MX2008007380A - Hydrophilic coating comprising a polyelectrolyte - Google Patents

Abstract

The invention relates to a hydrophilic coating formulation which when cured results in a hydrophilic coating, wherein the hydrophilic coating formulation comprises a polyelectrolyte and a non-ionic hydrophilic polymer. The invention further relates to a coating system, a hydrophilic coating, a lubricious coating, use of a polyelectrolyte and a non-ionic hydrophilic polymer in a lubricious coating, an article, a medical device or component and a method of forming on a substrate a hydrophilic coating.

Description

HYDROPHILIC COVERING THAT COMPRISES A POLYELECTROLYTE FIELD OF THE INVENTION This invention relates to a hydrophilic coating formulation, which when cured, results in a hydrophilic coating. The invention further relates to a coating system, a hydrophilic coating, a lubricious coating, the use of a polyelectrolyte and a nonionic hydrophilic polymer in a lubricious coating, an article, a medical device or component and a method for forming a coating. hydrophilic on a substrate.

BACKGROUND OF THE INVENTION Many medical devices, such as cardiovascular and urinary catheters, syringes and membranes, need to have a lubricant applied on the outer and / or inner surface to facilitate insertion into and removal of the body and / or facilitate fluid drainage. from the body. Lubricating properties are also required to minimize soft tissue damage after insertion or removal. Especially, for lubrication purposes, such medical devices may have a coating or layer of hydrophilic surface which becomes lubricious and achieves low friction properties after moistening, that is, applying a wetted fluid for a certain period of time before inserting the device into a patient's body. A hydrophilic surface coating or layer, which becomes lubricious after wetting, is hereinafter referred to as a lubricious coating. A well-recognized problem encountered when using lubricious coatings has been that the coatings can lose water and dry prior to insertion into the body or into the body when they come into contact with for example, a mucous membrane, such as when a urinary catheter is inserted in the urethra. Naturally, this affects the lubricity and low friction properties of the lubricious coating, and can lead to pain and injury of the patient when the device is inserted into the body or removed from the body. It could therefore be advantageous to have medical devices comprising a hydrophilic coating that remains lubricious after application of a moist fluid for a prolonged period to and after insertion into the body of a patient. The time that the hydrophilic coating remains lubricious after the application of a moist fluid is here also, referred to as the drying time.

SUMMARY OF THE INVENTION It is an object of the present invention to provide a hydrophilic coating that remains lubricious for a prolonged time after application to a wet fluid before and after insertion into the body of a patient. Surprisingly, it has been found that a lubricious coating with a prolonged and thereby improved drying time can be obtained when a polyelectrolyte is applied and a non-ionic hydrophilic polymer is included in the hydrophilic coating from which said lubricious coating is applied. shape by applying a wet fluid. It has further been found that the rate of water absorption is increased in a coating of the invention comprising a polyelectrolyte in combination with a nonionic hydrophilic polymer, compared to a similar coating without these components. This is a particular advantage in case the article is stored with a dry coating and the coating is moistened before use. Successfully moistening a coating, for example, of a catheter, can thus be accomplished within a few seconds after submersion in water or exposure to air with a relative humidity of 100%.

