A pouch for transmucosal delivery of an active compound

Abstract

A pouch 200 for transmucosal delivery of a neuroactive, psychoactive and / or bioactive compound in the mouth of a human or animal subject, comprises a liquid permeable cover 202 and a plurality of dissolvable lozenges 204, 206, 208 contained within the cover. Each of the plurality of lozenges comprises a matrix material and a neuroactive, psychoactive and / or bioactive compound suspended within the matrix material. A first lozenge of the plurality of lozenges comprises a first matrix material and a first concentration of a neuroactive, psychoactive and / or bioactive compound suspended in the first matrix for delivering a first dosage profile to the human or animal subject. A second lozenge of the plurality of lozenges comprises a second matrix material and a second concentration of the and / or a further neuroactive, psychoactive and / or bioactive compound suspended in the second matrix for delivering a second dosage profile to the human or animal subject. The pouch may also include an inner permeable cover (304, fig 3), which includes a plurality of inner dissolvable lozenges (308, fig 3). A first lozenge may comprise a plurality of layers (402, 404, fig 4), for delivering a different concentration and / or a further neuroactive, psychoactive and / or bioactive compound.

Description

Technical field The invention relates to intraoral drug delivery. More specifically, the invention relates to an intraoral, transmucosal delivery of a neuroactive, psychoactive or bioactive substance and / or compound. Background Commonly, the delivery of neuroactive, psychoactive and bioactive compounds to a subject results in changes in mood, perception, cognition and / or behaviour. There is increasing interest in the use of neuroactive compounds for medical purposes, such as treating mental health disorders. However, there are several challenges associated with the delivery of neuroactive compounds as a treatment. One such challenge is dosing. Neuroactive, psychoactive and bioactive compounds often have a narrow therapeutic window. That is, the dose must be carefully controlled to remain in a narrow envelope overtime. Determination of the dose may be based on absorption of the compound and / or a neurological effect on the subject. Tight control of dose avoids, on one hand, toxicity or, on the other hand, lack of efficacy. Controlling the dose can be challenging, as known delivery systems produce a dosage profile that varies significantly overtime. As used herein, the term ‘neuroactive compound’ encompasses substances that interact or affect the nervous system of a human or animal subject (subject hereafter). Neuroactive compounds can affect the function, communication, or regulation of neurons and neural activity. They may influence neurotransmitter release, receptor binding, or neuronal excitability. Not all neuroactive substances are necessarily psychoactive, as some may primarily affect physiological processes without causing noticeable changes in mental state. An example of a neuroactive substance is acetylcholine, which plays a vital role in nerve signal transmission. As used herein, the term ‘psychoactive compound’ encompasses substances that can affect the brain and alter mental processes of a subject such as mood, perception, cognition, and behaviour. These substances act on the central nervous system and can induce changes in consciousness and thought patterns. Examples of psychoactive substances include drugs like LSD, psilocybin (found in magic mushrooms), MDMA, and THC (found in marijuana). As used herein, the term ‘bioactive compound’ encompasses substances that have an effect on living organisms, encompassing both neurological and non-neurological effects. Bioactive compounds may interact with various biomolecules and biological systems, impacting physiological processes beyond just the nervous system. These effects can include antioxidant properties, anti-inflammatory actions, hormonal regulation, and more. Bioactive substances can be found in various natural sources like plants, animals, and microorganisms. Bioactive compounds may be found in Ganoderma Sichuanense (Reishi Mushroom) and Lion’s mane mushroom. Summary According to the invention in a first aspect, there is provided a pouch fortransmucosal delivery of a neuroactive, psychoactive and / or bioactive compound in the mouth of a human or animal subject. The pouch comprises a liquid permeable cover; and a plurality of dissolvable lozenges contained within the cover. Each of the plurality of lozenges comprises a matrix material; and a neuroactive, psychoactive and / or bioactive compound suspended within the matrix material. A first lozenge of the plurality of lozenges comprises a first matrix material and a first concentration of a neuroactive, psychoactive and / or bioactive compound suspended in the first matrix for delivering a first dosage profile to the human or animal subject. A second