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WO2025215377A1 - Véhicule pour composition non antimicrobienne - Google Patents

Véhicule pour composition non antimicrobienne

Info

Publication number
WO2025215377A1
WO2025215377A1 PCT/GB2025/050782 GB2025050782W WO2025215377A1 WO 2025215377 A1 WO2025215377 A1 WO 2025215377A1 GB 2025050782 W GB2025050782 W GB 2025050782W WO 2025215377 A1 WO2025215377 A1 WO 2025215377A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
salt
antimicrobial composition
wound
glycerol
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/GB2025/050782
Other languages
English (en)
Inventor
Genevieve HARRIS
Hollie HATHAWAY
David Parsons
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Convatec Ltd
Original Assignee
Convatec Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Convatec Ltd filed Critical Convatec Ltd
Publication of WO2025215377A1 publication Critical patent/WO2025215377A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/20—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing organic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/48—Surfactants
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00—Materials specially adapted for additive manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/21—Acids
    • A61L2300/214—Amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/22—Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions

Definitions

  • the present disclosure relates generally to wound care, and more particularly to a wound dressing or debridement tool comprising an absorbent layer at least partially impregnated or coated with a non-antimicrobial composition.
  • Normal wound healing comprises four intricate and overlapping phases: haemostasis, inflammation, proliferation, and remodelling.
  • leukocytes After the formation of a thrombus, leukocytes infiltrate the wound and remove bacteria and debris, preparing the wound for healing.
  • This enables the formation of new connective tissue and blood vessels, known as granulation tissue, and subsequent wound closure and re-epithelialisation.
  • An wound is classed as chronic if it fails to progress through this sequence within 4-6 weeks. Wound chronicity is often attributed to diabetes and vascular diseases. The resulting nerve damage and poor perfusion to extremities alter the wound microenvironment and delay healing.
  • Chronic wound healing stalls in the inflammatory phase due to an imbalance of cytokines, proteases, and their inhibitors. Prolonged inflammation leads to the accumulation of slough, a fibrinous substance composed of dead leukocytes and degraded proteins.
  • non-viable tissue may include necrotic (dead) tissues, slough (accumulating granulation and epithelial cells that are not surviving in the chronic wound environment) and biofilm (microbial matter including viable microorganisms and associated selfproduced mucilage or extracellular polymeric substance (EPS)).
  • Biofilm is are viable microbial tissue that can re-establish and multiply rapidly, returning to its original condition within a few days or even a few hours. Slough is a consequence of the inflammatory phase of wound healing and it comprises dead or redundant white blood cells, fibrin/ fibroblasts, cellular debris/ components of healing, and liquefied devitalised tissue.
  • Slough can provide a source of nutrients for bacterial cells and a suitable environment for their proliferation, subsequently enabling biofilm formation.
  • Necrotic tissue is an additional source of cellular debris in the form of fibrous proteins (such as collagen) and proteoglycans (components of the extracellular matrix).
  • fibrous proteins such as collagen
  • proteoglycans components of the extracellular matrix
  • WO 2021/186188 Al describes a wound dressing or debridement tool comprising an absorbent layer impregnated or coated with a composition comprising a chelating agent, an amphoteric surfactant, and an anionic surfactant.
  • compositions suitable for use in wound dressings or debridement tools that are able to promote autolytic debridement while having physical modes of action against biofilms and the microorganisms comprised therein.
  • non-antimicrobial compositions that have enhanced physical modes of action against biofilms and the microorganisms comprised therein are desirable.
  • compositions that are simple, economical and safe to prepare while maintaining efficacy and suitability for use in wound dressings and debridement tools for the purposes discussed above there is also a need for compositions with good stability, e.g.
  • compositions may be applied to substances such as fabrics and sheet-based materials by printing methods such as screen-printing, gravure printing, and rotary pad printing.
  • printing methods such as screen-printing, gravure printing, and rotary pad printing.
  • non-woven fabrics are uneven, porous, stretchable and easily creased materials. Due to the uneven surface structure of the substrate material, transfer of substances from a printing roller may lack uniformity and the substances may not completely transfer from the printing roller to the surface of the substrate material.
  • compositions known in the art may not be suitable for use (e.g.
  • compositions that are compatible with such printing processes so as to enhance the accuracy and/or control of the application of said compositions, for example to a wound dressing or debridement tool.
  • the present disclosure provides a non-antimicrobial composition for printing onto an absorbent layer of a wound dressing or debridement tool, said composition comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C1.4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1.
  • the present disclosure provides a process for preparing a non-antimicrobial composition as defined herein, said process comprising the steps of (a) combining the amphoteric surfactant and the anionic surfactant, (b) adding the chelating agent to the mixture of step (a), and (c) adding the solvent and carrier to the mixture of step (b), or (a) combining the solvent and the chelating agent, (b) adding the anionic surfactant to the mixture of step (a), (c) adding the amphoteric surfactant to the mixture of step (b), and adding the carrier to the mixture of step (c).
  • Another aspect of the present disclosure provides a process for preparing a non-antimicrobial composition as defined herein, wherein the one or more excipients comprise a chelating agent, an amphoteric surfactant, and an anionic surfactant, said process comprising the steps of (a) combining the amphoteric surfactant and the anionic surfactant, (b) adding the chelating agent to the mixture of step (a), and (c) adding the solvent and carrier to the mixture of step (b), or (a) combining the solvent and the chelating agent, (b) adding the anionic surfactant to the mixture of step (a), (c) adding the amphoteric surfactant to the mixture of step (b), and adding the carrier to the mixture of step (c).
  • Yet another aspect of the present disclosure provides a process for preparing a nonantimicrobial composition as defined herein further comprising a polyethylene glycol, wherein the polyethylene glycol has a weight average molecular weight of greater than about 1000 to less than about 8000, preferably about 1500 to about 7000, said process comprising the steps of:
  • step (b) heating the mixture of step (a) to a minimum of about 30°C until the polyethylene glycol is fully dissolved in the one or more C1-C4 alcohol;
  • step (c) adding the solution of step (b) to the carrier;
  • step (d) adding the one or more excipients to the solution of step (c).
  • a further aspect of the present disclosure provides a process for preparing a wound dressing or debridement tool, said process comprising printing the non-antimicrobial composition as defined herein onto a surface of an absorbent layer of the wound dressing or debridement tool.
  • Another aspect of the present disclosure provides a wound dressing or debridement tool obtained by the process defined herein, preferably wherein the absorbent layer is at least partially impregnated or coated with the non-antimicrobial composition, and wherein the absorbent layer comprises one or more gel-forming fibres.
  • the present disclosure also provides for the use of the foregoing wound dressing or debridement tool to prevent or minimise slough accumulation in a wound or to de-slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool, preferably wherein the wound is a chronic wound, acute wound, or burn.
  • FIG. 1 is a representation of the equipment used in the art for screen printing.
  • ink (1) is applied across the screen (5) by a squeegee (2).
  • the screen comprises an image (3) formed by way of a photoemulsion (4) which makes the screen impermeable to the ink in the areas to which the photoemulsion has been applied and cured (e.g. by UV light).
  • a second pass of the squeegee (2) then results in transfer of the ink from the areas of the screen that are permeable to the ink (i.e. where there is no photoemulsion applied) onto the substrate to form a printed image (6).
  • Figure 2A is a photograph of Formulation 10 from Experimental 2 consisting of disodium EDTA and oleic acid.
  • Figure 2B is a photograph of Formulation 11 from Experimental 2 consisting of disodium EDTA and sodium oleate.
  • Figure 3 is a bar chart showing the efficacy of sodium oleate ink and oleic acid ink prepared in Experimental 5 in a simulated non-viable matter model detailed in Experimental 3. The inks are compared to an AQUACEL® Extra control (% more efficacious than AQUAGEL® Extra) where AQ Clean is solvent flooded with the concentration of excipients stated in Table 2.
  • Sodium oleate ink is AQUACEL® Extra printed with 0.07g of the ink described in Table 9 on one side of a 10x10 cm sample
  • Oleic acid ink is AQUACEL® Extra printed with 0.07 g of the ink formulation stated in Table 9 on one side of a 10x10 cm sample
  • Glycerol only ink is AQUACEL® Extra printed with 0.07g of 77.77% glycerol 22.22% IDA ink on one side of a 10x10 cm sample.
  • Figure 4 is a table summarising the compatibility - solubility or miscibility - of potential carrier systems for the anionic surfactant, amphoteric surfactant and chelating agent.
  • Figure 5 is plot of stress and viscosity against shear rate showing the rheological behaviour of ink with a 50:50 ratio of triglycerol: glycerol throughout a flow ramp protocol as set out in the Examples. The Data is fit to a Newtonian fluid model using TRIOS software (TA Instruments, New Castle, Delaware, USA).
  • Figure 6 plots the efficacy of dressing samples printed with printing ink 1 (the formulation of Table 6) and triglycerol ink to disrupt simulated biofilm/non-viable matter substrate compared to an AQUAGEL® Extra control.
  • Figure 7 is from Experimental 4 and shows the change in viscosity against shear rate for the PEG thickeners tested in the ink formulation.
  • Figure 8 shows the open area pattern on a 120T screen. Black dots show the open area where ink will be printed onto a 10x10 cm AQUAGEL® Extra dressing in Experimental 1.
  • Figure 9 is a scatter plot of excipients mass added against total ink mass added to the dressing from Experimental 6. High, medium and low refers to the concentration of ink used.
  • the singular forms "a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
  • the term “about” modifying the quantity of a component refers to variation in the numerical quantity that can occur, for example, through typical measuring and handling procedures used for making concentrates, mixtures or solutions in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of the materials employed, or to carry out the methods; and the like.
  • the term “about” also encompasses amounts that differ due to different equilibrium conditions for a composition resulting from a particular initial mixture. Whether or not modified by the term “about”, the claims include equivalents to the quantities.
  • the term “at least” includes the end value of the range that is specified. For example, “at least 10 wt%” includes the value 10 wt%.
  • wt% means "weight percentage” as the basis for calculating a percentage. Unless indicated otherwise, all wt% values are calculated on an actives basis, and are provided with reference to the total weight of the product in which the substance is present. As used herein, w/w means "weight by weight” as the basis for calculating a percentage. Unless otherwise indicated, reference to “% by weight” (or “% by weight”) of a product or composition reflects the total wet weight of the product or composition (i.e., including carrier and solvent).
  • composition ingredients may be presented on a wt% basis as well as on an area density (weight per area) basis dependent on the form and application of the product. For example, %w/w may be most appropriate for a fluid product, whereas an area density may be more appropriate to a flat sheet dressing.
  • area density refers to the area of an absorbent layer as further described herein and the weight of the specified component comprised in or on said absorbent layer.
  • the composition may be applied to a wound dressing or debridement tool as described herein with an area density about 5 to about 40 g/m 2 . In specific examples, the composition may be applied at an area density of 30 g/m 2 or 15 g/m 2 .
  • An exemplary wound dressing may comprise an absorbent layer of dimensions 10 x 10 cm (width x length), giving an area of 0.01 m 2 .
  • an absorbent layer of dimensions 10 x 10 cm (width x length), giving an area of 0.01 m 2 .
  • 0.3 g of a composition as described herein would be applied to the absorbent layer to obtain an area density of 30 g/m 2 .
  • the composition may be applied to a single surface of the absorbent layer, for example in embodiments wherein the absorbent layer is comprised in a multi-layer wound dressing.
  • the composition may be applied to a first surface of the absorbent layer and to a second surface of the absorbent layer opposite to the first surface of the absorbent layer.
  • the composition may be applied to the wound dressing or debridement tool as described herein to contribute 15 g/m 2 on each of the first and second surfaces, i.e. such that the total area density applied to the absorbent layer is 30 g/m 2 .