Within the context of the "lubricious" invention, it is defined as having a sliding surface. A coating on the external or internal surface of a medical device, such as a catheter, is considered lubricious if (when it is wet), can be inserted into the proposed body part without leading to injury and / or causing unacceptable levels of discomfort to the subject. In particular, a coating is considered lubricious if it has a friction as measured in the Harland Friction Tester FTS5000 (HFT) of 20 g or less, preferably 15 g or less, a clamping force of 300 g, a draw speed of 1 cm / s, a temperature of 22 ° C and 35% relative humidity. The protocol is as indicated in the Examples. The term "wet" is generally known in the art and -in a broad sense- means "containing water". In particular, the term is used herein to describe a coating that contains enough water to be lubricious. In terms of the water concentration, usually a wetted coating contains at least 10% by weight of water, based on the dry weight of the coating, preferably at least 50% by weight, based on the dry weight of the coating, more preferably at least 100% by weight based on the dry weight of the coating. For example, in a particular mode of In the invention, water absorption of approximately 300-500% water is feasible. Examples of wetting fluids are treated or not treated with water, mixtures containing water with for example, organic solvents or aqueous solutions comprising, for example, salts, proteins or polysaccharides. In particular, a moisturizing fluid can be a body fluid. An important property of such a lubricious coating is that it can remain lubricious as soon as it is needed. Therefore, the drying time must be long enough to allow application in medical devices. Within the context of the experiment, the drying time is the duration of the coating that remains lubricious after a device comprising the lubricious coating has been taken from the wetting fluid where it has been stored and / or moistened. The drying time can be determined by measuring the friction in grams as a function of time that the catheter has been exposed to air in the HFT (see above). The drying time is the point in time where the friction reaches a value of 20 g or higher, or in a more severe tester 15 g or higher as measured at a temperature of 22 ° C and 35% relative humidity. Within the context of the invention, the term polymer is used by a molecule comprising two or more repeating units. In particular, it may be composed of two or more monomers which may be the same or different. As used herein, the term includes oligomers and prepolymers. Usually, the polymers have a molecular weight number (Mn) of about 500 g / mol or more, in particular, of about 1000 g / mol or more, although the Mn may be lower in the case that the copolymer is composed of relatively small monomer units. Here and later, the Mn is defined as the Mn determined by the scattering of light. Within the context of the invention, a polyelectrolyte is understood to be a cross-linked or branched polymer, linear, of high molecular weight, composed of macromolecules comprising constitutional units in which, between 5 and 100% of the constitutional units contain ionized groups when the polyelectrolyte is in the lubricious coating. Here, a constitutional unit is understood to be, for example, a repeating unit, for example a monomer. A polyelectrolyte here can refer to a type of electrolyte composed of one type of macromolecule, but can also refer to two or more different types of polyelectrolytes composed of different types of macromolecules. Considerations when selecting a suitable polyelectrolyte, are its solubility and viscosity in an aqueous medium, its molecular weight, its charge density, its affinity with the support network of the coating and its biocompatibility. Here, biocompatibility means biological compatibility without producing a toxic, harmful or immunological response in living mammalian tissue. For a reduced migration capacity, the polyelectrolyte is preferably a polymer having a weight average molecular weight of at least about 1000 g / mol, as can be determined by light scattering, optionally in combination with size exclusion chromatography. A polyelectrolyte of relatively high molecular weight is preferred to increase the drying time and / or reduced migration of the coating. The weight average molecular weight of the polyelectrolyte is preferably at least 20,000 g / mol, more preferably at least 100,000 g / mol, even more preferably at least about 150,000 g / mol, in particular about 200.00 g / mol or more. For ease of coating application, it is preferred that the average molecular weight is 1000,000 g / mol or less, in particular, 500,000 g / mol or less, more in particular 300,000 g / mol or less. Examples of ionized groups that may be present in the polyelectrolyte are ammonium groups, phosphonium groups, sulfonium groups, carboxylate groups, sulfate, sulfinic groups, sulfonic groups, phosphate groups, and phosphonic groups. Such groups are very effective in water binding. In one embodiment of the invention, the polyelectrolyte also comprises metal ions. Metal ions when dissolved in water, are formed into complexes with water molecules to form water ions [M (H20) x] n +, where x is the coordination number and n the metal ion charge, and they are both, particularly efficient in the water link. Metal ions that may be present in the polyelectrolyte are, for example, alkali metal ions, such as Na +, Li + or K + ions, or alkaline earth metals, such as Ca 2+ and Mg 2+. In particular, when the polyelectrolyte comprises salts of quaternary amine, for example, quaternary ammonium groups, anions may be present. Such anions can, for example, be halides, such as Cl ", Br", I "and F", and also sulphates, nitrates, carbonates and phosphates. Suitable polyelectrolytes are, for example, salts of homo and co-polymers of acrylic acid, salts of homo and co-polymers of methacrylic acid, salts of homo and co-polymers of maleic acid, salts of homo and co-polymers of fumaric acid , homo salts and co-polymers of monomers comprising sulfonic acid groups, homo and co-polymers of monomers comprising ammonium salts quaternary and mixtures and / or derivatives thereof. Examples of suitable polyelectrolytes are poly (acrylamide-co-acrylic acid) salts, for example, sodium salt of poly (acrylamide-co-acrylic acid), poly (acrylamide-co-methacrylic acid) salts, for example, sodium salt of poly (acrylamide-co-methacrylic acid), poly (methacrylamide-co-acrylic acid) salts, for example, sodium salt of poly (methacrylamide-co-acrylic acid), poly (methacrylamide-co-methacrylic acid) salts , for example, sodium salt of poly (methacrylamide-co-methacrylic acid), poly (acrylic acid) salts, for example, sodium salt of poly (acrylic acid), salts of poly (methacrylic acid), example, sodium salt of poly (methacrylic acid), salts of poly (acrylic acid-co-maleic acid), for example, sodium salt of poly (acrylic acid-co-maleic acid), salts of poly (methacrylic acid-co-acid) -maleic), for example, sodium salt of poly (methacrylic acid-co-maleic acid), poly (acrylic) salts aida-co-maleic acid), for example, sodium salt of poly (acrylamide-co-maleic acid), poly (methacrylamide-co-maleic acid) salts, for example, sodium salt of poly (methacrylamide-co-maleic acid) ), poly (acrylamido-2-methyl-l-propanesulfonic acid) salts, salts of poly (4-styrene sulfonic acid), poly (acrylamide-co-dialkylammonium chloride), poly [bis- (2-chloroethyl) - ether-alt-1, 3- [quaternized bis [3- (dimethylamino) propyl] urea], polyallylammonium phosphate, poly (diaryldimethylammonium chloride), poly (trimethyleneoxyethylene sodium sulfonate), poly (dimethyldodecyl (2-acrylamidoethyl) ammonium bromide), poly (iodine 2-) N-methylpyridinomethylene), polyvinylsulfonic acids and salts of poly (vinyl) pyridines, polyethylene imines and polylysines. Particularly suitable polyelectrolytes for use in the present invention are copolymer polyelectrolytes, wherein said copolymer polyelectrolyte is a copolymer comprising at least two different types of constitutional units, wherein at least one type of constitutional units comprises ionizable or ionized groups and at least one a type of constitutional units is absent of ionizable or ionized groups. Ionizable is meant to be ionizable in neutral aqueous solutions, ie, solutions having a pH between 6 and 8. Said copolymer polyelectrolyte may be a block or random copolymer. In general, between 5 and 99% by weight, preferably between 50 and 90% by weight, more preferably between 70 and 85% by weight of the constitutional units comprise ionizable or ionized groups. In the lubricious coating, that is, after wetting the hydrophilic coating, said ionizable groups can be ionized or non-ionized. Typically between 1 and 100% by weight of the total amount of ionized and ionizable groups are ionized when the copolymer polyelectrolyte is in the lubricious coating, preferably between 30 and 100% by weight, more preferably between 50 and 100% by weight, in particular between 60 and 100% by weight. Examples of constitutional units comprising ionizable groups are constitutional units comprising carboxylic acid groups, for example, acrylic acid, methacrylic acid, maleic acid, and formic acid; sulfonic acid groups; sulfinic acid groups; and phosphonic acid groups. Examples of constitutional units comprising ionized groups are constitutional units comprising salts of the ionizable groups mentioned above, ie carboxylate groups, sulfonium groups, sulfinic groups, sulfate groups, phosphate groups, phosphonic groups and phosphonium groups and quaternary ammonium salts. Examples of constitutional units that do not comprise ionizable groups are acrylamide, methacrylamide, vinyl alcohol, methacrylate, methyl methacrylate, vinylpyrrolidone and vinylcaprolactam.