lozenge of the plurality of lozenges comprises a second matrix material and a second concentration of the and / or a further neuroactive, psychoactive and / or bioactive compound suspended in the second matrix for delivering a second dosage profile to the human or animal subject. In an example, the first lozenge and second lozenge comprise the same neuroactive, psychoactive and / or bioactive compound. In an example, the first lozenge and second lozenge comprise the same matrix material. In an example, the concentration of the or each neuroactive, psychoactive and / or bioactive compound suspended in each respective matrix material is the same. In an example, the first lozenge and second lozenge are the same. In an example, the first and the second dosage profiles combine to determine an overall dosage profile for the pouch. In an example, the overall dosage profile is determined based, at least in part, on a combination of a plurality of neuroactive, psychoactive and / or bioactive compounds in the first and / or second lozenges. In an example, the first and / or the second dosage profiles result in an absorption rate and / or a release rate of the neuroactive, psychoactive and / or bioactive compound that remains within a range defined by an upper dosage profile threshold and a lower dosage profile threshold. In an example, the first and / or second dosage profile is dependent on one or more of: a surface area of the first and / or second lozenge; a concentration of the first and / or the further neuroactive, psychoactive and / or bioactive compound suspended in the first and / or the second matrix; and a rate of dissolution of the first and / or second matrix. In an example, the first concentration and / or the second concentration is substantially evenly distributed within the first and / or second matrix material. In an example, the first concentration is less than the second concentration. In an example, the first and / or second lozenges include an absorption enhancer for increasing a rate of absorption of the neuroactive, psychoactive and / or bioactive compound by the human or animal subject. In an example, the first and / or second lozenges include an absorption inhibiter for reducing a rate of absorption of the neuroactive, psychoactive and / or bioactive compound by the human or animal subject. In an example, at least one of the plurality of lozenges comprises an oral indicator configured to be released into the mouth of the human or animal subject after a predetermined time period. In an example, the oral indicator comprises a substance configured to change a flavour profile in the mouth of the human or animal subject. In an example, the first and / or second matrix materials include a sugar-based substance, a cellulose derivative substance and / or a polymer. In an example, the pouch further comprises an inner pouch and the inner pouch comprises an inner liquid permeable cover; and a plurality of inner dissolvable lozenges contained within the inner cover. Each of the plurality of inner lozenges comprises an inner matrix material; and the and / or a further neuroactive, psychoactive and / or bioactive compound suspended within the inner matrix material. In an example, a first inner lozenge of the plurality of inner lozenges comprises a first inner matrix material and a first inner concentration of the and / or a further neuroactive, psychoactive and / or bioactive compound suspended in the first inner matrix; and a second inner lozenge of the plurality of inner lozenges comprises a second inner matrix material and a second inner concentration of the and / or a further neuroactive, psychoactive and / or bioactive compound suspended in the second inner matrix. In an example, a liquid permeability of the permeable cover is different to a liquid permeability of the inner permeable cover. In an example, the first lozenge of the plurality of lozenges comprises a plurality of layers, wherein a first layer of the plurality of layers comprises the first matrix material and the first concentration of the neuroactive, psychoactive and / or bioactive compound suspended in the first matrix for delivering the first dosage profile to the human or animal subject; and a second layer of the plurality of layers comprises a third matrix material and a third concentration of the and / or a further neuroactive, psychoactive and / or bioactive compound suspended in the third matrix for delivering a third dosage profile to the human or animal subject. In an example, the second layer is exposed upon at least partial dissolution of the first layer. In an example, a difference between an absorption rate and / or a release rate of the neuroactive or bioactive compound in the first and second dosage profiles is less than a dosage threshold value. In an example, the neuroactive, psychoactive and / or bioactive compound comprises psilocybin or psilocyn. Brief description of the drawings Embodiments of the disclosed methods and apparatus