MXPA06006128A - Gentle preservative compositions for self-preserving solutions - Google Patents

Abstract

Compositions are described which are useful in preserving any topically applied solution. Compositions including one or more cationic polysaccharides in solution in an amount effective to preserve contact lenses are also described, as well as methods of making and using such solutions.

Description

MODERATE PRESERVATIVE COMPOSITIONS FOR SELF-CONSERVATION SOLUTIONS Field of the Invention: The present invention relates to the use of one or more cationic polysaccharides in the manufacture of moderate preservative systems. More particularly, the present invention relates to the use of compositions that include one or more cationic polysaccharides to provide moderate preservation of ophthalmic solutions and medical devices. BACKGROUND OF THE INVENTION: Contact lenses that are widely used today fall into two general categories, hard and soft. Hard or rigid corneal type lenses are formed from materials prepared by the polymerization of acrylic esters such as poly (methyl methacrylate) (PMMA). Gel, hydrogel or soft type lenses are prepared by polymerization of monomers such as 2-hydroxyethyl methacrylate (HEMA) or in the case of long-wearing lenses, by polymerizing silicone-containing monomers or macromonomers. Both hard and soft types of contact lenses are exposed to a broad spectrum of microbes during normal use and get dirty relatively quickly. Hard or soft contact lenses, therefore, require routine cleaning and disinfection. If they are not routinely cleaned and disinfected contact lenses properly can lead to various problems ranging from a mere discomfort when they are put to serious eye infections. Eye infections caused by virulent microbes such as Pseudomonas aeruginosa can lead to the loss of the infected eye or eyes if left untreated or allowed to reach an advanced stage before initiating treatment. U.S. Patent No. 4,758,595 discloses a disinfectant and preservative for contact lenses containing a biguanide or a water soluble salt thereof in combination with a buffer, preferably a borate buffer, eg, boric acid, sodium borate , potassium tetraborate, potassium metaborate or mixtures thereof. U.S. Patent No. 4,361,548 discloses a disinfectant and preservative for contact lenses containing dilute aqueous solutions of a polymer, ie, dimethyldiallylammonium chloride (DMDAAC) having molecular weights ranging from about 10,000 to 1,000,000. . The DMDAAC homopolymer amounts as low as 0.00001 percent can be employed when an enhancer such as thimerosal, sorbic acid or phenylmercuric salt is used therewith. Although the irritation in the binding and concomitant tissue of the lens was reduced to the eye with DMDAAC, it was found that some users were above the desired clinical levels. Despite the availability of various commercially available contact lens disinfection systems such as heat, hydrogen peroxide biguanides, polymeric biguanides, quaternary ammonium polyesters, amidoamines and other chemical agents, there continues to be a need to improve the disinfectant systems and / or preservatives. Such improved disinfectant and / or preservative systems include systems that are easy to use, are effective against a broad spectrum of microbes, are non-toxic and do not cause eye irritation as a result of bonding to contact lens material. There is a particular need in the field of disinfection of contact lenses and preservation of the ophthalmic composition by safe and effective chemical agents with antimicrobial activity. Summary of the Invention: The present invention relates to unique, moderate and self-preservative solutions such as, for example, but without limitation ophthalmic solutions and similar solutions useful for topical application. Such self-preservation solutions can be useful for cleaning, soaking, rinsing, moistening and conditioning all types of contact lenses, including rigid permeable contact lenses., for nasal sprays, for ear drops, for eye drops and the like. It has been found that solutions containing compositions that include one or more cationic polysaccharides have an excellent preservative effect, but also in the case of the use of the contact lens solution increases the comfort of the person wearing the lens. The polysaccharide-containing compositions of the present invention are also useful for the preservation of ophthalmic solutions, pharmaceuticals, artificial tears, accommodation drops and the like against microbial contamination. The present polysaccharide-containing compositions are effective preservatives useful in the manufacture of topical solutions that are non-toxic, easy to use and do not cause eye irritation.