  • the area densities recited herein refer to the total area density of composition applied to the absorbent layer, calculated on the basis of the area defined by the dimensions (width and length) of the absorbent layer and the total amount of the composition applied thereto, whether applied only to a single surface of the absorbent layer or applied to both a first surface and a second surface of the absorbent layer.
  • the absorbent layer has an area of 0.01 m 2 (10 x 10 cm)
  • 1.5 g of a composition as described herein could be applied to the first surface of the absorbent layer and 1.5 g of the composition applied to the second surface of the absorbent layer to obtain a total area density of 30 g/m 2 .
  • substantially free means no more than trace amounts, i.e. the amount of the substance(s) concerned is negligible. In various embodiments, “substantially free” means no more than 1000 ppm, preferably no more than 100 ppm, more preferably no more than 10 ppm, even more preferably no more than 1 ppm of the substance(s) concerned.
  • the disclosure includes, where appropriate, all enantiomers and tautomers of the compounds disclosed herein.
  • a person skilled in the art will recognise compounds that possess optical properties (one or more chiral carbon atoms) or tautomeric characteristics.
  • the corresponding enantiomers and/or tautomers may be isolated/prepared by methods known in the art.
  • Some of the compounds disclosed herein may exist as stereoisomers and/or geometric isomers - e.g. they may possess one or more asymmetric and/or geometric centres and so may exist in two or more stereoisomeric and/or geometric forms.
  • the present disclosure contemplates the use of all the individual stereoisomers and geometric isomers of those compounds, and mixtures thereof.
  • the terms used in the claims encompass these forms.
  • a non-antimicrobial composition for printing onto an absorbent layer of a wound dressing or debridement tool.
  • a wound dressing and a debridement tool are devices that are for direct placement on a subject's skin, namely for direct placement on a wound.
  • wound includes an injury to living tissue and may be caused by a cut, blow, or other impact, abrasion, pressure, heat or chemical. Typically the wound is one in which the skin is cut or broken.
  • composition of the present disclosure advantageously maintains the beneficial properties of an absorbent layer in a wound dressing or debridement tool, in particular an absorbent layer which is beneficial in terms of absorbency and conformability, whilst being suitable for use in a printing process, for example screen printing.
  • the absorbent layer comprises gelforming fibres and the composition advantageously maintains the beneficial properties of gelling, absorbency and conformability whilst being suitable for use in a printing process such as screen printing.
  • the process of screen printing involves pressing an ink or pigment through a stencilled mesh using a rubber blade or squeegee.
  • the mesh is stretched over a frame and remains under tension in order to act as the 'screen'.
  • a design or pattern may be created by making areas of the mesh impermeable to the ink. This may be carried out using an emulsion as is known in the art.
  • the blade or squeegee is moved across the screen to fill the open mesh apertures with ink (excipients fully dissolved in a liquid) or pigment (particles suspended in a liquid carrier), and a second pass of the blade or squeegee causes the screen to touch the substrate momentarily along a line of contact. This causes the ink or pigment to wet the substrate and be pulled out of the mesh aperture as the screen springs back after the blade or squeegee has passed.
  • FIG. 1 is a representative diagram of the equipment used for screen printing.
  • ink (1) is applied across the screen (5) by a squeegee (2).
  • the screen comprises an image (3) formed by way of a photoemulsion (4) which makes the screen impermeable to the ink in the areas to which the photoemulsion has been applied and cured (e.g. by UV light).
  • a second pass of the squeegee (2) then results in transfer of the ink from the areas of the screen that are permeable to the ink (i.e. where there is no photoemulsion applied) onto the substrate to form the printed image (6).
  • excipients should be formulated into a liquid, preferably an ink, with the appropriate viscosity and surface tension to allow reproducible printing (which may be a continuous process in the case of rotary screen printing). Both viscosity and surface tension pertain to the intermolecular forces present within the bulk of the liquid, i.e. cohesive forces, and at the liquid interface; with the ability of the ink to wet a surface being reliant on a balance between the adhesive forces (liquid-solid) and cohesive forces (liquid-liquid).
  • the properties of the substrate upon which the ink is to be printed must also be taken into account.
  • An absorbent layer such as those included in wound dressings or debridement tools may provide a porous, absorbent scaffold with the ability to wick liquid via capillary action.
  • the ink to be printed must have a suitable surface tension and viscosity to facilitate the printing process, yet resist the favourable adhesive forces offered by such absorbent layers prior to liquid transfer.
  • Desirable specifications for a carrier system include activity, biocompatibility, stability, and safety.
  • the carrier system should be largely inert and not exhibit activity with respect to the intended effect of the excipients (if still present in the final product), unless predesigned. If the carrier system exhibits a biochemical effect, this may affect the regulatory classification of the device and/or its safety profile. In addition, the carrier should not exhibit any interference with the activity of the excipients via chemical, biological and/or physical means.
  • the carrier system should similarly be biologically safe (especially if still present in the final product); it should not carry any significant additional risk(s) and should not alter the regulatory classification of the device. Stability overtime is also required; precipitation or phase separation of solutions decreases usability during manufacturing. Finally, due consideration should be given to any scale-up implications.
  • composition (ink) which was not only able to be used in a printing process for reproducible and accurate deposition onto or within an absorbent layer for a wound dressing or debridement tool, but which was inert, biocompatible, biologically safe, stable, and capable of solubilising one or more excipients aimed at enhancing the autolytic degradation and dissociation of detrimental material to promote wound healing in the absence of an antimicrobial agent.
  • the above detailed challenges were addressed by the inclusion of two components in the composition at a specific weight ratio: namely (i) a carrier which is glycerol, triglycerol, or a combination thereof, and (ii) a solvent which is one or more C1-4 alcohol at a weight ratio (i):(ii) of from about 2:1 to about 5:1.
  • the carrier is present at a concentration of at least about 50 wt% of the composition.
  • the one or more C1.4 alcohol is defined further herein.
  • the weight ratio of (i) to (ii) in the composition is from about 2.5:1 to about 4:1.
  • the composition includes 70 wt% glycerol (i)
  • the one or more Ci- 4 alcohol (ii) is present in an amount of 28 wt% (2.5:1) to 17.5 wt% (4:1).
  • the one or more Ci- 4 alcohol is defined further herein.
  • the weight ratio of (i) to (ii) in the composition is from about 13:4 to about 4:1.
  • the composition includes 75 wt% glycerol (i)
  • the one or more Ci-4 alcohol (ii) is present in an amount of 23.0 wt% (13:4) to 18.75 wt% (4:1).
  • the concentrations are included here for example purposes only.
  • the weight ratio range of (i):(ii) from about 2:1 to about 5:1, preferably from about 2.5:1 to about 4:1, more preferably from about 13:4 to about 4:1, is not limited to 60 wt% glycerol or 70 wt% glycerol or 75 wt% glycerol.
  • Glycerol is a colourless, odourless, viscous liquid that is non-toxic and used as a skin humectant since it reduces the rate of water loss. In the present invention, however, glycerol is used to improve the flow properties (rheology) of the composition.
  • Triglycerol is the backbone of triglycerides and is made of three glycerol molecules linked together with ether bonds; like glycerol it is Newtonian in nature, but with a higher viscosity.
  • the carrier is glycerol or a combination of glycerol and triglycerol.
  • the combination of glycerol and triglycerol may have a parts by weight ratio of about 99:1 to about 50:50 parts.
  • the combination of glycerol and triglycerol may have a parts by weight ratio of from about 60:40 to about 99:1, from about 70:30 to about 99:1, from about 80:20 to about 99:1, or from about 90:10 to about 99:1.
  • These ranges may be combined with the above weight ratio ranges for (i):(ii) as well as the concentration ranges described herein.
  • the composition may comprise (i) and (ii) at a weight ratio of from about 2.5:1 to about 4:1, wherein (i) is glycerol or a combination of glycerol and triglycerol, the combination having a parts by weight ratio of about 99:1 to about 50:50.
  • the composition may comprise (i) and (ii) at a weight ratio of from about 2.5:1 to about 4:1, wherein (i) is glycerol or a combination of glycerol and triglycerol, the combination having a parts by weight ratio of from about 60:40 to about 99:1, from about 70:30 to about 99:1, from about 80:20 to about 99:1, or from about 90:10 to about 99:1.
  • (i) in the composition is glycerol.
  • the concentration of (i) glycerol, triglycerol, or combination thereof is not critical to the present disclosure. As will be appreciated from the scope of the appended claims and the Examples, it is the relative amount of (i) to (ii) the one or more Ci- 4 alcohol which is important (from about 2:1 to about 5:1, preferably from about 2.5:1 to about 4:1, more preferably from about 13:4 to about 4:1), and the concentrations of (i) and (ii) will depend on the concentration of the one or more excipients. Should the skilled person require a lower limit for (i), (i) may be included in the composition in an amount of at least about 50 wt% and preferably about 55 wt%.
  • (i) may be included in the composition in an amount of no more than about 90 wt% and preferably no more than about 85 wt%. Combining these lower and upper limits provides a general range of at least about 50 wt% to no more than about 90 wt%, and a preferred range of at least about 55 wt% to no more than about 85 wt%.
  • the carrier (i) is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, and wherein (i) is present in the composition in an amount of at least about 50 wt% to no more than about 90 wt%.
  • (i) is glycerol
  • glycerol is present in the composition in an amount of at least about 50 wt% to no more than about 90 wt%.
  • (i) in the composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, and wherein (i) is present in the composition in an amount of at least about 55 wt% to no more than about 85 wt%.
  • (i) is glycerol
  • glycerol is present in the composition in an amount of at least about 55 wt% to no more than about 85 wt%.
  • the one or more Ci- 4 alcohol is included in the composition to assist the glycerol, triglycerol, or combination thereof, in the solubilisation of the one or more excipients. As the alcohol is volatile, it can be evaporated off the absorbent layer after printing.
  • the one or more Ci-4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof, preferably wherein the one or more Ci- 4 alcohol comprises ethanol.
  • industrial denatured alcohol is employed but the present disclosure is not limited to this specific form of the one or more Ci- 4 alcohol.
  • (i) in the composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50; wherein (i) is present in the composition in an amount of at least about 50 wt% to no more than about 90 wt%; and wherein (ii) the one or more Ci- 4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof.
  • (i) is glycerol
  • glycerol is present in the composition in an amount of at least about 50 wt% to no more than about 90 wt%.
  • (i) is glycerol, present in the composition in an amount of at least about 50 wt% to no more than about 90 wt% and the one or more C1.4 alcohol comprises ethanol.
  • (i) in the composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50; wherein (i) is present in the composition in an amount of at least about 55 wt% to no more than about 85 wt%; and wherein the one or more C1-4 alcohol comprises ethanol.
  • (i) is glycerol, and glycerol is present in the composition in an amount of at least about 55 wt% to no more than about 85 wt%.
  • (i) is glycerol, present in the composition in an amount of at least about 55 wt% to no more than about 85 wt% and the one or more C1-4 alcohol comprises ethanol.
  • the weight ratio of (i) to (ii) in the composition may be from about 2.5:1 to about 4:1, preferably from about 13:4 to about 4:1.
  • components (i) and (ii) form the substrate for printing the composition onto an absorbent layer of a wound dressing or debridement tool.
  • components (i) and (ii) are the vehicle for delivering the one or more excipients to the absorbent layer.
