Cleaning compositions for solid surfaces – auxiliary compositions – Cleaning compositions or processes of preparing – For cleaning a specific substrate or removing a specific...
Reexamination Certificate
2001-02-07
2003-05-27
Delcotto, Gregory (Department: 1751)
Cleaning compositions for solid surfaces, auxiliary compositions
Cleaning compositions or processes of preparing
For cleaning a specific substrate or removing a specific...
C510S113000, C422S028000, C514S840000
Reexamination Certificate
active
06569824
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a contact lens treating method and composition. In particular, the invention is directed to a contact lens disinfecting composition having reduced toxicity to the eye, wherein the composition comprises a monoperphthalic acid compound in a concentration of less than about 0.5% by weight of said composition.
BACKGROUND OF THE INVENTION
Contact lenses are worn on the cornea of the eye to improve sight. Both hard and soft contact lenses require periodic cleaning and disinfecting to remove protein deposits and undesirable microbes from the surface of the lens. In most cases, the lens is removed from the eye and cleaned with a lens cleaning solution. Then, the lens is disinfected. After disinfection, the lens usually is rinsed with saline solution for placement into the eye.
In the disinfecting of contact lenses, it is very important to select compositions that are effective to disinfect the lens but are not toxic to the eye. Thousands of compositions exist which are capable of disinfecting, but which exhibit toxic or undesirable discomfort to the eye when such compositions are used on lenses. Lens users sometimes fail to rinse the disinfectant solution from their lenses before placing lenses back into the eye. In some cases, lens wearers rinse their lenses poorly. Sometimes, the disinfecting composition adheres or adsorbs into the lens itself, such that even after a rinse, the relatively toxic substances from the disinfectant solution still may be temporarily retained within the surface of the lens. When that occurs, the toxic substances may be released into the eye once the lens is re-inserted. For these reasons, a desirable disinfectant solution preferably does not contain any compositions in concentration levels that exceed toxicity limits for the eye.
Unfortunately, many ophthalmic and lens care products which are effective disinfectants cause undesirable eye irritation. Also, many antimicrobial agents have a relatively narrow spectrum, and may be effective against certain microbes such as bacteria, but not against others such as fungi. Other compositions may be effective against a wide range of bacteria, yeast, and fungi, but may have limited efficacy. Many compositions that would otherwise be good lens disinfectant compositions undesirably react with other components in the lens care solution, producing unwanted side reactions and undesirable reaction products.
Magnesium perphthalate has been used in various medical applications, including contact lens disinfecting solutions. Magnesium perphthalate is a peroxy compound, and is known to have antimicrobial activity against bacteria and yeast.
Great Britain Patent 2,178,189A discloses the use of a monoperoxyphthalate salt such as magnesium monoperoxyphthalate hexahydrate in a contact lens cleaning solution. The patent teaches using magnesium monoperoxyphthalate hexahydrate in an amount from 1% to 20% by weight in aqueous solution. Another patent publication (WO 87/01562) discloses using alkaline earth metal salts of monoperphthalic acid for contact lens maintenance in aqueous concentration ranges between 0.5% and 10.0% by weight.
It recently has been discovered, however, that using such compounds in concentration ranges of 0.5% and above may have substantially adverse toxic effects to the user. Significantly elevated toxicity levels are experienced using lens care solutions having magnesium perphthalate concentrations of 0.5% or greater.
Recent data indicates that using such compounds in concentration levels below 0.5% provide surprisingly and unexpectedly reduced levels of toxicity, while still providing good lens disinfection.
ADDITIONAL BACKGROUND REFERENCES
European Patent Application 27,693, published Apr. 29, 1981, owned by Interox Chemicals Limited, discloses the magnesium salts of peroxycarboxylic acids, including the magnesium salt of monoperphthalic acid, and processes for preparing these compounds. The compounds are used as bleaching agents in washing compositions.