Accordingly, an object of the present invention is to provide compositions with enhanced biocidal activity useful in the manufacture of self-preservative ophthalmic systems. Another object of the present invention is to provide a method for using compositions with enhanced biocidal activity in the preservation of medical devices. Another object of the present invention is to provide compositions with enhanced biocidal activity useful in ophthalmic systems for preserving contact lenses. Another object of the present invention is to provide compositions with enhanced biocidal activity useful in the preservation of ophthalmic systems of microbial contamination. Another object of the present invention is to provide compositions with enhanced biocidal activity useful in ophthalmic systems for preserving contact lenses with reduced or eliminated ocular irritation. Another object of the present invention is to provide a method of preparing moderate compositions having biocidal activity useful in the preservation of ophthalmic systems. Still another object of the present invention is to provide a method of using moderate compositions with biocidal activity as preservatives. These and other objects and advantages of the present invention, some of which are specifically described and others not, will be apparent from the following detailed description and claims. Detailed Description of the Invention The compositions of the present invention can be used with all contact lenses such as hard and soft conventional lenses, as well as with rigid and soft gas permeable lenses. Said lenses suitable for use with compositions of the present invention include both hydrogel and non-hydrogel type lenses, as well as silicone and fluorine-containing lenses. The expression "soft contact lenses" as used herein generally refers to those contact lenses that flex easily with a small force. Typically, soft contact lenses are formulated from polymers having a certain proportion of repeating units derived from monomers such as 2-hydroxyethyl methacrylate and / or other hydrophilic monomers, typically cross-linked with a cross-linking agent. However, the newer soft lenses, especially for prolonged use, are being prepared from materials containing high Dk silicone. The compositions of the present invention also comprise one or more cationic polysaccharides. The polysaccharide-containing compositions of the present invention are useful in the production of self-preservation solutions. Self-preservation solutions are useful in the conservation of medical devices, pharmaceuticals, topically applied solutions and the like of microbial contamination. For example, the present saccharide / polysaccharide containing compositions are useful in the preservation of contact lens care solutions employed in the cleaning, soaking, rinsing and / or wetting of contact lenses. The compositions of the present invention are preferably in solution in a sufficient concentration to destroy harmful microorganisms and thus preserve the solution of microbial contamination during the entire intended life of the solution. The compositions of the present invention in solution are physiologically compatible or "ophthalmically safe" for use with contact lenses. Ophthalmically safe, as used herein, means that a contact lens treated with or in the present solution is generally suitable and safe for direct placement on the eye without rinsing. The present solutions are safe and comfortable for daily contact with the eye by a contact lens that has been moistened with the solution. An ophthalmically safe solution has a tonicity and a pH that is compatible with the eye and comprises materials, and quantities thereof, which are not cytotoxic in accordance with the ISO standards (International Standards Organization) and U.S. standards. FDA (Food and Drug Administration). The solutions of the present invention are sterile in the sense that the absence of microbial contaminants in the product prior to release should be statistically demonstrated to the extent necessary for such products. As indicated above, the compositions of the present invention include one or more cationic polysaccharides. One or more cationic polysaccharides are present in the present compositions in a total amount of about 0.001 to about 1.0 weight percent based on the total weight of the composition, but more preferably from about 0.005 to about 0, 1 percent by weight. Cationic polysaccharides suitable for use in the compositions of the present invention include, for example, but not limited to, variations of polyquaternium-10 such as, for example, Polymer JR 125 ™ (Dow Chemical Company) having a 2 percent solution viscosity of 75-125 cPs and a nitrogen percentage of 1.5 to 2.2, Polymer JR 400 ™ (Dow Chemical Company) having a solution viscosity at 2% from 300 to 500 cPs and a nitrogen percentage from 1.5 to 2.2, Polymer JR 30M ™ (Dow Chemical Company) having a 1% solution viscosity of 1,000 to 2,500 cPs and a nitrogen percentage of 1.5 to 2.2, Polymer LR 400 ™ (Dow Chemical Company) having a viscosity in 2% solution. percent from 300 to 500 cPs and a nitrogen percentage of 0.8 to 1.1, Polymer LR 30M ™ (Dow Chemical Company) that has a 1 percent solution viscosity of 1,250 to 2,250 cPs and a percentage of nitrogen from 0.8 to 1.1, and Polymer LK ™ (Dow Chemical Company) having a 2 percent solution viscosity of 300 to 500 cPs and a nitrogen percentage of 0.8 to 1.1. The preferred cationic polysaccharide for use in the present invention is Polymer JR 125 ™ or Polymer JR 400 ™. The cationic polysaccharides described above comprise a cellulosic structure derived from renewable natural resources. Cellulose is a linear chain polymer composed of anhydroglucose sugars bound by β-1,4 bonds. Each anhydroglucose sugar monomer has three hydroxyl groups (-OH) available. Cellulose, in its original state, has a regular crystal structure bound by hydrogens that is not readily soluble in water. The addition of hydroxyethyl groups to the cellulose structure alters the polymer into an easy-to-use water-soluble product. The quaternization of hydroxyethylcellulose results in the creation of multiple cationic sites to which the anionic surface groups of the microorganisms are attracted. Due to the multiple cationic sites of the cationic polysaccharides incorporated into the compositions of the present invention, antimicrobial agents commonly used in ophthalmic solutions for preservation are not necessary. Accordingly, the use of ophthalmic solutions of the present invention causes less tissue irritation, less topical toxicity, provides greater comfort to the user and provides a broader biocidal spectrum. In addition to one or more cationic polysaccharides, the compositions of the present invention may optionally include one or more buffers, such as aminoalcohol buffers, such as for example but not limited to ethanolamine buffers present in a total amount of about 0.02 to about 3.0 percent by weight based on the total weight of the composition. Suitable aminoalcohol buffers include, for example, but not limited to, monoethanolamine (MEA), diethanolamine (DEA), triethanolamine (TEA), 2-amino-2-methyl-1,3-propanediol (AMPD), 2-dimethylamino-2-methyl- l-propanediol (DMAMP), 2-amino-2-ethylpropanol (AEP), 2-amino-1-butanol (AB) and 2-amino-2-methyl-1-propanol (AMP) although preferably MEA, DEA or TEA . The compositions of the present invention may optionally also include one or more surfactants having known advantages in terms of cleaning efficiency and comfort. The surfactants may be present in the present compositions in a total amount of about 0.001 to about 5.0 weight percent based on the total weight of the composition, but more preferably from about 0.1 to about 0, 5 percent by weight. Suitable surfactants include, for example, but not limited to polyethers based on poly (ethylene oxide) -poly (propylene oxide) -poly (ethylene oxide), ie, (PEO-PPO-PEO), or poly (propylene oxide) ) -poly (ethylene oxide) -poly (propylene oxide), i.e. (PPO-PEO-PPO), or a combination thereof. PEO-PPO-PEO and PPO-PEO-PPO are commercially available under the tradenames Pluronics ™, R-Pluronics ™, Tetronics ™ and R-Tetronics (BASF yandotte Corp., Wyandotte, Michigan) and are further described in the U.S. Patent No. 4,820,352 incorporated herein by reference in its entirety. Suitable surfactants for use in the present composition should be soluble in the lens care solution, do not become cloudy and should not be irritating to eye tissues. Optionally, it may be desirable to include one or more water soluble viscosity agents in the present compositions. Due to the demulcent effect of the viscosity agents, they tend to enhance the comfort of the person wearing the lens by means of a film on the surface of the lens that cushions the impact against the eye. Suitable viscosity agents include, but are not limited to, cellulose polymers such as hydroxyethyl or hydroxypropylcellulose, carboxymethylcellulose, povidone, polyvinyl alcohol, and the like. Viscosity agents may be employed in amounts ranging from about 0.01 to about 4.0 weight percent or less. The compositions of the present invention when in solution include one or more buffers or a buffer system in addition to the aminoalcohol buffer, if any, to adjust the final pH of the solution. Suitable buffers include, for example, but not limited to, phosphate buffers, borate buffers, tris (hydroxymethyl) aminomethane (Tris) buffers, bis (2-hydroxyethyl) -imino-tris (hydroxymethyl) methane (bis-Tris) buffers, sodium bicarbonate and combinations thereof . A suitable buffering system for example may include at least one phosphate buffer and at least one borate buffer, said buffering system having a buffering capacity of 0.01 to 0.5 mM, preferably 0.03 to 0.45, 0.01 N HCl and 0.01 to 0.3, preferably 0.025 to 0.25 N 0.01 N NaOH to change the pH one unit. The buffering capacity is measured by a buffer solution alone. The pH of the lens care solutions of the present invention is preferably kept within the range of 5.0 to 8.0, more preferably of about 6.0 to 8.0, more preferably still of about 6.5 to 7.8. The compositions of the present invention may also optionally include one or more tonicity agents up to approximately the osmotic pressure of normal lacrimal fluids which is equivalent to a 0.9 percent solution of sodium chloride or a 2.5 glycerin solution. percent . Examples of suitable tonicity agents include but are not limited to sodium and potassium chloride, dextrose, mannose, glycerin, calcium and magnesium chloride. These agents are typically used individually in amounts ranging from about 0.01 to 2.5 weight percent by volume and preferably from about 0.2 to about 1.5 weight percent by volume. Preferably, the tonicity agent is employed in an amount to provide a final osmotic value of 200 to 450 mOsm / kg and more preferably between about 220 to about 350 mOsm / kg and more preferably still between about 220 to about 320 mOsm / kg. The compositions of the present invention can also include one or more sequestering agents for binding metal ions, which in the case of ophthalmic solutions, can otherwise react with protein deposits and accumulate on contact lenses. Suitable sequestering agents include, but are not limited to, ethylenediaminetetraacetic acid (EDTA) and its salts. Sequestering agents are preferably used in amounts ranging from about 0.01 to about 0.2 weight percent. Surprisingly, it has been observed in formulations of the present invention that the increase in the levels or in the amounts of EDTA and / or its salts in a formulation does not increase the preservation efficiency of the formulation. The compositions of the present invention are still described in greater detail in the following examples. EXAMPLE 1 - Preparation of Test Solutions; Sample solutions were prepared for testing according to the formulations shown below in Table 1.