  • the parts by weight ratio of (i) to (ii) is from about 60:40 to about 80:20, preferably from about 70:30 to about 80:20. This means that with, for example, 67 wt% glycerol and 19 wt% ethanol in the composition (a weight ratio of about 3.5:1), the substrate has 78 parts glycerol to 22 parts ethanol. Similarly, for example, 53 wt% glycerol and 17.7 wt% ethanol in the composition (a weight ratio of about 3:1), the substrate has 75 parts glycerol to 25 parts ethanol.
  • the carrier (i) is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, wherein (i) is present in the composition in an amount of at least about 50 wt% to no more than about 90 wt%, and wherein (i) and (ii) form the substrate for printing the composition onto the absorbent layer with a parts by weight ratio of (i) to (ii) in the substrate of from about 60:40 to about 80:20.
  • (i) is glycerol in an amount of at least about 50 wt% to no more than about 90 wt% of the composition, wherein (i) and (ii) form the substrate for printing the composition onto the absorbent layer with a parts by weight ratio of (i) to (ii) in the substrate of from about 70:30 to about 80:20.
  • the carrier (i) is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, wherein (i) is present in the composition in an amount of at least about 55 wt% to no more than about 85 wt%, and wherein (i) and (ii) form the substrate for printing the composition onto the absorbent layer with a parts by weight ratio of (i) to (ii) in the substrate of from about 50:40 to about 80:20.
  • (i) is glycerol in an amount of at least about 55 wt% to no more than about 85 wt% of the composition, wherein (i) and (ii) form the substrate for printing the composition onto the absorbent layer with a parts by weight ratio of (i) to (ii) in the substrate of from about 70:30 to about 80:20.
  • the one or more C1-4 alcohol is included in the composition to assist the glycerol, triglycerol, or combination thereof, in the solubilisation of the one or more excipients.
  • the alcohol is volatile, it can be evaporated off the absorbent layer after printing.
  • the one or more C1-4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof, preferably wherein the one or more C1-4 alcohol comprises ethanol.
  • industrial denatured alcohol is employed but the present disclosure is not limited to this specific form of the one or more C1.4 alcohol.
  • (i) in the composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50; wherein (i) is present in the composition in an amount of at least about 50 wt% to no more than about 90 wt%; and wherein (ii) the one or more C1-4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof.
  • (i) is glycerol
  • glycerol is present in the composition in an amount of at least about 50 wt% to no more than about 90 wt%.
  • (i) is glycerol, present in the composition in an amount of at least about 50 wt% to no more than about 90 wt% and the one or more C1-4 alcohol comprises ethanol.
  • (i) in the composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50; wherein (i) is present in the composition in an amount of at least about 55 wt% to no more than about 85 wt%; and wherein the one or more C1.4 alcohol comprises ethanol.
  • (i) is glycerol, and glycerol is present in the composition in an amount of at least about 55 wt% to no more than about 85 wt%.
  • (i) is glycerol, present in the composition in an amount of at least about 55 wt% to no more than about 85 wt% and the one or more C1-4 alcohol comprises ethanol.
  • the carrier (i) is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, wherein (i) is present in the composition in an amount of at least about 50 wt% to no more than about 90 wt%, wherein (ii) the one or more C1.4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof, and wherein (i) and (ii) form the substrate for printing the composition onto the absorbent layer with a parts by weight ratio of (i) to (ii) in the substrate of from about 60:40 to about 80:20.
  • (i) is glycerol in an amount of at least about 50 wt% to no more than about 90 wt% of the composition
  • the one or more C1-4 alcohol comprises ethanol
  • (i) and (ii) form the substrate for printing the composition onto the absorbent layer with a parts by weight ratio of (i) to (ii) in the substrate of from about 70:30 to about 80:20.
  • the carrier (i) is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, wherein (i) is present in the composition in an amount of at least about 55 wt% to no more than about 85 wt%, wherein (ii) the one or more C1-4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof, and wherein (i) and (ii) form the substrate for printing the composition onto the absorbent layer with a parts by weight ratio of (i) to (ii) in the substrate of from about 60:40 to about 80:20.
  • (i) is glycerol in an amount of at least about 55 wt% to no more than about 85 wt% of the composition
  • the one or more C1.4 alcohol comprises ethanol
  • (i) and (ii) form the substrate for printing the composition onto the absorbent layer with a parts by weight ratio of (i) to (ii) in the substrate of from about 70:30 to about 80:20.
  • the weight ratio of (i) to (ii) in the composition may be from about 2.5:1 to about 4:1, preferably from about 13:4 to about 4:1.
  • the exposure to water can be detrimental to the properties of said layer. It can, for example, cause premature gelling of the fibre(s) and thereby reduce the absorbent layer's absorbency and/or conformability. In some embodiments it is therefore desirable to minimise the amount of water in the composition.
  • surfactants are often available from commercial sources as diluted solutions. For example, sodium cocoamphoacetate is typically supplied as an aqueous solution comprising about 30-40% active. The "amount of water" in the composition is therefore used herein to refer to both water contributed by aqueous solutions of one or more excipients (e.g.
  • the composition includes no more than about 15 wt% water, preferably no more than about 12 wt% water, and more preferably no more than about 10 wt% water. In some embodiments, the composition is prepared without addition of water.
  • the composition includes one or more excipients aimed at enhancing or promoting the autolytic degradation and dissociation of detrimental material from a wound, thereby improving the healing of said wound.
  • an antimicrobial agent in the composition.
  • the composition of the present disclosure is therefore defined herein as a "non-antimicrobial" composition.
  • the composition does include any antimicrobial agents, including agents such as hypochlorous acid, silver compounds, polyhexamethylene biguanide (also known as polyhexanide biguanide), chlorhexidine, and chlorhexidine salts.
  • the non-antimicrobial compositions of the present disclosure include one or more excipients to disrupt and lift the loose components of wounds from the surface. Surprisingly the compositions further disrupt one or more biofilms. The latter is advantageous because the presence of microbes in wounds is an additional and common impediment to the healing of wounds and can lead to clinical complications.
  • the one or more excipients included within the non-antimicrobial composition of the present disclosure may comprise a chelating agent or chelator.
  • Chelating agents are organic or inorganic compounds capable of binding metal ions to form complex ring or cage-like structures called 'chelates'. In the case of chronic wound care, chelation of metal ions removes their ability to interact with the surrounding biochemical matrix, thereby limiting their effects and rendering them effectively inert.
  • Metal ions such as Mg2+ and Ca2+ have been shown to stabilise biofilms formed by a variety of microorganisms. Multi-valent metal ions enhance the structural integrity of bacterial biofilms via electrostatic interactions that serve to crosslink the polyanionic alginate and similar polysaccharide chains.
  • the resultant polymeric architecture is not an exclusive resource belonging to the producing organism. Instead, it can act as a shared housing utilised by additional species of bacteria less adept at EPS production. Therefore, removal of the ions holding the matrix together is not a species-specific strategy, rather a more generalised anti-biofilm measure aimed at disrupting the entire wound- associated bacterial ecosystem.
  • Multi-valent metal ions are also implicated in stabilising extracellular DNA (eDNA), an integral matrix component of multiple, clinically relevant biofilms, including those formed by Pseudomonas aeruginosa and Staphylococcus aureus.
  • eDNA extracellular DNA
  • eDNA an integral matrix component of multiple, clinically relevant biofilms, including those formed by Pseudomonas aeruginosa and Staphylococcus aureus.
  • eDNA extracellular DNA
  • eDNA extracellular DNA
  • eDNA extracellular DNA
  • the chelating agent may be selected from citrates, tartrates, tartramides, tartrimides, gluconates, lactates, glycolates, oxalates, phosphates, salts of ethylenediaminetetraacetic acid, and mixtures thereof.
  • the chelating agent may be selected from citrates, phosphates, oxalates, salts of ethylenediaminetetraacetic acid, and mixtures thereof.
  • the salts are metal ion or ammonium salts. The metal ion of said salts is not limited.
  • metal ion salts are preferred and may be selected from sodium and/or potassium salts.
  • the salts are sodium salts.
  • the chelating agent comprises a salt of ethylenediaminetetraacetic acid.
  • the ethylenediaminetetraacetate salt may be a mixture of di-, tri-, or tetra-basic salts of ethylenediaminetetraacetate (EDTA).
  • the EDTA salt may, for instance, be a di-sodium salt of EDTA, or calcium di-sodium salt of EDTA, or tetra-sodium salt of EDTA.
  • the salt of EDTA is a mixture of salts of EDTA. It is believed that EDTA, when present, will have a form which is dependent on the pH of the wound site.
  • EDTA may be added to the composition as a tetra-basic salt of EDTA such as tetrasodium EDTA. In some embodiments, EDTA is not in the form of the disodium salt.
  • the citrate salt may similarly be a mono-, di- or tri-citrate salt. In various embodiments the citrate salt may be mono-, di- or tri-potassium citrate or mono-, di- or tri-sodium citrate. In preferred embodiments, the citrate salt is a tri-citrate salt such as trisodium citrate.
  • the tartrate may be a mono-, or di-tartrate salt.
  • the tartrate salt may be mono- or di-potassium tartrate; or mono- or di-sodium tartrate.
  • the tartrate salt is a di-tartrate salt such as disodium tartrate.
  • the gluconate may be potassium gluconate or sodium gluconate.
  • the gluconate salt is sodium gluconate.
  • the lactate may be potassium lactate or sodium lactate.
  • the lactate salt is sodium lactate.
  • the glycolate may be potassium glycolate or sodium glycolate. In specific embodiments, the glycolate salt is sodium glycolate.
  • the oxalate may be a mono-, or di-oxalate salt.
  • the oxalate salt may be mono- or di-potassium oxalate; or mono- or di-sodium oxalate.
  • the oxalate salt is a di-oxalate salt such as disodium oxalate.
  • the phosphate salt may be an ortho-phosphate, a pyrophosphate, a tripolyphosphate or a derivatised phosphate.
  • the phosphate is typically in the form of a potassium or sodium salt. Examples include potassium phosphate dibasic, potassium pyrophosphate, tri-sodium ascorbate phosphate, disodium phosphate and sodium tripolyphosphate.
  • the phosphate salt is a di-phosphate salt such as disodium phosphate.
  • the chelating agent may be present in the composition in an amount of up to about 10 wt%, up to about 8 wt%, or up to about 6 wt% of the total weight of the composition. In various embodiments, the chelating agent may be present in the composition in an amount of at least about 0.5 wt%, at least about 1.0, or at least about 1.2 wt% of the total weight of the composition.
  • the chelating agent is present in the absorbent layer at up to about 2.5 g/m 2 , up to about 1.5 g/m 2 or up to about 1.0 g/m 2 on an actives basis.
  • the chelating salt is present in the absorbent layer in an amount of at least about 0.1, at least about 0.2, or at least about 0.25 g/m 2 on an actives basis.
  • the chelating agent is present in the composition in an amount of from about 0.5 to about 10 wt%, from about 1 to about 8 wt%, or from about 1.2 to about 6 wt% of the total weight of the composition.
  • the chelating agent is selected from citrates, tartrates, tartramides, tartrimides, gluconates, lactates, glycolates, oxalates, phosphates, salts of ethylenediaminetetraacetic acid, and mixtures thereof, and is present in the composition in an amount of from about 0.5 to about 10 wt%, from about 1 to about 8 wt%, or from about 1.2 to about 6 wt% of the total weight of the composition.
  • the chelating agent is a salt of ethylenediaminetetraacetic acid (EDTA), preferably a tetra-salt of ethylenediaminetetraacetic acid, and is present in the composition in an amount of from about 0.5 to about 10 wt%, from about 1 to about 8 wt%, or from about 1.2 to about 6 wt% of the total weight of the composition.
  • EDTA ethylenediaminetetraacetic acid
  • the salt of EDTA may in various embodiments be a sodium salt such as a tetrasodium salt.
