WO2019068441A1

WO2019068441A1 - Inhalation device and substrate

Info

Publication number: WO2019068441A1
Application number: PCT/EP2018/074616
Authority: WO
Inventors: David Lawson; Mark DIGNUM
Original assignee: Project Paradise Ltd
Current assignee: Project Paradise Ltd
Priority date: 2017-10-06
Filing date: 2018-09-12
Publication date: 2019-04-11
Anticipated expiration: 2020-04-06
Also published as: GB201716417D0

Abstract

An inhalation device is disclosed comprising a main body part provided with a heater, and a mouthpiece detachably connected to said main body part. The mouthpiece includes a substrate region internally thereof adapted to replaceably receive a substrate on which an amount of an aerosolisable composition is deposited. The mouthpiece also is also provided with an airflow pathway through its interior within which or adjacent which said substrate is disposed when received in said substrate region. Upon and after attachment of said mouthpiece to said main body part, said heater is arranged in the vicinity of the substrate region such that it is operative to be in thermal communication with the substrate region to heat the substrate to generate an aerosolised composition from the aerosolisable composition within the mouthpiece which can be inhaled by a user causing air to flow within and through the mouthpiece by suction.

Description

Inhalation Device and Substrate

Field

The present invention relates to an inhalation device. In particular, but not exclusively, one or more embodiments of the present invention may relate to an inhalation device comprising a heater to heat a substrate comprising an aerosolisable composition to generate an aerosolised composition for inhalation by a user. The present invention also relates to a substrate for use in such an inhalation device.

Although the present application will focus on heating aerosolisable compositions containing nicotine for inhalation by a user, it will be appreciated that the heater can be used for heating compositions comprising other compounds, for example, medicaments or flavourings.

Background

Pharmaceutical medicaments, physiologically active substances and flavourings for example may be delivered to the human body by inhalation through the mouth and/or nose. Such materials or substances may be delivered directly to the mucosa or mucous membrane lining the nasal and oral passages and/or the pulmonary system. One example of such a substance is nicotine which is consumed both for therapeutic or recreational purposes. Inhalation devices generally deliver the nicotine by vapourising or aerosolising the nicotine or a nicotine containing composition. Such devices may be powered or unpowered.

Vapourisation is the conversion of a substance into its gas phase at a temperature where the substance can also exist in the liquid or solid state, i.e. below the critical temperature of the substance. This can be achieved, for example, by increasing the substance's temperature or by reducing the pressure acting on it. Aerosolisation is the conversion of a substance into a suspension of tiny particles within a gas, i.e. an aerosol. Similarly, atomization is the process or act of separating or reducing a physical substance into fine particles and may include the generation of aerosols. Whilst the present application refers to the generation of an aerosolised composition, it will be appreciated that an aerosolised composition may also include a portion of the composition in its gaseous phase, i.e. a vapour. This is because a continuous state of equilibrium exists between a vapour and its condensed phases dependent on the atmospheric conditions.

Turning firstly to therapeutic uses of nicotine, nicotine replacement therapies are aimed at people who wish to stop smoking and overcome their dependence on nicotine. An example of nicotine replacement therapy is an inhalator such as the Nicorette© Inhalator. This is an unpowered device which allows a user to inhale a dose of nicotine but without the harmful combustion products of smoking a cigarette. It is aimed at people who crave the behaviour associated with consumption of combustible tobacco - the so-called hand-to-mouth aspect - of smoking tobacco. The inhalator has the general appearance of a plastic cigarette and comprises a replaceable nicotine cartridge. When a user inhales through the device, nicotine vapours are released from the cartridge and are inhaled by the user. Nicotine replacement therapies are generally classified as medicinal products and are regulated by appropriate medicine regulations in the various countries in which they are sold, for example, the Human Medicines Regulations in the United Kingdom.

Turning now to recreational uses of nicotine, these include smoking-substitute devices or nicotine delivery devices such as electronic cigarettes. These are generally powered devices and use heat and/or ultrasonic agitation to vaporize/aerosolise a solution comprising nicotine and/or other flavouring, propylene glycol and/or glycerol formulation into an aerosol, mist, or vapour for inhalation. The inhaled aerosol, mist or vapour typically bears nicotine and/or flavourings. In use, the user may experience a similar satisfaction and physical sensation to those experienced from combustible tobacco products, and exhales an aerosol mist or vapour of similar appearance to the smoke exhaled when using such combustible tobacco products.

