Silicone polymers comprising active agents

Abstract

The present invention relates to a silicone polymer composition comprising a silicone polymer, at least one active agent, and fibres of a polyhydroxylated polysaccharide distributed throughout the silicone polymer, as well as to wearable products comprising the silicone polymer composition, a pre-cure composition suitable for forming the silicone polymer composition upon curing, use of the silicone polymer composition for adhering articles to skin, and a method of manufacturing the silicone polymer composition.

Description

[0001] Silicone Polymers Comprising Active Agents

[0002] Field of the Invention

[0003] The present invention relates to improvements in silicone polymers, such as those useful as adhesives and sealants. Silicone polymers, and products comprising the silicone polymers, such as skin adhesives and wearable products comprising said skin adhesives, are described. The present disclosure also describes a pre-cure composition capable of forming the silicone polymer, as well as uses of the silicone polymer and a method of manufacturing the silicone polymer.

[0004] Background of the Invention

[0005] Silicone polymers are widely used as adhesives and sealants in a wide number of contexts. They are commonly used in commercial and household contexts to limit or prevent the infiltration of water, for example, in seals around sinks and other wet locations. They are also used in healthcare contexts, with a wide number of applications involving the adhesion of items to skin (such as wearable technology and wound dressings). They may also be used for the delivery of active agents to the skin surface or for transdermal delivery of active agents.

[0006] One issue facing silicone polymers comprising active agents is that the hydrophobic nature of the silicone polymer slows the rate at which the active agents can elute from the composition into the surrounding environment. In one example, silicone polymers are commonly used in humid environments (such as domestic or commercial premises, or in proximity with skin) that are suitable for hosting potentially harmful microbes, both around and on, or within, the silicone polymer itself. This concern is especially acute where silicone polymers are employed in healthcare contexts.

[0007] To counter this problem, antimicrobials are incorporated into silicone polymers as active agents. However, the hydrophobic nature of conventional silicone polymers makes it difficult to incorporate antimicrobials into the silicone polymer and limits the rate at which they are released into the surrounding environment. It has been proposed to encapsulate particulates of active agents, such as antimicrobials, within the silicone (see US10485892B2 and US11331406B2), with further approaches using chelating agents and, optionally, humectants (see CA2928330C). However, although these approaches can permit incorporation of the active agents into the silicone polymer, their release remains limited due to being trapped in the hydrophobic silicone, thereby mandating high

[0008] 69661675-1 loadings in order to deliver an effective amount of the active agent. These high loadings risk delivery of uncontrolled and excessive quantities of the active agent, which is potentially harmful, and risks diminishing the resilience and integrity of the silicone polymer.

[0009] The present invention seeks to obviate or mitigate one or more of the above mentioned disadvantages.

[0010] Summary of the Invention

[0011] A first aspect of the present invention relates to a silicone polymer composition comprising a silicone polymer, at least one active agent, and fibres of a polyhydroxylated polysaccharide distributed throughout the silicone polymer.

[0012] The fibres may be cellulose fibres, optionally wherein the fibres are cotton and I or regenerated cellulose, such as viscose rayon fibres. The fibres may have a number average fibre length in the range of from 20 pm - 1500 pm as determined by microscopy, optionally from 200 pm to 1000 pm, such as 200 pm to 900 pm. The fibres may be present in an amount of at least 0.1 %wt relative to the total weight of the silicone polymer composition, optionally from 0.25 to 5.0 %wt, optionally from 1.0 %wt to 3.0 %wt.

[0013] The at least one active agent may be selected from non-therapeutics, such as cosmetic agents and contraceptives, and therapeutic agents, such as antimicrobials. Preferably the at least one active agent is at least one therapeutic agent. The at least one active agent may comprise two or more active agents (by which it is meant two or more different active agents). In typical embodiments, only a single active agent is provided.

[0014] The at least one active agent may be at least one antimicrobial, preferably selected from guanides (including bisbiguanides (such as chlorhexidine and alexidine) and polymeric biguanides (such as polyhexamethylene biguanide (“PHMB”) and polyaminopropyl biguanide (“PAPB”))), bispyridines (such as octenidine), taurolidine, silver and silver compounds (such as silver nitrate and silver citrate), copper and copper compounds, zinc and zinc compounds and combinations thereof. Guanides and especially biguanides are particularly suitable. The at least one active agent may for instance comprise, or may be, chlorhexidine, PHMB or mixtures thereof. The at least one active agent may be PHMB. The at least one active agent may be chlorhexidine. The free form and salt forms

[0015] 69661675-1 of the respective active agents may be suitably used. Chlorhexidine gluconate is a particularly suitable salt form of chlorhexidine for use in the present invention.

[0016] The at least one antimicrobial may be present in an amount from 0.05 to 5 %wt, optionally from 0.1 to 2 %wt, optionally from 0.5 to 1 %wt, such as about 0.6 %wt.

[0017] The silicone polymer composition may have a peel strength of from 0.1 to 10 N / 2.5 cm, optionally from 0.5 to 5.0 N / 2.5cm, such as 1.0 to 3.0 N / 2.5cm, such as about 2.5 N / 2.5cm. The silicone polymer composition may have a moisture vapour transmission rate (MVTR) of from 700 g / m2 / 24hrs to 5000 g / m2 / 24hrs, optionally from 1000 g / m2 / 24hrs to 3000 g / m2 / 24hrs, such as about 3100 g / m2 / 24hrs.

[0018] The silicone polymer composition may be a silicone polymer skin adhesive.

[0019] The silicone polymer composition may be disposed on a substrate, optionally wherein the substrate is a wearable product or a component part of a wearable product. The combined thickness of the silicone polymer adhesive and substrate may be from 25 pm to 1000 pm or from 50 pm to 250 pm optionally from 75 pm to 150 pm, such as around 100 pm. The substrate may be a medical device ora component part of a medical device.

[0020] The silicone polymer composition may be provided in the form of a film, optionally wherein a release liner is disposed on the film.

[0021] A second aspect of the present invention relates to a wearable product comprising a silicone polymer composition according to the first aspect of the present invention, wherein the silicone polymer composition is a silicone polymer skin adhesive, the silicone polymer skin adhesive disposed on the product so as to be capable of adhering the product to the skin of a user.

[0022] The wearable product may further comprise a release liner disposed on the silicone polymer skin adhesive. The product may be a medical device or component part of a medical device.