  • the chelating agent is present in the absorbent layer from about 0.1 to about 2.5 g/m 2 , from about 0.2 to about 1.5 g/m 2 , or from about 0.25 to about 1.0 g/m 2 on an actives basis.
  • the chelating agent is selected from citrates, tartrates, tartramides, tartrimides, gluconates, lactates, glycolates, oxalates, phosphates, salts of ethylenediaminetetraacetic acid, and mixtures thereof, and is present in the absorbent layer at about 0.1 to about 2.5 g/m 2 , from about 0.2 to about 1.5 g/m 2 , or from about 0.25 to about 1.0 g/m 2 on an actives basis.
  • the chelating agent is a salt of ethylenediaminetetraacetic acid (EDTA), preferably a tetra-salt of ethylenediaminetetraacetic acid, and is present in the absorbent layer at about 0.1 to about 2.5 g/m 2 , from about 0.2 to about 1.5 g/m 2 , or from about 0.25 to about 1.5 g/m 2 on an actives basis.
  • EDTA ethylenediaminetetraacetic acid
  • the salt of EDTA may in various embodiments be a sodium salt such as a tetrasodium salt.
  • Surfactants are widely used as detergents, emulsifiers, wetting agents, foaming agents and dispersants in the cosmetics, hygiene, food and oil industries. They are also used in a clinical setting including advanced wound care. As surface-active agents, surfactants are amphiphilic; they contain both hydrophilic and hydrophobic components and are therefore capable of lowering the surface tension at the solid/liquid interface, allowing for greater penetration of fluids into the wound bed and subsequent removal of biological materials by irrigating agents such as water or saline.
  • Non-ionic surfactants e.g. poloxamer
  • Non-ionic surfactants are reported to be effective in the solubilisation and disaggregation of proteins. They are seemingly able to block the adhesion of certain proteins thus reducing microbial adhesion. Indeed, wound irrigation solutions containing non-ionic surfactants have been demonstrated to effectively cleanse and remove debris from wounds.
  • the present inventors found, however, that a combination of an anionic surfactant and an amphoteric surfactant is surprisingly able to effectively cleanse and remove debris from wounds when used in combination with the chelating agent defined above.
  • the one or more excipients may comprise an amphoteric surfactant.
  • the amphoteric surfactant is selected from hydrocarbyl-amphoacetates, alkenyl-amphoacetates, hydrocarbyl-amphodiacetates, alkenyl-amphodiacetates, hydrocarbylampho-propionates, hydrocarbylampho-diproprionates, hydrocarbylamphohydroxypropyl sultaines, and mixtures thereof.
  • the hydrocarbyl and alkenyl groups are C6 to C24, C8 to C24, or CIO to C20, hydrocarbyl or alkenyl groups.
  • the amphoteric surfactant has a counter-ion of an alkali metal such as sodium or potassium, or an ammonium ion.
  • the amphoteric surfactant has an alkali metal counter-ion, and more preferably the counter-ion is sodium.
  • hydrocarbyl includes a group such as alkyl, aryl, aralkyl, alkaryl, cycloalkyl or alkenyl, which may be linear or branched, and/or saturated or unsaturated.
  • the hydrocarbyl may be a linear or branched alkyl or alkenyl group.
  • the amphoteric surfactant is a hydrocarbyl-amphoacetate salt, preferably a fatty acid amphoacetate.
  • the fatty acid or salt thereof may be a C6-C24 fatty acid or salt thereof, or a mixture thereof.
  • the fatty acid or salt thereof may be saturated or unsaturated. When unsaturated, the unsaturated fatty acid or salt thereof may be mono- or di-unsaturated.
  • the unsaturated fatty acid or salt thereof may comprise cis- or trans- double bonds or mixtures thereof.
  • the fatty acid or salt thereof is a C12-C18 monounsaturated fatty acid or salt thereof.
  • fatty acids examples include stearic acid, ricinoleic acid, oleic acid, eladic acid, petrolselinic acid, palmitic acid, erucic acid, behenic acid, lauric acid, myristic acid, or linoleic acid.
  • the amphoteric surfactant comprises a cocoamphoacetate.
  • the counter-ion of the cocoamphoacetate is preferably sodium.
  • Sodium cocoamphoacetate is commercially available, for example under the trade name Dehyton® MC (BASF) or Amphosol® 1C (Stepan®). Such commercial preparations are typically solutions of sodium cocoamphoacetate, typically containing from about 30 to about 40 wt% sodium cocoamphoacetate on an actives basis.
  • the metal ions of the salt of the chelating agent and the salt of the amphoteric surfactant are the same.
  • both the chelating agent and surfactant are sodium salts.
  • the amphoteric surfactant may be present in the composition in an amount of up to about 15 wt%, up to about 10 wt% or up to about 5 wt% of the total weight of the composition. In various embodiments, the amphoteric surfactant may be present in the composition in an amount of at least about 1 wt% of the total weight of the composition.
  • the amphoteric surfactant is present in the absorbent layer in an amount of up to about 3 g/m 2 , up to about 2 g/m 2 , or up to about 1.5 g/m 2 on an actives basis. In various embodiments, the amphoteric surfactant is present in the absorbent layer in an amount of at least about 0.1 or at least about 0.25 g/m 2 .
  • the amphoteric surfactant is present in the composition in an amount of from about 1 wt% to about 15 wt%, about 1 wt% to about 10 wt% or from about 1 to about 5 wt% of the total weight of the composition.
  • the amphoteric surfactant comprises a fatty acid amphoacetate as defined herein, and the amphoteric surfactant is present in the composition in an amount of from about 1 to about 15 wt%. In various embodiments, the amphoteric surfactant comprises a fatty acid amphoacetate as defined herein, and the amphoteric surfactant is present in the composition in an amount of from about 1 to about 10 wt% or from about 1 to about 5 wt% of the total weight of the composition. In any of the foregoing embodiments, the fatty acid amphoacetate may be a cocoamphoacetate, preferably sodium cocoamphoacetate.
  • the amphoteric surfactant may be present in the absorbent layer in an amount of from about 0.1 to about 3 g/m 2 , from about 0.1 to about 2 g/m 2 , or from about 0.25 to about 1.5 g/m 2 on an actives basis.
  • the amphoteric surfactant comprises a fatty acid amphoacetate as defined herein and the amphoteric surfactant is present in the absorbent layer in an amount of from about 0.1 to about 3 g/m 2 , from about 0.1 to about 2 g/m 2 , or from about 0.25 to about 1.5 g/m 2 on an actives basis.
  • the fatty acid amphoacetate may be a cocoamphoacetate.
  • amphoteric surfactant may be an alkali metal salt, for example a sodium salt such as sodium cocoamphoacetate.
  • the anionic surfactant may include all forms of lipophilic oligomeric hydrocarbon and/or polyethoxylate with a negatively charged hydrophilic head group such as carboxylate, sulphate, sulphonate, sulphonated ester, sulphated ester, sulphated amide, carboxylated amide, or phosphate anionic head group.
  • a negatively charged hydrophilic head group such as carboxylate, sulphate, sulphonate, sulphonated ester, sulphated ester, sulphated amide, carboxylated amide, or phosphate anionic head group.
  • a fatty acid or fatty acid salt may comprise 6 to 24 carbon atoms, such as 10 to 20 carbon atoms, preferably 12 to 18 carbon atoms.
  • the anionic surfactant comprises a fatty acid or salt thereof.
  • the fatty acid may comprise 6 to 24 carbon atoms, such as 10 to 20 carbon atoms, preferably 12 to 18 carbon atoms.
  • Examples of fatty acids include stearic acid, ricinoleic acid, oleic acid, eladic acid, petrolselinic acid, palmitic acid, erucic acid, behenic acid, lauric acid, myristic acid, or linoleic acid.
  • the anionic surfactant may be a fatty acid or salt thereof which is a C6- C24 fatty acid or salt thereof, or a mixture thereof.
  • the salt may be an alkali metal or alkaline earth metal salt, preferably an alkali metal salt.
  • the alkali metal is sodium or potassium, more preferably sodium.
  • the fatty acid or salt thereof may be saturated or unsaturated. When unsaturated, the unsaturated fatty acid or salt thereof may be mono- or di-unsaturated. The unsaturated fatty acid or salt thereof may comprise cis- or trans- double bonds or mixtures thereof.
  • the fatty acid or salt thereof is a C12-C18 monounsaturated fatty acid or salt thereof.
  • the fatty acid or salt thereof is oleic acid or a salt thereof.
  • the salt of oleic acid is not limited and may be a metal salt of oleic acid.
  • the salt of oleic acid may be sodium oleate.
  • the salt of oleic acid may be formed by adding oleic acid to the composition such that the metal ions, e.g. sodium ions, are provided by provided by the chelating agent, the thickening agent and/or the amphoteric surfactant.
  • the amount of anionic surfactant in the composition is not necessarily limited.
  • the anionic surfactant may, for example, be present in the composition in an amount of up to about 15 wt%, up to about 10 wt%, or up to about 8 wt% of the total weight of the composition.
  • the anionic surfactant may be present in an amount of at least about 1 wt%, or at least about 1.5 wt% of the total weight of the composition.
  • the anionic surfactant is present in the composition in an amount of from about 1 wt% to about 15 wt%, preferably from about 1 wt% to about 10 wt%, more preferably from about 1.5 wt% to about 8 wt% of the total weight of the composition.
  • the anionic surfactant is selected from fatty acids, fatty acid salts, sulphates, sulphosuccinates, sarcosinates, isethionates, glutamates, taurates, and mixtures thereof, wherein the fatty acid comprises 6 to 24 carbon atoms, and the anionic surfactant is present in the composition in an amount of from about 1 wt% to about 15 wt%, preferably from about 1 wt% to about 10 wt% of the total weight of the composition.
  • the salt may be a sodium salt.
  • the anionic surfactant comprises a fatty acid and/or salt thereof, wherein the fatty acid comprises 6 to 24 carbon atoms, and the anionic surfactant is present in the composition in an amount of from about 1 wt% to about 15 wt%, preferably from about 1 wt% to about 10 wt% of the total weight of the composition.
  • the anionic surfactant comprises oleic acid and/or a salt thereof, which is present in the composition in an amount of from about 1 wt% to about 15 wt%, preferably from about 1 wt% to about 10 wt% of the total weight of the composition.
  • the oleic acid salt may be sodium oleate.
  • the anionic surfactant may be present in the absorbent layer in an amount of from about 0.1 to about 3 g/m 2 , from about 0.25 to about 2.5 g/m 2 , or from about 0.5 to about 2 g/m 2 on an actives basis.
  • the anionic surfactant is selected from fatty acids, fatty acid salts, sulphates, sulphosuccinates, sarcosinates, isethionates, glutamates, taurates, and mixtures thereof, wherein the fatty acid comprises 6 to 24 carbon atoms, and the anionic surfactant is present in the absorbent layer in an amount of from about 0.1 to about 3 g/m 2 , from about 0.25 to about 2.5 g/m 2 , or from about 0.5 to about 2 g/m 2 on an actives basis.
  • the anionic surfactant comprises a fatty acid and/or salt thereof, wherein the fatty acid comprises 6 to 24 carbon atoms, and the anionic surfactant is present in the absorbent layer in an amount of from about 0.1 to about 3 g/m 2 , from about 0.25 to about 2.5 g/m 2 , or from about 0.5 to about 2 g/m 2 on an actives basis.
  • the anionic surfactant comprises oleic acid and/or a salt thereof, which is present in the absorbent layer in an amount of from about 0.1 to about 3 g/m 2 , from about 0.25 to about 2.5 g/m 2 , or from about 0.5 to about 2 g/m 2 on an actives basis.