Examples of said copolymer polyelectrolytes are poly (acrylamide-co-acrylic acid) salts, poly (acrylamide-co-methacrylic acid) salts, poly (methacrylamide-co-acrylic acid) salts, poly (methacrylamide-co-acid) salts. methacrylic), poly (acrylamide-co-maleic acid) salts, poly (methacrylamide-co-maleic acid) salts, and poly (acrylamide-co-dialkylammonium chloride). Salts of poly (acrylamide-co-acrylic acid), for example, the sodium salt, have been found particularly suitable for obtaining high lubricity and drying time. The use of copolymer polyelectrolytes comprising both constitutional units or ionizable or ionized groups and constitutional units absent from ionizable or ionized groups, has several advantages. Usually, such polyelectrolytes characterize superior solubility to particular solvents and less tendency to crystallize when used in the cured hydrophilic coating. A nonionic hydrophilic polymer is understood to be a linear, high molecular weight, crosslinked or branched polymer, composed of macromolecules comprising constitutional units, wherein, less than 5, preferably less than 2% of the constitutional units contain ionized groups when he Non-ionic hydrophilic polymer is in the lubricious coating. The nonionic hydrophilic polymer is capable of providing hydrophilicity to a coating and can be synthetic or bio-derived and can be mixtures or copolymers of both. Nonionic hydrophilic polymers include, but are not limited to, poly (lactams), for example, polyvinylpyrrolidone (PVP), polyurethanes, homo and copolymers of acrylic and methacrylic acid, polyvinyl alcohol, polyvinyl ethers, copolymers based on maleic anhydride, polyesters, vinylamines, polyethyleneimines, polyethylene oxides, polycarboxylic acids, polyamides, polyanhydrides, polyphosphazenes, cellulosics for example, methylcellulose, carboxymethylcellulose, hydroxymethylcellulose and hydroxypropylcellulose, heparin, dextran, polypeptides, for example, collagen, fibrins and elastin, polysaccharides of eg chitosan , hyaluronic acid, alginates, gelatin and chitin, polyesters of for example, polylactides, polyglycolides and polycaprolactones, polypeptides of for example, collagen, oligopeptides albumin, polypeptides, short chain peptides, proteins and oligonucleotides. It has been found that the adhesion between the primer layer and the surface of the article and / or the primer layer and the outer layer, is improved with weight increased molecular weight of the functional nonionic hydrophilic polymer. Accordingly, the weight average molecular weight of the functional nonionic hydrophilic polymer, as determined by being considered by light scattering, optionally in combination with size exclusion chromatography, is usually at least 20,000 g / mol, in particular at least 55,000 g / mol, preferably at least 250,000 g / mol, in particular , at least 360,000 g / mol, more preferably at least 500,000 g / mol, in particular at least 750,000 g / mol. For practical reasons (ease of application and / or ease of making uniform coating thickness), the weight average molecular weight (Mw) is usually up to 10 million, preferably up to 5 million g / mol, more preferably up to 3 million g. / mol, more preferably up to 2 million g / mol, in particular, up to 1.5 million g / mol, more in particular, up to 1.3 million g / mol, even more in particular, up to 1 million g / mol. In particular, polyvinylpyrrolidone (PVP) and polyethylene oxide (PEO), having a Mw of at least 100000 g / mol, have been found to have a particular positive effect on lubricity and a low tendency to migrate out of the coating. In particular, for polyvinylpyrrolidone (PVP) and polymers of the same class, a polymer having a molecular weight corresponding to at least K15, more in particular K30, even more particularly K80, are preferred. Particular good results have been achieved with a polymer having a corresponding molecular weight of at least K90. With respect to the upper limit, a K120 or less, in particular a K100, is preferred. The value K is the value as determined by Method W1307, Revision 5/2001 of the automated relative viscometer Victotek Y501. This manual can be found at www. ispcorp. com / products / hairscin / index 3. html DETAILED DESCRIPTION OF THE INVENTION The invention relates to a hydrophilic coating formulation comprising a polyelectrolyte and a nonionic hydrophilic polymer, which when applied to a substrate and cured, results in a hydrophilic coating. Here, a hydrophilic coating formulation refers to a liquid hydrophilic coating formulation, for example, a solution or a dispensing comprising a liquid medium. Here, any liquid medium that allows the application of the hydrophilic coating formulation on one surface may be sufficient. Examples of liquid media are alcohols such as methanol, ethanol, propanal, butanol or respective isomers and aqueous mixtures thereof or acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane, toluene and aqueous mixtures or emulsions thereof. The hydrophilic coating formulation further comprises components which when cured, are converted to hydrophilic coating, and thus, remain in the hydrophilic coating after curing. Here, curing is understood to refer to hardening or physical or chemical solidification by any method, for example, heating, cooling, drying, crystallization or curing, as a result of a chemical reaction, such as radiation healing or heat curing. In the cured state, all or parts of the components in the hydrophilic coating formulation can be crosslinked by forming covalent bonds between all or part of the components, for example, using UV or electron beam radiation. However, in the cured state, all or part of the components can also be ionically bound, bound by dipole-dipole-type interactions, or linked via Van der aals or hydrogen bonds. The term "to cure" includes any form of treatment of the formulation such that it forms a firm or solid coating. In particular, the term includes a treatment by means of which the hydrophilic polymer in addition to polymerase, is provided with grafts such that it forms a graft polymer and / or is crosslinked, such that it forms a crosslinked polymer. The hydrophilic coating composition according to the invention typically comprises 1-90% by weight, preferably 3-50% by weight, more preferably 5-30% by weight, in particular, 10-20% by weight of polyelectrolyte based on the total weight of the drying coating. The nonionic hydrophilic polymer can be used in more than 1% by weight of the hydrophilic coating formulation, for example, more than 10% by weight, more than 20% by weight or more than 30% by weight, based on the total weight of the dry coating. The nonionic hydrophilic polymer may be present in the hydrophilic coating formulation up to 95% by weight, however, more often, the nonionic hydrophilic polymer will be used up to 50, 60, 70 or 80% by weight, based on the weight total dry coating. Hereinafter, all the percentages of components given in the application are based on the total weight of the dry coating, i.e. the hydrophilic coating formed after the cure of the hydrophilic coating composition. The invention also relates to a hydrophilic coating obtainable by applying the hydrophilic coating formulation according to the invention, to a substrate and cure it. The invention furthermore relates to a lubricious coating obtainable by applying a wetted fluid to said hydrophilic coating, and to the use of a polyelectrolyte and a nonionic hydrophilic polymer in a lubricious coating, to improve its drying time. Furthermore, the invention relates to an article, in particular, a medical device or a medical device component comprising at least one hydrophilic coating according to the invention and to a method for forming on a substrate, the hydrophilic coating in accordance with the invention. In one embodiment of the invention, the hydrophilic coating comprises the polyelectrolyte and the nonionic hydrophilic polymer. Said hydrophilic coating is formed by curing a hydrophilic coating formulation comprising the polyelectrolyte and the nonionic hydrophilic polymer. Preferably, the polyelectrolyte and the nonionic hydrophilic polymer are covalently and / or physically bonded together and / or trapped to form a polymer network after curing. In another embodiment of the invention, the hydrophilic coating comprises the polyelectrolyte, the nonionic hydrophilic polymer and a support network, the which can be a hydrophilic support network, and which is formed from a support monomer or polymer. Here, the support monomer or polymer, other than comprising a plurality of reactive portions capable of undergoing crosslinking reactions as described below, may also contain hydrophilic functional groups. Said hydrophilic coatings are formed by curing a hydrophilic coating formulation comprising the polyelectrolyte, the nonionic hydrophilic polymer and the support monomer or polymer. Preferably, the polyelectrolyte and / or the nonionic hydrophilic polymer and / or the hydrophilic support network are covalently bound and / or physically bonded together and / or trapped to form a polymer network upon cure. These embodiments, wherein the polyelectrolyte and / or the nonionic hydrophilic polymer and / or the support monomer or polymer are covalently and / or physically bound in the hydrophilic coating as part of a polymer network, are particularly preferred, since they have the advantage that the polyelectrolyte and the non-ionic hydrophilic polymer will not escape in the environment of the hydrophilic coating, for example, when coated on a medical device. This is particularly useful when the medical device is inside the human or animal body.

