Composition for sealing around stoma

Abstract

A cellulosic composition for sealing around a stoma, an ostomy device or an accessory for an ostomy device comprising the composition, and a method for sealing around a stoma are disclosed. The composition comprises a continuous phase and a discontinuous phase, where the continuous phase comprises a cellulose derivative material and a plasticizer, and the discontinuous phase comprises an absorbent material. The cellulose derivative material is soluble in the plasticizer, and the composition comprises 15%-40% (w / w) cellulose derivative material, 10%-30% (w / w) plasticizer; and 40%-70% (w / w) of an absorbent material.

Description

[0001] The present invention relates to compositions for sealing around a stoma as well as ostomy devices comprising such compositions and methods of using such compositions.

[0002] background

[0003] In the case of treatment for gastrointestinal diseases, part or all of the colon, ileum or urethra has to be surgically removed or temporarily bypassed. The patient has a temporary or permanent abdominal stoma, and the effluent or waste products of the body are discharged through the stoma and collected in a collection bag. The bag is usually adhered to the skin by an adhesive sheet or adhesive plate with an entrance for accommodating the stoma. Separated annular adhesives and / or adhesive pastes can be used as auxiliary materials to fill the area between the stoma and the adhesive sheet. DETAILED DESCRIPTION

[0004] In the following, whenever the proximal side of a device or a part of a device is mentioned, reference is made to the side that faces the skin when the ostomy appliance is worn by a user. Likewise, whenever the distal side of a device or a part of a device is mentioned, reference is made to the side that faces away from the skin when the ostomy appliance is worn by a user. In other words, the proximal side is the side that is closest to the user when the appliance is fitted to the user, and the distal side is the opposite side, the side that is farthest from the user during use.

[0005] The embodiment provides a cellulose composition for sealing around a stoma, the composition comprising: 20%-40% (w / w) of a cellulose derivative material; 10%-30% (w / w) of a plasticizer; and 40%-70% (w / w) of an absorbent material. As shown in the examples, this type of composition achieves desirable swelling characteristics to enable proper and rapid sealing around a stoma.

[0006] The composition is a cellulosic composition, which means that one or more cellulose derivative materials constitute a significant portion of the composition.

[0007] The composition is used to seal around a stoma, which means that it is suitable for being applied to or near a person's skin around a stoma and forming a seal between the stoma and the composition. The purpose of this sealing effect is to prevent discharge from leaking from the stoma onto the person's skin.

[0008] The cellulose derivative material of the composition can be said to have formed a matrix in which other components are mixed. In other words, the composition comprises a matrix (sometimes also referred to as a continuous phase) and some discrete components in the matrix (these components can be referred to as discontinuous phase or discrete phase). Embodiment provides a kind of cellulose composition, the cellulose composition comprises a continuous phase and a discontinuous phase, wherein the continuous phase comprises a cellulose derivative material and a plasticizer, and wherein the discontinuous phase comprises an absorbent material. In an embodiment, the continuous phase is hydrophilic. In an embodiment, the cellulose derivative material is soluble in a plasticizer. For example, a cellulose derivative hydroxypropyl cellulose (HPC) (which can be a component of the continuous phase) is soluble in a polyethylene glycol (PEG200) (which is a plasticizer) having an average molecular weight of 200 daltons. In an embodiment, an absorbent material is insoluble in a plasticizer. For example, carboxymethyl cellulose (CMC) (which is an absorbent material and is a possible component of a discontinuous phase) is insoluble in PEG200.

[0009] In the context of the present invention, solubility refers to the ability of one component of a composition to be dissolved by another component of the composition. If, for example, a cellulose-derived material is soluble in a plasticizer, this means that the plasticizer in the composition can dissolve the cellulose-derived material in the composition. On the contrary, if something is insoluble, this means that one component of the composition cannot be dissolved by another component of the composition. For example, if an absorbent material is insoluble in a plasticizer, this means that the plasticizer in the composition cannot dissolve the absorbent material. The inventors are aware that solubility is a relative term: only a certain amount of material can be dissolved in a given amount of solvent. In the context of the present invention, solubility should be considered in the context of the composition itself. The fact that the cellulose-derived material of the composition is soluble in a plasticizer does not mean that any amount of the cellulose-derived material can be dissolved in any amount of the plasticizer. It only means that the cellulose-derived material in the composition can be dissolved by the plasticizer in the composition.

