Product for oral delivery

Abstract

A product for oral delivery of a substance including an active agent is provided. The product includes: a first fabric; and the substance adhered to the first fabric. The substance is adhered to the first fabric in the form of discrete dots. Also provided is a method of manufacturing a product for oral delivery of a substance including an active agent. The method includes the steps of: providing a first fabric; providing the substance; and adhering the substance to the first fabric in the form of discrete dots.

Description

FIELD OF THE INVENTION

[0001] The present invention relates to a product for oral delivery of a substance comprising an active agent and a method of manufacturing a product for oral delivery of a substance comprising an active agent.BACKGROUND

[0002] It is known to use fabrics (e.g. non-woven fabrics) to manufacture products for oral delivery of a substance comprising an active agent (e.g. nicotine). For example, fabrics are used to make pouches for containing an individual portion of a product, such as smokeless tobacco (also known as “snus”), coffee, tea, etc. from which an active substance (e.g. nicotine, caffeine, and / or flavour compounds) is to be extracted. Examples of oral pouched products formed from a non-woven fabric can be found in US 2014 / 0026912 A1 and US 2012 / 0103353 A1.

[0003] Products comprising structures other than pouches are known, for example EP4117460A1 providing a chewable product for oral delivery of a substance having a non-woven fabric substrate having a matrix of interleaved fibres and a substance held within the matrix.

[0004] Release of the active agent to the user of such products is dependent on, amongst other factors, the amount of substance contained in the product, the ability of fluid to reach the substance, and the surface area of the substance in contact with fluid.

[0005] The present invention has been devised in light of the above considerations.SUMMARY OF THE INVENTION

[0006] At its most general, the present disclosure relates to the adherence of a substance comprising an active agent for oral delivery onto a fabric, the substance adhered onto the fabric in the form of discrete dots.

[0007] In a first aspect, there is provided a product for oral delivery of a substance comprising an active agent, the product comprising: a first fabric; and the substance adhered to the first fabric; wherein the substance is adhered to the first fabric in the form of discrete dots.

[0008] In contrast to conventional products for oral delivery of substances, where the substance is typically either impregnated into, or coated onto, the first fabric uniformly, distribution of the substance in the form of discrete dots can increase the surface area of the substance exposed to fluid (e.g. saliva) when positioned in a user's oral cavity and reduce occlusion of the substance. This can deliver increased transfer rates of the active agent to the user. Additionally, by there being regions of the first fabric not coated or impregnated with the substance (i.e. regions in between the discrete dots), permeation of fluid (e.g. saliva) through the first fabric can be increased.

[0009] Moreover, the position, size, and density of the dots on the first fabric can be tailored to provide bespoke functional capability and tuning of the substance release profile.

[0010] The discrete dots of the substance on the first fabric may provide a pattern (i.e. a regularly repeated arrangement of a plurality of dots). Such a pattern may allow for easier identification of the product (e.g. by the user). The discrete dots of the substance may be coloured (i.e. the substance may contain a colourant).

[0011] The active agent may be a pharmaceutical material, smokeless tobacco, nicotine salts, free nicotine base, cannabidiol (CBD), Tetrahydrocannabinol (THC), coffee, tea, flavourants, or the like. For example, the active agent may consist or comprise any one or more of: amino acids, in particular taurine, lysine, tryptophane, theanine, tyrosine, or 5-HTP; alkaloids, in particular nicotine, anatabine, caffeine, ketamine, theobromine or theophylline; natural or synthetic cannabinoids, in particular cannabinol, cannabidivarin, cannabichromen, cannabidiol, cannabigerol, tetrahydrocannabivarin, Delta-8-tetrahydrocannabinol, Delta-9-tetrahydrocannabinol or Delta-x-tetrahydro cannabidiol; hormones, in particular melatonin; vitamins or minerals. The adherence of such active agent in the form of discrete dots may provide increased transfer rates to the user over conventional products for the oral delivery of such substances.

[0012] The first fabric may be a non-woven fabric, a woven fabric, or a knitted fabric.

[0013] The non-woven fabric may comprise staple fibres of a material that complies with food contact regulations, i.e. is approved for use in food packaging or the like. The staple fibres may be natural fibres, such as cotton or bamboo, or regenerated cellulosic fibres, such as viscose and / or lyocell. The staple fibres may comprise bicomponent fibres or monofilament fibres. The staple fibres may be synthetic fibres such as nylon or polyester.

[0014] The non-woven fabric may comprise a matrix of staple fibres bonded together by a binder, for example, a conventional dry-laid chembond non-woven material, e.g. formed from viscose fibres that are chemically (e.g. adhesively) bonded together with a suitable binder. Alternatively, the non-woven fabric may be a needle-punched non-woven fabric, such that staple fibres of the non-woven fabric are entangled. The non-woven fabric may be a thermo-bonded non-woven fabric, a spun-bond non-woven fabric, a spun-lace non-woven fabric, a wet-laid non-woven fabric, or a carded non-woven fabric.