Smoking-substitute devices or nicotine delivery devices typically comprise a vaporization component such as a heater for atomizing, aerosolising and/or vaporizing the liquid and to thereby produce an aerosol, mist or vapour. In some devices such a component is known inter alia as an atomizer, cartomizer, or clearomizer. Other common components include a power source such as a battery, a reservoir for holding the liquid to be vaporized (often termed an e- liquid), a mouthpiece through which the user can draw the aerosol, mist or vapour for inhalation and control circuitry operable to actuate the vaporization component responsive to an actuation signal from a switch operative by a user or configured to detect when the user draws air through the mouthpiece by inhaling.

A person of ordinary skill in the art will appreciate that the terms "smoking-substitute device^'' and "nicotine delivery device" as used herein include, but are not limited to, electronic nicotine delivery systems (ENDS), electronic cigarettes, e-cigarettes, e-cigs, vaping cigarettes, pipes, cigars, cigarillos, vaporizers and devices of a similar nature that function to produce an aerosol mist or vapour that is inhaled by a user. Some electronic cigarettes are disposable; others are reusable, with replaceable and refillable parts. Figure 1 shows a known vaporisation component (1 ) for a conventional e-cigarette. The vaporisation component comprises a wick (3), which may be solid or flexible, with a heating coil (5) wrapped around it. Hence, the component is generally termed a wick-and-coil heater. In the e-cigarette, the wick is in fluid communication with a cartridge (not shown) containing an e-liquid and is saturated with the e-liquid. In use, an electric current is passed through the coil (5) thereby heating the coil. This heat is transferred to the e-liquid in the wick (3) causing it to evaporate. However, the wick (3) generally contains more e-liquid than would be vaporised during a single inhalation. This increases the thermal mass of the wick (3) and means that the heat generated by the coil (5) is unnecessarily expended in heating all of the e-liquid rather than the amount that actually needs to be vaporised. Heating surplus liquid reduces the energy efficiency of the device. Furthermore, the coil (5) is spaced apart from the wick (3) to prevent the coil (5) from burning the wick (3). This reduces heat transfer to the wick and means that the coil (5) has to be powered to a higher temperature than that necessary to merely vapourise the e-liquid, i.e. typically around 300 C, in order to compensate for the dissipation of heat and inefficiencies of heating a large substrate and volume of liquid. This again reduces the energy efficiency of the device. Moreover, surplus e-liquid and repeated heating to a higher temperature increases the risk that a user will receive a larger dose of nicotine than intended and increases the potential for degradation of both nicotine and excipients.

Wick-and-coil heaters need to be periodically replaced due to the build-up of residues on the coil. These residues can produce unwanted by-products during heating due to the heating temperatures used in e-cigarettes. When the replacement wick-and-coil heater is received within the heater it does not comprise or hold any e-liquid or other composition. The wick will absorb e-liquid once installed in the e-cigarette and is placed in fluid communication with the cartridge containing the e-liquid.

Another problem with known e-cigarettes is that a user can refill their device with e-liquids which are not intended for that device and consequently may have higher levels of nicotine or additives which undergo an adverse reaction upon heating. As a result, a user may be exposed to excessive levels of nicotine or potentially harmful by-products.

