Transmucosal deliver of a drug

Abstract

A dissolvable lozenge for transmucosal delivery of a neuroactive, psychoactive and / or bioactive compound during dissolution in the mouth of a human or animal subject, the lozenge comprising: a plurality of layers, each comprising a matrix material and the compound, wherein a first layer of the plurality of layers comprises a first matrix material and a first concentration of the compound suspended in the first matrix for delivering a first dosage profile to the human or animal subject, wherein a second layer of the plurality of layers comprises a second matrix material and a second concentration of the or a further compound suspended in the second matrix for delivering a second dosage profile to the human or animal subject.

Description

[0001] TRANSMUCOSAL DELIVER OF A DRUG

[0002] Technical field

[0003] 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.

[0004] Background

[0005] Commonly, the delivery of neuroactive, psychoactive and bioactive compounds to a subject results in changes in mood, perception, cognition and / or behaviour.

[0006] 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.

[0007] One such challenge is dosing. Neuroactive, psychoactive and bioactive compounds often require a precise dose to be delivered within a narrow therapeutic window. That is, the dose must be carefully and precisely controlled to remain in a narrow envelope over time. 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 unintended, adverse neurological effects) or, on the other hand, lack of efficacy.

[0008] Controlling the dose can be challenging, as known delivery systems produce a dosage profile that varies significantly over time.

[0009] 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).

[0010] 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.

[0011] In some examples, the neuroactive compound may correspond to, or be derived from, a neurotropic. The neurotropic may correspond to a nootropic, such as, e.g. Lion’s Mane Mushroom (or an active compound derived therefrom, such as one or more types of Hericenone and I or Erinacine). There is a growing body of evidence to suggest that nootropics can contribute to improved cognitive function, memory and nerve growth factor production.

[0012] Summary

[0013] Methods and apparatus disclosed herein are directed to solving one or more problems in the prior art.

[0014] According to the invention in an aspect, there is provided a dissolvable lozenge for transmucosal delivery of a neuroactive, psychoactive and / or bioactive compound during dissolution in the mouth of a human or animal subject, the lozenge comprising: a plurality of layers, each comprising a matrix material and the compound, wherein a first layer of the plurality of layers comprises a first matrix material and a first concentration of the compound suspended in the first matrix for delivering a first dosage profile to the human or animal subject, wherein a second layer of the plurality of layers comprises a second matrix material and a second concentration of the or a further compound suspended in the second matrix for delivering a second dosage profile to the human or animal subject. The dosage profile may be characterised by a release rate of the compound as the matrix material dissolves, and / or an absorption rate of the compound by the human or animal subject.

[0015] Optionally, the first and the second dosage profiles combine to determine an overall dosage profile for the lozenge.

[0016] Optionally, 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 layers.

[0017] Optionally, the first and / or the second dosage profiles result in an absorption rate and / or a release rate of the compound that remains within upper and lower dosage boundaries.

[0018] Optionally, 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.

[0019] Optionally, the first layer is an outer layer, relative to the second layer.

[0020] Optionally, the first layer surrounds the second layer.

[0021] Optionally, the plurality of layers are concentric.

[0022] Optionally, the first layer is adjacent the second layer.

[0023] Optionally, the first concentration and / or the second concentration is substantially evenly distributed within the first and / or second matrix material.

[0024] Optionally, the first concentration is based on one or more of a thickness of the first layer, a surface area of the first layer that is exposed in the mouth of the human or animal subject and a rate at which the first layer dissolves.

[0025] Optionally, the second concentration is based on one or more of a thickness of the second layer; a surface area of the second layer that is exposed in the mouth of the human or animal subject; and a rate at which the second layer dissolves. Optionally, the second matrix is configured to dissolve in the mouth of the subject at a rate quicker than the first matrix.

[0026] Optionally, the first concentration is less than the second concentration.

[0027] Optionally, a thickness of the first layer and / or the second layer is substantially uniform.

[0028] Optionally, a thickness of the first and / or second layers is less than a thickness threshold value.

[0029] Optionally, the first and / or second layers include an absorption enhancer for increasing a rate of absorption of the neuroactive compound by the human or animal subject.

[0030] Optionally, the first and / or second layers include an absorption inhibitor for reducing a rate of absorption of the neuroactive or bioactive compound by the human or animal subject.

[0031] Optionally, the first and / or second matrix materials include a sugar-based substance, a cellulose derivative substance and / or a polymer.