will be described in detail below, with reference to the accompanying drawings, in which: Figure 1 is an example of a typical dosage profile for an active compound that is ingested orally by a user; Figure 2 is a section through an example pouch for transmucosal delivery of an active compound; Figure 3 is an example of a pouch that comprises an outer liquid permeable cover and an inner liquid permeable cover; and Figure 4 is an example of a section through a lozenge for inclusion in a pouch. Detailed Description Generally, disclosed herein are drug delivery systems configured fortransmucosal delivery of a neuroactive, psychoactive and / or bioactive substance or compound (active compound from hereon). In exemplary arrangements, a pouch includes a liquid permeable outer cover that contains a plurality of lozenges. Each lozenge may comprise at least one active compound that is suspended in a matrix, wherein the matrix is configured to dissolve in the mouth of a subject to release the active compound for transmucosal delivery of the active compound. Each lozenge has a dosage profile describing a rate of delivery of the active compound. An overall dosage profile of the pouch is an aggregate of the dosage profiles of the plurality of lozenges. Accordingly, the overall dosage profile of the pouch may be determined by combining within the pouch a plurality of lozenges having various dosage profiles. This allows the overall dosage profile to be finely controlled. Known methods of delivery of active compounds include tablets, capsules and edibles that are ingested for delivery of the drug orally through the stomach. Figure 1 shows a typical dosage profile 100 that can be seen using these methods of delivery. The y-axis of Figure 1 shows absorption of the active compound, and the x-axis shows time. Because the active compound is delivered in a single dose, levels of compound absorption grow to a peak, and then reduce overtime, as shown in the typical dosage profile 100. The typical dosage profile 100 can mean that significant amounts of time are spent with the subject in the region 102 where compound absorption is too high, and which results in excessive neurological effects and impairment of the subject, or in the region 104 where compound absorption is too low, and which results in insufficient neurological effect to achieve a desired outcome for the subject. The inventors have appreciated that it is desirable to maintain active compound absorption in a third, or optimal, region 106, which results in a desired outcome forthe subject without having excessive neurological effect and the resulting impairment. The optimal dosage profile 108 increases active compound absorption until it reaches the optimal region 106, where it flattens off to maintain the correct level of active compound absorption over time. Active compound absorption remains within the limits of the optimal region 106. The optimal region 106 is in a range from an upper dosage profile threshold 110 to a lower dosage profile threshold 112. Figure 1 shows the optimal dosage profile 108 as being flat after reaching the optimal region 106. However, it will be appreciated that the optimal dosage profile 108 may exhibit increased or decreased active compound absorption overtime, whilst staying within the optimal region 106. The term ‘dosage profile’ as used herein encompasses a rate of active compound absorption by a subject and / or a rate of active compound release from a lozenge and / or pouch. The active compound absorption and rate of active compound release may be proportional but not necessarily equal. Differences in active compound absorption and rate of active compound release may be based on factors that are specific to a human or animal subject. Accordingly, the optimal region 106 of Figure 1 may be expressed as a region having a rate of active compound absorption, or rate of release of the active compound from the lozenge as it dissolves, that lies between upper and lower thresholds 110, 112. The term “lozenge” as used herein may encompass any type or shape of tablet configured to dissolve in the mouth of a subject. Accordingly, the lozenge may be hard or brittle, gum like structure or have any other structure capable of holding its own weight. Figure 2 shows a section through a pouch 200 for transmucosal delivery of an active compound. The pouch includes a liquid permeable cover 202. Contained within the cover 202 are a plurality of lozenges 204, 206, 208. One or more of the lozenges 204, 206, 208 includes a matrix material that is dissolvable in the mouth of a human or animal subject. An active compound is suspended in the matrix such that it is released into the mouth of the human or animal subject as the matrix dissolves. A first lozenge 204 includes a first matrix material and has a first concentration of at least one active compound suspended within the first matrix. The first lozenge 204 is configured to release the active compound(s) at a first rate. The