MXPA06009727A - Anti-infectious hydrogel compositions - Google Patents

Abstract

The present invention provides a hydrogel composition capable of preventing the intrusion of micro-organisms into body cavities or body openings of mammals comprising of a poly (N-vinyl lactam), a polysaccharide and water.

Description

COMPOSITIONS OF HIDROGEL ANT - INFECTIOUS Background of the Invention The cavities of the body with openings to the periphery of a mammal, both natural cavities and those that result from injury, have a high risk of microbial contamination. Infectious contamination can result in life-threatening consequences, particularly in immunocompromised mammals. Microbial infections, for example, of the ear canal, the eye, the nail or the hoof, the vagina, the theta, burns and lacerations, are well known to physicians and veterinarians. Examples of organisms involved include gram-negative and gram-positive species, strains of mycoplasma and various fungi. Frequent care and cleaning of cavities and body openings are required in order to minimize the risk of infections by these ubiquitous microbes. An example of a body cavity that is susceptible to infections are the tits of dairy animals. The infection of the tits is called mastitis. Although dairy mammals have a risk of mastitis through their milking cycle, dairy cows have a particularly high risk of mastitis during their dry periods. The dry period is approximately four to ten weeks immediately before the birth of a calf. This period is also known as the non-lactating period. Although during the dry period the cow is not at risk of contamination by the milking machines, more than 50% of the infections of the tits occur during the dry period of a cow. This high rate of infection occurs because the immune response of the cow is reduced during the dry period. Additionally, the teat is distended during the dry period, allowing microbes to penetrate the mammary gland more easily; and without the cleaning with liquid that provides lactation, the possibility of infections increases. The residual protein in the milk in the teat provides a good feeding field for the microorganisms that cause mastitis. Mastitis involves a wide range of environmental microorganisms, including bacteria, fungi and several strains of mycoplasma. Bacteria related to mastitis recognized by the Food and Drug Administration (FDA) of the United States and the National Mastitis Council (NMC) include Staphylococcus aureus, Klebsiella spp. , Streptococcus agalactiae, Pseudomonas spp. , Streptococcus dysgalactiae, Corynebacterium bovis, Streptococcus uberis, Nocardia, Streptococcus bovis, Candida albicans, Escherichia coli, and Mycoplasma spp. Mycoplasma species include Mycoplasma bovis, Mycoplasma calif ornicum, and Mycoplasma bovogeni talium. Additionally, strains of Salmonella, Proteus vulgaris, Bordetella bronchi septic, Pastorella multocida and others have received intense research attention due to their frequent occurrences. The NMC, in conjunction with the FDA and various international health and safety agencies, have expressed the importance of controlling the aforementioned microorganisms in mastitis related to the dairy industry. The consequences of mastitis during the dry period of the cow include contamination of the newborn calf and the milk produced subsequently, which leads to lower reproductive results; lower milk production; and, in severe cases, loss of cow and calf. In the United States alone, mastitis costs the dairy industry about 3,000 million dollars a year, or about 300 dollars per cow. Costs include drugs, veterinary treatments, and waste milk or reduced milk production. Several methods of preventing mastitis have been suggested in research publications and patent literature, including general hygiene programs, hygiene products, barrier baths for the milking cycle, dry baths for long-term cows, anti-microbial barrier products, systemic antibiotics and local application, internal treatments for tits and antibiotic cap systems for the tits channel. However, current methods to control mastitis have many limitations. For example, antibiotics can contaminate both the milk and the meat of a cow. Also, antibiotics do not provide complete prevention of infection. Furthermore, the extensive use of antibiotics leads to resistance of microorganisms, thereby forcing the development of new antibiotics. Likewise, most of the tits baths used today are used during the period of lactation of a mammal. For example, bath compositions for effective tits used during the regular milking cycle of a dairy cow are described in patents US 6,395,289 and 6,203,812 (from Hydromer, Inc., of Branchburg, New Jersey, United States).

These compositions are hydrophilic polymeric physical blends, which provide effective and long-lasting barrier properties while permitting rapid removal of the composition prior to milking. The exterior of a mammalian teat is rinsed in the composition. However, the consistency and physical properties of such tits baths make them unsuitable for treatment of the tits channel. For example, as these baths do not gel easily, they would tend to run out of the channel. Other bath compositions for tits used during the period of lactation of a mammal are disclosed in US Patents 4,113,854 and 5,017,369. Applied externally, these compositions form thick films that seal the end of the channel of a teat. These compositions include latex. As a result of the latex, these compositions remain viscous and sticky, thereby not allowing the treatment of the teat canal. Likewise, latex can be toxic. In addition to the contamination of milk, latex can stimulate allergic reactions in humans. Despite the fact that more than 50% of cases of mastitis occur during the dry period of a cow, there are only a few products on the market that are specifically designed to protect the dry teat of the cow. Treating a dairy animal during its dry period would complement the treatment during the milking cycle. The dry products for cows currently on the market have various limitations. For example, most of these products do not focus on the treatment of the teat canal. The treatment of the teat canal is important because the residual milk protein in the canal serves as an excellent breeding ground for microorganisms. Another limitation of some of the dry treatments for the cow teat channel available today is that they require complex process steps, such as irradiation, heat, catalysts or other specific additives to form a useful plug substance that maintains the shape. Additional limitations are that they are not stable over a wide range of temperatures and / or in changing humidity conditions. The patents US 6,254,881; 6,340,469; and 6,506,400 disclose an antibiotic-free formulation for the prophylactic treatment of mastitis in dry cows. The formulation is infused at the end of the teat to seal the teat canal against microorganisms that cause mastitis. The formulation consists of approximately 65% by weight of bismuth sub-nitrate in a gel based on aluminum stearate. Although these patents claim an antibiotic-free formulation, the use of antibiotics in conjunction with the formulation is recommended by the NMC. Among the disadvantages of this formulation is that the bismuth sub-nitrate becomes thick in cold weather, thereby impeding its ability to be sufficiently infused into the teat canal. Additionally, since these formulations can interfere with the mechanics of milking machines, it is required that these formulations be manually stripped from the teat canal prior to milking with a machine. US patent application 2003/0060414 describes a method of preventing contamination of a teat during the administration of a sealant by introducing a sterilizing agent into a teat before delivering a sealant. The sterilizing agent is a water-miscible gel, an oil-based gel, or an oil-based paste containing a bacteriocin, e.g., Lacticin 3147. The sterilizing agent may include thickeners and / or other excipients. The consistencies of these sterilizing agents are similar to a paste, and change shape irreversibly to be subject to certain forces.