  • the oleic acid salt may be sodium oleate.
  • the metal ions of the salt of the chelating agent and the salt of the anionic surfactant are the same.
  • both the chelating agent and surfactant are sodium salts.
  • the chelating agents and the anionic and amphoteric surfactants described herein operate together to disrupt biofilms and cleanse wounds. Without wishing to be bound by theory, it is believed that each of the chelating agent and the surfactant exert their action via different physicochemical means. For example, the chelating agent is believed to coordinate metal ions such as those present in the matrix and biofilm, weakening the structure of the biofilm. On the other hand, the anionic and amphoteric surfactant is believed to aid wetting (and hence aiding penetration of fluids into the wound bed), to solubilise proteins, DNA, and other components present in the wound.
  • the combination of chelating agent and surfactant have been found to be synergistic.
  • Synergy in the context of the present disclosure can be measured in a number of ways that conform to the generally accepted opinion that "synergy is an effect greater than additive".
  • One of the ways to assess whether synergy has been observed is to use the "chequerboard" technique. This is a well-accepted method that leads to the generation of a value called the fractional inhibitory concentration index (FICI). Orhan et al J. Clin. Microbiol.
  • FICI fractional inhibitory concentration index
  • the FICI value is a ratio of the sum of the MIC (Minimum Inhibitory Concentration) level of each individual component alone and in the mixture.
  • the combination is considered synergistic when the IFIC is ⁇ 0.5, indifferent when the 1 FIC is >0.5 but ⁇ 4.0, and antagonistic when the FIC is >4.0.
  • chelating agent and anionic and amphoteric surfactant do not cleanse/irrigate the wound effectively and/or disrupt the biofilm when used without the other, but in combination said chelating agent and anionic and amphoteric surfactant are effective at cleansing the wound and/or disrupting the biofilm.
  • the definition of the amphoteric and anionic surfactant set out above is combinable with the definition of the chelating agent.
  • the chelating agent is selected from the group consisting of a citrate salt, a phosphate salt, an oxalate salt, an ethylenediaminetetraacetate salt, and mixtures thereof
  • the anionic surfactant is selected from a fatty acid or salt thereof, a glutamate salt, a sarcosinate salt, and an isethionate salt, wherein the fatty acid comprises 6 to 24 carbon atoms
  • the amphoteric surfactant is a hydrocarbyl-amphoacetate salt.
  • the salts are metal ion salts, preferably sodium salts.
  • the chelating agent is an ethylenediaminetetraacetate salt
  • the anionic surfactant is a fatty acid or salt thereof, wherein the fatty acid comprises 6 to 24 carbon atoms
  • the amphoteric surfactant is a fatty acid amphoacetate salt, wherein the fatty acid has 10 to 20 carbon atoms.
  • the salts are metal ion salts, preferably sodium salts.
  • the chelating agent is an ethylenediamine tetraacetate salt
  • the anionic surfactant is oleic acid or a salt thereof
  • the amphoteric surfactant is a cocoamphoacetate.
  • the salts are metal ion salts, preferably sodium salts.
  • Each of the anionic surfactant, amphoteric surfactant and chelating agent may be present in an amount suitable to provide the desired cleansing and/or irrigation effect on the wound.
  • the specific combination of surfactants and chelating agent and their concentrations have been found by the inventors to provide a composition with antibiofilm activity without the need for an antimicrobial agent.
  • the surfactants and chelating agent are shown to disrupt non-viable proteins/carbohydrates and demonstrate enhanced efficacy when compared to commercially available products.
  • non-antimicrobial composition comprises:
  • the non-antimicrobial composition comprises:
  • the non-antimicrobial composition comprises:
  • the non-antimicrobial composition comprises:
  • the chelating agent may be present in an amount of about 0.5 wt% to about 10 wt%, about 1 wt% to about 8 wt% or about 1.2 wt% to about 6 wt%.
  • the chelating agent may be present in an amount of about 1 to about 8 wt% of the composition and selected from a citrate salt, a phosphate salt, an ethylenediaminetetraacetate salt, and mixtures thereof.
  • the anionic surfactant may be present in an amount of about 1 wt% to about 15 wt%, about 1 wt% to about 10 wt%, or about 1.5 wt% to about 8 wt%.
  • the anionic surfactant may be present in an amount of about 1% to about 10% by weight of the composition and selected from fatty acids and/or salts thereof, wherein the fatty acid comprises 6 to 24 carbon atoms.
  • the anionic surfactant is present in an amount of about 1.5 wt% to about 8 wt% and is oleic acid or a salt thereof.
  • the amphoteric surfactant may be present in an amount of about 1 wt% to about 15 wt%, about 1 wt% to about 10 wt%, or about 1 wt% to about 5 wt%.
  • the amphoteric surfactant may be present in an amount of about 1 wt% to about 10 wt% and selected from a hydrocarbyl-amphoacetate salt, a hydrocarbyl-amphodiacetate salt, and mixtures thereof, wherein the hydrocarbyl groups contain 6 to 24 carbon atoms.
  • amphoteric surfactant is present in an amount of about 1 wt% to about 5 wt%, and is a fatty acid amphoacetate salt, wherein the fatty acid comprises 8 to 24 carbon atoms.
  • the amphoteric surfactant is a cocoamphoacetate salt.
  • the non-antimicrobial composition comprises:
  • the non-antimicrobial composition comprises:
  • the non-antimicrobial composition comprises:
  • Ci- 4 alcohol (ii) one or more Ci- 4 alcohol; (iii) about 1 wt% to about 8 wt% of a salt of ethylenediamine tetraacetic acid;
  • the non-antimicrobial composition comprises:
  • the non-antimicrobial composition comprises:
  • non-antimicrobial composition comprises:
  • glycerol may be present in the composition in an amount of at least about 50 wt% to no more than about 90 wt%.
  • the one or more C1.4 alcohol may comprise ethanol.
  • the weight ratio of (i) to (ii) in the composition may be from about 13:4 to about 4:1.
  • the stability of the composition defined herein to separation can be enhanced by way of a lower ratio of amphoteric surfactant to anionic surfactant while maintaining sufficient efficacy.
  • the molar ratio of the anionic surfactant to the amphoteric surfactant is less than about 2.5:1, less than about 2:1, or less than about 1.5:1. The skilled person will understand that the molar ratio is to be calculated on an actives basis.
  • the molar ratio of the anionic surfactant to amphoteric surfactant is at least about 1:2.
  • the molar ratio of the anionic surfactant is from about 2.5:1 to about 1:2, or from about 2:1 to about 1:1.
  • the anionic surfactant comprises a fatty acid amphoacetate
  • the amphoteric surfactant comprises a fatty acid and/or salt thereof
  • the molar ratio of the anionic surfactant to the amphoteric surfactant is less than about 2.5:1, less than about 2:1, or less than about 1.5:1.
  • the anionic surfactant comprises a fatty acid amphoacetate
  • the amphoteric surfactant comprises a fatty acid and/or salt thereof
  • the molar ratio of the anionic surfactant to the amphoteric surfactant is from about 2.5:1 to about 1:2, or from about 2:1 to about 1:1.
  • the chelating agent comprises a salt of ethylenediaminetetraacetic acid
  • the amphoteric surfactant comprises a fatty acid amphoacetate
  • the anionic surfactant comprises a fatty acid or salt thereof
  • the molar ratio of the anionic surfactant to the amphoteric surfactant is less than about 2.5:1, less than about 2:1, or less than about 1.5:1.
  • the chelating agent comprises a salt of ethylenediaminetetraacetic acid
  • the amphoteric surfactant comprises a fatty acid amphoacetate
  • the anionic surfactant comprises a fatty acid or salt thereof
  • the molar ratio of the anionic surfactant to the amphoteric surfactant is from about 2.5:1 to about 1:2, or from about 2:1 to about 1:1.
  • the chelating agent comprises a salt of ethylenediaminetetraacetic acid
  • the amphoteric surfactant comprises a cocoamphoacetate
  • the anionic surfactant comprises oleic acid and/or a salt thereof
  • the molar ratio of the anionic surfactant to the amphoteric surfactant is less than about 2.5:1, less than about 2:1, or less than about 1.5:1.
  • the molar ratio of the anionic surfactant to the amphoteric surfactant is from about 2.5:1 to about 1:2, or from about 2:1 to about 1:1.
  • the non-antimicrobial composition comprises a thickening agent.
  • Thickening agents which may also be referred to as thickeners, are commonly used to modify the rheological properties of liquids.
  • thickening agents may be used to increase the viscosity of a liquid, preferably without substantially altering the other properties of said liquid.
  • Some thickening agents may form gels when dispersed in a liquid, or may act as a thixotropic additive.
  • certain liquids containing thickening agents may exhibit shear-thinning properties, i.e. wherein the viscosity is non-Newtonian and becomes lower as the shear force or time increases.
  • Nonlimiting examples of thickening agents include fumed silica, polysaccharides and derivatives thereof including cellulose derivatives such as hydroxyethylcellulose and carboxymethylcellulose, polyethylene glycols, vegetable gums, and poly(meth)acrylic acids and/or salts thereof.
  • the non-antimicrobial composition comprises a thickening agent which is a polyethylene glycol.
  • a thickening agent which is a polyethylene glycol.
  • Polyethylene glycol or PEG is a polyether compound derived from petroleum with many applications from industrial manufacturing to medicine. It is typically prepared by polymerization of ethylene oxide and commercially available over a wide range of molecular weights from 300 g/mol to 10,000,000 g/mol.
  • the numbers that are included in the names of PEGs indicate their average molecular weights. For example, a PEG 600 would have a weight average molecular weight of approximately 600 Daltons.
  • the polyethylene glycol included in the non-antimicrobial composition may have a weight average molecular weight of greater than 1000 to less than about 8000, preferably about 1500 to about 6000, i.e. the composition may comprise a PEG 1500 to a PEG 6000.
  • PEGs of suitable molecular weights are commercially available, from, for example, Dow Chemical.
  • the concentration of polyethylene glycol included in the composition is dependent on the average molecular weight of the PEG. This clearly shown in Figure 7.
  • the thickening agent is PEG1500
  • the polyethylene glycol is present in an amount of about 10 wt% to about 20 wt%.
  • the thickening agent is higher than PEG 1500 (e.g. PEG3350 or PEG6000)
  • the polyethylene glycol is present in an amount of about 0.5 wt% to about 10 wt%, preferably from about 1 wt% to about 8 wt%.
  • the pH of the composition of the present disclosure is not limited. However, in preferred embodiments, the pH of the composition is from about 5 to about 9. In various embodiments, the pH of the composition is from about 5 to about 8. In various embodiments, the pH of the composition is from about 6 to about 8. Compositions within said range of pH values may cause less discomfort upon application, for example from stinging sensations. In some embodiments, it has been surprisingly found that a mildly alkaline pH, for example about pH 8 may enhance the efficacy of the wound cleansing composition.
  • the composition may further comprise a non-ionic surfactant.
  • the non-ionic surfactant is not necessarily limited.
  • Exemplary non-ionic surfactants include esters of fatty acids, fatty acid amides, fatty acid ethoxylates, fatty acid amide ethoxylates, polyethoxylated compounds and polyalkyl ethers, polyhydroxyl compounds, hydrocarbyl glucosides and amine oxides.
  • polyoxyethylene fatty acid esters polyoxyethylene sorbitan fatty acid ester
  • polyoxyethylene glycol fatty acid esters polyoxyethylene glycol fatty acid ester
  • sucrose fatty acid esters sucrose fatty acid ester
  • polyoxyethylene hydrogen carbonate castor oils polyoxyethylene alkyl ethers (polyoxyethylene hydrogenated castor oil) ether (polyoxyethylene alkyl ether).