first rate may define a first dosage profile associated with the first lozenge 204. A second lozenge 206 includes a second matrix material and has a second concentration of at least one active compound suspended within the second matrix. The second lozenge 206 is configured to release the active compound(s) at a second rate. The second rate may define a second dosage profile associated with the second lozenge 206. The dosage profile may be dependent on one or more of: a rate of dissolution of the matrix material; a concentration of the at least one active compound; and a surface area of the lozenge that is exposed in the mouth of the human or animal subject (this may be proportional to the size of the lozenge). Accordingly, a lozenge may be configured using the features identified in the paragraph above to have a specific delivery profile. If the surface area of a lozenge is increased then the rate of release of the active compound is increased, and vice-versa. If the rate of dissolution of the matrix material is increased then the rate of release of the active compound is increased, and vice-versa. If the concentration of the active compound suspended in the matrix material is increased then the rate of release of the active compound is increased, and vice-versa. The liquid permeable cover 202 is configured to allow saliva to pass through for dissolution of the lozenges 204, 206, 208. One or more of the lozenges 204, 206, 208 may be configured to give an oral indication to the human or animal subject after a period of time. An oral indication encompasses any indication that may be detected by the subject through the mouth. For example, the oral indication may include a flavour that is detectable by the subject, or a chemical reaction in the mouth of the subject. In one specific example, one or more lozenges 204, 206, 208 may include a flavoured compound suspended in a matrix material thereof. The flavoured compound may be suspended in the matrix material below a surface of the lozenge 204, 206, 208 such that an outer layer of the lozenge 204, 206, 208 must be dissolved before the flavoured compound is released into the mouth of the subject. The time taken to dissolve the outer layer of the lozenge 204, 206, 208 is dependent on a rate of dissolution of the matrix material of the outer layer and / or a surface area of the outer layer. In other arrangements, the flavoured compound may be replaced with an alternative compound giving an alternative oral indication to the subject. The oral indication may be timed to coincide with a particular point in the overall dosage profile of the pouch 200. For example, the oral indication may prompt the subject to remove the pouch 200 from their mouth when a required dosage has been reached. The oral indication may illicit an involuntary action in the subject, such as a foul taste that causes the subject to instantly and rapidly remove the pouch 200 from the mouth. Figure 3 shows an exemplary pouch 300 including an outer liquid permeable cover 302 and an inner liquid permeable cover 304. The outer liquid permeable cover includes a plurality of outer lozenges 306. The inner liquid permeable cover 304 is at least partially contained within the outer liquid permeable cover 302. The inner liquid permeable cover 304 includes one or more inner lozenges 308. The outer liquid permeable cover 302 and the inner liquid permeable cover 304 may have different permeabilities. For example, the inner liquid permeable cover 304 may have a greater permeability than the outer liquid permeable cover 302. Alternatively, the inner liquid permeable cover 304 may have a lower permeability than the outer liquid permeable cover 302. The relative permeability of the inner and outer liquid permeable covers 302, 304 may allow greater control over the release rate of the active compound and the overall dosage profile of the pouch 300. For example, it may be possible to have: simultaneous or overlapping release of the active compound from the outer lozenges 306 and the inner lozenges 308; or sequential release of the active compound from the outer lozenges 306 and the inner lozenges 308. In addition, the release rate of the inner lozenges 308 may be restricted or enhanced by greater or lesser permeability of the inner liquid permeable cover 304. Figure 4 shows a section through a lozenge 400 for inclusion in pouch 200, 300. In the example of Figure 4, the lozenge 400 has a circular section and may be spherical or disc shaped. It will be appreciated that any other shapes of lozenge are possible and are encompassed by this disclosure, e.g., a rhomboid, a capsule shape or a pill shape. The exemplary lozenge 400 includes a plurality of layers and, in the case of Figure 4, a first layer 402 and a second layer 404. It will be apparent to a skilled person that further layers may be included, if desired or that there may be a single layer. Each of the plurality of layers 402, 404 of the lozenge 400 includes a matrix material