[0023] A third aspect of the present invention relates to a pre-cure composition capable of forming the silicone polymer composition according to the first aspect of the present

[0024] 69661675-1 invention upon curing, the pre-cure composition comprising a silicone polymer precursor mixture, at least one active agent, and fibres of the polyhydroxylated polysaccharide distributed throughout the mixture.

[0025] A fourth aspect of the present invention relates to the use of the silicone polymer composition according to the first aspect of the present invention for adhering a wearable product to skin, optionally mammalian skin, e.g. human skin.

[0026] A fifth aspect of the present invention relates to a method of manufacturing a silicone polymer composition according to the first aspect of the present invention, the method comprising curing the pre-cure composition according to the third aspect of the present invention.

[0027] Description of the figures

[0028] The present invention will now be described with reference to the following non-limiting examples and figures, which show:

[0029] Figure 1A shows the relationship between the rate of elution of polyhexamethylene biguanide (PHMB) from a silicone polymer composition of the present invention and the concentration of cellulose fibres within said silicone polymer composition. Elution rate increases with the concentration of cellulose fibre, with compositions with a loading of 0.10%wt cellulose fibres showed the lowest elution rate, 0.50%wt cellulose fibres showing the second lowest elution rate, 1.00%wt cellulose fibres the second highest elution rate, and 2.00%wt cellulose fibres showing the highest elution rate.

[0030] Figure 1 B shows the relationship between the rate of elution of chlorhexidine gluconate (CHG) from a silicone polymer composition of the present invention and the concentration of cellulose fibres within said silicone polymer composition. Elution rate increases with the concentration of cellulose fibre, with compositions with a loading of 0.10%wt cellulose fibres showed the lowest elution rate, 0.50%wt cellulose fibres showing the second lowest elution rate, 1.00%wt cellulose fibres the second highest elution rate, and 2.00%wt cellulose fibres showing the highest elution rate.

[0031] Figure 1C shows the relationship between the rate of elution of silver citrate from a silicone polymer composition of the present invention and the concentration of cellulose

[0032] 69661675-1 fibres within said silicone polymer composition. Elution rate increases with the concentration of cellulose fibre, with compositions with a loading of 0.10%wt cellulose fibres showed the lowest elution rate, 0.50%wt cellulose fibres showing the second lowest elution rate, 1.00%wt cellulose fibres the second highest elution rate, and 2.00%wt cellulose fibres showing the highest elution rate.

[0033] Detailed description of the invention

[0034] Silicone Polymer Composition

[0035] The silicone polymer composition of the present invention comprises a silicone polymer, at least one active agent and fibres of a polyhydroxylated polysaccharide distributed throughout the silicone polymer. The silicone polymer composition may be suitable for use as a sealant or as an adhesive. In particular, it is especially beneficial for skin adhesives and thus, in embodiments, the silicone polymer adhesive is a silicone polymer skin adhesive.

[0036] The term “skin adhesive” in this context refers to silicone polymer adhesives that are capable of safely contacting and adhering to the skin of a subject. Silicone adhesives are known to be particularly suitable for this purpose as they are typically able to adhere to the skin even in wet environments, whilst being readily removable following use. Exemplary silicone adhesive compositions are described in more detail herein.

[0037] The fibres are distributed throughout the silicone polymer, meaning that they are located throughout the body of the silicone polymer. This allows for consistent and reliable elution of the at least one active agent from the silicone polymer composition. It is contemplated that there may be variation in fibre density within the silicone polymer in some embodiments, i.e. whereby more fibres may be located in certain local regions compared to other local regions of the silicone polymer. It is however preferable to distribute the fibres as homogenously as possible within the silicone polymer to maximise consistency of active agent elution. This may be achieved by thorough mixing of the fibres within the pre-cure silicone precursor mixture prior to curing. It will be appreciated however that, due to the elongate geometry of fibres and practical experimental variability, some minor variation in fibre density within the polymer matrix may be observed even when a homogenous mixture is provided.

[0038] 69661675-1 Typically, at least some of the fibres will be interconnected (in direct physical contact) in the adhesive. In embodiments, at least 10% (by number) of the fibres in the adhesive are interconnected. At least 20% of the fibres in the adhesive may be interconnected. At least 30% of the fibres in the adhesive may be interconnected. At least 40% of the fibres in the adhesive may be interconnected. At least 50% of the fibres in the adhesive may be interconnected. At least 55% of the fibres in the adhesive may be interconnected. At least 60% of the fibres in the adhesive may be interconnected. This may be observable by microscopy.

[0039] The silicone polymer compositions of the present invention exhibit enhanced rates of active agent elution. It is believed that the polyhydroxylated polysaccharide polymer fibres provide polar channels through the hydrophobic silicone polymer due to the combination of the affinity of the polyhydroxylated polysaccharide chemical structure to water (by hydrogen bonding and other polar interactions) together with the elongate geometry of the fibres. Without wishing to be bound by theory, it is believed that the polyhydroxylated polysaccharide polymer fibres allow for effective elution of the active agents within the silicone polymer into the contacting fluid. It will be appreciated that active agents suitable for use in the present invention are generally polar compounds, and it is postulated that the polyhydroxylated polysaccharide fibres provide polar channels through and / or along which the at least one active agent may pass without inhibition from the hydrophobic silicone polymer. It is also believed that the polyhydroxylated polysaccharide polymer fibres and active agents associate during the formulation of the silicone composition, resulting in locally higher concentrations of active agent around the polar channels.

[0040] The silicone polymer compositions of the present invention also exhibit greater peel adhesion to surfaces.

[0041] The silicone polymer compositions of the present invention also exhibit greater rates of moisture transmission. Without wishing to be bound by theory, it is believed that moisture is primarily transported along the fibres and through the matrix, rather than being absorbed by the adhesive. The fibres appear to be acting as a conduit to allow water vapour to pass through the polymer and escape. This in turn makes the silicone polymer composition of the present disclosure less prone to swelling by absorption, and thus less prone to failure due to degradation / maceration effects that may otherwise be caused

[0042] 69661675-1 by such swelling. The resulting silicone polymer composition of the invention thus exhibit surprisingly improved longevity. Where the silicone polymer composition is a silicone polymer skin adhesive, this translates to greater wear time and user comfort.

[0043] Active Agents

[0044] The silicone polymer composition of the present invention comprises at least one active agent. The at least one active agent may be selected from non-therapeutics, such as cosmetic agents and contraceptives, and therapeutic agents, such as antimicrobials. Preferably, the active agent will be one that is suitable for topical application and / or transdermal delivery.

