WO2023052112A1 - Vapour delivery apparatus - Google Patents

Abstract

A vapour delivery apparatus is configured to deliver a vapour comprising an active ingredient to a user drawing air through the apparatus for inhalation. The apparatus comprises an air passage defined between an air inlet and an outlet, and a vapour generator arranged in the air passage. The vapour generator comprises a substrate loaded with a source of an active ingredient for generation of the vapour. The vapour generator also comprises a constricted air flow region adapted to provide a higher air flow velocity in the constricted air flow region than an air flow velocity in the air passage upstream of the vapour generator for a given air flow rate from the air inlet to the outlet. The constricted air flow region is bounded on at least one side by the substrate to extract vapour from the substrate into the air flow in the constricted air flow region. There is also provided a method of using a vapour delivery apparatus.

Description

VAPOUR DELIVERY APPARATUS

Cross reference to related applications

The present disclosure claims the benefit of priority from the following application(s), the entire contents of which are hereby incorporated by reference:

[ME ref: 7631765; Nerudia ref: P01223 - referred to herein as ‘Development A’] European patent application no. 21199521 .2 filed 28 September 2021

[ME ref: 7592702; Nerudia ref: P01189 - referred to herein as ‘Development B’] European patent application no. 21199516.2 filed 28 September 2021

[ME ref: 7631757; Nerudia ref: P01222 - referred to herein as ‘Development C’] European patent application no. 21199518.8 filed 28 September 2021

[ME ref: 7631773; Nerudia ref: P01224 - referred to herein as ‘Development D’] European patent application no. 21199524.6 filed 28 September 2021

[ME ref: 7631781 ; Nerudia ref: P01225 - referred to herein as ‘Development E’] European patent application no. 21199527.9 filed 28 September 2021

[ME ref: 7661846; Nerudia ref: P01282 - referred to herein as ‘Development F’] European patent application no. 21199529.5 filed 28 September 2021

Field of the Invention

The present invention relates to a vapour delivery apparatus. Such an apparatus is of particular, but not necessarily exclusive interest as a smoking substitute apparatus. It is a preferred feature of operation of the apparatus that it is able to deliver an active ingredient (such as nicotine) to a user for inhalation without producing a visible vapour cloud.

Background

The smoking of tobacco is generally considered to expose a smoker to potentially harmful substances. It is thought that a significant amount of the potentially harmful substances are generated through the burning and/or combustion of the tobacco and the constituents of the burnt tobacco in the tobacco smoke itself.

Low temperature combustion of organic material such as tobacco is known to produce tar and other potentially harmful by-products. There have been proposed various smoking substitute systems in which the conventional smoking of tobacco is avoided. Such smoking substitute systems can form part of nicotine replacement therapies aimed at people who wish to stop smoking and overcome a dependence on nicotine.

Known smoking substitute systems include electronic systems that permit a user to simulate the act of smoking by producing an aerosol (also sometimes referred to as a “vapour”) that is drawn into the lungs through the mouth (inhaled) and then exhaled. The inhaled aerosol typically bears nicotine and/or a flavourant without, or with fewer of, the health risks associated with conventional smoking.

In general, smoking substitute systems are intended to provide a substitute for the rituals of smoking, whilst providing the user with a similar, or improved, experience and satisfaction to those experienced with conventional smoking and with combustible tobacco products.

There are a number of different categories of smoking substitute systems, each utilising a different smoking substitute approach. Some smoking substitute systems are designed to resemble a conventional cigarette and are cylindrical in form with a mouthpiece at one end. Other smoking substitute devices do not generally resemble a cigarette (for example, the smoking substitute device may have a generally box-like form, in whole or in part).

One approach is the so-called “vaping” approach, in which a vaporisable liquid, or an aerosol former, sometimes typically referred to herein as “e-liquid”, is heated by a heating device (sometimes referred to herein as an electronic cigarette or “e-cigarette” device) to produce an aerosol vapour which is inhaled by a user. The e-liquid typically includes a base liquid, nicotine and may include a flavourant. The resulting vapour therefore also typically contains nicotine and/or a flavourant. The base liquid may include propylene glycol and/or vegetable glycerine.

A typical e-cigarette device includes a mouthpiece, a power source (typically a battery), a tank for containing e-liquid and a heating device. In use, electrical energy is supplied from the power source to the heating device, which heats the e-liquid to produce an aerosol (or “vapour”) which is inhaled by a user through the mouthpiece.

E-cigarettes can be configured in a variety of ways. For example, there are “closed system” vaping smoking substitute systems, which typically have a sealed tank and heating element. The tank is prefilled with e-liquid and is not intended to be refilled by an end user. One subset of closed system vaping smoking substitute systems include a main body which includes the power source, wherein the main body is configured to be physically and electrically couplable to a consumable including the tank and the heating element. In this way, when the tank of a consumable has been emptied of e-liquid, that consumable is removed from the main body and disposed of. The main body can then be reused by connecting it to a new, replacement, consumable. Another subset of closed system vaping smoking substitute systems are completely disposable, and intended for one-use only. There are also “open system” vaping smoking substitute systems which typically have a tank that is configured to be refilled by a user. In this way the entire device can be used multiple times.

An example vaping smoking substitute system is the myblu™ e-cigarette. The myblu™ e-cigarette is a closed system which includes a main body and a consumable. The main body and consumable are physically and electrically coupled together by pushing the consumable into the main body. The main body includes a rechargeable battery. The consumable includes a mouthpiece and a sealed tank which contains e-liquid. The consumable further includes a heater, which for this device is a heating filament coiled around a portion of a wick. The wick is partially immersed in the e-liquid, and conveys e-liquid from the tank to the heating filament. The system is controlled by a microprocessor on board the main body. The system includes a sensor for detecting when a user is inhaling through the mouthpiece, the microprocessor then activating the device in response. When the system is activated, electrical energy is supplied from the power source to the heating device, which heats e-liquid from the tank to produce a vapour which is inhaled by a user through the mouthpiece.

An alternative to vaping-type smoking substitute systems is a nicotine inhaler apparatus, of which a particular example is the Nicorette® inhalator (trade name). Such systems are often passive in the sense that they do not require a source of heat or other activation energy in order to generate a vapour. As with an e-cigarette, such an inhaler typically includes a mouthpiece and a main body containing a source of nicotine. In use, a user may inhale or “puff on the mouthpiece to draw air over or through the nicotine source. The nicotine source may be, for example, an air-permeable substrate impregnated with nicotine. When the supply of nicotine in the nicotine source is depleted, such that the user no longer receives sufficient (or any) nicotine with each puff, the user can replace the nicotine source in order to continue nicotine delivery.

A significant advantage of an inhaler apparatus of the type discussed above is that its use is generally permitted on aeroplanes. The smoking of conventional cigarettes (and cigars, tobacco pipes, etc.) is not permitted on aeroplanes. Similarly, the use of e-cigarettes is not permitted. This is considered to be due to the emission of visible vapour clouds from e-cigarettes and due to a heated wick being considered to be a potential ignition source.

Summary of the Invention

Smoking substitute systems (e.g. e-cigarettes) are generally regarded as having fewer of the health risks associated with conventional smoking, not only for the user themselves, but also for those nearby (i.e. those that would be affected by passive smoking by inhalation of smoke from conventional cigarettes). However, the exhaling of a visible vapour cloud by the user may still be regarded in some circumstances as socially unacceptable, in light of the negative views surrounding smoking itself. Therefore, many locations where smoking is not permitted also do not allow smoking substitute systems, instead requiring users to use the same designated smoking areas as smokers themselves. This can reduce the attractiveness of smoking substitute systems, and reduce their uptake as a smoking cessation aid. Furthermore, as discussed above, the use of e-cigarettes is not permitted on aeroplanes.

Accordingly, it would be advantageous to provide a smoking substitute system that can provide a similar user experience to an e-cigarette, but without producing a visible vapour cloud. Furthermore, it would be advantageous to provide improvements to the operation of conventional nicotine inhalers. Conventional nicotine inhalers are considered to provide a relatively poor user experience in terms of delivery of nicotine.

Further, based on the insight of the present inventors, it would be advantageous to provide a vapour delivery system, not necessarily limited to a smoking substitute system, for the delivery of an active ingredient to a user by inhalation, providing the beneficial effects referred to above.

The present disclosure has been devised in the light of the above considerations.

Development A

[ME ref: 7631765; Nerudia ref: P01223]

In a general aspect of Development A, the present invention relates to a vapour delivery system which increases the transfer of an active ingredient into an airflow.

According to a first aspect of Development A of the invention, there is provided a vapour delivery apparatus configured to deliver a vapour comprising an active ingredient to a user drawing air through the apparatus for inhalation, the apparatus comprising: an air passage defined between an air inlet and an outlet; a vapour generator arranged in the air passage, wherein the vapour generator comprises a substrate loaded with a source of an active ingredient for generation of the vapour, the vapour generator comprising a constricted air flow region adapted to provide a higher air flow velocity in the constricted air flow region than an air flow velocity in the air passage upstream of the vapour generator for a given air flow rate from the air inlet to the outlet, the constricted air flow region being bounded on at least one side by the substrate to extract vapour from the substrate into the air flow in the constricted air flow region.

According to a second aspect of Development A of the invention, there is provided a method of operating a vapour delivery apparatus, the vapour delivery apparatus comprising: an air passage defined between an air inlet and an outlet; a vapour generator arranged in the air passage, wherein the vapour generator comprises a substrate loaded with a source of an active ingredient for generation of the vapour, the vapour generator comprising a constricted air flow region, the constricted air flow region being bounded on at least one side by the substrate; wherein the method comprises the steps of: the user inhaling at the outlet to generate an air flow, wherein an air flow velocity in the constricted air flow region is higher than the air flow velocity in the air passage upstream of the vapour generator for a given air flow rate from the air inlet to the outlet; and the user receiving the active ingredient from extraction of a vapour from the substrate into the air flow in the constricted air flow region.

Development A of the invention provides an increased air flow velocity in the constricted air flow region, and consequently lower pressure, as a result of Bernoulli’s principle derived from the conservation of energy. The Venturi effect harnesses this reduction in pressure, leading to increased volatile transfer to the air flow.

In Development A of the present invention, the air passage defined between the air inlet and the outlet may be regarded as a Venturi tube. Since the constricted air flow region is bounded on at least one side by the substrate, the active ingredient positioned closest to the constricted air flow region is entrained in the high velocity airflow. Provided that there is sufficient active ingredient positioned close to the constricted air flow region, as the velocity of air flow increases, the amount of active ingredient entrained in the air flow increases because of the Venturi effect. Therefore a user, who inhales at the outlet of the apparatus, receives a greater concentration of active ingredient per inhalation as a result of the constricted air flow region.

In order to generate a vapour for inhalation, the apparatus comprises at least one volatile compound that is intended to be vaporised/aerosolised and that may provide the user with a recreational, wellness, nutritional, physiological and/or medicinal effect when inhaled. Such a volatile compound may be referred to herein interchangeably as an “active agent”, or “active ingredient”. The active agent is stored in a reservoir (typically referred to herein as a substrate).

The active agent may be formulated so as to produce a non-visible or substantially non-visible vapour. By producing a non-visible or substantially non-visible vapour, the apparatus may be used on an aeroplane. The active agent may comprise a base liquid. The active agent may additionally comprise nicotine. The active agent may be an e-liquid. The active agent may consist substantially of nicotine or a nicotine compound. The active agent may further comprise a flavourant. Alternatively, the active agent may be substantially flavourless. That is, the active agent may not contain any deliberately added additional flavourant. A flavourant may be provided as a separate flavourant vapour precursor, such that the active ingredient and flavourant vapour precursor may be separately vaporised to form a vapour comprising both the active ingredient and the flavourant vapour precursor.

The substrate may comprise nicotine and / or a flavourant. Preferably, the nicotine and / or flavourant is located in a reservoir region of the substrate, or throughout the substrate. Preferably the primary active ingredient is nicotine, in any derivative form suitable for this use, such as nicotine salt, or freebase. However, the active ingredient could also suitably be a stimulant relaxant, medicament or other wellbeing enhance. In particular, the active ingredient may be one or more of cocaine, caffeine, vitamins, minerals, amino acids, plant or herbal concentrated extracts, sugars, opiates and opioids, cathine and cathinone, kavalactones, mysticin, beta-carboline alkaloids, salvinorin A, cannabinoids, or phytocannabinoids, together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

Cannabinoid compounds include phyto-cannabinoids which include: cannabidiol (CBD) and its derivatives/homologues (e.g. cannabidiol mono(m)ethyl ether, cannabidivarin (CBDV), cannabidiorcol, cannabidiolic acid, cannabidivarinic acid); cannabinodiol (CBND) and its derivatives/homologues (e.g. carrabinodivarin); cannabigerol (CBG) and its derivatives/homologues (e.g. cannabigerol mono(m)ethyl ether, cannabinerolic acid A, cannabigerovarin, cannabigerolic acid A, cannabigerolic acid A mono(m)ethyl ether, cannabigerovarinic acid A); cannabinol (CBN) and its derivatives/homologues (e.g. cannabivarin/cannabivarol (CBV), cannabiorcol, cannabinolic acid, cannabinol (m)ethyl ester); tetrahydrocannabinol (THC) and its derivatives/homologues (e.g. tetrahydrocannabivarin (THCV), tetrahydrocannabiorcol, tetrahydrocannabinolic acid A/B, tetrahydrocannabivarinic acid A, tetrahydrocannabiorcolic acid A/B, isotetrahydrocannabinol, isotetrahydrocannabivarin); cannabicyclol (CBL) and its derivatives/homologues (e.g. cannabicyclolic acid, cannabicyclovarin); cannabichromene (CBC) and its derivatives/homologues (e.g. cannabichromenic acid A, cannabichromevarin (CBCV), cannabichromevarinic acid A); cannabielsoin (CBE) and its derivatives/homologues (e.g. cannabielsoic acid A/B, cannabiglendol, dehydrocannabifuran, cannabifuran); cannabicitran (CBT) and its derivatives/homologues; cannabitriol and its derivatives/homologues (e.g. ethyl cannabitriol, dihydroxy-tetrahydrocannabinol, cannabidiolic acid A cannabitriol ester, dihydroxy-hexahydrocannabinol (cannabiripsol), cannabitetrol, oxo-tetrahydrocannabinol); and cannabichromanone (CBCN) and its derivatives/homologues (e.g. cannabicoumaronone).

In some embodiments, the cannabinoid compound is selected from at least one of cannabidiol (CBD) and its derivatives/homologues e.g. cannabiodiol-Cs (CBD-C5), cannabidiol-C4 (CBD-C4), cannabidiol mono(m)ethyl ether (CBDM-C5), cannabidivarin (CBDV-C3), cannabidiorcol (CBD-C1), cannabidiolic acid (CBDA-C5), cannabidivarinic acid (CBDVA-C3).

In some embodiments, the cannabinoid compound is selected from at least one of tetrahydrocannabinol (THC) and its derivatives/homologues, e.g. A⁹-tetrahydrocannabinol (A⁹-THC-C5 / c/s-A⁹-THC-C5), A⁸- tetrahydrocannabinol (A⁸-THC-C5), AMetrahydrocannabinolic acid A (A⁸-THCA-C5 A), A⁹- tetrahydrocannabinol-C4 (A⁹-THC-C4), A⁹-tetrahydrocannabivarin (A⁹-THCV-C3), A⁹- tetrahydrocannabiorcol (A⁹-THCO-Ci), AMetrahydrocannabinolic acid A (A⁹-THCA-C5A), A⁹- tetrahydrocannabinolic acid B (A⁹-THCA-C5 B), AMetrahydrocannabinolic acid-C4 A and/or B (A⁹-THCA- C4 A and/or B), AMetrahydrocannabivarinic acid A (A⁹-THCVA-C3 A), AMetrahydrocannabiorcolic acid A and/or B (A⁹-THCOA-Ci A and/or B), isotetrahydrocannabinol and isotetrahydrocannabivarin. The total amount of cannabinoid compounds in the apparatus may be at least 200 mg; for example, it may be at least 250 mg, at least 300 mg, at least 400 mg, at least 500 mg. In some cases, lower amounts may be preferred. The total amount of cannabinoid compounds in the apparatus may therefore be at least 10 mg, at least 20 mg, at least 30 mg, at least 40 mg, at least 50 mg, at least 75 mg, at least 100 mg.

In some cases, it may be desirable to limit the total amount of cannabinoid compounds, which may be not more than 200 mg, not more than 175 mg, not more than 150 mg, not more than 125 mg, not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 10 mg. In some cases, the total amount of the cannabinoid compounds may be not more than 5 mg.

Where THC is included, either as one cannabinoid compound in a mixture or as the only cannabinoid, the total of amount of THC may be limited. In some cases, the total amount of THC in the substrate is not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 15 mg, not more than 10 mg, not more than 5 mg, not more than 3 mg. In some cases, the amount of THC may be 0.1 to 30 mg, for example 1 to 30 mg, for example 1 to 20 mg, for example 1 to 10 mg, for example 1 to 5 mg, for example 1 to 3 mg. In some embodiments, the vapour delivery apparatus is a smoking substitute apparatus. In such embodiments, the active ingredient may comprise or consist of nicotine. Preferably and additionally, the vapour delivery apparatus comprises an additive having an aroma or flavour which is tobacco flavour.

The term “flavourant” is used to describe a compound or combination of compounds that provide flavour and/or aroma. For example, the flavourant may be configured to interact with a sensory receptor of a user (such as an olfactory or taste receptor). The flavourant may include one or more volatile substances.

The flavourant may be provided in solid or liquid form. The flavourant may be natural or synthetic. For example, the flavourant may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour.

The substrate may comprise a porous material. The porous material allows for storage of the active ingredient. For example, the substrate may be impregnated with nicotine via immersion in a liquid containing nicotine and a volatile carrier (for example a solution of nicotine in ethanol). The substrate may be immersed to evenly soak the substrate. Once removed and left to dry or baked in an oven, the carrier is evaporated and the nicotine is left evenly spread throughout the substrate.

The substrate may comprise air-impermeable walls to prevent airflow from entering and / or exiting via the outer peripheral sides of the substrate. This ensures that the full potential of the Venturi effect may be achieved. Since airflow through the constriction air flow region is maximised by the presence of air- impermeable walls on the sides of the substrate, more active ingredient particles can be entrained in the low pressure high velocity air flow. Therefore, a user can receive a higher dose of active ingredient per inhalation, and therefore require fewer inhalations to stop their craving.

The vapour delivery apparatus may comprise a housing, and the air-impermeable walls may extend from the housing into the air passage. The air-impermeable walls may or may not be integral to the housing. The distance between the air-impermeable walls may be sufficient to hold the substrate in position in the apparatus.

The substrate may comprise a material of limited air-permeability. The material of limited air-permeability may only allow a limited amount of air to permeate through the substrate, so that the Venturi effect through the constricted air flow region is not substantially reduced. Additionally, the material allows a sufficient amount of air to permeate through the substrate to form a pressure differential within the substrate itself. The pressure differential promotes the migration of the active ingredient to regions of the substrate closest to the constricted air flow region, where the active ingredient can be transferred to the passing airflow. The pressure differential in the substrate can be considered in view of the air in regions of the substrate furthest from the constricted air flow region, this air being at or close to atmospheric pressure. Air in regions of the substrate closer to the constricted air flow region is at a lower pressure. Air in the constricted air flow region has the lowest pressure. In this way, during an inhalation, there is a pressure gradient established within the substrate. In this way, there is enhanced entrainment of active ingredient particles into the air flow, and also replenishment of the active ingredient in the parts of the substrate closest to the constricted air flow region from the remainder of the substrate.

Accordingly, more active ingredient particles can be transferred into the airflow, so that the user may receive a higher dose of active ingredient per inhalation, and therefore require fewer inhalations to stop their craving.

The pressure gradient in the substrate is gradually restored to atmospheric pressure after the user stops drawing air at the outlet. For example, consider a sample of the material of the substrate having a thickness of 3 mm, and a front surface and a back surface, the front surface being exposed and the back surface being sealed against air flow. A 2 Pa pressure drop below atmospheric pressure is applied at the front surface of the sample 10 seconds. In view of this pressure drop, some air flows out from the material through the front surface and is not replenished from the rear because the back surface is sealed against air flow. After the 10 seconds, the pressure at the front surface is restored to atmospheric pressure. A relevant measure of the air permeability of the material is therefore the time taken for the pressure in the material to recover. Accordingly, the air permeability of the substrate may be such that following the test protocol explained above, the pressure at a depth of 1 .5mm from the front surface recovers to 1 Pa or less below atmospheric pressure in a time of not less than 1 second. Accordingly, the recovery of pressure in the substrate takes time. This time may be not less than 5 seconds, not less than 10 seconds, not less than 30 seconds, or not less than 60 seconds, for example. However, the material still have some air permeability and therefore this time may be not more than 10 minutes, not more than 5 minutes, not more than 2 minutes, or not more than 1 minute. The substrate may comprise a foamed polymer which will allow for airflow to pass through the substrate at a given pressure drop value, so as to provide a comfortable ‘draw’ sensation for the user. The substrate may be, for example, a sintered polyethylene or PET foam.

The substrate may comprise plant material. The plant material may comprise at least one plant material selected from the list including Amaranthus dubius, Arctostaphylos uva-ursi (Bearberry), Argemone mexicana, Arnica, Artemisia vulgaris, Yellow Tees, Galea zacatechichi, Canavalia maritima (Baybean), Cecropia mexicana (Guamura), Oestrum noctumum, Cynoglossum virginianum (wild comfrey), Cytisus scoparius, Damiana, Entada rheedii, Eschscholzia califomica (California Poppy), Fittonia albivenis, Hippobroma longiflora, Humulus japonica (Japanese Hops), Humulus lupulus (Hops), Lactuca virosa (Lettuce Opium), Laggera alata, Leonotis leonurus, Leonurus cardiaca (Motherwort), Leonurus sibiricus (Honeyweed), Lobelia cardinalis, Lobelia inflata (Indian-tobacco), Lobelia siphilitica, Nepeta cataria (Catnip), Nicotiana species (Tobacco), Nymphaea alba (White Lily), Nymphaea caerulea (Blue Lily), Opium poppy, Passiflora incamata (Passionflower), Pedicularis densiflora (Indian Warrior), Pedicularis groenlandica (Elephant's Head), Salvia divinorum, Salvia dorrii (Tobacco Sage), Salvia species (Sage), Scutellaria galericulata, Scutellaria lateriflora, Scutellaria nana, Scutellaria species (Skullcap), Sida acuta (Wireweed), Sida rhombifolia, Silene capensis, Syzygium aromaticum (Clove), Tagetes lucida (Mexican Tarragon), Tarchonanthus camphoratus, Tumera diffusa (Damiana), Verbascum (Mullein), Zamia latifolia (Maconha Brava) together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

In some embodiments, the plant material is tobacco. Any type of tobacco may be used. This includes, but is not limited to, flue-cured tobacco, burley tobacco, Maryland Tobacco, dark-air cured tobacco, oriental tobacco, dark-fired tobacco, perique tobacco and rustica tobacco. This also includes blends of the above mentioned tobaccos. In addition, any suitable parts of the tobacco plant may be used. This includes leaves, stems, roots, bark, seeds and flowers. The tobacco may comprise one or more of leaf tobacco, stem tobacco, tobacco powder, tobacco dust, tobacco derivatives, expanded tobacco, homogenised tobacco, shredded tobacco, extruded tobacco, cut rag tobacco and/or reconstituted tobacco (e.g. slurry recon or paper recon).

The substrate may comprise a gathered sheet of homogenised (e.g. paper/slurry recon) tobacco or gathered shreds/strips formed from such a sheet. In some embodiments, the sheet used to form the aerosol-forming substrate has a grammage greater than or equal to 100 g/m², e.g. greater than or equal to 110 g/m² such as greater than or equal to 120 g/m². The sheet may have a grammage of less than or equal to 300 g/m² e.g. less than or equal to 250 g/m² or less than or equal to 200 g/m². The sheet may have a grammage of between 120 and 190 g/m².

The substrate may comprise at least 50 wt% plant material, e.g. at least 60 wt% plant material e.g. around 65 wt% plant material. The air-permeable substrate may comprise 80 wt% or less plant material e.g. 75 or 70 wt% or less plant material. The substrate may comprise one or more additives selected from flavourants, fillers and binders.

Typically, the substrate does not comprise a humectant. Humectants may be provided in heat not burn (HNB) tobacco charges. In such cases, humectants are provided as vapour generators, the generated vapour being used to help carry volatile active compounds and to increase visible vapour. Accordingly, it is preferred that the air-permeable substrate does not comprise one or more humectants such as polyhydric alcohols (e.g. propylene glycol (PG), triethylene glycol, 1 ,2-butane diol and vegetable glycerine (VG)) and their esters (e.g. glycerol mono-, di- or tri-acetate). If such humectants are present in the air- permeable substrate, they may be present at a low level, such as less than 0.5 wt%, more preferably less than 0.1 wt%.

Suitable binders are known in the art and may act to bind together the components forming the air- permeable substrate. Binders may comprise starches and/or cellulosic binders such as methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose and methyl cellulose, gums such as xanthan, guar, arabic and/or locust bean gum, organic acids and their salts such as alginic acid/ sodium alginate, agar and pectins.

Preferably the binder content is 5 to 10 wt% of the substrate e.g. around 6 to 8 wt%.

Suitable fillers are known in the art and may act to strengthen the air-permeable substrate. Fillers may comprise fibrous (non-tobacco) fillers such as cellulose fibres, lignocellulose fibres (e.g. wood fibres), jute fibres and combinations thereof.

Preferably, the filler content is 5 to 10 wt% of the aerosol-forming substrate e.g. around 6 to 9 wt%. The substrate may comprise an aqueous and/or non-aqueous solvent. In some embodiments, the substrate has a water content of between 4 and 10 wt% e.g. between 6-9 wt% such as between 7-9 wt%. Such low moisture content in substrate typically has the effect that, when the air-permeable substrate is exposed to heated air, there would typically not be produced a substantial visible vapour. It is to be noted that in one embodiment it is possible to use as the substrate a low moisture tobacco material with its natural nicotine content. The natural nicotine content then meets the requirements of the active agent.

The substrate may be at least partly circumscribed by a wrapping layer e.g. a paper wrapping layer. The wrapping layer may overlie an inner foil layer or may comprise a paper/foil laminate (with the foil innermost).

The plant material may comprise cannabis plant material including Cannabis sativa, Cannabis indica and Cannabis rudealis. The plant material may comprise Echinacea purpurea, Echinacea angustifolia, Acmella oleracea, Helichrysum umbraculigerum, or Radula marginata. This also includes blends of the above mentioned plant material. In some embodiments, the cannabinoid-containing plant material is cannabis. The plant may be a traditional strain, or may be a strain bred or other modified (e.g. genetically) to produce certain levels of some cannabinoids compounds, e.g. low levels of THC or high levels of THC.

Any suitable parts of the cannabinoid-containing plant may be used. Thus the cannabinoid-containing plant material may comprise leaves, stems, roots, bark, seeds, buds and flowers (which may be cured).

The substrate may be made of any material which is porous and chemically stable, so that it will not degrade when dosed with an active ingredient such as nicotine. For example, the substrate may comprise a ceramic which may be tailored to have a specific porosity and / or geometry to allow effective movement of an active ingredient through the substrate.

Preferably, the substrate comprises a liquid permeable material. Having a liquid permeable material in the substrate allows the active ingredient to migrate through the substrate by capillary flow or wicking through channels within the substrate. The liquid permeable material may therefore be a porous material, such that the active ingredient can migrate through the pores of the material. A pressure differential within the substrate may therefore further promote the migration of the active ingredient through the pores of the substrate.

The apparatus may have an overall form with a principal axis defined in terms of the air flow path from the air inlet to the outlet, in the manner of a conventional cigarette. The substrate may have an elongate form, configured with its elongate axis parallel to the principal axis of the apparatus.

Preferably, the constricted air flow region is parallel to the elongate axis of the substrate. Furthermore, the constricted air flow region may be positioned centrally through the substrate. Where the substrate comprises a discrete reservoir region, the constricted air flow region may pass through the centre of the reservoir region of the substrate. With this configuration, it is possible to ensure that the interface between the substrate and the constricted air flow region surrounds the constricted air flow region, thereby increasing the surface area of the substrate that is in contact with the constricted air flow region. Additionally, the central arrangement allows the active ingredient close to the outer periphery of the substrate to migrate the same distance through the substrate to the constricted air flow path. This results in a more uniform depletion of active ingredient from throughout the substrate.

Alternatively, the constricted air flow region may by bounded on one side by the substrate. Thus, the constricted air flow region may be positioned above or below the substrate. This may be more cost effective to manufacture than an arrangement comprising a constricted air flow region which passes through the centre of a substrate.

The constricted air flow region may consist of a single bore through the substrate. The bore may have the shape of a prism, for example a hexagonal or triangular prism. More preferably, the bore is rounded or circular in cross sectional shape. Manufacturing an apparatus with a single bore may be more cost effective than manufacturing an apparatus comprising multiple bores. The diameter of a single bore may also be larger than an apparatus comprising multiple bores. A suitable diameter for a bore may be at least 1 mm, at least 2mm, at least 3mm, at least 4mm, at least 5mm, at least 6mm, at least 7mm, at least 8mm, at least 9mm, or at least 10mm. Considering the user acceptability of a typical apparatus, the diameter of the bore is preferably not more than 15mm.