Thickeners are used in these agents, in part, to preserve the shape of these pastes. US Patent 4,472,374 describes veterinary compositions for reducing mammalian infections during the dry period. These compositions contain a siloxane elastomer with an incorporated antibacterial agent. These compositions are of sufficiently low viscosity to facilitate application to the vein channel; and these compositions remain in place during the dry period and can be removed by milk at the start of lactation. However, complex processes are necey to make these compositions, including the use of curing catalysts. Such catalysts raise toxicological concerns because these catalysts can be leached as highly reactive compounds. Hydropillic, film-forming, long-lasting polymeric physical mixtures for mastitis therapy in dry cows are described in US Pat. No. 6,440,442 (Hydromer, Inc., of Branchburg, New Jersey, United States). The films are formed on the outside of the teat and function as a barrier to prevent infection. The main components of these physical mixtures are polyurethane and poly (N-vinyl lactam). As these baths are viscous, they are not easily suitable for infusion into the inner channels of the teat. Despite many decades of intensive research on the prevention of mastitis and the availability of numerous bath products for tits, sanitarians and antibiotics, mastitis infections in dry cows still have a considerable negative impact on the economics of milk production . There is an increasing need for effective treatments for dry cows to supplement mastitis control treatments using during lactation periods. Such dry treatments would improve the economics and nutritional hygiene of milk production, and minimize the use of antibiotics. SUMMARY OF THE INVENTION The present invention is directed to novel hydrogel compositions capable of preventing the intrusion of microorganisms into cavities or openings in the body of a mammal. The compositions have a specific ratio of a polyvinyl lactam to a polysaccharide that form a gelatinous composition with water. The compositions optionally comprise consistency modifying agents, performance modifying agents, cross-linking agents, and therapeutic improvement agent. The hydrogel compositions are suitable for transfer to the natural cavities of the body of mammals, such as the teat canal of a dairy cow; and accidental cavities in the skin caused by injuries such as cuts, burns and diseases. The compositions are applied to the cavities or openings of the body by means of infusion tools, preferably a plastic syringe. The hydrogel compositions form a barrier or sealant to prevent the intrusion of microorganisms that cause infections. For example, hydrogel compositions prevent contamination of the teat duct of a dry cow by infections by microorganisms related to environmental mastitis. Simultaneously, the hydrogel compositions also clean, disinfect, prevent inflammation and promote healing of the interior walls of a cavity or body opening. Such cleaning / disinfection activity occurs without the inclusion of anti-microbial / antibiotic agents. The hydrogel compositions of the present invention provide various advantages over the treatments of baths for teats used today. For example, most breast-bath treatments are formulated for use during a cow's lactation period; although more than 50% of all cases of mastitis are detected in the dry period of dairy cows. The hydrogel compositions of the present invention are formulated for use during the dry period of a cow. Additionally, most treatments for dry cows currently available require the use of antibiotics. The hydrogel compositions of the present invention provide disinfection / cleansing activity without the need for antibiotics. Minimizing the use of antibiotics reduces the risk of side effects of antibiotics, avoids long waiting periods after antibiotic applications and reduces the risk of the development of resistance to antibiotics by microorganisms. Moreover, unlike most currently available dry cow treatments, which require complex processing steps, such as curing, and catalytic reactions, the hydrogel compositions of the present invention are made by a simple mixing procedure. Further, unlike most currently available treatments for dry cows, the hydrogel compositions of the present invention are stable over a wide range of temperatures. Detailed Description of the Invention The present invention relates to biocompatible hydrogel compositions, lubricants, which are suitable for filling body cavities and openings in the body of mammals. The hydrogel compositions are in the form of reversible or irreversible hydrogels. The hydrogel compositions function as sealants and / or sanitary cleaners of the body cavity or opening in the body. Throughout this description, there are ranges defined by upper and lower limits. Each lower limit can be combined with each upper limit to define a range. The lower and upper limits must be considered, each one, as a separate element. The hydrogel compositions of the present invention comprise a poly (N-vinyl lactam); a polysaccharide; and water. Preferably, the range of the ratio by weight of the poly (N-vinyl lactam) to the amount by weight of the polysaccharide has an upper limit of about 75: 1. Examples of other upper limits include about 1; 50: 1; 30: 1; 20: 1; 15: 1; 13: 1; 12: 1; and 1: 2. The poly (N-vinyl lactam) of the hydrogel compositions of the present invention can be any type of poly (N-vinyl lactam), such as, for example, a homopolymer, a copolymer or a terpolymer of N-vinyl lactam, or its mixtures. Examples of poly (N-vinyl lactam) polymers suitable for use in hydrogel compositions include N-vinylpyrrolidone, N-vinylbutyrolactam, N-vinylcaprolactam, and mixtures thereof. An example of a preferred poly (N-vinyl lactam) homopolymer is polyvinylpyrrolidone (PVP). Examples of copolymers and terpolymers of poly (N-vinyl lactam) include N-vinyl lactam polymers which are copolymerized with vinyl monomers. Examples of vinyl monomers include acrylates, hydroxyalkyl acrylates, methacrylate, acrylic acids, methacrylic acids, acrylamides, and mixtures thereof. The copolymerization of the N-vinyl lactams with vinyl monomers allows the modification of the consistency of the hydrogel compositions.