TABLE 1 Test Solutions Solutions Ingredients 1 2 3 4 Percentage w / w Borate Sodium 0,135 0,160 0,160 0,160 Boric acid 1,000 1,400 1,400 1,400 EDTA 0.05 0.05 0.05 0.05 Polymer JR 30M 0.02 0.02 0.01 0.005 pH 7.0-7.4 7.11 7.11 7.11 Osmolarity (mOsm / kg) 180-220 235 230 232 TABLE 1 - Continuation - Test Solutions Solutions Ingredients 5 6 7 Percentage w / w Borate Sodium 0,160 0,160 0,160 0,160 Boric acid 1,400 1,400 1,400 1,400 EDTA 0.10 0.05 0.025 0.05 Polymer JR 30M 0.02 0.02 0.02 0 Polymer JR 400 0 0 0 0.05 pH 7.03 7.10 7.14 7.15 Osmolarity 242 235 233 235 (mOsm / kg) TABLE 1 - Continuation - Test Solutions Solutions Ingredients 9 10 Percentage w / w Borate Sodium 0,160 0,160 Boric acid 1,400 1,400 EDTA 0,05 0,05 Polymer LR 400 0,05 0 Polymer LK 0 0,05 pH 7,15 7, 15 Osmolarity (mOsm / kg) 238 234 EXAMPLE 2 - Efficacy Test of the Microbial Preservative ISO / FDA of the Test Solutions with Five FDA / SO Stimulation Microorganisms: Each of the test solutions prepared according to Example 1 above, was tested for efficacy of the microbial preservative ISO / FDA using five FDA / ISO stimulation microorganisms, ie three bacteria and two fungi. Acceptance criteria established for bacteria require that the number of viable bacteria, recovered per ml, be reduced by no less than 3.0 logarithmic units at 14 days. After restimulation on day 14, the bacterial concentration was reduced by at least 3.0 logarithmic units on day 28. The established acceptance criteria for yeasts and molds require that the number of viable yeasts and molds, recovered per ml , remain at or below initial concentrations with an experimental error of ± 0.5 logarithmic units in 14 days. After day 28, the concentration of mold and yeast will remain at or below concentrations after restimulation with an experimental error of ± 0.5 logarithmic units. The results of the efficacy test of the ISO / FDA microbial preservative of the present test solution are shown below in Table 2.