In the hydrophilic coating formulation, which is used to produce said hydrophilic coating, the weight ratio of nonionic hydrophilic polymer to monomer or support polymer may for example vary between 10:90 or 90:10, such as between 27 : 75 and 75:25 or such as between 60:40 and 40:60. A support network can be formed after the curing of a support monomer or polymer or any combination of support monomers and polymers comprising a plurality of reactive portions capable of undergoing crosslinking reactions, which may be present in the Hydrophilic coating formulation. The reactive portion of the support monomer or polymer can be selected from the group consisting of radically reactive groups, such as alkenes, amino, amido, sulfhydryl (SH), ether esters and unsaturated amides, and acid / dry resins. The support monomer or polymer may have a structure and at least one of the reactive portions mentioned above. The structure of the support polymer can be selected from the group consisting of polyethers, polyurethanes, polyethylenes, polypropylenes, polyvinyl chlorides, polyepoxides, polyamides, polyacrylamides, poly (meth) acrylics, polyoxazolidones, polyvinyl alcohols, polyethyleneimines, polyesters as polyorthoesters and alkyd copolymers, polypeptides or polysaccharides, such as cellulose and starch or any combination of the foregoing. In particular, a support monomer, polymers with unsaturated esters, amides or ethers, thiol or mercaptan groups can also be suitably used in the invention. As used herein, the term "carrier monomer" refers to molecules with a molecular weight of less than about 1000 g / mol, and the term "carrier polymer" is used for molecules with a molecular weight of about 1000 g / mol or more . In general, the monomer or support polymer has a molecular weight in the range of about 500 to about 100,000 g / mol, and preferably, it is a polymer with a molecular weight in the range of about 1,000 to about 10,000 g / mol. Particularly, good results are obtained with a support polymer in the range of from about 1,000 to about 6,000 g / mol. The number of reactive groups per molecule of the support monomer or polymer is preferably in the range of about 1.2 to about 64, more preferably, in the range of about 1.2 to about 16, more preferably, in the range of about 1.2 to about 8. .

