Classifications

• • C—CHEMISTRY; METALLURGY
  • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
  • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
  • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
  • C11D3/0005—Other compounding ingredients characterised by their effect
  • C11D3/0078—Compositions for cleaning contact lenses, spectacles or lenses
• • A—HUMAN NECESSITIES
  • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
  • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
  • A01N43/00—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds
  • A01N43/34—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one nitrogen atom as the only ring hetero atom
  • A01N43/40—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one nitrogen atom as the only ring hetero atom six-membered rings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
  • A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
  • A61L12/14—Organic compounds not covered by groups A61L12/10 or A61L12/12
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
  • A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
  • A61L12/14—Organic compounds not covered by groups A61L12/10 or A61L12/12
  • A61L12/143—Quaternary ammonium compounds
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
  • A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
  • A61L12/14—Organic compounds not covered by groups A61L12/10 or A61L12/12
  • A61L12/143—Quaternary ammonium compounds
  • A61L12/145—Polymeric quaternary ammonium compounds
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/02—Ophthalmic agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• • C—CHEMISTRY; METALLURGY
  • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
  • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
  • C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
  • C11D1/008—Polymeric surface-active agents
• • C—CHEMISTRY; METALLURGY
  • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
  • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
  • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
  • C11D3/16—Organic compounds
  • C11D3/20—Organic compounds containing oxygen
  • C11D3/22—Carbohydrates or derivatives thereof
  • C11D3/222—Natural or synthetic polysaccharides, e.g. cellulose, starch, gum, alginic acid or cyclodextrin
• • C—CHEMISTRY; METALLURGY
  • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
  • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
  • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
  • C11D3/16—Organic compounds
  • C11D3/26—Organic compounds containing nitrogen
  • C11D3/28—Heterocyclic compounds containing nitrogen in the ring
• • C—CHEMISTRY; METALLURGY
  • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
  • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
  • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
  • C11D3/16—Organic compounds
  • C11D3/34—Organic compounds containing sulfur
  • C11D3/349—Organic compounds containing sulfur additionally containing nitrogen atoms, e.g. nitro, nitroso, amino, imino, nitrilo, nitrile groups containing compounds or their derivatives or thio urea
• • C—CHEMISTRY; METALLURGY
  • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
  • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
  • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
  • C11D3/48—Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions
• • C—CHEMISTRY; METALLURGY
  • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
  • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
  • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
  • C11D3/16—Organic compounds
  • C11D3/34—Organic compounds containing sulfur
  • C11D3/3409—Alkyl -, alkenyl -, cycloalkyl - or terpene sulfates or sulfonates

Definitions

• the present invention relates to compositions and methods for eye and contact lens care. More particularly, the invention relates to ophthalmic compositions which contain cetylpyridinium chloride as a decontaminating agent for preservation of the solution and/or disinfecting contact lenses.
• Description of the Prior Art Contact lens wear induces adverse changes in ocular tissues and the tear film. These changes include cornea lactic acidosis and subsequent cornea swelling as a consequence of hypoxia induced by low oxygen gas transmission, changes in corneal epithelial tissue thickness, changes in corneal epithelial and endothelial cell morphology, epithelial surface cell exfoliation, hyperemia (red eye), adverse changes in corneal and conjunctival cell membrane integrity and destabihzation of the tear film.
• CPC cetylpyridinium chloride
• cetylpyridinium chloride (CPC) at low concentrations, in combination with a non-ionic surfactant, can be efficacious as a contact lens disinfection agent.
• the non-ionic surfactant is a poly(oxypropylene)-poly(oxyethylene) block copolymer. Such efficacy may be seen in concentrations ranging from as low as 0.1 ppm or 0.3 ppm to about 8 ppm, 9 ppm or 10 ppm.
• Figure 1 shows the amount of CPC uptake by Purevision® lenses (Bausch & Lomb Incorporated, Rochester New York) as a function of CPC concentration at adsorption equilibrium.
• compositions include, in an aqueous liquid medium, a non-ionic surfactant and cetylpyridinium chloride.
• the non-ionic surfactant is a poly(oxypropylene)-poly(oxyethylene) block copolymer.
• Such solutions may also include one or more of the following: additional antimicrobial components, preferably reduced in concentration from the concentration that is typically used with only one antimicrobial component; a buffer component in an amount effective to maintain the pH of the solution within a physiologically acceptable range; an effective amount of a viscosity inducing component; a surfactant in an amount effective to clean a contact lens contacted with the solution; and a tonicity component in an amount effective to provide the desired tonicity to the solution.