TABLE 2 Efficacy Test Results of the Microbial Preservative ISO / FDA Efficiency of Logarithmic Reduction of the Solution Conservation Agent ISO Days Staphylococcus aureus 7 1.9 1.4 1.4 1.4 1.5 (ATCC 6538) 14 > 4.8 4.7 > 4.8 > 4.8 > 4.8 21 1.6 1.1 1.1 1.1 1.1 28 > 3.9 > 3.9 > 3.9 > 3.9 3.9 Pseudomonas aeruginosa 7 > 4.9 > 5.0 > 5.0 4.3 > 5.0 (ATCC 9027) 14 > 4.9 > 5.0 > 5.0 > 5.0 > 5.0 21 > 3.9 > 3.8 > 3.8 > 3.8 3.8 28 > 3.9 > 3.8 > 3.8 > 3.8 3.8 Escherichia coli 7 > 4.8 4.5 4.9 4.9 4.8 (ATCC 8739) 14 > 4.8 > 4.9 > 4.9 > 4.9 > 4.9 21 > 3.9 > 3.8 > 3.8 3.8 3.2 28 > 3.9 3.8 3.8 > 3.8 > 3.8 Candida albi cans 7 2.2 2.3 1.8 1.9 1.7 (ATCC 10231) 14 4.2 4.3 3.1 3.1 2.8 21 1.3 1.4 1.2 1.1 1.0 28 2.5 > 3.9 3.9 3.9 > 3.9 Aspergillus niger 7 1.6 1.4 1.3 1.3 1.4 (ATCC 16404) 14 1.3 1.2 1.1 1.1 1.1 21 0.6 0.4 0.4 0.4 0.3 28 0.1 0.3 0.2 0.1 0.1 ,3 TABLE 2 - Continuation Results of the Efficacy Test of the Microbial Preservative ISO / FDA Efficiency of Logarithmic Reduction of the Solution Conservation Agent ISO Days 6 7 8 9 10 Staphylococcus aureus 7 1.7 2.1 2.1 > 3.8 1.4 (ATCC 6538) 14 > 4.8 > 4.8 > 4.8 3.9 4.0 21 1.4 1.4 2.3 1.4 1.6 28 > 3.9 > 3.9 > 3.8 > 3.8 > 3.8 Pseudomouas aerug-inosa 7 > 5.0 > 5.0 > 4.8 > 4.8 > 4.8 (ATCC 9027) 14 > 5.0 > 5.0 > 4.8 4.7 > 4.8 21 3.8 > 3.8 > 3.8 > 3.8 > 3.8 28 3.8 > 3.8 > 3.8 > 3.8 > 3.8 It is ch eri chia coli 7 > 4.9 4.9 4.9 4.3 4.3 (ATCC 8739) 14 > 4.9 > 4.9 > 4.7 4.7 3.3 21 3.8 3.8 > 3.8 > 3.8 2.2 28 > 3.8 > 3.8 > 3.8 3.7 3.0 Candida albicans 7 2.1 2.6 2.1 0.5 0.3 (ATCC 10231) 14 3.7 4.7 4.8 1.8 1.8 21 1.3 1.8 2.4 0.9 0.8 28 3.9 3.9 > 3.9 2.7 2.6 Aspergillus niger 7 1.3 1.4 1.1 1.2 1.2 (ATCC 16404) 14 1.1 1.1 0.9 0.8 0.8 21 0.4 0.4 0.3 0.2 0.3 28 0.3 0.3 -0.1 0.0 0.0 EXAMPLE 3 - Preparation of the Preservative System; Sample solutions for testing were prepared according to the preservative system formulations shown below in Table 3.