Examples of preferred poly (N-vinyl lactam) copolymers include vinylpyrrolidone copolymer and an acrylamide copolymer. Examples of preferred terpolymers include terpolymers of vinylpyrrolidone, terpolymers of vinylcaprolac-tama, and terpolymers of dimethylaminoethylmethacrylate. Preferably, the poly (N-vinyl lactams) used in the hydrogel compositions of the present invention are commercially available poly (N-vinyl lactams), and do not require any pretreatment before use in the hydrogels. For example, preferably, the poly (N-vinyl lactams) are not treated to induce the opening of their lactam rings. In one embodiment, the hydrogel compositions of the present invention do not contain a polymer of an acid, e.g. , polyacrylic acid, or an acid-forming compound, such as an anhydride. The polysaccharide used in the hydrogel compositions can be any polysaccharide. For the purposes of this description, a polysaccharide includes any polysaccharide and any polysaccharide derivative. Examples of polysaccharides suitable for use in the composition include chitin; deacetylated chitin; chitosan; chitosan salts; chitosan sorbate; chitosan propionate; chitosan lactate; chitosan salicylate; pyrrolidone carboxylate of chitosan; chitosan itaconate; chitosan niacinate; Chitosan fornato; Chitosan acetate; chitosan gallate; Chitosan glutamate; chitosan maleate; chitosan aspartate; chitosan glycolate; Chitosan salts substituted with quaternary amine; N-carboxymethyl chitosan; O-carboxymethyl chitosan; N, O-carboxymethyl chitosan; equivalent butyl derivatives of chitosan; cellulosics; alkylcellulose; nitrocellulose; hydroxypropylcellulose; starch; starch derivatives; methyl gluceth derivatives; collagen; alginate; hyaluronic acid; heparin; heparin derivatives; and its combinations. The combined poly (N-vinyl lactam) and polysaccharide of the invention are hydrophilic, and are capable of absorbing many times their weight in water. The water content of the composition may vary depending on the particular use of the composition, as a person skilled in the art would know. Preferably, the range of water content in the composition has an upper limit of about 90% by weight of water. Examples of other upper limits include about 75% and 65% by weight of water. Preferably, the range of water content in the composition has a lower limit of about 25% by weight. Examples of other lower limits include about 45 and 55% by weight of water. As the water content of the hydrogel compositions increases, the hydrogel compositions become softer. In some embodiments of the invention, some of the water in the composition is replaced by an alcohol. Approximately 15 to 75% by weight, 35 to 65% by weight, or 45 to 55% by weight of water can be replaced with alcohol. Preferred examples of alcohols include ethyl alcohol and isopropyl alcohol. The hydrogel compositions comprising the combination of poly (N-vinyl lactam) and polysaccharide unexpectedly have a consistency that allows the hydrogel compositions to efficiently fill and remain in cavities / body openings. For example, in dairy cattle, hydrogels stay in the tits of the teats for prolonged periods of time even while the animals move or lie down. Additionally, the consistency of these hydrogels allows them to be removed in their entirety when needed or desired. After the compositions of the present invention form a gel, they can disintegrate and then, surprisingly, form a gel again in a few hours. In this way, these hydrogels are totally reversible. Although one does not wish to be bound by a theory, it is believed that the hydrogen bonds in these integrals are broken temporarily when such hydrogels are forced through small applicator holes. The hydrogen bonds merge again after a few hours. In some embodiments of the invention, the hydrogel compositions may further comprise at least one consistency modifying agent, a performance modifying agent, a crosslinking agent, or mixtures thereof. Up to about 5, 10, 20, 30, 40, 50, 60, 70, 80 or 90% by weight of the poly (N-vinyl lactam) can be replaced with the modifiers of consistency and / or performance. For example, in a formulation comprising polyvinyl pyrrolidone (PVP) and chitosan, or chitosan derivatives, preferably about 50% by weight of the PVP is replaced with consistency and / or performance modifying agents. Examples of preferred consistency modifiers and / or performance modifiers include polyvinyl alcohol; polyvinyl acetate; polyethylene oxide, poly (2-hydroxyethyl methacrylate); methyl vinyl ether co-maleic anhydride; poly (ethylene-co-vinyl acetate), polyethylene glycol diacrylate; poly (N-isopropyl acrylamide); polyurethane; dimethicone; polyglycol ester copolymers, prepolymer adhesives, polyethyleneimine; polypeptides; keratins; polyvinylpyrrolidone / polyethylene imine copolymers; polyvinylpyrrolidone / polycarbamyl / polyglycol ester (Aquamere® H-1212, H-1511, H-2012, A-1212); polyvinylpyrrolidone / dimethylaminoethyl methacrylate / polycarbamyl / polyglycol ester (Aquamere® C-1011, C-1031); polyvinylpyrrolidone / dimethiconacrylate / polycarbamyl / polyglycol ester (Aquamere® S-2011, S-2012); (Pecogel equivalents of Aquamere® products); lecithin; and its copolymers, derivatives and combinations. U.S. Patents 4,642,267; 4,769,013; 5,837,266; 5,851,540; and 5,888,520, assigned to Hydromer, Inc., are hereby incorporated by reference in their entirety. For example, US Patents 4,642,267 and 4,769,013 describe lubricity / hydrophilicity copolymers with performance modifying therapeutics and polymers; and lubricant, hydrophilic, anti-microbial coatings for the tip of a gel syringe applicator device. U.S. Patents 5,837,266; 5,851,540; and 5, 888, 520 describe acceptable dermatological polymers and copolymers with therapeutic agents and barrier performance against dermatitis. The polyvinylpyrrolidone / polyethylene imine copolymers; polyvinylpyrrolidone / polycarbamyl / polyglycol ester (Aquamere® H-1212, H-1511, H-2012, A-1212); polyvinyl pyrrolidone / dimethylaminoethyl methacrylate / polycarbamyl / polyglycol ester (Aquamere® C-1011, C-1031); polyvinylpyrrolidone / dimethylacrylate / polycarbamyl / polyglycol ester (Aquamere® S-2011, S-2012), and their Pecogel equivalents, are well known as cosmetic intermediates (Phoenix Chemicals, New Jersey, United States). Aquamere® copolymers are known to have unique hydrophobicizing properties. In particular, these copolymers provide unique polymeric encapsulating effects that slow down the release of active ingredients such as UV absorption agents, pigments, dyes, oxidants, preservatives, anti-microbials, antibiotics and drugs. For example, the methylconil acrylate version of the Aquamere® S-2011, S-2012 copolymers is known to form inclusion complex polymers, which may retard the solubility of emulsified actives. Aquamere® copolymers are viscous hydrophobic liquids and have been considered unsuitable for use as infusion gels in body cavities or openings in the body. However, it has now been discovered, surprisingly, that the gelation of the hydrogel compositions of the present invention is still achieved even though up to 90% by weight of the water is replaced in the compositions with the Aquamere® copolymers. The Aquamere® copolymers work to slow down the release of additives, e.g., from the therapeutic and anti-microbial agents. The addition of Aquamere® copolymers to the hydrogel composition affects the amount of poly (N-vinyl lactam) used in the composition. For example, if an original formulation is 35% by weight of PVP, 2% by weight of chitosan, and 63% by weight of water, then a corresponding formulation with Aquamere® is 25% by weight of PVP, 10% by weight. weight of Aquamere® copolymers, 2% by weight of chitosan, and 63% by weight of water. Lecithin, well known in the food and cosmetics industries, has similar functions to Aquamere® copolymers. For further performance improvement, the hydrogel compositions may optionally contain humectants, e.g., glycerin. The hydrogel compositions of the present invention can be a hydrogel either reversible or irreversible. The components of a reversible hydrogel dissolve in water. The components of an irreversible hydrogel do not dissolve in water due to the presence of crosslinking agents (ie, reticuladores) that provide, depending on the quantity used, a certain amount of irreversible links. The crosslinkers increase the ability of the hydrogel compositions to maintain their original shape, remain in a body cavity or opening, and / or increase the ability of the hydrogel compositions to be easily removed from the cavity or opening. For example, the crosslinkers increase the ability of the hydrogel compositions to remain in the teat channel, and allow easy removal of the teat by squeezing. Examples of crosslinkers that are suitable for use in the composition include glutaraldehyde, genipine, aziridine derivatives, carbodimide derivatives, colloidal silica, colloidal alumina, colloidal titanium dioxide, polyalkylaminosilanes, epoxies, primary polyamines, dialdehydes, polyaldehydes of reaction products of acrolein, paraformal-dehyde, acrylamides, polyethyleneimines, and combinations thereof. The crosslinkers can be used in any amount that provides the desired