Alternatively, the vapour generator may comprise multiple bores through the substrate. Since the surface area of the substrate in contact with the air flow is increased by having multiple bores (for the same total cross sectional area of the bores), a greater concentration of active ingredient may be entrained in the air flow with each inhalation. Thus, the greater the number of bores within the substrate, the greater the amount of active ingredient which is entrained within the constricted air flow region per inhalation. There may be 2, 3, 4, or 5 bores through the substrate. The bores may have different diameters, or all have the same diameter. A suitable diameter for a bore may be at least 1 mm, at least 2mm, at least 3mm, at least 4mm, at least 5mm. In some embodiments, there may be many bores, for example 6, 7, 8, 9, 10 or more bores, each of the bores having a small diameter, for example at least 0.5mm, at least 0.6mm, or at least 0.7mm, in order to further increase the surface area of the substrate in contact with the air flow, thereby increasing the concentration of active ingredient entrained in the air flow per inhalation. The bores may be arranged in an efficient packing arrangement, such as a hexagonal packing arrangement, to maximise the entrainment of active ingredient into the air flow with each inhalation.

In the discussion above, it is intended that the bores have substantially uniform cross sectional area along their length. Furthermore, the bores preferably extend parallel to the elongate axis of the substrate. This permits the air flow along the bores to be uniform (preferably lamellar) and therefore allows the air flow to have a high velocity. This is in contrast with air flow through the bulk of a porous substrate without a bore (e.g. a monolithic foamed polymer substrate without a bore) in which the air flow is from pore-to-pore and consequently has a low velocity.

The outlet may comprise a mouthpiece for the user to draw on.

The apparatus may comprise additional vapour generators. For example, the apparatus may comprise 2 or 3 vapour generators. Having more than 1 vapour generator ensures that a higher dose of active ingredient may be delivered to the user, regardless of whether the additional vapour generators do or do not comprise constricted air flow regions. To maximise the dose of active ingredient per inhalation, the additional vapour generators may also comprise constricted air flow regions. Preferably, these airflow restrictors operate using the Venturi effect, as described previously.

One particular advantage enabled by the present invention is an increase in entrainment of active ingredient into the air flow, for each inhale, without requiring the user to modify their inhalation behaviour. This can be achieved without active heating of the substrate (or active ingredient). Accordingly, preferably the apparatus is operated at room temperature. To the extent that the apparatus may be held in a user’s pocket or in a user’s hand, it is envisaged that the apparatus may have a temperature at or lower than body temperature. Accordingly, the temperature of operation of the apparatus is typically not more than 40°C. More typically, the temperature of operation is not more than 39°C, not more than 38°C, not more than 37°C, not more than 36°C, not more than 35°C, not more than 34°C, not more than 33°C, not more than 32°C, not more than 31 °C, or not more than 30°C.

The apparatus preferably does not include a source of heat. For example, known vapour generation apparatus may use an electrical heater or an exothermic reaction to generate heat, for the purpose of promoting vaporisation of the active ingredient. Such a source of heat, however, means that an apparatus of that type may not be permitted for use in locations where smoking is also prohibited, such as on aeroplanes.

Development B

[ME ref: 7592702; Nerudia ref: P01189]

In a general aspect of Development B, the present invention relates to a vapour delivery system which produces a non-visible or substantially non-visible vapour of an active ingredient. The present invention also enables a user to selectively control how much of an active ingredient they receive based on how airflow is controlled through the apparatus.

According to a first preferred aspect of Development B there is provided vapour delivery apparatus configured to deliver a vapour comprising an active ingredient to a user drawing air through the apparatus for inhalation, the apparatus comprising: an air passage defined between a primary air inlet and an outlet; a vapour generator arranged in the air passage, wherein the vapour generator comprises a first reservoir region formed from an air-permeable substrate and arranged to allow air to be drawn through the first reservoir region, the apparatus further comprising a second reservoir region formed from an air-permeable substrate, wherein the first and second reservoir regions are loaded with a source of an active ingredient, or different active ingredients, for generation of the vapour, the apparatus further comprising an auxiliary air inlet, the auxiliary air inlet being selectively configurable to permit air to flow through the apparatus:

- along a primary flow path passing through the first and second reservoir regions in series, and

- along an auxiliary flow path bypassing at least part of the first reservoir region.

According to a second preferred aspect of Development B, there is provided a method of using a vapour delivery apparatus, the vapour delivery apparatus comprising: an air passage defined between a primary air inlet and an outlet; a vapour generator arranged in the air passage, wherein the vapour generator comprises a first reservoir region formed from an air-permeable substrate and arranged to allow air to be drawn through the first reservoir region, the apparatus further comprising a second reservoir region formed from an air-permeable substrate, wherein the first and second reservoir regions are loaded with a source of an active ingredient, or different active ingredients, for generation of the vapour, the apparatus further comprising an auxiliary air inlet, wherein the method comprises the steps of: configuring the auxiliary air inlet selectively to permit air to flow through the apparatus:

- along a primary flow path passing through the first and second reservoir regions in series, or

- along an auxiliary flow path bypassing at least part of the first reservoir region, and inhaling through the outlet.

In order to generate a vapour for inhalation, the apparatus comprises at least one volatile compound that is intended to be vaporised/aerosolised and that may provide the user with a recreational, wellness, nutritional, physiological and/or medicinal effect when inhaled. Such a volatile compound may be referred to herein interchangeably as an “active agent”, “active ingredient” or “active substance”. The active agent is stored in a reservoir.

The active agent may be formulated so as to produce a non-visible or substantially non-visible vapour. By producing a non-visible or substantially non-visible vapour, the apparatus may be used on an aeroplane. The active agent may comprise a base liquid. The active agent may additionally comprise nicotine. The active agent may be an e-liquid. The active agent may consist substantially of nicotine or a nicotine compound. The active agent may further comprise a flavourant. Alternatively, the active agent may be substantially flavourless. That is, the active agent may not contain any deliberately added additional flavourant. A flavourant may be provided as a separate flavourant vapour precursor, such that the active ingredient and flavourant vapour precursor may be separately vaporised to form a vapour comprising both the active ingredient and the flavourant vapour precursor.

The vapour delivery apparatus comprises more than one passage for fluid (e.g. air) flow therethrough. For example, the apparatus provides a primary flow path and an auxiliary flow path. The passage through the reservoir may comprise at least one auxiliary air inlet to control fluid flow to allow flow through the passage in a desired direction.

The passages may extend through (at least a portion of) the vapour delivery apparatus, between openings that define a primary air inlet and an outlet of a passage. Each inlet and outlet may be in fluid communication with only one passage, or a subset of the passages, or all the passages in the vapour delivery apparatus. The outlet or outlets may be at a mouthpiece of the aerosol delivery apparatus. In this respect, a user may draw fluid (e.g. air) into and through a passage by inhaling at the outlet (i.e. using the mouthpiece).

The vapour delivery apparatus provides a unique way of customising a user’s vaping experience. By providing a first reservoir and a second reservoir, the user can select the active substance dosage or strength that they receive by allowing air to flow along a primary flow path passing through the first and second reservoir regions in series, or by allowing air to flow along an auxiliary flow path bypassing at least part of the first reservoir region. By allowing air to flow through the first and second reservoir regions in series, the user receives a higher dose of the active ingredient if the same active ingredient is stored in both the first and second reservoir regions. Since the first and second reservoir regions can be loaded with different active ingredients, the user may also receive both active ingredients in each inhalation if air flows along a primary flow path passing through the first and second reservoir regions in series.

If the user allows air to flow along an auxiliary flow path, the user decreases their dose of active ingredient because the user inhales some air that has not passed through both the first and second reservoirs. Alternatively, if the user allows air to flow only along an auxiliary flow path, the user receives an active ingredient from only one of the first and second reservoirs.

The reservoir region is formed from an air-permeable substrate. Using an air-permeable substrate is different from using a wick-based aerosol generator because a wick-based aerosol generator requires a powered electrical heater (and accordingly also a power supply such as a battery) to heat the reservoirs. In contrast, using an air-permeable substrate means that the apparatus does not require any electrical circuitry or electrical power supply, and is simple and discreet to operate.

An air-permeable substrate, storing the vapour precursor and/or a flavourant, may constitute the entirety of the reservoir. The air-permeable substrate may be impregnated with the active substance and/or the flavourant vapour precursor. The substrate material may be a foamed polymer which will allow for airflow to pass through the substrate at a given pressure drop value, so as to provide a comfortable ‘draw’ sensation for the user. The substrate may be, for example, a sintered polyethylene or PET foam.

The substrate may be impregnated with nicotine via immersion in a liquid containing nicotine and a volatile carrier (for example a solution of nicotine in ethanol). The substrate may be immersed to evenly soak the substrate. Once removed and left to dry or baked in an oven, the carrier is evaporated and the nicotine is left evenly spread throughout the substrate.

The air-permeable substrate may comprise plant material. The plant material may comprise at least one plant material selected from the list including Amaranthus dubius, Arctostaphylos uva-ursi (Bearberry), Argemone mexicana, Arnica, Artemisia vulgaris, Yellow Tees, Galea zacatechichi, Canavalia maritima (Baybean), Cecropia mexicana (Guamura), Oestrum noctumum, Cynoglossum virginianum (wild comfrey), Cytisus scoparius, Damiana, Entada rheedii, Eschscholzia califomica (California Poppy), Fittonia albivenis, Hippobroma longiflora, Humulus japonica (Japanese Hops), Humulus lupulus (Hops), Lactuca virosa (Lettuce Opium), Laggera alata, Leonotis leonurus, Leonurus cardiaca (Motherwort), Leonurus sibiricus (Honeyweed), Lobelia cardinalis, Lobelia inflata (Indian-tobacco), Lobelia siphilitica, Nepeta cataria (Catnip), Nicotiana species (Tobacco), Nymphaea alba (White Lily), Nymphaea caerulea (Blue Lily), Opium poppy, Passiflora incamata (Passionflower), Pedicularis densiflora (Indian Warrior), Pedicularis groenlandica (Elephant's Head), Salvia divinorum, Salvia dorrii (Tobacco Sage), Salvia species (Sage), Scutellaria galericulata, Scutellaria lateriflora, Scutellaria nana, Scutellaria species (Skullcap), Sida acuta (Wireweed), Sida rhombifolia, Silene capensis, Syzygium aromaticum (Clove), Tagetes lucida (Mexican Tarragon), Tarchonanthus camphoratus, Tumera diffusa (Damiana), Verbascum (Mullein), Zamia latifolia (Maconha Brava) together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

In some embodiments, the plant material is tobacco. Any type of tobacco may be used. This includes, but is not limited to, flue-cured tobacco, burley tobacco, Maryland Tobacco, dark-air cured tobacco, oriental tobacco, dark-fired tobacco, perique tobacco and rustica tobacco. This also includes blends of the above mentioned tobaccos. In addition, any suitable parts of the tobacco plant may be used. This includes leaves, stems, roots, bark, seeds and flowers. The tobacco may comprise one or more of leaf tobacco, stem tobacco, tobacco powder, tobacco dust, tobacco derivatives, expanded tobacco, homogenised tobacco, shredded tobacco, extruded tobacco, cut rag tobacco and/or reconstituted tobacco (e.g. slurry recon or paper recon).

The air-permeable substrate may comprise a gathered sheet of homogenised (e.g. paper/slurry recon) tobacco or gathered shreds/strips formed from such a sheet. In some embodiments, the sheet used to form the aerosol-forming substrate has a grammage greater than or equal to 100 g/m², e.g. greater than or equal to 110 g/m² such as greater than or equal to 120 g/m². The sheet may have a grammage of less than or equal to 300 g/m² e.g. less than or equal to 250 g/m² or less than or equal to 200 g/m². The sheet may have a grammage of between 120 and 190 g/m².

The air-permeable substrate may comprise at least 50 wt% plant material, e.g. at least 60 wt% plant material e.g. around 65 wt% plant material. The air-permeable substrate may comprise 80 wt% or less plant material e.g. 75 or 70 wt% or less plant material.

The air-permeable substrate may comprise one or more additives selected from flavourants, fillers and binders.

Typically, the air-permeable substrate does not comprise a humectant. Humectants may be provided in heat not burn (HNB) tobacco charges. In such cases, humectants are provided as vapour generators, the generated vapour being used to help carry volatile active compounds and to increase visible vapour.

Accordingly, it is preferred that the air-permeable substrate does not comprise one or more humectants such as polyhydric alcohols (e.g. propylene glycol (PG), triethylene glycol, 1 ,2-butane diol and vegetable glycerine (VG)) and their esters (e.g. glycerol mono-, di- or tri-acetate). If such humectants are present in the air-permeable substrate, they may be present at a low level, such as less than 0.5 wt%, more preferably less than 0.1 wt%.

Suitable binders are known in the art and may act to bind together the components forming the air- permeable substrate. Binders may comprise starches and/or cellulosic binders such as methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose and methyl cellulose, gums such as xanthan, guar, arabic and/or locust bean gum, organic acids and their salts such as alginic acid/ sodium alginate, agar and pectins.

Preferably the binder content is 5 to 10 wt% of the air-permeable substrate e.g. around 6 to 8 wt%. Suitable fillers are known in the art and may act to strengthen the air-permeable substrate. Fillers may comprise fibrous (non-tobacco) fillers such as cellulose fibres, lignocellulose fibres (e.g. wood fibres), jute fibres and combinations thereof.

Preferably, the filler content is 5 to 10 wt% of the aerosol-forming substrate e.g. around 6 to 9 wt%.

The air-permeable substrate may comprise an aqueous and/or non-aqueous solvent. In some embodiments, the air-permeable substrate has a water content of between 4 and 10 wt% e.g. between 6- 9 wt% such as between 7-9 wt%. Such low moisture content in the air-permeable substrate typically has the effect that, when the air-permeable substrate is exposed to heated air, there would typically not be produced a substantial visible vapour. It is to be noted that in one embodiment it is possible to use as the air-permeable substrate a low moisture tobacco material with its natural nicotine content. The natural nicotine content then meets the requirements of the active agent.

The air-permeable substrate may be at least partly circumscribed by a wrapping layer e.g. a paper wrapping layer. The wrapping layer may overlie an inner foil layer or may comprise a paper/foil laminate (with the foil innermost).

The plant material may comprise cannabis plant material including Cannabis sativa, Cannabis indica and Cannabis rudealis. The plant material may comprise Echinacea purpurea, Echinacea angustifolia, Acmella oleracea, Helichrysum umbraculigerum, or Radula marginata. This also includes blends of the above mentioned plant material.

In some embodiments, the cannabinoid-containing plant material is cannabis. The plant may be a traditional strain, or may be a strain bred or other modified (e.g. genetically) to produce certain levels of some cannabinoids compounds, e.g. low levels of THC or high levels of THC.

Any suitable parts of the cannabinoid-containing plant may be used. Thus the cannabinoid-containing plant material may comprise leaves, stems, roots, bark, seeds, buds and flowers (which may be cured).

Preferably, the vapour delivery apparatus is configured to operate at a temperature of between 30°C and 80°C, for example the apparatus may be operable at temperatures of 35°C, 40°C, 45°C, 50°C, 55°C, 60°C and 65°C. The temperature is preferably at least 30°C to promote vaporisation of the active ingredient. Typically the temperature is not greater than 70°C. Ideally, the vapour delivery device is operable at 50°C where an active substance is nicotine. Whilst it is possible to use a heater to heat air that passes through a reservoir that contains an active substance, it is more efficient to heat the reservoir of active substance itself. Additionally, operating the apparatus between 30°C and 80°C means that electrical power is not required to heat the substrate. Instead, the apparatus (optionally specifically the reservoir) can be heated by immersing it in a fluid, such as a container of hot liquid, such as water. This allows users to heat the apparatus on an aeroplane, where hot water is readily available and is not subject to safety restrictions of the type that control the use of electrical heaters or combustion-based heat sources.

The apparatus may comprise a housing comprising a first open end and a second open end. The apparatus may be configured so that the user can choose which of the first open end and the second open end forms the air outlet and the primary air inlet. This means that the apparatus may be reversible, so that the user can take 4 or 5 inhales (for example) at one open end and then switch the apparatus around to receive another 4 or 5 inhales (for example). This is more effective than taking 10 inhales in a single direction as nicotine per puff may drop off drastically in this scenario. By reversing the apparatus, a more consistent experience can be had by the user. It may also be possible for the user to extend their apparatus use by capping off the open ends and then using the un-used reservoir at a later point.

The housing may be biodegradable. This is particularly advantageous because each vapour delivery apparatus is designed to be single-use. Examples of possible biodegradable housing materials are cardboard, paper, bagasse or similar. The housing must also be constructed from a material which is resistant to the active ingredient, so as not to degrade over time.

The first reservoir may extend substantially throughout the housing, such that the auxiliary air inlet is positioned within the first reservoir. By selecting to draw air through the auxiliary air inlet, the user only receives a portion of the dose available for inhalation of the active substance. For example, in these circumstances the user may only receive 20%, 30%, 40%, 50%, 60%, 70% or 80% of the dose of the active substance in the first reservoir.

The auxiliary air inlet may be positioned between the first reservoir region and the second reservoir region. This enables an alternative air flow path to be established that bypasses one of the first reservoir region and the second reservoir region, depending on which open end the user chooses as the air outlet. A user can therefore receive air that has been drawn through a single reservoir of their choosing, in the case of a vapour delivery apparatus having two reservoirs,

The vapour delivery apparatus may also comprise a third reservoir region (e.g. formed from an air- permeable substrate), and a second auxiliary air inlet. This embodiment of the invention can be operated without reversing, if desired. The third reservoir region may be loaded with the same active ingredient as at least the first and second reservoir regions. Alternatively the third reservoir region may be loaded with a different active ingredient compared to the first and second reservoir regions. The user can then configure the second auxiliary air inlet to permit air to flow through the apparatus:

- along the primary flow path passing through the first, second and third reservoir regions in series, or

- along a first auxiliary flow path bypassing at least part of the first reservoir region; or

- along a second auxiliary flow path bypassing at least part of the first reservoir region and at least part of the second reservoir region. It will be understood that the first auxiliary flow path here is intended to encompass flow through the second and third reservoir regions (e.g. in series), and the second auxiliary flow path here is intended to encompass flow through the third reservoir region.

The second auxiliary air inlet may be positioned between the second reservoir region and the third reservoir region.

Further auxiliary air inlets may be provided that may be operable to open and close the passage such that fluid is enabled to or prevented from flowing through the passage. For example, three or four auxiliary air inlets may be provided. The auxiliary air inlets may be operated in combination or in synchronism with each other. Embodiments of the invention comprising further auxiliary air inlet, i.e. more than one auxiliary air inlets, need not be reversible.

An auxiliary air inlet to open and close a passage may be controlled by mechanical means (i.e. the user moves an opening/closing member of the auxiliary air inlet (such as a valve) using a control lever or similar). For example, the auxiliary air inlet may be covered by a removable member such as a removable layer, to direct airflow only along a primary flow path passing through the first and second reservoir regions in series while the auxiliary air inlet is covered by the removable member. An advantage of having a removable layer covering the auxiliary air inlet is that a user can easily remove the removable layer to permit airflow from the auxiliary air inlet to the outlet. An example of a removable layer is a sticker, which may be peeled away for use. Alternatively, the auxiliary air inlet may be configured to be opened using a sliding or threaded geometry. In the case of a sliding geometry, an auxiliary air inlet may be operated, for example, by a sliding push button, similar to finger buttons on a trumpet valve. When the push button is pushed down towards the housing, the auxiliary air inlet is closed, and the available flow path is from the primary air inlet through the first reservoir, and through any subsequent reservoirs and out through the air outlet. When the push button is left open, the auxiliary air inlet is open, and there is then an available flow path from the auxiliary air inlet to the air outlet. In the case of a threaded geometry, an auxiliary air inlet may be operated, for example, by a threaded screw. When the screw is twisted into the housing, the auxiliary air inlet is closed and so air only flows from the primary air inlet to the air outlet. When the screw is loosened, the auxiliary air inlet is open so that air can flow through the auxiliary air inlet and out through the air outlet.

An auxiliary air inlet to open and close a passage may also be controlled by electrical control (i.e. moved in response to a control signal from a processor or control system of the aerosol delivery apparatus).

The primary air inlet may be configured to be closeable. For example, the primary air inlet may be configured to be closed by a cap member. In this way, the user may choose to permit air only through one or more of the auxiliary air inlets. Since the primary air inlet may be chosen by the user as either the first open end or second open end, both open ends may be configured to be capped. By capping the primary air inlet, the un-used reservoir may be used at a later point. Capping the primary air inlet also ensures that the user only inhales vapour from a single reservoir or two chosen reservoirs. The vapour delivery apparatus may comprise an additive. The additive may be positioned between the auxiliary air inlet and the air outlet to ensure that the additive is always delivered, whether the air flow path passes through the primary air inlet or the auxiliary air inlet. Alternatively, the additive may be positioned coterminous with the active ingredient air permeable substrate between the auxiliary air inlet and the air outlet, thus ensuring that the additive is always delivered, whether the air flow path passes through the primary air inlet or the auxiliary air inlet.

The user may also have control over whether or not they inhale an additive. For example, the additive may be coterminous with an active substance in a second reservoir, and the user may select to inhale air which has passed through an auxiliary air inlet and out through an open end closest to a first reservoir. The user will therefore not inhale vapour comprising the additive or the active substance in the second reservoir. If however the user selects to inhale air through an auxiliary air inlet and an open end closest to the second reservoir, or alternatively through the primary air inlet only, the user will inhale vapour comprising the additive and at least the active substance of the second reservoir.

The vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when ambient air is drawn through the reservoir. Alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when heated air is drawn through the reservoir. Additionally or alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when the reservoir is heated and heated or ambient air is drawn through the reservoir.

The reservoir may comprise a monolithic substrate. The reservoir may consist of a plurality of substrates, each arranged to allow air to be drawn therethrough, and each comprising one or both of a vapour precursor and the flavourant vapour precursor. The vapour precursor and/or the flavourant vapour precursor may be provided in spatially coterminous or spatially distinct regions of the reservoir.

The user may also have control over which additive they inhale. For example, there may be a different additive coterminous with each air permeable substrate. In this situation, by selecting a particular air flow path, the user can select the additive they wish to inhale, as well as the active substance they wish to inhale.

The additive may either be a flavour or an aroma. The term “flavourant” is used to describe a compound or combination of compounds that provide flavour and/or aroma. For example, the flavourant may be configured to interact with a sensory receptor of a user (such as an olfactory or taste receptor). The flavourant may include one or more volatile substances.

The additive may, for example, be menthol, liquorice, chocolate, fruit flavour, vanilla, spice or tobacco flavour. Particularly, in the case of a tobacco flavour, the vapour delivery apparatus can be used as a smoking substitute apparatus. The flavourant may be provided in solid or liquid form. The flavourant may be natural or synthetic. For example, the flavourant may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour. The flavourant may be evenly dispersed or may be provided in isolated locations and/or varying concentrations.

Preferably, the active ingredient of at least one of the reservoirs is nicotine. Therefore, the vapour delivery apparatus can be used as a smoking substitute apparatus. Typically, the intended lifetime of a nicotine reservoir is about 5 to 10 minutes. The lifetime of the apparatus can however be extended by capping off the open ends and then using an un-used reservoir at a later point.

Alternatively, the active ingredient of at least one of the reservoirs is one or more of a nutritional agent or a pharmaceutical agent. There is a range of different combinations and permutations of active ingredients that can be used in a vapour delivery apparatus, and depending on the active substances in the vapour delivery apparatus, the user has a choice of which active substance or which combination of active substances they wish to inhale.

In particular, the nutritional agent or pharmaceutical agent may be one or more of cocaine, caffeine, vitamins, minerals, amino acids, plant or herbal concentrated extracts, sugars, opiates and opioids, cathine and cathinone, kavalactones, mysticin, beta-carboline alkaloids, salvinorin A, cannabinoids, or phytocannabinoids, together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

Cannabinoid compounds include phyto-cannabinoids which include: cannabidiol (CBD) and its derivatives/homologues (e.g. cannabidiol mono(m)ethyl ether, cannabidivarin (CBDV), cannabidiorcol, cannabidiolic acid, cannabidivarinic acid); cannabinodiol (CBND) and its derivatives/homologues (e.g. carrabinodivarin); cannabigerol (CBG) and its derivatives/homologues (e.g. cannabigerol mono(m)ethyl ether, cannabinerolic acid A, cannabigerovarin, cannabigerolic acid A, cannabigerolic acid A mono(m)ethyl ether, cannabigerovarinic acid A); cannabinol (CBN) and its derivatives/homologues (e.g. cannabivarin/cannabivarol (CBV), cannabiorcol, cannabinolic acid, cannabinol (m)ethyl ester); tetrahydrocannabinol (THC) and its derivatives/homologues (e.g. tetrahydrocannabivarin (THCV), tetrahydrocannabiorcol, tetrahydrocannabinolic acid A/B, tetrahydrocannabivarinic acid A, tetrahydrocannabiorcolic acid A/B, isotetrahydrocannabinol, isotetrahydrocannabivarin); cannabicyclol (CBL) and its derivatives/homologues (e.g. cannabicyclolic acid, cannabicyclovarin); cannabichromene (CBC) and its derivatives/homologues (e.g. cannabichromenic acid A, cannabichromevarin (CBCV), cannabichromevarinic acid A); cannabielsoin (CBE) and its derivatives/homologues (e.g. cannabielsoic acid A/B, cannabiglendol, dehydrocannabifuran, cannabifuran); cannabicitran (CBT) and its derivatives/homologues; cannabitriol and its derivatives/homologues (e.g. ethyl cannabitriol, dihydroxy-tetrahydrocannabinol, cannabidiolic acid A cannabitriol ester, dihydroxy-hexahydrocannabinol (cannabiripsol), cannabitetrol, oxo-tetrahydrocannabinol); and cannabichromanone (CBCN) and its derivatives/homologues (e.g. cannabicoumaronone).

In some embodiments, the cannabinoid compound is selected from at least one of cannabidiol (CBD) and its derivatives/homologues e.g. cannabiodiol-Cs (CBD-C5), cannabidiol-C4 (CBD-C4), cannabidiol mono(m)ethyl ether (CBDM-C5), cannabidivarin (CBDV-C3), cannabidiorcol (CBD-C1), cannabidiolic acid (CBDA-C5), cannabidivarinic acid (CBDVA-C3).

In some embodiments, the cannabinoid compound is selected from at least one of tetrahydrocannabinol (THC) and its derivatives/homologues, e.g. A⁹-tetrahydrocannabinol (A⁹-THC-C5 / c/s-A⁹-THC-C5), A⁸- tetrahydrocannabinol (A⁸-THC-C5), A⁸-tetrahydrocannabinolic acid A (A⁸-THCA-C5 A), A⁹- tetrahydrocannabinol-C4 (A⁹-THC-C4), A⁹-tetrahydrocannabivarin (A⁹-THCV-C3), A⁹- tetrahydrocannabiorcol (A⁹-THCO-Ci), A⁹-tetrahydrocannabinolic acid A (A⁹-THCA-C5A), A⁹- tetrahydrocannabinolic acid B (A⁹-THCA-C5 B), A⁹-tetrahydrocannabinolic acid-C4 A and/or B (A⁹-THCA- C4 A and/or B), A⁹-tetrahydrocannabivarinic acid A (A⁹-THCVA-C3 A), A⁹-tetrahydrocannabiorcolic acid A and/or B (A⁹-THCOA-Ci A and/or B), isotetrahydrocannabinol and isotetrahydrocannabivarin.

The total amount of cannabinoid compounds in the apparatus may be at least 200 mg; for example, it may be at least 250 mg, at least 300 mg, at least 400 mg, at least 500 mg. In some cases, lower amounts may be preferred. The total amount of cannabinoid compounds in the apparatus may therefore be at least 10 mg, at least 20 mg, at least 30 mg, at least 40 mg, at least 50 mg, at least 75 mg, at least 100 mg.

In some cases, it may be desirable to limited the total amount of cannabinoid compounds, which may be not more than 200 mg, not more than 175 mg, not more than 150 mg, not more than 125 mg, not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 10 mg. In some cases, the total amount of the cannabinoid compounds may be not more than 5 mg.

Where THC is included, either as one cannabinoid compound in a mixture or as the only cannabinoid, the total of amount of THC may be limited. In some cases, the total amount of THC in the substrate is not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 15 mg, not more than 10 mg, not more than 5 mg, not more than 3 mg. In some cases, the amount of THC may be 0.1 to 30 mg, for example 1 to 30 mg, for example 1 to 20 mg, for example 1 to 10 mg, for example 1 to 5 mg, for example 1 to 3 mg. In some embodiments, the vapour delivery apparatus is a smoking substitute apparatus. In such embodiments, the active ingredient may comprise or consist of nicotine. Preferably and additionally, the vapour delivery apparatus comprises an additive having an aroma or flavour which is tobacco flavour.

Preferably, the apparatus does not include an electrically powered heater. However in some embodiments, one or more of the fluid passages may comprise a heater for heating the fluid (i.e. air) passing through the passage. The heater may, for example, be arranged upstream of a reservoir formed from an air permeable substrate such that air warmed by the heater is drawn through the reservoir to enable or increase nicotine and/or flavourant vapourisation and subsequent entrainment in the air-flow. The heater to heat the air may comprise one or more meshes arranged within the fluid passage. The heater to heat the air may comprise one or more thermally conductive elements to conduct heat from a heater to the air passage or to increase the heat transfer between the heater and the air. The heat source may be non-electrical. For example, the heat to heat the air may be generated by an exothermic reaction. An exothermic reaction heat source may comprise a single-use (i.e. consumable) reaction container. Alternatively, an exothermic reaction heat source may be rechargeable (e.g. by using a reversible reaction such as a crystallisation process).

[ME ref: 7631757; Nerudia ref: P01222]

The present inventors have also realised that pre-heating of a consumable, for use in a vapour delivery apparatus, or for use as a vapour delivery apparatus, can provide significant advantages in terms of delivery of an active ingredient to a user.

In a general aspect of Development C, the present invention provides pre-heating of a consumable via an exothermic reaction.

According to a first preferred aspect of Development C there is provided a consumable preparation apparatus for storing and pre-heating a consumable for use in or as a vapour delivery apparatus, the consumable preparation apparatus comprising: a shaped recess in which said consumable is adapted to fit; a heat source in thermal contact with the shaped recess, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air; the consumable comprising a source of an active ingredient and being configured to deliver a vapour comprising said active ingredient to a user drawing air through the consumable.