Although originally marketed as an aid to assist habitual smokers wishing to quit smoking of combustible tobacco products, the problems relating to dosage and quality discussed above have prevented e-cigarettes and other types of smoking-substitute devices or nicotine delivery devices in general from receiving regulatory approval or being prescribed by doctors as nicotine replacement therapies. However, the popularity and use of smoking-substitute devices or nicotine delivery devices has grown rapidly in the past few years and consumers are increasingly viewing smoking substitute devices as desirable lifestyle accessories. Furthermore, the change in regulatory paradigm to that of a tobacco harm reduction one has further boosted consumer uptake of these products. This has caused concern that smoking-substitute devices and nicotine delivery devices may be becoming attractive to children, young adults and those currently not engaged in consumption of combustible tobacco products. Furthermore, there is on-going scientific debate about the long-terms effects on health from the prolonged use of such devices and concerns, particularly from healthcare professions, regarding the lack of information available to consumers regarding the use of such devices and associated liquids that prevent them from making informed decisions regarding their use. One area of particular concern is the quality and provenance of many e-liquids currently available on the market. In response to safety and quality concerns, a number of countries have introduced or are proposing to introduce stricter rules governing the marketing of tobacco products. For example, the European Union has agreed a revised Tobacco Products Directive (Tobacco and Related Products Regulations 2016) which stipulates specific requirements relating to the safety and quality of tobacco products.

Aspects and embodiments of the invention were devised with the foregoing in mind.

Summary

Viewed from a first aspect, there is provided an inhalation device comprising: a substrate region arranged to receive a substrate, the substrate comprising an aerosolisable composition; and a heater; wherein the heater is arranged such that it is operative to be in thermal communication with the substrate region to heat the substrate to generate an aerosolised composition from the aerosolisable composition for inhalation by a user. The substrate comprises a composition to be aerosolised, herein referred to as an "aerosolisable composition". In the present application, an aerosolisable composition means a composition which is capable of being aerosolised, either in whole or in part. The skilled person will appreciate that it is not necessary that the whole of the aerosolisable composition is eventually aerosolised but that a portion of the aerosolisable composition may comprise an aerosol precursor for generating an aerosol and a portion of the aerosolisable composition may comprise other constituents which are not aerosolised but may be included, for example, for retaining the aerosolisable composition on the substrate.

In the present application, the term "thermal communication" means that the heater is either thermally connected to the substrate by some form of thermal conduit or is arranged or located such that it is sufficiently near to the substrate region such that heat can be transferred from the heater to the substrate when the heater is operated and a substrate is received within the device. An advantage of using a heater to heat the aerosolisable composition compared to the medicinal inhaler or inhalator devices of the prior art described above is that the aerosolisable composition can be formulated to deliver the compound of interest either to the lung or to the buccal cavity. For aerosolisable compositions containing nicotine, delivery to the lung means that the user experiences an enhanced "hit", i.e. an increased rate of absorption of nicotine. Consequently, this may assist in allaying a craving for nicotine more quickly, with fewer inhalations, thereby helping a user to gradually reduce their intake of nicotine.

When a substrate comprising an aerosolisable composition is received in the substrate region of the device, the heater is operative to heat the aerosolisable composition so that at least a proportion of the aerosolisable composition vapourises or aerosolises. The skilled person will appreciate that an "aerosolised composition" is not limited to an aerosol per se but may also comprise a proportion of the composition in the vapour phase.

A further advantage of the device of the present application compared to, for example, a conventional e-cigarette, is that the aerosolisable composition is in contact with the substrate such that heat is conducted efficiently from the substrate into the aersolisable composition. There is no space or air gap, within accepted manufacturing tolerances, between the substrate and the aerosolisable composition. This means that the heater can vaporise the aerosolisable composition at lower temperatures (generally around 100 C to 180 C) compared to the wick- and-coil heaters of the prior art (around 300 C). This increases energy efficiency and reduces degradation of the heater.

Furthermore, the amount of aerosolisable composition can be carefully controlled so that the heater only heats the necessary amount of composition, for example, the amount of aerosolisable composition can be limited to a predetermined number of inhalations. Therefore, the energy lost, for example, by heating the excess e-liquid in an e-cigarette is eliminated. As a result, the substrate of the present invention has a much lower thermal mass and requires less energy to heat than the heaters of the prior art. This benefit combined with lower heated temperatures assists in increasing the efficiency of the device. Furthermore, this avoids the repeated heat-cool cycle observed in e-cigarettes which may lead to in-use instability of the composition and formation of toxicants.

The heater may be arranged in the vicinity of the substrate region. In other words, the heater is arranged sufficiently near to the substrate region such that heat can be transferred from the heater to the substrate when the heater is operated and a substrate is received within the device.