consistencies to the hydrogel compositions. For example, the composition may comprise up to about 2, 3, 4, 5 or 8% by weight of a crosslinker. Hydrogel compositions comprising poly (N-vinyl lactam) and polysaccharide surprisingly have sealing and sanitary cleaning / disinfecting properties. In some embodiments of the invention, the hydrogel compositions may further comprise at least one therapeutic performance enhancing agent. The therapeutic performance enhancing agent may comprise up to about 3, 7, 10, 15 or 20% by weight of the composition. Examples of therapeutic performance enhancing agents that are suitable for use in the composition include anti-microbial; anti-bacterial; anti-fungal; anti-candidiasis agents; growth stimulating agents; disinfectants; biocides; bactericides; conservatives; virucides; spermicides; germicides; sterilizers; sanitary cleaning ingredients; deodorants; antiseptics; sporicides; pharmaceutical agents; veterinary preparations; antibiotics; anti-inflammatory agents; natural ingredients; humectants; cosmetic ingredients; relief agents; vitamins; and its combinations. Specific examples of therapeutic performance enhancing agents include anti-microbial silver salts, silver zeolites, silver sulfadizine, ethyl alcohol, isopropyl alcohol, benzyl alcohol, propionic acid, sorbic acid, salicylic acid, undecanoic acid, bleaches, iodine, iodoform, potassium iodide, dodecyl benzene, sulfonic acid, peroxides, bronopol, terbinafine, miconacol, econacol, clotrima-zol, tolnaftate, triclosan, triclocarban, quaternary ammonium compounds, benzalkonium halogénides, polyquaternarians; polyquaternium derivatives (e.g., polyquaternium 28); formaldehyde releasing compounds, hexetidine, chlorhexidine, chlorhexidine derivatives, zinc pyrithione, zinc oxide, zinc propionate, parabens, phenoxyethanol, octoxynol-9, nonoxynol-9, ricinoleic acid, phenolic mercuric acetates, sulfur, lactic acid, acyclovir, yodoxiumidine, ribavirin, vidarabine, rimantadine, aspirin, vitamin A and vitamin A derivatives, vitamin E and vitamin E derivatives, vitamin C and vitamin C derivatives, beta-carotene, betamethasone, dexamethasone, cortinone, glycerin, and their combinations The agents that improve the therapeutic performance of the group of natural ingredients include, for example, plant or seed extracts, derivatives of plant extracts or herbal preparations, or combinations thereof. Examples of natural ingredients include extracts of rosemary, echinacea, nettle, fennel, juniper, ginger bar, gelsenium, witch hazel, lightning root, arnica, aconite, apis, baptisia, tuja, and aloe (Aloe barbadensis, vera, capensis), green tea, nasturtium, brionia, eupatorio and chamomile. Additional examples include essential oils of red thyme, allspice, cinnamon and red thyme. Examples of anti-microbial silver salts include silver iodide, silver chloride composite materials on titanium (IV) oxide, silver lactate, silver citrate, silver zeolites, hydrogenated sodium silver and zirconium phosphate, and sulfadiazine silver. Preferably, in order to minimize the buildup of resistance to the ingredients, different anti-microbial, antibiotic and anti-inflammatory agents can be used in the hydrogel compositions. Also, natural plant and seed extracts can be used in combination with the anti-inflammatory, anti-microbial and antibiotic agents to further minimize the accumulation of resistance. The amount of therapeutic performance enhancing agents in the hydrogel compositions is within the effective range of the individual agents. For example, hydrogel compositions with an effective concentration of a spermicide are suitable for use as anti-contraceptive hydrogels. Typically, the hydrogel compositions of the invention comprise up to about 3, 7, 10, 15, or 20% by weight of therapeutic performance enhancing agents. In some embodiments of the invention, the hydrogel compositions may additionally comprise a pigment, such as, for example, a control pigment, a food pigment, a cosmetic pigment, an FD &C pigment or a D &C pigment. approved . In some embodiments of the invention, the hydrogel compositions may further comprise a radio-opaque additive, such as, for example, barium sulfate, organic iodine compounds, iodine polymers, iodine contrast medium, organic compounds of bismuth, tungsten particles and their mixtures. In another aspect, the present invention provides a method of inhibiting or preventing the intrusion of microorganisms into a cavity or body opening of a mammal.; and / or reducing or eliminating the level of microorganisms in such cavity or opening. The method comprises applying the hydrogel compositions of the present invention to a body cavity or opening. A cavity or body opening can be of natural occurrence. Examples of cavities or body openings that occur naturally include the ear canal, an eye, the nasal canal, the mouth, the dental openings, the genital opening, the rectal opening, wrinkle openings or glands. An example of a gland opening is the teat canal of the dairy gland of a dairy animal. The teat canal is also called milk channel or vein channel. A cavity or body opening that does not occur naturally can be a result of a laceration, burn or disease. Examples of such cavities or openings include puncture wounds, knife wounds, scabs, diabetic ulcers, periodontal lesions, herpes fires, cold fires, blisters, superficial to severe burns, etc. The composition can be used with any mammal, including, for example, humans, zoo animals, pets and farm animals. An example of a farm animal for which the composition is particularly useful are dairy cows. Once applied to a cavity or body opening, the hydrogel compositions preferably have a dual function, that is, as a sealer and as a sanitary cleaner. In particular, the functional hydrogel compositions as sealants prevent / inhibit the intrusion of microorganisms to a cavity or opening. The hydrogel composition forms a hydrophilic, tissue-friendly barrier that provides long-lasting service. The composition exhibits a specific tackiness which allows the hydrogel compositions to remain in place for extended periods of time. Also, the hydrogel compositions, due to their unique formulation, function as sanitizing / disinfecting cleaning agents by reducing or eliminating the level of microorganisms in a cavity or opening. Surprisingly, the hydrogel compositions are capable of reducing or eliminating the level of microorganisms without the use of any therapeutic performance enhancing agent, such as antibiotics and anti-microbials. The hydrogel compositions can be applied in any manner that allows the hydrogel compositions to efficiently fill, and remain in, body cavities / openings. For example, the composition can be applied with a spatula; by hand; by means of an injection device; by means of infusion devices, such as plastic syringes; by emboli; or by means of applicators. Preferably, the hydrogel compositions are applied with plastic syringes. Preferably, the syringes have suitable tubular openings adjusted to the size of the intended area of application. The hydrogel compositions can be applied once, and replaced if desired or if necessary. In some application methods, such as injection, the hydrogels disintegrate during application to cavities. Once applied, it has surprisingly been found that the hydrogels fuse again when they are in place. Without being limited to any theory, it is believed that the hydrogen bonds of the hydrogels are temporarily broken when the hydrogels are forced through small holes in the applicator. After a few hours, surprisingly, the links merge again. The hydrogel compositions of the present invention are particularly useful as sealants for the teat canal for dairy mammals. In particular, the hydrogel compositions are useful as plugs for the teat channel for cows during their dry period. The dry period runs approximately from about four to about ten weeks immediately before the birth of a calf. The hydrogel compositions work as a sealer temporarily plugging the teat, thereby preventing the intrusion of microorganisms that cause mastitis. The hydrogel compositions also function as sanitizing / disinfecting cleansers of the teat canal by reducing / eliminating the microorganisms that cause mastitis within the teat canal. The hydrogel compositions are preferably applied in the teat channel, i.e., the vein channel, by an infusion device. Any suitable infusion device for intra-mammary administration, or easily adapted for such use, can be used. An example of a suitable infusion device is a syringe known as a "mastitis applicator". The syringes can have either a plastic cannula or a wide piercing hole. In some embodiments, a therapeutic performance enhancing agent can be injected separately from the hydrogel composition. For example, in the case where the hydrogel composition is used in conjunction with an anti-microbial, the composition and anti-microbial agent can be infused simultaneously using a standard one cylinder syringe, equipped with a suitable tip, such that the anti-microbial solution enters first into the body cavity, eg, the teat, followed by the composition. Alternatively, the anti-microbial solution and the hydrogel composition can be infused using separate syringes.