[0015] The substance may be adhered to the first fabric by a first adhesive interposed between the first fabric and the substance. In this way, it is possible to apply the substance to the first fabric in the form of discrete dots without the substance itself being adherent. The substance may be discrete from the first adhesive (e.g. in a different phase to, or applied in a subsequent step to, the first adhesive). The first adhesive may be a thermoplastic adhesive. Thermoplastic adhesives do not undergo a chemical reaction (e.g. cross linking) when setting and accordingly can be re-softened (e.g. by heating, or wetting) to allow for application of the substance after the initial application and setting of the adhesive. Adherence of the substance to the first fabric by a first adhesive interposed therebetween can allow for an active agent with poor dissolution characteristics within a soluble, printable composition to be included in the product.

[0016] The first adhesive may be applied to the first fabric in the form of discrete dots. In this way, the substance may be applied as a granular material (e.g. a powder) wherein each individual grain has a different form to the desired shape and / or size of the discrete dots of substance on the fabric. By way of example, the first adhesive may be applied to the first fabric by screen printing of discrete dots of adhesive, and optionally, a substance in granular form scatter coated onto the first fabric to adhere to the discrete dots of first adhesive. Additionally, applying the first adhesive in the form of discrete dots, rather than, for example, uniformly coating the first fabric in first adhesive, can improve the permeability of the first fabric and reduce the amount of adhesive used.

[0017] The first adhesive may comprise a further active agent (a first adhesive active agent) in addition to the active agent comprised in the substance (the substance active agent). The first adhesive active agent may be the same as, or different to, the substance active agent. In this way, increased amounts of, or different, active agents can be included in the product. In one example, a different active agent can be included as the first adhesive active agent without the first adhesive active agent needing to be included in the substance. Accordingly, active agents that are not compatible with (e.g. are unstable in the presence of) the substance active agent, can be included in the product.

[0018] The first adhesive may be coloured (i.e. the first adhesive may contain a colourant).

[0019] The substance may be in the form of solid particulates. By way of example, where the substance is adhered to the first fabric by the first adhesive in the form of discrete dots, the substance may be applied to the first fabric by scatter coating solid particulates of the substance over the first fabric and the first adhesive.

[0020] Alternatively, the substance may be directly adhered (i.e. absent any intervening layer or adhesive) to the first fabric (e.g. in the form of a gel material). In this way, an intermediate step of applying an adhesive to the first fabric, to which the substance containing active agent is then applied in a subsequent step, can be omitted. That is, the active agent-containing substance can itself be an adhesive. This can simplify manufacture of the product. A gel material may provide a convenient carrier medium for the active agent. The first fabric may provide a robust framework for the gel material to adhere itself to, in order to permit release of the active agent in an aqueous environment (e.g. within a user's oral cavity). The gel material may be an aqueous gel (i.e. a hydrogel) formed by mixing water with a suitable gelling agent, such as agar-agar, alginates, carrageenan, cellulose derivates, in particular carboxy methylcellulose and hydroxypropyl methylcellulose, polyvinyl pyrrolidone, polyvinyl acetate, and mixtures of at least two of the afore-said hydrogel forming components.

[0021] The substance may be directly adhered to the first fabric by screen printing of discrete dots of the substance. This provides a convenient way to apply the substance directly to the fabric within a fabric production line.

[0022] The first adhesive, or the substance directly adhered to the fabric, may also act as a binder for the non-woven fabric. By way of example, said substance or first adhesive may comprise an acrylic compound; a biodegradable binder compound such as polybutylene succinate (PBS); or polyurethane.

[0023] The viscosity of the first adhesive or the substance directly adhered to the fabric may be greater than or equal to 19 cPas and less than or equal to 30 cPas. Preferably, the viscosity may be around 25 cPas, e.g. between 24 cPas and 26 cPas. Such viscosities are suitable for (screen) printing of said substance or first adhesive, such that the dots do not flow and amass after printing. Depending on the composition of the compounds in said first adhesive or substance (e.g. a binder compound, such as PBS), said first adhesive or substance may further comprise a thickening agent in order to provide the first adhesive or substance with such a viscosity. The thickening agent may be selected from the group consisting of: kappa-carrageenan (Kappa-C), sulphated polysaccharides (SP), Hydroxypropyl Methylcellulose (HPMC)). Such thickening agents are food-contact safe and thus suitable for inclusion in products for oral delivery of a substance.

[0024] The substance, in addition to the active agent, may be soluble in fluid (e.g. saliva) from a user's oral cavity. In this way, the substance and active agent may be dissolved and removed from the product during use of the product. Where the substance contains a colourant, the dissolution of the substance from the product, and thus the fading of the colour on the product, may indicate the consumption of the active agent to the user.

