WO1986005401A1 - Production of cleansing and disinfecting solutions - Google Patents

Production of cleansing and disinfecting solutions Download PDF

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Publication number
WO1986005401A1
WO1986005401A1 PCT/GB1986/000146 GB8600146W WO8605401A1 WO 1986005401 A1 WO1986005401 A1 WO 1986005401A1 GB 8600146 W GB8600146 W GB 8600146W WO 8605401 A1 WO8605401 A1 WO 8605401A1
Authority
WO
WIPO (PCT)
Prior art keywords
agent
solid composition
tap water
composition
sodium
Prior art date
Application number
PCT/GB1986/000146
Other languages
French (fr)
Inventor
James Frederick Pickard
Original Assignee
Derwentside Laboratories Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GB858506677A external-priority patent/GB8506677D0/en
Priority claimed from GB858528714A external-priority patent/GB8528714D0/en
Application filed by Derwentside Laboratories Limited filed Critical Derwentside Laboratories Limited
Publication of WO1986005401A1 publication Critical patent/WO1986005401A1/en

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Classifications

    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/0005Other compounding ingredients characterised by their effect
    • C11D3/0078Compositions for cleaning contact lenses, spectacles or lenses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L12/00Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • A61L12/12Non-macromolecular oxygen-containing compounds, e.g. hydrogen peroxide or ozone
    • A61L12/124Hydrogen peroxide; Peroxy compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L12/00Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • A61L12/14Organic compounds not covered by groups A61L12/10 or A61L12/12
    • A61L12/143Quaternary ammonium compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L12/00Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • A61L12/14Organic compounds not covered by groups A61L12/10 or A61L12/12
    • A61L12/148Mercury containing compounds, e.g. thimerosal
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D1/00Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
    • C11D1/38Cationic compounds
    • C11D1/62Quaternary ammonium compounds
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11DDETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/48Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions

Definitions

  • This invention relates to the production of cleansing solutions and more particularly, but not exclusively, is concerned with the production of cleansing solutions for disinfecting both so called hard and so called soft contact lenses.
  • Contact lenses are now widely available for correcting optical deficiencies of the human eye and, as the name implies, they are worn in direct contact with the eye tissue.
  • the lenses and particularly in the case of soft lenses, proteinaceous, mucal and mineral deposits tend to build up on the surface of the lens and these may cause blurred vision and irritation.
  • the lenses When the lenses are removed from the eye for cleansing or storage (e.g. overnight) or for other manipulation, it is necessary to disinfect the lenses to avoid subsequent infection of the eye.
  • the lenses need to be cleansed and disinfected period- ically and conventionally this is done by heating the lenses in saline or the like or by placing the lenses in a cleansing solution containing a disinfecting agent for a period of time.
  • compositions in solid form which are to be dissolved in water to produce the desired cleansing solution.
  • these conventional compositions do, in practice, have to be dissolved in distilled or demineralised water and this is not always 0 readily available.
  • the present invention provides a solid composition
  • a solid composition comprising an antimicrobial agent, 0 other than chlorhexidine or a salt thereof, or a -_ precursor for such an antimicrobial agent for dis- ' ⁇ infecting the article to be disinfected, a sequestering agent for the calcium and magnesium ions ordinarily present in typical tap water, and a dechlorinating 5 agent for removing the chlorine from typical tap water, the composition being suitable for dissolving in tap water to produce a cleansing solution for dis ⁇ infecting the article.
  • the relative proportions of the ingredients of the composition are such that, when the mixture is dissolved in a specified amount of typical tap water, the resultant cleansing solution contains sufficient of the antimicrobial agent to effectively disinfect the article, sufficient of the sequestering agent to effectively remove the calcium and magnesium ions present in the tap water, and sufficient of the dechlorinating agent to effectively remove the chlorine from the tap water.
  • the solution prepared from dissolving the solid composition in tap water will be generally such that the concentrations of the disinfecting agent, sequest ⁇ ering agent, and dechlorinating agent in the cleansing solution are as low as possible. This will particular ⁇ ly be so in the case where the article is a contact lens or like device which is used in contact with human or animal tissue.
  • Any suitable antimicrobial agent other than chlorhexidine or a salt thereof may be used provided that it gives rise to a cleansing solution which efficiently disinfects the articles in a reasonable time.
  • one embodiment of the present invention includes ' the use of an antimicrobial agent which is such that it can be - tolerated by the tissue in the amounts in which it ⁇ s likely to be present when the article wet with the cleansing solution is placed in contact with the tissue.
  • the antimicrobial agent will be ophthalmically acceptable in the case where the cleansing solution is to be used for disinfecting contact lenses.
  • Typical ophthalmic ⁇ ally acceptable antimicrobial agents are salts such as benzalkonium chloride, thiomersal, alkyltriethanol ammonium chloride, and mixtures of two or more there ⁇ of.
  • the content of antimicrobial agent will ordinarily be from about 0.0001 g to 0.0025 g.
  • the antimicrobial agent is not such that it can be tolerated by such tissue but, in this case, the agent is effectively neutralised before the disinfected article is placed in contact with the tissue.
  • An example of such an antimicrobial agent is hydrogen peroxide.
  • the antimicrobial agent is hydrogen peroxide
  • it will be present in the solid composition in the form of a precursor therefor.
  • Typical precursors are anhydrous sodium perborate, sodium perborate trihydrate, sodium percarbonate, urea hydrogen peroxide, and mixtures of two or more thereof.
  • Sufficient of such hydrogen peroxide precursor should be present in the composition to provide a cleansing solution containing an effective amount of H2O2.
  • an effective amount is from 0.5% to 3.0%, preferably 0.5% to 1.5%, H2O2 where the cleansing solution is to be used for disinfecting lenses. In other cases, the amount of H2O2 may be increased up to about 6%.
  • a cleansing solution containing 0.5% H2O2 can be produced by dissolving, in 10 ml of tap water, 0.23g of sodium perborate trihydrate, 0.15g of anhydrous sodium perborate, 0.16g of sodium per ⁇ carbonate, or 0.014g of urea hydrogen peroxide (urea content 0.09g).
  • Cleansing solutions containing higher concentrations of H2O2 can be produced by increasing the amount of precursor, pro rata.
  • the amount of solid composition needed to produce a cleansing solution having a given concentration of H2O2 can be reduced by reducing the amount of tap water used. Generally, however, at least 7ml of cleansing solution will be required to disinfect two contact lenses.
  • the antimicrobial agent is hydrogen peroxide and neutralisation of the hydrogen peroxide is necessary, this can be achieved using, for example, sodium pyruvate or other reducing agent as neutralising agent.
  • This neutralising agent can be incorporated in the solid composition or may be in the form of a separate isotonic buffered solution with which the article is treated after being disinfected.
  • the sequestering agent may be any sequestering agent for calcium and magnesium ions and, in the case of articles which are to be used in contact with human or animal tissue, which can be tolerated by the tissue in the amount in which it is likely to be present when the article wet with the cleansing solution is placed in contact with the tissue.
  • Suitable sequestering agents are ethylene-diamine tetraacetic acid and its salts, or a polyphosphate such as sodium pyrophosphate, sodium hexa etaphosphate, and sodium tripolyphosphate.
  • the sequestering agent content of the composition is preferably from 0.01 to 0.1g.
  • Any dechlorinating agent may be used with the proviso that, in the case where the article is to be used in contact with human or animal tissue, the dechlorinating agent should be such that it can be tolerated by the tissue in the amounts in which it is likely to be present when the article wet with the cleansing solution is placed in contact with the tissue.
  • suitable dechlorinating agents are sodium metabisulphite, sodium sulphite and sodium thiosulphate.
  • the dechlor ⁇ inating agent content is preferably from 0.0001 to 0.01g.
  • the composition may contain other components conventionally present in disinfecting solutions.
  • the solution can contain an acid (to adjust the pH) and /or a tonicity adjusting agent.
  • the acid usually will be present in an amount sufficient to provide the solution with a pH in the range 4.0 to 8.0, preferably 5.5 to 8.0, especially 6.0 to 7.5.
  • Suitable acids include fumaric, citric, maleic, adipic and, preferably, malic acid.