The hydrogel composition can be placed in a teat channel by infusion of about one cubic centimeter in each teat channel. Once the hydrogel compositions are placed in a teat channel and have gelled, the hydrogels retain their shape. Due to some stickiness, hydrogel plugs can remain in the teat canal for prolonged periods of time even when cows move or lie down. For example, hydrogels preferably remain in the teat canal during the dry period for about one to ten days. The hydrogels can be removed by squeezing in their entirety if needed or desired. The procedure of treatment of dry cows by means of intra-mammary infusion is a potentially dangerous procedure. The danger lies in non-sanitary infusion practices, which may introduce additional environmental organisms into the udder, posing the increased risk of mastitis infection. Accordingly, it is recommended to sterilize hydrogel compositions and infusion devices. For example, to prevent cross-contamination during the application of the hydrogel compositions, the tips of the infusion devices are coated with anti-microbial lubricant coatings known in the art. For example, anti-microbial coatings lubricants for medical devices are disclosed in US Patents 4,642,267 and 4,769,013. Preferably, the anti-microbials are silver-based compositions. Preferably, the interior of the tip of the device is also coated with the lubricant coating to improve the ease with which the hydrogel compositions are forced through the opening of the infusion devices. Once applied, the hydrogel compositions form a barrier or seal for the prevention and / or inhibition of microorganisms towards the teat. The hydrogel compositions prevent contamination of the teat duct of a dry cow against infections by microorganisms related to environmental mastitis. Simultaneously, the cap of sanitary clean composition disinfects and prevents inflammation of the interior walls of a cavity or body opening. Sanitary cleaning and disinfection occur without the optional addition of antibiotics / anti-microbials. The hydrogel compositions can be used in conjunction with an external hydrophilic film-forming product for additional protection of the teat. For example, hydrogel compositions can be infused into the teat canal, while simultaneously a dry cows tits bath is applied, such as the dry cows tits bath described in US Pat. No. 6,440,442, outside of the tit. In one embodiment, the invention provides an anti-contraceptive hydrogel comprising a poly (N-vinyl lactam), a polysaccharide, water and a spermicide, wherein the ratio of the amount by weight of the poly (N-vinyl lactam) to the amount by weight of the polysaccharide is from about 75: 1 to 1: 5, about 50: 1 to 1: 1, or about 30: 1 to 5: 1, and where the composition comprises about 25 to 55 % by weight of water. In this embodiment, the hydrogel comprises an effective concentration of a spermicide to function as a suitable anti-contraceptive. The hydrogel compositions of the present invention can be produced by a variety of methods. Preferably, the poly (N-vinyl lactam) component and the polysaccharide component of the hydrogel compositions are pre-formulated in separate solutions. In a preferred embodiment, the two solutions are approximately equal in volume. The solutions can be aqueous solutions or aqueous / alcohol solutions. Any ingredients optionally added, ie consistency and / or performance modifying copolymers, crosslinkers, therapeutic performance enhancing agents, radiopaque pigments and / or additives are preferably added in equal amounts to the pre-formulated solution of poly (N-vinyl lactam) and the pre-formulated polysaccharide solution before combining the two solutions. Alternatively, all optionally added ingredients can be placed in either the pre-formulated poly (N-vinyl lactam) solution or the pre-formulated polysaccharide solution before combining the two solutions. Also, any fraction of the optionally added ingredients can be placed in any of the pre-formulated solutions before combining the two solutions. For example, as much as twice as much crosslinker may be provided in the pre-formulated solution of poly (N-vinyl lactam) as the pre-formulated polysaccharide solution before combining the two necessary parts for the total composition. The pre-formulated solutions are mixed in any manner that allows homogeneous mixing of the two solutions before the time when gelation begins to occur. For example, mixing can be accomplished using a screw mixer or simply by mixing the two parts in a container. The initial gelation of the composition can occur from a few seconds to a few minutes after mixing the two solutions. No other process steps, curing or additional additives are necessary for gelation to occur. For example, irradiation, heat or catalysts are not required for the formation of these hydrogels. The hydrogel compositions are preferably allowed to gel completely at room temperature for about two to ten hours. The composition can then be placed in suitable devices for convenient applications to the cavities or body openings of mammals.