The heater may be arranged such that it is operative to be in thermally conductive engagement with the substrate when the substrate is received in the substrate region. This allows thermal conduction between the heater and the substrate. The heater may be arranged to contact the substrate when the substrate is received in the substrate region. This allows thermal conduction between the heater and the substrate.

The inhalation device may further comprise a biasing element to urge the substrate into contact with the heater when the substrate is received in the substrate region. This improves contact between the heater and the substrate assisting thermal conduction.

Optionally, the biasing element may comprises a spring, clip or clamp. These have been found to be suitable biasing elements. The substrate region may be arranged such that the substrate is located adjacent to or within an airflow pathway through the device when the substrate is received in the substrate region. This assists in entraining the aerosolised composition with an airflow for inhalation by a user.

The substrate region may be arranged in the vicinity of a mouthpiece of the device. This assists in delivery the aerosolised composition to the user and reduces the distance that the aerosolised composition has to travel through the device before being inhaled, thereby reducing the potential for condensation or other losses of the aerosolised composition on the internal surface of the device. The inhalation device may further comprise thermal insulation arranged to inhibit heat loss from at least a part of a surface of the heater, which part of a surface is not facing the substrate region. This improves the transfer of heat to the substrate region and substrate. Optionally, the thermal insulation may be arranged to inhibit heat loss from all surfaces of the heater which are not facing the substrate region. This further improves the transfer of heat to the substrate region and substrate.

The heater may be a resistive heater. Optionally, the heater comprises a nickel chromium alloy. This has been found to be a suitable type of heater.

Alternatively, the heater may be an inductive heater.

The heater may comprise a first heater and the inhalation device may further comprise a second heater, wherein the second heater is spaced apart from and opposes the first heater. This provides further heating capacity and flexibility. Optionally, the first and second heaters may be arranged on opposite sides of an airflow pathway. This allows for heating of the airflow which passes over the aerosolisable composition and assists with aerosolisation.

The inhalation device may further comprise a housing, wherein the housing may comprise a main body part and a mouthpiece, the mouthpiece being removably attachable to the main body part.

Viewed from a second aspect, there is provided a substrate for use in an inhalation device as described above, wherein the substrate comprises an aerosolisable composition

The substrate may be thermally conductive. This assists with heating of the substrate and the conduction of heat to the aerosolisable composition.

The substrate may comprise a material selected from one or more of the following materials: glass; ceramic; and metal. Optionally, the substrate may comprise aluminium. Aluminium has suitable thermal conductivity properties.

The substrate may be substantially flat. This has been found to be suitable configuration and assists in providing sufficient contact area for thermal conduction. The substrate is replaceable. This reduces the build-up of residues or unwanted by-products as these are removed each time the substrate is replaced, thereby improving the safety and hygiene of the device. The aerosolisable composition may be supported on the substrate.

Optionally, the aerosolisable composition may be bonded to the substrate by hydrogen bonds or electromagnetic forces. Optionally, the aerosolisable composition may be deposited on the substrate by one or more of the following processes: screen-printing; inkjet printing; aerosol jet printing; and activated metal printing. These have been found to be suitable deposition processes and are straightforward to integrate into a manufacturing process. The aerosolisable composition may be encased by a solid layer bonded to the substrate. The solid layer provides a means of retaining the aerosolisable composition on the substrate. Optionally, the solid layer may comprise polyethylene glycol.

The aersolisable composition may comprise nicotine. Such a composition could be used in a nicotine replacement therapy or a smoking substitute device.

The aerosolisable composition may comprises a plume generating compound. This assists with the generation of an aerosol. Optionally, the plume generating compound may comprise glycerol or propylene glycol.

Viewed from a third aspect, there is provided an inhalation device as described above, comprising a substrate as described above.

Viewed from a fourth aspect, there is provided a kit of parts comprising an inhalation device as described above and a substrate as described above.

Brief Description of the Drawings

One or more specific embodiments in accordance with aspects of the present invention will be described, by way of example only, and with reference to the following drawings in which:

Figure 1 is a schematic diagram of a prior art e-cigarette wick-and-coil heater. Figure 2 is a schematic cross-sectional side view of a device in accordance with an embodiment of the present invention. Figure 3 is an enlarged schematic cross-sectional view of the mouthpiece end of the device of Figure 2.