According to a second preferred aspect of Development C, there is provided a method of using the consumable preparation apparatus of the first preferred aspect, wherein the method comprises the steps of: providing a consumable fitted into the shaped recess; exposing the heat source to air; and pre-heating the consumable.

According to a third preferred aspect of Development C, there is provided a vapour delivery system comprising a vapour delivery apparatus and a consumable preparation apparatus, the vapour delivery apparatus being configured to deliver a vapour comprising an active ingredient to a user drawing air through the vapour delivery apparatus for inhalation, the vapour delivery apparatus comprising a vapour generator arranged in an air passage, wherein the vapour generator comprises a source of an active ingredient, for generation of the vapour, the consumable preparation apparatus being for storing and pre-heating a consumable, the consumable preparation apparatus comprising: a shaped recess in which said consumable is adapted to fit; a heat source in thermal contact with the shaped recess, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, and wherein the consumable comprises a source of the active ingredient.

In Development C, the consumable preparation apparatus, method of use and its incorporation into a system offer an inexpensive and simple way of heating one or more consumables prior to use. The heat source is non-electrical for the purpose of reducing complexity and cost for such a system. In particular, the apparatus does not include an electrically powered heater. The heat source of the consumable preparation apparatus uses an air-reactive exothermic chemical reaction to heat the consumable. As air is always present, the product is always usable and requires no extra effort. The consumable preparation apparatus may therefore be suitable for use on an aircraft.

The consumable preparation apparatus is suitable for storing and pre-heating one or more consumables. The consumable may comprise an air-permeable substrate loaded with a source of an active ingredient, such as nicotine. The consumable may be adapted to be loaded into a vapour delivery apparatus configured to deliver a vapour comprising the active ingredient to a user drawing air through the vapour delivery apparatus for inhalation. The consumable may comprise a biodegradable housing, made from materials that would also conduct enough heat into the consumable to increase the volatilisation of nicotine and therefore result in a higher nicotine delivery.

Preferably, the consumable preparation apparatus further comprises one or more air access holes configurable to permit air to access the heat source. The one or more air access holes allow the ingress of air to the heat source in order to produce an exothermic reaction, and thereby produce heat. The air access holes can vary in size, for example the consumable preparation apparatus may comprise a single large air access hole or several small air access holes.

The consumable preparation apparatus may further comprise an open configuration in which the one or more air access holes allow air to access the heat source and a closed configuration in which the one or more air access holes do not allow access air to access the heat source. In the closed configuration, the one or more air access holes may be covered, whilst in the open configuration, the one or more air access holes are left uncovered to allow air to enter the consumable preparation apparatus and interact with the heat source. The consumable preparation apparatus may be changeable from the closed configuration to the open configuration and vice versa. This means that the heat source can be reactivated repeatedly, until the substance has been used up. The reaction stops once the air is removed from the consumable preparation apparatus. Alternatively, the consumable preparation apparatus may only be configured to be moveable from a closed configuration to an open configuration, such that the consumable preparation apparatus can only be used once.

Optionally, the consumable preparation apparatus comprises a top cover and a bottom cover and wherein the one or more air access holes are located in the top cover, and the heat source is located within the bottom cover. The top and bottom covers are moveable with respect to each other, such that moving them apart may form one or more air access holes. Alternatively, the one or more air access holes may be located in the top or bottom covers, such that moving the top and bottom covers apart can allow air to reach the heat source. The top cover and bottom cover advantageously allow the consumable preparation apparatus to be reactivated repeatedly, until the substance has been used up. Preferably, the one or more air access holes are located in the top cover, and the heat source is located in the bottom cover. In this arrangement, the heat source may form the shaped recess in which one or more consumables are adapted to fit. An advantage of having a consumable preparation apparatus having a top cover and a bottom cover is that a user can easily remove a consumable within the consumable preparation apparatus by removing the top cover from the bottom cover.

The consumable preparation apparatus may further comprise one or more selectively removable covers positioned over the one or more air access holes. The selectively removable cover may be peelable or tearable. The selectively removable covers provide a simple way of stopping air from accessing the heat source, whilst also being easily removable from the air access holes. The selectively removable covers may be single-use, so when the selectively removable covers are removed from the air access holes, the air access holes may be permanently left open for air to enter the heat source. The exothermic reaction will stop when the substance in the heat source has been used up.

Optionally, the consumable preparation apparatus further comprises separate compartments, each separate compartment being adapted for a single consumable to fit and each separate compartment comprising at least a portion of the heat source. In this configuration, the consumable preparation apparatus can heat a single consumable, or heat more than one consumable simultaneously. Preferably, the consumable preparation apparatus may store up to and including 20 consumables. Having 20 consumables in a consumable preparation apparatus is particularly advantageous because it provides a similar feel to a standard packet of cigarettes. However, more than 20 consumables may be stored in the consumable preparation apparatus. Ideally, the consumable preparation apparatus is configured to store 5, 10 or 15 consumables. If a smaller consumable preparation apparatus is required, the apparatus may be configured to hold 2, 3, 5 or 6 consumables. It is particularly advantageous to be able to have each of these consumables in separate compartments with each compartment having its own heat source, because a user can choose which consumable and how many consumables he wishes to heat, and when he wishes to heat it or them. In order to provide air to the heat source, each separate compartment may comprise one or more air access holes covered by one or more selectively removable covers. For example, the selectively removable cover may be peelable or tearable. Once a selectively removable cover is removed, the air access holes may not be covered again, and so the heat source will continue to release heat until the substance in the heat source is used up. Thus, it is advantageous to have more than one compartment such that a user can heat a consumable as and when they require.

Preferably, the heat source substance comprises elemental iron. This is particularly advantageous because on interaction with air, iron oxidises to form iron oxide (e.g. Fe20s). This oxidising reaction is an exothermic reaction, thereby releasing heat which can be used to heat one or more consumables. The heat source may comprise a powder. The heat source may further comprise cellulose, water, vermiculite, activated carbon and salt. Cellulose may be used to provide bulk to the heat source, but an alternative such as sawdust may also be used. Vermiculite may serve as a water reservoir. Activated carbon advantageously distributes heat uniformly and ensures that the whole consumable is heated. Salt may act as a catalyst, so the exothermic reaction has an increased rate, and the user has to wait less time for the consumable to be heated.

The heat source may also comprise an air-permeable mesh for containing the heat source. The air- permeable mesh is a breathable material which allows enough air into the heat source for the exothermic reaction to occur, but provides enough support to retain the heat source, particularly any particulate material.

The consumable preparation apparatus is operable to heat the consumable to a temperature up to 50°C. For example, the consumable preparation apparatus may be operable to heat the consumable to temperatures of 25°C, 30°C, 35°C, 40°C, 45°C, or 50°C. Preferably the consumable preparation apparatus is operable from 20°C to 40°C because this range advantageously delivers approximately 60% more nicotine. Preferably, the consumable preparation apparatus is operable between 40°C and 50°C, because this range delivers a satisfactory amount of active ingredient to the user. For example, the consumable preparation apparatus may be operable at temperatures of 42°C, 44°C, 46°C, or 48°C.

The heat source may be shaken after exposure to air. Simple bench-top tests have shown that a heat source powder can reach approximately 45°C after 30 seconds of air exposure at a depth of 3mm below the surface of the powder without agitation. In a further investigation, the heat source powder was placed in an open top cover. The cover allows room for the user to apply gentle movement to agitate the heat source powder. This ‘shake to wake’ process may therefore decrease heat-up time of the consumable and increase the heating temperature.

The consumable may comprise an air-permeable substrate loaded with a source of the active ingredient. Having an air-permeable substrate advantageously allows air to easily access the active ingredient. In some embodiments, the vapour delivery apparatus is a smoking substitute apparatus. In such embodiments, the active ingredient may comprise or consist of nicotine.

Once heating of the consumable has begun, the user may wait for the consumable to be sufficiently preheated for generation of a vapour comprising the active ingredient for inhalation, and then remove the pre-heated consumable from the consumable preparation apparatus for a user to draw air through the consumable for inhalation. The time for sufficiently heating the consumable may vary according to the proportion of air access holes that are uncovered or the size of the air access hole that is uncovered, thus altering the air flow to the heat source. Having a larger number of air inlet holes uncovered, or a larger size of an air access hole that is uncovered leads to a faster heat-up time of the consumable.

Additionally, agitating the heat source while permitting air to access the heat source also leads to a faster heat-up time of the consumable. A faster heat-up time reduces the time that the user has to wait for the consumable to be sufficiently heated for inhalation, for example the user may only need to wait between 30 and 60 seconds for the consumable to be ready for inhalation. The user may wait 40, 50, 60, 70, 80, 90, 100, 110 or 120 seconds for the consumable to be sufficiently warmed for inhalation.

Turning now to the consumable which may be adapted to be loaded into a vapour delivery apparatus, in order to generate a vapour for inhalation, the apparatus comprises at least one volatile compound that is intended to be vaporised/aerosolised and that may provide the user with a recreational, wellness, nutritional, physiological and/or medicinal effect when inhaled. Such a volatile compound is referred to herein as an “active agent” or “active ingredient”. The active agent may be stored in a reservoir, described later.

The active ingredient may comprise or consist of nicotine. However, in some embodiments, the active ingredient may not comprise nicotine, and may instead comprise or consist of one or more of a nutritional agent, a pharmaceutical agent or a flavour agent.

Suitable active agents include the group consisting of: nicotine, cocaine, caffeine (anhydrous or salts thereof), vitamins, minerals, amino acids, plant or herbal concentrated extracts, sugars, opiates and opioids, cathine and cathinone, kavalactones, mysticin, beta-carboline alkaloids, salvinorin A, cannabinoids, phytocannabinoids, one or more flavourants, together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

Example flavourants may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour.

Cannabinoid compounds include phyto-cannabinoids which include: cannabidiol (CBD) and its derivatives/homologues (e.g. cannabidiol mono(m)ethyl ether, cannabidivarin (CBDV), cannabidiorcol, cannabidiolic acid, cannabidivarinic acid); cannabinodiol (CBND) and its derivatives/homologues (e.g. carrabinodivarin); cannabigerol (CBG) and its derivatives/homologues (e.g. cannabigerol mono(m)ethyl ether, cannabinerolic acid A, cannabigerovarin, cannabigerolic acid A, cannabigerolic acid A mono(m)ethyl ether, cannabigerovarinic acid A); cannabinol (CBN) and its derivatives/homologues (e.g. cannabivarin/cannabivarol (CBV), cannabiorcol, cannabinolic acid, cannabinol (m)ethyl ester); tetrahydrocannabinol (THC) and its derivatives/homologues (e.g. tetrahydrocannabivarin (THCV), tetrahydrocannabiorcol, tetrahydrocannabinolic acid A/B, tetrahydrocannabivarinic acid A, tetrahydrocannabiorcolic acid A/B, isotetrahydrocannabinol, isotetrahydrocannabivarin); cannabicyclol (CBL) and its derivatives/homologues (e.g. cannabicyclolic acid, cannabicyclovarin); cannabichromene (CBC) and its derivatives/homologues (e.g. cannabichromenic acid A, cannabichromevarin (CBCV), cannabichromevarinic acid A); cannabielsoin (CBE) and its derivatives/homologues (e.g. cannabielsoic acid A/B, cannabiglendol, dehydrocannabifuran, cannabifuran); cannabicitran (CBT) and its derivatives/homologues; cannabitriol and its derivatives/homologues (e.g. ethyl cannabitriol, dihydroxy-tetrahydrocannabinol, cannabidiolic acid A cannabitriol ester, dihydroxy-hexahydrocannabinol (cannabiripsol), cannabitetrol, oxo-tetrahydrocannabinol); and cannabichromanone (CBCN) and its derivatives/homologues (e.g. cannabicoumaronone).

In some embodiments, the cannabinoid compound is selected from at least one of cannabidiol (CBD) and its derivatives/homologues e.g. cannabiodiol-Cs (CBD-C5), cannabidiol-C4 (CBD-C4), cannabidiol mono(m)ethyl ether (CBDM-C5), cannabidivarin (CBDV-C3), cannabidiorcol (CBD-C1), cannabidiolic acid (CBDA-C5), cannabidivarinic acid (CBDVA-C3).

In some embodiments, the cannabinoid compound is selected from at least one of tetrahydrocannabinol (THC) and its derivatives/homologues, e.g. A⁹-tetrahydrocannabinol (A⁹-THC-C5 / c/s-A⁹-THC-C5), A⁸- tetrahydrocannabinol (A⁸-THC-C5), AMetrahydrocannabinolic acid A (A⁸-THCA-C5 A), A⁹- tetrahydrocannabinol-C4 (A⁹-THC-C4), A⁹-tetrahydrocannabivarin (A⁹-THCV-C3), A⁹- tetrahydrocannabiorcol (A⁹-THCO-Ci), AMetrahydrocannabinolic acid A (A⁹-THCA-C5A), A⁹- tetrahydrocannabinolic acid B (A⁹-THCA-C5 B), AMetrahydrocannabinolic acid-C4 A and/or B (A⁹-THCA- C4 A and/or B), AMetrahydrocannabivarinic acid A (A⁹-THCVA-C3 A), AMetrahydrocannabiorcolic acid A and/or B (A⁹-THCOA-Ci A and/or B), isotetrahydrocannabinol and isotetrahydrocannabivarin.

The total amount of cannabinoid compounds in the apparatus may be at least 200 mg; for example, it may be at least 250 mg, at least 300 mg, at least 400 mg, at least 500 mg. In some cases, lower amounts may be preferred. The total amount of cannabinoid compounds in the apparatus may therefore be at least 10 mg, at least 20 mg, at least 30 mg, at least 40 mg, at least 50 mg, at least 75 mg, at least 100 mg.

In some cases, it may be desirable to limited the total amount of cannabinoid compounds, which may be not more than 200 mg, not more than 175 mg, not more than 150 mg, not more than 125 mg, not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 10 mg. In some cases, the total amount of the cannabinoid compounds may be not more than 5 mg.

Where THC is included, either as one cannabinoid compound in a mixture or as the only cannabinoid, the total of amount of THC may be limited. In some cases, the total amount of THC in the substrate is not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 15 mg, not more than 10 mg, not more than 5 mg, not more than 3 mg. In some cases, the amount of THC may be 0.1 to 30 mg, for example 1 to 30 mg, for example 1 to 20 mg, for example 1 to 10 mg, for example 1 to 5 mg, for example 1 to 3 mg.

The vapour delivery apparatus typically comprises a reservoir configured to store a vapour precursor. The vapour precursor may be formulated so as to produce a non-visible or substantially non-visible vapour. The vapour precursor may comprise a base liquid. The vapour precursor may additionally comprise nicotine. The vapour precursor may be an e-liquid. The vapour precursor may consist substantially of nicotine or a nicotine compound. The vapour precursor may further comprise a flavourant. Alternatively, the vapour precursor may be substantially flavourless. That is, the vapour precursor may not contain any deliberately added additional flavourant. A flavourant may be provided as a separate flavourant vapour precursor, such that the vapour precursor and flavourant vapour precursor may be separately vaporised to form a vapour comprising both the vapour precursor and the flavourant vapour precursor.

An air-permeable substrate, storing the vapour precursor and/or the flavourant, may constitute the entirety of the reservoir. The air-permeable substrate may be impregnated with the vapour precursor and/or the flavourant vapour precursor. The substrate material may be a foamed polymer which will allow for airflow to pass through the substrate at a given pressure drop value, so as to provide a comfortable ‘draw’ sensation for the user. The substrate may be, for example, a sintered polyethylene or a PET foam.

The substrate may be impregnated with nicotine via immersion in a liquid containing nicotine and a volatile carrier (for example a solution of nicotine in ethanol). The substrate may be immersed to evenly soak the substrate. Once removed and left to dry or baked in an oven, the carrier is evaporated and the nicotine is left evenly spread throughout the substrate.

The vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when ambient air is drawn through the reservoir. Alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when heated air is drawn through the reservoir. Additionally or alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when the reservoir is heated and heated or ambient air is drawn through the reservoir. The reservoir may comprise a monolithic substrate. The reservoir may consist of a plurality of substrates, each arranged to allow air to be drawn therethrough, and each comprising one or both of a vapour precursor and the flavourant vapour precursor. The vapour precursor and/or the flavourant vapour precursor may be provided in spatially coterminous or spatially distinct regions of the reservoir.

The vapour delivery apparatus may comprise more than one passage for fluid (e.g. air) flow therethrough. Where more than one passage is present, one or more of the passages may be distinct, such that there is no intersection between the passages. One or more of the passages may comprise junctions or openings therebetween such that fluid within the passages can mix within the apparatus. The passage through the reservoir may comprise one or more valves to control fluid flow. The valves may include one or more one-way valve to ensure fluid (i.e. air) can only flow through the passage in a desired direction. Further valves may be provided that may be operable to open and close the passage such that fluid is enabled to or prevented from flowing through the passage. More than one such valve may be linked such that the valves may be operated in combination or in synchronism with each other. A valve to open and close a passage may be controlled by mechanical means (i.e. the user moves the valve using a control lever or similar) or by electrical control (i.e. moved in response to a control signal from a processor or control system of the aerosol delivery apparatus).

The passages may extend through (at least a portion of) the vapour delivery apparatus, between openings that may define an inlet and an outlet of a passage. Each inlet and outlet may be in fluid communication with only one passage, or a subset of the passages, or all the passages in the vapour delivery apparatus. The outlet or outlets may be at a mouthpiece of the aerosol delivery apparatus. In this respect, a user may draw fluid (e.g. air) into and through a passage by inhaling at the outlet (i.e. using the mouthpiece).

The term “flavourant” is used to describe a compound or combination of compounds that provide flavour and/or aroma. For example, the flavourant may be configured to interact with a sensory receptor of a user (such as an olfactory or taste receptor). The flavourant may include one or more volatile substances.

The flavourant may be provided in solid or liquid form. The flavourant may be natural or synthetic. For example, the flavourant may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour. The flavourant may be evenly dispersed or may be provided in isolated locations and/or varying concentrations.

The first aerosol generator comprises an air-permeable substrate. This may comprise plant material. The plant material may comprise least one plant material selected from the list including Amaranthus dubius, Arctostaphylos uva-ursi (Bearberry), Argemone mexicana, Arnica, Artemisia vulgaris, Yellow Tees, Galea zacatechichi, Canavalia maritima (Baybean), Cecropia mexicana (Guamura), Oestrum noctumum, Cynoglossum virginianum (wild comfrey), Cytisus scoparius, Damiana, Entada rheedii, Eschscholzia califomica (California Poppy), Fittonia albivenis, Hippobroma longiflora, Humulus japonica (Japanese Hops), Humulus lupulus (Hops), Lactuca virosa (Lettuce Opium), Laggera alata, Leonotis leonurus, Leonurus cardiaca (Motherwort), Leonurus sibiricus (Honeyweed), Lobelia cardinalis, Lobelia inflata (Indian-tobacco), Lobelia siphilitica, Nepeta cataria (Catnip), Nicotiana species (Tobacco), Nymphaea alba (White Lily), Nymphaea caerulea (Blue Lily), Opium poppy, Passiflora incamata (Passionflower), Pedicularis densiflora (Indian Warrior), Pedicularis groenlandica (Elephant's Head), Salvia divinorum, Salvia dorrii (Tobacco Sage), Salvia species (Sage), Scutellaria galericulata, Scutellaria lateriflora, Scutellaria nana, Scutellaria species (Skullcap), Sida acuta (Wireweed), Sida rhombifolia, Silene capensis, Syzygium aromaticum (Clove), Tagetes lucida (Mexican Tarragon), Tarchonanthus camphoratus, Tumera diffusa (Damiana), Verbascum (Mullein), Zamia latifolia (Maconha Brava) together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing. In some embodiments, the plant material is tobacco. Any type of tobacco may be used. This includes, but is not limited to, flue-cured tobacco, burley tobacco, Maryland Tobacco, dark-air cured tobacco, oriental tobacco, dark-fired tobacco, perique tobacco and rustica tobacco. This also includes blends of the above mentioned tobaccos.

Any suitable parts of the tobacco plant may be used. This includes leaves, stems, roots, bark, seeds and flowers.

The tobacco may comprise one or more of leaf tobacco, stem tobacco, tobacco powder, tobacco dust, tobacco derivatives, expanded tobacco, homogenised tobacco, shredded tobacco, extruded tobacco, cut rag tobacco and/or reconstituted tobacco (e.g. slurry recon or paper recon).

The air-permeable substrate may comprise a gathered sheet of homogenised (e.g. paper/slurry recon) tobacco or gathered shreds/strips formed from such a sheet.

In some embodiments, the sheet used to form the aerosol-forming substrate has a grammage greater than or equal to 100 g/m², e.g. greater than or equal to 110 g/m² such as greater than or equal to 120 g/m².

The sheet may have a grammage of less than or equal to 300 g/m² e.g. less than or equal to 250 g/m² or less than or equal to 200 g/m².

The sheet may have a grammage of between 120 and 190 g/m².

The air-permeable substrate may comprise at least 50 wt% plant material, e.g. at least 60 wt% plant material e.g. around 65 wt% plant material. The air-permeable substrate may comprise 80 wt% or less plant material e.g. 75 or 70 wt% or less plant material.

The air-permeable substrate may comprise one or more additives selected from flavourants, fillers and binders.

Typically, the air-permeable substrate does not comprise a humectant. Humectants may be provided in heat not burn (HNB) tobacco charges. In such cases, humectants are provided as vapour generators, the generated vapour being used to help carry volatile active compounds and to increase visible vapour. Accordingly, it is preferred that the air-permeable substrate does not comprise one or more humectants such as polyhydric alcohols (e.g. propylene glycol (PG), triethylene glycol, 1 ,2-butane diol and vegetable glycerine (VG)) and their esters (e.g. glycerol mono-, di- or tri-acetate). If such humectants are present in the air-permeable substrate, they may be present at a low level, such as less than 0.5 wt%, more preferably less than 0.1 wt%. Suitable binders are known in the art and may act to bind together the components forming the air- permeable substrate. Binders may comprise starches and/or cellulosic binders such as methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose and methyl cellulose, gums such as xanthan, guar, arabic and/or locust bean gum, organic acids and their salts such as alginic acid/ sodium alginate, agar and pectins.

Preferably the binder content is 5 to 10 wt% of the air-permeable substrate e.g. around 6 to 8 wt%. Suitable fillers are known in the art and may act to strengthen the air-permeable substrate. Fillers may comprise fibrous (non-tobacco) fillers such as cellulose fibres, lignocellulose fibres (e.g. wood fibres), jute fibres and combinations thereof.

Preferably, the filler content is 5 to 10 wt% of the aerosol-forming substrate e.g. around 6 to 9 wt%.

The air-permeable substrate may comprise an aqueous and/or non-aqueous solvent. In some embodiments, the air-permeable substrate has a water content of between 4 and 10 wt% e.g. between 6- 9 wt% such as between 7-9 wt%. Such low moisture content in the air-permeable substrate typically has the effect that, when the air-permeable substrate is exposed to heated air, there would typically not be produced a substantial visible vapour. It is to be noted that in one embodiment it is possible to use as the air-permeable substrate a low moisture tobacco material with its natural nicotine content. The natural nicotine content then meets the requirements of the active agent.

The air-permeable substrate may be at least partly circumscribed by a wrapping layer e.g. a paper wrapping layer. The wrapping layer may overlie an inner foil layer or may comprise a paper/foil laminate (with the foil innermost).

The plant material may comprise cannabis plant material including Cannabis sativa, Cannabis indica and Cannabis rudealis. The plant material may comprise Echinacea purpurea, Echinacea angustifolia, Acmella oleracea, Helichrysum umbraculigerum, or Radula marginata. This also includes blends of the above mentioned plant material.

In some embodiments, the cannabinoid-containing plant material is cannabis. The plant may be a traditional strain, or may be a strain bred or other modified (e.g. genetically) to produce certain levels of some cannabinoids compounds, e.g. low levels of THC or high levels of THC.

Any suitable parts of the cannabinoid-containing plant may be used. Thus the cannabinoid-containing plant material may comprise leaves, stems, roots, bark, seeds, buds and flowers (which may be cured).

Development D

[ME ref: 7631773; Nerudia ref: P01224]

In a first aspect of Development D, the present invention provides a consumable apparatus for delivering an active ingredient to a user, the consumable apparatus comprising: an air inlet, an outlet, a substrate loaded with a source of active ingredient for generating a vapour for inhalation by a user, a heat source in thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, an air flow path between the air inlet and the outlet for conveying the active ingredient to the user, wherein the apparatus is configurable to control access of air to the heat source and thereby to control the generation of heat by the heat source, the apparatus comprising a removable seal, the removable seal being configured to be permanently opened prior to use of the consumable apparatus to allow ingress of air to the heat source.

In a second aspect of Development D, the present invention provides a method of operating a consumable apparatus to deliver an active ingredient to a user, the consumable apparatus comprising: an air inlet, an outlet, a substrate loaded with a source of active ingredient for generating a vapour for inhalation by a user, a heat source in thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, an air flow path between the air inlet and the outlet for conveying the active ingredient to the user, a removable seal, wherein, before use, the removable seal seals the apparatus from ingress of air to the heat source, the method including the step of permanently removing the seal to allow access of air to the heat source.

In the Development D, the present invention therefore allows the substrate to be heated by the exothermic reaction and for the delivery of active ingredient to the user to be improved by virtue of the heating of the substrate, while avoiding the need for electrical power to heat the substrate.

Optional features of the invention of Development D will now be set out. These are applicable singly or in any combination with any development or aspect of the invention, unless the context demands otherwise.

The removable seal may be removed by peeling. This is considered to be a simple operation for the user to achieve. A user-operable tab may be provided on the seal, to allow the user to gain an easy purchase on the seal to remove it. Peeling of the seal from the apparatus allows the user to dispose of the seal, ensuring that the seal is permanently removed. In other arrangements, the seal may be removed by piercing or other irreversible breaking of the seal.

There may be provided an inlet seal and an outlet seal. These may be provided at opposing ends of the apparatus, corresponding to the direction of air flow intended through the apparatus. The heat source may be disposed around the substrate. For example, the heat source may be disposed annularly around the substrate. This allows the heat source to heat the substrate efficiently and yet for the axial extent of the apparatus to be advantageously limited.

The substrate may include an air flow passage. The air flow passage may, for example, be formed substantially centrally through the substrate. Considering an air flow path through the apparatus, the air flow passage is typically aligned with the air flow path.

When the heat source is disposed annularly around the substrate, the substrate, heat source and the air flow passage may be coaxial.

The substrate may be formed of air-permeable material. This permits some air flow through the substrate. This may enhance the removal of the active ingredient into the air flow as a vapour.

The heat source may be at least partially enclosed by an air-permeable layer. When the seal is removed, air may access the heat source via the air-permeable layer. The air-permeable layer may for example be a mesh or a perforated layer.

An air-impermeable barrier may be provided between the heat source and the substrate. This is preferred in order to prevent ingress of air into the heat source before it is required.

There may be provided a housing, configured for the user to hold. The housing may provide an outer wall enclosing the heat source. In this arrangement, the housing is disposable with the substrate and heat source. By “disposable”, it is intended that the item is single use and understood by the user as to be disposed of after its single use.

Alternatively, there may be provided a housing, configured for the user to hold. The consumable apparatus may be configured to be removably attachable to the housing to form a system for delivering the active ingredient to the user. In this arrangement, it may be that the consumable apparatus is disposable and the housing is re-usable.

In use, the heat source typically heats at least part of the substrate to a temperature of at least 35°C. More preferably, this temperature is at least 40°C and may be at least 45°C. Furthermore, in use, the heat source may heat the substrate so that no part of the substrate is at a temperature greater than 80°C. More preferably, this temperature is not more than 75°C, not more than 70°C, not more than 65°C or not more than 60°C. It is considered that within these temperature ranges, the advantageous effects of the invention are best seen in terms of the promotion of the delivery of the active ingredient in a user- and regulation-acceptable manner.

In some embodiments, the vapour delivery apparatus is a smoking substitute apparatus. In such embodiments, the active ingredient may comprise or consist of nicotine. Preferably, the apparatus does not include an electrically powered heater.

In order to generate a vapour for inhalation, the apparatus comprises at least one volatile compound that is intended to be vaporised/aerosolised and that may provide the user with a recreational, wellness, nutritional, physiological and/or medicinal effect when inhaled. Such a volatile compound is referred to herein as an “active agent” or “active ingredient”. The active agent may be stored in a reservoir, described later.

The active ingredient may comprise or consist of nicotine. However, in some embodiments, the active ingredient may not comprise nicotine, and may instead comprise or consist of one or more of a nutritional agent, a pharmaceutical agent or a flavour agent.

Suitable active agents include the group consisting of: nicotine, cocaine, caffeine (anhydrous or salts thereof), vitamins, minerals, amino acids, plant or herbal concentrated extracts, sugars, opiates and opioids, cathine and cathinone, kavalactones, mysticin, beta-carboline alkaloids, salvinorin A, cannabinoids, phytocannabinoids, one or more flavourants, together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

Example flavourants may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour.