[0032] Optionally, the compound comprises psilocybin or psilocyn.

[0033] Optionally, the first layer is configured to dissolve in the mouth of the subject at a rate that is quicker than the second layer.

[0034] Optionally, the lozenge has a size and shape that at least partially corresponds with an oral cavity of the human or animal subject, such that when ingested by the subject, the lozenge fits ergonomically within a region of the subject’s oral cavity.

[0035] Optionally, the shape and size of the lozenge is configured to facilitate at least one of buccal and sublingual absorption of the lozenge.

[0036] Optionally, the upper and lower dosage boundaries correspond to an overall dosage profile in which the rate of active compound absorption by the subject and / or a rate of active compound release from the lozenge is substantially uniform over a given time period.

[0037] Optionally, the overall dosage profile is determined, based, at least in part, on a total number of the plurality of layers. Optionally, the second layer of the plurality of layers comprises a further active compound, different from the active compound suspended in the first matrix, and the further active compound is based on one or more parameters of the first layer of the plurality of layers.

[0038] Optionally, the second concentration of the or further active compound is based on one more parameters of the first layer of the plurality of layers. The one or more parameters of the first layer may include at least one of:

[0039] (i) the first matrix material;

[0040] (ii) the active compound suspended within the first matrix material;

[0041] (iii) the first concentration of the active compound suspended within the first matrix material;

[0042] (iv) the thickness of the first layer;

[0043] (v) the surface area of the first layer;

[0044] (vi) the shape of the first layer; and

[0045] (vii) the arrangement of the first layer relative to the second layer and optionally, at least one other of the plurality of layers.

[0046] Brief description of the drawings

[0047] Embodiments of the disclosed methods and apparatus will be described in detail below, with reference to the accompanying drawings, in which:

[0048] Figure 1 is a plot of compound absorption over time using different delivery methods; and Figure 2 is a section through an exemplary lozenge.

[0049] Detailed Description

[0050] Generally, disclosed herein are drug delivery systems configured for transmucosal delivery of a neuroactive, psychoactive and / or bioactive substance or compound. In exemplary arrangements, the neuroactive, psychoactive or bioactive substance and / or compound is suspended in a matrix that is configured to dissolve in the mouth of a subject for transmucosal delivery of the drug.

[0051] More generally, the lozenge is configured such that it dissolves, and I or the active compound(s) contained therein are absorbed in the mouth of the human or animal subject efficiently and evenly over a given time interval. Known methods of delivery of neuroactive, psychoactive or bioactive substances and / or compounds (active compounds from hereon) 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 over time, as shown in the typical dosage profile 100.

[0052] 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.

[0053] 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 for the subject without having excessive neurological effect and impairment.

[0054] The optimal dosage profile 108 increases compound absorption until it reaches the optimal region 106, where it flattens off to maintain the correct level of compound absorption overtime. Compound absorption remains within the limits of the optimal region 106.

[0055] 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, the two being proportional but by a factor that potentially differs based on the 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 boundaries.

[0056] Figure 2 shows a section through a lozenge 200 for transmucosal delivery of a drug, which in this case may be an active compound. In the example of Figure 2, the lozenge 200 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.

[0057] 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 have a hard or brittle structure, a gum like structure or any other type of structure capable of holding its own weight. A lozenge may be positioned on a delivery structure, such as a lollipop stick or other suitable structure allowing the lozenge to be easily inserted into and / or removed from the mouth of a subject.

[0058] The lozenge 200 includes a plurality of layers and, in the case of Figure 2, a first layer 202 and a second layer 204. It will be apparent to a skilled person that further layers may be included, if desired.

[0059] Each of the plurality of layers 202, 204 of the lozenge 200 includes a matrix material and an active compound. 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. Hence, the matrix material acts as a soluble carrier for the active compound. 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. The matrix material also facilitates even (uniform) distribution of one or more active compounds throughout the lozenge (or specific layers thereof), thereby encouraging uniform dissolution thereof.

[0060] In exemplary arrangements, the plurality of layers 202, 204 may be concentric and share a common centre. The first layer 202 may encompass the second layer 204. Where further layers are included, these may also be concentric and be encompassed by one or more outer layers.

[0061] The first layer 202 may be adjacent to the second layer 204. In other arrangements, a spacer layer containing no active compound may be placed between the first and second layers 202, 204. The spacer layer may be dissolvable and may comprise the matrix material.