The hydrogel compositions of the present invention have various advantages over the general competitive hydrogel types. Hydrogel compositions that exhibit the desired performance and consistency are formed simply by physically mixing the major components in specific ratios. The addition of performance enhancing agents and / or consistency modifying agents is generally not necessary. The hydrogel compositions are formed during a period of time ranging from a few seconds to a few minutes. No other process steps, or other additives are needed. They can be molded into shapes to fit an existing product design. They can be used as a hydrophilic plug forming consistencies with unique protective barrier properties. The gels have moisturizing and absorbing properties and are compatible with a wide range of cosmetic ingredients and drugs. They absorb water, saline, derma-fluids or other fluids, provide moisture barriers to cool and soothe and improve the healing of damaged skin. Single or with a variety of anti-microbial agents or antibiotics, anti-inflammatories, anti-candidiasis agents or related pharmaceutical and veterinary preparations, contribute to the sanitary cleaning of cavities / mammalian body openings, and simultaneously prevent the subsequent intrusion of microbes, such as bacteria, fungi, spores, germs, viruses and the like. The hydrogel compositions of the present invention have shown a good inert trait within a relatively broad pH range around the neutral pH. They are stable for at least one year in the proper evaporation proof packaging. The results of long-term tests with the active ingredients formulated in these hydrogel compositions show no interaction or incompatibility with vitamins and their derivatives, plant or seed extracts, phospholipids, astringents, anti-microbials, antibiotics, anti-candidiasis agents or other pharmaceutical products related to drugs, transdermal ingredients, skin whiteners, green tea, active anti-wrinkles, alpha-hydroxy acids or cooling agents. E tests Microbial Tests The hydrogels of the present invention were tested for their anti-microbial / biostatic potential by a laboratory test method, which provides a qualitative and semi-quantitative method for the evaluation of anti-microbial activity by diffusion of the anti-microbial agent through agar. The method is derived from the "Paralell Streak Method" (parallel vein method), which is based on test method 147-1998, determination of anti-bacterial activity of textile materials; AATCC. The cultures were prepared fresh during the night. The test organisms used were Escherichia coli, ATCC # 25922 and Staphylococcus aureus, ATCC # 29213. The organisms were incubated with Tryptone Soy Broth (TSB) at 37 ° C the day before the test. The suspension of bacterial cells in TSB was > 107 cells per ml. On the day of the test, hot agar samples were cooled in sterile tubes and then 0.1 ml of the individual culture was added to the melted agar. The agar samples were poured onto plates after mixing, allowed to gel and then the hydrogels test samples of the present invention were placed on the top of the agar. The incubation was then continued for one and five days and the zone of bacterial growth inhibition approximated around each sample. All percentages in the examples are percentages by weight unless otherwise specified. Example 1 Method of Making a Hydrogel 1.4 g of propylene glycol and 3.0 g of a 20% aqueous solution of a block copolymer of ethylene oxide and propylene oxide (Pluronic F88, BASF Corporation) were added to 8.6 g of a solution in 25% water of polyvinylpyrrolidone (PVP) (Kollidon K90, BASF Corporation). To that solution, 5 g of a 3% aqueous solution of chitosan neutralized with pyrrolidone carboxylic acid (Kitamer PCA, Amerchol Corporation) was added. The mixture was stirred for a few minutes and transferred to plastic syringes for applications in cavities. Example 2 Method of Making a Hydrogel 5.0 g of a 20% solution of PVP in water were mixed with 5.0 g of a 2% solution of N, O-carboxymethyl chitosan (NOCC, Nova Chem Ltd.). The mixture was poured into a hemispherical mold. Fraguó in 10 seconds at room temperature to form a gel sticky, not able to flow. The gel was deformable and relatively non-adherent to a wound. Example 3 Method of Making a Hydrogel A solution of 5.0 g of 20% PVP, 5 g of deionized water, 5.0 g of 2% neutralized chitosan, 0.25 g of polyethylene glycol (Carbowax 400, Union Carbide Corporation) as a plasticizer and 0.25 g of a block copolymer of ethylene glycol and propylene glycol (Pluronic F88, BASF Corporation) was mixed gently until gelation occurred. Example 4 Variations in the Concentration of the PVP Portion of the Hydrogel A solution of 20 g of a solution of 30% PVP and 5% polyvinylpyrrolidone / dimethiconilacrylate / polycarbamyl / polyglycol ester in deionized water was mixed with 20 g of a 2.0% chitosan solution in deionized water. In a few minutes a hydrogel of firm, sticky consistency was formed. The formulation of 20 g of PVP solution was changed to 25% PVP and 10% polyvinylpyrrolidone / dimethiconilacrylate / polycarbamyl / polyglycol ester. Again, a firm hydrogel was obtained after a few minutes. The formulation of 20 g of PVP solution was changed to 17.5% PVP and 17.5% polyvinylpyrrolidone / dimethylsilacrylate / to / polycarbamyl / polyglycol ester. After a few minutes, a firm, sticky gel formed. A complete replacement of the PVP with polyvinylpyrrolidone / dimethiconilacrylate / polycarbamyl / polyglycol ester does not form a gel with the 2% solution of chitosan. Example 5 Anti-Microbial Activity A solution of 10 g of 35% PVP in deionized water was mixed with 10 g of a 2.0% chitosan solution in deionized water where both solutions contained 1% of a silver anti-microbial composition available in the market under the AlphaSan brand, by Milliken. The composition gels shortly after the two parts are combined in a ratio 1 to 1. The gel is transferred to a graduated plastic syringe of 5 ce. For anti-microbial efficacy tests, the gel was transferred to the standard test vessel in an agar petri dish. After one day and after five days, no development of either Escherichia coli or Staphylococcus aureus was observed. A zone of inhibition of about 2 mm was formed by S. aureus. No actual zone of inhibition was detected for E. coli. EXAMPLE 6 Method of Making a Hydrogel 44 g of a 35% PVP solution and 6 g of a 40% aqueous polyurethane solution were mixed with 0.25% chitosan to yield 50.25 g of a hydrogel composition that gels in a few minutes to a consistency with a stickiness that makes it suitable for infusion in body cavities, body openings, e.g., glands. Example 7 Anti-Microbial Activity 20 g of a 35% PVP solution containing 0.1% triclosan was mixed with 20 g of an aqueous 2% chitosan solution also containing 0.1% triclosan. The gel was transferred to a plastic syringe and applied in the form of a standard 1 x 1 x 0.5 cm3 lump for antimicrobial testing. After one day and five days, no development of either E. coli or S was observed. aureus. A zone of inhibition of about 6 to 9 mm was observed for E. coli and 9 to 10 mm for S. aureus. EXAMPLE 8 Effect of Reticulator A 44 g of a 35% PVP solution and 6 g of a 40% aqueous polyurethane solution, as in Example 6, 0.2% commercially available genipin was added. Chitosan at 0.25% was prepared according to Example 6. Before mixing, both parts were stained with a few drops of 0.1 crystal violet solution for better optical visibility. To test the adhesion of the cross-linked and non-crosslinked gel in a stimulated teat channel, the finished hydrogels of this example and of Example 6 were infused into a medical tube 20 cm long of about 3 mm internal diameter. The amount of about 3 cm gel length was injected into each end of the tube. Subject to the center of the tube and rotated at increasing rpm up to 600 rpm, the non-crosslinked hydrogel of Example 6 was able to remain in place until 600 rpm, while the hydrogel crosslinked with genipine was expelled at about 450 rpm. 500 rpm. A hydrogel of Example 5 remained in place until about 700 to 800 rpm. Example 9 Anti-Microbial Activity 20 g of a 35% aqueous PVP solution containing 0. 