Classifications

• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L53/00—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
  • C08L53/02—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers of vinyl-aromatic monomers and conjugated dienes
  • C08L53/025—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers of vinyl-aromatic monomers and conjugated dienes modified
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/13—Amines
  • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• • 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
  • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
  • A61L15/24—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
• • 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
  • A61L15/44—Medicaments
• • 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
  • 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
  • A61L2300/402—Anaestetics, analgesics, e.g. lidocaine
• • 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
  • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
• • 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
  • A61L2300/41—Anti-inflammatory agents, e.g. NSAIDs
• • 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
  • A61L2300/412—Tissue-regenerating or healing or proliferative agents

Definitions

• the present invention relates to the use of a resin as a metformin release agent.
• the present invention relates in particular to the use of a resin selected from aromatic resins to promote the release of metformin in an elastomeric matrix, and to a composition comprising it.
• Wound healing usually depends on the proliferation of new epithelial, endothelial and connective tissues. It therefore involves a set of nested and interconnected events by successive and reciprocal inductions of the various cells involved. Each step is induced by the previous one and can only take place if the previous step ends. This is a complex process that is underpinned by successive waves of growth factors and inflammatory mediators.
• the pharmaceutical market currently offers many recommended topical preparations to promote wound healing.
• their action results from the complementarity of the different products that compose them and give them, to a certain extent, their healing properties. They protect wounds from the surrounding environment with an antiseptic coating. They stimulate the development of vascularization and regulate epidermization.
• These topical forms consist mainly of a lipid mixture (lanolin, petrolatum, glycerin ...) in which are added acids (salicylic, benzoic, malic), minerals (zinc oxide, titanium) or halides (iodide of starch).
• Some also contain collagen, fibrinogen, enzymatic serum proteolysate (amino acid supply) or vitamins (vitamin A) hormones (4-chlorotosterone acetate).
• Patent FR 2 809 310 describes the use of metformin in a topical composition having a healing and / or angiogenic effect.
• the various galenical forms of compositions envisaged are of the oil, cream, mousse, detergent, lotion, ointment, liquid, gel, milk, powder or spray type.
• active ingredient (s) in the form of topical composition needs to be frequently repeated to ensure an effect on healing.
• a device such as a dressing, comprising an active ingredient, in particular metformin, to effectively treat wounds for several days.
• the dressing should ideally be applied for a duration of about 72 hours.
• a too frequent change of the dressing induces additional costs with regard to the expenses of nursing personnel necessary to change said dressing.
• a change that is too frequent can also increase the risk of infections. Indeed, at the time of removal of the dressing, the wound is exposed to bacteria in the environment.
• the active agent has a high affinity for exudates, as is the case with metformin, the latter tends to be salted out too quickly on the wound, so that a peak of concentration of the active ingredient is free from the dressing within hours of its application, and the beneficial effects of the treatment do not last more than a few hours.
• the dressing should instead allow a controlled and continuous release of the asset for several days, including for about three days.
• a sufficient amount of active agent should be released upon application of the device, and then a lower but continuous release of the asset should be maintained throughout the duration of application of the device on the wound to maintain the desired effects. This is, in other words, to administer a particular release profile involving a bolus in the first application of the formulation, and then maintain a lower level of release of active throughout the duration of treatment.
• the present invention aims to respond to these problems, by proposing a composition that can be implemented in a device dressing type comprising metformin, allowing a release of it in a continuous profile and controlled for several days.
• the present invention has made it possible to develop a specific composition based on triblock copolymers of the ABA type, comprising two thermoplastic end blocks A styrene and a central elastomer block B which is a saturated olefin, allowing the preparation of an elastomeric matrix may be implemented in a dressing, which may be in the form of a self-weight dressing, said matrix allowing a release of metformin in a continuous profile and controlled for several days.
• the addition of specific resins also makes it possible to reduce the viscosity of the elastomeric mixture and to mechanically reinforce the elastomeric matrix. This is particularly advantageous in the method of manufacturing the elastomeric matrix.