Figure 4 is an enlarged schematic cross-sectional view of the mouthpiece end the device of Figure 2 with the mouthpiece removed.

Figure 5 is a schematic exploded perspective view of the mouthpiece end of the device of Figure 2 and the mouthpiece itself, prior to being attached to the device.

Detailed Description of the Invention Figure 2 shows an inhalation device 100 comprising a main body part 102 and a mouthpiece 104. Heater 106 is provided at an attachment end 102a of the main body part 102, specifically the end of the main body part 102 to which the mouthpiece 104 is (preferably) detachably connected. The heater 106 is mounted or otherwise provided on a protrusion 108 (see Figure 4 for more detail), said protrusion extending beyond the attachment end 102a of the main body part 102 into the mouthpiece 104 and, in one embodiment, being integrally formed with or as part of the main body part 102.

A substrate 1 10 is provided substantially or completely within the mouthpiece 104, specifically in a substrate region 1 12 defined therein. Substrate 1 10 has essentially planar and rectangular upper and lower surfaces 1 10C, 1 10D respectively which together define its thickness, and proximal and remote ends 1 1 OA, 1 10B respectively which together define its overall length. As can be seen in the Figure, an amount of aerosolisable composition 1 14 has been deposited on or applied to the upper surface 1 10C of said substrate adjacent the proximal end 1 10C thereof. In preferred embodiments, the mouthpiece 104 comprises a recess or slot (not specifically referenced) adapted to receive the remote end 1 10B of the substrate 1 10 which may thus be subsequently slid into and along said recess or slot until the remote end 1 10B of the substrate abuts a partially or substantially closed end of said recess or slot. The provision of the said recess or slot within the mouthpiece therefore allows the substrate to be releasably held within the mouthpiece in the desired position therein, and in preferred embodiments, one or both of the upper and lower surfaces (or the edge regions thereof) may engage with corresponding surfaces of the recess or slot such that the insertion of the substrate into (and, more importantly, the removal from) said recess or slot is frictionally resisted at least to some extent. As can be seen in the Figure, once the substrate 1 10 is properly located within the mouthpiece 104 (whether in the recess or slot provided therein or not), and the mouthpiece is connected to the main body part 102 of the device, the arrangement is such that at least a portion of the substrate, specifically that portion thereof to one surface of which the aerosolisable composition 1 14 has been deposited or applied, substantially or completely overlies the heater 106.

In further preferred embodiments, a biasing element (not shown) such as a spring, clip or clamp, either provided within the mouthpiece 104 or on the attachment end 102A of the main body part 102, urges the substrate 1 10 into contact with the heater 106 to enhance heat transfer between the heater 106 and the substrate 1 10.

The heater 106 is a resistive heater, preferably constituted of a nickel chromium alloy, although other compositions and materials are of course possible. When an electric current is passed through the heater 106, its temperature rises due to its resistance, and the heat generated thereby is conducted from the heater 106 through the substrate 1 10 to the aerosolisable composition 1 14, ultimately causing at least some aerosolisation thereof. The main body part 102 of the inhalation device 100 comprises an electric power source, e.g. a battery (not shown) and control circuitry (not shown) which are electrically connected to the heater 106. The control circuitry may comprise a sensor, such as a pressure transducer (not shown), which can detect a drop in pressure inside the mouthpiece 104 due to a user inhaling through the device 100. The control circuitry may further include a proportional-integral- derivative (PID) controller (not shown) for controlling the electrical power supplied to the heater 106 to maintain the temperature of the heater within a predetermined range when being heated, based on a measured resistance of the heater. This temperature range is 100 C to 180 C to facilitate aerosolisation of the aerosolisable composition 1 14 from the substrate 1 10. Referring to Figure 3, this shows an enlarged view of the mouthpiece end of the inhalation device 100. An air inlet 1 16 is formed at the interface between attachment end 102a of the main body part 102 and the mouthpiece 104. When a user inhales through the mouthpiece 104, air enters the air inlet 1 16 and follows an airflow pathway 1 18 (denoted by a dotted line in Figure 3) through the mouthpiece 104 to an air outlet 120, from where the air enters a user^'s mouth. The substrate 1 10 is disposed within the mouthpiece 104 so that is adjacent, or indeed within, the airflow pathway 1 18. When the heater 106 is activated, heat is transferred through the substrate 1 10 to the aerosolisable composition 1 14 such that a proportion of the aerosolisable composition 1 14 is vaporised or aerosolised. The vaporised or aerosolised composition becomes entrained within the moving airflow passing adjacent to the substrate 1 10 and moves along the airflow pathway to the air outlet 120 where it is inhaled by a user.