[0045] It is contemplated that active agents that contain hydrophilic groups may be particularly suitable for use in the present invention as such groups would tend to exhibit favourable intermolecular interactions with the polyhydroxylated polysaccharide fibres distributed throughout the silicone polymer.

[0046] In embodiments, the at least one active agent comprises one active agent. In alternative embodiments, the at least one active agent comprises two or more active agents, such as two active agents or three active agents.

[0047] References herein to active agents includes references to such compounds per se, to tautomers of such compounds, as well as to pharmaceutically acceptable salts or solvates, or pharmaceutically functional derivatives of such compounds.

[0048] Cosmetic Agents

[0049] The at least one active agent may be selected from cosmetic agents. Cosmetic agents may be selected from colorants, bleaching agents, moisturisers, fragrances, and exfol iants.

[0050] 69661675-1 Therapeutic agents

[0051] The at least one active agent may be selected from therapeutic agents. Therapeutic agents may be those suitable for topical application or transdermal delivery. The therapeutic agent may be selected from antimicrobials, anaesthetics, hormones, stimulants, antipsychotics, and antimuscarinics.

[0052] Anaesthetics

[0053] The at least one active agent may be selected from anaesthetics, such as lidocaine, prilocaine, benzocaine, dibucaine, pramoxine, menthol, methyl salicylate, capsaicin, tetracaine, camphor, phenol, and opioids (e.g. morphine).

[0054] Hormones

[0055] The at least one active agent may be selected from hormones, such as estradiol, testosterone, oestrogen, progesterone, and corticosteroids (e.g. hydrocortisone, clobetasone, beclometasone, betamethasone, clobetasol, fluticasone and mometasone). The hormones may be selected from those suitable for hormone replacement therapies. Alternatively, the hormones may be selected from those suitable for contraceptive applications. Further alternatively, the hormones may be selected from those suitable for treating inflammation.

[0056] Stimulants

[0057] The at least one active agent may be selected from stimulants, such as nicotine, caffeine, and amphetamines. The stimulant may be selected from those suitable for use in cessation therapies (e.g. smoking cessation).

[0058] Antipsychotics

[0059] The at least one active agent may be selected from antipsychotics, such as aripiprazole, asenapine, blonanserin, chlorpromazine, haloperidol, olanzapine, prochlorperazine, quetiapine, and risperidone.

[0060] Antimuscarinics

[0061] The at least one active agent may be selected from antimuscarinics, such as oxybutynin, scopolamine.

[0062] 69661675-1 Antimicrobials

[0063] The at least one active agent may be selected from at least one antimicrobial. Antimicrobials are particularly suited for use in the present invention, especially in the context of wound care applications where delivery of an antimicrobial in or around a wound may be beneficial. Preferably, the at least one antimicrobial is selected from those that are suitable for topical applications.

[0064] In embodiments, the at least one antimicrobial comprises one antimicrobial. In alternative embodiments, the at least one antimicrobial comprises two or more antimicrobials, such as two antimicrobials or three antimicrobials. It can be advantageous to use combinations of antimicrobials, so as to target a wider variety of microbes, and I or to reduce the likelihood of microbes becoming resistant to the antimicrobials or developing such resistance.

[0065] References herein to antimicrobials includes references to such compounds per se, to tautomers of such compounds, as well as to pharmaceutically acceptable salts or solvates, or pharmaceutically functional derivatives of such compounds.

[0066] In embodiments, the at least one antimicrobial is selected from the following classes of antimicrobials: guanides (such as bisbiguanides and polymeric biguanides), bispyridines, taurolidine, silver and its compounds (such as silver salts), copper and its compounds (such as copper salts), zinc and its compounds (such as zinc salts), and combinations thereof. Guanides and especially biguanides are particularly suitable for use in the present invention.

[0067] Preferably, the at least one antimicrobial is water-soluble, for example, having a water solubility at 20°C in excess of 1 %w / v, such as 5 %w / v, 10 %w / v, 20 %w / v, 30 %w / v, 40 %w / v, or 50 %w / v.

[0068] Antimicrobial guanide compounds contain a guanide functional group. Bisbiguanides are a family of antimicrobial compounds featuring two biguanide groups, examples of which include chlorhexidine (such as in the form of its gluconate salt: chlorhexidine gluconate (CHG)) and alexidine. Polymeric biguanides are a family of antimicrobial compounds featuring multiple biguanide groups. Examples include polyhexamethylene biguanide

[0069] 69661675-1 (PHMB) and polyaminopropyl biguanide (PAPB). PHMB is typically useful for topical applications, such as in wound dressings.

[0070] Bispyridines are a family of compounds with antimicrobial activity, including octenidine.

[0071] Silver and its compounds that generate silver ions are widely used as topical antimicrobials. Examples include silver salts, such as silver nitrate, silver sulphate and silver citrate. Silver nitrate and silver sulphate are particularly preferred for this invention among silver salts because of their aqueous solubility.

[0072] Copper and its compounds that generate copper ions are widely used as topical antimicrobials. Examples include copper salts, such as copper nitrate, copper sulphate, and copper citrate.

[0073] Zinc and its compounds that generate zinc ions are widely used as topical antimicrobials. Examples include zinc salts, such as zinc nitrate, zinc citrate, and zinc oxide.

[0074] In embodiments, the at least one antimicrobial is selected from chlorhexidine, alexidine, PHMB, PAPB, octenidine, taurolidine, silver citrate, silver nitrate, and combinations thereof. Optionally, the at least one antimicrobial is selected from PHMB, chlorhexidine, and silver citrate. The at least one active agent may comprise, or may be, chlorhexidine, PHMB or mixtures thereof. The at least one antimicrobial may include, or may be, PHMB. The at least one antimicrobial may include, or may be, chlorhexidine, e.g. chlorhexidine gluconate. The at least one antimicrobial may include, or may be, silver citrate.

[0075] The at least one antimicrobial may be present in the silicone polymer adhesive in an amount of from 0.05 %wt to 5 %wt, optionally from 0.1 to 2 %wt, optionally from 0.5 to 1 %wt, such as about 0.6 %wt. In embodiments, the quantity of the at least one antimicrobial is chosen such that an effective concentration is formed in fluid contacting the silicone polymer adhesive to prevent or inhibit microbial growth.

[0076] In particular embodiments, the active agent may be selected from nicotine, estradiol, testosterone, scopolamine, buprenorphine, chlorhexidine (such as chlorhexidine gluconate), polyhexamethylene biguanide (PHMB), and silver citrate.