[0010] An embodiment provides a cellulose composition for sealing around a stoma, the composition comprising a continuous phase and a discontinuous phase, wherein the continuous phase comprises a cellulose derivative material and a plasticizer, and wherein the discontinuous phase comprises an absorbent material, and wherein the cellulose derivative material is soluble in the plasticizer, and wherein the composition comprises 20%-40% (w / w) of the cellulose derivative material, 10%-30% (w / w) of the plasticizer and 40%-70% (w / w) of the absorbent material.

[0011] The composition is water-swellable, which means that it swells in the presence of water. Water swelling is the increase in the volume of the composition caused by the absorption of water by the composition. Water swelling can be caused by the absorption of water by the cellulose derivative matrix itself and / or by the absorption of water by the absorbent material. Swelling requires an increase in the volume of the composition, which contrasts with, for example, sponges or other porous materials that absorb water by combining water into existing cavities or holes (the intake of such water does not lead to an increase in the volume of the material). The swelling of the composition and the resulting volume increase are the reasons for the sealing effect. The composition expands in volume and is able to fill gaps and provide sealing around, for example, a stoma. Swelling is the result of the absorption of liquid by the absorbent material and possibly also by the cellulose derivative matrix. The inventors have found that the mixture of the disclosed cellulose derivative matrix, plasticizer and absorbent material provides a suitable balance between rapid swelling and sufficient cohesion.

[0012] In an embodiment, the composition is plastic, which means that it may be permanently deformed by applying pressure. The plasticity of the composition can be adjusted, for example, by increasing the amount of the continuous phase, which will make it softer and more plastic. On the other hand, increasing the amount of the discontinuous phase will generally make the composition harder and less plastic.

[0013] The present inventors have found that it is difficult to obtain a good and effective seal around the stoma. On the one hand, the seal must be quite snug to prevent leakage. On the other hand, the stoma is usually very sensitive and cannot withstand high pressure or material friction. The stoma may be easily irritated, which may cause additional secretions from the stoma. In addition, it is important to establish a seal around the stoma as quickly as possible after the composition is applied to the skin. If the seal is established too slowly, there will be time for the discharge and secretions from the stoma to leak onto the skin of the person before the seal is established. This means that the skin and anything attached to the skin (such as an ostomy adhesive patch) will be damaged by discharge or secretions on the skin from the beginning. And this also means that the risk of skin damage and the risk of possible failure of the attachment of other devices to the skin increase dramatically.

[0014] When an ostomy product (such as an ostomy bag mounted on an adhesive base) is used, there is often a gap between the product and the stoma. In this gap, the skin is potentially exposed to discharge from the stoma. Because the discharge contains surface-active bile salts and proteolytic enzymes, this can damage the skin. The adhesive portion of the ostomy product often contains various absorbent and gelling compounds, and when exposed to moisture in the discharge, the adhesive portion will begin to swell and close the gap over time. However, this process is very slow and may not close the gap sufficiently and quickly enough to prevent skin damage.

[0015] Recognizing all this, the inventors have designed the composition of the present invention to provide a rapid sealing effect around the stoma, while still being gentle enough not to damage or irritate the stoma.

[0016] The composition comprises a matrix as a skeleton of the composition. The matrix generally has sufficient cohesiveness to maintain sufficient structural integrity of the composition and prevent it from falling off or dissolving when exposed to liquid for a short period of time (such as 2-12 hours). The matrix comprises a cellulose derivative material.

[0017] The composition further comprises a plasticizer, which has the effect of plasticizing or softening the composition and imparting to it the desired rheological properties.