Cannabinoid compounds include phyto-cannabinoids which include: cannabidiol (CBD) and its derivatives/homologues (e.g. cannabidiol mono(m)ethyl ether, cannabidivarin (CBDV), cannabidiorcol, cannabidiolic acid, cannabidivarinic acid); cannabinodiol (CBND) and its derivatives/homologues (e.g. carrabinodivarin); cannabigerol (CBG) and its derivatives/homologues (e.g. cannabigerol mono(m)ethyl ether, cannabinerolic acid A, cannabigerovarin, cannabigerolic acid A, cannabigerolic acid A mono(m)ethyl ether, cannabigerovarinic acid A); cannabinol (CBN) and its derivatives/homologues (e.g. cannabivarin/cannabivarol (CBV), cannabiorcol, cannabinolic acid, cannabinol (m)ethyl ester); tetrahydrocannabinol (THC) and its derivatives/homologues (e.g. tetrahydrocannabivarin (THCV), tetrahydrocannabiorcol, tetrahydrocannabinolic acid A/B, tetrahydrocannabivarinic acid A, tetrahydrocannabiorcolic acid A/B, isotetrahydrocannabinol, isotetrahydrocannabivarin); cannabicyclol (CBL) and its derivatives/homologues (e.g. cannabicyclolic acid, cannabicyclovarin); cannabichromene (CBC) and its derivatives/homologues (e.g. cannabichromenic acid A, cannabichromevarin (CBCV), cannabichromevarinic acid A); cannabielsoin (CBE) and its derivatives/homologues (e.g. cannabielsoic acid A/B, cannabiglendol, dehydrocannabifuran, cannabifuran); cannabicitran (CBT) and its derivatives/homologues; cannabitriol and its derivatives/homologues (e.g. ethyl cannabitriol, dihydroxy-tetrahydrocannabinol, cannabidiolic acid A cannabitriol ester, dihydroxy-hexahydrocannabinol (cannabiripsol), cannabitetrol, oxo-tetrahydrocannabinol); and cannabichromanone (CBCN) and its derivatives/homologues (e.g. cannabicoumaronone).

In some embodiments, the cannabinoid compound is selected from at least one of cannabidiol (CBD) and its derivatives/homologues e.g. cannabiodiol-Cs (CBD-C5), cannabidiol-C4 (CBD-C4), cannabidiol mono(m)ethyl ether (CBDM-C5), cannabidivarin (CBDV-C3), cannabidiorcol (CBD-C1), cannabidiolic acid (CBDA-C5), cannabidivarinic acid (CBDVA-C3).

In some embodiments, the cannabinoid compound is selected from at least one of tetrahydrocannabinol (THC) and its derivatives/homologues, e.g. A⁹-tetrahydrocannabinol (A⁹-THC-C5 / c/s-A⁹-THC-C5), A⁸- tetrahydrocannabinol (A⁸-THC-C5), A⁸-tetrahydrocannabinolic acid A (A⁸-THCA-C5 A), A⁹- tetrahydrocannabinol-C4 (A⁹-THC-C4), A⁹-tetrahydrocannabivarin (A⁹-THCV-C3), A⁹- tetrahydrocannabiorcol (A⁹-THCO-Ci), A⁹-tetrahydrocannabinolic acid A (A⁹-THCA-C5A), A⁹- tetrahydrocannabinolic acid B (A⁹-THCA-C5 B), A⁹-tetrahydrocannabinolic acid-C4 A and/or B (A⁹-THCA- C4 A and/or B), A⁹-tetrahydrocannabivarinic acid A (A⁹-THCVA-C3 A), A⁹-tetrahydrocannabiorcolic acid A and/or B (A⁹-THCOA-Ci A and/or B), isotetrahydrocannabinol and isotetrahydrocannabivarin.

The total amount of cannabinoid compounds in the apparatus may be at least 200 mg; for example, it may be at least 250 mg, at least 300 mg, at least 400 mg, at least 500 mg. In some cases, lower amounts may be preferred. The total amount of cannabinoid compounds in the apparatus may therefore be at least 10 mg, at least 20 mg, at least 30 mg, at least 40 mg, at least 50 mg, at least 75 mg, at least 100 mg.

In some cases, it may be desirable to limited the total amount of cannabinoid compounds, which may be not more than 200 mg, not more than 175 mg, not more than 150 mg, not more than 125 mg, not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 10 mg. In some cases, the total amount of the cannabinoid compounds may be not more than 5 mg.

Where THC is included, either as one cannabinoid compound in a mixture or as the only cannabinoid, the total of amount of THC may be limited. In some cases, the total amount of THC in the substrate is not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 15 mg, not more than 10 mg, not more than 5 mg, not more than 3 mg. In some cases, the amount of THC may be 0.1 to 30 mg, for example 1 to 30 mg, for example 1 to 20 mg, for example 1 to 10 mg, for example 1 to 5 mg, for example 1 to 3 mg.

The vapour delivery apparatus typically comprises a reservoir configured to store a vapour precursor. The vapour precursor may be formulated so as to produce a non-visible or substantially non-visible vapour. The vapour precursor may comprise a base liquid. The vapour precursor may additionally comprise nicotine. The vapour precursor may be an e-liquid. The vapour precursor may consist substantially of nicotine or a nicotine compound. The vapour precursor may further comprise a flavourant. Alternatively, the vapour precursor may be substantially flavourless. That is, the vapour precursor may not contain any deliberately added additional flavourant. A flavourant may be provided as a separate flavourant vapour precursor, such that the vapour precursor and flavourant vapour precursor may be separately vaporised to form a vapour comprising both the vapour precursor and the flavourant vapour precursor.

A substrate (optionally an air-permeable substrate), storing the vapour precursor and/or the flavourant, may constitute the entirety of the reservoir. The air-permeable substrate may be impregnated with the vapour precursor and/or the flavourant vapour precursor. The substrate material may be a foamed polymer which will allow for airflow to pass through the substrate at a given pressure drop value, so as to provide a comfortable ‘draw’ sensation for the user. The substrate may be, for example, a sintered polyethylene or a PET foam.

The substrate may be impregnated with nicotine via immersion in a liquid containing nicotine and a volatile carrier (for example a solution of nicotine in ethanol). The substrate may be immersed to evenly soak the substrate. Once removed and left to dry or baked in an oven, the carrier is evaporated and the nicotine is left evenly spread throughout the substrate.

The vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when ambient air is drawn through the reservoir. Alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when heated air is drawn through the reservoir. Additionally or alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when the reservoir is heated and heated or ambient air is drawn through the reservoir. The reservoir may comprise a monolithic substrate. The reservoir may consist of a plurality of substrates, each arranged to allow air to be drawn therethrough, and each comprising one or both of a vapour precursor and the flavourant vapour precursor. The vapour precursor and/or the flavourant vapour precursor may be provided in spatially coterminous or spatially distinct regions of the reservoir.

The vapour delivery apparatus may comprise more than one passage for fluid (e.g. air) flow therethrough. Where more than one passage is present, one or more of the passages may be distinct, such that there is no intersection between the passages. One or more of the passages may comprise junctions or openings therebetween such that fluid within the passages can mix within the apparatus.

The passage through the reservoir may comprise one or more valves to control fluid flow. The valves may include one or more one-way valve to ensure fluid (i.e. air) can only flow through the passage in a desired direction. Further valves may be provided that may be operable to open and close the passage such that fluid is enabled to or prevented from flowing through the passage. More than one such valve may be linked such that the valves may be operated in combination or in synchronism with each other. A valve to open and close a passage may be controlled by mechanical means (i.e. the user moves the valve using a control lever or similar) or by electrical control (i.e. moved in response to a control signal from a processor or control system of the aerosol delivery apparatus). The passages may extend through (at least a portion of) the vapour delivery apparatus, between openings that may define an inlet and an outlet of a passage. Each inlet and outlet may be in fluid communication with only one passage, or a subset of the passages, or all the passages in the vapour delivery apparatus. The outlet or outlets may be at a mouthpiece of the vapour delivery apparatus. In this respect, a user may draw fluid (e.g. air) into and through a passage by inhaling at the outlet (i.e. using the mouthpiece).

The term “flavourant” is used to describe a compound or combination of compounds that provide flavour and/or aroma. For example, the flavourant may be configured to interact with a sensory receptor of a user (such as an olfactory or taste receptor). The flavourant may include one or more volatile substances.

The flavourant may be provided in solid or liquid form. The flavourant may be natural or synthetic. For example, the flavourant may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour. The flavourant may be evenly dispersed or may be provided in isolated locations and/or varying concentrations.

The first aerosol generator comprises an air-permeable substrate. This may comprise plant material. The plant material may comprise least one plant material selected from the list including Amaranthus dubius, Arctostaphylos uva-ursi (Bearberry), Argemone mexicana, Arnica, Artemisia vulgaris, Yellow Tees, Galea zacatechichi, Canavalia maritima (Baybean), Cecropia mexicana (Guamura), Oestrum noctumum, Cynoglossum virginianum (wild comfrey), Cytisus scoparius, Damiana, Entada rheedii, Eschscholzia califomica (California Poppy), Fittonia albivenis, Hippobroma longiflora, Humulus japonica (Japanese Hops), Humulus lupulus (Hops), Lactuca virosa (Lettuce Opium), Laggera alata, Leonotis leonurus, Leonurus cardiaca (Motherwort), Leonurus sibiricus (Honeyweed), Lobelia cardinalis, Lobelia inflata (Indian-tobacco), Lobelia siphilitica, Nepeta cataria (Catnip), Nicotiana species (Tobacco), Nymphaea alba (White Lily), Nymphaea caerulea (Blue Lily), Opium poppy, Passiflora incamata (Passionflower), Pedicularis densiflora (Indian Warrior), Pedicularis groenlandica (Elephant's Head), Salvia divinorum, Salvia dorrii (Tobacco Sage), Salvia species (Sage), Scutellaria galericulata, Scutellaria lateriflora, Scutellaria nana, Scutellaria species (Skullcap), Sida acuta (Wireweed), Sida rhombifolia, Silene capensis, Syzygium aromaticum (Clove), Tagetes lucida (Mexican Tarragon), Tarchonanthus camphoratus, Tumera diffusa (Damiana), Verbascum (Mullein), Zamia latifolia (Maconha Brava) together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

In some embodiments, the plant material is tobacco. Any type of tobacco may be used. This includes, but is not limited to, flue-cured tobacco, burley tobacco, Maryland Tobacco, dark-air cured tobacco, oriental tobacco, dark-fired tobacco, perique tobacco and rustica tobacco. This also includes blends of the above mentioned tobaccos.

Any suitable parts of the tobacco plant may be used. This includes leaves, stems, roots, bark, seeds and flowers. The tobacco may comprise one or more of leaf tobacco, stem tobacco, tobacco powder, tobacco dust, tobacco derivatives, expanded tobacco, homogenised tobacco, shredded tobacco, extruded tobacco, cut rag tobacco and/or reconstituted tobacco (e.g. slurry recon or paper recon).

The air-permeable substrate may comprise a gathered sheet of homogenised (e.g. paper/slurry recon) tobacco or gathered shreds/strips formed from such a sheet.

In some embodiments, the sheet used to form the aerosol-forming substrate has a grammage greater than or equal to 100 g/m², e.g. greater than or equal to 110 g/m² such as greater than or equal to 120 g/m².

The sheet may have a grammage of less than or equal to 300 g/m² e.g. less than or equal to 250 g/m² or less than or equal to 200 g/m².

The sheet may have a grammage of between 120 and 190 g/m².

The air-permeable substrate may comprise at least 50 wt% plant material, e.g. at least 60 wt% plant material e.g. around 65 wt% plant material. The air-permeable substrate may comprise 80 wt% or less plant material e.g. 75 or 70 wt% or less plant material.

The air-permeable substrate may comprise one or more additives selected from flavourants, fillers and binders.

Typically, the air-permeable substrate does not comprise a humectant. Humectants may be provided in heat not burn (HNB) tobacco charges. In such cases, humectants are provided as vapour generators, the generated vapour being used to help carry volatile active compounds and to increase visible vapour. Accordingly, it is preferred that the air-permeable substrate does not comprise one or more humectants such as polyhydric alcohols (e.g. propylene glycol (PG), triethylene glycol, 1 ,2-butane diol and vegetable glycerine (VG)) and their esters (e.g. glycerol mono-, di- or tri-acetate). If such humectants are present in the air-permeable substrate, they may be present at a low level, such as less than 0.5 wt%, more preferably less than 0.1 wt%.

Suitable binders are known in the art and may act to bind together the components forming the air- permeable substrate. Binders may comprise starches and/or cellulosic binders such as methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose and methyl cellulose, gums such as xanthan, guar, arabic and/or locust bean gum, organic acids and their salts such as alginic acid/ sodium alginate, agar and pectins.

Preferably the binder content is 5 to 10 wt% of the air-permeable substrate e.g. around 6 to 8 wt%. Suitable fillers are known in the art and may act to strengthen the air-permeable substrate. Fillers may comprise fibrous (non-tobacco) fillers such as cellulose fibres, lignocellulose fibres (e.g. wood fibres), jute fibres and combinations thereof.

Preferably, the filler content is 5 to 10 wt% of the aerosol-forming substrate e.g. around 6 to 9 wt%.

The air-permeable substrate may comprise an aqueous and/or non-aqueous solvent. In some embodiments, the air-permeable substrate has a water content of between 4 and 10 wt% e.g. between 6- 9 wt% such as between 7-9 wt%. Such low moisture content in the air-permeable substrate typically has the effect that, when the air-permeable substrate is exposed to heated air, there would typically not be produced a substantial visible vapour. It is to be noted that in one embodiment it is possible to use as the air-permeable substrate a low moisture tobacco material with its natural nicotine content. The natural nicotine content then meets the requirements of the active agent.

The air-permeable substrate may be at least partly circumscribed by a wrapping layer e.g. a paper wrapping layer. The wrapping layer may overlie an inner foil layer or may comprise a paper/foil laminate (with the foil innermost).

The plant material may comprise cannabis plant material including Cannabis sativa, Cannabis indica and Cannabis rudealis. The plant material may comprise Echinacea purpurea, Echinacea angustifolia, Acmella oleracea, Helichrysum umbraculigerum, or Radula marginata. This also includes blends of the above mentioned plant material.

In some embodiments, the cannabinoid-containing plant material is cannabis. The plant may be a traditional strain, or may be a strain bred or other modified (e.g. genetically) to produce certain levels of some cannabinoids compounds, e.g. low levels of THC or high levels of THC.

Any suitable parts of the cannabinoid-containing plant may be used. Thus the cannabinoid-containing plant material may comprise leaves, stems, roots, bark, seeds, buds and flowers (which may be cured).

Development E

[ME ref: 7631781 ; Nerudia ref: P01225]

In a general aspect of Development E, the present invention relates to a vapour delivery apparatus for timed constrained delivery of a vapour to a user drawing air through the apparatus.

According to a first preferred aspect of Development E there is provided a vapour delivery apparatus for the delivery of a vapour to a user drawing air through the apparatus, the apparatus comprising: an air inlet; an outlet; a first vapour generator disposed between the air inlet and the outlet, the vapour generator comprising a substrate containing an active ingredient, the vapour generator being configured to generate a vapour comprising the active ingredient for entrainment in an air flow between the air inlet and the outlet; a valve configured to control said air flow between the air inlet and the outlet; wherein the valve is operable by a user to adopt an open configuration and to remain in the open configuration for a predetermined period of time after operation of the valve and then adopting a closed configuration after the predetermined period of time.

According to a second preferred aspect of Development E, there is provided a method of operating a vapour delivery apparatus, the vapour delivery apparatus comprising: an air inlet; an outlet; a first vapour generator disposed between the air inlet and the outlet, the vapour generator comprising a substrate containing an active ingredient, the vapour generator being configured to generate a vapour comprising the active ingredient for entrainment in an air flow between the air inlet and the outlet, said air flow being driven by a user inhaling air through the vapour delivery apparatus; and a valve; wherein the method comprises the step of: the user operating the valve to control the air flow between the air inlet and the outlet, operation of the valve causing the valve to adopt an open configuration and then to remain in said open configuration for a predetermined period of time and then to adopt a closed configuration without further operation of the valve by the user.

In of Development E, the present invention provides an apparatus and method which aims to provide a time constraint indication for the use of a vapour delivery apparatus. The invention may therefore be used as a smoking cessation aid. At present, a user uses their vapour delivery apparatus because they have a craving which they need to satisfy. When a user is using a cigarette, a heat-not-burn consumable or a vapour system, there is considered to be a transition in use from a ‘need’ to a ‘habit’ during use. As the user begins to smoke or vape, their craving is often satisfied within the first 5 inhalations. However, the user continues to smoke or vape because habit is driving their hand to mouth action. With cigarettes and heat-not-burn sticks, the user is time-bound and the cigarette either burns out, or the device switches off. The present invention therefore preferably provides a time constraint indication for the delivery of a vapour to a user. The time constraint indication is provided by a valve which remains in an open configuration for a predetermined period of time after operation of the valve. The advantage of having such a valve is that the user may identify that their craving has been satisfied, and therefore may be more inclined to stop the vapour inhalation session. Thus, the invention improves upon prior vapour inhalation apparatus by relating the user experience back to more familiar smoking practices such as a cigarette.

In order to generate a vapour for inhalation, the apparatus comprises at least one volatile compound that is intended to be vaporised/aerosolised and that may provide the user with a recreational, wellness, nutritional, physiological and/or medicinal effect when inhaled. Such a volatile compound is referred to herein as an “active agent” or “active ingredient”. The active agent may be stored in a reservoir. The term reservoir refers to any suitable substrate in terms of chemical resistance and porosity for holding an evenly distributed volatile liquid such as nicotine or a flavourant. The term nicotine refers to any type of nicotine currently in use, in development or currently on the market. Examples include nicotine freebase, nicotine salts and derivatives of such. In the present invention, any active ingredient, applied to the reservoir in a suitable liquid format, could theoretically be used.

The active ingredient may comprise or consist of nicotine. However, in some embodiments, the active ingredient may not comprise nicotine, and may instead comprise or consist of one or more of a nutritional agent, or a pharmaceutical agent or a flavour agent.

Suitable active agents include the group consisting of: nicotine, cocaine, caffeine (anhydrous or salts thereof), vitamins, minerals, amino acids, plant or herbal concentrated extracts, sugars, opiates and opioids, cathine and cathinone, kavalactones, mysticin, beta-carboline alkaloids, salvinorin A, cannabinoids, phytocannabinoids, one or more flavourants, together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

Cannabinoid compounds include phyto-cannabinoids which include: cannabidiol (CBD) and its derivatives/homologues (e.g. cannabidiol mono(m)ethyl ether, cannabidivarin (CBDV), cannabidiorcol, cannabidiolic acid, cannabidivarinic acid); cannabinodiol (CBND) and its derivatives/homologues (e.g. carrabinodivarin); cannabigerol (CBG) and its derivatives/homologues (e.g. cannabigerol mono(m)ethyl ether, cannabinerolic acid A, cannabigerovarin, cannabigerolic acid A, cannabigerolic acid A mono(m)ethyl ether, cannabigerovarinic acid A); cannabinol (CBN) and its derivatives/homologues (e.g. cannabivarin/cannabivarol (CBV), cannabiorcol, cannabinolic acid, cannabinol (m)ethyl ester); tetrahydrocannabinol (THC) and its derivatives/homologues (e.g. tetrahydrocannabivarin (THCV), tetrahydrocannabiorcol, tetrahydrocannabinolic acid A/B, tetrahydrocannabivarinic acid A, tetrahydrocannabiorcolic acid A/B, isotetrahydrocannabinol, isotetrahydrocannabivarin); cannabicyclol (CBL) and its derivatives/homologues (e.g. cannabicyclolic acid, cannabicyclovarin); cannabichromene (CBC) and its derivatives/homologues (e.g. cannabichromenic acid A, cannabichromevarin (CBCV), cannabichromevarinic acid A); cannabielsoin (CBE) and its derivatives/homologues (e.g. cannabielsoic acid A/B, cannabiglendol, dehydrocannabifuran, cannabifuran); cannabicitran (CBT) and its derivatives/homologues; cannabitriol and its derivatives/homologues (e.g. ethyl cannabitriol, dihydroxy-tetrahydrocannabinol, cannabidiolic acid A cannabitriol ester, dihydroxy-hexahydrocannabinol (cannabiripsol), cannabitetrol, oxo-tetrahydrocannabinol); and cannabichromanone (CBCN) and its derivatives/homologues (e.g. cannabicoumaronone). In some embodiments, the cannabinoid compound is selected from at least one of cannabidiol (CBD) and its derivatives/homologues e.g. cannabiodiol-Cs (CBD-C5), cannabidiol-C4 (CBD-C4), cannabidiol mono(m)ethyl ether (CBDM-C5), cannabidivarin (CBDV-C3), cannabidiorcol (CBD-C1), cannabidiolic acid (CBDA-C5), cannabidivarinic acid (CBDVA-C3).

In some embodiments, the cannabinoid compound is selected from at least one of tetrahydrocannabinol (THC) and its derivatives/homologues, e.g. A⁹-tetrahydrocannabinol (A⁹-THC-C5 / c/s-A⁹-THC-C5), A⁸- tetrahydrocannabinol (A⁸-THC-C5), A⁸-tetrahydrocannabinolic acid A (A⁸-THCA-C5 A), A⁹- tetrahydrocannabinol-C4 (A⁹-THC-C4), A⁹-tetrahydrocannabivarin (A⁹-THCV-C3), A⁹- tetrahydrocannabiorcol (A⁹-THCO-Ci), A⁹-tetrahydrocannabinolic acid A (A⁹-THCA-C5A), A⁹- tetrahydrocannabinolic acid B (A⁹-THCA-C5 B), A⁹-tetrahydrocannabinolic acid-C4 A and/or B (A⁹-THCA- C4 A and/or B), A⁹-tetrahydrocannabivarinic acid A (A⁹-THCVA-C3 A), A⁹-tetrahydrocannabiorcolic acid A and/or B (A⁹-THCOA-Ci A and/or B), isotetrahydrocannabinol and isotetrahydrocannabivarin.

The total amount of cannabinoid compounds in the apparatus may be at least 200 mg; for example, it may be at least 250 mg, at least 300 mg, at least 400 mg, at least 500 mg. In some cases, lower amounts may be preferred. The total amount of cannabinoid compounds in the apparatus may therefore be at least 10 mg, at least 20 mg, at least 30 mg, at least 40 mg, at least 50 mg, at least 75 mg, at least 100 mg.

In some cases, it may be desirable to limit the total amount of cannabinoid compounds, which may be not more than 200 mg, not more than 175 mg, not more than 150 mg, not more than 125 mg, not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 10 mg. In some cases, the total amount of the cannabinoid compounds may be not more than 5 mg.

Where THC is included, either as one cannabinoid compound in a mixture or as the only cannabinoid, the total of amount of THC may be limited. In some cases, the total amount of THC in the substrate is not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 15 mg, not more than 10 mg, not more than 5 mg, not more than 3 mg. In some cases, the amount of THC may be 0.1 to 30 mg, for example 1 to 30 mg, for example 1 to 20 mg, for example 1 to 10 mg, for example 1 to 5 mg, for example 1 to 3 mg.

The substrate of the first vapour generator may comprise an air-permeable material. The air-permeable material may provide an equivalent resistance to draw to that of a conventional cigarette, which improves user satisfaction. An air-permeable substrate, storing the vapour precursor and/or the flavourant, may constitute the entirety of the reservoir. The air-permeable substrate may be impregnated with the vapour precursor and/or the flavourant vapour precursor. The substrate material may be a foamed polymer which will allow for airflow to pass through the substrate at a given pressure drop value, so as to provide a comfortable ‘draw’ sensation for the user. The substrate may be, for example, a sintered polyethylene or a polyethylene terephthalate (PET) foam. This air-permeable substrate may comprise plant material. The plant material may comprise least one plant material selected from the list including Amaranthus dubius, Arctostaphylos uva-ursi (Bearberry), Argemone mexicana, Arnica, Artemisia vulgaris, Yellow Tees, Galea zacatechichi, Canavalia maritima (Baybean), Cecropia mexicana (Guamura), Oestrum noctumum, Cynoglossum virginianum (wild comfrey), Cytisus scoparius, Damiana, Entada rheedii, Eschscholzia califomica (California Poppy), Fittonia albivenis, Hippobroma longiflora, Humulus japonica (Japanese Hops), Humulus lupulus (Hops), Lactuca virosa (Lettuce Opium), Laggera alata, Leonotis leonurus, Leonurus cardiaca (Motherwort), Leonurus sibiricus (Honeyweed), Lobelia cardinalis, Lobelia inflata (Indian-tobacco), Lobelia siphilitica, Nepeta cataria (Catnip), Nicotiana species (Tobacco), Nymphaea alba (White Lily), Nymphaea caerulea (Blue Lily), Opium poppy, Passiflora incamata (Passionflower), Pedicularis densiflora (Indian Warrior), Pedicularis groenlandica (Elephant's Head), Salvia divinorum, Salvia dorrii (Tobacco Sage), Salvia species (Sage), Scutellaria galericulata, Scutellaria lateriflora, Scutellaria nana, Scutellaria species (Skullcap), Sida acuta (Wireweed), Sida rhombifolia, Silene capensis, Syzygium aromaticum (Clove), Tagetes lucida (Mexican Tarragon), Tarchonanthus camphoratus, Tumera diffusa (Damiana), Verbascum (Mullein), Zamia latifolia (Maconha Brava) together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

In some embodiments, the plant material is tobacco. Any type of tobacco may be used. This includes, but is not limited to, flue-cured tobacco, burley tobacco, Maryland Tobacco, dark-air cured tobacco, oriental tobacco, dark-fired tobacco, perique tobacco and rustica tobacco. This also includes blends of the above mentioned tobaccos.

The tobacco may comprise one or more of leaf tobacco, stem tobacco, tobacco powder, tobacco dust, tobacco derivatives, expanded tobacco, homogenised tobacco, shredded tobacco, extruded tobacco, cut rag tobacco and/or reconstituted tobacco (e.g. slurry recon or paper recon). Any suitable parts of the tobacco plant may be used. This includes leaves, stems, roots, bark, seeds and flowers.

The substrate may be impregnated with nicotine via immersion in a liquid containing nicotine and a volatile carrier (for example a solution of nicotine in ethanol). The substrate may be immersed to evenly soak the substrate. Once removed and left to dry or baked in an oven, the carrier is evaporated and the nicotine is left evenly spread throughout the substrate.

The air-permeable substrate may comprise a gathered sheet of homogenised (e.g. paper/slurry recon) tobacco or gathered shreds/strips formed from such a sheet.

In some embodiments, the sheet used to form the aerosol-forming substrate has a grammage greater than or equal to 100 g/m², e.g. greater than or equal to 110 g/m² such as greater than or equal to 120 g/m². The sheet may have a grammage of less than or equal to 300 g/m² e.g. less than or equal to 250 g/m² or less than or equal to 200 g/m².

The sheet may have a grammage of between 120 and 190 g/m².

The air-permeable substrate may comprise at least 50 wt% plant material, e.g. at least 60 wt% plant material e.g. around 65 wt% plant material. The air-permeable substrate may comprise 80 wt% or less plant material e.g. 75 or 70 wt% or less plant material.

The plant material may comprise cannabis plant material including Cannabis sativa, Cannabis indica and Cannabis rudealis. The plant material may comprise Echinacea purpurea, Echinacea angustifolia, Acmella oleracea, Helichrysum umbraculigerum, or Radula marginata. This also includes blends of the above mentioned plant material.

In some embodiments, the cannabinoid-containing plant material is cannabis. The plant may be a traditional strain, or may be a strain bred or other modified (e.g. genetically) to produce certain levels of some cannabinoids compounds, e.g. low levels of THC or high levels of THC.

Any suitable parts of the cannabinoid-containing plant may be used. Thus the cannabinoid-containing plant material may comprise leaves, stems, roots, bark, seeds, buds and flowers (which may be cured). The air-permeable substrate may comprise one or more additives selected from flavourants, fillers and binders.

Typically, the air-permeable substrate does not comprise a humectant. Humectants may be provided in heat not burn (HNB) tobacco charges. In such cases, humectants are provided as vapour generators, the generated vapour being used to help carry volatile active compounds and to increase visible vapour. Accordingly, it is preferred that the air-permeable substrate does not comprise one or more humectants such as polyhydric alcohols (e.g. propylene glycol (PG), triethylene glycol, 1 ,2-butane diol and vegetable glycerine (VG)) and their esters (e.g. glycerol mono-, di- or tri-acetate). If such humectants are present in the air-permeable substrate, they may be present at a low level, such as less than 0.5 wt%, more preferably less than 0.1 wt%.

Suitable binders are known in the art and may act to bind together the components forming the air- permeable substrate. Binders may comprise starches and/or cellulosic binders such as methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose and methyl cellulose, gums such as xanthan, guar, arabic and/or locust bean gum, organic acids and their salts such as alginic acid/ sodium alginate, agar and pectins.

Preferably the binder content is 5 to 10 wt% of the air-permeable substrate e.g. around 6 to 8 wt%. Suitable fillers are known in the art and may act to strengthen the air-permeable substrate. Fillers may comprise fibrous (non-tobacco) fillers such as cellulose fibres, lignocellulose fibres (e.g. wood fibres), jute fibres and combinations thereof.

Preferably, the filler content is 5 to 10 wt% of the aerosol-forming substrate e.g. around 6 to 9 wt%. The air-permeable substrate may comprise an aqueous and/or non-aqueous solvent. In some embodiments, the air-permeable substrate has a water content of between 4 and 10 wt% e.g. between 6- 9 wt% such as between 7-9 wt%. Such low moisture content in the air-permeable substrate typically has the effect that, when the air-permeable substrate is exposed to heated air, there would typically not be produced a substantial visible vapour. It is to be noted that in one embodiment it is possible to use as the air-permeable substrate a low moisture tobacco material with its natural nicotine content. The natural nicotine content then meets the requirements of the active agent.

The air-permeable substrate may be at least partly circumscribed by a wrapping layer e.g. a paper wrapping layer. The wrapping layer may overlie an inner foil layer or may comprise a paper/foil laminate (with the foil innermost).