[0077] 69661675-1 Fibres of Polyhydroxylated Polysaccharide

[0078] As used herein, the term “polyhydroxylated polysaccharide” is intended to refer to a polymer chain composed of adjoining monosaccharide units, wherein each monosaccharide unit contains at least one pendant hydroxyl group. In preferred embodiments, each monosaccharide unit contains two or more pendant hydroxyl groups, such as two or three hydroxyl groups, e.g. three. The term hydroxyl group in this context is intended to refer to an alcoholic -OH group. It is postulated that the presence of free hydroxyl groups along the length of the polymer allows for the effective transport of moisture along the fibres and thus through the silicone adhesive due to polar and hydrogen bonding interactions. The polyhydroxylated polysaccharide may be composed of one or more different monosaccharide units. Typically, the monosaccharide units of the polyhydroxylated polysaccharide are of a single monosaccharide species, preferably glucose. Fibres of multiple different types of polyhydroxylated polysaccharide (e.g. differing in terms of their monosaccharide constituents) may be provided in the silicone polymer composition. Typically, however, fibres of only a single type of polyhydroxylated polysaccharide are present, e.g. cellulose fibres.

[0079] The fibres may comprise, or may be, cellulosic fibres. Cellulose fibres in particular are especially suitable. Thus, in embodiments, the fibres of the polyhydroxylated polysaccharide are cellulose fibres. The fibres may be cotton and I or regenerated cellulose, such as viscose rayon fibres.

[0080] As can be seen in the examples, cellulose fibres in particular are especially effective in providing the beneficial effects discussed above. The term “cellulose” is intended in the conventional meaning of the term to refer to cellulose specifically. It is not intended to encompass functionalised derivatives of cellulose such as carboxyalkylated cellulose or other alkylated or hydroxyalkylated celluloses.

[0081] The cellulose fibres may be obtained from any suitable source, such as wood cellulose. The cellulose fibres may be synthetic, semi-synthetic or natural. Cotton and I or viscose rayon may be used. The cellulose fibres may be wood cellulose fibres. The fibres may be cotton fibres. The fibres may be viscose rayon fibres. Combinations of one or more of these are also contemplated.

[0082] 69661675-1 Suitable cellulose fibres may have a Mw of at least 100,000, such as at least 150,000, e.g. at least 160,000. The Mw may by calculated by light scattering. The degree of polymerisation may be at least 800, such as at least 900, e.g. at least 1000.

[0083] As described above, the elongate geometry of the fibres included in the silicone polymer compositions of the invention is understood to contribute significantly to the beneficial properties discussed herein in the context of silicone polymers. The fibres may have a number average fibre length in the range of from 20 pm to 1500 pm, such as from 20 pm to 900 pm. In this regard, it will be appreciated that the area and thickness dimensions of the silicone polymer composition will have an effect on the selection of suitable fibre length. The fibres may have a number average fibre length in the range of from 100 to 1000 pm as determined by microscopy (method described herein), such as from 100 pm to 900 pm. The fibres may have a number average fibre length in the range of from 200 pm to 1000 pm, as determined by microscopy (calculation method described herein), such as from 200 pm to 900 pm. The fibres may have a number average fibre length in the range of from 20 pm to 5 0 pm, e.g. around 30 pm. The fibres may have a number average fibre length in the range of from 200 pm to 300 pm, e.g. around 250 pm. The fibres may have a number average fibre length in the range of from 300 pm to 400 pm, e.g. around 350 pm. The fibres may have a number average fibre length in the range of from 500 pm to 600 pm, e.g. around 550 pm. The fibres may have a number average fibre length in the range of from 700 pm to 900 pm, e.g. around 800 pm. Longer fibre lengths as described have a greater propensity to become entangled and thus interconnect in the silicone polymer, which is expected to provide beneficial effects on antimicrobial elution. However, longer fibre lengths cause an increase the viscosity of the pre-cure mixture and thus make handling and manufacture more difficult, so fibres which are too long will be practically disadvantageous for processing purposes. The ranges above indicate suitable exemplary ranges. The number average fibre lengths described herein refer to lengths as determined by microscopy.

[0084] The concentration of fibres in the silicone polymer composition may be tailored according to the given practical application (e.g. greater or lesser need for active agent elution). It will be appreciated that increasing the concentration of fibres in the silicone polymer composition will be expected to increase its rate of active agent elution. However, as the fibres tend to have a relatively low density, significant increases in concentration will increase the viscosity of the pre-cure silicone polymer mixture used to form the silicone

[0085] 69661675-1 polymer composition, therefore making handling of the pre-cure composition more difficult, and making it difficult to obtain a uniform silicone polymer composition coating to be cured onto an appropriate substrate. It is therefore desirous to avoid using excessively high concentrations of fibres, for practical purposes.

[0086] The fibres of the polyhydroxylated polysaccharide may be present in the silicone polymer composition in an amount of at least 0.1 %wt, such as at least 0.25 %wt or 0.5 %wt, relative to the total weight of the silicone polymer composition. The fibres may be present in the silicone polymer composition in an amount of from 0.1 %wt to 5.0 %wt, such as from 0.25 %wt to 4 %wt. The fibres may for instance be provided in the silicone polymer composition in an amount of from 1.0 %wt to 3.0 %wt, such as around 2.0 %wt.

[0087] Uses of the Silicone Polymer Composition

[0088] The silicone polymer composition may be used as a sealant or adhesive. For example, the silicone polymer composition may be used as a construction sealant or adhesive, for example, in proximity to windows, doors, or items of sanitary-ware and / or kitchenware.

[0089] Silicone skin adhesives are particularly contemplated. Silicone skin adhesives are suitable for topical applications, such as wound care applications or other systems for delivery of agents to the skin. In particular, the silicone polymer composition may be used as a skin adhesive. The silicone skin adhesive may be suitable for application in negative pressure wound therapy (NPWT); transdermal drug delivery systems, topical drug delivery systems, cosmetic treatments, contraceptives, primary wound contact layers, securement devices, scar reduction / prevention, flexible surgical dressings, surgical incise drapes, and industrial applications such as wearable technologies and bio-diagnostic devices.

[0090] When used as a skin adhesive, it is preferable that the silicone polymer composition has an average wear time (i.e. the time the adhesive is able to remain reliably bonded to the skin in use) of at least 7 days, such as at least 14 days, e.g. at least 28 days.

[0091] The skin adhesive may be provided in any suitable form and dimensions depending on the wearable item and the intended practical use. For example, the skin adhesive may be formed as a margin portion within an island wound dressing system. In other

[0092] 69661675-1 instances, the skin adhesive may be formed as an annular ring component suitable for attaching faecal or ostomy collection pouches to the perianal or peristomal skin of a user.