  • the composition may include a buffer so that the resultant solution has the required pH.
  • the composition may be such that the resultant cleansing solution is substantially isotonic but the isotonicity may be provided by components present for other purposes. If it is required to use a tonicity adjusting agent, sodium chloride or urea can be used. It is also preferred that the composit ⁇ ion includes a surfactant. Suitable non-ionic-surfact ⁇ ants include polyoxyethylene alkyl ethers, polyoxy ⁇ ethylene alkyl phenyl ethers, and polyoxyethylene sorbitan and other sugar-based alkyl esters.
  • Presently preferred surfactants are polyethylene glycol monocetyl ethers (e.g. Cetomacrogols) , polyoxyethylene- (20)sorbitan monooleate (e.g. Polysorbate 80), sucrose monostearate, nonylphenolethoxylate (e.g. available under the Trade Marks "Antarox CO-630" and “EMPILAN N92”), and, especially, polyoxyethylen (20)stearyl ether (e.g. available under the Trade Mark “Brij 78").
  • polyethylene glycol monocetyl ethers e.g. Cetomacrogols
  • polyoxyethylene- (20)sorbitan monooleate e.g. Polysorbate 80
  • sucrose monostearate e.g. available under the Trade Marks "Antarox CO-630" and "EMPILAN N92”
  • polyoxyethylen (20)stearyl ether e.g. available under the Trade Mark "Brij 78"
  • the composition In use of the composition, it is merely necessary to dissolve the composition in tap water to form a cleansing solution whenever the articles in question require to be disinfected. This is particul ⁇ arly easy when the composition is packaged in unit dosage form so that dissolution of one such unit dosage in a specified amount of tap water produces the desired cleansing solution.
  • the solid composition it is. particularly preferred for the solid composition to be in tablet form since this facilitates the manipulation of the composition by the user when dissolving the composition in the tap water.
  • the composition may include conventional tableting addit ⁇ ives such as lubricants, anti-adhesives, and binders in order to optimise the characteristics of the tablets. Examples of suitable additives are alkyloxycelluloses, docusate sodium, polyvinyl pyrrolidone, and poly- ethylene glycol.
  • a neutralising agent may be included in the tablet.
  • the tablet may be in two layers, a first layer including the antimicrobial agent or precursor therefor and a second layer including the neutralising agent and dissolving in the tap water at a slower rate than the first layer.
  • the composition may be in the form of a - compression coated tablet wherein the neutralising agent is located at the core of the tablet and the antimicrobial agent or precursor therefor surrounds the core and hence dissolves before dissolution of the neutralising agent occurs.
  • two separate tablets may be used.
  • a first tablet containing the antimicrobial agent or precursor therefor, together with the sequestering agent and dechlorinating agent, is dissolved in the appropriate amount of tap water and the articles to be disinfected are immersed in the resultant cleansing solution for an appropriate period. Thereafter, a second tablet containing the neutralising agent is added to the cleansing solution to neutralise the antimicrobial agent therein before the articles are removed.
  • tap water contains calcium and magnesium ions, usually as carbonates and sulphates, at a combined concentration of up to 650 mg/litre and chlorine at levels of up to 3 ppm.
  • the present invention provides a solid composition in unit dosage form for dissolution in such tap water to produce a disinfecting solution, said composition comprising (a) an antimicrobial agent or precursor therefore in an amount such that on dissolution of the composition in 10 ml of such tap water the resultant cleansing solution contains an amount of antimicrobial agent effective to disinfect two contact lenses, (b) from 5 to 25% by weight of a sequestering agent for calcium and magnesium ions, and
  • the cleansing solution By making up the cleansing solution from the solid composition and tap water as and when needed, the risk of causing contamination of the cleansing solution is greatly reduced. Moreover, the ability to use tap water, as opposed to distilled or demineralised water, is particularly convenient.
  • Example 1 illustrates the invent ⁇ ion.
  • Example 2 0.15g of urea, 0.0005g of benzalkonium chlor ⁇ ide, 0.04g of sodium tripolyphosphate, 0.001g of sodium thiosulphate, 0.001g of a polyoxyethylene stearyl ether, and 0.005g of malic acid were admixed together.
  • the resultant solid composition was processed into a tablet.
  • the tablet was dissolved in 10 ml of tap water to form a cleansing solution which efficient ⁇ ly sterilised hard contact lenses immersed therein overnight.
  • Example 2 Example 2
  • a solid composition was prepared by admixing together 0.0005g of benzalkonium chloride, 0.04g of sodium pyrophosphate, 0.001g of sodium thiosulphate, 0.09g of sodium chloride, 0.001g of polyoxyethylene sorbitan mono oleate, and 0.005g of malic acid. The composition was blended together and processed into a tablet.
  • Example 3 In use, the tablet was dissolved in 10 ml of tap water to produce a cleansing solution. Two contact lenses immersed in this solution over night were found to be efficiently disinfected.
  • Example 3 In use, the tablet was dissolved in 10 ml of tap water to produce a cleansing solution. Two contact lenses immersed in this solution over night were found to be efficiently disinfected.
  • a solid composition was prepared by admixing 0.00025g of alkyltriethanol ammonium chloride, 0.04g of " sodium pyrophosphate, 0.001g of sodium thiosulphate, 0.09g of sodium chloride, 0.001g of polyoxyethylene sorbitan mono oleate, and 0.005g of malic acid.
  • the composition was formed into a tablet and the tablet was dissolved in 10 ml of tap water.
  • the resultant cleansing solution efficiently disinfected two contact lenses which were immersed therein overnight.
  • Example 3 was repeated with the inclusion of ⁇ 5%, by weight of the solid composition, of polyethylene glycol. A particularly advantageous tablet was obtained. •
  • Example 5
  • a solid composition was prepared by admixing together 0.140g of urea hydrogen peroxide, 0.160g sodium percarbonate, 0.040g sodium tripolyphosphate, 0.001g sodium thiosulphate, and 0.002g of polyethylene glycol monocetyl ether. The composition was formed into a tablet which was then dissolved in 10 ml of tap water to produce a cleansing solution containing 1%
  • a solid composition was prepared by admixing 0.42g of urea hydrogen peroxide, 0.04g of sodium tripolyphosphate, 0.001g of sodium thiosulphate, and 0.003g of polyethylene glycol monocetyl ether. The composition was formed into a tablet which was then dissolved in 10ml of tap water to produce a cleansing solution containing 1.5% H2O2.
  • Example 6 was repeated with the polyethylene glycol monocetyl ether replaced by 0.001g of polyoxy- ethylene(20)stearyl ether.
  • Example 8
  • Example 5 was repeated using a tablet formed from 0.460g sodium percarbonate-, 0.040g sodium tripoly ⁇ phosphate, 0.001g of sodium thiosulphate, and 0.002g of 5 polyethyleneglycol monocetyl ether.
  • the resultant cleansing solution had a H2O2 content of 1.5%.
  • a solid composition was prepared by admixing

