screw pump and before the step of continuing dispensing. Applying vibration at this point can further help to dislodge any blockage of the solid dosage form in or around the screw, to allow the dispensing of the solid dosage form to continue.

[0144] Although this method is advantageous in its own right, the method steps may be advantageously combined with the previously described embodiments to result in a dispensing device which is particularly effective at avoiding jamming and allowing for accurate and reliable dispensing of solid dosage form using the vibration means of those embodiments.

[0145] Although the above method is described in relation to specific devices described, this is of course for illustrative purposes. This method could be used to avoid jamming in any mechanism for dispensing a solid dosage form that uses a rotating member, for example in any device with a rotating member for dispensing tablets, e.g. mini-tablets. This method has been found to be effective at avoiding jamming of solid dosage form for various different dispensing devices with rotating members. The method has also been found to be particularly effective at avoiding jamming of a screw pump, especially when dispensing small dosage form medication, such as pellets or minitablets. It is of course important to avoid jamming when dispensing a medication, to ensure that the device is able to function effectively.

[0146] The handheld device may combine medical knowledge with digital capabilities. The control assembly may be reusable, and may be combined with various different cartridges 200 that are prefilled with a prescribed medication. For ADHD, for example, a cartridge 200 could be prefilled with the relevant medication for use over a one-month period. The cartridges 200 could be filled with solid dosage form. The solid dosage form could be taken with liquid or soft foods supporting swallowing of the medicine. Although the device have a particular use with ADHD, the technology disclosed herein is applicable to many other treatments and especially for paediatric use or for use in psychiatry, neurology, cardio-metabolic disorders or oral cancer treatments.

[0147] Example treatments that may be associated with the device described herein are Attention Deficit Hyperactivity Disorder (“ADHD” - wherein the medication used in the device could include amphetamines and / or methylphenidate), general pain (wherein the medication could include one or more of fentanyl, methadone, meperidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrocodone, oxycodone, hydromorphone, naltrexone, buprenorphine and methadone), immunosuppression post organ transplant (wherein the medication could include one or more of tacrolimus, sirolimus, everolimus, corticosteroids, cyclosporine, mycophenolate and azathioprine), diabetes (wherein the medication could include one or more of sitagliptin, vildagliptin, saxagliptin, linagliptin, metformin, canagliflozin, Dapagliflozin, empagliflozin and semaglutide), heart failure (wherein the medication could include one or more of carvedilol, metoprolol, bisoprolol and diurethics), Parkinson's disease (“PD” - wherein the medication could include levodopa and / or carbidopa ), epilepsy (wherein the medication could include one or more of sodium valproate, carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, ethosuximide and topiramate), depression (wherein the medication could include one or more of Citalopram, bupropion, paroxetine, milnacipran, fluoxetine, duloxetine, fluvoxamine and reboxetine), schizophrenia (wherein the medication could include one or more of aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone and olanzapine), cancer, animal health, oncology (substances mercaptopurine, methotrexate, temozolomide, isotretinoin, imatinib). For example, the device may be combined with medication that is aimed or associated with the aforementioned treatments, for example any or all of those described above.

[0148] The control assembly (in any of the aspects or embodiments described herein) may include an input device or user interface, which may include one or more buttons for operating the device, for example the dispensing mechanisms therein.

[0149] The control assembly may comprise a or the control system configured to operate the various electrical and mechanical parts of the device, for example a user interface, display and dispensing mechanisms. A prefilled cartridge 200 (e.g., for ADHD, with a one-month prescription) may have an integrated circuit board trip that communicates relevant information to the control assembly. The control assembly, and specifically the control system thereof, may set the dosage, prevent taking more than a maximum dosage, allow titration, and ensure notification of tampering. The control system may record dispensing of medication, for example over a defined period (e.g., the one- month prescription).

[0150] The methods, method steps, or functional features disclosed herein, for example in connection with the control system of the control assembly described above, may be implemented at least partially using software, e.g., computer programs. These may be located on a data processor on the control assembly itself. It will thus be seen that when viewed from further aspects the present invention provides computer software specifically adapted to carry out the methods, method steps, or functional features herein described when installed on data processing means, a computer program element comprising computer software code portions for performing the methods, method steps, or functional features herein described when the program element is run on data processing means, and a computer program comprising code means adapted to perform all the steps of a methods, method steps, or functional features herein described 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.

[0151] Although the present invention has been described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the scope of the invention as set forth in the accompanying claims.

Claims

Claims1 . A device for dispensing a solid dosage form (e.g., a drug or medicament), the device comprising: a receptacle for containing a plurality of units of the solid dosage form; means for vibrating the units of solid dosage form within the receptacle; and dispensing means for dispensing the solid dosage form from the receptacle.

2. The device of claim 1 , wherein the receptacle is substantially enclosed and the means for vibration causes the solid dosage form within the enclosed receptacle to vibrate within the receptacle.

3. The device of claim 1 or 2, wherein the receptacle is substantially sealed and forms at least part of the dispensing means.

4. The device of any preceding claim, wherein the dispensing means is configured to transport the solid dosage form from the receptacle to at least one outlet of the device, the means for vibrating the units of solid dosage form causing the solid dosage form being transported to vibrate.

5. The device of any preceding claim, wherein the dispensing means comprises a screw pump which is configured such that the dose of solid dosage form being dispensed can be varied by varying the amount of rotation of the screw pump.