[0018] The composition further comprises an absorbent material. The absorbent material can absorb liquid (such as water).

[0019] In an embodiment, said composition is a non-adhesive composition.Non-adhesive means that the composition itself can not keep properly adhering to the surface (such as people's skin).In an embodiment, non-adhesive means that when measured by the peeling force test method described herein, the composition shows a peeling force lower than 1N / 25mm.This peeling force lower than 1N / 25mm means that the composition can be removed very easily from, for example, people's skin without causing any damage.In order to ensure that the non-adhesive composition remains in place, it can be for example incorporated into the multi-component product that itself just can keep adhering.Or the composition can be fixed to the skin by other adhesive components (such as the adhesive on the base plate of ostomy device).

[0020] In an embodiment, the cellulose derivative material is selected from the group consisting of hydroxypropyl cellulose, methylhydroxypropyl cellulose, ethyl cellulose and methylhydroxyethyl cellulose.

[0021] In an embodiment, the plasticizer is selected from the group consisting of diethylene glycol, triethylene glycol and tetraethylene glycol, polyethylene glycol, dipropylene glycol, tripropylene glycol, polypropylene glycol, glycerol, glyceryl glucoside, diglycerol, triglycerol, polyglycerol, ethoxylated glycerol, ethoxylated methyl glucoside, glyceryl monoacetate, glyceryl diacetate, glyceryl triacetate, aliphatic diols, aliphatic triols, and aliphatic polyols, xylitol, erythritol, sorbitol, mannitol, inositol, dibutyl tartrate, diethyl tartrate, choline, urea, hydroxyethyl urea, PPG-10 methyl glucose ether, aliphatic esters of dicarboxylic acids and tricarboxylic acids, and aliphatic esters of fatty acids. In an embodiment, the plasticizer is selected from liquid rosin derivatives, aromatic olefin oligomers, vegetable and animal oils and derivatives, polar oils (such as esters, ethers and glycols), polypropylene oxides (such as α-butoxy-polyoxypropylene), mineral oils, citrate oils, paraffin oils, phthalates, adipates (such as DOA) and liquid or solid resins.

[0022] In an embodiment, the absorbent material is selected from the group consisting of: hydrocolloids, starches, water-soluble salts, monosaccharides, disaccharides and oligosaccharides, sugar alcohols, polypeptides, organic acids, inorganic acids, amino acids, amines, urea, superabsorbent particles (such as polyacrylic acid), glycols (such as polyethylene glycol), fumed silica and bentonite. In an embodiment, the absorbent material is selected from the group consisting of: carboxymethylcellulose, methylcellulose, hydroxypropyl methylcellulose, potato starch, corn starch, modified starch, hydroxyethyl starch, hydroxypropyl distarch phosphate, pectin, guar gum, locust bean gum, tara gum, agar, alginates, sodium alginate, calcium alginate, carrageenan, gellan gum, xanthan gum, gelatin, cellulose derivatives, salts of carboxymethylcellulose, sodium carboxymethylcellulose, methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, sodium starch glycolate and polyvinyl alcohol. In an embodiment, the absorbent material is hydroxyethyl cellulose having a weight average molecular weight in the range of 500,000-2,000,000 g / mol, such as 750,000-1,500,000 g / mol, such as 800,000-1,200,000 g / mol, such as 1,000,000 g / mol. In an embodiment, the absorbent material is Natrosol 250HX hydroxyethyl cellulose from Ashland.

[0023] In an embodiment, the cellulose derivative material and the absorbent material are different materials.

[0024] In embodiments, the composition comprises 15%-40%, 15%-25%, 15%-20%, 20%-30%, 30%-40%, 20%-25%, 25%-30%, 30%-35% or 35%-40% (w / w) cellulose derivative material.

[0025] In embodiments, the composition comprises 15%-30%, 20%-30%, 25%-30%, 15%-25%, or 15%-20% (w / w) plasticizer.