Abstract

A solid composition comprises an antimicrobial agent, other than chlorhexidine or a salt thereof, or a precursor for such an antimicrobial agent, a sequestering agent for the calcium and magnesium ions ordinarily present in typical tap water, and a dechlorinating agent for removing the chlorine from typical tap water. In use the composition, which is preferably in the form of a tablet, is dissolved in tap water to produce a cleansing solution for disinfecting articles such as hard and soft contact lenses, veterinary instruments, and surgical instruments.

Description

Production of cleansing and disinfecting solutions.
This invention relates to the production of cleansing solutions and more particularly, but not exclusively, is concerned with the production of cleansing solutions for disinfecting both so called hard and so called soft contact lenses.
Contact lenses are now widely available for correcting optical deficiencies of the human eye and, as the name implies, they are worn in direct contact with the eye tissue. During use of the lenses, and particularly in the case of soft lenses, proteinaceous, mucal and mineral deposits tend to build up on the surface of the lens and these may cause blurred vision and irritation. When the lenses are removed from the eye for cleansing or storage (e.g. overnight) or for other manipulation, it is necessary to disinfect the lenses to avoid subsequent infection of the eye. Thus, the lenses need to be cleansed and disinfected period- ically and conventionally this is done by heating the lenses in saline or the like or by placing the lenses in a cleansing solution containing a disinfecting agent for a period of time.
These cleansing solutions are ordinarily marketed in bottles in the form of ready-to-use solutions. In use, a quantity of the solution is poured out of the bottle into a suitable container and the lenses are immersed in the solution in the contain¬ er for an appropriate period of time. It is not very convenient to have to pour out a quantity of the solution in this way. More importantly, however, each time the bottle is handled there is a risk of the solution in the bottle becoming contaminated. Further, there is a risk of interaction between the solution and the material of the bottle during storage. With a view to minimising these risks, bottles are normally marketed which contain only a few weeks supply of the solution.
These problems have been overcome to some extent by providing compositions in solid form which are to be dissolved in water to produce the desired cleansing solution. However, these conventional compositions do, in practice, have to be dissolved in distilled or demineralised water and this is not always 0 readily available.
It is an object of the present invention to overcome the foregoing problem by providing a solid composition which can be dissolved in ordinary tap water to make a cleansing solution for disinfecting 5 contact lenses and other articles which need to be disinfected such as surgical instruments, dental instruments, and veterinary instruments.
Accordingly, the present invention provides a solid composition comprising an antimicrobial agent, 0 other than chlorhexidine or a salt thereof, or a -_ precursor for such an antimicrobial agent for dis- '^ infecting the article to be disinfected, a sequestering agent for the calcium and magnesium ions ordinarily present in typical tap water, and a dechlorinating 5 agent for removing the chlorine from typical tap water, the composition being suitable for dissolving in tap water to produce a cleansing solution for dis¬ infecting the article.
The relative proportions of the ingredients of the composition are such that, when the mixture is dissolved in a specified amount of typical tap water, the resultant cleansing solution contains sufficient of the antimicrobial agent to effectively disinfect the article, sufficient of the sequestering agent to effectively remove the calcium and magnesium ions present in the tap water, and sufficient of the dechlorinating agent to effectively remove the chlorine from the tap water. Subject to these minimum require¬ ments, the solution prepared from dissolving the solid composition in tap water will be generally such that the concentrations of the disinfecting agent, sequest¬ ering agent, and dechlorinating agent in the cleansing solution are as low as possible. This will particular¬ ly be so in the case where the article is a contact lens or like device which is used in contact with human or animal tissue.
Any suitable antimicrobial agent other than chlorhexidine or a salt thereof may be used provided that it gives rise to a cleansing solution which efficiently disinfects the articles in a reasonable time.
In the case of articles which are to be used in contact with human or animal tissue, one embodiment of the present invention includes' the use of an antimicrobial agent which is such that it can be - tolerated by the tissue in the amounts in which it ~άs likely to be present when the article wet with the cleansing solution is placed in contact with the tissue. Thus, in accordance with this embodiment the antimicrobial agent will be ophthalmically acceptable in the case where the cleansing solution is to be used for disinfecting contact lenses. Typical ophthalmic¬ ally acceptable antimicrobial agents are salts such as benzalkonium chloride, thiomersal, alkyltriethanol ammonium chloride, and mixtures of two or more there¬ of. In the case where antimicrobial agents of this type are used and the composition is to be admixed with 10 ml of tap water, the content of antimicrobial agent will ordinarily be from about 0.0001 g to 0.0025 g. In a second embodiment, the antimicrobial agent is not such that it can be tolerated by such tissue but, in this case, the agent is effectively neutralised before the disinfected article is placed in contact with the tissue. An example of such an antimicrobial agent is hydrogen peroxide.