and at least one active compound suspended in the matrix. The matrix material may be configured to be dissolvable in the mouth of a subject. The active compound is suspended in the matrix so that it may be released in the mouth of the subject as the matrix material dissolves and absorbed transmucosally. Accordingly, the rate of release of the active compound may be controlled by the concentration of the active compound suspended in the matrix and / or the rate of dissolution of the matrix material in the mouth of the subject. In exemplary arrangements, the plurality of layers 402, 404 may be concentric and share a common centre. The first layer 402 may encompass the second layer 404. Where further layers are included, these may also be concentric and be encompassed by one or more outer layers. The first layer 402 may be adjacent to the second layer 404. In other arrangements, a spacer layer containing no active compound may be placed between the first and second layers 402, 404. The spacer layer may be dissolvable and may comprise the matrix material. The thickness of each layer 402, 404 may be substantially uniform. Further, the thickness of each layer 402, 404 may be less than a layer thickness threshold value. As will be apparent from the description below, this allows release of the active compound to remain within dosage profile boundaries as the surface area of the layer that is exposed in the mouth of the subject reduces with dissolution, thereby affecting the release rate of the active compound. The matrix material may comprise a sugar-based material, e.g., sucrose, glucose or fructose. These sugars have a pleasant taste, are readily available and are relatively inexpensive. In some exemplary arrangements, the matrix material may comprise cellulose derivatives, such as hydroxypropyl methylcellulose (HPMC), which can form gels when hydrated and can provide sustained release of the active compound. Polymers such as polyvinyl alcohol (PVA) and polyethylene glycol (PEG) could also be used as a matrix material, and can provide enhanced drug solubility, increased stability, and controlled release. In addition, flavourings, colours, and sweeteners can be added to the matrix material to improve the palatability of the lozenge. For example, fruit flavours, such as strawberry or orange, are commonly used, as well as sweeteners such as stevia and xylitol, which can provide a sweet taste without increasing the caloric content of the lozenge. The matrix material may be configured to dissolve at a known rate in the mouth of the subject, which permits consistent and sustained release of the active compound as the matrix material dissolves. The active compound may be any neuroactive, psychoactive or bioactive substance or compound, e.g., psilocybin or psilocylin. In exemplary arrangements, the active compound may be evenly distributed within the first and / or second layers 402,404. The concentration of the active compound within the first and / or second layers 402, 404 may be isotropic. As discussed in greater detail below, one or more of a concentration of the active compound, the dissolution rate of the matrix material, a layer thickness and a combination of active compounds in one or more layers may be used to control a dosage profile associated with each layer 402, 404 and an overall dosage profile associated with the lozenge 400. In exemplary arrangements, the fist layer 402 comprises a first matrix material and a first concentration of the active compound suspended in the first matrix material. The first matrix material and the first concentration of the active compound are configured to achieve a first dosage profile for the active compound. In some examples the first dosage profile may provide compound absorption and / or a compound release rate that remains within dosage profile boundaries over a given time period. The second layer 404 may comprise a third matrix material and a third concentration of the active compound suspended in the third matrix material. The third matrix material and the third concentration of the active compound are configured to achieve a third dosage profile for the active compound. The third dosage profile may provide compound absorption and / or a compound release that remains within the dosage boundaries over a given time period. Further, the third dosage profile may be substantially the same as the first dosage profile. An active compound absorption rate and / or an active compound release rate of the first dosage profile may differ from an active compound absorption rate and / or an active compound release rate of the second dosage profile by less than a dosage threshold value. The first matrix material may be the same as the second matrix material. The concentration of the active compound in the first layer 402 may be less than the concentration of the active compound in the second layer 404. In particular, if the matrix material of the first layer 402 and the second layer 404 are the