[0025] The product may further comprise a second fabric; and the substance may be sandwiched between the first and second fabrics. By sandwiching the substance between the first and second fabrics, the second fabric acts to protect the substance and the active agent therein (e.g. from oxidation or abrasion leading to detachment of the dots from the first fabric) and provide bulk for the product itself. Such a product may be suitable for direct application within a user's oral cavity, e.g. without containment within a pouch (e.g. without sealing the first fabric to the second fabric at the edges thereof) or any other further protective structure.

[0026] The second fabric may be a non-woven fabric, a woven fabric, or a knitted fabric. The second fabric may be the same as the first fabric (e.g. in composition and structure).

[0027] The second non-woven fabric may comprise staple fibres of a material that complies with food contact regulations, i.e. is approved for use in food packaging or the like. The staple fibres may be natural fibres such as cotton or bamboo, or regenerated cellulosic fibres such as viscose and / or lyocell. The staple fibres may comprise bicomponent fibres or monofilament fibres. The staple fibres may be synthetic fibres such as nylon or polyester.

[0028] The second non-woven fabric may comprise a matrix of staple fibres bonded together by a binder, for example, a conventional dry-laid chembond non-woven material, e.g. formed from viscose fibres that are chemically (e.g. adhesively) bonded together with a suitable binder. Alternatively, the second non-woven fabric may be a needle-punched non-woven fabric, such that staple fibres of the non-woven fabric are entangled. The second non-woven fabric may be a thermo-bonded non-woven fabric, a spun-bond non-woven fabric, a spun-lace non-woven fabric, a wet-laid non-woven fabric, or a carded non-woven fabric.

[0029] The second fabric may be adhered to the substance and / or the first fabric. Adhering the second fabric to the first fabric (and not to the substance) may be advantageous in reducing occlusion of the dots of substance and increasing the surface area of the substance that is exposed to fluid (e.g. saliva) when positioned in a user's oral cavity, thereby delivering increased transfer rates of the active agent to the user. By adhering the second fabric to the substance, rather than the first fabric, permeation of fluid through said fabrics and into a space therebetween containing the substance may be increased, as a reduced portion of the first and second fabrics are bonded to each other (bonding reducing permeability). The second fabric may be adhered to the substance and / or the first fabric by a second adhesive interposed between the second fabric and the substance and / or the first fabric. In this way, the first and second fabric do not need to be heat-sealable to each other, which may provide increased flexibility with regards to the composition of the first fabric and second fabric and may allow for a lower thermoplastic content in the first fabric and second fabric.

[0030] The second adhesive may be different to the first adhesive (or the substance directly adhered to the first fabric). For example, the first adhesive (or the substance directly adhered to the first fabric) may have a higher melting temperature than the second adhesive. In this way, the first adhesive (or the substance directly adhered to the first fabric) may not soften or melt when the second adhesive is applied to the product.

[0031] The second adhesive may be applied to the second fabric in the form of discrete dots. Distribution of the second adhesive in the form of discrete dots can increase the surface area of the second fabric through which fluid (e.g. saliva) from a user's oral cavity can easily permeate (i.e. the areas to which the second adhesive has not been applied) and reduce occlusion of the substance. This can deliver increased transfer rates of the active agent to the user. The second adhesive may be screen printed on to one or more of the first fabric, the substance, and the second fabric. This provides a convenient manner in which to apply the second adhesive in the form of discrete dots.

[0032] The second fabric may be adhered to the first fabric (and, optionally, not to the substance) by the spacing of the discrete dots of second adhesive applied to the second fabric being different to the spacing of the discrete dots of the substance on the first fabric and / or the discrete dots of second adhesive being offset from (e.g. interposed between) the dots of substance on the first fabric when the substance is sandwiched between the first and second fabrics. To avoid the second fabric from being adhered to the substance, the position of the discrete dots of second adhesive may be positioned such that they are not coincident with the discrete dots of the substance on the first fabric when the substance is sandwiched between the first and second fabrics. By adhering the second fabric to the first fabric and not the substance, occlusion of the surface of the substance can be reduced, increasing the surface area of the substance that is exposed to fluid (e.g. saliva) when positioned in a user's oral cavity, thereby delivering increased transfer rates of the active agent to the user.

[0033] The discrete dots of the second adhesive on the second fabric may have an average distance of 150-450 μm between adjacent dots, more preferably 300-400 μm (for example, about 350 μm), or alternatively 300-600 μm between adjacent dots.

[0034] The discrete dots of the substance (and / or first adhesive, where present) on the first fabric have an average distance of 300-550 μm between adjacent dots, preferably 400-500 μm (for example, about 450 μm) or 300-400 μm between adjacent dots.