The vapour delivery apparatus typically comprises a reservoir configured to store a vapour precursor. The vapour precursor may be formulated so as to produce a non-visible or substantially non-visible vapour. The vapour precursor may comprise a base liquid. The vapour precursor may additionally comprise nicotine. The vapour precursor may be an e-liquid. The vapour precursor may consist substantially of nicotine or a nicotine compound. The vapour precursor may further comprise a flavourant. Alternatively, the vapour precursor may be substantially flavourless. That is, the vapour precursor may not contain any deliberately added additional flavourant. A flavourant may be provided as a separate flavourant vapour precursor, such that the vapour precursor and flavourant vapour precursor may be separately vaporised to form a vapour comprising both the vapour precursor and the flavourant vapour precursor.

The vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when ambient air is drawn through the reservoir. Alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when heated air is drawn through the reservoir. Additionally or alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when the reservoir is heated or ambient air is drawn through the reservoir. The reservoir may comprise a monolithic substrate. The reservoir may consist of a plurality of substrates, each arranged to allow air to be drawn therethrough, and each comprising one or both of a vapour precursor and the flavourant vapour precursor. The vapour precursor and/or the flavourant vapour precursor may be provided in spatially coterminous or spatially distinct regions of the reservoir.

Passages may extend through (at least a portion of) the vapour delivery apparatus, between openings that may define an inlet and an outlet of a passage. Each inlet and outlet may be in fluid communication with only one passage, or a subset of the passages, or all the passages in the vapour delivery apparatus. The outlet or outlets may be at a mouthpiece of the apparatus. In this respect, a user may draw fluid (e.g. air) into and through a passage by inhaling at the outlet (i.e. using the mouthpiece).

In use, air flows through the air inlet, through the first vapour generator, and through the valve when the valve is in the open configuration, to deliver air comprising an active ingredient to the user inhaling at the outlet of the apparatus. In a pre-use state, the apparatus may be sealed at the air inlet and the outlet to prevent the escape of any active ingredient particles.

The valve utilised in the present invention is configured to control the air flow between the air inlet and the outlet. The valve advantageously has an arrangement whereby an open configuration is adopted on operation of the valve, the open configuration being retained for a predetermined period of time thereafter. Therefore, the valve may adopt an open configuration when the valve has been activated, and the valve may automatically adopt a closed configuration after a predetermined time period. The predetermined time period in which the valve is in an open configuration is intended to be set such that the user can inhale enough of the active ingredient stored in the vapour generator during the predetermined time period for their craving to be satisfied. The closing of the valve after the predetermined time period means that the user receives a cue that the smoking session has finished, and therefore the user is discouraged from further using the apparatus after the session has finished. Thus, the apparatus may be used as a smoking cessation product.

The user may deform the shape of the valve in order to operate the valve by applying a force to the valve. The user may then release the force on the valve, the valve then remains in a deformed shape and thereby in the open configuration for a predetermined period of time. The valve may then recover from its deformed shape back to a non-deformed shape to adopt a closed configuration. The user may then inhale on the vapour delivery apparatus and receive a vapour comprising at least said active ingredient during the predetermined period of time.

The valve may comprise an elastomeric material. An elastomeric material has the ability to be deformed, and then elastically spring back to its original form. Therefore, a user may deform the elastomeric material of the valve to operate the valve. After the user has deformed the valve, the valve automatically adopts an open configuration for a predetermined period of time whilst the valve elastically returns to its original form. The user can inhale on the vapour delivery apparatus and receive a vapour comprising at least an active ingredient during the predetermined period of time. After the predetermined period of time has elapsed, the valve returns to its original form, and therefore vapour comprising the active ingredient cannot reach the user when they draw on the apparatus. The user only receives a vapour comprising an active ingredient when they inhale on the vapour delivery apparatus during the predetermined period of time.

The valve comprising elastomeric material may be operated by, for example, undergoing compressive deformation. In this case, the user may compress the valve, and the valve may automatically adopt an open configuration for a predetermined period of time whilst the valve expands to its original size and shape. The valve adopts a closed configuration once the valve has expanded to its original size and shape. When the user wishes to inhale more active ingredient at a later time, the user may again compress the elastomeric material of the valve to operate the valve.

Alternatively, the valve comprising elastomeric material may be operated by, for example, undergoing a tensile deformation. In this case, the user may elongate or stretch the valve, and the valve may automatically adopt an open configuration for a predetermined period of time whilst the valve contracts back to its original size and shape. When the user wishes to inhale more active ingredient at a later time, the user may again stretch the elastomeric material of the valve to operate the valve.

An advantage of having a valve comprising an elastomeric material is that the user may only need to provide a force, e.g. a compressive or tensile force, for the valve to be activated, and the user does not need to provide any further force for the valve to enter an open and closed configuration. The elastomeric material allows the valve to recover to its original size and shape after operation of the valve, thereby closing the air channel between the air inlet and the outlet. The action of the valve opening and closing is therefore an automatic movement. A further advantage of having a valve comprising an elastomeric material is that it provides a simple way of providing time constrained delivery of active ingredient to the user. The user is therefore restricted in how long they can use the device and therefore how much active ingredient they inhale. Therefore the device can be used as a smoking cessation aid.

The whole or part of the valve may comprise an elastomeric material. The elastomeric material may be a foamed polymer material, such as polyurethane. Foamed polymer materials are particularly effective at returning to their original size and shape with a slow recovery rate, which therefore provides enough time for a user to have several inhalations of active ingredient.

The first vapour generator may be disposed upstream of the valve. The valve can therefore control the flow of air comprising the active ingredient to the user. In a closed configuration, the valve stops the flow of air comprising the active ingredient to the user. In an open configuration, after the valve has been activated, an air flow is allowed to pass through the valve, and so air comprising the active ingredient can reach the user on inhalation.

Additionally or alternatively, the passage through the reservoir may comprise one or more valves to control fluid flow through the reservoir. The valves may include one or more one-way valves to ensure fluid (i.e. air) can only flow through the passage in a desired direction. Further valves may be provided that may be operable to open and close the passage such that fluid is enabled to or prevented from flowing through the passage. More than one such valve may be linked such that the valves may be operated in combination or in synchronism with each other. A valve to open and close a passage may be controlled by mechanical means (i.e. the user moves the valve using a control lever or similar) or by electrical control (i.e. moved in response to a control signal from a processor or control system of the aerosol delivery apparatus). Preferably the apparatus further comprises a deformable housing region comprising an elastomeric material, the deformable housing region being positioned in the apparatus to enable the user to operate the valve via the deformable housing region. The deformable housing region can therefore return to its original size and shape after the valve is activated. The deformable housing region therefore provides a simple, and easy to use system which allows manual control over the activation of the valve. A user can deform the deformable housing region, by for example compressing or stretching the deformable housing region so that, in turn, it deforms the valve and therefore operates the valve. After operation of the valve, the deformable housing region initially inhibits the flow of air from the vapour generator to the outlet. The deformable housing region may form a part of, or a whole of, a housing of the apparatus. If the deformable housing region forms a part of the housing, the deformable housing region is preferably disposed in proximity to the valve such that when a user deforms the deformable housing region, the valve is also deformed and the valve is operated. For example, the deformable housing region may be in the form of a cover which surrounds the valve. Alternatively, the deformable housing region may be in the form of a button which a user can press to operate the valve.

The housing of the apparatus may be elongate such that it provides a substantially straight airflow path through the apparatus, from the air inlet to the outlet. For example, the housing may be in the shape of a cylinder, a cuboid or a prism. Alternatively, the housing may be irregular in shape.

The elastomeric material of the deformable housing region may have a faster elastic return rate than the elastomeric material of the valve. The elastic return rate is defined as the time taken for the elastomeric material to return to its original position. For the deformable housing region, the original position is when the deformable housing region is in a non-deformed state. For the valve, the original position is when the valve is in a non-deformed state, such that the valve is in a closed configuration. If the elastomeric material of the deformable housing region has a faster elastic return rate than the elastic return rate of the elastomeric material of the valve, then an air passage forms between the air inlet and the outlet, and the user can receive an active ingredient when drawing on the apparatus. If there is a significant difference between the elastic return rate of the deformable housing region and the valve, the air passage is open for a longer period of time than if the elastic return rates of the deformable housing region and the valve are similar. The elastomeric material for the valve may therefore be chosen to provide enough time for a user to receive enough active ingredient to stop their craving. For example, to provide a predetermined time period for inhalation of 3 minutes, the elastic return rate of the deformable housing may be 1 second, and the elastic return rate of the valve may be approximately 3 minutes. Alternatively, the elastic return rate of the deformable housing may be 2, 3, 4, 5, 6, 7, 8, 9 or 10 seconds and the elastic return rate of the valve may be 3, 4, 5, 6, 7 or 8 minutes. Preferably, the deformable housing region instantaneously returns to its original position after it has been deformed and released.

Preferably, the apparatus comprises a second vapour generator comprising a substrate containing an active ingredient and / or a flavourant. Having a substrate containing an active ingredient means that a user may receive an active ingredient from both the first vapour generator and the second vapour generator, therefore increasing the dose of active ingredient. This may mean that the predetermined period of time that the valve is open can be reduced because the user’s craving will have stopped earlier. The active ingredient may be dosed accordingly to release greater than 50%, preferably greater than 95%, into the airflow during a single session. Having a substrate containing a flavourant allows the user to receive a flavour in addition to the active ingredient supplied by the first vapour generator. Example flavourants may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour.

The term “flavourant” is used to describe a compound or combination of compounds that provide flavour and/or aroma. For example, the flavourant may be configured to interact with a sensory receptor of a user (such as an olfactory or taste receptor). The flavourant may include one or more volatile substances.

The flavourant may be provided in solid or liquid form. The flavourant may be natural or synthetic. For example, the flavourant may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour. The flavourant may be evenly dispersed or may be provided in isolated locations and/or varying concentrations. The presence of flavourant within the vapour helps to mitigate the harsh throat hit sensation the user is exposed to with a pure nicotine delivery system. The level of flavour may change during use, or disappear completely which can be used as a cue that the session is effectively over.

Like the first vapour generator, the substrate of the second vapour generator may comprise an air- permeable material. The air-permeable substrate, storing the vapour precursor and/or the flavourant, may constitute the entirety of a second vapour generator reservoir. The air-permeable material may provide an equivalent resistance to draw to that of a conventional cigarette, which improves user satisfaction. Alternatively, the reservoir may feature a single or multiple hollow bores through which the active ingredient is drawn into the airflow by a generated venturi action.

The second vapour generator may be disposed upstream of the valve. This advantageously allows a flavour supplied by the second vapour generator to be ‘switched off’ by the expansion or closing of the valve. Thus, both the flavour and the active ingredient will not be delivered to the user when the valve is in a closed configuration. This allows for delivery of a flavour in a more advanced way, improving user experience whilst satisfying a craving.

Alternatively, the second vapour generator may be disposed downstream of the valve and the apparatus may further comprise an auxiliary air inlet, the auxiliary air inlet being disposed downstream of the valve and the upstream of the second vapour generator. Thus, the vapour delivery apparatus may comprise more than one passage for fluid (e.g. air) flow therethrough. Where more than one passage is present, one or more of the passages may be distinct, such that there is no intersection between the passages. One or more of the passages may comprise junctions or openings therebetween such that fluid within the passages can mix within the apparatus. The arrangement of having an auxiliary air inlet disposed downstream of the valve and upstream of the second vapour generator allows air to flow through the auxiliary air inlet, and through the second vapour generator to deliver either an active ingredient or a flavour to the user. If the second vapour generator comprises an active ingredient and the auxiliary air inlet is disposed downstream of the valve and upstream of the second vapour generator, a user can receive the active ingredient regardless of whether the valve is in an open or closed configuration. However, the user may receive a lower dose of the active ingredient from air that has passed through the auxiliary air inlet, compared to the air inlet, because there may be less airflow through the auxiliary air inlet compared to the air inlet. Therefore, the user can only receive a higher dose of the active ingredient after the valve has been activated and air can flow from the air inlet. If the reservoir region comprises a flavourant and the auxiliary air inlet is positioned between the valve and the second vapour generator, the user only receives a flavour when the valve is in a closed configuration.

Preferably, the opening area of the auxiliary air inlet is smaller than the opening area of the air inlet to allow a small volume of air to flow in upstream from the reservoir region. This auxiliary air inlet creates a higher pressure drop and an unpleasant sensation for the user, helping to enforce the designated end of the session. Once the valve is opened, the combination of inlet size, valve state and reservoir porosity will create an overall pressure drop which is comfortable for the user. The opening area of the auxiliary air inlet and / or the air inlet may be regular, for example circular or hexagonal or the opening area may be irregular in shape.

The predetermined period of time may be between 3 and 5 minutes, similar to the length of use of a typical cigarette or HNB consumable. Preferably, the predetermined period of time may be 4 minutes. However, it is possible that the predetermined period of time may be more than 5 minutes, for example, it may be 6, 7, or 8 minutes to provide a suitable inhalation session which is dependent on the active ingredient in use. Alternatively, the predetermined period of time may be measured by the number of inhalations. For example, the predetermined period of time may be 5 inhalations. This is because a user’s craving is often satisfied within the first 5 inhalations. This means that the user does not unnecessarily continue to inhale the active ingredient beyond their need. Alternatively, the predetermined period of time may be 3, 4, 6, 7, 8, 9 or 10 inhalations. The elastic return rate of the valve can be configured to deliver particular session lengths (or a predetermined period of time) depending on the active ingredient in use.

The end of the predetermined time period may be signalled by the valve fully expanding back to its original size and shape, so that it seals off the air flow from the first vapour generator and any further upstream vapour generators.

The apparatus may comprise a third vapour generator. The third vapour generator may comprise an active ingredient and / or a flavourant. The third vapour generator may be disposed either upstream or downstream of the valve. The apparatus may be disposable. Since the apparatus preferably does not include an electrically powered heater, or any other electrical components, the apparatus can be disposed of easily.

[ME ref: 7661846; Nerudia ref: P01282]

In a first aspect of Development F, the present invention provides a system for delivering an active ingredient to a user, the system comprising: a substrate housing; a heat source housing, wherein the substrate housing and heat source housing are configured to be removably attachable to form the system, the substrate housing comprising a substrate loaded with a source of active ingredient for generating a vapour for inhalation by a user, the heat source housing comprising a heat source for thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, the system further comprising an air inlet and an outlet and an air flow path between the air inlet and the outlet for conveying the active ingredient to the user, wherein the system is configurable to control access of air to the heat source and thereby to control the generation of heat by the heat source, wherein the heat source housing comprises a reservoir wall enclosing the substance and defining an air ingress port and a cover portion movable with respect to the reservoir wall selectively to uncover the air ingress port to expose the substance to the air.

In a second aspect of Development F, the present invention provides a heat source housing for providing heat to a system for delivering an active ingredient to a user, the heat source housing being configured to be removably attachable to a substrate housing to form the system, the heat source housing comprising a heat source for thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, the heat source housing comprising an air inlet and an outlet and an air flow path between the air inlet and the outlet, wherein the heat source housing is configurable to control access of air to the heat source and thereby to control the generation of heat by the heat source, wherein the heat source housing comprises a reservoir wall enclosing the substance and defining an air ingress port and a cover portion movable with respect to the reservoir wall selectively to uncover the air ingress port to expose the substance to the air. In a third aspect of Development F, the present invention provides a method of operating a system for delivering an active ingredient to a user, the system comprising: a substrate housing; a heat source housing, the substrate housing comprising a substrate loaded with a source of active ingredient for generating a vapour for inhalation by a user, the heat source housing comprising a heat source for thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, wherein the heat source housing comprises a reservoir wall enclosing the substance and defining an air ingress port and a cover portion movable with respect to the reservoir wall selectively to uncover the air ingress port to expose the substance to the air, the system further comprising an air inlet and an outlet and an air flow path between the air inlet and the outlet for conveying the active ingredient to the user, the method including the steps: attaching the substrate housing and heat source housing to form the system, and controlling access of air to the heat source and thereby to control the generation of heat by the heat source by moving the cover portion with respect to the reservoir wall selectively to uncover the air ingress port to expose the substance to the air.

In Development F, the present invention therefore allows the substrate to be heated by the exothermic reaction and for the delivery of active ingredient to the user to be improved by virtue of the heating of the substrate, while avoiding the need for electrical power to heat the substrate.

Optional features of the invention will now be set out. These are applicable singly or in any combination with any development or aspect of the invention, unless the context demands otherwise.

When the system is assembled, the heat source may be disposed axially adjacent the substrate. In this configuration, the heat source may be upstream of the substrate in the system. In addition to heat conducted directly from the heat source to the substrate, there may also be heat transfer via heating of air passing the heat source and on to the substrate.

The substrate may include an air flow passage. The air flow passage may, for example, be formed substantially centrally through the substrate. Considering an air flow path through the apparatus, the air flow passage is typically aligned with the air flow path.

When the system is assembled, the substrate, heat source and the air flow passage may be coaxial.

The substrate may be formed of air-permeable material. This permits some air flow through the substrate. This may enhance the removal of the active ingredient into the air flow as a vapour. An air-impermeable barrier may be provided between the heat source and the substrate. This is preferred in order to prevent ingress of air into the heat source before it is required.

The reservoir wall may include an air-permeable layer portion at the air ingress port, to retain exothermic reaction substance within the heat source. The air-permeable layer may for example be a mesh or a perforated layer.

The substrate housing may be configured to be single use disposable. The heat source housing may be configured to be re-usable. In this manner, the user may assemble a system, use the system to deliver an active ingredient, then detach the heat source housing from the used substrate housing and dispose of the substrate housing. The used heat source housing may still contain useful exothermic reaction substrate. Therefore the used heat source housing may be attached to a fresh substrate housing to form a new system for delivery of active ingredient.

The cover portion may be moved with respect to the reservoir wall to cover the air ingress port to prevent further ingress of air into the heat source. This allows the user to slow down or stop the exothermic reaction in the heat source. This could be to allow later use of the same system, or detachment of the heat source housing from the used substrate housing, as described above.

In use, the heat source typically heats at least part of the substrate to a temperature of at least 35°C. More preferably, this temperature is at least 40°C and may be at least 45°C. Furthermore, in use, the heat source may heat the substrate so that no part of the substrate is at a temperature greater than 80°C. More preferably, this temperature is not more than 75°C, not more than 70°C, not more than 65°C or not more than 60°C. It is considered that within these temperature ranges, the advantageous effects of the invention are best seen in terms of the promotion of the delivery of the active ingredient in a user- and regulation-acceptable manner.

In some embodiments, the vapour delivery apparatus is a smoking substitute apparatus. In such embodiments, the active ingredient may comprise or consist of nicotine.

Preferably, the apparatus does not include an electrically powered heater.

In order to generate a vapour for inhalation, the apparatus comprises at least one volatile compound that is intended to be vaporised/aerosolised and that may provide the user with a recreational, wellness, nutritional, physiological and/or medicinal effect when inhaled. Such a volatile compound is referred to herein as an “active agent” or “active ingredient”. The active agent may be stored in a reservoir, described later.

The active ingredient may comprise or consist of nicotine. However, in some embodiments, the active ingredient may not comprise nicotine, and may instead comprise or consist of one or more of a nutritional agent, a pharmaceutical agent or a flavour agent. Suitable active agents include the group consisting of: nicotine, cocaine, caffeine (anhydrous or salts thereof), vitamins, minerals, amino acids, plant or herbal concentrated extracts, sugars, opiates and opioids, cathine and cathinone, kavalactones, mysticin, beta-carboline alkaloids, salvinorin A, cannabinoids, phytocannabinoids, one or more flavourants, together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

Example flavourants may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour.

Cannabinoid compounds include phyto-cannabinoids which include: cannabidiol (CBD) and its derivatives/homologues (e.g. cannabidiol mono(m)ethyl ether, cannabidivarin (CBDV), cannabidiorcol, cannabidiolic acid, cannabidivarinic acid); cannabinodiol (CBND) and its derivatives/homologues (e.g. carrabinodivarin); cannabigerol (CBG) and its derivatives/homologues (e.g. cannabigerol mono(m)ethyl ether, cannabinerolic acid A, cannabigerovarin, cannabigerolic acid A, cannabigerolic acid A mono(m)ethyl ether, cannabigerovarinic acid A); cannabinol (CBN) and its derivatives/homologues (e.g. cannabivarin/cannabivarol (CBV), cannabiorcol, cannabinolic acid, cannabinol (m)ethyl ester); tetrahydrocannabinol (THC) and its derivatives/homologues (e.g. tetrahydrocannabivarin (THCV), tetrahydrocannabiorcol, tetrahydrocannabinolic acid A/B, tetrahydrocannabivarinic acid A, tetrahydrocannabiorcolic acid A/B, isotetrahydrocannabinol, isotetrahydrocannabivarin); cannabicyclol (CBL) and its derivatives/homologues (e.g. cannabicyclolic acid, cannabicyclovarin); cannabichromene (CBC) and its derivatives/homologues (e.g. cannabichromenic acid A, cannabichromevarin (CBCV), cannabichromevarinic acid A); cannabielsoin (CBE) and its derivatives/homologues (e.g. cannabielsoic acid A/B, cannabiglendol, dehydrocannabifuran, cannabifuran); cannabicitran (CBT) and its derivatives/homologues; cannabitriol and its derivatives/homologues (e.g. ethyl cannabitriol, dihydroxy-tetrahydrocannabinol, cannabidiolic acid A cannabitriol ester, dihydroxy-hexahydrocannabinol (cannabiripsol), cannabitetrol, oxo-tetrahydrocannabinol); and cannabichromanone (CBCN) and its derivatives/homologues (e.g. cannabicoumaronone).

In some embodiments, the cannabinoid compound is selected from at least one of cannabidiol (CBD) and its derivatives/homologues e.g. cannabiodiol-Cs (CBD-C5), cannabidiol-C4 (CBD-C4), cannabidiol mono(m)ethyl ether (CBDM-C5), cannabidivarin (CBDV-C3), cannabidiorcol (CBD-C1), cannabidiolic acid (CBDA-C5), cannabidivarinic acid (CBDVA-C3).

In some embodiments, the cannabinoid compound is selected from at least one of tetrahydrocannabinol (THC) and its derivatives/homologues, e.g. A⁹-tetrahydrocannabinol (A⁹-THC-C5 / c/s-A⁹-THC-C5), A⁸- tetrahydrocannabinol (A⁸-THC-C5), A⁸-tetrahydrocannabinolic acid A (A⁸-THCA-C5 A), A⁹- tetrahydrocannabinol-C4 (A⁹-THC-C4), A⁹-tetrahydrocannabivarin (A⁹-THCV-C3), A⁹- tetrahydrocannabiorcol (A⁹-THCO-Ci), A⁹-tetrahydrocannabinolic acid A (A⁹-THCA-C5A), A⁹- tetrahydrocannabinolic acid B (A⁹-THCA-C5 B), A⁹-tetrahydrocannabinolic acid-C4 A and/or B (A⁹-THCA- C4 A and/or B), A⁹-tetrahydrocannabivarinic acid A (A⁹-THCVA-C3 A), A⁹-tetrahydrocannabiorcolic acid A and/or B (A⁹-THCOA-Ci A and/or B), isotetrahydrocannabinol and isotetrahydrocannabivarin.

The total amount of cannabinoid compounds in the apparatus may be at least 200 mg; for example, it may be at least 250 mg, at least 300 mg, at least 400 mg, at least 500 mg. In some cases, lower amounts may be preferred. The total amount of cannabinoid compounds in the apparatus may therefore be at least 10 mg, at least 20 mg, at least 30 mg, at least 40 mg, at least 50 mg, at least 75 mg, at least 100 mg.

In some cases, it may be desirable to limited the total amount of cannabinoid compounds, which may be not more than 200 mg, not more than 175 mg, not more than 150 mg, not more than 125 mg, not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 10 mg. In some cases, the total amount of the cannabinoid compounds may be not more than 5 mg.

Where THC is included, either as one cannabinoid compound in a mixture or as the only cannabinoid, the total of amount of THC may be limited. In some cases, the total amount of THC in the substrate is not more than 100 mg, not more than 75 mg, not more than 50 mg, not more than 40 mg, not more than 30 mg, not more than 20 mg, not more than 15 mg, not more than 10 mg, not more than 5 mg, not more than 3 mg. In some cases, the amount of THC may be 0.1 to 30 mg, for example 1 to 30 mg, for example 1 to 20 mg, for example 1 to 10 mg, for example 1 to 5 mg, for example 1 to 3 mg.

The vapour delivery apparatus typically comprises a reservoir configured to store a vapour precursor. The vapour precursor may be formulated so as to produce a non-visible or substantially non-visible vapour. The vapour precursor may comprise a base liquid. The vapour precursor may additionally comprise nicotine. The vapour precursor may be an e-liquid. The vapour precursor may consist substantially of nicotine or a nicotine compound. The vapour precursor may further comprise a flavourant. Alternatively, the vapour precursor may be substantially flavourless. That is, the vapour precursor may not contain any deliberately added additional flavourant. A flavourant may be provided as a separate flavourant vapour precursor, such that the vapour precursor and flavourant vapour precursor may be separately vaporised to form a vapour comprising both the vapour precursor and the flavourant vapour precursor.

A substrate (optionally an air-permeable substrate), storing the vapour precursor and/or the flavourant, may constitute the entirety of the reservoir. The air-permeable substrate may be impregnated with the vapour precursor and/or the flavourant vapour precursor. The substrate material may be a foamed polymer which will allow for airflow to pass through the substrate at a given pressure drop value, so as to provide a comfortable ‘draw’ sensation for the user. The substrate may be, for example, a sintered polyethylene or a PET foam. The substrate may be impregnated with nicotine via immersion in a liquid containing nicotine and a volatile carrier (for example a solution of nicotine in ethanol). The substrate may be immersed to evenly soak the substrate. Once removed and left to dry or baked in an oven, the carrier is evaporated and the nicotine is left evenly spread throughout the substrate.

The vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when ambient air is drawn through the reservoir. Alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when heated air is drawn through the reservoir. Additionally or alternatively, the vapour precursor and/or the flavourant vapour precursor may be formulated to form a vapour when the reservoir is heated and heated or ambient air is drawn through the reservoir. The reservoir may comprise a monolithic substrate. The reservoir may consist of a plurality of substrates, each arranged to allow air to be drawn therethrough, and each comprising one or both of a vapour precursor and the flavourant vapour precursor. The vapour precursor and/or the flavourant vapour precursor may be provided in spatially coterminous or spatially distinct regions of the reservoir.

The vapour delivery apparatus may comprise more than one passage for fluid (e.g. air) flow therethrough. Where more than one passage is present, one or more of the passages may be distinct, such that there is no intersection between the passages. One or more of the passages may comprise junctions or openings therebetween such that fluid within the passages can mix within the apparatus.

The passage through the reservoir may comprise one or more valves to control fluid flow. The valves may include one or more one-way valve to ensure fluid (i.e. air) can only flow through the passage in a desired direction. Further valves may be provided that may be operable to open and close the passage such that fluid is enabled to or prevented from flowing through the passage. More than one such valve may be linked such that the valves may be operated in combination or in synchronism with each other. A valve to open and close a passage may be controlled by mechanical means (i.e. the user moves the valve using a control lever or similar) or by electrical control (i.e. moved in response to a control signal from a processor or control system of the aerosol delivery apparatus).

The passages may extend through (at least a portion of) the vapour delivery apparatus, between openings that may define an inlet and an outlet of a passage. Each inlet and outlet may be in fluid communication with only one passage, or a subset of the passages, or all the passages in the vapour delivery apparatus. The outlet or outlets may be at a mouthpiece of the vapour delivery apparatus. In this respect, a user may draw fluid (e.g. air) into and through a passage by inhaling at the outlet (i.e. using the mouthpiece).

The term “flavourant” is used to describe a compound or combination of compounds that provide flavour and/or aroma. For example, the flavourant may be configured to interact with a sensory receptor of a user (such as an olfactory or taste receptor). The flavourant may include one or more volatile substances. The flavourant may be provided in solid or liquid form. The flavourant may be natural or synthetic. For example, the flavourant may include menthol, liquorice, chocolate, fruit flavour (including e.g. citrus, cherry etc.), vanilla, spice (e.g. ginger, cinnamon) and tobacco flavour. The flavourant may be evenly dispersed or may be provided in isolated locations and/or varying concentrations.

The first aerosol generator comprises an air-permeable substrate. This may comprise plant material. The plant material may comprise least one plant material selected from the list including Amaranthus dubius, Arctostaphylos uva-ursi (Bearberry), Argemone mexicana, Arnica, Artemisia vulgaris, Yellow Tees, Galea zacatechichi, Canavalia maritima (Baybean), Cecropia mexicana (Guamura), Oestrum noctumum, Cynoglossum virginianum (wild comfrey), Cytisus scoparius, Damiana, Entada rheedii, Eschscholzia califomica (California Poppy), Fittonia albivenis, Hippobroma longiflora, Humulus japonica (Japanese Hops), Humulus lupulus (Hops), Lactuca virosa (Lettuce Opium), Laggera alata, Leonotis leonurus, Leonurus cardiaca (Motherwort), Leonurus sibiricus (Honeyweed), Lobelia cardinalis, Lobelia inflata (Indian-tobacco), Lobelia siphilitica, Nepeta cataria (Catnip), Nicotiana species (Tobacco), Nymphaea alba (White Lily), Nymphaea caerulea (Blue Lily), Opium poppy, Passiflora incamata (Passionflower), Pedicularis densiflora (Indian Warrior), Pedicularis groenlandica (Elephant's Head), Salvia divinorum, Salvia dorrii (Tobacco Sage), Salvia species (Sage), Scutellaria galericulata, Scutellaria lateriflora, Scutellaria nana, Scutellaria species (Skullcap), Sida acuta (Wireweed), Sida rhombifolia, Silene capensis, Syzygium aromaticum (Clove), Tagetes lucida (Mexican Tarragon), Tarchonanthus camphoratus, Tumera diffusa (Damiana), Verbascum (Mullein), Zamia latifolia (Maconha Brava) together with any combinations, functional equivalents to, and/or synthetic alternatives of the foregoing.