In the case where the antimicrobial agent is hydrogen peroxide, it will be present in the solid composition in the form of a precursor therefor. Typical precursors are anhydrous sodium perborate, sodium perborate trihydrate, sodium percarbonate, urea hydrogen peroxide, and mixtures of two or more thereof. Sufficient of such hydrogen peroxide precursor should be present in the composition to provide a cleansing solution containing an effective amount of H2O2. Generally, an effective amount is from 0.5% to 3.0%, preferably 0.5% to 1.5%, H2O2 where the cleansing solution is to be used for disinfecting lenses. In other cases, the amount of H2O2 may be increased up to about 6%. A cleansing solution containing 0.5% H2O2 can be produced by dissolving, in 10 ml of tap water, 0.23g of sodium perborate trihydrate, 0.15g of anhydrous sodium perborate, 0.16g of sodium per¬ carbonate, or 0.014g of urea hydrogen peroxide (urea content 0.09g). Cleansing solutions containing higher concentrations of H2O2 can be produced by increasing the amount of precursor, pro rata. The amount of solid composition needed to produce a cleansing solution having a given concentration of H2O2 can be reduced by reducing the amount of tap water used. Generally, however, at least 7ml of cleansing solution will be required to disinfect two contact lenses.
In the case where the antimicrobial agent is hydrogen peroxide and neutralisation of the hydrogen peroxide is necessary, this can be achieved using, for example, sodium pyruvate or other reducing agent as neutralising agent. This neutralising agent can be incorporated in the solid composition or may be in the form of a separate isotonic buffered solution with which the article is treated after being disinfected. The sequestering agent may be any sequestering agent for calcium and magnesium ions and, in the case of articles which are to be used in contact with human or animal tissue, which can be tolerated by the tissue in the amount in which it is likely to be present when the article wet with the cleansing solution is placed in contact with the tissue. Typical examples of suitable sequestering agents are ethylene-diamine tetraacetic acid and its salts, or a polyphosphate such as sodium pyrophosphate, sodium hexa etaphosphate, and sodium tripolyphosphate.
In the case where the composition is for addition to 10 ml of tap water, the sequestering agent content of the composition is preferably from 0.01 to 0.1g. Any dechlorinating agent may be used with the proviso that, in the case where the article is to be used in contact with human or animal tissue, the dechlorinating agent should be such that it can be tolerated by the tissue in the amounts in which it is likely to be present when the article wet with the cleansing solution is placed in contact with the tissue. Typical examples of suitable dechlorinating agents are sodium metabisulphite, sodium sulphite and sodium thiosulphate. In the case where the composit- ion is to be admixed with 10 ml of water, the dechlor¬ inating agent content is preferably from 0.0001 to 0.01g.
The composition may contain other components conventionally present in disinfecting solutions. For example, and particularly in the case where the solution is for disinfecting contact lenses, it can contain an acid (to adjust the pH) and /or a tonicity adjusting agent.
The acid usually will be present in an amount sufficient to provide the solution with a pH in the range 4.0 to 8.0, preferably 5.5 to 8.0, especially 6.0 to 7.5. Suitable acids include fumaric, citric, maleic, adipic and, preferably, malic acid. If required, the composition may include a buffer so that the resultant solution has the required pH.
The composition may be such that the resultant cleansing solution is substantially isotonic but the isotonicity may be provided by components present for other purposes. If it is required to use a tonicity adjusting agent, sodium chloride or urea can be used. It is also preferred that the composit¬ ion includes a surfactant. Suitable non-ionic-surfact¬ ants include polyoxyethylene alkyl ethers, polyoxy¬ ethylene alkyl phenyl ethers, and polyoxyethylene sorbitan and other sugar-based alkyl esters.
Presently preferred surfactants are polyethylene glycol monocetyl ethers (e.g. Cetomacrogols) , polyoxyethylene- (20)sorbitan monooleate (e.g. Polysorbate 80), sucrose monostearate, nonylphenolethoxylate (e.g. available under the Trade Marks "Antarox CO-630" and "EMPILAN N92"), and, especially, polyoxyethylen (20)stearyl ether (e.g. available under the Trade Mark "Brij 78").
In use of the composition, it is merely necessary to dissolve the composition in tap water to form a cleansing solution whenever the articles in question require to be disinfected. This is particul¬ arly easy when the composition is packaged in unit dosage form so that dissolution of one such unit dosage in a specified amount of tap water produces the desired cleansing solution. In this regard, it is. particularly preferred for the solid composition to be in tablet form since this facilitates the manipulation of the composition by the user when dissolving the composition in the tap water. In such a case, the composition may include conventional tableting addit¬ ives such as lubricants, anti-adhesives, and binders in order to optimise the characteristics of the tablets. Examples of suitable additives are alkyloxycelluloses, docusate sodium, polyvinyl pyrrolidone, and poly- ethylene glycol.