TABLE 3 Test Solutions Ingredients Solutions Percentage p / p 11 12 13 14 15 Sodium Borate 0,160 0 0 0 0 Boric acid 1,400 0 0 0 0 EDTA 0.05 0.05 0.05 0.05 0.50 Polymer JR 30M 0.02 0.02 0 0 0 Polymer JR 400 0 0 0.05 0 0 Polymer LR 400 0 0 0 0.05 0 Polymer LK 0 0 0 0 0.05 Triethanolamine HCl 0 0.934 0.934 0.934 0.934 (98%) Sodium Chloride 0 0,340 0,340 0,340 0,340 pH 7,15 7,15 7,15 7,15 7,15 Osmolarity (mOsm / kg) 237 212 241 203 209 EXAMPLE 4 - Efficacy Test of the Microbial Preservative ISO / FDA of the Test Solutions with Five FDA / ISO Stimulation Microorganisms; Each of the test solutions prepared according to Example 3 above was tested for efficacy of the ISO / FDA microbial preservative using five FDA / ISO stimulation microorganisms, ie three bacteria and two fungi. Acceptance criteria established for bacteria require that the number of viable bacteria, recovered per ml, be reduced by no less than 3.0 logarithmic units at 14 days. After restimulation on day 14, the bacterial concentration will be reduced by at least 3.0 logarithmic units by day 28. The accepted acceptance criteria for yeasts and molds require that the number of viable yeasts and molds, recovered per ml , remain at or below the initial concentrations with an experimental error of ± 0.5 logarithmic units at 14 days. After day 28, the mold and yeast concentration will remain at or below the concentrations after restimulation with an experimental error of ± 0.5 logarithmic units. The results of the efficacy test of the ISO / FDA microbial preservative of the present test solution are shown below in Table 5. As shown by the results shown in Table 4.