In some embodiments, the plant material is tobacco. Any type of tobacco may be used. This includes, but is not limited to, flue-cured tobacco, burley tobacco, Maryland Tobacco, dark-air cured tobacco, oriental tobacco, dark-fired tobacco, perique tobacco and rustica tobacco. This also includes blends of the above mentioned tobaccos.

Any suitable parts of the tobacco plant may be used. This includes leaves, stems, roots, bark, seeds and flowers.

The tobacco may comprise one or more of leaf tobacco, stem tobacco, tobacco powder, tobacco dust, tobacco derivatives, expanded tobacco, homogenised tobacco, shredded tobacco, extruded tobacco, cut rag tobacco and/or reconstituted tobacco (e.g. slurry recon or paper recon).

The air-permeable substrate may comprise a gathered sheet of homogenised (e.g. paper/slurry recon) tobacco or gathered shreds/strips formed from such a sheet.

In some embodiments, the sheet used to form the aerosol-forming substrate has a grammage greater than or equal to 100 g/m², e.g. greater than or equal to 110 g/m² such as greater than or equal to 120 g/m².

The sheet may have a grammage of less than or equal to 300 g/m² e.g. less than or equal to 250 g/m² or less than or equal to 200 g/m². The sheet may have a grammage of between 120 and 190 g/m².

The air-permeable substrate may comprise at least 50 wt% plant material, e.g. at least 60 wt% plant material e.g. around 65 wt% plant material. The air-permeable substrate may comprise 80 wt% or less plant material e.g. 75 or 70 wt% or less plant material.

The air-permeable substrate may comprise one or more additives selected from flavourants, fillers and binders.

Typically, the air-permeable substrate does not comprise a humectant. Humectants may be provided in heat not burn (HNB) tobacco charges. In such cases, humectants are provided as vapour generators, the generated vapour being used to help carry volatile active compounds and to increase visible vapour. Accordingly, it is preferred that the air-permeable substrate does not comprise one or more humectants such as polyhydric alcohols (e.g. propylene glycol (PG), triethylene glycol, 1 ,2-butane diol and vegetable glycerine (VG)) and their esters (e.g. glycerol mono-, di- or tri-acetate). If such humectants are present in the air-permeable substrate, they may be present at a low level, such as less than 0.5 wt%, more preferably less than 0.1 wt%.

Suitable binders are known in the art and may act to bind together the components forming the air- permeable substrate. Binders may comprise starches and/or cellulosic binders such as methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose and methyl cellulose, gums such as xanthan, guar, arabic and/or locust bean gum, organic acids and their salts such as alginic acid/ sodium alginate, agar and pectins.

Preferably the binder content is 5 to 10 wt% of the air-permeable substrate e.g. around 6 to 8 wt%. Suitable fillers are known in the art and may act to strengthen the air-permeable substrate. Fillers may comprise fibrous (non-tobacco) fillers such as cellulose fibres, lignocellulose fibres (e.g. wood fibres), jute fibres and combinations thereof.

Preferably, the filler content is 5 to 10 wt% of the aerosol-forming substrate e.g. around 6 to 9 wt%. The air-permeable substrate may comprise an aqueous and/or non-aqueous solvent. In some embodiments, the air-permeable substrate has a water content of between 4 and 10 wt% e.g. between 6- 9 wt% such as between 7-9 wt%. Such low moisture content in the air-permeable substrate typically has the effect that, when the air-permeable substrate is exposed to heated air, there would typically not be produced a substantial visible vapour. It is to be noted that in one embodiment it is possible to use as the air-permeable substrate a low moisture tobacco material with its natural nicotine content. The natural nicotine content then meets the requirements of the active agent. The air-permeable substrate may be at least partly circumscribed by a wrapping layer e.g. a paper wrapping layer. The wrapping layer may overlie an inner foil layer or may comprise a paper/foil laminate (with the foil innermost).

The plant material may comprise cannabis plant material including Cannabis sativa, Cannabis indica and Cannabis rudealis. The plant material may comprise Echinacea purpurea, Echinacea angustifolia, Acmella oleracea, Helichrysum umbraculigerum, or Radula marginata. This also includes blends of the above mentioned plant material.

In some embodiments, the cannabinoid-containing plant material is cannabis. The plant may be a traditional strain, or may be a strain bred or other modified (e.g. genetically) to produce certain levels of some cannabinoids compounds, e.g. low levels of THC or high levels of THC.

Any suitable parts of the cannabinoid-containing plant may be used. Thus the cannabinoid-containing plant material may comprise leaves, stems, roots, bark, seeds, buds and flowers (which may be cured).

The invention includes the combination of the developments, aspects and preferred features described except where such a combination is clearly impermissible or expressly avoided.

Summary of the Figures

So that the invention may be understood, and so that further aspects and features thereof may be appreciated, embodiments illustrating the principles of the invention will now be discussed in further detail with reference to the accompanying figures, in which:

Figure 1 is a schematic front view of a smoking substitute system (e-cigarette), according to a first reference arrangement, in an engaged position;

Figure 2 is a schematic front view of the smoking substitute system of the first reference arrangement in a disengaged position;

Figure 3 is a schematic front view of a smoking substitute system (nicotine inhaler), according to a second reference arrangement, in an engaged position;

Figure 4 is a schematic front view of the smoking substitute system of the second reference arrangement in a disengaged position;

Figure 5 is a schematic side view of a consumable element;

Figure 6 is a part-cutaway view of an implementation of the consumable element of Figure 5 showing the position of the substrate within the consumable element; Figure 7 is a part-cutaway view of an implementation of the consumable element of Figure 5 showing the substrate and a flavour element within the consumable element;

Figure A8 is a schematic side view of a vapour delivery apparatus according to an embodiment of Development A of the present invention, showing its constituent components.

Figure A9 is a schematic side view of the vapour delivery apparatus shown in Figure A8, showing the movement of active ingredient in the substrate.

Figure A10 is a schematic side view of the vapour delivery apparatus shown in Figure A8, showing the varying pressures across the apparatus.

Figure B8 is a schematic side view of a first embodiment of Development B of the invention;

Figure B9 is a schematic side view of a second embodiment of Development B of the invention;

Figure B10A is a schematic side view of a first air flow through the first embodiment of Development B of the invention, shown in Figure B8;

Figure B10B is a schematic side view of a second air flow through the first embodiment of Development B of the invention, shown in Figure B8;

Figure B10C is a schematic side view of a third air flow through the first embodiment of Development B of the invention, shown in Figure B8;

Figure B11 is a schematic side view of a third embodiment of Development B of the invention;

Figure B12A is a schematic side view of a first air flow through the third embodiment of Development B of the invention, shown in Figure B11 ;

Figure B12B is a schematic side view of a second air flow through the third embodiment of Development B of the invention, shown in Figure B11 ;

Figure B12C is a schematic side view of a third air flow through the third embodiment of Development B of the invention, shown in Figure B11 .

Figure C8 is a perspective view of a first embodiment of Development C of the invention;

Figure C9 is an interior perspective view of the first embodiment of Development C of the invention, shown in Figure C8; Figure C10 is a perspective view of a second embodiment of Development C of the invention;

Figure C11 is a top view of the interior of the bottom cover of the second embodiment of Development C of the invention, shown in Figure C10.

Figure C12 is a side view of the bottom cover of the second embodiment of Development C of the invention, shown in Figure C10.

Figure C13 is a perspective view of a third embodiment of Development C of the invention.

Figure D8 shows a schematic longitudinal cross sectional view of a consumable apparatus according to a first embodiment of Development D;

Figure D9 shows the apparatus of Figure D8 during use;

Figure D10 shows a schematic longitudinal cross sectional view of a consumable apparatus according to a second embodiment of Development D;

Figure D11 shows the apparatus of Figure D10 with the seals removed;

Figure D12 shows the apparatus of Figure D11 being inserted into a re-usable housing;

Figure D13 shows a system, comprising the apparatus of Figure D11 inserted into a re-usable housing, in use;

Figure D14 shows a graph of the effect of air temperature on the release of nicotine from a conventional inhaler;

Figure D15 shows a graph comparing the release of nicotine from different apparatus under different conditions of temperature.

Figure E8 is a schematic side view of an embodiment of the vapour delivery apparatus of a first embodiment of Development E of the present invention when the valve is in a closed configuration.

Figure E9 is a schematic side view of the embodiment of Figure E8 when the valve is an intermediate configuration, being compressed, immediately before the valve is in an open configuration.

Figure E10 is a schematic side view of the embodiment of Figure E8 when the valve is in an open configuration. Figure F8 shows a schematic longitudinal cross sectional view of a substrate housing for use in a system according to an embodiment of Development F;

Figure F9 shows a heat source apparatus for use in a system according to an embodiment of Development F (note that Figure F9 is enlarged compared with Figures F10 and F11);

Figure F10 shows a system according to an embodiment of Development F, in a before-use configuration, in which the substrate housing of Figure F8 and the heat source housing of Figure F9 are attached;

Figure F11 shows a system according to an embodiment of Development F, in an in-use configuration, in which the substrate housing of Figure F8 and the heat source housing of Figure F9 are attached.

Detailed Description of the Invention

Further background to the present invention and further aspects and embodiments of the present invention will now be discussed with reference to the accompanying figures. Further aspects and embodiments will be apparent to those skilled in the art. The contents of all documents mentioned in this text are incorporated herein by reference in their entirety.

The embodiments of the invention are described as smoking substitute apparatuses or systems, in which the active ingredient typically comprises or consists of nicotine. However, on the basis of the present disclosure it will be apparent that the invention can be embodied more generally as an aerosol delivery apparatus or system. In such aerosol delivery apparatuses or systems the active ingredient may not comprise nicotine, and may instead comprise or consist of one or more of a nutritional agent, a pharmaceutical agent or a flavour agent.

Some embodiments of the invention are also described as consumable preparation apparatuses for preheating a consumable which may be all or part of a smoking substitute apparatus.

Before considering the embodiments of the invention, a known type of e-cigarette system is first described. Figures 1 and 2 illustrate a known smoking substitute system in the form of an e-cigarette system 110. The system 110 comprises a main body 120 of the system 110, and a smoking substitute apparatus in the form of an e-cigarette consumable (or “pod”) 150. In the illustrated arrangement the consumable 150 (sometimes referred to herein as a smoking substitute apparatus) is removable from the main body 120, so as to be a replaceable component of the system 110. The consumable comprises a reservoir containing e-liquid. The e-cigarette system 110 is a closed system in the sense that it is not intended that the consumable should be refillable with nicotine-based liquid by a user.

As is apparent from Figures 1 and 2, the consumable 150 is configured to engage the main body 120.

Figure 1 shows the main body 120 and the consumable 150 in an engaged state, whilst Figure 2 shows the main body 120 and the consumable 150 in a disengaged state. When engaged, a portion of the consumable 150 is received in a cavity of corresponding shape in the main body 120 and is retained in the engaged position by way of a snap-engagement mechanism. Engagement protrusion 158 of the consumable 158 may be guided into engagement recess 157 of the main body 120. In other arrangements, the main body 120 and consumable 150 may be engaged by screwing one into (or onto) the other, or through a bayonet fitting, or by way of an interference fit.

This known system has a power source (not shown) in the main body 120 in the form of a battery (e.g. a rechargeable battery such as a lithium ion battery). The main body 120 typically comprises a connector in the form of e.g. a USB port for recharging this battery. The main body 120 typically also comprises a controller that controls the supply of power from the power source to the main body electrical contacts (and thus to a heater located in the consumable 150). The controller is therefore configured to control a voltage applied across the main body electrical contacts, and thus the voltage applied across the heater. In this way, the heater may only be heated under certain conditions (e.g. during a puff and/or only when the system is in an active state). In this respect, the main body 120 may include a puff sensor (not shown) that is configured to detect a puff (i.e. inhalation). The puff sensor may be operatively connected to the controller so as to be able to provide a signal, to the controller, which is indicative of a puff state (i.e. puffing or not puffing). The puff sensor may, for example, be in the form of a pressure sensor or an acoustic sensor.

Although not shown, the main body 120 and consumable 150 may comprise a further interface which may, for example, be in the form of an RFID reader, a barcode or QR code reader. This interface may be able to identify a characteristic (e.g. a type) of a consumable 150 engaged with the main body 120. In this respect, the consumable 150 may include any one or more of an RFID chip, a barcode or QR code, or memory within which is an identifier and which can be interrogated via the interface.

The system 110 is configured to vaporise an aerosol precursor. The aerosol precursor is typically an e- liquid stored in the reservoir of the consumable 150. A cotton wick conducts e-liquid from the reservoir to a heater, typically in the form of a resistive metallic coil wound around a portion of the wick. When the heater is energised, the e-liquid is vaporised to produce an aerosol for inhalation by a user via mouthpiece 154.

The arrangement illustrated in Figures 1 and 2 therefore typically has a relatively complex construction and operation, made necessary by the desire to vaporise e-liquid in order to generate an aerosol that is acceptable to a user seeking a close approximation to conventional smoking.

However, as discussed above, it is preferred in some circumstances that a vapour is generated that is not visible (or is substantially not visible) and that the apparatus does not include a potential ignition source, such as an electrical heater. Nicotine inhalers are known. For example, a schematic of a further reference arrangement is illustrated in Figures 3 and 4. In Figure 3, the system is assembled Fig. 4 shows the system in exploded view.

Nicotine inhaler 210 according this reference arrangement has a mouthpiece part 250 and a main body part 220. These are connected together by an engagement region 222 of the main body part fitting over a corresponding engagement region 252 of the mouthpiece part 250 by an interference fit. The main body part 220 and the mouthpiece part 250 each define a respective interior bore, together defining an air flow passage leading from an air inlet 212 at one end of the main body 220 to an air outlet 214 at one end of the mouthpiece part 250.

Consumable nicotine-impregnated substrate 230 fits, via an interference fit, into the interior bore of the main body 220 and the interior bore of the mouthpiece part 250. Substrate 230 is held in position within the inhaler when the main body 220 and the mouthpiece part 250 are assembled together.

In use, a user selects a substrate 230 from a sealed package (not shown) and inserts the substrate 230 into the interior bore of the main body part 220 and attaches the mouthpiece part 250 to the main body part 220 over the protruding part of the substrate 230. The user then draws air through the inhaler by applying suction at the air outlet 214 of the mouthpiece part 250. The air passes through the substrate, evaporating nicotine from the substrate into the airflow for delivery to the user.

Development A

The vapour delivery apparatus of the preferred embodiments of Development A of the present invention is configured to deliver a vapour comprising an active ingredient to a user drawing air through the apparatus for inhalation. The active ingredient is stored in a reservoir region, and the reservoir region is formed from a substrate having limited air permeability. In contrast to an e-cigarette, the active agent in the present invention may be formulated so as to produce a non-visible or substantially non-visible vapour. In addition, embodiments of the invention may provide multiple reservoirs of active ingredient(s) and the ability for a user to select their dosage or strength of the active ingredient(s).

Considering now in more detail the substrate loaded with an active substance which is a vapour precursor, in the preferred embodiments the active substance in liquid form is impregnated into the substrate. When air is drawn through the vapour generator, the active substance is vaporised and entrained in the airflow to thereby be delivered to a user. The vapour produced by this process is less visible than an aerosol produced by vaporisation and subsequent condensation of a conventional e-liquid from an e-cigarette, including the remaining aerosol during exhalation by a user. Preferably, the vapour generated by the embodiment is invisible or substantially invisible when exhaled by a user. The air flow characteristics of the substrate may be selected so as to provide a resistance to draw to a user that is comparable to a conventional cigarette.

A substrate may be impregnated with, for example, nicotine by immersion in a solution of nicotine in a volatile carrier solvent (e.g. ethanol) such that the substrate is evenly soaked. The substrate can then be removed and left to dry or baked in an oven, meaning that the carrier is evaporated and the nicotine is left evenly spread throughout the substrate. The nicotine solution may further comprise a flavourant. Alternatively, a flavourant solution and a nicotine solution may be separately impregnated into the substrate.

Further details are now set out relating to the substrate and its impregnation with an active ingredient. These details also apply to other developments of the present invention as indicated later.

Substrate and its impregnation with active ingredient

Suitable materials and methods for manufacturing air permeable substrates are disclosed, for example, in US4800903, US4284089, US4813437, and US5167242, the entire contents of which are incorporated herein by reference.

US4800903 discloses that preferred materials for a polymeric plug are olefinic polymers, and preferably polyethylene or polypropylene, most preferably high density polyethylene. Use of high density polyethylene is preferred over, for example, amorphous polyethylene, since it provides a balance between ease of manufacturing and capacity for reversible nicotine absorption.

Meanwhile, some polymers are considered to be inherently unsuitable for use as an air permeable substrate containing nicotine. For example, some polymeric substances such as polystyrene and polycarbonate are dissolved by nicotine, rendering them unsuitable for forming a nicotine impregnated substrate. Furthermore, polymers containing halogens or nitrogen or sulphur are undesirable since they can produce noxious fumes.

To improve user satisfaction, it may be preferable to use an air permeable substrate that provides an equivalent resistance to draw to that of a conventional cigarette. For example, US4284089 discloses that a non-combustible cigarette with a draw resistance approximating that of a conventional cigarette would permit about 35 millilitres of air to be drawn through it during a 2 second period.

A substrate may be impregnated with nicotine by a variety of methods. For example, US4800903 indicates that liquid nicotine, nicotine vapour or a solution of nicotine may be used, and suggests that a solution of nicotine in supercritical liquid carbon dioxide may advantageously be used to impregnate the substrate. Alternatively, the substrate may be impregnated with nicotine via immersion in a liquid containing nicotine and a volatile carrier (for example a solution of nicotine in ethanol). The substrate is immersed to evenly soak the substrate. Once the substrate is removed from the liquid it can be left to dry or baked in an oven, evaporating away the carrier so that the nicotine is left evenly distributed throughout the substrate.

US5167242 discloses that a polyethylene plug can be charged or loaded with a mixture of nicotine, menthol and ethanol in a weight ratio (nicotine: menthol: ethanol) of about 10:1 :120 or 10:1 :160. The menthol and nicotine are sequentially added to the ethanol in a mixing vessel to produce a solution. Meanwhile, the plugs are placed in a vacuum dryer, which is partially evacuated to create a lower internal pressure than that of the mixing vessel, allowing the nicotine/ethanol/methanol solution to be sucked into the vacuum dryer. The plugs remain immersed in the solution within the vacuum dryer for 10 minutes, after which the temperature is raised and the vacuum pump is started to evaporate the ethanol. The vacuum dryer is then filled with nitrogen, and a nitrogen atmosphere is maintained for the remainder of the packaging procedure to prevent oxygen contamination of the nicotine.

In alternative embodiments, the air-permeable substrate may be formed in a different manner. For example, the air-permeable substrate may be formed from tobacco. The tobacco may be leaf tobacco, tobacco derivatives, expanded tobacco, shredded tobacco, reconstituted tobacco or tobacco substitutes. Preferably the tobacco has a relatively low moisture content, for example less than 10wt% moisture. A typical minimum moisture content for the tobacco is not less than 4wt% moisture. Such low moisture content tobacco, when exposed to heated air, would typically not produce a substantial vapour. Accordingly, such an air-permeable substrate may be loaded with a source of an active ingredient, as described above.

Where the air-permeable substrate is formed for example of tobacco, the active agent may be applied to the air-permeable substrate by mixing and/or dissolving the active agent in a suitable carrier liquid such as a solvent (e.g. water, ethanol, PG, glycerine, macrogol, caster oil, paraffin, (and derivatives thereof)).

In some embodiments, the air drawn through the substrate may be heated to a suitable temperature. This temperature may be at least 30°C. This is in order to promote vaporisation of the active ingredient. The temperature is typically not greater than 80°C, or typically not greater than 70°C. This is in order to promote user comfort. It may also reduce or prevent the degradation of the air-permeable substrate and/or the active ingredient.

In other embodiments, the substrate itself may be heated. This may be done after installation of the substrate into the apparatus. Alternatively, the substrate may be heated before installation into the apparatus. This temperature may be at least 30°C. This is in order to promote vaporisation of the active ingredient. The temperature may typically not be greater than 80°C, or typically not greater than 70°C. This is in order to promote user comfort. It may also reduce or prevent the degradation of the air- permeable substrate and/or the active ingredient.

However, in some embodiments of the invention, the apparatus does not include a heat source. Furthermore, preferably neither the air drawn through the apparatus nor the substrate is actively heated. This allows the apparatus more clearly to fit within a regulatory framework in which conventional nicotine inhalers are permitted for use.

Consumable element (also described herein as a consumable) 320 is illustrated in Figures 5-7.

Consumable element 320 has generally cylindrical form with its curved outer surface covered and protected by a wrapping layer 322, formed for example from a biodegradable material such as cardboard, paper, bagasse or similar. Sealing elements 324, 326 are disposed at opposing ends of the substrate. These may be piercable or removable for use. Together, the sealing elements 324, 326 and wrapping layer 322 provide protection for a substrate 330 contained within the consumable element 320, to reduce or prevent loss of active ingredient from the substrate and thus ensure freshness for use.

Substrate 330 is shown in ghosted outline in Figure 6. In some embodiments, the substrate may consist of a simple monolithic air-permeable material such as described above. In Figure 6, additionally, there is provided a collar 332 around a core 334 of the substrate, the core being formed of air-permeable material that is impregnated with the active ingredient and the collar being formed of a material that is impermeable to the active ingredient. Collar 332 therefore prevents the active ingredient from wicking to the wrapping layer 322.

An alternative arrangement is shown in Figure 7. Substrate 330 is present as a monolith and a separate flavour element 336 is provided, upstream or downstream of the substrate 330. In this arrangement, the flavour element is an air-permeable plug loaded with flavour. Alternatively, the flavour can be loaded onto substrate 330, co-mixed with the active ingredient or segregated into a different region of the substrate. Still further, flavour can be provided in a flavour card or a flavour crushball.

Development A - continued

Figure A8 shows a schematic side view of a vapour delivery apparatus according to an embodiment of Development A of the present invention. The vapour delivery apparatus A810 comprises an air inlet A820, an outlet A840, and an annular substrate A830. The substrate A830 is positioned between the air inlet A820 and the outlet A840, and comprises a reservoir region loaded with active ingredient. The substrate is held in position by air impermeable walls A880. Through the centre of the substrate A830 is a constricted air flow region A850, comprising a single bore, which allows air to travel from the air inlet A820 to the outlet A840. The cross-sectional area of the constricted air flow region A850 in the substrate A830 is smaller than the cross-sectional area of an inlet region A860 located upstream of the substrate A830, and smaller than the cross-sectional area of an outlet region A870 located downstream of the substrate.

Figure A9 shows the movement of air and active ingredient through the vapour delivery apparatus according to the present invention, when in use. A user inhales at the outlet A840 (for example at a mouthpiece (not shown)) and air is drawn into the apparatus at the air inlet A820. Air then travels through the inlet region A860 and into the constricted air flow region A850 in the substrate A830. No significant flow of air is permitted through the outer peripheral sides (outer circumference and axial ends) of the substrate A830 because the air impermeable walls A880 prevent this from occurring. Since the constricted air flow region A850 has a smaller cross-sectional area than the inlet region A860 and the outlet region A870, then during an inhalation the pressure in the constricted air flow region A850 reduced compared with the pressure in the inlet region A860 and outlet region A870. The constricted air flow region A850 is therefore, in effect, a Venturi tunnel. The active ingredient within the substrate moves by capillary flow through pores within the substrate A830 from the outer peripheral region A832 of the substrate to the central region A834 of the substrate. This ensures that there is a constant supply of active ingredient at the centre A834 of the substrate for entrainment into the constricted air flow region A850. The passing airflow comprising the entrained active ingredient then travels through the outlet region A870 to the outlet A840 and is inhaled by the user.

Figure A10 shows a further mechanism of movement of the active ingredient through the substrate, this mechanism using a pressure gradient within the substrate itself. This mechanism of active ingredient migration may be an alternative to, or in addition to, the capillary flow of an active ingredient through the substrate. Figure A10 shows the particular case of the substrate comprising a material of limited airpermeability, in order to still retain the Venturi effect within the constricted air flow region and to achieve an air pressure gradient within the substrate.

Figure A10 shows a distribution of air pressure across the inlet region A860, the air passage A850 and the substrate A830 whilst a user is inhaling at the outlet A840. [The air pressure distribution in the outlet region is not illustrated but can be assumed to be the same as in the inlet region.] The darker regions illustrate regions of higher pressure. The lighter regions illustrate regions of lower pressure. The inlet region A860 has a high air pressure because of its large cross-sectional area and therefore relatively slow air velocity. The lowest pressure is found in the constricted air flow region A850 as a result of the Venturi effect. In view of the low pressure in the constricted air flow region A850 and the original ambient pressure externally of the substrate, there is a pressure gradient from the central region A834 of the substrate A830 to the peripheral region A832 of the substrate A830 during an inhalation.

As the pressure in the peripheral region A832 of the substrate A830 is greater than at the central region A834 of the substrate A830, active ingredient in the peripheral region A832 of the substrate is actively forced towards the central region A834 of the substrate, where it is extracted by and entrained in the passing airflow in the constricted air flow region A850. During an inhalation, the air pressure may gradually also equalise in the radial direction across the substrate, so that the pressure differential decreases over time during a single inhalation. For example, near the end of an inhalation, the air pressure at the peripheral region A832 of the substrate A830 may less than at the start of the inhalation, due to this equalisation effect. After an inhalation, the pressure in the substrate may gradually recover, to equalise at atmospheric pressure in the central region and the peripheral region of the substrate. After an inhalation, there is therefore no longer a driving force for the migration of active ingredient to the central region of the substrate.

Development B

Details are set out above in the section “Substrate and its impregnation with active ingredient” relating to the air-permeable substrate and its impregnation with an active ingredient. Those details also apply to Development B. Figure B8 shows a first embodiment of Development B of the present invention. The device comprises a tube B802 having a first open end B804 and a second open end B806. The tube also comprises an auxiliary air inlet B808, covered by a tab B810. Because the auxiliary air inlet B808 is covered by the tab B810, the primary air flow path is that air flows directly from one of the open ends through the tube to the other open end. Between the two open ends is a first reservoir B812 of active substance, and a second reservoir B814 of active substance. The reservoirs B812, B814 are positioned on either side of the auxiliary air inlet B808.

Figure B9 shows a second embodiment of Development B of the present invention, which is a modification of the first embodiment. The second embodiment has all the features of Figure B8. However, Figure B9 additionally has a further reservoir B920 of a secondary additive, which is positioned beneath the auxiliary air inlet B808, and in between the first and second reservoirs B812, B814. The secondary additive may be, for example, a flavour.

Figure B10A shows an example of one way in which the consumable of Figure B8 may be used. In Figure B10A, the auxiliary air inlet B808 is opened to allow air to enter through the auxiliary air inlet B808 and only pass through the first reservoir B812 to the first open end B804. The first open end therefore forms an air outlet. The second open end B806 is covered by a cap B820 so that air can only enter the device through the auxiliary air inlet B808. With this auxiliary air flow path, the air flow bypasses the second reservoir B814, and ensures that air only passes through one reservoir of active substance, in this case the first reservoir B812. Therefore a user receives a (typically) smaller dose of the active substance on inhalation and the second reservoir B814 is not depleted.

Figure B10B shows an example of a second way in which the consumable of Figure B8 may be used. Similar to Figure B10A, the auxiliary air inlet B808 is opened. However, cap B820 has been placed on the first open end B804 of the device. Therefore, when a user inhales from the second open end B806 of the device, air passes from the auxiliary air inlet B808 through the second reservoir B814 to the second open end B806. With this auxiliary air flow path, as for Fig. B10A, the user receives a (typically) smaller dose of the active substance on inhalation than if air was permitted to travel directly from the first open end B804 to the second open end B806. Where the active substance on reservoirs B812, B814 is the same, and at the same concentration and in similar format air permeable plugs, the user experience of Figs. B10A and B10B is the same.

Accordingly, Figures B10A and B10B illustrate that the device is reversible, such that a user can draw air from either the first open end or the second open end of the device.

When the first reservoir and the second reservoir contain different active substances, this means that the user can choose which active substance they wish to inhale and based on their decision, cap off the open end of the device closest to the active substance that they do not wish to inhale. If the first reservoir or second reservoir contain the same active substance, the user can choose whether they wish to have a higher dose of the active substance. If the user does wish to have a higher dose of the active substance, they merely need to cover the auxiliary air inlet, as now explained.

Figure B10C shows an example of a third way in which the consumable of Figure B8 may be used. In this example, the auxiliary air inlet B808 remains closed by tab B810. The user inhales through the second open end B806 of the device. This means that air travels through the first open end B804, through the first reservoir B812 and through the second reservoir B814 and out through the second open end B806. In this case, where the active substances on the first and second reservoirs are the same, the user will receive a higher dose. Where the active substances on the first and second reservoirs are different, the user will receive a mix of these active substances.

Furthermore, considering a modification of Fig. B8, the first and second reservoir regions may be a part of a single monolithic plug, with the inlet B808 located part way along the plug. In this case, the user may operate the device with the air flow similar to that shown in Fig. B10A, e.g. for 4-5 inhales, and then reverse the operation of the device to use it in a similar manner to that shown in Fig. B10B, e.g. for 4-5 inhales. This is of interest from a user experience point of view because it is found that taking 10 inhales in a single direction leads to nicotine per puff dropping off significantly. By operating the apparatus as suggested here, a more consistent experience can be had.