• the composition because of its reduced viscosity, can be coated more easily on a frame. In the case of a self-weight dressing, the improvement of the cohesion of the elastomeric matrix allows a better molding and demolding of the latter.
• the manufacturing temperature of the composition can be reduced by about 10 ° C., which makes it possible to introduce into the mixture components that are sensitive to heat treatments, such as active ingredients, for example.
• the dressing according to the invention does not adhere to latex surgical gloves.
• the subject of the present invention is a composition comprising:
• At least one triblock copolymer of the ABA type comprising two styrene thermoplastic end blocks and a central elastomer block B which is a saturated olefin or of a mixture of triblock copolymers of the ABA type, comprising two styrene thermoplastic end blocks and a central elastomer block B which is a saturated olefin, based on the total weight of the composition
• an alpha-methylstyrene resin having a softening point of between 80 and 125 ° C., preferably between 90 and 110 ° C. 0.1 to 15% metformin
• the present invention relates to an elastomeric matrix obtained from such a composition and an interface dressing, with support or self-supporting comprising said elastomeric matrix.
• the subject of the invention is also the use of an alpha-methyl styrene-type resin to promote the release of metformin in a composition, in particular used in a dressing.
• composition according to the invention comprises at least one triblock copolymer of the type
• the block copolymers used in the context of the invention are triblock copolymers of the ABA type comprising two styrene thermoplastic end blocks and a central elastomer block B which is a saturated olefin.
• the saturated olefin B blocks are, for example, ethylene-butylene, ethylene-propylene or ethylene-ethylene-propylene blocks.
• block A refers to a poly (styrene) block
• block B or “saturated olefin block” refers to a poly (saturated olefin) block
• the composition comprises a mixture of two copolymers, said mixture comprising at least one copolymer which has a viscosity of between 0.01 and 1 Pa.s, measured in a 5% mass / mass solution. in toluene and at least one copolymer having a viscosity of between 0.01 and 0.5 Pa.s, measured in a 15% solution (weight / mass) in toluene.
• the saturated central block triblock copolymers are well known to those skilled in the art and are for example marketed:
• KRATON G particularly grades KRATON ® G1651, G1654 ® KRATON, KRATON ® G 1657, KRATON ® G1652 or KRATON G1650 and by the company KURARAY under the names SEPTON® and in particular the grades 8006 or 8004 for block copolymers poly (styrene-ethylene-butylene-styrene) (abbreviated as SEBS);
• SEPS block copolymers poly (styrene-ethylene-propylene-styrene)
• SEEPS block polymers poly (styrene-ethylene-ethylene - propylene-styrene) and in particular the grades 4033, 4044, 4055, 4077 or 4099.
• SEBS SEBS, SEPS or SEEPS triblock copolymers having a styrene content of between 25 and 45% by weight relative to the weight of said SEBS, SEPS or SEEPS copolymer.
• the composition comprises a single triblock copolymer of the ABA type, and more preferably a single elastomeric block copolymer.
• the amount of copolymers in the final composition may be between 5 and 20% by weight, preferably between 7 and 15% by weight, relative to the total weight of the composition.
• Resins used in the composition according to the invention are aromatic hydrocarbon resins, that is to say based on aromatic monomers only. They are distinguished from aliphatic resins, based on aliphatic monomers only, or aliphatic / aromatic resins based on aliphatic and aromatic monomers. Without wishing to be bound by any theory, it seems that these resins have a good solubility in the A block of the ABA copolymers and reinforce this styrene block, which improves the cohesion of the final elastomeric matrix obtained.
• the aromatic monomer is alpha-methyl styrene.
• the aromatic hydrocarbon resin is chosen from alpha-methyl-styrene homopolymer and copolymer resins.
• the resins used in the compositions according to the invention are alpha-methyl styrene type resins whose softening point is between 80 and 125 ° C, preferably between 90 and 110 ° C.
• the softening point is measured according to ISO 4625 (Ring
• the resin according to the invention is an alpha-methyl styrene resin having a softening point between 95 and 105 ° C or between 115 and 125 ° C or a poly (styrene-co-alpha-methyl styrene) resin having a softening point between 95 ° C and 115 ° C.