• the solutions may also include taurine. The benefits of including taurine are disclosed in U.S. Patent Application Ser. No. 10/328,641, to S. Huth, entitled “Contact Lens Care Compositions, Methods of Use, and Preparation which Protect Ocular Tissue," which is incorporated herein by reference.
• the solutions of the present invention provide the desired antimicrobial activity and performance effectiveness and, importantly, substantial, preferably enhanced, lens wearer/user comfort and acceptability benefits.
• contact lens cleaning and disinfecting solutions typically contain significant amounts of surfactants in order to clean the contact lens surface which is contaminated mainly by tear protein and lipids.
• surfactants include non-ionic surfactants and non-ionic surfactants.
• non-ionic surfactants are commonly used for contact lens cleaning.
• non-ionic surfactants are also commonly used to neutralize quaternary-based antimicrobial- agents in microbiology test labs. Thus, the concentration must be carefully controlled.
• Anionic surfactants such as soap are generally not compatible with quaternary amine based antimicrobials that are positively charged.
• anionic surfactants would defy the microbial activity of non-polymeric based polyquaternary ammonium compounds. Electrostatic interaction between ion of the surfactant and cation of the quaternary ammonium would neutralize the net charge, eliminate the antimicrobial activity and form a precipitate due to the loss of hydrophilicity by charge neutralization.
• j Cationic surfactants are compatible with alkyl amines, but they themselves are antimicrobial agents, and therefore cannot be added in large amounts without irritating the eye.
• CPC is highly active in specific concentration ranges and can be used in contact lens disinfecting. That is, CPC can be used for contact lens disinfection without significantly building up in a contact lens, provided that it is used with a certain type of surfactant which functions as a cleaning and/or solubilizing agent, and the two are used according to a special mixing ratio.
• a certain type of non-ionic surfactant, used in a certain mixing ratio can reduce CPC lens uptake while maintaining anti-microbial effectiveness for disinfection.
• the present compositions which may be multi-purpose solutions, have a multitude of applications, for example, as disinfecting, cleaning, soaking, wetting, rewetting, rinsing, storing, in-the-eye cleaning, and conditioning compositions, for contact lens care, while providing substantial lens wearer/user comfort and acceptability.
• the present compositions also increase user compliance, that is promote regular and consistent contact lens care, and, ultimately, lead to or facilitate better ocular health.
• Any contact lenses for example, conventional hard contact lenses, rigid gas permeable contact lenses and soft, hydrophilic or hydrogel, contact lenses, including silicone hydrogel contact lenses, can be treated in accordance with the present invention.
• CPC in the presence of a selected non-ionic surfactant, can be efficacious as a contact lens disinfection agent at low concentration ( ⁇ 10 ppm).
• non-ionic surfactants for use in the present invention are disclosed in, for example, Kirk-Othmer, Encyclopedia of Chemical Technology, 3rd Edition, Vol. 22 (John Wiley E Sons, 1983), Sislet & Wood, Encyclopedia of Surface Active Agents (Chemical Publishing Co., Inc. 1964), McCutcheon's Emulsifiers & Detergents, North American and International Edition (McCutcheon Division, The MC Publishing Co., 1991), Ash, The Condensed Encyclopedia of Surfactants (Chemical Publishing Co., Inc., 1989), Ash, What Every Chemical Technologist Wants to Know About . . . Emulsifiers and Wetting Agents, Vol.
• Such surfactants include Tetronic® 1307, Tetronic® 904, Tetronic® 1304, Tetronic® 1107 (BASF Corporation, Mount Olive, New Jersey) and Pluronic® F87 (BASF Corporation, Mount Olive, New Jersey).
• the additional antimicrobial component may be any suitable, preferably ophthalmically acceptable, material effective to disinfect a contact lens contacted with the present solutions or alternatively adequately preserve a solution such as a contact lens rewetting solution.
• the additional antimicrobial component is selected from biguanides, biguanide polymers, salts thereof and mixtures thereof, and is present in an amount in the range of about 0.1 ppm to about 3 ppm or less than 5 ppm (w/v).
• the additional antimicrobial component may be a monomeric quaternary ammonium or biguanide compound such as chlorhexidine digluconate, chlorhexidine diacetate, benzethonium chloride and myristamidopropyldimethylamine.
• the additional antimicrobial component may also be a polymeric quaternary ammonium compound such as Polyquad.RTM. (polyquatemium-1) or poly [oxyethylene (dimethyliminio) ethylene-(dimethyliminio) ethylene dichloride] (sold under the trademark WSCP by Buckman Laboratories, Inc.).