TABLE 4 Results of the Efficacy Test of the Microbial Preservative ISO / FDA Conservation Effectiveness Logarithmic Reduction of the Solution ISO Agent Days 11 12 13 14 15 Staphylococcus aureus 7 1.4 > 3.8 > 3.8 > 3.8 1.3 (ATCC 6538) 14 > 4.8 2.9 3.4 3.4 4.0 21 1.8 0.7 1.3 1.1 1.3 28 > 3.8 2.9 3.4 3.3 > 3.8 Pseudomonas aeruginosa 7 > 4.8 ND ND ND ND (ATCC 9027) 14 > 4.8 1.8 1.5 1.5 1.5 21 > 3.8 ND ND ND ND 28 > 3.8 ND ND ND ND Escherichia coli 7 > 4.7 4.0 3.4 > 3.7 > 3.7 (ATCC 8739) 14 > 4.7 4.7 > 4.7 2.1 2.7 21 > 3.8 3.5 3.8 1.8 0.9 0.9 > 3.8 > 3.8 > 3.8 3.8 ND Candida albi cans 7 1.8 0.2 0.2 0.2 0.2 (ATCC 10231) 14 3.2 0.8 0.7 0.5 0.7 21 1.6 0.5 0.5 0.5 0.5 28 3.6 0.9 1.0 1.1 0 9 Aspergillus niger 7 1,2 > 2.6 > 2.6 > 2.6 > 2,6 (ATCC 16404) 14 0.9 0.1 0.0 0.0 -0.1 21 0.3 -0.1 0.0 -0.1 0.0 28 0.1 -0.1 -0, 1 0,0 0,0 The cationic polysaccharide-containing compositions of the present invention are useful in solutions for the care of contact lenses to preserve contact lenses. A preservative amount of one or more cationic polysaccharides is an amount that will at least partially reduce the population of microorganisms in the formulations employed. Preferably, a preservative amount is one that will reduce the microbial load of the representative bacteria in two logarithmic orders in four hours and more preferably in a logarithmic order in one hour. More preferably still, a preservative amount is an amount that will eliminate the microbial load on a contact lens when used in accordance with its recommended soaking time regime (FDA Chemical Desinfection Efficacy Test - July 1985 Contact Lens Solution Draft Guidelines). Unexpectedly, in the presence of one or more cationic polysaccharides, an antimicrobial agent is not needed to achieve effective conservation of the solution. As indicated above, contact lenses are conserved by contacting the lenses with a solution containing an effective amount of one or more compositions of the present composition. Although this can be achieved by simply soaking the lenses in the present solution, further cleaning can be achieved if a few drops of the solution are initially placed on each side of the lens and the lens is rubbed over a period of time, for example about 20 seconds. . The lens can then be submerged subsequently in several milliliters of the present solution. Preferably, the lens is allowed to soak in the solution for at least four hours. The lenses are removed after the solution, rinsed with it or with a different solution, for example an isotonic saline solution preserved with cationic polysaccharide prepared according to the present invention, and put back into the eye.