• Sylvares SA 100 and Sylvares SA 120 from Arizona Chemical alpha-methyl styrene resins having a softening point located between 95 and 105 ° C. or between 115 and 125 ° C. respectively,
• compositions according to the invention do not comprise any resin other than the alpha-methyl styrene previously described, and in particular, do not comprise tackifying or sticky resin.
• the resin is preferably present in an amount of 0.5 to 15%, preferably 2 to 10% by weight, based on the total weight of the composition.
• the mixture of copolymers and the resin present in the composition according to the invention are associated with one (or more) plasticizer compound (s).
• plasticizers that can be used are well known and intended to improve the stretching, flexibility, extrudability or implementation properties of the copolymers.
• One or more plasticizers may be used for this purpose if necessary.
• plasticizers liquid compounds which are compatible with the saturated olefin central sequence of the abovementioned block copolymers will be preferred.
• plasticizer compounds that may be used for this purpose, mention may in particular be made of mineral plasticizing oils.
• saturated-based liquid hydrocarbon mixtures synthetic products such as the products marketed by the company TOTAL under the name Gemseal ® and in particular the product Gemseal ® 60 which is an isoparaffinic mixture derived from a completely hydrogenated petroleum cut.
• plasticizing oils and in particular mineral oils formed of compounds of a paraffinic or naphthenic nature, or of their mixtures, in variable proportions.
• plasticizing mineral oils are formed from mixtures of paraffinic and naphthenic compounds, and in particular such mixtures in which the proportion of paraffinic compounds is predominant.
• plasticizing oils that are particularly suitable, mention may be made of the products marketed by SHELL under the names ONDINA and in particular ONDINA 919 or the oil marketed by the company PETRO CANADA under the reference
• the plasticizer may comprise petroleum jelly.
• the petrolatum used in the compositions of the invention is a vaseline according to the French Pharmacopoeia commercially available.
• the petrolatum is present in an amount of 1 to 30%, preferably 5 to 25% by weight, based on the total weight of the composition.
• the plasticizer is present in an amount of 50 to 80%, preferably 60 to 70% by weight, based on the total weight of the composition.
• the plasticizer consists of a mixture of mineral oil and petrolatum, the mineral oil being present in an amount ranging from 45 to 60% by weight relative to the total weight of the composition, the petroleum jelly being present in one amount ranging from 5 to 20% by weight relative to the total weight of the composition.
• Metformin is an oral antidiabetic of the biguanide normoglycemic family used in the treatment of type 2 diabetes. Its role is to reduce insulin resistance of the body intolerant to carbohydrates and decrease hepatic gluconeogenesis. The mode of administration of metformin is per os. Metformin is absorbed in the small intestine, circulates in the blood unconnected and is excreted unchanged by the kidneys. Its mechanism of action is complex and is not yet fully understood. Metformin is a normoglycemic agent: it does not act on the insulin secretion, nor on the insulin sensitivity of tissues that use glucose (muscles, adipose tissue).
• Metformin also has a role in the inhibition of gluconeogenesis, by inhibiting mitochondrial glycerophosphate dehydrogenase, and in membrane transport of glucose (decreased intestinal resorption). It also increases the release of Glucagon-like peptide-1, inhibits the glucagon pathway, increases lactate production by enterocytes.
• the metformin used is in the form of a metformin hydrochloride.
• the particle size of the metformin when calculated according to the Fraunhoffer optical model between 0.375 ⁇ and 2000 ⁇ , measured by laser with the dry powder module, satisfies the following characteristics:
• the particle size distribution of metformin is unimodal.
• the amounts of metformin introduced into the dressings are from 0.5 to 15% by weight, preferably 1 to 10% by weight, relative to the total weight of the elastomeric matrix.
• composition according to the present invention may comprise at least one other active agent that makes it possible to induce or accelerate healing or that may have a favorable role in the treatment of a wound.