• the preferred relatively reduced concentration of the additional antimicrobial component has been found to be very effective, in the present compositions, in disinfecting contact lenses contacted with the compositions, while at the same time promoting lens wearer/user comfort and acceptability.
• any suitable, preferably ophthalmically acceptable viscosity inducing or thickening agent may be included in the present compositions.
• the viscosity inducing component preferably is selected from cellulosic derivatives and mixtures thereof and is present in an amount in the range of about 0.05% or about 1.5% to about 3% or about 5.0% (w/v).
• a viscosity inducing component at least assists in providing the lens wearer/user comfort and acceptability benefits of the present invention, which promote regular and consistent contact lens care and ultimately lead to or facilitate better ocular health.
• the present combinations of components for example, including such viscosity inducing components, are effective in providing the degree of lens wearer/user comfort and acceptability benefits described herein.
• an extremely useful tonicity component is a combination of sodium chloride and potassium chloride.
• the present compositions preferably include an effective amount of a chelating component.
• a chelating component Any suitable, preferably ophthalmically acceptable, chelating component may be included in the present compositions, although ethylenediaminetetraacetic acid (EDTA), salts thereof and mixtures thereof are particularly effective.
• the present compositions include chelating components in effective amounts less than about 0.05% (w/v) and still more preferably 0.02°s (w/v) or less. Such reduced amounts of chelating component in the present compositions remain effective in providing the desired chelating and/or sequestering functions while, at the same time, are better tolerated in the eye, thereby reducing the risk of user discomfort and/or ocular irritation.
• each of the components, in the concentration employed, included in the solutions and the formulated solutions of the present invention generally are ophthalmically acceptable.
• each of the components (in the case of the CPC, in combination with the non-ionic surfactant as described above), in the concentration employed included in the present solutions usually is soluble in the liquid aqueous medium.
• the solution may also optionally include an additional antimicrobial component in an amount effective to, in association with the remainder of the solution, disinfect a contact lens contacted with the composition.
• a solution or component thereof is "ophthalmically acceptable" when it is compatible with ocular tissue, that is, it does not cause significant or undue detrimental effects when brought into contact with ocular tissue.
• each component of the present compositions is also compatible with the other components of the present compositions.
• the present compositions are more preferably substantially ophthalmically optimized.
• An ophthalmically optimized composition is one which, within the constraints of component chemistry, minimizes ocular response, or conversely delivers ophthalmic benefit to the lens wearing eye.
• the presently useful additional antimicrobial components include chemicals which derive their antimicrobial activity through a chemical or physiochemical interaction with microbes or microorganisms, such as those contaminating a contact lens.
• Suitable additional antimicrobial components are those generally employed in ophthalmic applications and include, but are not limited to, quaternary ammonium salts used in ophthalmic applications such as poly [dimethylimino-2-butene-l, 4-diyl] chloride, alpha - [4-tris (2-hydroxyethyl) ammonium] -dichloride (chemical registry number 75345-27-6, available under, the trademark Polyquateraium 1® from Onyx Corporation), benzalkonium halides, and biguanides, such as salts of alexidine, alexidine-free base, salts of chlorhexidine, hexamethylene biguanides and their polymers, and salts thereof, antimicrobial polypeptides, chlorine dioxide precursors, and the like and mixtures thereof
• PHMB hexamethylene biguanide polymers
• PAPB polyaminopropyl biguanide
• the antimicrobial component is present in the liquid aqueous medium at an ophthalmically acceptable or safe concentration such that the user can remove the disinfected lens from the liquid aqueous medium and thereafter directly place the lens in the eye for safe and comfortable wear.
• the antimicrobial component is present in the liquid aqueous medium at an ophthalmically acceptable or safe concentration and sufficient for maintaining preservative effectiveness.
• the additional antimicrobial components suitable for inclusion in the present invention include chlorine dioxide precursors.
• chlorine dioxide precursors include stabilized chlorine dioxide (SCD), metal chlorites, such as alkali metal and alkaline earth metal chlorites, and the like and mixtures thereof.
• Technical grade sodium chlorite is a very useful chlorine dioxide precursor.
• Chlorine dioxide containing complexes such as complexes of chlorine dioxide with carbonate, chlorine dioxide with bicarbonate and- mixtures thereof are also included as chlorine dioxide precursors.
• the exact chemical composition of many chlorine dioxide precursors, for example, SCD and the chlorine dioxide complexes, is not completely understood.
• the manufacture or production of certain chlorine dioxide precursors is described in McNicholas, U.S. Patent 3,278,447, which is incorporated in its entirety herein by reference.