[0093] The skin adhesive may be disposed on a substrate (e.g. as a coating), optionally wherein the substrate is a wearable product or a component part of a wearable product. The skin adhesive may be provided as continuous layer. The skin adhesive may be present as a discontinuous layer, e.g. containing perforations. The skin adhesive may be provided as a standalone product, in which case the product may be suitably disposed on a transfer layer for transport and storage. Typically such products would be provided also with a release liner, to prevent adhesion in transit.

[0094] Typically, the skin adhesive may be provided in the form of a film. It will be appreciated that such films may be coated on a suitable substrate, such as a backing layer. For instance, as described below, the film may be suitably formed by casting the pre-cure composition onto a substrate (e.g. backing layer) and then curing the adhesive directly on the substrate (e.g. backing layer) to form a multi-layer structure including a substrate and adhesive disposed thereon, e.g. in the form of a film coating. In embodiments, the multi-layer structure including a substrate and adhesive disposed thereon may have a moisture vapour transmission rate (MVTR) of from 700 g / m2 / 24hrs to 5000 g / m2 / 24hrs, optionally from 1000 g / m2 / 24hrs to 3000 g / m2 / 24hrs, such as about 3100 g / m2 / 24hrs.

[0095] The substrate may be a polymer film or a polymer foam or a combination thereof (e.g. a laminate). As referred to in this context the polymer film may be a polyurethane (Pll) film. The polymer foam may be a polyurethane foam. The foam may be provided in flood and I or pattern formats. Other substrates are also contemplated, such as polyethylene (PE), polypropylene (PP), ethyl methacrylate, paper, or non-woven articles (such as non- wovens made from fibrous polysaccharides, cellulose, rayon, or melt blown Pll, PE, PP). The substrate may also be in the form of a mesh, typically, a woven mesh fabric.

[0096] In embodiments, the substrate is a Pll film. The Pll film may have a thickness of from 5pm to 100pm, preferably from 10pm to 50pm. The Pll film may have a thickness of from 10pm to 20pm, such as around 15pm, or from 20pm to 40pm, such as around 30pm.

[0097] 69661675-1 Polymer films, such as a Pll film, suitable for use as a substrate I backing layer may have a moisture vapour transmission rate (MVTR) of from 3000 g / m2 / 24hrs to 16000 g / m2 / 24hrs, for instance, of from 3000 g / m2 / 24hrs to 4000 g / m2 / 24hrs or from 15000 g / m2 / 24hrs to 16000 g / m2 / 24hrs.

[0098] The combined thickness of the skin adhesive and substrate may be from 25 pm to 1000 pm or from 50 pm to 250 pm optionally from 75 pm to 150 pm, such as around 100 pm.

[0099] Typically, to prevent unwanted adhesion of the skin adhesive in transit (bonding to itself or to packaging), the skin adhesive may be provided with a release liner disposed thereon. This liner can then be readily removed prior to practical use. Thus, a release liner may be disposed on the skin adhesive (e.g. film) and I or the skin adhesive (e.g. film) may be disposed on a substrate.

[0100] The substrate referred to herein (on which the skin adhesive is provided, e.g. coated) may be a component part of a wearable product, optionally a medical device, optionally an ostomy device.

[0101] In another aspect is thus provided a wearable product comprising a skin adhesive as described according to any embodiment herein, the skin adhesive disposed so as to be capable of adhering the product to the skin of a user.

[0102] The wearable product may be a medical product or component part of a medical product such as wherein the medical product is a medical device, optionally a wound care or ostomy device. Exemplary wearable products comprising the skin adhesive include: a wound dressing comprising the skin adhesive as a wound or skin contact layer (as protection for minor cuts, abrasion or even areas of fragile skin), optionally wherein the wound dressing is a multi-layer dressing; a Negative Pressure Wound Therapy (NPWT) device comprising the skin adhesive as an interface layer (drape); a transdermal drug delivery system comprising the skin adhesive as a skin contact layer and drug depot; a topical drug delivery system comprising the skin adhesive as a skin contact layer and drug depot;

[0103] 69661675-1 a contraceptive comprising the skin adhesive as a skin contact layer and a contraceptive depot; an ostomy barrier or annular ring component comprising the skin adhesive as part of the interface between ostomy pouch and skin; a wearable smart device; and a fixation device for other medical devices (e.g. IV lines, tubing, etc.).

[0104] As discussed above, the wearable product may suitably further comprise a release liner disposed on the skin adhesive. It will be appreciated that the release liner will be removed to expose the silicone adhesive prior to use.

[0105] Methods of Producing the Silicone Polymer Composition

[0106] In another aspect is provided a pre-cure composition capable of forming a silicone polymer composition as described herein upon curing, the pre-cure composition comprising a silicone polymer precursor mixture (i.e. capable of forming a silicone polymer matrix upon curing), at least one active agent and fibres of the polyhydroxylated polysaccharide distributed throughout the mixture. The precursor mixture may for instance include a polyorganosiloxane containing at least one reactive functional group (e.g. a carbon-carbon double bond), and an organosiloxane containing a functional group capable of reacting with the reactive functional group of the polyorganosiloxane (e.g. containing an Si-H group), and optionally a curing catalyst capable of catalysing reaction between the polyorganosiloxane and organosiloxane polymer upon curing, e.g. platinum. In embodiments, the pre-cure composition may include an alkenyl-substituted polydimethylsiloxane having a silicon-bonded vinyl, allyl or hexenyl group, and an organosiloxane containing a silicon-bonded hydrogen atom (Si-H group), and a catalyst, such as a platinum metal, for causing cross-linking via the reaction of the Si-H groups with the Si-alkenyl groups. Suitable reaction conditions for curing of the pre-cure mixture are described herein.

[0107] Also provided is a method of manufacturing a silicone polymer composition as defined herein, the method comprising curing the pre-cure composition described above.

[0108] The step of curing the pre-cure composition may include casting or disposing the precure composition onto a substrate (e.g. backing layer). The substrate, as described herein, may be a Pll film. The pre-cure composition may be cast or disposed upon the

[0109] 69661675-1 substrate at a coat weight of from about 5 grams per m2to about 300 grams per m2or from about 100 grams per m2to about 200 grams. Preferably, at a coat weight of from about 125 grams per m2to about 175 grams per m2is used, for instance, 150 grams per m2. The step of casting or disposing may be performed using any suitable coating liner apparatus, such as wherein casting blades may be used to control the coat weight.