• agents that promote healing such as retinol, vitamin A, vitamin E, N-acetylhydroxyproline, extracts of Centella Asiatica, papain, silicone, essential oils of thyme, niaouli, rosemary, sage, l hyaluronic acid, sucrose octasulfate potassium, sucralfate, allantoin; antibacterial agents such as salts or silver complexes (such as silver sulphates, silver nitrates, silver sulphonamides or silver-based zeolites), zinc or copper salts , metronidazole, neomycin, penicillins, clavulanic acid, tetracyclines, mynocycline, chlorotetracycline, aminoglycosides, amikacin, gentamicin, probiotics;
• antiseptics such as chlorhexidine, trichlosan, biguanide, hexamidine, thymol, lugol, povidone iodine, benzalkonium chloride and benzethonium;
• anti-pain agents such as paracetamol, codeine, dextropropoxyphene, tramadol, morphine and its derivatives, corticosteroids and their derivatives;
• lidocaine such as lidocaine, benzocaine, dibucaine, pramoxine hydrochloride, bupivacaine, mepivacaine, prilocaine, etidocaine;
• anti-inflammatories such as nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or acetylsalicylic acid, ibuprofen, ketoprofen, flurbiprofen, diclofenac, aceclophenac, ketorolac, meloxicam, piroxicam, tenoxicam, naproxen, indomethacin, naproxcinod, nimesulid, celecoxib, etoricoxib, parecoxib, rofecoxib, valdecoxib, phenylbutazone, niflumic acid, mefenamic acid;
• NSAIDs nonsteroidal anti-inflammatory drugs
• composition according to the invention may also comprise one or more other compounds known for their action in the debridement phase, for example:
• the healing promoting agent is chosen from the agents that promote the healing of retinol, vitamin A, vitamin E, N-acetylhydroxyproline, extracts of Centella Asiatica, papain, silicone, essential oils and the like. thyme, niaouli, rosemary, sage, hyaluronic acid, potassium sucrose octasulfate, sucralfate, allantoin.
• composition according to the invention comprises 0.1 to 15% additional active ingredient, preferably 1 to 10% by weight, based on the total weight of the composition.
• compositions according to the invention comprise hydrophilic particles of a hydrocolloid (or particles hydrocolloid). These particles indeed allow the painless removal of an interface dressing and the maintenance of a moist environment at the wound level to promote healing.
• a small amount of hydrophilic particles of a hydrocolloid is thus disposed on the surface of the elastomeric matrix once formed and is preferably dispersed homogeneously within the composition according to the invention.
• hydrocolloid or “hydrocolloid particles” is meant here any compound usually used by those skilled in the art for its ability to absorb aqueous liquids such as water, physiological saline or exudates. a wound.
• Suitable hydrocolloids include, for example, pectin, alginates, natural vegetable gums such as, in particular, Karaya gum, cellulose derivatives such as carboxymethylcelluloses and their alkali metal salts such as sodium or calcium, and that synthetic polymers based on acrylic acid salts, known as "superabsorbents", such as for example the products sold by CIBA Specialty Chemicals under the name SALCARE SC91 and mixtures of these compounds.
• microcolloid Some of these superabsorbents described as "microcolloid" because they have a particle size of less than 10 micrometers can of course also be used.
• hydrocolloids preferred in the context of the present invention are the alkali metal salts of carboxymethylcellulose, and in particular sodium carboxymethylcellulose (CMC).
• the size of the hydrocolloid particles is generally between 50 and 100 microns, advantageously of the order of 80 microns.
• the quantity of hydrocolloid particles incorporated in the composition according to the invention will advantageously be less than or equal to 25% by weight, advantageously of the order of 2 to 20% by weight, preferably 5 to 18% by weight, more preferably 10 to 15% by weight, based on the total weight of said composition.
• hydrocolloid particles are disposed on the surface of the elastomeric matrix once it has been formed, their quantity will preferably be of the order of 1 to 10% and more particularly of 2 to 5% by weight, based on the total weight of said elastomeric matrix.
• composition according to the invention may also comprise at least one tackifying resin to give them an adhesive character facilitating their positioning on the wound.