In the case where the composition is in tablet form and is such that the resultant cleansing solution needs to be neutralised, a neutralising agent may be included in the tablet. In one example of this embodiment, the tablet may be in two layers, a first layer including the antimicrobial agent or precursor therefor and a second layer including the neutralising agent and dissolving in the tap water at a slower rate than the first layer. In another example of this embodiment, the composition may be in the form of a - compression coated tablet wherein the neutralising agent is located at the core of the tablet and the antimicrobial agent or precursor therefor surrounds the core and hence dissolves before dissolution of the neutralising agent occurs. In another embodiment, two separate tablets may be used. In this case, a first tablet containing the antimicrobial agent or precursor therefor, together with the sequestering agent and dechlorinating agent, is dissolved in the appropriate amount of tap water and the articles to be disinfected are immersed in the resultant cleansing solution for an appropriate period. Thereafter, a second tablet containing the neutralising agent is added to the cleansing solution to neutralise the antimicrobial agent therein before the articles are removed. Typically tap water contains calcium and magnesium ions, usually as carbonates and sulphates, at a combined concentration of up to 650 mg/litre and chlorine at levels of up to 3 ppm. In accordance with a particularly preferred embodiment therefore the present invention provides a solid composition in unit dosage form for dissolution in such tap water to produce a disinfecting solution, said composition comprising (a) an antimicrobial agent or precursor therefore in an amount such that on dissolution of the composition in 10 ml of such tap water the resultant cleansing solution contains an amount of antimicrobial agent effective to disinfect two contact lenses, (b) from 5 to 25% by weight of a sequestering agent for calcium and magnesium ions, and
(c) from 0.01 to 2.5% by weight of a dechlor¬ inating agent for removing chlorine from tap water, the amount of said sequestering agent and dechlorinat- ing agent present in said unit dosage being such that when one or a plurality of said unit dosages are dissolved in 10ml of such tap water, the resultant cleansing solution contains from 50 to 250 grams per litre of said sequestering agent, and from 0.1 to 25 grams per litre. Preferably the weight of the unit dosage will be from 200 to 800mg.
By making up the cleansing solution from the solid composition and tap water as and when needed, the risk of causing contamination of the cleansing solution is greatly reduced. Moreover, the ability to use tap water, as opposed to distilled or demineralised water, is particularly convenient.
The following Examples illustrate the invent¬ ion. Example 1
0.15g of urea, 0.0005g of benzalkonium chlor¬ ide, 0.04g of sodium tripolyphosphate, 0.001g of sodium thiosulphate, 0.001g of a polyoxyethylene stearyl ether, and 0.005g of malic acid were admixed together. The resultant solid composition was processed into a tablet. The tablet was dissolved in 10 ml of tap water to form a cleansing solution which efficient¬ ly sterilised hard contact lenses immersed therein overnight. Example 2
A solid composition was prepared by admixing together 0.0005g of benzalkonium chloride, 0.04g of sodium pyrophosphate, 0.001g of sodium thiosulphate, 0.09g of sodium chloride, 0.001g of polyoxyethylene sorbitan mono oleate, and 0.005g of malic acid. The composition was blended together and processed into a tablet.
In use, the tablet was dissolved in 10 ml of tap water to produce a cleansing solution. Two contact lenses immersed in this solution over night were found to be efficiently disinfected. Example 3
A solid composition was prepared by admixing 0.00025g of alkyltriethanol ammonium chloride, 0.04g of " sodium pyrophosphate, 0.001g of sodium thiosulphate, 0.09g of sodium chloride, 0.001g of polyoxyethylene sorbitan mono oleate, and 0.005g of malic acid. The composition was formed into a tablet and the tablet was dissolved in 10 ml of tap water. The resultant cleansing solution efficiently disinfected two contact lenses which were immersed therein overnight. Example 4
Example 3 was repeated with the inclusion of 5%, by weight of the solid composition, of polyethylene glycol. A particularly advantageous tablet was obtained. • Example 5
A solid composition was prepared by admixing together 0.140g of urea hydrogen peroxide, 0.160g sodium percarbonate, 0.040g sodium tripolyphosphate, 0.001g sodium thiosulphate, and 0.002g of polyethylene glycol monocetyl ether. The composition was formed into a tablet which was then dissolved in 10 ml of tap water to produce a cleansing solution containing 1%
H202.
Two soft hydrophilic contact lenses were immersed in this cleansing solution overnight and were then transferred to a sterile solution containing 0.05g sodium pyruvate and 0.01 Og malic acid to neutralise the peroxide. The contact lenses were found to be effic¬ iently disinfected. Example 6
A solid composition was prepared by admixing 0.42g of urea hydrogen peroxide, 0.04g of sodium tripolyphosphate, 0.001g of sodium thiosulphate, and 0.003g of polyethylene glycol monocetyl ether. The composition was formed into a tablet which was then dissolved in 10ml of tap water to produce a cleansing solution containing 1.5% H2O2.
Two soft hydrophilic contact lenses were immersed in this cleansing solution overnight. Then a tablet comprising 0.050g of sodium pyruvate and 0.01Og of malic acid was added to neutralise the solution. The contact lenses were found to be efficiently disinfected. Example 7
Example 6 was repeated with the polyethylene glycol monocetyl ether replaced by 0.001g of polyoxy- ethylene(20)stearyl ether. Example 8
Example 5 was repeated using a tablet formed from 0.460g sodium percarbonate-, 0.040g sodium tripoly¬ phosphate, 0.001g of sodium thiosulphate, and 0.002g of 5 polyethyleneglycol monocetyl ether. The resultant cleansing solution had a H2O2 content of 1.5%. Example 9
A solid composition was prepared by admixing
0.230g sodium perborate trihydrate, 0.040g of sodium Q hexametaphosphate, 0.001g of sodium thiosulphate, and
0.003g of polyethylene glycol monocetyl ether. The composition was formed into a tablet which was then
* dissolved in 10ml of tap water to produce a cleansing solution having a H2O2 content of 0.5%. 5 Two soft hydrophilic contact lenses were immersed in this cleansing solution overnight and then transferred into a sterile solution containing 0.050g of sodium pyruvate, 0.005g of malic acid, and 0.050g of urea to neutralise the peroxide. The contact lenses 0 were found to be efficiently disinfected.