  • the nonionic surfactant may comprise polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, PEG-40 stearate, PEG-100 stearate, sucrose stearate, sucrose myristate, isopropyl myristate, sucrose oleate, sucrose palmitate, sucrose laurate, laureth-21 (laureth field 21), ceteth-15 (ceteth field 15), steareth-20 (steareth field 20), oleth-15 (oleth field 15), beheneth-20 and ceteareth- 20 (beheneth field 20).
  • the non-ionic surfactant may be a polysorbate, typically polysorbate 20.
  • Polysorbate 20 is also known by the trade name Tween® 20.
  • the non-ionic surfactant is present in the composition in an amount of from about 0.01 wt% to about 1 wt%, or from about 0.1 wt% to about 0.5 wt% of the total weight of the composition.
  • the non-ionic surfactant may be a polysorbate, such as polysorbate 20, that is present in the composition in an amount of from about 0.01 wt% to about 1 w%, or from about 0.1 wt% to about 0.5 wt% of the total weight of the composition.
  • the composition does not include a non-ionic surfactant.
  • compositions of the present invention do not contain further components other than those already described above.
  • the compositions are preferably supplied as a sterile solution, e.g. wherein such solutions are prepared from sterilised components in a sterile environment, or wherein the final solution is sterilised by methods commonly known in the art.
  • the present disclosure provides a process for preparing the composition. Whilst the process is not limiting, any suitable process may be used to prepare the composition, in some embodiments the process comprises the steps of (a) mixing the carrier with the solvent, and (b) adding the one or more excipients to the mixture of (a), preferably wherein the one or more excipients comprise a chelating agent, an anionic surfactant and an amphoteric surfactant, and wherein the anionic surfactant is added to the mixture of step (a) before the chelating agent and the amphoteric surfactant.
  • the carrier, solvent, chelating agent, anionic surfactant, and amphoteric surfactant are defined hereinabove.
  • the process for preparing the non-antimicrobial composition comprises the steps of (a) combining the amphoteric surfactant and the anionic surfactant, (b) adding the chelating agent to the mixture of step (a), and (c) adding the solvent and carrier to the mixture of step (b), or (a) combining the solvent and the chelating agent, (b) adding the anionic surfactant to the mixture of step (a), (c) adding the amphoteric surfactant to the mixture of step (b), and adding the carrier to the mixture of step (c).
  • the carrier, solvent, chelating agent, anionic surfactant, and amphoteric surfactant are defined hereinabove.
  • composition when the composition includes a thickening agent which is a polyethylene glycol, the composition may be prepared by a process comprising the steps of:
  • step (b) heating the mixture of step (a) to a minimum of about 30°C until the polyethylene glycol is fully dissolved in the one or more C1-C4 alcohol;
  • step (c) adding the solution of step (b) to the carrier;
  • step (d) adding the one or more excipients to the solution of step (c).
  • polyethylene glycol and its concentration is defined hereinabove.
  • one or more excipients are defined hereinabove.
  • compositions of the present disclosure are useful for the treatment of wounds, including initial treatment in first response settings, as well as in ongoing wound management such as in primary care settings.
  • a wound is often described as chronic or acute.
  • Acute wounds occur as a result of surgery or trauma, typically when not too severe and where the subject is otherwise in good health. Wounds progress through well-defined stages of healing. Chronic wounds begin as acute wounds. For example, an acute wound can become a chronic wound when it does not follow the normal healing pathway resulting in a lengthened recovery. It is believed that the transition from acute to chronic can be due to an inadequate immune response, for example the patient being immuno-compromised, the wound being insufficiently perfused or being highly contaminated.
  • Chronic wounds may include venous ulcers, diabetic ulcers, arterial ulcers, and pressure injuries due to immobility. Wounds may also include a deep tissue injury; this is an expression used to describe a unique form of pressure ulcers.
  • the composition described herein is comprised in a wound dressing or debridement tool.
  • the wound dressing or debridement tool comprises an absorbent layer and the composition is at least partially impregnated or coated with the composition.
  • “debridement” refers to deeply removing adherent, dead or contaminated tissue from a wound.
  • the present disclosure provides a wound dressing, wherein the dressing comprises an absorbent layer at least partially impregnated or coated with the nonantimicrobial composition as defined herein.
  • the present disclosure provides a debridement tool wherein the debridement tool comprises an absorbent layer at least partially impregnated or coated with the non-antimicrobial composition as defined herein.
  • Wound dressings and debridement tools are devices suitable for placement in direct contact with a wound.
  • a debridement tool may typically be used for mechanical debridement.
  • the debridement tool may form instance be a sponge or pad.
  • a common material used to prepare a sponge or pad is a foam, typically a polyurethane foam, polypropylene foam, polyester foam or polyvinyl alcohol (PVA) foam.
  • a polyester foam may be useful for a wipe.
  • a wound dressing may typically debride by autolysis.
  • Autolytic debridement refers to the lysis or breakdown of necrotic debris and devitalised tissues from a wound through the body's own mechanisms, such as moist environments and endogenous enzymes.
  • the wound dressing comprises at least one layer comprising a foam, fabric, or technical textile.
  • the textile may be a non-woven or woven fibrous layer, a gel-forming fibre, or gauze. Gauze may be made from a cellulose such as cotton or viscose.
  • the absorbent layer comprises one or more gel-forming fibres.
  • the wound dressing disclosed herein may have a thickness between 0.5 to 20, or 2 to 10, or 3 to 7 mm.
  • the wound dressing may be buffered to have a pH of from about 4 to about 10, or from about 5 to about 8, or from about 5.5 to about 6.5.
  • said buffering may be achieved by the composition of the present disclosure without requiring any additional buffering agents.
  • the wound dressing may be comprised of one or more layers selected from the group comprising an outer cover layer, an absorbent layer, a gel-forming fibre, an adhesive layer, a wound contact layer, a distribution layer, and combinations thereof.
  • a wound dressing includes one or more absorbent layer(s).
  • the outer cover layer of the dressing is a bacterial and viral barrier layer which typically resists the ingress of liquid but allows moisture vapour transmission.
  • the absorbent layer may be a superabsorbent.
  • the wound dressing comprises an outer cover layer and one or more absorbent layer(s) comprising one or more gel-forming fibres.
  • the gelforming fibre is in direct contact with the wound, and thus no additional wound contact layer is required.
  • gel forming fibres hygroscopic fibres which upon the uptake of wound exudate become moist slippery or gelatinous.
  • the gel forming fibres can be of the type that retain their structural integrity on absorption of exudate or can be of the type that lose their fibrous form and become an amorphous or structureless gel.
  • the gel forming fibres are typically sodium carboxymethylcellulose fibres, chemically modified cellulosic fibres, alkyl sulphonate modified cellulosic fibres such as those described in WO2012/061225, pectin fibres, alginate fibres, chitosan fibres, hyaluronic acid fibres, or other polysaccharide fibres or fibres derived from gums, as well as non-cellulose synthetic fibres such as poly(vinyl alcohol) and polyacrylate.
  • the gel forming fibres are typically chemically modified cellulosic fibres in the form of a fabric and in particular carboxymethylated cellulose fibres as described in PCT WO00/01425.
  • Sodium carboxymethylcellulose fibres typically have a degree of substitution of at least 0.05 carboxymethyl groups per glucose unit.
  • the gel forming fibres typically have an absorbency of at least 2 grams (or at least 8 grams, or at least 10 grams), 0.9% solution A (8.298 g/L sodium chloride and 0.368 g/L calcium chloride dehydrate) per gram of fibre (as measured by BS EN 13726-1 (2002) "Test methods for primary wound dressings", section 3.2 "Free swell absorptive capacity").
  • the carboxymethylated cellulosic fabrics typically have a degree of substitution between 0.12 to 0.35 (as defined in WO00/01425), more typically a degree of substitution of between 0.20 and 0.30, such that the absorbency of a fabric produced from is increased when compared to the unmodified cellulose.
  • Particular useful fabrics have an absorbency of from about 10 g/g to about 30 g/g of isotonic aqueous solution as measured by the method described in BS EN 13726-1 (2002).
  • the cellulosic fabric typically consists solely of cellulosic fibre but may contain a proportion of a textile fibre or gel forming fibre.
  • This textile fibre may be for example a cellulose fibre of a known kind and may comprise continuous filament yarn and/or staple fibre.
  • the gel-forming fibres are carboxymethylcellulose fibres such as sodium carboxymethylcellulose fibres.
  • the absorbent layer consists of the gel-forming fibres, and the dressing does not contain additional dressing layers.
  • the wound dressing or debridement tool consists of an absorbent layer, where the absorbent layer consists of a nonwoven fabric and the nonwoven fabric consists of gelling (gel-forming) fibres and non-gelling (non-gel-forming) fibres; preferably wherein the gelling fibres are present in an amount of from about 60 to about 95 wt% of the absorbent layer and the nongelling fibres are present in an amount of from about 5 to about 40 wt% of the absorbent layer.
  • a wound dressing or debridement tool comprising an absorbent layer, wherein the absorbent layer comprises a nonwoven fabric, the nonwoven fabric comprising gelling fibres and non-gelling fibres, wherein the gelling fibres are present in an amount of from about 60 to about 95 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 5 to about 40 wt% of the absorbent layer.
  • the gelling fibres are present in an amount of from about 65 to about 95 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 5 to about 35 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 95 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 5 to about 30 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 75 to about 95 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 5 to about 25 wt% of the absorbent layer.
  • the gelling fibres are present in an amount of from about 80 to about 95 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 5 to about 20 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 85 to about 95 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 5 to about 15 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 95 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 5 to about 10 wt% of the absorbent layer.
  • the gelling fibres are present in an amount of from about 65 to about 90 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 10 to about 35 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 90 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 10 to about 30 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 75 to about 90 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 10 to about 25 wt% of the absorbent layer.
  • the gelling fibres are present in an amount of from about 80 to about 90 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 10 to about 20 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 85 to about 90 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 10 to about 15 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 65 to about 85 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 15 to about 35 wt% of the absorbent layer.
  • the gelling fibres are present in an amount of from about 70 to about 85 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 15 to about 30 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 75 to about 85 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 15 to about 25 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 80 to about 85 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 15 to about 20 wt% of the absorbent layer.
  • the gelling fibres are present in an amount of from about 90 to about 85 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 15 to about 10 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 65 to about 80 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 20 to about 35 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 80 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 20 to about 30 wt% of the absorbent layer.
  • the gelling fibres are present in an amount of from about 75 to about 80 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 20 to about 25 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 85 to about 80 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 20 to about 15 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 80 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 20 to about 10 wt% of the absorbent layer.
  • the gelling fibres are present in an amount of from about 65 to about 75 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 25 to about 35 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 75 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 25 to about 30 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 80 to about 75 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 25 to about 20 wt% of the absorbent layer.
  • the gelling fibres are present in an amount of from about 85 to about 75 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 25 to about 15 wt% of the absorbent layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 75 wt% of the absorbent layer and the non-gelling fibres are present in an amount of from about 25 to about 10 wt% of the absorbent layer.
  • the gelling fibres may be any of the gelling fibres already described herein above.
  • the gelling fibres are selected from: carboxymethylcellulose fibres and derivatives thereof, modified cellulosic fibres, alkyl sulphonate modified cellulosic fibres, pectin fibres, alginate fibres, chitosan fibres, hyaluronic acid fibres, fibres derived from gums, non-cellulose synthetic fibres, superabsorbent fibres, such as polyacrylate fibres, and combinations thereof.
  • the gelling fibres are carboxymethylcellulose fibres or derivatives thereof (e.g. HYDROGELTM).