5% AlphaSan silver and 0.5% aspirin were mixed with 20 g of an aqueous 2% chitosan solution that also contained 1% aspirin. The gel was transferred to a plastic syringe and applied to a standard lump for antimicrobial testing. In a surprising way, after one day and five days, no development of any of the organisms was observed. An inhibition zone of about 3 to 4 mm was observed for E. coli. An inhibition zone of about 4 to 6 mm was observed for S. aureus. Example 10 Anti-Microbial Activity 20 g of a 35% aqueous PVP solution containing 0.5% AlphaSan silver and 0.5% aspirin were mixed with 20 g of an aqueous 2% chitosan solution also containing 0.5% AlphaSan silver and 0.5% aspirin. The gel was transferred to a plastic syringe and applied to a standard lump for antimicrobial testing. After one day and five days, no development of any of the organisms was observed. An inhibition zone of about 1 mm was observed for E. coli. An inhibition zone of about 3 mm was observed for S. aureus. Example 11 Anti-Microbial Activity 20 g of an aqueous solution of 35% PVP containing 1% of a 48% solution of commercially available zinc pyrithione (Zinc Omadine) were mixed with 20 g of a 2% aqueous solution of chitosan also containing 1% of the 48% solution of zinc pyrithione. The gel was transferred to a plastic syringe and applied to a standard lump for antimicrobial testing. After one day and five days, no development of any of the organisms was observed, with an inhibition zone of around 8 to 9 mm for E. coli and 4 to 5 mm for S. aureus. Example 12 Anti-Microbial Activity 20 g of an aqueous solution of 35% PVP containing 0.05% triclosan and 0.5% of a 40% solution of commercially available zinc pyrithione (Zinc Omadine) were mixed with 20 g of an aqueous solution of 2% chitosan also containing 0.05% triclosan and 0.5% of the 40% solution of zinc pyrithione. The gel was transferred to a plastic syringe and applied to a standard lump for antimicrobial testing. After one day and five days, no development of any of the organisms was observed, with an inhibition zone of around 8 to 9 mm for E. coli and 10 to 12 mm for S. aureus. Example 13 Anti-Microbial Activity 20 g of a 35% aqueous PVP solution containing 0.05% triclosan and 0.5% anti-microbial silver AlphaSan were mixed with 20 g of a 2% aqueous chitosan solution also containing 0.05% triclosan and 0.5% AlphaSan antimicrobial silver. The gel was transferred to a plastic syringe and applied to a standard lump for antimicrobial testing. After one day and five days, no development of any of the organisms was observed, with a zone of inhibition of about 4 to 6 mm for E. coli. , and about 1 mm for S. aureus. Example 14 Anti-Microbial Activity 20 g of an aqueous solution of 35% PVP containing 0.5% zinc pyrithione and 0.5% anti-microbial silver AlphaSan were mixed with 20 g of a 2% aqueous solution of chitosan also containing 0.5% zinc pyrithione and 0.5% AlphaSan anti-microbial silver. The gel was transferred to a plastic syringe and applied to a standard lump for antimicrobial testing. After one day and five days, no development of any of the organisms was observed, with a zone of inhibition of about 3 to 4 mm for E. coli. , and around 6 mm for S. aureus. Example 15 Anti-Microbial Activity 20 g of an aqueous solution of 35% PVP without additional anti-microbial or drug were mixed with 20 g of a 2% aqueous solution of chitosan also without additional antimicrobial or drug. The gel was transferred to a plastic syringe and applied to a standard lump for antimicrobial testing. Surprisingly, after one day and five days, no development of either organism was observed. No development was detected directly on the surface of the gel or on either side of the lump test sample. A zone of inhibition could not be determined. In this way, although those which are currently believed to be the preferred embodiments of the present invention have been described, other and additional embodiments, modifications and improvements will be envisioned by those skilled in the art, and are intended to include all such forms of additional realization, modifications and improvements that fall within the true scope of the claims indicated below.

Claims (33)

1. CLAIMS 1. A hydrogel composition capable of preventing the intrusion of microorganisms into cavities or body openings of mammals, comprising a poly (N-vinyl lactam), a polysaccharide and water.
2. 2. The hydrogel composition of claim 1, wherein the upper limit of the ratio of the amount by weight of the poly (N-vinyl lactam) to the amount by weight of the polysaccharide is about 75: 1, 50 : 1, 30: 1, 20: 1, 15: 1, 13: 1, 12: 1, or 1: 2.
3. 3. The hydrogel composition of claim 1, wherein the lower limit of the ratio of the amount by weight of the poly (N-vinyl lactam) to the amount by weight of the polysaccharide is about 1:10. : 5, 1: 3, 1: 1, 5: 1, 12: 1, 13: 1, 15: 1, 20: 1, 30: 1 or 50: 1.
4. 4. The hydrogel composition of claim 1, comprising about 25 to 90% by weight of water; around 45 to 75% by weight of water; or about 55 to 65% by weight of water.
5. The hydrogel composition of claim 1, wherein the poly (N-vinyl lactam) is a homopolymer, a copolymer, a terpolymer of N-vinyl lactam, or mixtures thereof.
6. The hydrogel composition of claim 5, wherein the poly (N-vinyl lactam) is selected from the group consisting of N-vinylpyrrolidone, β-vinylbutyrolactam, β-vinylcaprolactam, and mixtures thereof.
7. The hydrogel composition of claim 5, wherein the poly (N-vinyl lactam) comprises a vinyl monomer copolymerized with the N-vinyl lactam.
8. The hydrogel composition of claim 7, wherein the vinyl monomer is selected from the group consisting of an acrylate, a hydroxyalkyl acrylate, a methacrylate, an acrylic acid, a methacrylic acid, an acrylamide, and mixtures thereof.
9. 9. The hydrogel composition of claim 5, wherein the homopolymer is polyvinylpyrrolidone (PVP).
10. The hydrogel composition of claim 5, wherein the copolymer is selected from the group consisting of a copolymer of vinylpyrrolidone and an acrylamide copolymer.
11. The hydrogel composition of claim 5, wherein the terpolymer is selected from the group consisting of a terpolymer of vinylpyrrolidone, a terpolymer of vinylcaprolactam, and a terpolymer of dimethylaminoethyl methacrylate.
12. The composition of claim 1, wherein the polysaccharide is selected from the group consisting of chitin, deacetylated -cytine; chitosan; chitosan salts; chitosan sorbate; chitosan ponate; chitosan lactate; chitosan salicylate; pyrrolidone carboxylate of chitosan; chitosan itaconate; chitosan niacinate; chitosan format; Chitosan acetate; chitosan gallate; Chitosan glutamate; chitosan maleate; chitosan aspartate; chitosan glycolate; Chitosan salts substituted with quaternary amine; N-carboxymethyl chitosan; O-carboxymethyl chitosan; N, O-carboxymethyl chitosan; equivalent butyl chitosan derivatives; cellulosics, alkylcellulose; nitrocellulose, -hydroxyplcellulose; starch; starch derivatives; methyl derivatives of gluceth; collagen; alginate; hyaluronic acid; heparin; heparin derivatives; and its combinations.
13. The hydrogel composition of claim 2, further comprising a consistency modifying agent, a performance modifying agent, a crosslinking agent, or mixtures thereof.