[0062] The thickness of each layer 202, 204 is substantially uniform. Further, the thickness of each layer 202, 204 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 boundaries as the surface area of the layer that is exposed in the mouth of the subject reduces with dissolution. Each layer may be relatively thin and of a substantially uniform shape, but with different respective thicknesses. In exemplary arrangements, the lozenge is designed for buccal (cheek) or sublingual (under the tongue) absorption. To facilitate this, the lozenge has a shape that at least partially (approximately) corresponds with a portion of the mouth of the human or animal subject. This allows the lozenge to interact optimally with the subject’s oral cavity, by maximising the surface area of the lozenge that is in contact with the mucosa of the subject’s mouth and ensuring relatively uniform contact therewith. In this way, a more uniform rate of dissolution of the lozenge, and therefore release of the active compound(s) contained therein, is encouraged. Hence, the shape of the lozenge may contribute to obtaining a desired overall dosage profile for the lozenge.

[0063] The shape of the lozenge may ensure that the lozenge comfortably fits at one or more of: (i) under the subject’s tongue; (ii) between their cheek and their gums; and (iii) at the roof of their mouth. By providing an ergonomic shape, the user is less likely to crunch the lozenge, or swirl it around their mouth, thereby enhancing overall delivery efficiency (and uniformity). The shape of the lozenge may correspond to a thin, curved shape, for example. In one example, the shape may be a hyperbolic paraboloid shape (i.e. pringle-shaped). In another example, the shape may be circular or oval. It will be appreciated that the shape of lozenge need not necessarily be specific to a specific individual but may have a shape that approximately conforms to the ‘typical’ shape of the relevant portion of the human or animal subject’s oral cavity.

[0064] 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.

[0065] 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.

[0066] 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. In some examples, the matrix material dissolves at a substantially uniform rate, ensuring a steady release of the active compound suspended therein. Moreover, the active compound is distributed uniformly within the matrix material.

[0067] 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 202, 204. The concentration of the active compound within the first and / or second layers 202, 204 may be isotropic.

[0068] 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 202, 204 and an overall dosage profile associated with the lozenge 200.

[0069] As mentioned above, the overall dosage profile associated with the lozenge 200 may also be controlled based on one or more of: the geometric shape of the lozenge (or one or more of its respective layers), the number of layers comprising one or more active compounds, and the relative arrangement of the plurality of layers. Each layer may be configured to have a predetermined dissolution rate, based on the factors described previously (and described further, below). The shape, number and / or relative arrangement of the layers may be selected such that the overall dosage profile corresponds to a substantially uniform release I absorption rate of the one or more active compounds contained within the lozenge.

[0070] In exemplary arrangements, the fist layer 202 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.

[0071] In some examples the first dosage profile may provide compound absorption and / or a compound release rate that remains within dosage boundaries over a given time period. The dosage boundaries may be coincident with boundaries of the optimal region 106 shown in Figure 1.

[0072] The second layer 204 may comprise a second matrix material and a second concentration of the active compound suspended in the second matrix material. The second matrix material and the second concentration of the active compound are configured to achieve a second dosage profile for the active compound. Alternatively, or in addition, the second matrix material may comprise an active compound that is different from the active compound suspended in the first matrix material.

[0073] The second dosage profile may provide compound absorption and / or a compound release that remains within the dosage boundaries over a given time period. Further, the second 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.

[0074] The first matrix material may be the same as the second matrix material. Alternatively, the two matrix materials may be different.

[0075] In order to achieve first and second dosage profiles that have an active compound absorption rate and / or an active compound release rate within the dosage threshold value, the concentration of the active compound in the first layer 202 may be less than the concentration of the active compound in the second layer 204. In particular, if the matrix material of the first layer 202 and the second layer 204 are the same or otherwise have the same dissolution rate, the concentration of the active compound in the first layer 202 may be less than the concentration of the active compound in the second layer 204.

[0076] In some arrangements, if the matrix material of the first layer 202 dissolves more quickly than the matrix material of the second layer 204 then the concentration of the active compound in the first layer 202 may be the same or greater than the concentration of the active compound in the second layer 204.

[0077] Determination of the concentration of the active compound and / or the rate of dissolution of the matrix material in the first and second layers 202, 204 may be based on the desired first and second dosage profiles. Further, the determination of the concentration of the active compound and / or the rate of dissolution of the matrix material in the first and second layers 202, 204 may be based on one or more of a thickness of the first and / or second layers 202, 204; and a surface area of the first and / or second layers 202, 204 that is exposed in the mouth of the subject.