  • the non-gelling fibres are selected from: cellulosic fibres, modified cellulosic fibres, polyester fibres, polypropylene fibres, polyamide fibres, or combinations thereof.
  • the non-gelling fibres are cellulosic fibres, modified cellulosic fibres, or a combination thereof.
  • Highly preferred non-gelling fibres are lyocell fibres (e.g. LYOCELLTM).
  • the gelling fibres and non-gelling fibres are present in the nonwoven fabric at a weight ratio of from about 85:15 to about 65:35. In a various embodiments, the gelling fibres and non-gelling fibres are present in the nonwoven fabric at a weight ratio of about 80:20 to about 70:30. In a preferred embodiment the gelling fibres and non-gelling fibres are present in the nonwoven fabric at a weight ratio of about 75:25.
  • the composition, wound dressing or debridement tool as defined herein is used for the treatment of a chronic wound, acute wound, or burn. Such use typically comprises contacting the composition, wound dressing or debridement tool with the wound or contacting the wound with the composition, wound dressing or debridement. In various embodiments, the chronic wound, acute wound or burn comprises a biofilm.
  • the present disclosure also contemplates a method of treating a wound, wherein said method comprises contacting the wound with a composition, wound dressing or debridement tool as defined herein, or contacting the composition, wound dressing or debridement tool as defined herein with the wound.
  • the wound is a chronic wound, acute wound, or burn.
  • the chronic wound, acute wound or burn may comprise a biofilm.
  • the wound dressing or debridement tool as defined herein is used to prevent or minimise slough accumulation in a wound or to de-slough a wound.
  • the term "slough" is defined herein above.
  • Such uses typically comprise contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool.
  • the wound is a chronic wound, acute wound, or burn.
  • the chronic wound, acute wound or burn may comprise a biofilm.
  • methods for preventing or minimising slough accumulation in a wound, or for desloughing a wound are also contemplated; wherein said methods comprise contacting the wound with a composition, wound dressing or debridement tool as defined herein.
  • the wound is a chronic wound, acute wound, or burn.
  • the chronic wound, acute wound or burn may comprise a biofilm.
  • compositions, wound dressing or debridement tool described herein to remove slough, necrosis or other foreign matter from a wound.
  • biofilm means a syntrophic consortium of microorganisms in which cells stick to each other and optionally also to a surface. These adherent cells become embedded within a slimy extracellular matrix that is composed of extracellular polymeric substances (EPSs).
  • EPSs extracellular polymeric substances
  • the wound comprises one or more biofilms, wherein “biofilm” is as defined herein.
  • the wound comprises one or more biofilms and treating the wound comprises disrupting said one or more biofilms.
  • disrupting in the context of the one or more biofilms means loosening, softening, and detaching the biofilm from the wound bed.
  • compositions for treating wounds that do not contain antimicrobial agents may also be preferable in certain applications because they may not be classed as medicaments.
  • the generally accepted criterion for an antimicrobial cleanser solution is a 3-loglO reduction in microbial cell number in a given contact time period.
  • the nonantimicrobial compositions described herein cause less than about a 3-loglO reduction in the number of microbial cells in the wound when contacted with the wound for about 10 minutes.
  • the non-antimicrobial compositions described herein cause less than about a 2-logl0 reduction in the number of microbial cells in the wound when contacted with the wound for about 10 minutes.
  • the non-antimicrobial compositions described herein cause less than about a 1-loglO reduction in the number of microbial cells in the wound when contacted with the wound for about 10 minutes.
  • the composition described herein is comprised in a wound dressing or debridement tool, wherein said wound dressing or debridement tool comprises an absorbent layer at least partially impregnated or coated with said composition.
  • said wound dressing or debridement tool comprises an absorbent layer at least partially impregnated or coated with said composition.
  • absorbent layer at least partially impregnated or coated with said composition.
  • the composition may be added as an ink by a printing process, for example a screen-printing process, where the addition can be closely controlled by use of the screen.
  • the print could be a continuous, for example as achieved by flood-coating, or, more preferably as a discontinuous coating (regular or random patterned) as it has less impact on porosity/breathability, flexibility and ability to contour to the complex topography of the wound bed and both the macroscopic (physiology) and microscopic (cellular) levels.
  • the composition may be added as a separate layer, for example as a gel coating directly onto the dressing/debridement tool, for example by way of a knife- over-roll or gravure coating technique.
  • the composition may be cast as a film by a similar coating technique and then adhered to the wound device by tackifying the device or the film by, for example humidification, or by the addition of an adhesive.
  • the direct printing method consists of applying a formulation directly onto the material and subsequently fixing said formulation onto the fibres of the material.
  • direct printing may be carried out by using conventional roller printing or flat screen-printing procedures.
  • the method utilises equipment generally consists of a plurality of cylinders and/or rollers on which a number of engraved rollers may apply a particular formulation to an interceding material, such as a fabric material or other sheet-based materials.
  • roller printing methods such as a Gravure printing process or a Rotary Pad printing process
  • a formulation i.e. a printing roller
  • the formulation is typically provided to the printing roller by passing through an underlying tray, where the printing roller takes up the formulation from the underlying tray, while a doctor blade eliminates any excess ink.
  • compositions of the present disclosure are particularly suited for the above discussed processes, and in particular processes for producing discontinuous coatings such as regular or random patterns such as dot arrays.
  • the compositions of the present disclosure are particularly suitable for screen-printing as discussed above.
  • compositions of the present disclosure are also specifically adapted for novel printing processes, such as the process referred to herein as "hybrid printing”.
  • Said process can be defined as a process for applying one or more substance(s), for example a composition as described herein, to one or more substrate layers (e.g. an absorbent layer as described herein) of a wound dressing or debridement tool (e.g. as described herein.
  • a process typically comprises: (a) providing at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, and wherein the transfer member is provided on the exterior of the impression member;
  • Sodium cocoamphoactetate (Dehyton MC) was supplied as a sample from BASF. Sorbitan monooleate (Span®80), cetyl alcohol and oleic acid (Priolene 6907 and Super RefinedTM Oleic Acid NF) were received as samples from CRODA Europe Ltd.
  • AQUACEL® EXTRA dressings are commercially available from ConvaTec.
  • Initial prototype wound dressings were manufactured by solvent flooding using 90% or more industrial denatured alcohol (IDA; containing 96% ethanol) with 10% or less water and tested for efficacy.
  • IDA industrial denatured alcohol
  • the formulations of excipients for inclusion within the absorbent layer are set out in Table 1.
  • Vth theoretical ink deposit
  • W mesh aperture
  • d wire diameter
  • D cloth thickness
  • Figure 8 is a drawing of the open area used to print a 10x10 cm AQUACEL® Extra dressing to make the initial screen printed prototypes. This has dots with a 2.5 mm diameter and covers a total of 9.51% of the dressing surface area.
  • a 10x10 cm dressing with an open area of 961 mm 2 should have the following volume of ink added per application:
  • the screen was clamped into place on a screenprinting rig (as shown in Figure 1) and a 2.6 kg weight was added on top of the squeegee to provide an appropriate pressure.
  • the 10x10 cm AQUAGEL® Extra dressing was placed onto the loading tray, which is moved under the screen with a bottom switch. Approximately 5 ml of ink was poured onto the screen between the squeegee and open pattern. An upper switch moved the squeegee across the screen, pushing ink through the mesh.
  • the dressings were weighed before and after printing to determine the ink deposited and as predicted from the properties of the absorbent layer and the alteration in fluid dynamics using surfactant-based ink, the theoretical ink deposition did not match the experimentally calculated mass of ink transferred to the substrate. Briefly, the mass deposited equated to 0.15 g per 10 x 10 cm dressing (15 g nr 2 ).
  • the excipients are required in concentrations 100 times greater than those required for the dope solution during solvent flooding. This is owing to the greatly reduced mass added to the dressing; 15 g nr 2 during printing compared to 1500 ml m' 2 during solvent flooding.
  • Suitable carrier systems were investigated with the intention of reducing the volume of volatile solvent used during solvent flooding and replacing it with a non-volatile viscous liquid. Owing to the largely oil-based properties of viscous liquids, the investigated carrier systems included a proportion of alcohol-based solvent, namely industrial denatured alcohol (IDA) containing 96% ethanol. This was intended to assist in solubilising the three components and to decrease the overall viscosity of the ink formulation in order to facilitate printing.
  • IDA industrial denatured alcohol
  • the immiscibility of oil/ water and the detrimental effect of water on the gel-forming fibres in the absorbent layer meant that the aqueous phase was excluded in the first instance.
  • surfactants added to the formulation was considered as this has the potential to encourage the formation of emulsions, allowing a proportion of water, for example up to 15 wt% (including water contributed by e.g. commercial aqueous solutions of excipients such as amphoteric surfactants), to be included in order to solubilise the water-soluble excipients (namely EDTA).
  • a proportion of water for example up to 15 wt% (including water contributed by e.g. commercial aqueous solutions of excipients such as amphoteric surfactants), to be included in order to solubilise the water-soluble excipients (namely EDTA).
  • the excipients were mixed at their intended % w/w without the addition of a carrier to form a paste which was subsequently diluted with the carrier of choice.
  • the excipient in highest concentration in the ink is sodium oleate (or oleic acid), this compound requires a dual component solvent, requiring a minimum amount of alcohol within the carrier system. Based on this information, initial testing evaluated miscibility with IDA in order to assess carrier suitability as co-solvents for sodium oleate. The results are shown in Figure 4.
  • Oleic acid on the other hand, does not require IDA in the presence of the other excipients, meaning it could (in theory) be mixed directly with the carriers.
  • addition of tetrasodium EDTA caused the in-situ conversion to the oleate anion, which mirrored the solubility characteristics seen with the original sodium oleate starting material. Therefore, carriers were mixed with IDA prior to oleic acid addition in order to account for the eventual presence of the anion upon addition of EDTA, and the subsequent reaction with sodium ions to form solid aggregates. Only glycerol and triglycerol were compatible with all components.
  • Formulations 10 and 11 are shown in Figure 2. It can be seen how Formulation 10 is a three-phase system: oleic acid remains at the surface, followed by glycerol as the bulk of the solution, and disodium EDTA remaining undissolved at the bottom. Formulation 11 also shows the undissolved disodium EDTA at the base of the vial while the sodium oleate exists in the glycerol above.
  • the formulation was prepared by either combining the amphoteric surfactant (SCAA) and the anionic surfactant (Na Oleate/Oleic Acid), adding chelating agent (EDTA), adding IDA, adding glycerol, heating and stirring, or combining IDA and chelating agent (EDTA), adding anionic surfactant (Na Oleate/Oleic Acid), adding amphoteric surfactant (SCAA), adding glycerol, and heating and stirring. Sonication was only used if needed.
  • glycerol is able to solubilise the ionic oleate (which is the predominant species even when using oleic acid as a result of the in-situ conversion mediated by tetrasodium EDTA), via the formation of stable micelles. If this occurs prior to addition of EDTA, the EDTA cannot be solubilised in the glycerol as it is likely excluded from the ionic interactions in the closed molecular structure.
  • Formulations 8 and 9 from Experimental 2 were tested for efficacy in a simulated biofilm/non- viable material test model. This model measures the ability of the test formulations to disrupt and loosen an artificial substance designed to mimic biofilm and slough.
  • the key components included in the simulated biofilm/non-viable material wound matrix are set out below in Table 6. Table 6
  • the inks detailed in Table 4 were prepared at their corresponding concentrations on a %w/w basis as shown in Table 3 (oleic acid was used in place of sodium oleate at the same concentration in the case of Formulation 9).
  • a screen was clamped into place on a screen-printing rig and a 2.6 kg weight was added on top of the squeegee to provide an appropriate pressure.