14. The hydrogel composition of claim 13, wherein the performance modifier and / or modifier is selected from the group consisting of polyvinyl alcohol; polyvinyl acetate; polyethylene oxide, poly (2-hydroxyethyl methacrylate); methyl vinyl ether-co-maleic anhydride; poly (ethylene-co-vinyl acetate); polyethylene glycol diacrylate; poly (N-isopl acrylamide); polyurethane; polyethyleneimine; polypeptides; keratins; polyvinylpyrrolidone / polyethylenimine; polyvinylpyrrolidone / polycarbamyl / polyglycol ester; polyvinylpyrrolidone / dimethylaminoethyl methacrylate / polycarbamyl / polyglycol ester; polyvinylpyrrolidone / dimethylconilacrylate / polycarbamyl / polyglycol ester; lecithin; and its copolymers, derivatives and combinations.
15. 15. The hydrogel composition of claim 13, wherein up to 5, 10, 20, 30, 40, 50, 60, 70, 80 or 90% by weight of the poly (N-vinyl lactam) is replaced with the modifier copolymers of the consistency and / or performance.
16. 16. The hydrogel composition of the claim 13, wherein the crosslinker is selected from the group consisting of glutaraldehyde, genipine, aziridine derivatives, carbodimide derivatives, colloidal silica, colloidal alumina, colloidal titanium dioxide, polyalkylaminosilanes, epoxies, primary polyamines, dialdehydes, polyaldehydes of reaction products of acrolein, paraformaldehyde, acrylamides, polyethyleneimines, and combinations thereof.
17. 17. The hydrogel composition of claim 1, further comprising a therapeutic performance enhancing agent.
18. 18. The hydrogel composition of claim 17, wherein the therapeutic performance enhancing agent is selected from the group consisting of an anti-microbial, antibacterial, anti-fungal, anti-candidiasis agent, disinfecting agent, biocide, bactericidal, preservative, virucide, spermicide, germicide, sterilizer, sanitary cleaning ingredient, deodorant, antiseptic, sporicide, a pharmaceutical agent, a veterinary preparation, an antibiotic, an anti-inflammatory agent, an extract of plant or seed, a derivative of a plant extract , an herbal preparation, a moisturizer, and their combinations.
19. 19. The hydrogel composition of claim 18, wherein the therapeutic performance enhancing agent is selected from the group consisting of anti-microbial silver salts; silver zeolites; silver sulfadiazine; ethyl alcohol; isopropyl alcohol; benzyl alcohol; propionic acid; sorbic acid; salicylic acid; undecanoic acid; whiteners; iodo; iodoform; potassium iodide; dodecyl benzene sulfonic acid; peroxides; bronopol; terbinafine; miconacol; econacol; clotrimazole; tolnaftate; triclosan; triclocarban; quaternary ammonium compounds; benzalkonium halogenides; policuaterna-rios, - polyquaternium derivatives; compounds that release formaldehyde; hexetidine; chlorhexidine; Chlorhexidine derivatives; zinc pyrithione; zinc oxide; zinc propionate; parabens; phenoxyethanol; octoxynol-9; nonoxynol-9; ricinoleic acid, - phenolic mercuric acetates; sulfur; lactic acid; essential oils of red thyme, allspice, cinnamon and red thyme; extracts of rosemary, echinacea, nettle, fennel, juniper, ginger bar, gelsenio, witch hazel, lightning root, arnica, aconite, apis, baptisia, tuja, and aloe (Aloe barbadensis, vera, capensis), green tea, nasturtium, brionia, eupatorio and chamomile; acyclovir; idoxiumidine; ribavirin; vidarabine; rimantadine; aspirin; vitamin A and vitamin A derivatives; vitamin E and vitamin E derivatives; vitamin C and vitamin C derivatives; beta-carotene; betamethasone; dexamethasone; cortinone; glycerin; and its combinations.
20. The hydrogel composition of claim 17, wherein the therapeutic performance enhancing agent comprises up to about 3, 7, 10, 15 or 20% by weight of the composition.
21. The hydrogel composition of claim 1, wherein 15 to 75% by weight, 35 to 65% by weight, or 45 to 55% by weight of the water is replaced by ethyl alcohol or isopropyl alcohol.
22. 22. The hydrogel composition of claim 1, further comprising a pigment selected from the group consisting of a control pigment, a food pigment, a cosmetic pigment, an FD &C pigment or an approved D &C pigment.
23. The hydrogel composition of claim 1, further comprising a radiopaque additive selected from the group consisting of barium sulfate, organic iodine compounds, iodine polymers, iodine contrast medium, organic bismuth compounds and tungsten.
24. 24. A method of inhibiting the intrusion of microorganisms in a body cavity of a mammal, comprising applying to the body cavity a hydrogel composition comprising a poly (N-vinyl lactam), a polysaccharide, and water, thereby inhibiting the intrusion of microorganisms in a body cavity.
25. 25. The method according to claim 24, wherein the body cavity is a natural body cavity or a cavity that is the result of an injury.
26. 26. The method according to claim 25, wherein the natural body cavity is a canal of the ear, an eye, nasal canal, mouth, genital opening, rectal opening, wrinkle or gland opening.
27. 27. The method according to claim 26, wherein the gland opening is a teat channel of the mammary gland of a dairy animal.
28. The method according to claim 24, wherein the composition is applied by an injection device, an infusion device, an applicator or a plastic syringe.
29. The method according to claim 24, wherein the upper limit of the range of the ratio by weight of the poly (N-vinyl lactam) to the amount by weight of the polysaccharide is about 75: 1, 50 : 1, 30: 1, 20: 1, 15: 1, 13: 1, 12: 1, or 1: 2.
30. 30. The method according to claim 24, wherein the lower limit of the ratio of the amount by weight of the poly (N-vinyl lactam) to the amount by weight of the polysaccharide is about 1:10. : 5, 1: 3, 1: 1, 5: 1, 12: 1, 13: 1, 15: 1, 20: 1, 30: 1, or 50: 1.
31. The method according to claim 24, wherein the composition comprises about 25 to 90% by weight of water, about 45 to 75% by weight of water, or about 55 to 65% by weight of water.
32. The method according to claim 24, wherein the composition further comprises a therapeutic performance enhancing agent selected from the group consisting of an anti-microbial, anti-bacterial, anti-fungal, anti-candidiasis agent, disinfecting agent, biocide , bactericide, preservative, virucide, spermicide, germicide, sterilizer, sanitary cleaning ingredient, deodorant, antiseptic, sporicide, a pharmaceutical agent, a veterinary preparation, an antibiotic, an anti-inflammatory agent, an extract of plant or seed; a derivative of plant extract, an herbal preparation, a humectant, and their combinations.
33. 33. An anti-contraceptive hydrogel comprising a poly (N-vinyl lactam), a polysaccharide, water and a spermicide, wherein the ratio of the amount by weight of the poly (N-vinyl lactam) to the amount by weight of the polysaccharide is about 75: 1 to 1: 5, about 50: 1 to 1: 1, or about 30: 1 to 5: 1, and where the composition comprises about 25 to 55% by weight of water.