[0078] The concentration of the active compound in the first and second layers 202, 204 and / or the rate of dissolution of the matrix material in the first and second layers 202, 204 determines the rate of release of the active compound and therefore the dosage profile of the lozenge 200 as it dissolves. In order to achieve a dosage profile that remains within the dosage boundaries, the concentration of the active compound in each layer and / or the rate of dissolution of the matrix material in each layer may be chosen based on layer thickness.

[0079] For example, the thickness of the first layer 202 determines a surface area of an outer surface 206 of the layer and a surface area of an inner surface 208 of the layer. The surface area of the first layer 202 that is exposed in the mouth of the subject determines, at least in part, the rate of delivery of the active compound. This is because the greater the surface area of the first layer 202 that is exposed to the mouth of the subject then the greater the amount of active compound that will be released as the layer dissolves.

[0080] The thickness of the first layer 202 may be determined such that the rate of release and / or the rate of absorption of the active compound results in a dosage profile that remains within the dosage boundaries at the beginning of the dissolution of the first layer 202 and at the end of the dissolution of the first layer 202, based on the rate of release of the active compound.

[0081] Further, the inner and outer surface areas 206, 208 of the first later 202 are determined in combination with the rate of release of the active compound to achieve the desired dosage profile.

[0082] 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.

[0083] The above also applies to the second layer 204.

[0084] In exemplary arrangements, at least one of the layers comprises a different respective active compound than another of the layers. Alternatively, or in addition, each layer may comprise at least one active compound, but with concentration of that active compound being different relative to another of the layers. The active compound(s) used, and their relative concentrations, may be selected so as to obtain a predetermined rate of dissolution for a given layer, and an overall uniform dosage profile for the lozenge. In addition to the active compound, one or more of the plurality of layers 202, 204 of the lozenge 200 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 202, 204 may include an absorption inhibitor. Where absorption enhancers and / or inhibitors are used in one or more layers 202, 204, 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 inhibitor.

[0085] In exemplary arrangements, one or more spacer or boundary layers may be incorporated into the lozenge 200. 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.

[0086] 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.

[0087] In some arrangements, the lozenge employs a gradient release mechanism, with an outer layer dissolving more quickly than an inner layer. As will be appreciated, in such arrangements, the other parameters of each layer may be configured so as to ensure a substantially uniform overall release rate of the one or more active compounds within the lozenge. For example, if the outer layer dissolves more quickly than an inner layer, a greater concentration of the active compound may be provided within the inner layer, and / or a different active compound or blend of active compounds, that dissolves more quickly, may be provided in the inner layer.

[0088] More generally, it will be appreciated that, for a given layer, any of the parameters described herein may be configured such that the overall dosage profile of the lozenge corresponds to a substantially uniform release and I or absorption rate of the one or more active compounds contained therein.

[0089] In some arrangements, the parameters of one layer may be dependent on the parameters of another layer. For example, for a given layer, one or more of the: (i) matrix material used, (ii) concentration of an active compound, (iii) specific active compound used, (iii) thickness, (iv) shape and (v) surface area of that layer may depend on one or more corresponding parameters of another layer. Moreover, one or more of these parameters may also depend on the total number of layers of the lozenge and the arrangement of a given layer relative to the other layers. For example, the size and shape of the lozenge may impose certain constraints on e.g. the number of feasible layers, their relative arrangement, and the concentration of active compounds that can be suspended within each of them. To compensate for this, one or more parameters of a given layer may be configured to compensate for a parameter that might otherwise cause a non-uniform dissolution rate of the active compound(s) contained therein. For example, if the surface area decreases for each successive layer away from an outermost layer, the corresponding reduction in dissolution rate may be compensated for, by e.g. increasing the concentration of active compound, using a more soluble matrix material, using a different, more soluble active compound, using an absorption enhancer, and so on and so forth.

[0090] Manufacture of a lozenge in accordance with the present disclosure may be performed using 3D printing techniques, for example. Techniques such as these can be used to ensure precise layering and distribution of the one or more active compounds within the respective layers. Manufacturing a lozenge may include, for example, obtaining or creating a soluble carrier matrix, selecting one or more active compounds for being suspended therein, determining a concentration of the one or more active compounds that are to be suspended within the matrix, causing the selected active compound(s) to be suspended within the matrix (at the determined concentration), and optionally, incorporating one or more of: an absorption enhancer, absorption inhibitor and I or synergistic compound into the carrier matrix. Here, the term ‘synergistic compound’ refers to a compound that, when taken together with another active compound of the lozenge, complements or enhances the neurological effect of that compound on the subject.