The aerosolisable composition 1 14 comprises a liquid containing nicotine and propylene glycol, which is a plume generating compound and aids in the production of an aerosolised composition. The aerosolisable composition 1 14 is manufactured by mixing appropriate quantities of the constituent ingredients to form a mixture, which may then be deposited or dosed onto the substrate 1 10 in the appropriate location thereon by a screen-printing or other suitable process. The aerosolisable composition 1 14 has sufficient viscosity or surface tension to remain on the substrate 10 after it is printed on or otherwise applied to the substrate. The substrate 1 10 is manufactured from glass as this has been found to have suitable thermal properties. The substrate and aerosolisable composition assembly may be kept in a sealed container or package prior to use to prevent degradation of the aerosolisable composition 1 14.

The mouthpiece 104 is releasably attachable to the main body part 102 by attachment elements (not shown) mounted on the main body part 102 and the mouthpiece 104. Once the aerosolisable composition 1 14 has been exhausted through heating and inhalation by user, the mouthpiece 104 may be removed from the main body part 102 in order to replace the substrate 1 10 with a fresh substrate comprising an aerosolisable composition. The substrate 1 10 is therefore a replaceable consumable, which enhances the safety and hygiene of the compound as any potentially undesirable by-products or residue generated on the substrate 1 10 during heating are removed when the substrate 1 10 is replaced.

Referring to Figure 4, this shows an enlarged view of the mouthpiece end of the inhalation device 100 with the mouthpiece 104 removed. In the embodiment illustrated, the heater 106 is mounted on a protrusion 108 which extends beyond the attachment end 102a of the main body part 102, said protrusion being integrally formed therewith, or at least forming an integral part of the attachment end 102a thereof. The sides and base of heater 106 may be surrounded by insulation material 122 which inhibits heat loss from those surfaces of the heater 106 facing the insulation material 122. Therefore, heat is predominantly transferred from the heater 106 via the surface of the heater 106 which is not insulated, i.e. the surface facing the substrate 1 10. This increases the heat transferred to the substrate 1 10 and the overall efficiency of the device 100. Referring to Figure 5, the arrangement of the various component parts of both device main body part 102 and mouthpiece 104 can be seen more clearly, and in particular, it can be seen how, as a result of the connection of the mouthpiece 104 to the mouthpiece attachment end 102a of the device main body part 102, protrusion 108 on which the heater 106 is mounted is ultimately correctly, precisely and essentially automatically disposed immediately underneath the substrate 1 10, said substrate already having been fully inserted and thus correctly disposed within said mouthpiece 104. In essence, the act of connecting the mouthpiece to the device main body part 102, in the figure by rotating said mouthpiece as shown by arrow 140 such that an end surface 104A of the mouthpiece is brought into mating engagement with the attachment end 102a, ensures that the protrusion 108 and the heater mounted thereon is simultaneously disposed underneath the substrate 1 10 already within the mouthpiece 104, as schematically indicated by dotted lines 131 . In the particular embodiment shown in Figure 5, the device main body part is also shown as being provided with resilient lugs 132 extending perpendicularly away from the attachment end 102a thereof, and corresponding recesses 134, preferably internally profiled so as to be of complementary shape to that of the lugs 132 and provided in appropriate locations corresponding to the location of the lugs, are also provided in the end surface 104A of the mouthpiece 104. The provision of said lugs and recesses not only provides a means whereby the mouthpiece can be releasably attached to the mouthpiece in snap-fit manner, but also the lugs 132 and the corresponding recesses 134 may provide useful locating and guide means whereby the mouthpiece 104 can quickly be brought into the correct transverse and lateral juxta positional arrangement with the attachment end 102a of the main body part 102. It is also to be noted that the cross-sectional shapes of both the attachment end 102a (and indeed the device main body part 102a) and the mouthpiece end surface 104A are of broadly identical shape and size. This particular arrangement is useful in at least two respects: firstly, when the mouthpiece 104 is connected to the main body part 102, the respective exterior side walls of each of the main body 102 and mouthpiece 104 lie flush with one another in aesthetically pleasing fashion; secondly, prior to connection of the mouthpiece with the main body part, the fact that both main body part and mouthpiece, or at least attachment end 102a and end surface 104A respectively thereof, are of identical height (or width, depending on viewpoint), provides a very useful visual cue to a user as to how to position the mouthpiece with respect to the main body part immediately prior connecting the two together. In particular, this visual cue enables both parts to be correctly (and largely subconsciously) juxtaposed such that the protrusion 108 is automatically already in the correct position with respect to the substrate 1 10 already disposed completely within and inside the mouthpiece and which, at the point of connection and immediately prior thereto, will therefore be completely concealed from the view of the user. As the skilled reader will further understand, the particular locations of both the protrusion 108 on the attachment end 102a, and the substrate 1 10 within the mouthpiece are important in the context of the present invention, because the act of connecting the mouthpiece 104 to the main body part 102 must ensure that these components are brought into intimate juxtaposition to ensure a sound thermal communication between the heater 106 on the protrusion and (at least) the underside of the substrate 1 10.