[0110] The step of curing the pre-cure composition according to the a method of manufacturing a silicone polymer composition as described herein may include curing the pre-cure composition at a temperature of from 80°C to 200°C, such as 90°C to 150°C, or 100°C to 120°C. This can be achieved by feeding the pre-cure composition through an oven set a suitable temperature. The pre-cure composition may be fed to the oven at a rate (line speed) of from 0.1 meters / minute to 2.0 meters / minute, for instance, from 0.5 meters / minute to 1 .5 meters / minute. Preferably the rate (line speed) is 0.6 meters / minute to 1.0 meters / minute, such as, 0.8 meters / minute. The step of curing is typically performed after the step of casting or disposing the pre-cure composition onto a substrate is performed, as described herein. In such embodiments, the pre-cure composition cast upon the substrate is fed into the oven at a rate (line speed) of 0.6 meters / minute to 1.0 meters / minute, such as, 0.8 meters / minute

[0111] In accordance with the invention, the pre-cure composition comprises the silicone polymer precursor mixture containing the at least one active agent and fibres of the polyhydroxylated polysaccharide distributed throughout the mixture (as described herein). In embodiments, the method includes the step of preparing the pre-cure composition by mixing the silicone polymer precursor mixture with the at least one active agent and the fibres of the polyhydroxylated polysaccharide such that the fibres are distributed throughout the mixture. This is, in some embodiments, achieved using a suitable mixing apparatus such as a paddle mixer.

[0112] In embodiments, other suitable additive components may be added to silicone polymer precursor mixture and fibres during the step of preparing the pre-cure composition.

[0113] The pre-cure composition described herein may include the silicone polymer precursor mixture in amount of at least than 90 %wt, for example, at least 95 %wt or 98 %wt relative to the total weight of the pre-cure composition. The at least one active agent may be provided in an amount of from 0.05 %wt to 5 %wt. The at least one active agent may for

[0114] 69661675-1 instance be provided in the silicone pre-cure composition in an amount of from 0.1 to 2 %wt, such as from 0.5 to 1 %wt or about 0.6 %wt. The pre-cure composition may include the fibres of the polyhydroxylated polysaccharide in amount of at least 0.1 %wt, such as at least 0.25 %wt or 0.5 %wt, relative to the total weight of the pre-cure composition. The fibres may be present in the pre-cure composition in an amount of from 0.1 %wt to 5.0 %wt, such as from 0.25 %wt to 4 %wt. The fibres may for instance be provided in the silicone pre-cure composition in an amount of from 1.0 %wt to 3.0 %wt, such as around 2.0 %wt.

[0115] In certain embodiments, the pre-cure composition contains the silicone polymer precursor mixture in amount of at least 90 %wt, the at least one active agent in an amount of from 0.01 %wt to 5 %wt and the fibres of the polyhydroxylated polysaccharide in amount of from 0.1 %wt to 5.0 %wt, for example, the silicone polymer precursor mixture in amount of at least 95 %wt, the at least one active agent in an amount of from 0.1 %wt to 2 %wt, and the fibres of the polyhydroxylated polysaccharide in amount of from 1 %wt to 3 %wt, or the silicone polymer precursor mixture in amount of about 97.4 %wt, the at least one active agent in an amount of about 0.6 %wt, and the fibres of the polyhydroxylated polysaccharide in amount of at about 2.0 %wt.

[0116] Throughout the present application, it will be appreciated that the references to skin and adhesion to skin typically refer to mammalian skin, e.g. primate skin, preferably human skin.

[0117] Examples

[0118] The silicone polymer composition of the present invention may be suitably prepared according to the exemplary method directed to an antimicrobial comprising silicone polymer composition provided below:

[0119] Preparation of pre-cure silicone composition (i.e. uncured precursor to the silicone polymer composition)

[0120] 1 . A suitable silicone gel starting material which is capable of undergoing curing to form a silicone polymer composition material is used. Typically, in an exemplary composition, the silicone gel starting material is SILPURAN® 2114 A / B which is supplied as two separate gel components (component A and component B). The silicone gel starting material contains polydimethylsiloxane with reactive

[0121] 69661675-1 functionality (e.g. unsaturated aliphatic group) in component A, an organosiloxane with reactive functionality (silicone-hydride group) in component B and a platinum catalyst to allow for cross-linking once gel components A and B are brought together and cured.

[0122] 2. Appropriate amounts of gel component A and gel component B are weighed into a container and are mixed manually (e.g. with a spatula) or using a mixer (e.g. a paddle mixer).

[0123] 3. The active agent, in this case an antimicrobial, is added and the combination mixed until fully incorporated. If the antimicrobial is in a solution or a dispersion, this is done via pipette. For PHMB and chlorhexidine gluconate (CHG), each of the antimicrobials was provided in an aqueous solution at a concentration of 20 w / w% and the solutions were added to the gel at 3 and 3.5 w / w% respectively (providing antimicrobial loadings of 0.6 and 0.7 w / w% respectively). If the antimicrobial is a solid, it is added as a powder. For example, silver citrate was added as a powder in the required amounts. Antimicrobial may be added before, during, or after step 2.

[0124] 4. The cellulose fibres are then added and mixed until homogeneous (e.g. for at least two minutes).

[0125] It will be understood that the foregoing order of mixing may be varied (e.g. the active agent may be added to either or each of component A and component B prior to mixing component A and component B, the cellulose fibres may be added to mixed component A and component B prior to adding the active agent, the cellulose fibres may be added to either or each of component A and component B prior to mixing component A and component B and prior to adding the active agent, the cellulose fibres and active agent may be mixed prior to adding to either or each of component A and component B, or the cellulose fibres and active agent may be mixed prior to adding to mixed component A and component B). Preferably, the cellulose fibres are the final component to be added as they increase the viscosity of the mixture.

[0126] Casting and curing of pre-cure silicone composition to form the silicone polymer composition

[0127] 69661675-1 1 . The pre-cure silicone composition is disposed upon a polyurethane substrate and spread evenly using a bar. Other substrates capable of withstanding the curing process, such as polyesters or high density polyethylenes, may be used. The substrate may have a non-stick coating, such as a fluorosilicone, in order to permit transfer the cured silicone to other target materials (e.g. porous and / or heat sensitive materials such as non-woven fabrics). The cured silicone may be adhered to the target material using an adhesive.