• the tackifying resins that can optionally be used in the composition of the invention are chosen in particular from low molecular weight polyisobutylenes.
• the use of hydrogenated resins such as Escorez® resins of the 5000 series is preferred, and even more preferentially, the Escorez 5380® resin. antioxidants
• composition according to the invention may also comprise antioxidants.
• antioxidants is meant here the compounds commonly used by those skilled in the art to ensure the stability of the compounds used in the formulation of the compositions, particularly with respect to oxygen, heat, ozone or ultraviolet radiation.
• antioxidants examples include phenolic antioxidants such as in particular the products marketed by BASF under the names IRGANOX ® 1010, Irganox ® 565, Irganox ® 1076.
• antioxidants may be used alone or in combination in an amount of the order of 0.05 to 1% by weight, preferably 0.05 to 0.2% by weight, based on the total weight of the composition.
• IRGANOX 1010 in an amount of between 0.05 and 0.2% by weight, relative to the total weight of the composition.
• adjuvants that can be used in the compositions according to the invention, mention may be made of compounds known to promote the release of active agents, such as, for example, Montanox ® 80 or Sepinov ® EMT 10 (copolymer of sodium salt). 2-methyl-2 [(1-oxo-2-propenyl) amino] -1-propanesulfonic acid and 2-hydroxyethyl ester of propenoic acid or of the mixture of 2-octyl-1-dodecanol, D-xylopyranoside, 2-octyldodecyl and polyethylene glycol dipolyhydroxystearate) which are commonly used in URGOTUL products that incorporate active agents. These adjuvants may be used in an amount of about 0.01 to 10% by weight, preferably 0.05 to 5% by weight, relative to the total weight of the elastomeric matrix.
• compositions according to the invention make it possible in particular to produce self-supporting interface dressings or interface dressings having an armature or a support.
• composition which comprises compounds (copolymers, mineral oil, petrolatum, antioxidant and hydrocolloids) of the same nature as, or identical to, those used in the preparation of an interface dressing.
• compounds copolymers, mineral oil, petrolatum, antioxidant and hydrocolloids
• compositions according to the invention will be formed in a thin layer, with through holes, preferably distributed in said layer to form an elastomeric matrix.
• the invention thus provides, in another aspect, an elastomeric matrix obtained from a composition according to the invention as described above.
• the through holes may be made by perforation or punching of a composition according to the invention previously formed in a thin layer, alone or in combination with a temporary support or a protective film usually used for the manufacture of a dressing, or else by a coating screened on a temporary support.
• the polymer matrices according to the invention can be manufactured by hot casting a composition as described above on a plate etched with the pattern retained to form through holes, followed by cooling and demolding.
• the polymer matrices according to the invention will have a thickness of between 0.4 mm and 2 mm, preferably between 0.5 mm and 1 mm, more preferably of the order of 0.6 to 0.7 mm.
• the through holes may be of any geometry and will have for example a circular cross section, rectangular, trapezoidal or square.
• Their surface will generally be between 1 and 7 mm 2 .
• These holes will be distributed, preferably regularly, with a density such that the total area of the holes is between 20 and 70, and preferably between 30 and 60% of the total surface of the dressing.
• the polymeric matrix when it is used in an interface dressing, preferably self-supporting, is in the form of an aerated net (or grid) preferably of square mesh having:
• a "wire width" width of the space between two consecutive holes of between 1 and 10 mm, and preferably between 1 and 5 mm;
• such an elastomeric matrix will be in the form of a square mesh aerated mesh having:
• this elastomeric matrix may also be envisaged to use this elastomeric matrix to coat an armature or a support.
• the elastomeric matrices obtained using the compositions according to the invention are not tacky, that is to say they have an adhesive power on the skin, according to the method EN 1939, less than 40 cN / cm. and preferably less than 35 cN / cm.
• a support sample 20 mm wide and 150 mm long is placed on the forearm. After 10 minutes, the adhesive power was measured with a dynamometer at a pulling speed of 900 mm / min at an angle of 90 °.