In use, a user seals their lips around mouthpiece 104 of inhalation device 100 and inhales. As the user inhales air is drawn in through the air inlet 1 16, past substrate 1 10 and aerosolisable composition 1 14 and exits the device 100 via air outlet 120. In order that the heater is energised, in one embodiment, a sensor (not shown) may be provided within one or both of the main body part 102 or the mouthpiece 104 which detects a drop in pressure inside the mouthpiece 104 due to the user inhaling. Control circuitry (not shown) provided in the main body part 102, upon identifying the existence of such a pressure drop, may then activate the heater 106 by directing an electric current from an electric power source (not shown) through the heater 106 causing it to generate heat causing at least a portion of the aerosolisable composition 1 14 deposited on the substrate 1 10 to be aerosolised and subsequently become entrained in the moving airflow and moves along airflow pathway 1 18 to air outlet 120 where the aerosolised composition is inhaled by a user. The device 100 then resets in preparation for the next inhalation. Of course, in a simpler arrangement, rather than using a sensor such as a pressure transducer to detect a drop in pressure in the mouthpiece when a user inhales, the device could be activated by a simple switch or button, for example provided on or in an exterior surface of the device main body part, which could be simply pressed by the user to cause heater activation.

As will be understood by the skilled reader, the fact that the aerosolisable composition 1 14 is in direct contact with the substrate allows heater 106 to vaporise the required amount of composition at much lower temperatures, e.g. between 100 C and 180 C, compared to wick- and-coil heaters of conventional e-cigarettes which typically heat to around 300 C

In view of the foregoing description it will be evident to a person skilled in the art that various modifications may be made within the scope of the invention. For example, rather than a resistive heater, the heater could be an inductive heater with the inductive elements such as the inductive coil being arranged within the main body part of the device. Instead of glass, the substrate could be manufactured from a ceramic, a metal such as aluminium or any other material suitable for an inhalation device. Alternatively, the substrate could be made from materials suitable for inductive heating or the substrate could be polarised so that it can be heated by means of an inductive heating process.

Rather than a liquid, the aerosolisable composition could be a solid, for example a nicotine salt, and rather than nicotine the aerosolisable composition could comprise other medicines or flavourings intended for inhaled or oromucosal delivery. Furthermore, other plume generating compounds could be used such as glycerol. In addition, other processes for depositing the aerosolisable composition could be used such as inkjet printing, aerosol jet printing and activated metal printing.

Instead of maintaining the aerosolisable composition on the substrate using viscosity or surface tension, the aerosolisable composition could be encased in a solid layer such as polyethylene glycol (PEG) or be bound to the surface of the substrate by hydrogen or electromagnetic forces.