6. The device of claim 5, wherein the screw pump comprises a screw thread, and the screw thread cooperates with an inner cylindrical surface of the device to form the screw pump, such that, as the screw pump rotates in use, the screw thread rotates within the inner cylindrical surface, causing units of the solid dosage form contained within the receptacle to enter the screw thread, and travel down the screw thread for dispensing from the screw pump.

7. The device of claim 6, wherein the means for vibrating the units of solid dosage form is configured to vibrate solid dosage form located in the screw thread of the screw pump.

8. The device of any preceding claim, wherein the vibration means is located adjacent to the dispensing means.

9. The device of any preceding claim, wherein the vibration means is located adjacent to the receptacle.

10. The device of any preceding claim, wherein the device is a hand-held device.11 . The device of any preceding claim, wherein the dispensing means is configured to dispense a number of units of the dosage form in a dispensing action, and such that the number of units being dispensed in one action can be adjusted.

12. The device of any preceding claim, wherein the solid dosage form comprises pellets and / or mini-tablets.

13. The device of any preceding claim, further comprising a plunger in the receptacle configured to press and compact the solid dosage form therein.

14. The device of any preceding claim, wherein the device comprises a replaceable cartridge, and the receptacle is part of the replaceable cartridge.

15. The device of claim 14, wherein the means for vibrating the units of solid dosage form is located in a control apparatus configured to be attached to the replaceable cartridge, the control apparatus comprising means for actuating the dispensing means.

16. The device of any preceding claim, wherein the means for vibrating the units of solid dosage form comprises a vibration motor.

17. The device of any preceding claim, further comprising a control unit configured to control the means for vibrating the units of solid dosage form.

18. The device of claim 17, wherein the control unit is configured to cause the means for vibrating the units of solid dosage form to vibrate for a total of between 100 milliseconds and 20 seconds in total each time a dose of solid dosage form is dispensed.

19. The device of claim 17 or 18, wherein the control unit is configured to progressively increase an amplitude and / or a frequency of vibration.

20. The device of claim 19, wherein the control unit is configured to cause the amplitude and / or the frequency of vibration to increase according to a ramp function, optionally the ramp function lasting between 2 and 6 seconds, optionally between 3 and 5 seconds.21 . The device of any preceding claim, further comprising a sensor, for example an accelerometer, configured to measure a frequency and / or an amplitude of vibration, optionally the sensor being adjacent to the screw pump.

22. The device of claim 21 , further comprising a or the control unit configured to receive data from the sensor and to control the means for vibrating the units of solid dosage form based on the data from the sensor.

23. The device of claim 22, wherein the control unit is configured to stabilise vibration of the device by controlling the means for vibrating the units of solid dosage form based on variations in the data received from the sensor.

24. The device of claim 22 or 23, wherein the control unit comprises a proportional integral derivative ("PID") controller for controlling vibration of the means for vibrating the units of solid dosage form based on the data from the sensor.

25. A method for dispensing a solid dosage form (e.g., a drug or medicament) from a device, the device comprising a receptacle for containing the solid dosage form and dispensing means for dispensing the solid dosage form from the receptacle, the method comprising: vibrating the solid dosage form within the receptacle; and then dispensing a dose of the solid dosage form from the device.

26. The method of claim 25, wherein the method further comprises vibrating the solid dosage form within the receptacle during the dispensing step.

27. The method of claim 25 or 26, wherein the dispensing step includes rotating a screw pump, wherein rotating the screw pump comprises rotating a screw thread of the screw pump within aninner cylindrical surface of the device such that solid dosage form contained within the receptacle enters the screw thread, travels down the screw thread, and is dispensed from the device.

28. The method of claim 27, wherein the method comprises vibrating the solid dosage form within the screw of the screw pump during the dispensing step.

29. The method of any of claims 25 to 28, further comprising compacting the solid dosage form within the receptacle using a plunger.

30. The method of any of claims 25 to 29, wherein the step of vibrating the units of solid dosage form comprises vibrating the units of solid dosage form for a total of between 100 milliseconds and 20 seconds in total each time a dose of solid dosage form is dispensed.31 . The method of any of claims 25 to 30, wherein the step of vibrating the units of solid dosage form further comprises progressively increasing an amplitude and / or a frequency of vibration.

32. The method of claim 31 , wherein the amplitude and / or the frequency is progressively increased according to a ramp function, optionally the ramp function lasting between 2 and 6 seconds, optionally between 3 and 5 seconds.

33. The method of any of claims 25 to 32, further comprising measuring a frequency and / or an amplitude of vibration using a sensor, wherein the sensor is optionally adjacent to a or the screw pump.

34. The method of claim 33, further comprising receiving data from the sensor at a control unit, and using the control unit to control the vibration of the units of solid dosage form based on the data from the sensor.

35. The method of claim 34, further comprising using the control unit to stabilise vibration of the device by controlling the vibration of the units of solid dosage form based on variations in the data received from the sensor.

36. The method of claim 34 or 35, further comprising using a proportional integral derivative ("PID") controller to control vibration of the units of solid dosage form based on the data from the sensor.

37. A method for filling a device for dispensing a solid dosage form (e.g., a drug or medicament), the device comprising a receptacle for containing the solid dosage form and dispensing means for dispensing the solid dosage form from the receptacle, the method comprising: at least partially filling the receptacle with a plurality of units of the solid dosage form; and while carrying out the step of filling the receptacle, vibrating the units of solid dosage form within the receptacle.

38. The method of claim 37, further comprising providing a funnel for guiding the solid dosage form into the receptacle, and vibrating the funnel during the filling step.

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