[0026] In embodiments, the composition comprises 40%-60%, 40%-50%, 50%-60%, 60%-70%, 50%-55%, 50%-65%, 55%-60%, 60%-65% or 65%-70% (w / w) absorbent material.

[0027] In embodiments, the composition comprises or consists essentially of 15%-25% (w / w) cellulose derivative material, 15%-25% plasticizer, and 50%-65% absorbent material.

[0028] In an embodiment, the composition further comprises an antioxidant, such as butylated hydroxytoluene. Antioxidants can be particularly useful when ethers are used in the composition. In an embodiment, the composition comprises an antioxidant in an amount of less than 5%, such as less than 2%, such as less than 1%, such as less than 0.5% (w / w).

[0029] In an embodiment, the composition further comprises one or more filler materials, such as calcium carbonate, magnesium oxide, magnesium hydroxide, aluminum hydroxide, fumed silica, and lignin. The filler material may include non-reinforcing fillers, such as talc, calcium carbonate, wood powder, or precipitated or fumed silica. More specifically, examples of such fillers include: calcium carbonate (such as dry ground calcium carbonate, wet ground calcium carbonate, selected calcium carbonate, precipitated calcium carbonate, surface treated calcium carbonate); kaolin and other clay-based minerals; talc (such as dry ground talc, calcined talc); quartz and silica, including natural silica (such as crystalline silica, fused silica, microcrystalline silica, microcrystalline homogeneous quartzite, diatomaceous earth, perlite) or synthetic silica (such as fumed silica). Silica, precipitated silica); mica (including ground mica, white mica, surface modified mica, metal coated mica); metal oxides and other compounds (such as titanium dioxide, aluminum trihydrate, wollastonite, barium sulfate, antimony oxide, magnesium oxide, magnesium hydroxide, calcium sulfate, anhydrous calcium sulfate, calcium sulfate dihydrate, feldspar and nepheline syenite); microspheres, solid microspheres, hollow microspheres (such as coated hollow microsphere fillers, metal aluminum (metalite aluminum) microspheres, polymer encapsulated gas microspheres); synthetic silicates (such as aluminum silicate, mullite, sillimanite, kyanite, andalusite, synthetic alkali metal aluminum silicate, calcium silicate, magnesium silicate, zirconium silicate). Optional fillers include, for example, calcium carbonate, magnesium oxide, fumed hydrophobic silica, or lignin. Suitable hydrophobic fumed silica includes, for example R812 (BET surface area g / cm 2 230-290) R974 (BET surface area g / cm 2 150-190) or 200 (BET surface area g / cm 2 200±25).

[0030] In an embodiment, the composition is in the shape of a ring. The ring shape is particularly useful for providing a seal around the entire stoma. The composition may alternatively be in the form of a half ring, in which case the user may apply one or two half rings according to need and preference.

[0031] In an embodiment, the ring has an outer diameter of 40-100 mm, such as 50-80 mm, such as 50-60 mm, and a central hole with a diameter of 5-30 mm, such as 10-20 mm.

[0032] In an embodiment, the ring has a thickness of 0.2-3 mm, such as 0.3-2 mm, such as 0.5-1.5 mm.

[0033] In an embodiment, the composition has a swelling of at least 0.75 mm, 1 mm, 1.25 mm or 1.5 mm after 30 minutes when measured according to the Swelling Rate Test Method described in the specification. Such swelling rates are preferred in terms of sealing around the stoma fairly quickly and minimizing the risk of leakage of discharge onto the user's skin. In an embodiment, the swelling may be at least 2 mm after 1 hour.

[0034] In an embodiment, the composition comprises 15%-25% (w / w) cellulose derivative material, 15%-25% (w / w) plasticizer and 45%-70% (w / w) absorbent material.

[0035] In an embodiment, the composition consists essentially of 15%-25% (w / w) cellulose derivative material, 15%-25% (w / w) plasticizer and 45%-70% (w / w) absorbent material.