same or otherwise have the same dissolution rate, the concentration of the active compound in the first layer 402 may be less than the concentration of the active compound in the second layer 404. In some arrangements, if the matrix material of the first layer 402 dissolves more quickly than the matrix material of the second layer 404 then the concentration of the active compound in the first layer 402 may be the same or greater than the concentration of the active compound in the second layer 404. Determination of the concentration ofthe active compound and / or the rate of dissolution of the matrix material in the first and second layers 402, 404 may be based on the desired first and third dosage profiles. Further, the determination ofthe concentration ofthe active compound and / or the rate of dissolution ofthe matrix material in the first and second layers 402, 404 may be based on one or more of a thickness of the first and / or second layers 402, 404; and a surface area of the first and / or second layers 402, 404 that is exposed in the mouth of the subject. The concentration ofthe active compound in the first and second layers 402, 404 and / or the rate of dissolution ofthe matrix material in the first and second layers 402, 404 determines the rate of release ofthe active compound and therefore the dosage profile ofthe lozenge 400 as it dissolves. The concentration of the active compound in each layer and / or the rate of dissolution ofthe matrix material in each layer may be chosen based on layer thickness. The thickness ofthe first layer 402 may be determined such that the rate of release and / or the rate of absorption ofthe active compound results in a dosage profile that remains within the dosage boundaries at the beginning ofthe dissolution ofthe first layer 402 and at the end of the dissolution ofthe first layer 402, based on the rate of release ofthe active compound. Further, the inner and outer surface areas 406, 408 of the first layer 402 are determined in combination with the rate of release ofthe active compound to achieve the desired dosage profile. A plurality of active compounds may be included in the first layer and suspended within the matrix material. The ratio between the plurality of active compounds may affect the dosage profile. For example, if the first layer includes a combination of psilocybin and psilocyn then the rate of absorption by the subject will be affected. Psilocyn is more quickly absorbed by the subject and so a higher ratio of psilocyn compared to psilocybin will increase the rate of absorption. The above also applies to the second layer 404. In addition to the active compound, one or more of the plurality of layers 402, 404 of the lozenge 400 may include absorption enhancer. For example, the first and / or second layers may include a substance that increases the permeability of the oral mucosa of the subject to allow for greater absorption. Alternatively, or in addition, one or more of the plurality of layers 402, 404 may include an absorption inhibiter. Where absorption enhancers and / or inhibiters are used in one or more layers 402, 404, the concentration of the active compound and the rate of dissolution of the matrix material in the associated layers may be altered based on the effect of the absorption enhancer and / or absorption inhibiter. In exemplary arrangements, one or more spacer or boundary layers may be incorporated into the lozenge 400. The spacer layers may include a substance configured to provide a certain pH value within the mouth of the subject. For example, the spacer layer may include sodium bicarbonate, nitric acid, citric acid and / or other compounds in order to maintain a specific pH level in the mouth. The pH level in the mouth can affect the absorption of the active compound. It is noted that the optimal region may be different for different subjects as each subject may react to the active compound differently. Accordingly, it is envisaged that a number of lozenges may be available, wherein the dissolution rate and / or the active compound concentration in each layer of each lozenge is configured to provide a dosage profile that remains within different dosage threshold boundaries. In arrangements, a plurality of lozenges may be manufactured, each having one of a plurality of predetermined dosage profiles. A pouch may be manufactured by selecting two or more of the plurality of lozenges such that their dosage profiles combine to create a desired overall dosage profile. The overall dosage profile may be determined based on physiological characteristics of a human or animal subject to whom the active compound is to be delivered. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed systems and methods. Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the disclosed systems and methods. It is intended that the specification and examples be considered as exemplary 5 only, with a true scope being indicated by the following claims and their equivalents.