[0035] Increasing the average distance between the discrete dots of the substance can provide larger pathways for permeation of fluid to the substance, potentially increasing the dissolution rate of the substance and / or active agent. However, increasing the average distance between the discrete dots of the substance also reduces the amount of substance per unit area of the first fabric.

[0036] The average distance between the discrete dots of the substance (and / or first adhesive) on the first fabric may be different to the average distance between the discrete dots of the second adhesive on the second fabric. With a difference in distance between the discrete dots of the substance (and / or first adhesive) and second adhesive, excessive occlusion of the discrete dots of the substance can be avoided and fluid flow through the product is improved, increasing contact of fluid (e.g. saliva) when positioned in a user's oral cavity. Furthermore the properties of the first and second adhesives can be tailored to materials they are adhering together, as the first adhesive may primarily adhere the first fabric to the substance and the second adhesive may primarily adhere the second fabric to the first fabric. By way of example, the average distance between the discrete dots of the substance (and / or first adhesive) on the first fabric may be less than the average distance between the discrete dots of the second adhesive on the second fabric.

[0037] The discrete dots of the substance on the first fabric may have an average diameter of greater than or equal to 100 μm and less than or equal to 800 μm, preferably 450-650 μm, more preferably 500-600 μm, or alternatively 300-600 μm.

[0038] The discrete dots of the second adhesive on the second fabric may have an average diameter of greater than or equal to 100 μm and less than or equal to 800 μm, preferably 200-400 μm, more preferably 250-350 μm, or alternatively 300-600 μm.

[0039] The size and density of the dots (of the substance, the first adhesive (where present) and / or second adhesive (where present)) may influence the flexural rigidity of the product. Increased dot diameter and reduced distance between dots corresponds to increased flexural rigidity. The flexural rigidity influences the mouthfeel of the product, with low flexural rigidity corresponding to improved mouthfeel. The preferred dot diameters and distance between dots above help to provide a product having a desirable flexural rigidity, whilst also providing sufficient loading of the substance (and thus active agent).

[0040] The diameter of, and the distance between, dots may be defined by first defining a circle around a given dot which is the smallest circle containing the entire dot. The diameter of that circle can then be taken as the (effective) diameter of the dot; the minimum distance between any point of that circle and a point on any adjacent circle around another dot can be taken as the distance between those dots. That is, it is the distance between the edges of the circles (dots), rather than the distance between their centres, which is considered.

[0041] In general dot diameter and spacing may be affected by factors such as the specific substance / adhesive / gel used and, where the dots are screen printed, the print screen selected.

[0042] The second adhesive may comprise an active agent. The second adhesive active agent may be the same as, or different to, the substance active agent (and / or the first adhesive active agent, where present). In this way, a further active agent can be included in the product without that active agent needing to be included in the substance comprising the active agent.

[0043] The product may be an oral pouched product, wherein the product comprises a pouch for containing a pouch filling, and the pouch comprises the first fabric. The first fabric may be comprised in the pouch such that the discrete dots of substance are provided on an exterior surface and / or an interior surface of the pouch, Providing the substance on the exterior surface of the pouch may provide increased transfer rates of the active agent to the user, as the substance, once dissolved in liquid (e.g. saliva) does not need to diffuse through the fabric to reach the user. Providing the substance on the interior surface of the pouch may provide improved shelf-life of the active agent within the substance (e.g. through slower oxidation). The pouch may comprise a second fabric, for example, the first and second fabric may form opposite portions of the pouch and define a pouch cavity therebetween. The second fabric may have discrete dots of a substance containing an active agent adhered thereto (e.g. the same substance as applied to the first fabric, or a different substance). The discrete dots of the substance on the second fabric may be provided on an exterior surface and / or an interior surface of the pouch. By providing the discrete dots of the substance on an exterior surface of the pouch, dissolution and delivery of the active agent therefrom to the user may occur faster than delivery of an active agent contained in the pouch filling.

[0044] Alternatively, the product may be a non-pouched oral product, e.g. comprising single layer of fabric with the substance adhered thereto in the form of discrete dots, or a multi-layered product comprising a plurality of layers and with the substance adhered to one of said layers, and optionally sandwiched between two of said layers. Where a plurality of layers of fabric are present, each layer may comprise a substance adhered to that fabric, the substance containing an active agent (as described above in relation to the first fabric and substance). An active agent in a substance adhered to one layer may be different from an active agent in a substance adhered to another layer.

[0045] In a second aspect there is provided a method of manufacturing a product for oral delivery of a substance comprising an active agent, the method comprising the steps of: providing a first fabric, providing the substance; and adhering the substance to the first fabric in the form of discrete dots.

[0046] The product manufactured by the method may be the product according to the first aspect. Any one or more of the optional features set out in relation to the first aspect may be applied to the second aspect, except where such a combination is clearly impermissible or expressly avoided.