[0036] In an embodiment, the composition consists of 15%-25% (w / w) cellulose derivative material, 15%-25% (w / w) plasticizer and 45%-70% (w / w) absorbent material.

[0037] In an embodiment, the cellulose derivative material is hydroxypropyl cellulose. In an embodiment, the absorbent material comprises carboxymethyl cellulose and polyacrylic acid. In an embodiment, the plasticizer comprises polyethylene glycol having a molecular weight of 200 Daltons.

[0038] An ostomy device is provided, comprising an adhesive for attaching the device to the skin of a user, a release liner on the proximal side of the adhesive, a backing layer on the distal side of the adhesive, a hole for accommodating a stoma, and a collecting bag attached to the backing layer, wherein the ostomy device further comprises a composition as described herein. In an embodiment, the composition is disposed on the distal side of the backing layer. In an embodiment, the composition is disposed between the adhesive and the backing layer.

[0039] An attachment for an ostomy device is provided, the attachment comprising an adhesive for attaching the attachment to the skin around the stoma of a user, a hole for accommodating the stoma, and a composition as described herein disposed on a distal side of the adhesive. In an embodiment, the attachment further comprises a release liner on a proximal side of the adhesive. In an embodiment, the attachment further comprises a backing layer on a distal side of the composition.

[0040] A method for sealing around a stoma is provided, the method comprising the steps of: providing a composition as described herein; applying the composition around the stoma; and allowing the composition to swell, thereby sealing around the stoma.

[0041] Terms

[0042] 1. A cellulose composition for sealing around a stoma, the composition comprising:

[0043] -20%-40% (w / w) of cellulose derivative materials;

[0044] - 10% to 30% (w / w) of a plasticizer; and

[0045] - 40% - 70% (w / w) absorbent material.

[0046] 2. The composition of clause 1, wherein the composition is water-swellable.

[0047] 3. The composition of clause 1 or 2, wherein the composition is non-adhesive.

[0048] 4. The composition of any of the preceding clauses, wherein the cellulose derivative material is selected from the group consisting of hydroxypropyl cellulose, methylhydroxypropyl cellulose, ethyl cellulose and methylhydroxyethyl cellulose.

[0049] 5. A composition as described in any of the preceding clauses, wherein the absorbent material is selected from the group consisting of hydrocolloids, starches, water-soluble salts, mono-, disaccharides and oligosaccharides, sugar alcohols, polypeptides, organic acids, inorganic acids, amino acids, amines, urea, superabsorbent particles, glycols, fumed silica and bentonite.

[0050] 6. The composition of any of the preceding clauses, wherein the composition is in the shape of a ring.

[0051] 7. A composition as described in any of the preceding clauses, wherein the composition has a swelling of at least 1.5 mm after 30 minutes when measured according to the Swell Rate Test Method described in the specification.

[0052] 8. A composition as described in any of the preceding clauses, wherein the composition comprises 15%-25% (w / w) cellulose derivative material, 15%-25% (w / w) plasticizer and 45%-70% (w / w) absorbent material.

[0053] 9. A composition as described in any of the preceding clauses, wherein the composition essentially consists of 15%-25% (w / w) cellulose derivative material, 15%-25% (w / w) plasticizer and 45%-70% (w / w) absorbent material.

[0054] 10. An ostomy device comprising an adhesive for attaching the device to the skin of a user, a release liner on the proximal side of the adhesive, a backing layer on the distal side of the adhesive, a hole for accommodating a stoma, and a collecting bag attached to the backing layer, wherein the ostomy device further comprises a composition according to any one of the preceding claims.

[0055] 11. The ostomy device of Clause 10, wherein the composition is disposed on a distal side of the backing layer or between the adhesive and the backing layer.

[0056] 12. An attachment for an ostomy appliance, the attachment comprising an adhesive for attaching the attachment to the skin around a stoma of a user, an aperture for accommodating the stoma and a composition according to any one of clauses 1 to 9 disposed on a distal side of the adhesive.