The monomer or support polymer can be used in more than 0% by weight, based on the total weight of the dry coating, eg, more than 10%, more than 20% by weight, more than 30% by weight or more of 40% by weight. The monomer or support polymer may be present in the hydrophilic coating formulation up to 90% by weight, however, more often, the monomer or support polymer will be used up to 50 or 60% by weight, based on the total weight of the dry coating. The hydrophilic coating formulation according to the invention can be, for example, cured using visible or UV light, electron beam, plasma, gamma or IR radiation, optionally in the presence of a photo initiator or thermal initiator, to form the coating hydrophilic Examples of photoinitiators that can be used in the hydrophilic coating are free radical photoinitiators, which in general, are divided into two classes in accordance with the processes by which the initiating radicals are formed. Compounds that undergo unimolecular bond cleavage after irradiation are called Norrish Type I or homolytic photoinitiators. A Norrish Type II photoinitiator interacts with a second molecule, that is, a synergist, which can be a low molecular weight compound of a polymer, in an excited state generate radicals in a biomolecular reaction. In general, the two main reaction paths for Norrish Type II photoinitiators, are hydrogen abstraction by the excited initiator or photoinduced electron transfer. Examples of suitable free radical photoinitiators are described in WO 00/18696 and are incorporated herein by reference. Preferred are photoinitiators that are soluble in water or can be adjusted to become water soluble, also preferred are polymeric photoinitiators or polymerizable photoinitiators. In one embodiment of the invention, the polyelectrolyte is present in a wetted fluid and is introduced into the hydrophilic coating when the hydrophilic coating is wetted. This is particularly useful for medical devices with a hydrophilic coating, which are packaged in a fluid, or wherein the hydrophilic coating is moistened in a separate wetting fluid containing the polyelectrolyte. The invention therefore also relates to coating systems for preparing a lubricious coating, said coating system comprising a coating formulation comprising a nonionic hydrophilic polymer and a wetting fluid comprising a polyelectrolyte. However, the invention is refers to a coating system for preparing a lubicose coating, said coating system comprises a coating formulation according to the invention and a humectant fluid comprises a polyelectrolyte. In one embodiment of the invention, the hydrophilic coating formulation according to the invention further comprises at least one surfactant, which can improve the surface properties of the coating. Surfactants constitute the most important group of detergent components. In general, these water-soluble surface active agents comprise a hydrophobic portion, usually a long-chain alkyl, linked to functional groups that improve solubility or hydrophilicity in water. Surfactants can be categorized in accordance with the charge present in the hydrophilic portion of the molecule (after dissociation in aqueous solution): ionic surfactants, for example, ammonium or cationic surfactants and nonionic surfactants. Examples of ionic surfactants include sodium dodecyl sulfate (SDS), sodium cholate, salt of bis (2-ethexyl) sodium sulfosuccinate, cetplmethylammonium bromide (C ), lauryldimethylamine oxide (LDAO), N-lauroyl sarcosine salt Sodium and sodium deoxycholate (DOC). Examples of nonionic surfactants include, alkyl polyglucosides such as TRITON ™ BG-10 surfactant and TRITON CG-100 surfactant, branched secondary alcohol ethoxylates, such as TERGITOL ™ TMN Series, ethylene oxide / propylene oxide copolymers such as, TERGITOL L and TERGITOL XD series surfactants, XH and XJ, nonylphenol ethoxylates such as TERGITOL NO series, octylphenol ethoxylates, such as TRITON X series, secondary alcohol ethoxylates, such as TERGITOL 15-S series and alkoxylated specialties, such as surfactant TRITON CA, surfactant TRITON N- 57, surfactant TRITON X-207, Tween 80 and Tween 20. Typically, 0.001 to 1% by weight of surfactant is applied, preferably 0.05-0.5% by weight, based on the total weight of the dry coating. In one embodiment of the invention, the hydrophilic coating formulation according to the invention, further comprises at least one plasticizing agent, which can improve the flexibility of the coating, which may be preferable when the object to be coated is probably bent. during use. Said plasticizing agent may be included in the coating formulation in a concentration from about 0.01% by weight to about 15% by weight, based on the total weight of the dried coating, preferably from about 1% by weight to about 5.0% by weight. Suitable plasticizers are high boiling compounds, preferably with a boiling point at atmospheric pressure of > 200 ° C, and with a tendency to remain homogeneously dissolved and / or dispersed in the coating after curing. Examples of suitable plasticizers are mono and polyalcohols and polyethers, such as decanol, glycerol, ethylene glycol, diethylene glycol, polyethylene glycol, and / or copolymers with propylene glycol and / or fatty acids. The invention also relates to a lubricious coating having an initial lubricity measured in a Harland FTS Friction Tester of 20 g or less. The hydrophilic coating according to the invention can be coated on an article. The hydrophilic coating can be coated on a substrate which can be selected from a range of geometries and materials. The substrate may have a texture, such as porous, non-porous, smooth, rough, uniform or uneven. The substrate supports the hydrophilic coating on its surface. The hydrophilic coating can be in all areas of the substrate or in selected areas. The hydrophilic coating can be applied to a variety of physical forms including films, sheets, rods, tubes, molded parts (regular or irregular shape), fibers, fabrics and particulates. Surfaces suitable for use in the invention are surfaces that provide the desired properties such as porosity, hydrophobicity, hydrophilicity, colorability, strength, flexibility, permeability, abrasion resistance of elongation and tear resistance. Examples of suitable surfaces are, for example, surfaces consisting of or comprising metals, plastics, ceramics, glass and / or compounds. The hydrophilic coating can be applied directly to said surfaces or it can be applied to a coated or pre-treated surface, wherein the pretreatment or coating is designed to assist in the adhesion of the hydrophilic coating to the substrate. In one embodiment of the invention, the hydrophilic coating according to the invention is coated on a biomedical substrate. A biomedical substrate refers, in part, to the fields of medicine, and the study of cells and living systems. These fields include diagnosis, therapeutic and experimental human medicine, veterinary medicine and agriculture. Examples of medical fields include ophthalmology, orthopedics and prosthetics, immunology, dermatology, pharmacology and surgery; Non-limiting examples of search fields include, cell biology, microbiology, and chemistry. He "biomedical" term also refers to chemicals and chemical compositions, with respect to their source, which (i) mediate a biological response in vivo, (ii) are active in an in vitro assay or another model, eg, a immunological or pharmacological assay, or (iii) can be found inside a cell or organism. The term "biomedical" also refers to separation sciences, such as those involving chromatography, osmosis, reverse osmosis, and filtration processes. Examples of biomedical items include diagnostic tools, industrial applications and consumers. Biomedical items include, separation items, implantable items and ophthalmic items. Ophthalmic articles include soft and hard contacts, infraocular lenses and pliers, retractors or other surgical tools that contact the surrounding eye or tissue. A preferred biomedical article is a soft contact lens made of a silicon-containing hydrogel polymer, which is highly permeable to oxygen. Separation articles include, filters, osmosis and reverse osmosis membranes and dialysis membranes, as well as bio-surfaces such as artificial skins or other membranes. Implantable items include artificial catheters and segments of bone, joints or cartilage. An item can be in one or more Categories, for example, an artificial skin is a porous, biomedical article. Examples of cell culture articles are glass beakers, plastic petri dishes and other implements used in tissue cell culture or cell culture processes. A preferred example of a cell culture article is a bioreactor microcarrier, a silicon polymer matrix used in immobilized cell bioreactors, wherein the geometry, porosity and density of the particulate microcarrier can be controlled to optimize the operation . Ideally, the micro-carrier is resistant to chemical or biological degradation, high-impact stress, mechanical stress (agitation), and repeated steam or chemical sterilization. In addition to silicon polymers, other materials may also be suitable. This invention can also be applied in the food industry, the paper printing industry, hospital supplies, diapers and other coatings, and other areas where hydrophilic, wettable or drainage articles are desired. The medical device can be an implantable device or an extracorporeal device. The devices can be of short-term temporary use or long-term permanent implantation. In certain modalities, suitable devices are those that are typically used to provide medical therapy and / or diagnostics in heart rhythm disorders, heart failure, valve disease, vascular disease, diabetes, neurological and orthopedic diseases and disorders, neurosurgery, oncology, ophthalmology and ENT surgery. Suitable examples of medical devices include, but are not limited to, stent graft, stent graft, anastomotic connector, synthetic patch, lead, electrode, needle, guidewire, catheter, sensor, surgical instrument, angioplasty balloon, wound drainage , derivations, tubing, infusion magi, urethral insert, pellet, implant, blood oxygenator, pump, vascular graft, vascular access port, heart valve, annuloplasty ring, suture, surgical fasteners, surgical staples, trainers, implantable defibrillators, neurostimulators, orthopedic devices, cerebrospinal fluid derivations, implantable drug pump, spinal cage, artificial disc, replacement device for nucleus pulposus, auricular tube, infraocular lenses and any tubing used in minimally invasive surgery. Articles that are particularly suitable for use in the present invention include, medical devices or components, such as catheters, for example, Intermittent catheters, guide wires, stent, syringes, metal and plastic implants, contact lenses and medical tubing. The hydrophilic coating formulation can be applied to the substrate for example, dip coating. Other methods of application include, atomization, washing, vapor deposition, brushing, roller and other methods known in the art. The concentration of ionic or ionizable groups in the hydrophilic coating and the thickness of the hydrophilic coating according to the invention can be controlled by altering the type of polyelectrolyte, concentration of polyelectrolyte in the hydrophilic coating formulation, soaking time, extraction speed, viscosity of the hydrophilic coating formulation and the number of coating steps. Typically, the thickness of a hydrophilic coating on a substrate ranges from 0.1-300 μm, preferably 0.5-100 μm, more preferably, 1-30 μm. The invention further relates to a method of forming on a substrate, a hydrophilic coating which has a low coefficient of friction when moistened with a water-based liquid, wherein said hydrophilic coating comprises a polyelectrolyte.