Figure B11 shows a third embodiment of Development B of the present invention. The device comprises a tube B802 having a first open end B804 and a second open end B806. Figure B11 illustrates that the second open end B806 can be closed by a cap B820. The tube also comprises a first auxiliary air inlet B1108 and a second auxiliary air inlet B1118. In Figure B11 , the first auxiliary air inlet B1108 is covered by a tab B1110 and the secondary auxiliary air inlet B1118 is covered by a tab B1120. Within the tube B802, there is a first reservoir B1112, a second reservoir B1113 and a third reservoir B1114, each containing an active substance (which may be the same or different). These are arranged such that the first reservoir B1112 is positioned between the first open end B804 and the first auxiliary air inlet B1108, the second reservoir B1113 is positioned between the first auxiliary air inlet B1108 and the second auxiliary air inlet B1118, and the third reservoir B1114 is positioned between the second auxiliary air inlet B1118 and the second open end B806. There are multiple ways in which the device of Figure B11 may be operated, as will now be explained.

Figure B12A shows a first way in which the device of Figure B11 may be operated. In Figure B12A, the first open end B804 and first auxiliary air inlet B1108 are both open, the secondary auxiliary air inlet B1118 is covered by tab B1120 and the second open end B806 is covered by cap B820. When the user inhales at the first open end 804 of the tube B802, air enters the tube through the first auxiliary air inlet B1108 and passes through the first reservoir B1112 before reaching the user. Therefore air only passes through a single reservoir of active substance before it reaches the user.

Figure B12B shows a second way in which the device of Figure B11 may be operated. In Figure B12B, the first open end B804 and the second auxiliary air inlet B1118 are both open, the first auxiliary air inlet is covered by tab B1110 and the second open end B806 is covered by cap B820. When the user inhales at the first open end B804, air flows from the secondary air inlet B1118, through the second reservoir B1113 and the first reservoir B1112 before reaching the user. Therefore air passes through two reservoirs of active substance before it reaches the user. The two reservoirs may contain the same active substance or different active substances.

Figure B12C shows a third way in which the device of Figure B11 may be operated. In Figure B12C, the first auxiliary air inlet B1108 is covered by tab B1110 and the second auxiliary air inlet B1118 is covered by tab B1120. The first open end B804 and second open end B806 are not covered. When the user inhales at the first open end B804, air flows directly from the second open end B806 through the third reservoir B1114, through the second reservoir B1113 and through the first reservoir B1112 before it reaches the user. Therefore air passes through three reservoirs of active substance before it reaches the user. Some or all of the reservoirs may contain the same active substance, or all three reservoirs may contain different active substances.

Figures B12A, B12B and B12C show that the first open end B804 is where the user may inhale. However, the user may also inhale from the second open end B806, so that the user has the option of inhaling air that has passed through only the third reservoir B1114, or the third reservoir B1114 and the second reservoir B1113. In this way, the device of Figures B11 and B12 is reversible, like the devices shown in Figures B8, B9 and B10. This means that the user chooses and sets which open end is an outlet, and if necessary, which open end is a primary air inlet.

Alternatively, the apparatus may be constructed so that it is not intended to be reversible. This may be preferred where the construction of the apparatus is such that a dedicated mouthpiece is provided, so that the user will always operate the apparatus with the dedicated mouthpiece as the outlet.

With the arrangement shown for example in Fig. B11 , it may be advantageous to select reservoirs having suitable porosity so that the pressure drop across all three reservoirs is not too high. Tailoring each reservoir based on its position within the apparatus may help to alleviate a high pressure drop, as may increasing the inlet(s) opening area depending on how many reservoirs the air must pass through.

Development C

The consumable preparation apparatus of the preferred embodiments of the present invention is configured for storing and pre-heating a consumable for use in or as a vapour delivery apparatus. The consumable preparation apparatus comprises a shaped recess in which the consumable is adapted to fit. The consumable preparation apparatus also comprises a heat source which is in thermal contact with the shaped recess. The heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air. The consumable comprises a source of an active ingredient and is configured to deliver a vapour comprising the active ingredient to a user drawing air through the consumable. The preferred embodiments of the present invention provide heating for a single consumable or heating for more than one consumable. To heat a single consumable, the consumable preparation apparatus is arranged such that only a portion of the heat source is exposed to air. To heat more than one consumable, the consumable preparation apparatus is arranged such that all of the heat source is exposed to air.

Figure C8 shows a first embodiment of Development C of the present invention. The consumable preparation apparatus C810 comprises a top cover C820 and a bottom cover C830. The top cover and bottom cover each comprise four exterior walls and a base. The consumable preparation apparatus has a height y, a width x, and a depth z. The overall assembled height y of the consumable preparation apparatus is divided into the height y 1 of the top cover C820 and the height y2 of the bottom cover C830. The height y1 of the top cover C820 in the first embodiment is smaller than the height y2 of the bottom cover C830. For example, the height y1 of the top cover C820 is approximately one third of the overall height y of the consumable preparation apparatus C810, and the height y2 of the bottom cover C830 is approximately two thirds of the overall height y of the consumable preparation apparatus C810. The consumable preparation apparatus comprises a heat source, and is adapted to store and heat one or more consumables. The top cover C820 fits onto the bottom cover C830, to provide a storage configuration for the apparatus in which it is ensured that the heat source is not exposed to air. By having the heat source not exposed to air, the heat source cannot heat up the contents (for example, one or more consumables) of the consumable preparation apparatus.

Figure C9 shows the internal arrangement of the first embodiment of Development C, as shown in Figure C8. The top cover C820 of the consumable preparation apparatus is shown in ghosted outline in Figure C9. The top cover C820 sits on top of the bottom cover C830. The top and bottom covers may be connected by a clip or other locking mechanism. The bottom cover C830 comprises a heat source C950 which defines a central recess C945. The central recess is adapted to fit consumables C320 (each for example being according to Figure C5). In Figure C9, twenty consumables C320 are arranged to fit into the recess provided in the bottom cover C830. A pack of twenty consumables mimics a packet of cigarettes for a familiar feel and purchase quality. The consumables C320 extend from the recess in the bottom cover into the top cover, such that the top cover C820 protects exposed ends of the consumables. The top cover C820 also covers the heat source C950 from exposure to air, to avoid heating the consumables until the top cover is removed, prior to use.

In order to heat the consumables, the user therefore simply removes the top cover C820 in order to expose the heat source C950 to air. All of the consumables C320 are therefore heated at the same time.

Figure C10 shows a second embodiment of Development C of the present invention. Figures C11 and C12 show the bottom cover C830 of the second embodiment, in relation to line PQ. The second embodiment is similar to the first embodiment because it comprises a top portion C820 having four exterior walls and a base, and a bottom portion C830 having four exterior walls and a base C1080. In contrast to the first embodiment, the second embodiment comprises air access holes C1060 positioned across the width x and depth z of the top cover C820. Figure C10 shows 3 rows of air inlet holes in the top cover in the y direction. When the top cover C820 and the bottom cover C830 are fully engaged, the air access holes C1060 are located centrally in the y direction and extend around the apparatus in the width x and depth z directions of the consumable preparation apparatus.

The arrangement of the heights of the top cover and bottom cover are different compared to the first embodiment of Development C. In the second embodiment of Development C, the overall height y of the consumable apparatus is divided such that the height y1 of the top cover C820 is greater than the height y2 of the bottom cover C830, at least as would be seen by an observer of the apparatus in the closed configuration shown in Fig. C10. For example, in this closed configuration, the height y1 of the top cover C820 may be approximately two thirds of the height y of the consumable preparation apparatus. Unseen to the observer of the apparatus in the closed configuration, the bottom cover C830 additionally comprises an internal portion C1070 (shown in Figures C11 and C12) comprising four internal walls parallel to the four exterior walls of the bottom cover, as shown in Figure C11 . The internal portion has a smaller width and smaller depth than the width x and depth z of the consumable preparation apparatus and extends upwardly from the remainder of the bottom cover C830. As shown in Figure C12, the height of the internal portion of the bottom cover is y3. The internal portion is arranged such the top cover C820 can slide over the internal portion C1070 of the bottom cover. When the top cover C820 is fully engaged with the bottom cover C830 as shown in Figure C10, the air inlet holes C1060 in the top cover are blocked by the internal portion C1070 of the bottom cover.

The apparatus is operable so that the top cover and bottom cover are moveable with respect to each other from the closed configuration, shown in Figure C10, in which all the air access holes C1060 are closed, to an open configuration, in which all the access holes are open. In the closed configuration, the air access holes are closed because the top portion is completely engaged with the bottom portion, such that the top cover fits over the internal portion C1070 of the bottom portion. The top cover can be moved into the open configuration by pulling the top cover partially away from the bottom cover, such that the air access holes are open and are not blocked by the internal portion of the bottom cover. Since in this embodiment there are three rows of air inlet holes C1060, a user can choose how far to pull the top cover away from the bottom cover, thereby controlling the number of rows of the air inlet holes through which air can enter the apparatus. For example, the user may choose to pull the top cover away from the bottom portion so that all of the air inlet holes C1060 can let air pass into the apparatus, and thereby interact with the heat source. Alternatively, the user may choose to only allow one row of air inlet holes to let air into the apparatus. In the latter case, since the flow of air into the apparatus is reduced, compared to having all three rows of air inlet holes open, the heat-up time for the heat source is longer than having all of the air inlet holes open. In the latter case, the user will need to wait longer for the consumable to be sufficiently warmed for use. By closing the top cover, air is no longer free to flow through the air inlet holes and therefore the exothermic reaction is stopped and the heat source in the bottom cover cools down.

Alternatively, the air inlet holes C1060 may be replaced by a single large air inlet, which may span, for example, at least a part of the width of the top portion and / or at least a part of the depth of the top portion. As discussed previously, the flow of air to the heat source may be controlled by altering whether or not, and how far the top cover C820 is moved apart from the bottom cover C830.

Figure C13 shows a third embodiment of Development C of the present invention. Unlike the first and second embodiments, the consumable preparation apparatus of the third embodiment of Development C does not comprise a separable top cover and a bottom cover in order to control air ingress to the heat source. Instead, the third embodiment comprises a cover C1310 having four side walls C1316, a base C1312 and a top C1314. The cover comprises multiple compartments C1320. Figure C13 shows a consumable preparation apparatus having nine compartments. Each compartment comprises a heat source and a recess for a consumable to be fitted. In this embodiment, each compartment is completely separate from the next compartment. (In some other embodiments, adjacent compartments may be operationally linked. For example, the heat source may be continuous through the apparatus.) Each compartment comprises air access holes C1360 to allow access of air to a single compartment, and therefore only allow access of air to the heat source provided to heat an individual consumable housed in the compartment. The air access holes are positioned on a side wall C1316 and on the base C1312. The air access holes are covered by a peelable cover C1380 for each compartment, to enable selective heating of a single consumable. The consumable preparation apparatus is initially provided with all the air access holes covered by peelable covers C1380. When the user wishes to use a consumable, the user peels off a peelable cover to allow air to access the compartment and therefore the heat source, providing an exothermic reaction, and therefore heating a single consumable. Once heated, the consumable is removed from the top C1314 of the consumable preparation apparatus for use. The third embodiment of Development C therefore provides an arrangement in which individual consumables may be heated separately.

As indicated above, it is possible for the consumable itself to be a vapour delivery apparatus for use by a user, the consumable itself presenting an outer housing for the user to hold and having an air inlet and an outlet, the outlet being defined at a mouthpiece via which the user draws air through the vapour delivery apparatus. Alternatively, and as illustrated, the consumable may be intended for loading into a vapour delivery apparatus similar to that illustrated in Fig. 3 and 4.

Development D

Considering now in more detail the air-permeable reservoir loaded with a vapour precursor, in the illustrated embodiment the reservoir comprises a nicotine-based liquid impregnated into a substrate. When air is drawn through or over the nicotine-impregnated substrate, the nicotine is vaporised and entrained in the airflow to thereby be delivered to a user. The vapour produced by this process is less visible than an aerosol produced by vaporisation and subsequent condensation of a conventional e-liquid from an e-cigarette, including the remaining aerosol during exhalation by a user. Preferably, the vapour generated by the embodiment is invisible or substantially invisible when exhaled by a user. The porosity or air permeability of at least part of the substrate may be selected so as to provide a resistance to draw to a user that is comparable to a conventional cigarette. A substrate may be impregnated with nicotine by immersion in a solution of nicotine in a volatile carrier solvent (e.g. ethanol) such that the substrate is evenly soaked. The substrate can then be removed and left to dry or baked in an oven, meaning that the carrier is evaporated and the nicotine is left evenly spread throughout the substrate. The nicotine solution may further comprise a flavourant. Alternatively, a flavourant solution and a nicotine solution may be separately impregnated into the substrate.

Further details are set out above in the section “Substrate and its impregnation with active ingredient” relating to the air-permeable substrate and its impregnation with an active ingredient. These details also apply to Development D.

In the embodiments of Development D of the invention, the substrate is heated during use of the apparatus. The substrate may be heated to a temperature of at least 30°C. This is in order to promote vaporisation of the active ingredient. The temperature is typically not greater than 80°C, or typically not greater than 70°C. This is in order to promote user comfort. Avoiding using high temperatures may also reduce or prevent the degradation of the substrate and/or the active ingredient, and/or other constructional features of the apparatus.

Figure D8 shows a longitudinal cross sectional view of a consumable apparatus D400 according to a first embodiment of Development D. Figure D8 shows the apparatus before use and Figure D9 shows the same apparatus during use.

Consumable apparatus D400 has a generally cylindrical form defined by housing D420. Housing D420 may for example be formed from card. The housing D420 is substantially impermeable to air, if necessary by the providing of an air-impermeable layer (not shown) on the inner surface of the housing. One end of the housing defines an air inlet D402 and the other end of the housing defines an outlet D404. In this way, there is defined an upstream to downstream direction in the apparatus. As shown in Figure D8, the air inlet is covered and sealed by an inlet removable seal D412. Inlet removable seal D412 takes the form of a peelable member, provided with inlet tab D414 to enable the user to gain a purchase on the peelable member in order to peel it from the inlet and thereby permanently open the air inlet. The outlet is covered and sealed by an outlet removable seal D416. Outlet removable seal D416 takes the form of a peelable member, provided with outlet tab D418 to enable the user to gain a purchase on the peelable member in order to peel it from the outlet and thereby permanently open the outlet. As will be understood, in other embodiments, the removable seals may take different forms, such as pierceable seals.

The outlet D404 may define a mouthpiece for engagement with the user’s lips. This may simply be an external surface of the housing at the outlet end of the apparatus, or a mouthpiece element (not shown) may be provided.

Inside the housing of the consumable apparatus is substrate D406. In this embodiment, substrate D406 has a generally annular form, defining an air flow path D410 through it, from the air inlet to the outlet. The substrate is loaded with a source of active ingredient (for example nicotine) for generating a vapour for inhalation by a user. The substrate may be formed from polyethylene, for example. Suitable approaches for manufacturing and impregnating the substrate are explained above.

Also inside the housing of the consumable apparatus is heat source D408. The heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air. The heat source has an annular form, surrounding the substrate but separated from the substrate by an annular air-impermeable layer D424. A radial air-impermeable layer D426 is provided at the downstream end of the heat source D408, extending radially from the downstream end of the annular air-impermeable layer D424 to the inner surface of the housing D420. At the upstream end of the substrate, a further radial air- impermeable layer D428 is provided, this extending from the upstream end of the annular air- impermeable layer D424 to cover the upstream end of the substrate D406 but to leave open the air flow path D410.

Air-impermeable layers D424, D426, D428 may be formed from PLA, bagasse or foil film

At the upstream end of the heat source D408, there is a radially extending air-permeable layer D422, extending from the upstream end of the annular air-impermeable layer D424 to the inner surface of the housing D420. The purpose of the air-permeable layer D422 is to retain the material of the heat source D408 but to allow air to access the heat source D408. Air ingress into the heat source through the air- permeable layer D422 is indicated by arrow D432 in Figure D9. Air-permeable layer D422 may be formed from PLA mesh. PLA is biodegradable and therefore suitable for use in a consumable apparatus.

Before use, as in Figure D8, the internal space D430 in the consumable apparatus is filled with inert gas, such as nitrogen.

When ready for use of the consumable apparatus, the user removes the seals D412, D416. This permits air into the apparatus. Air ingress into the heat source D408 therefore takes place through the air- permeable layer D422. The heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air.

The heat source D408 is in thermal contact with the substrate D406 via the annular air-impermeable layer D424. Accordingly, as the air enters into the heat source D408 and the exothermic reaction progresses, heat is conducted through the annular air-impermeable layer D424 to heat the substrate. Since the substrate is loaded with a source of active ingredient for generating a vapour, this temperature increase results in an increase in vapour generation and therefore further vapour made available for inhalation by the user.

In a modification of this embodiment (the modification not being shown in the drawings), it is possible for at least one further air ingress port to be provided to the heat source. For example, a further air ingress port may be provided through the housing, at an axial position corresponding to the heat source. The air ingress port may be constituted by an air-permeable layer, similar to the material used for the air- permeable layer D422. Before use, the air ingress port may be covered by a removable seal. The user removes the removable seal from around the housing (the seal covering and sealing the air ingress port) in order to allow additional air to enter into the heat source, to allow heat to be generated faster.

As already mentioned, the heat source generates heat via an exothermic reaction with air. Providing heat through a chemical reaction is a simple and effective method for generating heat without using electrical power. The type of heat source used in the preferred embodiments is similar to that used in hand warmer packs. While some hand warmers use a liquid formulation, others use a dry particle or powder formulation. Liquid formulations (such as super saturated sodium acetate trihydrate) create complexity as they are harder to contain, activate and last for less time. They are often used in view of their re-usable nature. However, in the consumable apparatus disclosed herein, re-usability is not intended.

Accordingly, a dry formulation for the heat source is preferred.

Considering dry powder hand warmer packets, these react with the air around them to generate heat. A suitable formulation includes iron particles, cellulose (or sawdust - to bulk up the product), water, vermiculite (serves as a water reservoir), activated carbon (distributes heat uniformly), and salt (acts as a catalyst). When air enters into the formulation, the iron is oxidized, generating heat.

As they are designed for direct human skin contact, hand warmers are typically designed so that their temperature in operation does not exceed about 60°C, in order to prevent burning. According to testing carried out in the development of this disclosure, using an infra-red camera, typical hand warmers reach a temperature of between 40 and 50°C. However, it has been found to be possible to reach temperatures up to 80°C, by exposing more air to the heat source formulation.

Tests have shown that exposing a pot of hand warmer powder (20mm diameter, 20mm long) where only the top surface is exposed, generates heat 3mm below the surface of 45°C after 30 seconds, and about 55°C after 60 seconds.

Figures D10-D13 illustrate a second embodiment of Development D of the invention, which is in effect a modification of the first embodiment. The modification is based on the idea that a re-usable housing may be used with a consumable apparatus (capsule) providing the heat source and the substrate.

Figure D10 shows a longitudinal cross sectional view of a consumable apparatus D500, or capsule, intended for insertion into a reusable housing D520 (shown in Figures D12 and D13).

Capsule D500 has a generally cylindrical form defined by an outer wall of air-impermeable layer D501. One end of the capsule defines an air inlet D502A and the other end of the capsule defines an outlet D504A. In this way, there is defined an upstream to downstream direction in the capsule. As shown in Figure D10, the air inlet is covered and sealed by an inlet removable seal D512. Inlet removable seal D512 takes the form of a peelable member, provided with inlet tab D514 to enable the user to gain a purchase on the peelable member in order to peel it from the inlet and thereby permanently open the air inlet. The outlet is covered and sealed by an outlet removable seal D516. Outlet removable seal D516 takes the form of a peelable member, provided with outlet tab D518 to enable the user to gain a purchase on the peelable member in order to peel it from the outlet and thereby permanently open the outlet. As will be understood, in other embodiments, the removable seals may take different forms, such as pierceable seals.

When the capsule D500 is inserted into the re-usable housing D520 to form a system, the system has air inlet D502 and outlet D504. In this case, the outlet D504 may define a mouthpiece for engagement with the user’s lips. This may simply be an external surface of the housing at the outlet end of the apparatus, or a mouthpiece element (not shown) may be provided.

Inside the capsule is substrate D506. In a similar manner to the first embodiment, substrate D506 has a generally annular form, defining an air flow path D510 through it, from the air inlet to the outlet. The substrate is loaded with a source of active ingredient (for example nicotine) for generating a vapour for inhalation by a user. The substrate may be formed from polyethylene, for example. Suitable approaches for manufacturing and impregnating the substrate are explained above.

Also inside the capsule is heat source D508. The heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air. The heat source has an annular form, surrounding the substrate but separated from the substrate by an annular air-impermeable layer D524. A radial air-impermeable layer D526 is provided at the downstream end of the heat source D508, extending radially from the downstream end of the annular air-impermeable layer D524 to the outer wall air-impermeable layer D501 . At the upstream end of the substrate, a further radial air-impermeable layer D528 is provided, this extending from the upstream end of the annular air-impermeable layer D524 to cover the upstream end of the substrate D506 but to leave open the air flow path D510.

Air-impermeable layers D501 , D524, D526, D528 may be formed from PLA, bagasse or foil film.

At the upstream end of the heat source D508, the air-impermeable layer D528 also extends radially outwardly towards the outer wall D501 but incorporates an air-permeable layer D522, extending from the upstream end of the annular air-impermeable layer D524 to the outer wall D501 . The purpose of the air- permeable layer D522 is to retain the material of the heat source D508 but to allow air to access the heat source D508. Air ingress into the heat source through the air-permeable layer D522 is indicated by arrow D532 in Figure D13. Air-permeable layer D522 may be formed from PLA mesh. PLA is biodegradable and therefore suitable for use in a consumable apparatus.

At the downstream end of the capsule, but interiorly of seal D516, there is provided protective layer D503.

Before use, the internal space D530 in the capsule may be filled with inert gas, such as nitrogen. When ready for use of the capsule, the user removes the seals D512, D516. Air ingress into the heat source D508 therefore takes place through the air-permeable layer D522. The heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air. The heat source D508 therefore starts to heat up.

The user inserts the capsule of Figure D11 into the re-usable housing D520, as shown in Figure D12, by pushing and sliding the capsule into the housing in the direction indicated by arrow D507.

The heat source D508 is in thermal contact with the substrate D506 via the annular air-impermeable layer D524. Accordingly, as the air enters into the heat source D508 and the exothermic reaction progresses, heat is conducted through the annular air-impermeable layer D524 to heat the substrate. Since the substrate is loaded with a source of active ingredient for generating a vapour, this temperature increase results in an increase in vapour generation and therefore further vapour made available for inhalation by the user.

Figure D14 shows a graph of the effect of environmental temperature on the release of nicotine from a conventional inhaler. The temperature is shown on the horizontal axis. The vertical axis shows the average nicotine output (measured in pg per inhalation) over five 55 ml inhalations at each measurement temperature. The dotted line is to guide the eye towards the trend. The results show that as the temperature is increased, the amount of nicotine released increases significantly.

Further studies were carried out on the same type of conventional nicotine inhaler as used in Figure D14, to investigate the effect of directly heating the nicotine-impregnated substrate. The horizontal axis indicates the use period of the apparatus, with the initial inhalations (inhalations 1-5) shown on the far left.

Figure D15 indicates a base line performance in a chain dot-dash line. This indicates the expected performance of a conventional nicotine inhaler at ambient temperature (25°C).

Figure D15 also indicates an upper level of performance for a typical cigarette, using a dashed line. A suitable performance for a smoking substitute apparatus would therefore approach this performance.

In order to investigate the principles underlying the present disclosure, a cartridge heater was inserted into a conventional nicotine inhaler substrate (polymer foam plug impregnated with nicotine) and the heater operated in order to heat the substrate to the different temperatures shown in the graph. This arrangement is referred to as “Noshaq” in the graph. Note that for each temperature, the substrate was identically dosed with nicotine.

Four temperatures were used: ambient, 35°C, 40°C and 45°C. The solid lines in Figure D15 show the performance for the temperatures from bottom to top of the graph with increasing temperature. For each temperature, the trend was that the amount of nicotine released was initially higher and gradually reduced over the course of 20 inhalations. This is as expected, given the initially high availability of nicotine and then the reducing amount of available nicotine for vaporisation as the test progressed. Furthermore, it is possible that the heater volatilised the nicotine near the heater quickly, giving high initial readings and then tailing off. Note that in contrast to these experimental tests, the embodiments described above use an annular substrate, with an air flow passage formed centrally through the substrate, and it is considered that this geometry can reduce the gradient of the decrease of nicotine release from the substrate.

Another phenomenon which may cause a comparative high initial measurement of nicotine vapour may be due to the presence of the seals. The seals completely contain within the apparatus any volatilised nicotine. The pressure within the apparatus may therefore be determined at least in part by the vapour pressure of the nicotine solution. Accordingly, the initial inhale may therefore draw all the volatiles out alongside any further vaporised nicotine from the substrate. This phenomenon indicates that in any implementation, there may be an initially relatively high delivery of active ingredient, followed by a steadier state of delivery of active ingredient that is dependent on temperature.

In general Figures D14 and D15 show that the application of heat is successful in liberating greater quantities of nicotine from identically dosed reservoirs. Note that Figures D14 and D15 are not directly comparable with each other.

Accordingly, the embodiments of Development D of the present disclosure provide a means for heating the substrate in a manner that is compliant with safety regulations and yet results in a substantial increase in the release of active ingredient from the substrate over a time period that is consistent with a typical time of use of a smoking substitute apparatus. Furthermore, the apparatus and system can be manufactured efficiently and at a large scale, enabling cost-effective single use disposability of elements of the system.

Development E

The vapour delivery apparatus of the preferred embodiments of Development E of the present invention is configured to deliver a vapour comprising an active ingredient to a user drawing air through the apparatus for inhalation. The active ingredient is stored in a reservoir region, and the reservoir region is formed from an air-permeable substrate. In contrast to an e-cigarette, the active agent in the present invention may be formulated so as to produce a non-visible or substantially non-visible vapour. In addition, embodiments of the invention may provide multiple reservoirs of active ingredient(s) and the ability for a user to select their dosage or strength of the active ingredient(s).

Considering now in more detail the air-permeable reservoir loaded with an active ingredient which is a vapour precursor, in the preferred embodiments the reservoir comprises an active ingredient in liquid form impregnated into a substrate. When air is drawn through the substrate, the active ingredient is vaporised and entrained in the airflow to thereby be delivered to a user. The vapour produced by this process is less visible than an aerosol produced by vaporisation and subsequent condensation of a conventional e- liquid from an e-cigarette, including the remaining aerosol during exhalation by a user. Preferably, the vapour generated by the embodiment is invisible or substantially invisible when exhaled by a user. The porosity or air permeability of at least part of the substrate may be selected so as to provide a resistance to draw to a user that is comparable to a conventional cigarette.

A substrate may be impregnated with, for example, nicotine by immersion in a solution of nicotine in a volatile carrier solvent (e.g. ethanol) such that the substrate is evenly soaked. The substrate can then be removed and left to dry or baked in an oven, meaning that the carrier is evaporated and the nicotine is left evenly spread throughout the substrate. The nicotine solution may further comprise a flavourant. Alternatively, a flavourant solution and a nicotine solution may be separately impregnated into the substrate.

Further details are set out above in the section “Substrate and its impregnation with active ingredient” relating to the air-permeable substrate and its impregnation with an active ingredient. These details also apply to Development E.

Figures E8, E9 and E10 show an embodiment of Development E of the present invention. The apparatus comprises a housing E802 comprising an air inlet E804 and an outlet E806. The housing is in the form of a cylinder. Between the air inlet E804 and the outlet E806 are two vapour generators E810, E812. A first vapour generator E810, which comprises nicotine, is disposed adjacent to the air inlet E804. A second vapour generator E812, which comprises a flavourant, is disposed closer to outlet E806. Between the first vapour generator E810 and the second vapour generator E812 is a valve E814. The valve E814 is surrounded by a deformable housing region E816 which forms part of the housing E802. The deformable housing region E816 is in the form of a collar around the valve E814. The deformable housing region E816 is made of an elastomeric material. An auxiliary air inlet E808 is disposed downstream of the valve E814 and upstream of the second vapour generator E812. The auxiliary air inlet E808 has a smaller opening area than the air inlet E804.

Figure E8 illustrates an arrangement of the apparatus when the valve E814 is in a closed configuration. In the closed configuration, the valve E814 is in a non-deformed state and fills an internal volume of the deformable housing region E816, such that air cannot pass from the air inlet E804 to the outlet E806 through the apparatus. In use, a user can draw on the apparatus at the outlet E806 and air can flow from the auxiliary air inlet E808, through the second vapour generator E812 to the outlet E806. A user therefore inhales vapour comprising only a flavour (from the second vapour generator E812).

Figure E9 illustrates an arrangement of the apparatus when the compressible valve E814 is in an intermediate configuration. The intermediate configuration is a configuration immediately before the valve adopts an open configuration. In the intermediate configuration, the deformable housing region E816 surrounding the valve E814 is compressed by a user (not shown). This in turn compresses the valve E816. In terms of the possibility of air flow through the apparatus, there is little difference between the closed configuration shown in Figure E8 and the intermediate configuration shown in Figure E9. Air is not permitted to flow from the air inlet E804 to the outlet E806, because the deformable housing region E816 is still in contact with the valve E814 so no air passage is available. Air can only flow through the auxiliary air inlet E808, through the second vapour generator E812 to the outlet E806. Again, the user can only receive vapour comprising the flavour from the second vapour generator E812 on inhalation at the outlet E806.

Figure E10 illustrates an arrangement of the apparatus when the valve E814 is in an open configuration. In the open configuration, the user has released the deformable housing region E816 surrounding the valve E814 and the deformable housing region E816 has returned to its rest configuration as shown in Figure E8. In this configuration, the housing and the deformable housing region adopt a continuous cylindrical shape. The valve E814, being formed from a material with a slower rate of return than the deformable housing region E816, only gradually expands to fill the internal volume of the deformable housing region E816. As shown in Figure E10 , the valve E814 has not yet fully expanded. Thus there is an air passage E818 surrounding the valve E814 and internally of the deformable housing region E816 which allows air to flow from the air inlet E804 to the outlet E806. As indicated above, an air passage is achieved because the speed at which the deformable housing region E816 returns to its original shape is faster than the speed at which the valve E814 expands to fill the volume inside the deformable housing region. Since the opening area of the air inlet E804 is larger than the opening area of the auxiliary air inlet E808, the air flow from the air inlet E804 to the outlet E806 is the predominant air flow through the apparatus when a user inhales at the outlet E806. Thus, a user can receive both nicotine (from the first vapour generator E810) and a flavour (from the second vapour generator E812) on inhalation through the outlet E806.