[0057] 13. The accessory device of clause 12, wherein the accessory further comprises a release liner on the proximal side of the adhesive.

[0058] 14. The accessory device of clause 12 or 13, wherein the accessory further comprises a backing layer on the distal side of the composition.

[0059] 15. A method for sealing around a stoma, the method comprising the steps of

[0060] - providing a composition according to any one of clauses 1 to 9;

[0061] - applying the composition around the stoma; and

[0062] The composition is allowed to swell, thereby forming a seal around the stoma.

[0063] Test Method

[0064] Peel force test method

[0065] For the peel test, a rectangular sample with the dimensions of 25 mm x 100 mm was provided. The sample was firmly pressed onto a thoroughly cleaned Teflon plate. 2 The auxiliary tape piece is placed on top of the sample and the whole sample is rolled to ensure a strong adhesion between the tape and the sample to be tested. After conditioning at 23 degrees Celsius for 30 minutes, the sample is mounted in a tensile tester and a 90 degree peel test is performed at a speed of 304mm / min. The results are given in N / 25mm.

[0066] Swelling rate test method

[0067] The swelling rate is tested by hot pressing the composition to be tested between sheets of release liner (siliconized paper) at 90° C. for 30 seconds to a thickness of 1 mm. From this, rings (outer diameter 57 mm, hole diameter 27 mm) are cut.

[0068] A hard plastic (polyoxymethylene, "POM") disk (17 mm diameter, 3 mm thick) was attached to the center of a glass petri dish with double-sided tape. A ring of swellable composition was mounted in the glass petri dish centered around the POM disk to give a gap of 5 mm between the POM and the ring of swellable composition.

[0069] When isotonic saline is added to the sample to induce swelling, the process is essentially a low-contrast event. To increase contrast, a crossed polarizing filter is used: a piece of polarizing film is attached to a light-transmitting table. The sample is placed on top of this film. A camera (Canon EOS1200D) is installed to observe the sample from above. Another polarizing filter is installed on the lens of the camera. The filter is then adjusted to allow the minimum amount of light to pass (this occurs when the 2 filters are oriented at 90° to each other). The first photo of the sample is taken, saline is added to cover the ring, and subsequent photos are taken at predetermined time points (such as 1-24 hours). Now, use ImageJ to measure the gap between the ring and the POM disk at the 12-3-6-9 o'clock position, both at the start (t0) and at a later time point. The average change in gap size at different time points (in mm) is calculated and reported.

[0070] Corrosion resistance test method

[0071] To test the erosion resistance, the composition was hot pressed between 2 release liners (siliconized paper) to reach 0.5 mm. A square sample (25×25 mm) was made and a triangular notch (about 10×10×10 mm) of the material was cut from the top of the square, with the tip of the triangle pointing to the center of the square. The notched square was mounted on a glass plate. The glass plate was then mounted in a vertical position (about 10° from the vertical) in front of a light transmission table (also in a vertical position) with a polarizing filter (as in the above-mentioned swelling rate test method). The sample was observed with a camera with a polarizing filter. The filter was adjusted to maximum darkness. A reservoir with saline was placed below the sample and saline was pumped from the reservoir to the notch in the sample at 4 mL / min. Time-lapse photography was started and the time taken for the flowing liquid to carve a distinct channel in the material was used as a measure of erosion resistance.

[0072] Examples

[0073] The following composition was produced. CMC is carboxymethylcellulose sodium salt and GR-221 is sodium polyacrylate superabsorbent powder, both of which are absorbent materials. PEG200 is polyethylene glycol with an average molecular weight of 200 Daltons, which is a plasticizer. HPC is hydroxypropyl cellulose. BHT is butylated hydroxytoluene, which is an antioxidant.

[0074] Table 1

[0075]

[0076] Formulations A, B, C and D were prepared to test HPC grades with different molecular weights. These formulations were all produced as described in Example 3 below, where BHT was added to the matrix mixture produced according to Example 1, except for the different grades of HPC components.