Solutions containing one or more compositions of the present invention can be formulated into specific products for the care of contact lenses for use as is usually done in the field of ophthalmology. Such products include, but are not limited to, wetting solutions, soaking solutions, cleaning and conditioning solutions as well as cleaning and conditioning solutions within the eye. Although the invention has been described along with specific examples thereof, this is only illustrative. Accordingly, many alternatives, modifications and variations will be apparent to those skilled in the art in light of the foregoing description and it is therefore intended to encompass all these alternative modifications and variations that fall within the spirit and scope of the appended claims. .

Claims (15)

Claims

1. Compositions comprising: one or more cationic polysaccharides in solution in an effective amount for the conservation of the solution.

2. Compositions comprising: one or more cationic polysaccharides in an effective amount as a preservative agent.

3. The compositions of claim 1 or 2 wherein said one or more cationic polysaccharides are selected from the group consisting of polyquaternium-10 variations.

. The compositions of claim 1 or 2 wherein said one or more cationic polysaccharides are selected from the group consisting of Polymer JR 125, Polymer JR 400, Polymer JR 30M, Polymer LR 400, Polymer LR 30M and Polymer LK.

5. A method of producing compositions of claim 1 or 2 comprising: combining one or more cationic polysaccharides in an effective amount for the preservation of the solution.

6. The method of claim 5 wherein said one or more cationic polysaccharides are selected from the group consisting of polyquaternium-10 variations.

The method of claim 5 wherein said one or more cationic polysaccharides are selected from the group consisting of Polymer JR 125, Polymer JR 400, Polymer JR 30M, Polymer LR 400, Polymer LR 30M and Polymer LK.

8. A solution comprising one or more compositions of claim 1 or 2.

9. The solution of claim 8 wherein said solution includes one or more buffers or buffering agents.

10. The solution of claim 8 wherein said solution includes one or more tonicity agents.

11. The solution of claim 8 wherein said solution includes one or more surfactants.

12. The solution of claim 8 wherein said solution includes one or more viscosity agents.

13. A method for using the solution of claim 8 comprising: contacting a surface of a contact lens with said solution for a suitable period of time to eliminate a microbial load on said contact lens.

14. A method for using the solution of claim 8 comprising: contacting a surface of a medical device with said solution for a suitable period of time to eliminate a microbial load on said medical device.

15. A method for producing the solution of claim 8 comprising: adding an effective amount of one or more cationic polysaccharides to a solution.