• the invention thus has, according to a preferred embodiment, an interface dressing characterized in that it comprises an elastomeric matrix previously described.
• the present application aims to cover a self-supporting interface dressing comprising an elastomeric matrix in the form of a thin layer having through holes for passing the exudates, obtained from a composition comprising:
• the percentages being based on the total weight of the composition.
• the interface dressing according to the present invention does not adhere to latex gloves.
• the composition may preferably comprise:
• a plasticizer H preferably a plasticizing oil
• Vaseline V from 90 to 600 parts by weight of Vaseline V;
• the total amount, represented by P + H + V, of elastomer mixture, plasticizer and petrolatum is between 490 and 1700 parts by weight;
• the ratio of the total amount of the mixture of elastomers, the plasticizer and the petrolatum and the amount of petrolatum, represented by P + H + V / V, is less than 11;
• said mixture of 2 copolymers comprises at least 20% by weight of the first copolymer
• composition further comprising from 0.5 to 15% by weight of an alpha-methyl styrene resin having a softening point of 80 to 125 ° C, preferably 90 to 110 ° C, and 0, 1 to 15% by weight of metformin,
• the percentages being based on the total weight of the composition.
• the interface dressing may be covered, preferably on each of its faces, with a temporary protective film which will be removed before use by the user.
• the figure is a graphical representation of the dissolution profiles, evaluated as a percentage of metformin released relative to the quantity contained in the mass from the dressings described in Example 1 and in Example 4.
• compositions of Examples 1 to 4 were prepared using the following constituents in the proportions, expressed as percentage by weight, mentioned in Table 1 below.
• Elastomer block copolymer of poly (styrene-ethylene-butylene-styrene) (abbreviated to SEBS):
• Plasticizer Pioneer 2076P mineral oil marketed by Hansen & Rosenthal
• Vaseline vaseline Codex A marketed by the company AIGLON
• Antioxidant IRGANOX 1010 marketed by BASF
• Hydrocolloid sodium carboxymethylcellulose CMC BLANOSE ® 7H4XF sold by ASHLAND,
• Resins Sylvares SA 100, alpha-methyl styrene resin having a softening point between 95 and 105 ° C, marketed by Arizona Chemical
• the carboxymethylcellulose, the metformin and the SEPINOV EMT 10 are premixed and sieved at 400 ⁇ .
• the petrolatum and the oil are introduced into a kneader at a set temperature of 90 ° C., at a speed of 60 to 70 rotations per minute (rpm), and then the powders of carboxymethylcellulose, SEPINOV EMT 10 and metformin are introduced. dim. It is kneaded for 5 minutes.
• the set temperature is increased to 140 ° C.
• the elastomer and antioxidant are then introduced. It is kneaded for 45 minutes (until a smooth and homogeneous mixture is obtained). The resin is introduced 15 minutes before the end.
• the mixture was then allowed to cool, and the mixer was drained.
• compositions thus obtained were coated on a weft (marquisette 601 marketed by MDB Texinov) according to the methods described in patent applications WO 00 16725 and FR 2 936 159 or WO 2015/018720.
• the dressings are weighed before being placed on the cylinders.
• HPLC system equipped with a UV detector, a sample changer and a column oven
• Ammonium dihydrogen phosphate for analysis for example: ref. VWR 21305.290 or equivalent
• Acetonitrile low UV for analysis For example: ref. VWR 20048.290 or equivalent, Sodium chloride for analysis.
• ref. VWR 27810.295 or equivalent for example:
• Sucrose potassium octasulfate secondary reference stored in a closed bottle stored in a drying cabinet
• the mobile phase is a solution of ammonium dihydrogenphosphate at 17 g / L to which 2% of acetonitrile is added.
• the physiological saline used during the analysis will be pre-thermostated at 32 ° C.
• Vaseline (Vaseline Codex A of 5.0 5.0
• alpha-methyl styrene resin 0 9,6 having a
• the alpha-methyl-styrene resin makes it possible to increase the percentage of metformin released.
• we put 20% of said resin we find about the same proportions of metformin released as when the composition does not include resin.

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