[0077] Formulation E is the exact formulation obtained from Example 3 below.

[0078] Formulations F and G were produced in the same manner as described in Example 3, but with different amounts of these various components.

[0079] Example 1: Hydroxypropylcellulose-based matrix

[0080] 34.5 g of PEG200 was added to a glass beaker. Then 34.5 g of hydroxypropylcellulose (Klucel LF PHARM, Ashland) was added under stirring. The mixture was left at room temperature for 1 hour to solidify and then hot mixed (Brabender) at 80° C. at 50 rpm for 40 minutes. This produced a soft, viscous paste at room temperature.

[0081] Example 2: Ethylcellulose-based matrix

[0082] 34.5 g of tributyl citrate was added to a glass beaker. Then 34.5 g of ethylcellulose (Aqualon EC N4, Ashland) was added under stirring. The mixture was left at room temperature for 1 hour and then hot mixed (Brabender) at 80° C. at 50 rpm for 40 minutes. This produced a soft, slightly viscous paste at room temperature.

[0083] Example 3: Swellable composition with a matrix binder based on hydroxypropyl cellulose

[0084] 21 g of the matrix paste of Example 1, 19.5 g of carboxymethylcellulose (Akucell AF2881, Nouryon) and 19.5 g of sodium polyacrylate (GR-221 superabsorbent powder, Chase Corporation) were added to a Speedmixer cup and mixed at 2000 rpm (3 x 1 min) (Speedmixer DAC150.1 FVZ (Hauschild). The result was a soft paste when hot which solidified into a hard paste when cooled to room temperature.

[0085] Example 4: Swellable composition having an ethylcellulose-based matrix

[0086] 21 g of the matrix of Example 2, 19.5 g of carboxymethylcellulose (Akucell AF2881, Nouryon) and 19.5 g of sodium polyacrylate (GR-221 superabsorbent powder, Chase) were added to a Speedmixer cup and mixed at 2000 rpm (3 x 1 min) (Speedmixer DAC150.1 FVZ (Hosched)). This resulted in a soft paste when hot, which solidified to a hard paste when cooled to room temperature.

[0087] Example 5: Comparison of the swelling rates of a commercial ostomy sealing ring and a swellable composition "Formulation B"

[0088] The swelling rate of a commercial ostomy sealing ring (hydrophobic adhesive matrix with hydrocolloid) was measured as described above in the "Swelling Rate Test Method" section. This commercial product is a hydrophobic adhesive with hydrophilic filler particles. The swelling rate was measured at 0, 1.5, 4, 8, 12 and 16 hours.

[0089] Similarly, the swellable composition according to Formulation B in Table 1 was tested by the "Swelling Rate Test Method" described herein, wherein measurements were taken at 15, 30, 60 and 120 minutes. Since Formulation B was observed to swell much faster, measurements were taken earlier and at shorter intervals.

[0090] The results comparing the swelling rates of commercial ostomy seals and Formulation B are shown in Table 2. All reported results are averages of four individual samples. The results in parentheses are calculated values ​​based on fitting a curve to the measured results.

[0091] Table 2

[0092]

[0093] The results in Table 2 show that commercial ostomy sealing products swell quite slowly and therefore take a long time to close the gap between the adhesive and the POM disk. Even after 4 hours, the ostomy seal had only swelled by 1.3 mm. Translated into a use scenario, where the POM disk simulates a stoma and the gap simulates exposed skin, the skin will be exposed to stoma discharge for a very long time before being sealed by the slowly swelling adhesive. This is in contrast to the swelling composition of Formula B, which swelled by 2.6 mm after only 1 hour. And even after only 15 minutes, the composition of Formula B swelled by 1.6 mm, acting very quickly to close the gap between the applied composition and the POM disk.