[0047] The step of adhering the substance to the first fabric may comprise: applying a first adhesive to the first fabric in the form of discrete dots; and applying the substance to the first adhesive.

[0048] The method may comprise applying the substance to the first adhesive by scatter coating. Scatter coating may be understood to mean scattering particles of the substance over the fabric. Alternatively, the application of the substance to the first adhesive may be conducted by applying the adhesive-treated surface of the first fabric to a bed of particles. The substance may be applied by a revolving brush; or an engraved roller; a knurled roller; or by a vibrating plate or sieve. Some such methods may result in excess (non-adhered) particles of the substance being present on the first fabric. Thus, the method may further comprise a step of removing excess substance from the first fabric, leaving only the particles adhered to the first fabric by the first adhesive. Such removal may be achieved by, for example, a simple shaking or other agitation technique, or vacuum suction (at a level insufficient to remove particles adhered to the first fabric by the first adhesive).

[0049] The first adhesive may be screen printed onto the first fabric.

[0050] Alternatively, the substance may be directly adhered (i.e. absent any intervening layer or adhesive) to the first fabric (e.g. in the form of a gel material), and the step of adhering the substance to the first fabric may comprise directly adhering the substance to the first fabric. The step of adhering the substance may comprise: preparing the substance (e.g. gel material); heating the substance and, optionally, the first fabric, to an application temperature; and depositing the substance directly onto the first fabric. It may be advantageous to apply the substance at an elevated temperature to promote ingress or migration of the substance into the first fabric so that strong adherence is achieved. For example, the substance may permeate into the first fabric more readily at an elevated temperature. The application temperature may be equal to or greater than 40° C., e.g. any temperature in the range 40-60° C.

[0051] The method may comprise screen printing the substance (e.g. gel material) onto the first fabric.

[0052] The method may further comprise the steps of: providing a second fabric; and sandwiching the substance between the first and second fabrics. The step of sandwiching the substance between the first and second fabrics may comprise adhering the second fabric to the substance and / or the first fabric. The method may comprise adhering the second fabric to the substance and / or the first fabric using a second adhesive, the second adhesive, for example, being in the form of discrete dots. The method may further comprise applying the second adhesive to the second fabric, or alternatively applying the second adhesive to the first fabric and / or the substance.

[0053] Where the second adhesive is in the form of discrete dots, the method may comprise screen printing the second adhesive onto the second fabric. The step of screen printing the second adhesive onto the second fabric may be conducted before, concurrently with, or after, the step of adhering the substance to the first fabric and / or applying the first adhesive to the first fabric. Alternatively, the method may comprise screen printing the second adhesive onto the first fabric and / or the substance.

[0054] In some embodiments, there may be a significant period of time between applying the first adhesive to the first fabric and applying the substance to the first adhesive; accordingly, the step of applying the substance to the first adhesive may be conducted after the first adhesive has dried / solidified, and thus the method may comprise re-softening (e.g. by reheating (e.g. to melt) and / or re-wetting (e.g. to hydrate)) the first adhesive. Similarly, there may be a significant period of time between applying the second adhesive (e.g. to the second fabric, or to the first fabric and / or substance) and sandwiching the substance between the first and second fabrics; accordingly, the step of sandwiching the substance between the first and second fabrics may be conducted after the second adhesive has dried / solidified, and thus the method may comprise re-softening (e.g. by reheating (e.g. to melt) and / or re-wetting (e.g. to hydrate)) the second adhesive.

[0055] The invention includes the combination of the aspects and preferred features described except where such a combination is clearly impermissible or expressly avoided.SUMMARY OF THE FIGURES

[0056] Embodiments and experiments illustrating the principles of the invention will now be discussed with reference to the accompanying figures in which:

[0057] FIG. 1A is a schematic of a first embodiment of a product according to the present disclosure;

[0058] FIG. 1B is a schematic of a second embodiment of a product according to the present disclosure;

[0059] FIG. 2A is a schematic of a third embodiment of a product according to the present disclosure;

[0060] FIG. 2B is a schematic of a fourth embodiment of a product according to the present disclosure;

[0061] FIG. 2C is a schematic of a fifth embodiment of a product according to the present disclosure;

[0062] FIG. 2D is a schematic of a sixth embodiment of a product according to the present disclosure; and

[0063] FIG. 3 is a flowchart schematically showing steps of a method according to the present disclosure.DETAILED DESCRIPTION OF THE INVENTION

[0064] 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. All documents mentioned in this text are incorporated herein by reference.

[0065] As explained above, the present invention relates to product for oral delivery of a substance 1 comprising an active agent. The product comprises a first, non-woven, fabric 10, and the substance 1 is adhered to the first fabric in the form of discrete dots.