[0091] Manufacture of the lozenge may also include controlling one or more of: the number of layers, their thickness, shape, and the relative concentration of one or more compounds contained therein. Each of these parameters may be precisely controlled such that each layer of the lozenge dissolves at a predetermined rate. Preferably, the parameters are controlled such that the overall dosage profile of the lozenge corresponds to a substantially uniform or constant rate of release and I or absorption, over a predetermined time period. Preferably further still, the dosage profile corresponds to a dose within predetermined upper and lower dosage boundaries. Quality control measures may be employed to ensure consistency and accuracy of the lozenges produced. The lozenges may be packaged with protective materials, to help maintain stability until consumption.

[0092] 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 only, with a true scope being indicated by the following claims and their equivalents.

Claims

CLAIMS1. A dissolvable lozenge for transmucosal delivery of a neuroactive, psychoactive and / or bioactive compound during dissolution in the mouth of a human or animal subject, the lozenge comprising: a plurality of layers, each comprising a matrix material and the compound, wherein a first layer of the plurality of layers comprises a first matrix material and a first concentration of the compound suspended in the first matrix for delivering a first dosage profile to the human or animal subject, wherein a second layer of the plurality of layers comprises a second matrix material and a second concentration of the or a further compound suspended in the second matrix for delivering a second dosage profile to the human or animal subject; and wherein the first and / or the second dosage profiles result in an absorption rate and / or a release rate of the compound that remains within upper and lower dosage boundaries.

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

3. The lozenge 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 layers.

4. The lozenge according to any preceding claim, 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.

5. The lozenge according to any preceding claim, wherein the first layer is an outer layer, relative to the second layer.

6. The lozenge according to any preceding claim, wherein the first layer surrounds the second layer.

7. The lozenge according to any preceding claim, wherein the plurality of layers are concentric.

8. The lozenge according to any preceding claim, wherein the first layer is adjacent the second layer.

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

10. The lozenge according to any preceding claim, wherein the first concentration is based on one or more of a thickness of the first layer, a surface area of the first layer that is exposed in the mouth of the human or animal subject and a rate at which the first layer dissolves.

11. The lozenge according to any preceding claim, wherein the second concentration is based on one or more of a thickness of the second layer; a surface area of the second layer that is exposed in the mouth of the human or animal subject; and a rate at which the second layer dissolves.

12. The lozenge according to any preceding claim, wherein the second matrix is configured to dissolve in the mouth of the subject at a rate quicker than the first matrix.

13. The lozenge according to any preceding claim, wherein the first layer is configured to dissolve in the mouth of the subject at a rate that is quicker than the second layer.

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

15. The lozenge according to any preceding claim, wherein a thickness of the first layer and / or the second layer is substantially uniform.

16. The lozenge according to any preceding claim, wherein a thickness of the first and / or second layers is less than a thickness threshold value.

17. The lozenge according to any preceding claim, wherein the first and / or second layers include an absorption enhancer for increasing a rate of absorption of the neuroactive compound by the human or animal subject.

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

19. The lozenge 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.

20. The lozenge according to any preceding claim wherein the compound comprises psilocybin or psilocyn.

21. The lozenge according to any preceding claim, wherein the lozenge has a size and shape that at least partially corresponds with an oral cavity of the human or animal subject, such that when ingested by the subject, the lozenge fits ergonomically within a region of the subject’s oral cavity.

22. The lozenge according to claim 21 , wherein the shape and size of the lozenge is configured to facilitate at least one of buccal and sublingual absorption of the lozenge.

23. The lozenge according to any preceding claim, wherein the upper and lower dosage boundaries correspond to an overall dosage profile in which the rate of active compound absorption by the subject and / or a rate of active compound release from the lozenge is substantially uniform over a given time period.

24. The lozenge according to any preceding claim, wherein the overall dosage profile is determined, based, at least in part, on a total number of the plurality of layers.

25. The lozenge according to any preceding claim, wherein the second layer of the plurality of layers comprises a further active compound, different from the active compound suspended in the first matrix, and wherein the further active compound is based on one or more parameters of the first layer of the plurality of layers.

26. The lozenge according to any preceding claim, wherein the second concentration of the or further active compound is based on one more parameters of the first layer of the plurality of layers.

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