European Patent Application 96,525, published Dec. 21, 1983, owned by Interox Chemicals Limited, discloses compositions containing magnesium salts of organic peroxy acid/carboxylate compounds, including magnesium monoperphthalate. These compositions are used for the cleansing and sanitization of reusable diapers.
Great Britain Patent Application 2,137,882, published Oct. 17, 1984, owned by Interox Chemicals Limited, discloses disinfectants containing magnesium peroxycarboxylates, including magnesium monoperphthalate. Such compositions are used for disinfecting/sterilizing hard surfaces such as toilets, drains, or equipment used in medical or food processing environments.
U.S. Pat. No. 4,490,269, issued Dec. 25, 1984 to Gallopo discloses cleansing compositions comprising an effervescent agent and a monoperphthalate, or an effervescent agent and a potassium monopersulfate and a monoperphthalate, as bleaching agents. These compositions are used to cleanse removable orthodontic appliances such as false teeth, dental plates and bridges.
European Patent Application 133,354 published Feb. 20, 1985, owned by Interox Chemicals Limited discloses compositions, generally in tablet form, containing a peroxygen compound (including monoperphthalate) and an effervescence generator. These compositions are dissolved in water to produce a bath in which to soak, and thereby cleanse, removable dentures.
U.S. Pat. No. 3,988,433, issued Oct. 26, 1976 to Benedict, and Great Britain Patent 1,477,691, issued Oct. 19, 1977 to Jones et al., disclose compositions containing alkyl and aryl peroxy acids. These compositions are used to remove stains from teeth.
U.S. Pat. No. 4,350,681, issued Sep. 21, 1982 to Fulton, discloses compositions containing benzoyl peroxide stabilized in an aqueous medium by the presence of glycerol. These compositions are used as toothpastes or body scrubs.
SUMMARY OF THE INVENTION
Surprisingly, it has been discovered that using perphthalic acid compounds in concentration levels below 0.5% provides reduced levels of toxicity while still providing unexpectedly good lens disinfection.
The invention is directed to a contact lens treating method and composition. In particular, the invention is directed to a contact lens disinfecting composition having reduced toxicity to the eye, wherein the composition comprises a monoperphthalic acid compound in a concentration of less than about 0.5% by weight of said composition.
In the invention, methods and compositions are provided. In some cases, lens care disinfectant solutions are disclosed. Other embodiments provide a powder or tablet containing a monoperphthalic acid compound wherein the powder or tablet may be dissolved in an aqueous environment such as deionized water or saline solution just prior to soaking a contact lens in the solution. One convenient method of using the invention is to provide such powder or tablet with standard saline solution for disinfecting lenses, so that a lens wearer may use solutions already on hand and commercially available to perform the disinfecting operation. One embodiment of the invention is a method of employing a composition wherein the monoperphthalic acid compound is selected from the group of compounds consisting of the following: magnesium monoperphthalate hexahydrate, magnesium monoperoxyphthalate hydrates, calcium monoperphthalate, sodium monoperphthalates, sodium monoperoxyphthalates, potassium monoperphthalates, potassium monoperoxyphthalates, magnesium perphthalates, calcium perphthalates, potassium perphthalates, sodium perphthalates, sodium potassium perphthalates, potassium hydrogen perphthalates, sodium hydrogen perphthalate, potassium acid perphthalates, perphthalic acid, monoperphthalic acid, magnesium perphthalate hexahydrates, perphthalate hydrates, 1,2 benzenedicarboperoxoic acid alkali metal salts, 1,2 benzenedicarboperoxoic acid dialkali metal salts, 2-carboxy benzenecarboperoxoic acid salts, 2-carboxy benzenemonocarboperoxoic acid alkaline earth metal salts, 2-carboxy benzenemonocarboperoxoic acid alkali metal
Delcotto Gregory
Gearhart Richard I
Gorman, Jr. Robert
Meece R. Scott
Novartis AG
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