[0066] FIGS. 1A and 1B illustrate first and second embodiments of the product, respectively. It can be appreciated that FIGS. 1A and 1B are schematic and not to scale. In the first and second embodiments, the product comprises only a first fabric 10 to which the substance 1 is adhered, rather than the substance 1 being adhered to, and sandwiched between the first fabric 10 and a second fabric. This single fabric configuration can reduce the time for fluid (e.g. saliva) to reach the substance when the product is placed in the user's oral cavity compared to where the substance 1 is sandwiched between two fibre layers, since permeation of fluid through a fabric layer is not required for the active agent to reach the user.

[0067] As illustrated in FIGS. 1A and 1B, the substance 1 is positioned on the first fabric 10 in the form of discrete dots, with uniform distance between adjacent dots. As can be appreciated from the figures, this can increase the surface area (per unit volume) of the substance 1 that is exposed to fluid compared to a continuous layer of substance 1 on the first fabric 10, because material at the sides of the dots, as well as the top surface of the dots, is exposed to form an interface with the fluid.

[0068] The average distance between the discrete dots of the substance 1 (indicated by dimension x in FIGS. 1A and 1B) is between 400 and 500 μm in order to provide the desired balance between the ability of fluid to permeate between the dots (increased by increased distance), the flexural rigidity of the product (reduced by increased distance), and the amount of substance 1 per unit area of the first fabric 10 (increased by reduced distance). The average diameter of the discrete dots of the substance 1 on the first fabric (indicated by the dimension y in FIGS. 1A and 1B) is between 500 and 600 μm. This can provide the desired balance between the surface area-to-volume ratio of the substance 1 (increased by reduced diameter), the flexural rigidity of the product (reduced by reduced diameter), and the and the amount of substance 1 per unit area of the first fabric 10 (increased by increased diameter).

[0069] In the first embodiment in FIG. 1A, the substance 1 is adhered to the first fabric 10 by a first adhesive 11 interposed between the first fabric 10 and the substance 1. This can allow the substance 1 itself to not be adhesive (e.g. in the form of solid granules). The adhesive 11 is applied to the first fabric 10 in the form of discrete dots, with the size, shape, and position of the dots of adhesive 11 then dictating (to at least a large extent) the size, shape and position of the dots of substance 1.

[0070] The viscosity of the first adhesive 11 is around 25 cPas in order to facilitate printing of the discrete dots (e.g. screen printing) without the dots flowing and amassing after printing.

[0071] The first embodiment in FIG. 1A may be manufactured by providing the first fabric 10, printing the first adhesive 11 onto the first fabric 10 in the form of discrete dots, and subsequently applying the substance 1 to the first adhesive 11. The printing of the first adhesive 11 onto the first fabric 10 may be conducted by a screen-printing technique. Where the substance 1 is not itself adhesive, the substance 1 does not need to be printed (e.g. screen printed) as discrete dots in addition to printing the first adhesive 11 as discrete dots. The position of the dots of first adhesive 11 already dictates where the substance 1 will be adhered to the first fabric 10 in the form of discrete dots, since the substance 1 only adheres to the first fabric 10 at the locations where adhesive 11 is provided. Accordingly, the substance 1 may be applied to the first fabric 10 in a uniform manner (e.g. via scatter coating), and any unadhered substance 1 can subsequently be removed (e.g. by agitation or suction).

[0072] In the second embodiment in FIG. 1B, the substance 1 is adhered directly to the first fabric 10 (i.e. absent an intervening adhesive). This is typically achieved by the substance 1 being a gel material (e.g. a hydrogel), which provides a convenient carrier for the active agent of the substance 1. The gel material can be adhered directly to the first fabric 10 in the form of discrete dots as illustrated in FIG. 1B by screen printing. Whilst the second embodiment may be more restricted with regards to the form and composition of the substance 1, because it needs to adhere to the first fabric 10 absent an intermediate adhesive, it does provide a manufacturing process with fewer steps than the first embodiment, as only one deposition (e.g. printing) process onto the first fabric 10 is required. The viscosity of the substance 1 is around 25 cPas in order to facilitate printing of the discrete dots (e.g. screen printing) without the dots flowing and amassing after printing.

[0073] FIGS. 2A-2D illustrate third, fourth, fifth and sixth embodiments of the product, respectively. In these embodiments, the product comprises a first fabric 10 to which the substance 1 is adhered, and a second fabric 20, with the discrete dots of substance 1 being sandwiched between the first fabric 10 and second fabric 20. By sandwiching the substance between the first and second fabrics 10, 20, the second fabric 20 acts to protect the substance 1 and the active agent therein and provide bulk for the product itself. It can be appreciated that FIGS. 2A-2D are schematic and not to scale, including the illustration of large spaces between the first and second fabrics 10, 20 in between the discrete dots of the substance 1 and / or the adhesives 11, 21.