To apply the hydrophilic coating on the substrate, a primer coating may be used to provide a bond between the hydrophilic coating and the substrate. The primer coating is often referred to as the primary coating, base coat or ligation coating. Said primer coating is a coating that facilitates the adhesion of the hydrophilic coating to a given substrate, as described in for example WO02 / 10059. The bond between the primer coating and the hydrophilic coating can occur due to covalent or ionic bonds, hydrogen bonding, fisisorption or polymer entanglements. These primer coatings may be solvent based, water based (latexes or emulsions) or solvent free and may comprise linear, branched and / or crosslinked components. Typical primer coatings that could be used comprise, for example, polyether sulfones, polyurethanes, polyesters, including polyacrylates, as described in example US6,287,285, polyamides, polyethers, polyolefins and copolymers of the aforementioned polymers. In particular, the primer coating comprises a support polymer network, the support network optionally comprises a functional hydrophilic polymer. entangled in the polymeric support network as described in WO06 / 056482 Al. The information regarding the formulation of the primer coating is hereby incorporated by reference herein. A primer layer as described above is in particular used to improve the adhesion of a coating comprising a hydrophilic polymer such as a polylactam, in particular PVP and / or other hydrophilic polymers identified above, in particular in polyvinylchloride ( PVC), silicone, polyamide, polyester, polyolefin, such as polyethylene, polypropylene and ethylene-propylene rubber (e.g., EPDM), or a surface having approximately the same or lower hydrophilicity. In one embodiment, the surface of the article is subjected to oxidative, photo-oxidative and / or polarizing surface treatment, for example, plasma and / or corona treatment, to improve the adhesion of the coating which is provided. Suitable conditions are known in the art. The application of the formulation of the invention can be done in any way. The cure conditions can be determined, based on known cure conditions for the photoinitiator and polymer or routinely determined.

In general, the cure can be carried out at any suitable temperature depending on the substrate, as soon as the mechanical properties or other properties of the article are not adversely affected to an unacceptable extent. The intensity and wavelength of the electromagnetic radiation can be routinely chosen based on the photoinitiator of choice. In particular, a suitable wavelength in the UV, visible or IR spectrum, or part, can be used. The invention will also be illustrated by the following examples.

EXAMPLES In the following examples, hydrophilic coating formulations according to the invention and comparative coating formulations have been applied to PVC pipes, as described below, and subsequently cured to form hydrophilic coatings according to the invention.

PVC male catheters PVC uncoated pipes are coated with a hydrophilic coating. The PVC pipe has a length of 23 cm, an external diameter of 4.5 mm (14 Fr), and an inner diameter of 3 mm. The pipes are sealed on one side to prevent the coating formulation from reaching the inside of the pipe during the dive.

Synthesis of PTGL1000 (TH) 2 In an inert dry atmosphere, toluene diisocyanate (TDI or T, Aldrich, 95% pure, 87.1 g, 0.5 mol), Irganox 1035 (Ciba Specialty Chemicals, 0.58 g, 1 wt. ratio to hydroxy ethyl acrylate (HEA or H) and tin (II) 2-ethyl hexanoate (Sigma, 95% purity, 0.2 g, 0.5 mol) were placed in a 1 liter flask and stirred for 30 minutes, then from which the ice bath was removed and the mixture was allowed to warm to room temperature.After 3 hours, the reaction was complete, Poly (2-methyl-1,4-butanediol) -alpha-poly (tetramethylene glycol) was added dropwise. ) (PTGL, Hodogaya, Mn = 1000 g / mol, 250 g, 0.25 mmol) in 30 minutes Subsequently, the reaction mixture was heated to 60 ° C and stirred for 18 hours, until the reaction was complete as described. indicated by GPC (showing complete consumption of HEA), IR (does not exhibit NCO related bands) and NCO titration (low NCO content 0.02%).

Primer coating formulation (used in Examples 1-6 and Comparative Examples A-D PTGL 1000 (T-H) 2: 4.25% (w / w) Polyvinylpyrrolidone (1.3 M, Aldrich) (PVP): 0.75% (w / w) Irgacure 2959 (Aldrich): 0.20% (w / w) Ethanol (Merck pa): 94.8% (w / w) Primer coating formulation (used in Example 7) PTGL 1000 (T-H) 2: 4.50% (w / w) Polyvinylpyrrolidone (1.3 M Aldrich) (PVP): 0.50% (w / w) Irgacure 2959 (Aldrich): 0.20% (p / p) Ethanol (Merck pa): 94.8% (w / w) Example 1: Hydrophilic coating formulation Polyethylene glycol diacrylate (PEG4000DA): 5% (w / w) Polyethylene oxide with Mn = 200,000 g / mol PEO 200K (Aldrich): 3.75% (w / w) Partial sodium salt of Poly (acrylamide-co-acrylic acid): 1.25% (w / w) (14.5% in p Na +), 20% p in Acrylamide (PAcA) (Aldrich): 1.25% (w / w) Irgacure 2959: 0.1% (w / w) Tween 80 (surfactant) (Mecrk): 0.01% (w / w) Distilled water: 44.94% (w / w) Methanol (Merck pa): 44.95% (w / w) Example 2. Formulation of hydrophilic coating PEG4000DA: 5% (w / w) PEO 200K: 3.75% (w / w) PAcA: 1.25% (p / p) Irgacure 2959: 0.1% (w / w) Distilled water: 44.95% (w / w) Methanol: 44.95% (w / w) Example 3. Hydrophilic coating formulation PVP: 5% (w / w) PAcA: 1.25% (p / p) Benzophenone: 0.1% (w / w) Distilled water: 46.83% (w / w) Methanol: 46.83% (w / w) Example 4. Formulation of hydrophilic coating PEG4000DA: 5% (w / w) PEO 200K: 3.75% (w / w) Sodium salt of poly (acrylic acid) (Sigma-Aldrich, average Pm 30,000): 1.25% (p / p) p) Irgacure 2959: 0.1% (w / w) Distilled water: 44.95% (w / w) Methanol: 44.95% (w / w) Example 5. Formulation of hydrophilic coating PEG4000DA: 5% (w / w) PEO 200K: 3.75% (w / w) Sodium salt of polyacrylic acid-co-maleic acid (Sigma-aldrich, average Pm 70,000): l-25% (w / w) Irgacure 2959: 0.1% (w / w) Distilled water: 44.95% (w / w) Methanol: 44.95% (w / w) Comparative Experiment A. Coating formulation PEG4000DA: 5% (p / p) PEO 200K: 5% (p / p) Irgacure 2959: 0.1% (w / w) Distilled water: 44.95% (w / w) Methanol: 44.95% (w / w) Comparative Example B. PVP coating formulation: 5% (w / w) Benzophenone: 0.1% (w / w) Distilled Water: 47.45% (p / p) Methanol: 47.45% (w / w) Example 6. Formulation of hydrophilic coating PEG4000DA: 2% (w / w) PVP: 1.33% (p / p) PAcA: 0.67% (p / p) Irgacure 2959: 0.04% (w / w) Tween 80: 0.04% (w / w) Distilled water: 47.95% (w / w) Methanol: 47.96% (w / w) Comparative Experiment C. Hydrophilic coating formulation PEG4000DA: 2% (w / w) PVP: 2% (p / p) Irgacure 2959: 0.04% (w / w) Tween 80: 0.04% (w / w) Distilled water: 47.96% (w / w) Methanol: 47.96% (w / w) Comparative Experiment D. Hydrophilic coating formulation PEG4000DA: 2% (w / w) PAcA: 2% (w / w) Irgacure 2959: 0.04% (w / w) Tween 80: 0.04% (w / w) Distilled water: 47.96% (w / w) Methanol: 47.96% (w / w) Example 7. Hydrophilic coating formulation comprising glycerol PVP: 5.50% on p PAcA: 0.75% in p Benzophenone: 0.12% in p Glycerol: 0.30% on p Distilled water: 46.67% in p Methanol: 6.67% in p All the ingredients are commercially obtained. The coating obtained after curing the formulation of Example 7 is found to be lubricious, to have a good drying time and to adhere sufficiently to the PVC catheter, also after gamma sterilization.