Claims

1. A solid composition for use in producing a cleansing solution for disinfecting articles, which composition comprises (i) an antimicrobial agent, other e than chlorhexidine or a salt thereof, or a precursor for such an agent, (ii) a sequestering agent for the calcium and magnesium ions ordinarily present in tap water, and (iii) a dechlorinating agent for removing the chlorine ordinarily present in tap water, the 0 composition being suitable for dissolving in tap water to produce the desired cleansing solution.
2. A solid composition as claimed in claim 1 wherein said antimicrobial agent is ophthalmically •acceptable. 5
3. A solid composition as claimed in claim 2 wherein said antimicrobial agent is benzalkonium chloride, thiomersal, alkyltriethanol ammonium chloride, or a mixture of two or more thereof.
4. A solid composition as claimed in claim 1 0 wherein said antimicrobial agent is not ophthalmically acceptable.
5. A solid composition as claimed in claim 1 wherein said precursor is a precursor for hydrogen peroxide. 5
6. A solid composition as claimed in claim 5 wherein said precursor is sodium perborate, sodium percarbonate, or urea hydrogen peroxide.
7. A solid composition as claimed in claim 1 wherein the sequestering agent is ethylene diamine Q tetra-acetic acid or salt thereof, or a polyphosphate.
8. A solid composition as claimed in claim 1 wherein the dechlorinating agent is sodium thio¬ sulphate, sodium sulphite, or sodium metabisulphite.
9. A solid composition as claimed in claim 1 for 5 adding to 10 ml of tap water, which composition contains from 0.0001 to 0.01g of said dechlorinating agent and from 0.01 to 0.1g of said sequestering agent.
10. A solid composition as claimed in claim 1 in the form of a tablet.
PCT/GB1986/000146 1985-03-14 1986-03-13 Production of cleansing and disinfecting solutions WO1986005401A1 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
GB8506677 1985-03-14
GB858506677A GB8506677D0 (en) 1985-03-14 1985-03-14 Cleansing of contact lenses
GB858507664A GB8507664D0 (en) 1985-03-14 1985-03-25 Production of cleansing solutions
GB8507664 1985-03-25
GB8528714 1985-11-21
GB858528714A GB8528714D0 (en) 1985-03-14 1985-11-21 Production of cleansing solutions

Publications (1)

Publication Number Publication Date
WO1986005401A1 true WO1986005401A1 (en) 1986-09-25

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Country Status (6)