[0094] Example 6: Corrosion resistance

[0095] The compositions were tested for erosion resistance as described in the Erosion Resistance Test Method described above. Formulations AD were tested to better understand the effect of different HPC grades, and Formulation EG was tested to examine the effect of different amounts of HPC in the composition. The results are shown in Table 3, where erosion resistance is reported as the time it takes for the liquid to carve a channel in the material. Higher numbers indicate higher erosion resistance.

[0096] Table 3

[0097]

[0098] The results in Table 3 show that higher molecular weight HPC materials lead to increased erosion resistance. On the other hand, an increase in HPC (and plasticizer) content relative to the absorbent leads to a decrease in erosion resistance. This information can be used to fine-tune the properties of compositions for commercial use. The test method used cannot be directly translated into the erosion rate expected when the composition is worn on the skin of, for example, an ostomy user. However, all compositions tested are considered to have acceptable levels of erosion resistance in terms of compositions suitable for use as seals around stomas.

Claims

1. A cellulosic composition for sealing around a stoma, the composition comprising a continuous phase and a discontinuous phase, wherein the continuous phase comprises a cellulose derivative material and a plasticizer, and wherein the discontinuous phase comprises an absorbent material, and wherein the cellulose derivative material is soluble in the plasticizer, and wherein the composition comprises: - 15% to 40% (w / w) of said cellulose derivative material, - 10% to 30% (w / w) of said plasticizer, and - 40% - 70% (w / w) of said absorbent material.

2. The composition according to claim 1, wherein The absorbent material is insoluble in the plasticizer.

3. The composition according to claim 1 or 2, wherein The composition is water-swellable.

4. A composition as claimed in any one of the preceding claims, wherein The composition is non-adhesive.

5. A composition as claimed in any one of the preceding claims, wherein The cellulose derivative material is selected from the group consisting of hydroxypropyl cellulose, methyl hydroxypropyl cellulose, ethyl cellulose and methyl hydroxyethyl cellulose.

6. A composition as claimed in any one of the preceding claims, wherein The absorbent material is selected from the group consisting of hydrocolloids, starches, water soluble salts, mono-, disaccharides and oligosaccharides, sugar alcohols, polypeptides, organic acids, inorganic acids, amino acids, amines, urea, superabsorbent particles, glycols, fumed silica and bentonite.

7. A composition as claimed in any one of the preceding claims, wherein The composition is in the shape of a ring.

8. A composition as claimed in any one of the preceding claims, wherein The composition has a swelling of at least 0.75 mm after 30 minutes when measured according to the Swell Rate Test Method described in the specification.

9. A composition as claimed in any one of the preceding claims, wherein The composition comprises 15%-25% (w / w) of a cellulose derivative material, 15%-25% (w / w) of a plasticizer and 45%-70% (w / w) of an absorbent material.

10. A composition as claimed in any one of the preceding claims, wherein The composition consists essentially of 15%-25% (w / w) cellulose derivative material, 15%-25% (w / w) plasticizer and 45%-70% (w / w) absorbent material.

11. An ostomy device comprising an adhesive for attaching the device to the skin of a user, a release liner on the proximal side of the adhesive, a backing layer on the distal side of the adhesive, a hole for accommodating a stoma, and a collecting bag attached to the backing layer, wherein the ostomy device further comprises a composition according to any one of the preceding claims.

12. The ostomy device of claim 11, wherein: The composition is disposed on the distal side of the backing layer or between the adhesive and the backing layer.

13. An attachment for an ostomy device, the attachment comprising an adhesive for attaching the attachment to the skin around a stoma of a user, a hole for accommodating the stoma, and a composition according to any one of claims 1 to 10 disposed on a distal side of the adhesive.

14. The accessory device of claim 13, wherein: The attachment further includes a release liner on a proximal side of the adhesive.

15. An accessory device as claimed in claim 13 or 14, wherein: The attachment further comprises a backing layer on a distal side of the composition.

16. A method for sealing around a stoma, the method comprising the steps of - providing a composition according to any one of claims 1 to 10, - applying the composition around the stoma, and - allowing the composition to swell, thereby sealing around the stoma.

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