No fractures visible to the naked eye are observed.

Synthesis of PEG4000DA 150 g (75 mmol OH) of polyethylene glycol (PEG, Biochemika Ultra of Fluka, OH value 28.2 mg KOH / g, 499.5 μg / kg, Mn = 40004 g / mol), dissolved in 350 ml of toluene dry at 45 ° C under nitrogen atmosphere. 0.2 g (0.15% by weight) of Irganox 1035 was added as a radical stabilizer. The resulting solution was azeotropically distilled overnight (50 ° C, 70 mbar), leading to toluene condensed on sieves of 4Á mol. For each batch of PEG, the OH value was exactly determined by OH trituration, which was carried out in accordance with the method described in the 4th. Edition of the European Pharmacopeia, paragraph 2.5.3, Hydroxyl Valué, page 105. This is made possible to calculate the amount of acryloyl chloride to be added and determine the degree of acrylate esterification during the reaction. 9.1 g (90 mmol) of triethylamine was added to the reaction mixture, followed by a dropwise addition of 8.15 g (90 mmol) of acryloyl chloride dissolved in 50 ml of toluene in 1 hour. Triethylamine and acryloyl were colorless liquids. The reaction mixture was stirred for 2 to 4 hours at 45 ° C under nitrogen atmosphere. During the reaction, the temperature was maintained at 45 ° C to prevent the crystallization of PEG. To determine the conversion, a sample was extracted from the reaction mixture, dried and dissolved in deuterated chloroform. Trifluoroacetic anhydride (TFAA) was added and a spectrum of 1 H NMR was recorded. The TFAA reacts with any of the remaining hydroxyl groups to form a trifluoroacetic ester, which can be easily detected using 1 NMR spectroscopy (the triplet signal of the methylene protons in the OI position of the trifluoroacetic acid group (g, 4.45 ppm), can be clearly distinguished from the signal of the groups of methylene at the a position of the acrylate ester (d, 4.3 ppm)). When the degree of acrylate esterification is 98%, an additional 10 mmol of acryloyl chloride and triethylamine is added to the reaction mixture, allowing it to react for 1 hour. To a degree of acrylate esterification > 98%, the hot solution is filtered to remove the triethylamine hydrochloride salts. Approximately 300 ml of toluene are removed under vacuum (50 ° C, 20 mbar). The remaining solution is kept at 45 ° C in a heated drip funnel and 1 liter of diethyl ether (cooled in an ice bath) is added dropwise. The ether suspension is cooled for 1 hour before the PEG diacrylate product is obtained by filtration. The product is dried overnight at room temperature under reduced pressure to air atmosphere (300 mbar). Performance: 80-90% as white crystals.

Coating and curing process for Examples 1-7 and Comparative Experiments AD PVC pipes were first coated by immersion with the primer coating formulation, and cured using a Harland PCX / 175/24 coater, in accordance with the dip for the primer coating in Table 2.

Subsequently, the hydrophilic coating formulation was applied and cured using a Harland PCX / 175/24 coater, in accordance with the dip protocol for the hydrophilic coating. The Harland PCX / 175/24 coater was equipped with a UV 400 lamp from Harland Medical Systems. The intensity of the Harland PCX / 175/24 coater lamps was on average 60 mW / cm2 and was measured using a Solatell Sola 1 sensor, equipped with an International Light detector SED005 # 989, Optical input: W # 11521, filter: bs320 # 27794. The IL1400A international light instruction manual was applied, which is available on the internet: www.intl-light.com. The UV dose was approximately 1.8 J / cm2 for the primer coating and 21.6 J / cm2 for the hydrophilic coating. For applied coating parameters see Table 1. Visual inspection of coated PVC pipes showed good wettability of the hydrophilic coating. A uniform coating was obtained.

Table 1. Coating parameters applied Test methods Lubricity tests The lubricity tests were performed on a Harland FTS5000 (HFT) friction tester. The protocol was selected: see Table 2 for the HFT settings. The friction tester pads were used from Harland Medical Systems, P / N 102692, Friction Tester Pads FTS5000, 0.125 * 0.5 ** 0.125, 60 durometers. Subsequently, the desired test description was inserted when the "run of the test" was achieved. After inserting a guide wire into the catheter, the catheter will be attached in the holder. The device was adjusted down to the desired position, so that the catheter was dipped in demineralized water for 1 min. After calibrating to zero in water, the protocol was activated by pressing "start". The data was saved after finishing. The bra was removed from the strength gauge and subsequently, the catheter was removed from the bra.

Table 2. HFT adjustments Drying time The drying time is here defined as the duration of the coating that remains lubricious after the device has been taken from the wetting fluid where it has been stored and / or moistened. The drying time can be determined by measuring the friction in grams as a function of time that the catheter has been exposed to air in the HFT (see above). The drying time is the point in time where the friction reaches a value of 20 g or more, or in a stricter tester of 15 g or more, as measured at a temperature of 22 ° C and 35% relative humidity. After inserting the guidewire into the coated PVC male catheter, the catheter is attached to the fastener. The catheter is wetted in demineralized water for 1 minute. The clamp with the catheter was placed in the force gauge and the device was trotted down to the desired position and the test was started immediately in accordance with the same settings for the lubricity test. Measurements were made after 1, 2, 5, 7.5, 10, 12.5 and 15 minutes. The friction tester pads were cleaned and dried after such measurement. The data was saved after finishing. The bra was removed from the strength gauge and subsequently, the catheter was removed from the bra. In Table 3, lubricity is provided as a time function of the lubricious coating prepared in accordance with Examples 1-5, as well as the results of Comparative Experiments A and B.

Table 3. Lubricity as a time function of the lubricious coating prepared in accordance with Examples 1-5 and Comparative Experiments A-B.