Claims

1. A pouch for transmucosal delivery of a neuroactive, psychoactive and / or bioactive compound in the mouth of a human or animal subject, the pouch comprising:a liquid permeable cover; anda plurality of dissolvable lozenges contained within the cover, each of the plurality of lozenges comprising:a matrix material; anda neuroactive, psychoactive and / or bioactive compound suspended within the matrix material,wherein a first lozenge of the plurality of lozenges comprises a first matrix material and a first concentration of a neuroactive, psychoactive and / or bioactive compound suspended in the first matrix for delivering a first dosage profile to the human or animal subject,and wherein a second lozenge of the plurality of lozenges comprises a second matrix material and a second concentration of the and / or a further neuroactive, psychoactive and / or bioactive compound suspended in the second matrix for delivering a second dosage profile to the human or animal subject.

2. The pouch according to claim 1, wherein the first and the second dosage profiles combine to determine an overall dosage profile for the pouch.

3. The pouch according to claim 2, wherein the overall dosage profile is determined based, at least in part, on a combination of a plurality of neuroactive, psychoactive and / or bioactive compounds in the first and / or second lozenges.

4. The lozenge according to claim 2 or 3, wherein the first and / or the second dosage profiles result in an absorption rate and / or a release rate of the neuroactive, psychoactive and / or bioactive compound that remains within a range defined by an upper dosage profile threshold and a lower dosage profile threshold.

5. The pouch according to any preceding claim, wherein the first and / or second dosage profile is dependent on one or more of:a surface area of the first and / or second lozenge;a concentration of the first and / or the further neuroactive, psychoactive and / or bioactive compound suspended in the first and / or the second matrix; anda rate of dissolution of the first and / or second matrix.

6. The pouch according to any preceding claim, wherein the first concentration and / orthe second concentration is substantially evenly distributed within the first and / or second matrix material.

7. The pouch according to any preceding claim, wherein the first concentration is less than the second concentration.

8. The pouch according to any preceding claim, wherein the first and / or second lozenges include an absorption enhancer for increasing a rate of absorption of the neuroactive, psychoactive and / or bioactive compound by the human or animal subject.

9. The pouch according to any preceding claim, wherein the first and / or second lozenges include an absorption inhibitor for reducing a rate of absorption of the neuroactive, psychoactive and / or bioactive compound by the human or animal subject.

10. The pouch according to any preceding claim, wherein at least one of the plurality of lozenges comprises an oral indicator configured to be released into the mouth of the human or animal subject after a predetermined time period.

11. The pouch according to claim 10, wherein the oral indicator comprises a substance configured to change a flavour profile in the mouth of the human or animal subject.

12. The pouch according to any preceding claim, wherein the first and / or second matrix materials include a sugar-based substance, a cellulose derivative substance and / or a polymer.

13. The pouch according to any preceding claim, further comprising an inner pouch, the inner pouch comprising:an inner liquid permeable cover; anda plurality of inner dissolvable lozenges contained within the inner cover, each of the plurality of inner lozenges comprising:an inner matrix material; andthe and / or a further neuroactive, psychoactive and / or bioactive compound suspended within the inner matrix material.

14. The pouch according to claim 13, whereina first inner lozenge of the plurality of inner lozenges comprises a first inner matrix material and a first inner concentration of the and / or a further neuroactive, psychoactive and / or bioactive compound suspended in the first inner matrix,and wherein a second inner lozenge of the plurality of inner lozenges comprises a second inner matrix material and a second inner concentration of the and / or a further neuroactive, psychoactive and / or bioactive compound suspended in the second inner matrix.

15. The pouch according to claim 13 or 14, wherein a liquid permeability of the permeable cover is different to a liquid permeability of the inner permeable cover.

16. The pouch according to any preceding claim, wherein the first lozenge of the plurality of lozenges comprises a plurality of layers,wherein a first layer of the plurality of layers comprises the first matrix material and the first concentration of the neuroactive, psychoactive and / or bioactive compound suspended in the first matrix for delivering the first dosage profile to the human or animal subject,and wherein a second layer of the plurality of layers comprises a third matrix material and a third concentration of the and / or a further neuroactive, psychoactive and / or bioactive compound suspended in the third matrix for delivering a third dosage profile to the human or animal subject.

17. The pouch according to claim 16, wherein the second layer is exposed upon at least partial dissolution of the first layer.

18. The pouch according to claim 16 or 17, wherein a difference between an absorption rate and / or a release rate of the neuroactive or bioactive compound in the first and second dosage profiles is less than a dosage threshold value.

19. The pouch according to any preceding claim wherein the neuroactive, psychoactive and / or bioactive compound comprises psilocybin or psilocyn.17

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