[0074] In the third embodiment in FIG. 2A, the substance 1 is adhered to the first fabric 10 by a first adhesive 11 interposed between the first fabric 10 and the substance 1, and the substance 1 is adhered to the second fabric 20 by a second adhesive 21 interposed between the second fabric 20 and the substance 1. Both the first adhesive 11 and second adhesive 21 are in the form of discrete dots on their respective fabrics 10, 20. In the case of FIG. 2A, the spacing of the discrete dots of the first adhesive 11 on the first fabric 10 is the same as the spacing of the discrete dots of the second adhesive 21 on the second fabric 20 and the position of the dots are aligned when sandwiching the substance 1 between the first and second fabrics 10, 20. In this way, the first fabric 10 is only attached to the second fabric 20 at locations where the substance 1 is present.

[0075] The product according to the third embodiment may be manufactured by firstly manufacturing a product according to the first embodiment (see above description), applying the second adhesive 21 to the substance 1 and / or the second fabric 20 in the form of discrete dots, and subsequently sandwiching the substance 1 between the first fabric 10 and the second fabric 20 and thereby adhering the substance 1 to the second fabric 20 using the second adhesive 21.

[0076] In the fourth embodiment in FIG. 2B, the substance 1 is directly adhered to the first fabric 10 and the second fabric 20 (i.e. absent any interposed adhesive on either fabric). In this way, the product can be manufactured by first manufacturing a product according to the second embodiment (see above description) and after screen printing the gel material onto the first fabric 10, the second fabric 20 may be overlaid on the first fabric 10 such as to sandwich the gel material therebetween, the gel material being used to adhere the second fabric 20 to the first fabric 10. Similarly to the second embodiment, this can provide a product whose manufacture comprises fewer steps of applying compounds to the fabrics 10, 20, as no adhesive application steps are required.

[0077] In the fifth embodiment in FIG. 2C, the substance 1 is directly adhered to the first fabric 10 (i.e. absent any interposed adhesive) as in the second embodiment, and the first fabric 10 and second fabric 20 are adhered to each other by a second adhesive 21 that is interposed therebetween. The second adhesive 21 is in the form of discrete dots between the first fabric 10 and the second fabric 20. The position of the discrete dots of second adhesive 21 are such that they are not coincident with the discrete dots of the substance 1 on the first fabric 10, but instead interposed between adjacent dots of the substance 1. In the case of FIG. 2C, the discrete dots of second adhesive 21 are spaced apart with an average distance between adjacent dots of second adhesive 21 that is similar to the average distance between adjacent dots of the substance 1 (e.g. an average distance between adjacent dots between 300 and 600 μm). By adhering the second fabric 20 to the first fabric 10 and not the substance 1, occlusion of the surface of the substance 1 can be reduced, increasing the surface area of the substance that is exposed to fluid (e.g. saliva) when positioned in a user's oral cavity, thereby delivering increased transfer rates of the active agent to the user.

[0078] The product according to the fifth embodiment can be manufactured by firstly manufacturing a product according to the first embodiment (see above description), applying the second adhesive 21 to the first fabric 10 such that the discrete dots of second adhesive 21 are interposed between adjacent discrete dots of the substance 1, and subsequently sandwiching the substance 1 and the second adhesive 21 between the first fabric and the second fabric 20 and thereby adhering the first fabric 10 to the second fabric 20. Alternatively, the second adhesive 21 can be applied to the second fabric 20 in the form of discrete dots and subsequently, the first fabric 10 and second fabric 20 can be aligned such that the discrete dots of second adhesive 21 are misaligned with the discrete dots of the substance 1 and brought together to sandwich the substance 1 and the second adhesive 21 between the first fabric and the second fabric 20, thereby adhering the first fabric 10 to the second fabric 20.

[0079] In the sixth embodiment in FIG. 2D is similar to the third embodiment in that the substance 1 is the substance 1 is adhered to the first fabric 10 by a first adhesive 11 interposed between the first fabric 10 and the substance 1, and the substance 1 is adhered to the second fabric 20 by a second adhesive 21 interposed between the second fabric 20 and the substance 1. Both the first adhesive 11 and second adhesive 21 are provided on their respective fabrics 10, 20 in the form of discrete dots. However, in contrast to the third embodiment, the discrete dots of first adhesive 11 on the first fabric 10 have a different spacing to the discrete dots of second adhesive 21 on the second fabric 20. The average distance between adjacent discrete dots of the first adhesive 11 (and thus the substance 1) is greater than the average distance between adjacent discrete dots of the second adhesive 21. By way of example, the average distance between adjacent discrete dots of the first adhesive 11 is between 500 and 600 μm and the average distance between adjacent discrete dots of the second adhesive 21 is between 250 and 350 μm. As illustrated by FIG. 2D, this can reduce the proportion of the surface area of the substance that is occluded by adhesive, and thereby increase contact of fluid (e.g. saliva) with the substance 1 when positioned in a user's oral cavity. Such difference in spacing could equally be applied to an embodiment wherein the substance 1 is directly adhered to the first fabric 10.