[0128] 2. The pre-cure silicone composition was then placed in an incubator (BINDER™) at a temperature of 105°C for 5 to 10 minutes. It will be appreciated that other suitable apparatus with alternative curing temperatures and times may be used. For example, a linear oven may be used, applying temperatures such as from 140 to 180°C for a time of from 2 to 10 minutes (e.g. a temperature of 160°C for 6 minutes).

[0129] 3. Once cured, a suitable non-adherent release liner (e.g. low-density polyethylene film) is placed on top of the cured silicone polymer layer to form a multi-layered silicone polymer composition product.

[0130] Adhesive Strength Testing

[0131] The peel adhesion data presented in Table 1 was obtained using a method aligned with ASTM F2256-05, as described below.

[0132] Silicone polymer composition samples and silicone control samples prepared using the method as described under the section titled “Preparation of silicone polymer composition” were subjected to peel adhesion test. For the avoidance of doubt, the samples used to calculate peel adhesion data are silicone polymer composition products formed of a polyurethane film backing layer substrate, silicone polymer composition layer and release liner, prepared in line with the method disclosed above. A sample of the silicone polymer composition sample is cut to 25 mm x 100mm using a cutting press (M A Series 3 Cutting Press). Approximately 10 mm of release liner is removed at one end of the sample to expose a portion of the silicone polymer composition layer. The exposed portion of the silicone polymer composition layer is tape wrapped to form a tab portion of the sample for use with the tensometer (WI230 Zwick Roell Z0.5 tensometer).

[0133] 69661675-1 A piece of Kraft paper of suitable dimensions is prepared. The remainder of the release liner of the silicone polymer composition product sample is removed and the sample is applied to the Kraft paper by bringing the newly exposed silicone polymer composition layer into contact with the surface of the Kraft paper. The tab portion does not adhere to the Kraft paper. The sample and Kraft paper are placed on a calibrated 'roll down' machine at a speed of 12 inch / min.

[0134] The Kraft paper is gripped inside to the upper jaw of the tensometer and the tab portion of the sample is gripped inside the lower jaw. The grip-to-grip separation is set to 100mm, the test speed is 150 mm / min and the test path is 150 mm. The peel angle is 180°. The maximum force and the average force are measured using the software Zwick TestXpert III.

[0135] As can be seen, the inclusion of both the active agent and the cellulose fibres increases the peel adhesion strength of the silicone polymer composition to a greater extent than either component alone.

[0136] Moisture Vapour Transmission Rate Testing

[0137] The moisture vapour transmission rate data presented in Table 2 was obtained using a method which is aligned with ISO 13726-1 :2002 Test Methods for Primary Wound Dressings - Part 1: Aspects of Absorbent section 3.3 Fluid Handling Capacity.

[0138] Silicone polymer composition samples and silicone control samples prepared using the method as described under the section titled “Preparation of silicone polymer composition” were subjected to fluid handling tests. For the avoidance of doubt, the

[0139] 69661675-1 samples used to calculate MVTR are silicone polymer composition products formed of a polyurethane film backing layer substrate, silicone polymer composition layer according to the method described above, and further comprising a release liner disposed on the silicone polymer composition to permit ease of handling. The method requires a circular sample of the silicone polymer composition having a 55 cm diameter to be cut. Release liners are removed and the circular sample silicone polymer composition (3) is then attached to the flange of a Paddington cup (1) and secured in place with a retaining ring (2). The Paddington cup is made of corrosion-resistant material and has an internal diameter of 35.7 mm ± 0.1 mm with a cross sectional area of 10 cm2cross section.

[0140] 20ml of Solution A is added to the Paddington cup and the screw top applied. Solution A is a standard test solution used in wound care containing 142 millimoles of sodium ions and 2.5 millimoles of calcium ions dissolved in distilled water (made as per ISO 13726- 1 :2002). The Paddington cup is positioned such that the sample silicone polymer composition is in contact with Solution A. The Paddington cup is then weighed and the weight is recorded (W1). The Paddington cup is placed into a 37°C environmental chamber for 24 hours in an upright position. Upon removal from the environmental chamber, the Paddington cup is left to stand for 30 minutes and the weight recorded (W2).

[0141] The Moisture Vapour Transmission Rate (MVTR) for the silicone polymer composition sample was calculated according to the following wherein the unit weight of W1 and W2 is grams.

[0142] MVTR = W1 - W2 x 1000 (Units: g / m2 / 24hrs)

[0143] 69661675-1 As can be seen, the inclusion of both the active agent and the cellulose fibres increases the MVTR of the silicone polymer composition to a greater extent than either component alone.

[0144] Active Agent Elution Testing

[0145] Silicone polymer composition product samples with active agent concentrations of 0.6 wt% and varying fibre amounts were prepared using the method as described under the section titled “Preparation of silicone polymer composition” were subjected to antimicrobial elution tests.

[0146] A die cutter was used to obtain 6.35x6.35 cm squares of the silicone polymer composition, which were adhered to a rigid plastic frame, leaving the silicone in the centre of the frame exposed. The silicone samples are then immersed in 100 mL of deionised water for a period (4h, 24h, 48h, etc). At the end of each period, an aliquot of the sample is taken and placed in a quartz cuvette and placed into a spectrophotometer (a Jenway™ 7315 UVA / isible Single Beam Spectrophotometer). The absorbance is recorded at a wavelength relevant to the active agent being tested and converted to a concentration by comparison with a calibration curve for each active agent. The aliquot is then returned to the bulk water. The results for each active agent are shown in Figs 1A (for PHMB), 1 B (for CHG), and 1C (for silver citrate).

[0147] The results show a clear relationship between the quantity of the fibres incorporated within the silicone polymer and the rate at which the active agents are released. Without wishing to be bound by theory, it is hypothesised that incorporation of the hydrophilic fibres within the hydrophobic silicone creates channels through which the active agent may diffuse into the surrounding aqueous phase, with an increased concentration of the fibres correlating with increased active agent elution.

[0148] Antimicrobial Efficacy

[0149] Silicone polymer composition product samples with active agent that is an antimicrobial in concentrations of 0.6 wt% and 2 wt% cellulose fibre were prepared using the method as described under the section titled “Preparation of silicone polymer composition”, as were fibre-free control compositions. These compositions were subjected to antimicrobial elution tests (as described above) and antimicrobial efficacy tests.