After a predetermined period of time, the valve E814 will expand to fill the internal volume of the deformable housing region E816 and the device will adopt the closed configuration of Figure E8. The valve E814 may be held in place within the internal volume of the deformable housing region by a web (not shown), for example, which does not impede the flow of air through the air passage E818.

There are alternative embodiments of Development E of the present invention which comprise having more than two vapour generators, or having both the first and second vapour generators upstream of the compressible valve. Vapour generators which are upstream of the compressible valve are not utilised when the valve is in a closed configuration, and active ingredients and / or flavours are only received by the user for a predetermined period of time when the valve is in an open configuration.

The operation of the valve may be understood by consideration of a simple ear plug made of a foamed polymer. In an uncompressed state, the earplug is at its maximum size and shape, corresponding to its rest shape. When a central region of the earplug is compressed, a neck forms in the central region. As the earplug gradually expands over time due to its elastic properties, the neck becomes wider. Eventually, the earplug returns to its rest shape, and the neck disappears. Development F

Considering now in more detail the air-permeable reservoir loaded with a vapour precursor, in the illustrated embodiment the reservoir comprises a nicotine-based liquid impregnated into a substrate. When air is drawn through or over the nicotine-impregnated substrate, the nicotine is vaporised and entrained in the airflow to thereby be delivered to a user. The vapour produced by this process is less visible than an aerosol produced by vaporisation and subsequent condensation of a conventional e-liquid from an e-cigarette, including the remaining aerosol during exhalation by a user. Preferably, the vapour generated by the embodiment is invisible or substantially invisible when exhaled by a user. The porosity or air permeability of at least part of the substrate may be selected so as to provide a resistance to draw to a user that is comparable to a conventional cigarette.

A substrate may be impregnated with nicotine by immersion in a solution of nicotine in a volatile carrier solvent (e.g. ethanol) such that the substrate is evenly soaked. The substrate can then be removed and left to dry or baked in an oven, meaning that the carrier is evaporated and the nicotine is left evenly spread throughout the substrate. The nicotine solution may further comprise a flavourant. Alternatively, a flavourant solution and a nicotine solution may be separately impregnated into the substrate.

Further details are set out above in the section “Substrate and its impregnation with active ingredient” relating to the air-permeable substrate and its impregnation with an active ingredient. These details also apply to Development F.

In the embodiments of Development F of the invention, the substrate is heated during use of the apparatus. The substrate may be heated to a temperature of at least 30°C. This is in order to promote vaporisation of the active ingredient. The temperature is typically not greater than 80°C, or typically not greater than 70°C. This is in order to promote user comfort. Avoiding using high temperatures may also reduce or prevent the degradation of the substrate and/or the active ingredient, and/or other constructional features of the apparatus.

Figure F10 shows a schematic longitudinal cross sectional view of a system F600 for delivering an active ingredient to a user. The system comprises a substrate and a heat source. The substrate is provided in a substrate housing F611 , shown in Figure F8. The heat source is provided in a heat source housing F621 , shown in Figure F9. The substrate housing F611 and heat source housing F621 are configured to be removably attachable to form the system.

The substrate housing F611 comprises a substrate F606 loaded with a source of active ingredient for generating a vapour for inhalation by a user. The heat source housing F621 comprises a heat source F608 for thermal contact with the substrate F606. The heat source F608 comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air.

The system comprises an air inlet F602 and an outlet F604 and an air flow path F610 between the air inlet and the outlet for conveying the active ingredient to the user. As is explained in more detail below, the system is configurable to control access of air to the heat source F608 and thereby to control the generation of heat by the heat source.

The heat source housing F621 comprises a reservoir wall F601 enclosing the exothermic reaction substance. The reservoir wall F601 defines an air ingress port F615 and a cover portion F617 movable with respect to the reservoir wall F601 selectively to uncover the air ingress port F615 to expose the exothermic reaction substance to the air.

The substrate housing F611 has a generally cylindrical form defined by housing tube F620. Housing tube F620 may for example be formed from card. The housing F620 is substantially impermeable to air, if necessary by the provision of an air-impermeable layer (not shown) on the inner surface of the housing tube.

Considering the air inlet F602 and the outlet F604 of the system, there is defined an upstream to downstream direction in the system as a whole and in the substrate housing and in the heat source housing.

Although not shown in Figure F8, the upstream end of the substrate housing may be covered and sealed by an inlet removable seal. The inlet removable seal may take the form of a peelable member, provided with an inlet tab to enable the user to gain a purchase on the peelable member in order to peel it from the inlet and thereby permanently open the substrate housing. The downstream end of the substrate housing may be covered and sealed by an outlet removable seal (not shown). The outlet removable seal may take the form of a peelable member, provided with an outlet tab to enable the user to gain a purchase on the peelable member in order to peel it from the outlet and thereby permanently open the outlet. As will be understood, in other embodiments, the removable seals may take different forms, such as pierceable seals.

The downstream end of the substrate housing may define a mouthpiece for engagement with the user’s lips. This may simply be an external surface of the housing tube at its downstream end, or a mouthpiece element (not shown) may be provided.

Inside the substrate housing F611 is substrate F606. In this embodiment, substrate F606 has a generally annular form, defining an air flow path F610 through it, from the air inlet to the outlet. The substrate is loaded with a source of active ingredient (for example nicotine) for generating a vapour for inhalation by a user. The substrate may be formed from polyethylene, for example. Suitable approaches for manufacturing and impregnating the substrate are explained above.

The substrate F606 is held within the housing tube F620. The seals (not shown) assist in keeping the substrate fresh and ready for use. The heat source F608 comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air. The heat source has an annular form. In this embodiment it is intended that the heat source axially abuts the substrate when the system is assembled, but separated by radial air- impermeable layer F626, disposed at the downstream end of the heat source. An annular air- impermeable layer F624 is provided to define the inner periphery of the heat source F608 and to provide an air flow path through the heat source housing. At the upstream end of the heat source, there is provided a further radial air-impermeable layer F628.

Accordingly, the exothermic reaction substance of the heat source is enclosed by air-impermeable layers F624, F626, F628 and by reservoir wall F601 . The layers may be formed from PLA, bagasse or foil film. The air ingress port F615 defined in the reservoir wall F601 includes an air-permeable layer F622 which permits air to pass through it but which prevents the exothermic reaction substance from passing through the air ingress port F615.

Cover portion F617 includes an annular part F619 and a radial end wall F621. Projecting radially inwardly from the annular part F619 is projection F623, which is sized to be received and retained in air ingress port F615.

Reservoir wall F601 also has recess F625, disposed axially from the air ingress port but not defining a pathway for air to reach the heat source. Recess F625 is sized, shaped and positioned to receive the projection F623.

Fig. F9 shows the cover portion F617 in a closed position. The cover portion F617 is axially moveable with respect to the reservoir wall F601 in order to expose the air ingress port F615. The cover portion F617 can therefore be placed into an open position, in which the air ingress port F615 is open and the projection F623 is received into the recess F625 in order to retain the cover portion F617 in the open position.

In use, the substrate housing and the heat source housing are prepared by the user. The user attaches the heat source housing to the substrate housing as shown in Figure F10, with the cover F617 of the heat source housing in the closed position. When properly assembled, the heat source is in thermal contact with the substrate. The cover F617 is then moved to the open position, so that the air ingress ports F615 are open, to allow air into the heat source and thereby to start the exothermic reaction to generate heat. Air ingress is indicated schematically in Figure F11 by arrows F632. Heat is conducted into the substrate, increasing the vaporisation of active ingredient from the substrate. The heat source also heats air flowing through the central bore defined by the annular air-impermeable layer F624.

The user may operate the system to return the cover F617 to the closed position. For example, the user may do this when the substrate F606 is exhausted of active ingredient. The heat source housing F621 may then be removed from the substrate housing F611 . The substrate housing may be disposed of. However, the heat source may have further useful life, when the exothermic reaction substance in the heat source is not yet exhausted. Accordingly, at a later time, the user may take the same heat source housing and attach it to a further substrate housing to form a further system for delivering an active ingredient to the user, and operate the system as described above.

Figures D14 and D15 are also relevant to Development F and the discussion of these graphs with respect to Development D is incorporated here with respect to Development F.

Accordingly, the embodiments of Development F of the present disclosure provide a means for heating the substrate in a manner that is compliant with safety regulations and yet results in a substantial increase in the release of active ingredient from the substrate over a time period that is consistent with a typical time of use of a smoking substitute apparatus. Furthermore, the apparatus and system can be manufactured efficiently and at a large scale, enabling cost-effective single use disposability of elements of the system.

**************

The features disclosed in the foregoing description, or in the following claims, or in the accompanying drawings, expressed in their specific forms or in terms of a means for performing the disclosed function, or a method or process for obtaining the disclosed results, as appropriate, may, separately, or in any combination of such features, be utilised for realising the invention in diverse forms thereof.

While the invention has been described in conjunction with the exemplary embodiments described above, many equivalent modifications and variations will be apparent to those skilled in the art when given this disclosure. Accordingly, the exemplary embodiments of the invention set forth above are considered to be illustrative and not limiting. Various changes to the described embodiments may be made without departing from the spirit and scope of the invention.

For the avoidance of any doubt, any theoretical explanations provided herein are provided for the purposes of improving the understanding of a reader. The inventors do not wish to be bound by any of these theoretical explanations.

Any section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

Throughout this specification, including the claims which follow, unless the context requires otherwise, the words “have”, “comprise”, and “include”, and variations such as “having”, “comprises”, “comprising”, and “including” will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

It must be noted that, as used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by the use of the antecedent “about,” it will be understood that the particular value forms another embodiment. The term “about” in relation to a numerical value is optional and means, for example, +/- 10%.

The words "preferred" and "preferably" are used herein refer to embodiments of the invention that may provide certain benefits under some circumstances. It is to be appreciated, however, that other embodiments may also be preferred under the same or different circumstances. The recitation of one or more preferred embodiments therefore does not mean or imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the disclosure, or from the scope of the claims.

In the following numbered “clauses” are set out statements of broad combinations of novel and inventive features of the present invention herein disclosed.

Development B

[ME ref: 7592702; Nerudia ref: P01189]

B1 . A vapour delivery apparatus configured to deliver a vapour comprising an active ingredient to a user drawing air through the apparatus for inhalation, the apparatus comprising: an air passage defined between a primary air inlet and an outlet; a vapour generator arranged in the air passage, wherein the vapour generator comprises a first reservoir region formed from an air-permeable substrate and arranged to allow air to be drawn through the first reservoir region, the apparatus further comprising a second reservoir region formed from an air-permeable substrate, wherein the first and second reservoir regions are loaded with a source of an active ingredient, or different active ingredients, for generation of the vapour, the apparatus further comprising an auxiliary air inlet, the auxiliary air inlet being selectively configurable to permit air to flow through the apparatus:

- along a primary flow path passing through the first and second reservoir regions in series, and

- along an auxiliary flow path bypassing at least part of the first reservoir region.

B2. A vapour delivery apparatus according to clause B1 , wherein the apparatus is configured to operate at a temperature of between 30°C and 80°C.

B3. A vapour delivery apparatus according to clause B1 or clause B2, wherein auxiliary air inlet is positioned between the first reservoir region and the second reservoir region.

B4. A vapour delivery apparatus according to any one of clauses B1 to B3, wherein the apparatus further comprises a third reservoir region formed from an air-permeable substrate, and a second auxiliary air inlet.

B5. A vapour delivery apparatus according to clause B4, wherein the secondary auxiliary air inlet is positioned between the second reservoir region and the third reservoir region.

B6. A vapour delivery apparatus according to any one of clauses B1 to B5, wherein the active ingredient of at least one of the reservoir regions comprises nicotine.

B7. A vapour delivery apparatus according to any one of clauses B1 to B6, wherein the primary air inlet is configurable to be closed, when the user chooses to permit air only through one or more of the auxiliary air inlets.

B8. A vapour delivery apparatus according to any one of clauses B1 to B7, wherein the auxiliary air inlet is covered by a removable member.

B9. A method of using a vapour delivery apparatus, the vapour delivery apparatus comprising: an air passage defined between a primary air inlet and an outlet; a vapour generator arranged in the air passage, wherein the vapour generator comprises a first reservoir region formed from an air-permeable substrate and arranged to allow air to be drawn through the first reservoir region, the apparatus further comprising a second reservoir region formed from an air-permeable substrate, wherein the first and second reservoir regions are loaded with a source of an active ingredient, or different active ingredients, for generation of the vapour, the apparatus further comprising an auxiliary air inlet, wherein the method comprises the steps of: configuring the auxiliary air inlet selectively to permit air to flow through the apparatus:

- along a primary flow path passing through the first and second reservoir regions in series, or

- along an auxiliary flow path bypassing at least part of the first reservoir region, and inhaling through the outlet.

B10. A method according to clause B9 further including the step of the user reversing the apparatus so that air is drawn through the apparatus and out of the primary air inlet.

B11 . A method according to clause B9 or clause B10, wherein the first reservoir region and/or the second reservoir region are heated to a temperature between 30°C and 80°C.

B12. A method according to clause B11 , wherein the heating is achieved by immersion in a liquid.

B13. A method according to any one of clauses B9 to B12, wherein the vapour delivery apparatus comprises a third reservoir region loaded with a source of said active ingredient or a different active ingredient to the first and/or second reservoir regions, and a second auxiliary air inlet, the method further comprising the step of configuring the second auxiliary air inlet to permit air to flow through the apparatus:

- along the primary flow path passing through the first, second and third reservoir regions in series, or

- along a first auxiliary flow path bypassing at least part of the first reservoir region; or

- along a second auxiliary flow path bypassing at least part of the first reservoir region and at least part of the second reservoir region.

B14. A method according to any one of clauses B9 to B13, wherein the vapour generated by operation of the apparatus is substantially not visible. Development C

[ME ref: 7631757; Nerudia ref: P01222]

C1 . A consumable preparation apparatus for storing and pre-heating a consumable for use in or as a vapour delivery apparatus, the consumable preparation apparatus comprising: a shaped recess in which said consumable is adapted to fit, a heat source in thermal contact with the shaped recess, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, the consumable comprising a source of an active ingredient and being configured to deliver a vapour comprising said active ingredient to a user drawing air through the consumable.

C2. A consumable preparation apparatus according to clause C1 , wherein the consumable preparation apparatus further comprises one or more air access holes configurable to permit air to access the heat source.

C3. A consumable preparation apparatus according to clause C2, wherein the consumable preparation apparatus further comprises an open configuration in which the one or more air access holes allow air to access the heat source and a closed configuration in which the one or more air access holes do not allow air to access the heat source.

C4. A consumable preparation apparatus according to any one of clauses C1 to C3, wherein the consumable preparation apparatus comprises a top cover and a bottom cover, and wherein the one or more air access holes are located in the top cover, and the heat source is located within the bottom cover.

C5. A consumable preparation apparatus according to any one of clauses C1 to C4, wherein the consumable preparation apparatus further comprises one or more selectively removable covers positioned over the one or more air access holes.

C6. A consumable preparation apparatus according to clause C1 , wherein the consumable preparation apparatus further comprises separate compartments, each separate compartment being adapted for a single consumable to fit and each separate compartment comprising at least a portion of the heat source.

C7. A consumable preparation apparatus according to clause C6, wherein each separate compartment comprises one or more air access holes covered by one or more selectively removable covers.

C8. A consumable preparation apparatus according to any one of clauses C1 to C7, wherein the heat source substance comprises elemental iron. C9. A consumable preparation apparatus according to clause C8, wherein the heat source further comprises cellulose, water, vermiculite, activated carbon and salt.

C10. A consumable preparation apparatus according to clauses C8 or C9, wherein the heat source comprises an air-permeable mesh for containing the heat source.

C11. A consumable preparation apparatus according to any one of clauses C1 to C10, wherein the consumable preparation apparatus is operable to heat the consumable to a temperature up to 50°C.

C12. A consumable preparation apparatus according to any one of clauses C1 to C11 wherein the consumable comprises an air-permeable substrate loaded with the source of the active ingredient.

C13. A method of using a consumable preparation apparatus according to any one of clauses C1 to C12, wherein the method comprises the steps of: providing a consumable fitted into the shaped recess; exposing the heat source to air; and pre-heating the consumable.

C14. A method according to clause C13, wherein the method further comprises the steps of waiting for the consumable to be sufficiently pre-heated for generation of a vapour comprising the active ingredient for inhalation, and then removing the pre-heated consumable from the consumable preparation apparatus for a user to draw air through the consumable for inhalation.

C15. A vapour delivery system comprising a vapour delivery apparatus and a consumable preparation apparatus, the vapour delivery apparatus being configured to deliver a vapour comprising an active ingredient to a user drawing air through the vapour delivery apparatus for inhalation, the vapour delivery apparatus comprising a vapour generator arranged in an air passage, wherein the vapour generator comprises a source of an active ingredient, for generation of the vapour, the consumable preparation apparatus being for storing and pre-heating a consumable, the consumable preparation apparatus comprising: a shaped recess in which said consumable is adapted to fit, a heat source in thermal contact with the shaped recess, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, and wherein the consumable comprises a source of the active ingredient. Development D

[ME ref: 7631773; Nerudia ref: P01224]

D1 . A consumable apparatus for delivering an active ingredient to a user, the consumable apparatus comprising: an air inlet, an outlet, a substrate loaded with a source of active ingredient for generating a vapour for inhalation by a user, a heat source in thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, an air flow path between the air inlet and the outlet for conveying the active ingredient to the user, wherein the apparatus is configurable to control access of air to the heat source and thereby to control the generation of heat by the heat source, the apparatus comprising a removable seal, the removable seal being configured to be permanently opened prior to use of the consumable apparatus to allow ingress of air to the heat source.

D2. An apparatus according to clause D1 wherein the heat source is disposed around the substrate.

D3. An apparatus according to clause D1 or clause D2 wherein the substrate includes an air flow passage.

D4. An apparatus according to any one of clauses D1 to D3 wherein the substrate is formed of air- permeable material.

D5. An apparatus according to any one of clauses D1 to D4 wherein the heat source is at least partially enclosed by an air-permeable layer through which, when the seal is removed, air can access the heat source.

D6. An apparatus according to any one of clauses D1 to D5 wherein an air-impermeable barrier is provided between the heat source and the substrate.

D7. An apparatus according to any one of clauses D1 to D6 wherein there is provided a housing for the user to hold, the housing providing an outer wall enclosing the heat source, the housing being disposable with the substrate and heat source.

D8. An apparatus according to any one of clauses D1 to D6 wherein there is provided a housing for the user to hold, the consumable apparatus being configured to be removably attachable to the housing to form a system for delivering the active ingredient to the user. D9. An apparatus according to clause D8 wherein the consumable apparatus is single use and the housing is re-usable.

D10. A method of operating a consumable apparatus to deliver an active ingredient to a user, the consumable apparatus comprising: an air inlet, an outlet, a substrate loaded with a source of active ingredient for generating a vapour for inhalation by a user, a heat source in thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, an air flow path between the air inlet and the outlet for conveying the active ingredient to the user, a removable seal, wherein, before use, the removable seal seals the apparatus from ingress of air to the heat source, the method including the step of permanently removing the seal to allow access of air to the heat source.

D11. A method according to clause D10 wherein the removable seal is removed by peeling.

D12. A method according to clause D10 or clause D11 wherein there is provided a housing for the user to hold, the housing providing an outer wall enclosing the heat source, the housing being disposed of with the substrate and heat source after a single use.

D13. A method according to clause D10 or clause D11 wherein there is provided a housing for the user to hold, the consumable apparatus being attached to the housing to form a system for delivering the active ingredient to the user, operating the system to delivering the active ingredient to the user.

D14. A method according to clause D13 including the further step of then detaching the consumable apparatus from the housing and re-using the apparatus by attaching a fresh consumable apparatus to the housing to form a further system for delivering the active ingredient to the user.

D15. A method according to any one of clauses D10 to D14 wherein the heat source heats at least part of the substrate to a temperature of at least 35°C. Development E

[ME ref: 7631781 ; Nerudia ref: P01225 ]

E1 . A vapour delivery apparatus for the delivery of a vapour to a user drawing air through the apparatus, the apparatus comprising: an air inlet; an outlet; a first vapour generator disposed between the air inlet and the outlet, the vapour generator comprising a substrate containing an active ingredient, the vapour generator being configured to generate a vapour comprising the active ingredient for entrainment in an air flow between the air inlet and the outlet; a valve configured to control said air flow between the air inlet and the outlet; wherein the valve is operable by a user to adopt an open configuration and to remain in the open configuration for a predetermined period of time after operation of the valve and then adopting a closed configuration after the predetermined period of time.

E2. The apparatus according to clause E1 , wherein the valve comprises an elastomeric material.

E3. The apparatus according to clauses E1 or E2, wherein the first vapour generator is disposed upstream of the valve.

E4. The apparatus according to any one of clauses E1 to E3, wherein the substrate of the first vapour generator comprises an air-permeable material.

E5. The apparatus according to any one of clauses E1 to E4, wherein the apparatus further comprises a deformable housing region comprising an elastomeric material, the deformable housing region being positioned in the apparatus to enable the user to operate the valve via the deformable housing region.

E6. The apparatus according to clause E5, wherein the elastomeric material of the deformable housing region has a faster elastic return rate than the elastomeric material of the valve.

E7. The apparatus according to any one of clauses E1 to E6, wherein the apparatus further comprises a second vapour generator comprising a substrate containing an active ingredient and / or a flavourant.

E8. The apparatus according to clause E7, wherein the second vapour generator is disposed upstream of the valve.

E9. The apparatus according to clause E7, wherein the second vapour generator is disposed downstream of the valve and the apparatus further comprises an auxiliary air inlet, the auxiliary air inlet being disposed downstream of the valve and upstream of the second vapour generator. E10. The apparatus according to clause E9, wherein the opening area of the auxiliary air inlet is smaller than the opening area of the air inlet.

E11. The apparatus according to any one of clauses E7 to E10, wherein the substrate of the second vapour generator comprises an air-permeable material.

E12. The apparatus according to any one of clauses E1 to E11 , wherein the predetermined period of time is between 3 and 5 minutes.

E13. A method of operating a vapour delivery apparatus, the vapour delivery apparatus comprising: an air inlet; an outlet; a first vapour generator disposed between the air inlet and the outlet, the vapour generator comprising a substrate containing an active ingredient, the vapour generator being configured to generate a vapour comprising the active ingredient for entrainment in an air flow between the air inlet and the outlet, said air flow being driven by a user inhaling air through the vapour delivery apparatus; and a valve; wherein the method comprises the step of: the user operating the valve to control the air flow between the air inlet and the outlet, operation of the valve causing the valve to adopt an open configuration and then to remain in said open configuration for a predetermined period of time and then to adopt a closed configuration without further operation of the valve by the user.

E14. A method according to clause E13, wherein the method further comprises the steps of: the user deforming the shape of the valve in order to operate the valve by applying a force to the valve; the user releasing the force on the valve, the valve then remaining in a deformed shape and thereby in the open configuration for a predetermined period of time, the valve then recovering from its deformed shape back to a non-deformed shape to adopt a closed configuration, and the user inhaling on the vapour delivery apparatus and receiving a vapour comprising at least said active ingredient during the predetermined period of time.

E15. A method according to clauses E13 or E14, wherein the predetermined period of time is between 3 and 5 minutes. F

[ME ref: 7661846; Nerudia ref: P01282 ]

F1 . A system for delivering an active ingredient to a user, the system comprising: a substrate housing; a heat source housing, wherein the substrate housing and heat source housing are configured to be removably attachable to form the system, the substrate housing comprising a substrate loaded with a source of active ingredient for generating a vapour for inhalation by a user, the heat source housing comprising a heat source for thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, the system further comprising an air inlet and an outlet and an air flow path between the air inlet and the outlet for conveying the active ingredient to the user, wherein the system is configurable to control access of air to the heat source and thereby to control the generation of heat by the heat source, wherein the heat source housing comprises a reservoir wall enclosing the substance and defining an air ingress port and a cover portion movable with respect to the reservoir wall selectively to uncover the air ingress port to expose the substance to the air.

F2. A system according to clause F1 wherein, when the system is assembled, the heat source is disposed axially adjacent the substrate.

F3. A system according to clause F1 or clause F2 wherein the substrate includes an air flow passage.

F4. A system according to any one of clauses F1 to F3 wherein the heat source includes an air flow passage.

F5. A system according to any one of clauses F1 to F4 wherein the substrate is formed of air- permeable material.

F6. A system according to any one of clauses F1 to F5 wherein an air-impermeable barrier is provided between the heat source and the substrate.

F7. A system according to any one of clauses F1 to F6 wherein the reservoir wall includes an air- permeable layer portion at the air ingress port, to retain exothermic reaction substance within the heat source. F8. A system according to any one of clauses F1 to F7 wherein the substrate housing is configured to be single use disposable and the heat source housing is configured to be re-usable.

F9. A heat source housing for providing heat to a system for delivering an active ingredient to a user, the heat source housing being configured to be removably attachable to a substrate housing to form the system, the heat source housing comprising a heat source for thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, the heat source housing comprising an air inlet and an outlet and an air flow path between the air inlet and the outlet, wherein the heat source housing is configurable to control access of air to the heat source and thereby to control the generation of heat by the heat source, wherein the heat source housing comprises a reservoir wall enclosing the substance and defining an air ingress port and a cover portion movable with respect to the reservoir wall selectively to uncover the air ingress port to expose the substance to the air.

F10. A method of operating a system for delivering an active ingredient to a user, the system comprising: a substrate housing; a heat source housing, the substrate housing comprising a substrate loaded with a source of active ingredient for generating a vapour for inhalation by a user, the heat source housing comprising a heat source for thermal contact with the substrate, wherein the heat source comprises a substance capable of producing an exothermic reaction to generate heat when exposed to air, wherein the heat source housing comprises a reservoir wall enclosing the substance and defining an air ingress port and a cover portion movable with respect to the reservoir wall selectively to uncover the air ingress port to expose the substance to the air, the system further comprising an air inlet and an outlet and an air flow path between the air inlet and the outlet for conveying the active ingredient to the user, the method including the steps: attaching the substrate housing and heat source housing to form the system, and controlling access of air to the heat source and thereby to control the generation of heat by the heat source by moving the cover portion with respect to the reservoir wall selectively to uncover the air ingress port to expose the substance to the air.

F11 . A method according to clause F10 wherein, when the system is assembled, the heat source is disposed axially adjacent the substrate.

F12. A method according to clause F10 or clause F11 wherein the substrate housing is configured to be single use disposable and the heat source housing is configured to be re-usable. F13. A method according to any one of clauses F10 to F12, the method further including the step of moving the cover portion with respect to the reservoir wall to cover the air ingress port to prevent further ingress of air into the heat source.

F14. A method according to clause F13, the method further including the step of detaching the heat source housing from the substrate housing, disposing of the substrate housing, and attaching the same heat source housing to a fresh substrate housing to form a new system.

F15. A method according to any one of clauses F10 to F14 wherein the heat source heats at least part of the substrate to a temperature of at least 35°C.

Claims

Claims:

1 . A vapour delivery apparatus configured to deliver a vapour comprising an active ingredient to a user drawing air through the apparatus for inhalation, the apparatus comprising: an air passage defined between an air inlet and an outlet; a vapour generator arranged in the air passage, wherein the vapour generator comprises a substrate loaded with a source of an active ingredient for generation of the vapour, the vapour generator comprising a constricted air flow region adapted to provide a higher air flow velocity in the constricted air flow region than an air flow velocity in the air passage upstream of the vapour generator for a given air flow rate from the air inlet to the outlet, the constricted air flow region being bounded on at least one side by the substrate to extract vapour from the substrate into the air flow in the constricted air flow region.

2. A vapour delivery apparatus according to claim 1 , wherein the substrate comprises nicotine and / or a flavourant.

3. A vapour delivery apparatus according to claims 1 or 2, wherein the substrate comprises air impermeable walls.

4. A vapour delivery apparatus according to any one of claims 1 to 3, wherein the substrate comprises a material of limited air-permeability.

5. A vapour delivery apparatus according to any one of claims 1 to 4, wherein the substrate comprises a liquid permeable material.

6. A vapour delivery apparatus according to any one of claims 1 to 5, wherein the constricted air flow region passes axially through the substrate.

7. A vapour delivery apparatus according to any one of claims 1 to 6, wherein the constricted air flow region comprises a single bore through the substrate.

8. A vapour delivery apparatus according to any one of claims 1 to 6, wherein the constricted air flow region comprises multiple bores through the substrate.

9. A vapour delivery apparatus according to any one of claims 1 to 8, wherein the apparatus comprises more than one vapour generator.

10. A vapour delivery apparatus according to any one of claims 1 to 9 which does not include a source of heat.

11. A method of operating a vapour delivery apparatus, the vapour delivery apparatus comprising: an air passage defined between an air inlet and an outlet; a vapour generator arranged in the air passage, wherein the vapour generator comprises a substrate loaded with a source of an active ingredient for generation of the vapour, the vapour generator comprising a constricted air flow region, the constricted air flow region being bounded on at least one side by the substrate; wherein the method comprises the steps of: the user inhaling at the outlet to generate an air flow, wherein an air flow velocity in the constricted air flow region is higher than the air flow velocity in the air passage upstream of the vapour generator for a given air flow rate from the air inlet to the outlet; and the user receiving the active ingredient from extraction of a vapour from the substrate into the air flow in the constricted air flow region.

12. A method according to claim 11 wherein the substrate is not actively heated.