[0080] FIG. 3 is a flowchart schematically showing the steps of a method for producing a product according to the present disclosure. At step S100, a first fabric 10 is provided, for example, a non-woven fabric. At step S200, which may be conducted simultaneously with, prior to, or subsequent to, step S100, a substance 1 comprising an active agent is provided.

[0081] Subsequent to steps S100 and S200, at step S300 the substance 1 is adhered to the first fabric 10 in the form of discrete dots.

[0082] The method illustrated in FIG. 3 can be applied in manufacturing a product according to any one of the first to sixth embodiments.

[0083] Where the method is applied in manufacturing a product according to the first, third or sixth embodiments, the step of adhering the substance 1 to the first fabric 10 comprises applying a first adhesive 11 to the first fabric 10 in the form of discrete dots (e.g. by screen printing) and subsequently applying the substance 1 to the first adhesive 11 (e.g. by scatter coating).

[0084] Where the method is applied in manufacturing a product according to the second, fourth or fifth embodiments, the substance 1 may be a gel material and the step of adhering the substance 1 to the first fabric 10 then comprises directly adhering the gel material to the first fabric 10 (e.g. by screen printing).

[0085] Where the method is applied in manufacturing a product according to any of the third to sixth embodiments, the method further comprises: providing a second fabric 20; and sandwiching the substance 1 between the first and second fabrics 10, 20.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] Any section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0090] Throughout this specification, including the claims which follow, unless the context requires otherwise, the word “comprise” and “include”, and variations such as “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.

[0091] 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%.

Claims

1: A product for oral delivery of a substance comprising an active agent, the product comprising:a first fabric; andthe substance adhered to the first fabric;wherein the substance is adhered to the first fabric in the form of discrete dots.2: The product according to claim 1, wherein the substance is adhered to the first fabric by a first adhesive interposed between the first fabric and the substance.3: The product according to claim 2, wherein the first adhesive is provided on the first fabric in the form of discrete dots.4: The product according to claim 2, wherein the first adhesive comprises a further active agent.5: The product according to claim 1, wherein the substance is in the form of solid particulates.6: The product according to claim 1, wherein the substance is directly adhered to the first fabric.7: The product according to claim 1, wherein the product further comprises:a second fabric; andthe substance is sandwiched between the first and second fabrics.8: The product according to claim 7, wherein the second fabric is adhered to one or both of the substance and the first fabric by a second adhesive interposed therebetween, wherein the second adhesive is in the form of discrete dots.9: The product according to claim 8, wherein the discrete dots of the second adhesive on the second fabric have an average distance of 300 μm to 550 μm between adjacent dots.10: The product according to claim 1, wherein the discrete dots of the substance on the first fabric have an average distance of 300 μm to 550 μm between adjacent dots.11: The product according to claim 1, wherein the discrete dots of the substance on the first fabric have an average diameter of 100 μm to 800 μm.12: A method of manufacturing a product for oral delivery of a substance comprising an active agent, the method comprising the steps of:providing a first fabric;providing the substance; andadhering the substance to the first fabric in the form of discrete dots.13: The method according to claim 12, wherein the step of adhering the substance to the first fabric comprises:applying a first adhesive to the first fabric in the form of discrete dots; andapplying the substance to the first adhesive by scatter coating.14: The method according to claim 13, wherein the step of applying the first adhesive to the first fabric comprises screen printing the first adhesive onto the first fabric.15: The method according to claim 13, wherein the method comprises:allowing the first adhesive to dry or solidify subsequent to the step of applying the first adhesive to the first fabric; andre-softening the first adhesive prior to the step of applying the substance to the first adhesive.16: The method according to claim 12, wherein the step of adhering the substance to the first fabric comprises screen printing a gel material onto the first fabric to directly adhere the substance to the first fabric.17: The method according to claim 12, wherein the method further comprises the steps of:providing a second fabric; andsandwiching the substance between the first and second fabrics, wherein the step of sandwiching the substance between the first and second fabrics comprises adhering the second fabric to one or both of the substance and the first fabric.18: The method according to claim 17, comprising adhering the second fabric to one or both of the substance and the first fabric using a second adhesive, the second adhesive optionally being in the form of discrete dots.19: The method according to claim 18, wherein the method comprises screen printing the second adhesive onto the second fabric.20: The method according to claim 18, wherein the second adhesive is different to the first adhesive, optionally wherein the first adhesive has a higher melting temperature than the second adhesive.

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