• Specific examples of useful SCD products include that sold under the tiademark Dura Klor® by Rio Linda Chemical Company, Inc., and that sold under the trademark Anthium Dioxide® by International Dioxide, Inc.
• a chlorine dioxide precursor in included in the present compositions it generally is present in an effective preservative or contact lens disinfecting amount.
• Such effective preservative or disinfecting concentrations usually are in the range of about 0.002 to about 0.06% (w/v) of the present compositions.
• the chlorine dioxide precursors may be used in combination with other antimicrobial components, such as biguanides, biguanide polymers, salts thereof and mixtures thereof.
• the compositions usually have an osmolality of at least about 200 mOsmol/kg and are buffered to maintain the pH within an acceptable physiological range, for example, a range of about 6 to about 10.
• compositions usually further comprise effective amounts of one or more additional components, such as a detergent or surfactant component; a viscosity inducing or thickening component; a chelating or sequestering component; a tonicity component; and the like and mixtures thereof.
• additional component or components may be selected from • materials which are known to be useful in contact lens care compositions and are included in amounts effective to provide the desired effect or benefit.
• an additional component is included, it is generally compatible under typical use and storage conditions with the other components of the composition.
• the aforesaid additional component or components are substantially stable in the presence of the antimicrobial and buffer components described herein.
• the viscosity inducing components employed in the present solutions preferably are effective at low or reduced concentrations, compatible with the other components of the present solutions, and anionic and non-ionic. Such viscosity inducing components are effective to enhance and/or prolong the cleaning and wetting activity of the surfactant component and/or condition the lens surface rendering it more hydrophilic (less lipophilic) and/or to act as a demulcent on the eye. Increasing the solution viscosity provides a film on the lens which may facilitate comfortable wearing of the treated contact lens. The viscosity inducing component may also act to cushion the impact on the eye surface during insertion and serves also to alleviate eye irritation.
• Suitable viscosity inducing components include, but are not limited to, water soluble natural gums, cellulose-derived polymers and the like.
• Useful natural gums include guar gum, gum tragacanth and the like.
• Useful cellulose-derived viscosity inducing components include cellulose-derived polymers, such as hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose, methyl cellulose, hydroxyethyl cellulose and the like. More preferably, the viscosity inducing agent is selected from cellulose derivatives (polymers) and mixtures thereof.
• a very useful viscosity inducing component is hydroxypropylmethyl cellulose (HPMC).
• a reduced amount is employed, for example, in the range of less than about 0.05% (w/v) or even about 0.02% (w/v) or less.
• Such reduced amounts of chelating component have been found to be effective in the present compositions while, at the same time, providing for reduced cytotoxicity, discomfort and/or ocular irritation.
• the liquid aqueous medium preferably includes an effective amount of a tonicity component to provide the liquid medium with the desired tonicity.
• a tonicity component may be present in the liquid aqueous medium and/or may be introduced into the liquid aqueous medium.
• suitable tonicity adjusting components that may be employed are those conventionally used in contact lens care products, such as various inorganic salts.
• Sodium chloride and/or potassium chloride and the like are very useful tonicity components.
• the amount of tonicity component included is effective to provide the desired degree of tonicity to the solution. Such amount may, for example, be in the range of about 0.1% to about 1.5% (w/v). If a combination of sodium chloride and potassium chloride is employed, it is preferred that the weight ratio of sodium chloride to potassium chloride be in the range of about 2.5 to about 6 or about 8.
• Candida albicans ATCC 10231, is one of five organisms specified per FDA and ISO/CLI tests for the testing of contact lens disinfectants (FDA Premarket Notification (510k) Guidance Document for Contact Lens Care Products, Appendix A and B, May 1, 1997 and ISO/FDIS 14729: Ophthalmic optics-Contact lens care products- Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses, January 2001).
• Contact lens disinfectants are also known as contact lens multipurpose solutions when they are used for rinsing, cleaning, disinfection, storage and rewetting contact lenses.
• the five FDA/ISO specified test organisms are listed below:
• Candida albicans is often the most resistant of the five organisms to commonly used cationic antimicrobial agents in contact lens multi-purpose solutions. Thus, achievement of adequate antimicrobial activity against Candida is often the most difficult task to pass a particular disinfection efficacy standard.
• FDA and ISO guidelines specify two disinfection efficacy standards, indicated in the table below: Stand Alone Disinfectant (Primary) Criteria: Organism Average log reduction at labeled soak time S. marcescens 3.0 logs S. aureus 3.0 logs P. aeruginosa 3.0 logs C. albicans 1.0 log F. solani 1.0 log

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• 2004
  • 2004-04-07 US US10/820,486 patent/US7578996B2/en active Active
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