In addition, the device could comprise two heaters; a first heater as described above and a second heater spaced apart from and opposing the first heater. In one embodiment, the first and second heaters could be arranged on opposite sides of an airflow pathway. A purpose of the second heater could be to heat the air passing over the aerosolisable composition to enhance the aerosolisation process, in which case the second heater may heat to a lower temperature, i.e. around 40 to 60 C.

As used herein any reference to "one embodiment" or "an embodiment" means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" or the phrase "in an embodiment" in various places in the specification are not necessarily all referring to the same embodiment.

As used herein, the terms "comprises." "comprising." "includes," "including," "has." "having" or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Further, unless expressly stated to the contrary, "or" refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present). In addition, use of the "a" or "an" are employed to describe elements and components of the invention. This is done merely for convenience and to give a general sense of the invention. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise.

The scope of the present disclosure includes any novel feature or combination of features disclosed therein either explicitly or implicitly or any generalisation thereof irrespective of whether or not it relates to the claimed invention or mitigate against any or all of the problems addressed by the present invention. The applicant hereby gives notice that new claims may be formulated to such features during prosecution of this application or of any such further application derived therefrom. In particular, with reference to the appended claims, features from dependent claims may be combined with those of the independent claims and features from respective independent claims may be combined in any appropriate manner and not merely in specific combinations enumerated in the claims.

In abstract form, the invention may be summarised thus:

Claims

1. An inhalation device comprising:

a main body part provided with a heater,

a mouthpiece detachably connected to said main body part, said mouthpiece including a substrate region internally thereof and adapted to replaceably receive substrate on which an amount of an aerosolisable composition is deposited, said mouthpiece providing an airflow pathway through its interior within which or adjacent which said substrate is disposed when received in said substrate region

Wherein, upon and after attachment of said mouthpiece to said main body part, said heater is arranged in the vicinity of the substrate region such that it is operative to be in thermal communication with the substrate region to heat the substrate to generate an aerosolised composition from the aerosolisable composition within the mouthpiece for inhalation by a user.

2. An inhalation device according to claim 1 , wherein the heater is arranged such that it is operative to be in thermally conductive engagement with the substrate when the substrate is received in the substrate region.

3. An inhalation device according to claim 2, wherein the heater is arranged to contact the substrate when the substrate is received in the substrate region.

4. An inhalation device according to claim 3, further comprising a biasing element to urge the substrate into contact with the heater.

5. An inhalation device according to any preceding claim, wherein said heater is mounted or otherwise provided on a protrusion extending from a free end of the main body part of the device.

6. An inhalation device according to claim 5 wherein the heater is surrounded with thermal insulation arranged to inhibit heat loss from at least a part of a surface of the heater, said surface part not facing the substrate region.

7. An inhalation device according to any preceding claim, wherein the heater is one of: a resistive heater, and an inductive heater.

8. An inhalation device according to any preceding claim, wherein the main body part of the device is provided with first and second spaced-apart heaters which oppose one another.

9. An inhalation device according to claim 8, wherein the first and second heaters are arranged on opposite sides of the airflow pathway.

10. A substrate for use in an inhalation device according to any of claims 1 to 16, wherein the substrate is thermally conductive and is provided with at least on substantially planar surface on which an aerosolisable composition, comprising at least a plume generating compound and nicotine, is deposited and thereby supported.

1 1 . A substrate according to claim 10, wherein the material of which the substrate is constituted is selected from one or more of the following: glass; ceramic; and metal.

12. A substrate according to claim 1 1 , wherein the substrate is aluminium.

13. A substrate according to any of claims 10-12, wherein the aerosolisable composition is deposited on the substrate by one or more of the following processes:

• screen-printing;

• Inkjet printing;

• aerosol jet printing; and

• activated metal printing.

14. A substrate according to any of claims 10-13, wherein the aerosolisable composition is encased by a polyethylene glycol solid layer bonded to the substrate.

15. A substrate according to any of claims 10-14, wherein the plume generating compound comprises one or more of: glycerol and propylene glycol.

16. An inhalation device according to any of claims 1 to 9, comprising a substrate according to any of claims 10 to 15.