Country Link
CN (1) CN86102440A (en)
AU (1) AU5623086A (en)
ES (1) ES552999A1 (en)
GR (1) GR860706B (en)
PT (1) PT82205B (en)
WO (1) WO1986005401A1 (en)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0242998A2 (en) * 1986-03-22 1987-10-28 SMITH & NEPHEW plc Disinfecting composition
FR2677013A1 (en) * 1991-06-03 1992-12-04 Rouleau Henri System for treating water treated as a surgical irrigation liquid
GB2354442A (en) * 1999-09-23 2001-03-28 Allied Bio Corp Ltd Sterilising block comprising a compound which produces sulphur dioxide on reaction with moisture absorbed by the block, eg a metabisulphite
GB2355198A (en) * 1999-05-06 2001-04-18 Medichem Internat Ltd An aldehyde-free sterilant and disinfectant based on a peroxide source in powder or kit form for mixing and/or diluting
EP1495772A1 (en) * 2003-07-11 2005-01-12 HERDEIS, Claus Use of taurolidine and its metabolites as antimicrobial additive in preparations for treating, cleaning, storing and conditioning of contact lenses
WO2009111170A1 (en) * 2008-02-29 2009-09-11 Bausch & Lomb Incorporated Pharmaceutical formulations comprising polyanionic materials and source of hydrogen peroxide

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3873696A (en) * 1972-01-31 1975-03-25 Allergan Pharma Cleaning and sterilizing soft contact lens
FR2247327A1 (en) * 1973-10-12 1975-05-09 Flow Pharma Inc
FR2256767A1 (en) * 1974-01-07 1975-08-01 Nat Patent Dev Corp
FR2446499A1 (en) * 1979-01-15 1980-08-08 Allergan Pharma METHOD AND COMPOSITION FOR TREATING CONTACT LENSES
DE3007397A1 (en) * 1980-02-27 1981-09-03 Titmus Eurocon Kontaktlinsen Gmbh & Co Kg, 8750 Aschaffenburg Contact lens preservative and rinsing soln. - contg. ethylene di:amine tetra:acetic acid in addn. to chlorhexidine, thio-mesal and polyvinyl pyrrolidone
DE3329922A1 (en) * 1983-08-19 1985-02-28 Fa. Carl Zeiss, 7920 Heidenheim CLEANING AND DISINFECTING SYSTEM FOR HARD AND SOFT CONTACT LENSES

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3873696A (en) * 1972-01-31 1975-03-25 Allergan Pharma Cleaning and sterilizing soft contact lens
FR2247327A1 (en) * 1973-10-12 1975-05-09 Flow Pharma Inc
FR2256767A1 (en) * 1974-01-07 1975-08-01 Nat Patent Dev Corp
FR2446499A1 (en) * 1979-01-15 1980-08-08 Allergan Pharma METHOD AND COMPOSITION FOR TREATING CONTACT LENSES
DE3007397A1 (en) * 1980-02-27 1981-09-03 Titmus Eurocon Kontaktlinsen Gmbh & Co Kg, 8750 Aschaffenburg Contact lens preservative and rinsing soln. - contg. ethylene di:amine tetra:acetic acid in addn. to chlorhexidine, thio-mesal and polyvinyl pyrrolidone
DE3329922A1 (en) * 1983-08-19 1985-02-28 Fa. Carl Zeiss, 7920 Heidenheim CLEANING AND DISINFECTING SYSTEM FOR HARD AND SOFT CONTACT LENSES

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0242998A2 (en) * 1986-03-22 1987-10-28 SMITH & NEPHEW plc Disinfecting composition
EP0242998A3 (en) * 1986-03-22 1988-07-06 Smith And Nephew Associated Companies P.L.C. Disinfecting composition
FR2677013A1 (en) * 1991-06-03 1992-12-04 Rouleau Henri System for treating water treated as a surgical irrigation liquid
GB2355198A (en) * 1999-05-06 2001-04-18 Medichem Internat Ltd An aldehyde-free sterilant and disinfectant based on a peroxide source in powder or kit form for mixing and/or diluting
GB2354442A (en) * 1999-09-23 2001-03-28 Allied Bio Corp Ltd Sterilising block comprising a compound which produces sulphur dioxide on reaction with moisture absorbed by the block, eg a metabisulphite
EP1495772A1 (en) * 2003-07-11 2005-01-12 HERDEIS, Claus Use of taurolidine and its metabolites as antimicrobial additive in preparations for treating, cleaning, storing and conditioning of contact lenses
WO2009111170A1 (en) * 2008-02-29 2009-09-11 Bausch & Lomb Incorporated Pharmaceutical formulations comprising polyanionic materials and source of hydrogen peroxide

Also Published As

Publication number Publication date
PT82205A (en) 1986-04-01
CN86102440A (en) 1986-10-15
GR860706B (en) 1986-07-11
AU5623086A (en) 1986-10-13
PT82205B (en) 1987-08-17
ES552999A1 (en) 1987-11-16

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