  • a 2x2 cm AQUAGEL® Extra dressing (commercially available from ConvaTec) was then placed onto the loading tray, which is moved under the screen with a bottom switch. Approximately 5 ml of ink was poured onto the screen between the squeegee and open pattern. An upper switch moved the squeegee across the screen, pushing ink through the mesh.
  • Test Solution A is according to BS EN 13726-1:2002.
  • Test Solution A is an artificial exudate.
  • the dressings with Test Solution A were placed onto the substrate prepared above and incubated at 37°C for 18 hours.
  • "Biofilm” disruption was characterised by the change in colour of the dressings resulting from absorption of the stained material. This was quantified by extraction of the crystal violet stain from the dressings. Dressings were removed from the substrate, added to 2 ml of 33% acetic acid and the crystal violet stain extracted for 30 minutes on a roller mixer. The absorbance of each solution was read at 595 nm.
  • Figure 3 highlights the observed efficacy of both screen-printed dressings in their ability to disrupt the simulated non-viable matter.
  • AQCIean is a solvent-flooded dressing used as a comparative, which was prepared as set out in Experimental 1.
  • the Glycerol Only ink was used as a control to ensure no significant change in efficacy resulting from the use of the non-volatile carrier (which unlike the volatile solvent will remain on the dressing post - manufacture).
  • the screen-printed dressings retain efficacy similar to the original solvent- printed dressings ( ⁇ 200% more effective than AQUAGEL® Extra), using the same % w/w excipients on the dressings.
  • the values are specified as the concentration of the active mass for each excipient within the ink.
  • the purity of raw materials may vary from batch to batch; therefore, the actual mass of each component added should be calculated each time. For example, if the purity of oleic acid is 70% then the concentration of the raw material that should be added to the ink to give a concentration of 3.2345% (w/w) is 4.6206%.
  • the remainder of the ink consists of glycerol and IDA at a pbw ratio of 77 : 23. The actual concentration of glycerol and IDA is adjusted depending on the purity of excipients.
  • the second option for increasing the viscosity of the printing ink is not to change the carrier system, but to add a thickener to the current formulation.
  • Table 8 shows the thickeners which were trialled and rejected. The solubility in IDA and glycerol both separately and combined in the 23:77 pbw ratio was tested; heat was applied if the thickener had not dissolved after stirring at ambient temperature for one hour. Initially, 1% (w/w) of thickener was tested, from here the concentration was increased or decreased depending on the solubility and thickening capacity of each thickener. If the thickener was found to be soluble in the carrier system, an ink including the three excipients and the thickener was formulated. Adding the excipients to the formulation reduced the solubility of many thickeners.
  • Viscosity was measured using a Discovery HR2 hybrid rheometer with a 40mm stainless steel 2° cone geometry with a 55 pm truncation and a solvent trap filled with IDA to prevent evaporation during longer tests.
  • a flow ramp with the above protocol was used to determine the viscosity of inks over a range of shear rates.
  • a temperature ramp with the above protocol was used to determine the viscosity of inks over a range of temperature at a constant low shear rate.
  • the triglycerol ink has Newtonian rheological behaviour and an average viscosity 0.19 Pa. s.
  • Figure 5 shows the rheological behaviour of this ink throughout the flow ramp protocol.
  • the Data was fitted to a Newtonian fluid model using TRIOS software (TA Instruments, New castle, Delaware, USA).
  • Polyethylene glycol was the only thickener tested which could make a homogenous ink which was also thickened sufficiently. Therefore, a range of different molecular weight PEGs were the only thickeners investigated further.
  • the series of polyethylene glycols (PEGs) of different molecular weights trialled are shown above in Table 8.
  • Figure 7 shows the rheology of the inks formulated with different molecular weights of PEG during a flow ramp as outlined above with shear rates from 1 to 800 1/s.
  • a molecular weight below 1000 did not produce a shear thinning ink, this is seen in the flat lines for these inks in Figure 7. Over a molecular weight of 1000 the inks produced were shear thinning, with the initial viscosity increasing with molecular weight. PEG 6000 showed the greatest stability, not phase separating after a month of storage.
  • Figure 3 shows the efficacy of sodium oleate ink and oleic acid ink compared to an AQUACEL® Extra control (% more efficacious than AQUAGEL® Extra) where AQ Clean is solvent flooded with the concentration of excipients stated in Table 2.
  • Sodium oleate ink is AQUAGEL® Extra printed with 0.07g of the ink described in Table 9 on one side of a 10x10 cm sample
  • Oleic acid ink is AQUACEL® Extra printed with 0.07g of the ink formulation stated in Table 9 on one side of a 10x10 cm sample
  • Glycerol only ink is AQUACEL® Extra printed with 0.07g of 77.77% glycerol 22.22% IDA ink on one side of a 10x10 cm sample.
  • a non-antimicrobial composition for printing onto an absorbent layer comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C1.4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1.
  • the non-antimicrobial composition of any preceding clause wherein the one or more Ci. 4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof, preferably wherein the one or more Ci. 4 alcohol comprises ethanol.
  • non-antimicrobial composition of any preceding clause further comprising a chelating agent which is selected from citrates, tartrates, tartramides, tartrimides, gluconates, lactates, glycolates, oxalates, phosphates, salts of ethylenediaminetetraacetic acid, and mixtures thereof, preferably wherein the chelating agent comprises a salt of ethylenediaminetetraacetic acid.
  • a chelating agent which is selected from citrates, tartrates, tartramides, tartrimides, gluconates, lactates, glycolates, oxalates, phosphates, salts of ethylenediaminetetraacetic acid, and mixtures thereof, preferably wherein the chelating agent comprises a salt of ethylenediaminetetraacetic acid.
  • non-antimicrobial composition of any preceding clause further comprising an amphoteric surfactant which is selected from hydrocarbyl-amphoacetates, alkenyl- amphoacetates, hydrocarbyl-amphodiacetates, alkenyl-amphodiacetates, hydrocarbylampho-propionates, hydrocarbylampho-diproprionates, hydrocarbylamphohydroxypropyl sultaines, and mixtures and salts thereof; preferably wherein the hydrocarbyl or alkenyl groups are C 6 to C 24 hydrocarbyl or alkenyl groups.
  • the non-antimicrobial composition of Clause 10 wherein the anionic surfactant comprises a fatty acid or salt thereof, preferably oleic acid or a salt thereof.
  • non-antimicrobial composition of any preceding clause, wherein the non-antimicrobial composition comprises an anionic surfactant at a concentration from about 1 wt.% to about 15 wt.% on an actives basis, based on the total weight of the composition, preferably from about 1 wt.% to about 10 wt.% on an actives basis, based on the total weight of the composition.
  • non-antimicrobial composition of any preceding clause, wherein the non-antimicrobial composition comprises an amphoteric surfactant at a concentration from about 1 wt.% to about 15 wt.% on an actives basis, based on the total weight of the composition, preferably from about 1 wt.% to about 10 wt.% on an actives basis, based on the total weight of the composition.
  • non-antimicrobial composition of any preceding clause wherein the non-antimicrobial composition comprises a chelating agent at a concentration from about 0.5 wt.% to about 10 wt.% on an actives basis, based on the total weight of the composition, preferably from about 1 wt.% to about 8 wt.% on an actives basis, based on the total weight of the composition.
  • the non-antimicrobial composition of any preceding clause wherein the non-antimicrobial composition comprises: a. an anionic surfactant and an amphoteric surfactant on an actives basis at a weight ratio of about 2:5 to about 5:2, b.
  • non-antimicrobial composition of any preceding clause, wherein the non-antimicrobial composition comprises:
  • non-antimicrobial composition of any preceding clause, wherein the non-antimicrobial composition comprises:
  • non-antimicrobial composition of any preceding clause, wherein the non-antimicrobial composition comprises:
  • non-antimicrobial composition of any preceding clause, wherein the non-antimicrobial composition comprises:
  • composition further comprises a non-ionic surfactant, preferably wherein the non-ionic surfactant is selected from polyoxyethylene fatty acid esters, polyoxyethylene glycol fatty acid esters, sucrose fatty acid esters, polyoxyethylene hydrogen carbonate castor oils, polyoxyethylene alkyl ethers, and mixtures thereof.
  • composition further comprises a thickening agent.
  • step (b) heating the mixture of step (a) to a minimum of about 30°C until the polyethylene glycol is fully dissolved in the one or more C1-C4 alcohol;
  • step (c) adding the solution of step (b) to the carrier;
  • step (d) adding the one or more excipients to the solution of step (c).
  • a process for preparing a wound dressing or debridement tool comprising printing the non-antimicrobial composition as defined in any one of clauses 1 to 24 onto a surface of an absorbent layer of the wound dressing or debridement tool.
  • the process of clause 28, wherein the composition is screen printed onto the surface of the absorbent layer.
  • a wound dressing or debridement tool obtained by the process of Claim 28 or 29.
  • the wound dressing or debridement tool of Clause 30 or 31 to prevent or minimise slough accumulation in a wound or to de-slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool.

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Abstract

La présente invention concerne de manière générale les soins des plaies, et plus particulièrement un pansement ou un outil de débridement comprenant une couche absorbante au moins partiellement imprégnée ou revêtue d'une composition non antimicrobienne.
PCT/GB2025/050782 2024-04-12 2025-04-11 Véhicule pour composition non antimicrobienne Pending WO2025215377A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000001425A1 (fr) 1998-07-01 2000-01-13 Acordis Speciality Fibres Limited Pansements et materiaux constitutifs adaptes
WO2012061225A2 (fr) 2010-11-01 2012-05-10 Becton, Dickinson And Company Essai de gardnerella vaginalis
CN109200335A (zh) * 2018-10-08 2019-01-15 江阴奔翔生物科技有限公司 医用壳聚糖伤口敷料
CN110025571A (zh) * 2019-04-30 2019-07-19 南京广方生物科技有限公司 一种清创消毒液
WO2021186188A1 (fr) 2020-03-20 2021-09-23 Convatec Limited Composition de débridement
US20210290815A1 (en) * 2020-03-20 2021-09-23 Convatec Limited Debridement Composition

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000001425A1 (fr) 1998-07-01 2000-01-13 Acordis Speciality Fibres Limited Pansements et materiaux constitutifs adaptes
WO2012061225A2 (fr) 2010-11-01 2012-05-10 Becton, Dickinson And Company Essai de gardnerella vaginalis
CN109200335A (zh) * 2018-10-08 2019-01-15 江阴奔翔生物科技有限公司 医用壳聚糖伤口敷料
CN110025571A (zh) * 2019-04-30 2019-07-19 南京广方生物科技有限公司 一种清创消毒液
WO2021186188A1 (fr) 2020-03-20 2021-09-23 Convatec Limited Composition de débridement
US20210290815A1 (en) * 2020-03-20 2021-09-23 Convatec Limited Debridement Composition

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Title
MOREIRA RAMON ET AL: "Kinematic Viscosity and Refractive Index of Aqueous Solutions of Ethanol and Glycerol", INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH, vol. 48, no. 4, 8 January 2009 (2009-01-08), pages 2157 - 2161, XP093291515, ISSN: 0888-5885, DOI: 10.1021/ie801410d *
ORHAN ET AL., J. CLIN. MICROBIOL., vol. 43, no. 1, 2005, pages 140
SLEEM ASMAA S. ET AL: "Evaluation of glycerol antiseptic effect on Gram positive and Gram negative bacteria", MENOUFIA MEDICAL JOURNAL, vol. 36, no. 3, 5 October 2023 (2023-10-05), XP093291259, ISSN: 2314-6788, DOI: 10.59204/2314-6788.1100 *

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