[0150] 69661675-1 A die cutter was used to obtain 5x5cm samples; these were placed in a sterile petri dish and 0.4ml of test inoculum was applied to the surface. Test inoculums are made containing clinically relevant microorganism at concentration of 6x105CFU / ml (CFU= colony forming units). The samples are covered with a rectangular piece of film (made from polyethylene, polypropylene or polyester at a thickness range of 0.05-0.10mm) measuring 4x4cm. The petri dish containing the inoculated sample is subsequently incubated in a humid environment (>90% R.H.) at 37°C for the desired amount of challenge time (i.e. 24hours).

[0151] Once the challenge period is complete, the samples are removed from the incubator and the cover film is carefully removed. 10 mL of suitable neutraliser is added to the Petri dish containing the test sample. A pipette is used to collect and release the neutraliser 4 times in order to ensure a successful wash of the sample specimen.

[0152] Serial dilutions are performed into agar plates and incubated for a time appropriate for the challenge organisms (i.e. 48 I 72 hours); once incubation period is complete CFU counts are performed taking into account the appropriate dilution factor in order to calculate the CFU per sample.

[0153] Finally the antimicrobial efficacy is calculated through the colony reduction observed in samples in relation to a control samples lacking antimicrobial agent.

[0154] 69661675-1

[0155] The results show that inclusion of the fibres greatly enhances both the antimicrobial elution and the antimicrobial efficacy of the silicone polymer compositions against a range of clinically relevant microbes.

[0156] It will be appreciated that numerous modifications to the embodiments herein made without departing from the spirit and scope of the invention, for instance, the scope of the invention as defined in the appended claims. Moreover, any one or more of the above described embodiments could be combined with one or more features of the other embodiments and all such combinations are intended within the present disclosure.

[0157] Optional and / or preferred features may be used in other combinations beyond those explicitly described herein and optional and / or preferred features described in relation to one aspect of the invention may also be present in another aspect of the invention, where appropriate.

[0158] The described and illustrated embodiments are to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the scope of the inventions as defined in the claims are desired to be protected. It should be understood that while the use of words such as “preferable”, “preferably”, “preferred” or “more preferred” in the description suggest that a feature so described may be desirable, it may nevertheless not be necessary and embodiments lacking such a feature may be

[0159] 69661675-1 contemplated as within the scope of the invention as defined in the appended claims. In relation to the claims, it is intended that when words such as “a,” “an,” or “at least one,” are used to preface a feature there is no intention to limit the claim to only one such feature unless specifically stated to the contrary in the claim.

[0160] 69661675-1

Claims

CLAIMS:1 . A silicone polymer composition comprising a silicone polymer, at least one active agent, and fibres of a polyhydroxylated polysaccharide distributed throughout the silicone polymer.

2. The silicone polymer composition according to claim 1 , wherein the fibres are cellulose fibres, optionally wherein the fibres are cotton and I or regenerated cellulose, such as viscose rayon fibres.

3. The silicone polymer composition according to any previous claim, wherein the fibres have a number average fibre length in the range of from 20 pm - 1500 pm as determined by microscopy, optionally from 200 pm to 1000 pm, such as from 200 pm to 900 pm.

4. The silicone polymer composition according to any previous claim, wherein the fibres are present in an amount of at least 0.1 %wt relative to the total weight of the silicone polymer composition, optionally from 0.25 to 5.0 %wt, optionally from 1 .0 %wt to 3.0 %wt.

5. The silicone polymer composition according to any previous claim, wherein the at least one active agent is selected from non-therapeutic agents, such as cosmetic agents and contraceptives, and therapeutic agents, such as antimicrobials.

6. The silicone polymer composition according to claim 5, wherein the at least one active agent is at least one antimicrobial, preferably selected from guanides (including bisbiguanides (such as chlorhexidine and alexidine) and polymeric biguanides (such as PHMB and PAPB)), bispyridines (such as octenidine), taurolidine, silver and silver compounds (such as silver nitrate, silver sulphate and silver citrate), copper and copper compounds, zinc and zinc compounds and combinations thereof.

7. The silicone polymer composition according to any previous claim, wherein the at least one antimicrobial is present in an amount from 0.05 to 5 %wt, optionally from 0.1 to 2 %wt, optionally from 0.5 to 1 %wt, such as about 0.6 %wt.69661675-18. The silicone polymer composition according to any previous claim, wherein the silicone polymer composition has a peel strength of from 0.1 to 10 N / 2.5 cm, optionally from 0.5 to 5.0 N / 2.5cm, such as 1.0 to 3.0 N / 2.5cm, such as about 2.5 N / 2.5cm.

9. The silicone polymer composition according to any previous claim, wherein the composition has a moisture vapour transmission rate (MVTR) of from 700 g / m2 / 24hrs to 5000 g / m2 / 24hrs, optionally from 1000 g / m2 / 24hrs to 3000 g / m2 / 24hrs, such as about 3100 g / m2 / 24hrs.

10. The silicone polymer composition according to any previous claim, wherein the silicone polymer composition is a silicone polymer skin adhesive.

11. The silicone polymer composition according to any previous claim, wherein the silicone polymer composition is disposed on a substrate, optionally wherein the substrate is a wearable product or a component part of a wearable product.

12. The silicone polymer composition according to claim 11 , wherein the combined thickness of the silicone polymer adhesive and substrate is from 25 pm to 1000 pm or from 50 pm to 250 pm optionally from 75 pm to 150 pm, such as around 100 pm.

13. The silicone polymer composition according to claim 11 or 12, wherein the substrate is a medical device or a component part of a medical device.

14. The silicone polymer composition according to any previous claim, wherein the silicone polymer composition is provided in the form of a film, optionally wherein a release liner is disposed on the film.

15. A wearable product comprising a silicone polymer composition according to any one of claims 1-12, wherein the silicone polymer composition is a silicone polymer skin adhesive, the silicone polymer skin adhesive disposed on the product so as to be capable of adhering the product to the skin of a user.69661675-116. The wearable product according to claim 16, further comprising a release liner disposed on the silicone polymer skin adhesive.

17. The wearable product according to claim 15 or 16, wherein the product is a medical device or component part of a medical device.

18. A pre-cure composition capable of forming the silicone polymer composition according to any of claims 1-15 upon curing, the pre-cure composition comprising a silicone polymer precursor mixture, at least one antimicrobial, and fibres of the polyhydroxylated polysaccharide distributed throughout the mixture.

19. Use of the silicone polymer composition according to any of claims 1-15 for adhering a wearable product to skin, optionally mammalian skin, e.g. human skin.

20. A method of manufacturing a silicone polymer composition according to any of claims 1-15, the method comprising curing the pre-cure composition according to claim 18.69661675-1

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