The table shows that the lubricity is significantly higher (i.e., the friction is low) for the lubricious coatings according to the invention (Examples 1-5), which comprise partial sodium salt of poly (acrylamide-co-acrylic acid), sodium salt of poly (acrylic acid) or sodium salt of poly (acrylic acid-co-maleic acid), which for the lubricious coatings of Comparative Experiments A and B, which do not comprise a polyelectrolyte. The lubricious coating according to the invention remains lubricious by a very long period in the drying test than the coatings of the comparative examples. In Table 4, the lubricity of the lubricious coatings prepared in accordance with Examples 6 and Comparative Experiments C and D is provided.

Table 4. Lubricity of the lubricious coating prepared according to Example 6 and Comparative Experiments C-D The Table shows that the coatings in accordance with Example 6 are more lubricious (ie, lower friction alloys), than the coatings in accordance with Comparative Experiment C, which involves a coating formulation comprising a nonionic hydrophilic polymer. , but not polyelectrolyte, or Example D, which involves a coating formulation comprising a polyelectrolyte, but not a nonionic hydrophilic polymer. The results of the lubricity measurements as a function of time (Table 3) and the measurements of lubricity, show that the combination of a polyelectrolyte and a non-ionic hydrophilic polymer, results in high lubricity and high drying time of the coating.

Claims (20)

1. NOVELTY OF THE INVENTION
2. Having described the present is considered as a novelty, and therefore, the content of the following is claimed as property:
3. CLAIMS 1. Hydrophilic coating formulation which when cured results in a hydrophilic coating, characterized in that the hydrophilic coating formulation comprises a polyelectrolyte and a nonionic hydrophilic polymer. 2. A coating formulation according to claim 1, characterized in that the polyelectrolyte is selected from the group consisting of homo- and co-polymer salts of acrylic acid, salts of homo- or co-polymers of methacrylic acid, salts of homo and co-polymer of maleic acid, homo- and co-polymer salts of fumaric acid, salts of homo- and co-polymers of monomers comprising sulfonic acid groups, homo- and co-polymers of monomers comprising salts of quaternary ammonium and mixtures and / or derivatives thereof. 3. Hydrophilic coating formulation according to claim 1 or claim 2, characterized in that the polyelectrolyte is a copolymer polyelectrolyte, wherein the copolymer polyelectrolyte is a copolymer comprising at least two different types of constitutional units, wherein at least one type of constitutional units comprises ionizable or ionized groups and at least one type of constitutional units is observed from ionizable or ionized groups .
4. 4. Hydrophilic coating formulation according to any of claims 1-3, characterized in that the polyelectrolyte is selected from the group consisting of poly (acrylamide-acid-co-acrylic) salts, poly (methacrylamide-acid-co) salts -acrylic), poly (acrylamide-co-methacrylic acid) salts, poly (methacrylamide-co-methacrylic acid) salts, poly (acrylamide-co-maleic acid) salts, poly (methacrylamide-acid) salts co-maleic), poly (acrylamide-co-dialkylammonium chloride) or poly (methacrylamide-co-dialkylammonium chloride).
5. 5. Hydrophilic coating formulation according to any of claims 1-4, characterized in that the nonionic hydrophilic polymer is selected from the group consisting of poly (lactams), for example polyvinylpyrrolidone (PVP), polyurethanes, homo- and copolymers of acrylic and methacrylic acid, polyvinyl alcohol, polyethers, maleic anhydride based copolymers, polyesters, vinylamines, polyethyleneimines, polyethylene oxides, polycarboxylic acids, polyamides, polyanhydrides, polyphosphazenes, cellulosics, for example methyl cellulose, carboxymethyl cellulose, hydroxymethyl cellulose and hydroxypropyl cellulose, heparin, dextran, polypeptides, for example collagens, fibrins and elastins , polysaccharides, for example chitosan, hyaluronic acid, alginates, gelatin and chitin, polyesters, for example polylactides, polyglycolides and polycaprolactones, polypeptides, for example, collagen, albumin, oligo peptides, polypeptides, short chain peptides, proteins and oligonucleotides.
6. 6. Hydrophilic coating formulation according to any of claims 1-5, characterized in that the hydrophilic coating formulation further comprises a monomer and / or support polymer, which comprises a plurality of reactive portions capable of undergoing crosslinking reactions.
7. 7. Hydrophilic coating formulation according to claim 6, characterized in that the monomer and / or support polymer is a monomer and / or hydrophilic support polymer.
8. 8. Hydrophilic coating formulation according to any of claims 1-7, characterized in that the coating formulation hydrophilic also comprises at least one surfactant.
9. 9. Hydrophilic coating formulation according to any of claims 1-8, characterized in that the hydrophilic coating formulation further comprises at least one plasticizer.
10. 10. Hydrophilic coating obtained by curing a hydrophilic coating formulation according to any of claims 1-9.
11. 11. Lubricious coating, characterized in that it is obtained by applying a wetting fluid to a hydrophilic coating according to claim 10.
12. 12. Lubricating coating, characterized in that it has an initial lubricity after 1 cycle as measured in a Harland FTS Friction Test Tester of 20 g. less.
13. 13. Lubricant coating according to claim 11, characterized in that it has an initial lubricity after 1 cycle as measured in a Harland FTS Friction Test Tester of 20 g or less.
14. 14. Coating system for preparing a lubricous coating, characterized in that said coating system comprises a coating formulation comprising a nonionic hydrophilic polymer and a wetting fluid comprising a polyelectrolyte. 4
15. 15. Coating system for preparing a lubricous coating, characterized in that said coating system comprises a coating formulation according to any of claims 1-9 and a humectant fluid comprising a polyelectrolyte.
16. 16. Use of a polyelectrolyte and a nonionic hydrophilic polymer in a lubricious coating, to improve the drying time of the lubricious coating, wherein the drying time is defined as the duration of the coating that remains lubricious after a device comprising the lubricious coating has been taken from the wetting fluid, where it has been stored and / or moistened, which is determined by measuring the fraction in g as a function of time in a Harland FTS friction tester.
17. 17. Article, characterized in that it comprises at least one hydrophilic coating or lubricious coating according to any of claims 10-13.
18. 18. Article in accordance with the claim 17, characterized in that the article is a medical device or component. Device or medical component according to claim 18, characterized in that it comprises a catheter, a medical line, a guide wire, a stent, or a membrane. 20. Method for forming a hydrophilic coating in a substrate, characterized in that the method comprises: - applying a hydrophilic coating formulation according to any of claims 1-9, at least one surface of the article; and allowing the coating formulation to cure exposing the formulation to electromagnetic radiation thereby, activating the initiator.