WO1990006126A1 - Compositions desinfectantes pour dispositifs ophtalmiques - Google Patents

Compositions desinfectantes pour dispositifs ophtalmiques Download PDF

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Publication number
WO1990006126A1
WO1990006126A1 PCT/US1989/005292 US8905292W WO9006126A1 WO 1990006126 A1 WO1990006126 A1 WO 1990006126A1 US 8905292 W US8905292 W US 8905292W WO 9006126 A1 WO9006126 A1 WO 9006126A1
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WO
WIPO (PCT)
Prior art keywords
chlorine dioxide
stabilized chlorine
weight
solution
volume percent
Prior art date
Application number
PCT/US1989/005292
Other languages
English (en)
Inventor
Bobby C. Danner
Original Assignee
Bio-Cide International, Inc.
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
Application filed by Bio-Cide International, Inc. filed Critical Bio-Cide International, Inc.
Publication of WO1990006126A1 publication Critical patent/WO1990006126A1/fr

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Classifications

    • 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
    • A61L12/10—Halogens or compounds thereof
    • A61L12/102—Chlorine dioxide (ClO2)
    • 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
    • A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/40—Peroxides

Definitions

  • the present invention relates to preserving ophthal- mic solutions. More particularly it relates to the use of stabilized chlorine dioxide to preserve ophthalmic solutions.
  • the present invention further relates to a composition for disinfecting ophthalmic devices wherein such composition comprises at least 0.02 weight/volume percent stabilized chlorine dioxide.
  • contact lenses has become widespread as a replacement for conventional eye glasses because of the improved vision obtained by the wearer or for aesthetic reasons.
  • Contact lenses accumulate microorganisms and cellular debris from the eye. Thus, the lenses must be periodically removed and cleaned to prevent irritation of the eye or infection. Solutions used in lens care must be preserved by some means to interdict introducing microbial contaminants onto contact lenses or the eye. Disinfecting preparations are part of the regimen indi ⁇ cated for contact lens care.
  • ophthalmic solutions have heretofore been used with lenses.
  • the composition of the ophthalmic solution will often be dictated by the polymeric materials employed in the fabrication of the contact lens. Because of the chemical composition of most ophthalmic solutions, the contact lenses cleaned and soaked in such solutions must be rinsed prior to place- ment in the wearer's eye to prevent irritation of the eye.
  • U.S. patent Nos. 4,696,811 and 4,689,215 disclose the use of stabilized chlorine dioxide for the treatment and prevention of oral disease, the reduction of malodor, as an anti-plaque agent, an anti-gingivitis and anti- periodontitis agent, as well as a denture soak and a contact lens soak. That is, the two before-referenced patents disclose the use of 0.005 percent to 0.02 percent stabilized chlorine dioxide in sterilized water as a contact lens soaking formulation.
  • the referen- ces are void of any teaching or suggestion that stabi ⁇ lized chlorine dioxide can be incorporated into an aqueous saline ophthalmic solution as a preservative for such a solution.
  • the present invention relates to an aqueous ophthalmic solution containing an effective minor amount of stabilized chlorine dioxide to effectively preserve the ophthalmic solution.
  • the present invention relates to an aqueous ophthalmic solution
  • an aqueous ophthalmic solution comprising purified water as a vehicle, from about 0.0002 to about 0.02 weight/volume percent stabilized chlorine dioxide, and an effective minor amount of an ophthalmically acceptable inorganic salt to provide the ophthalmic solution with a tonicity value substantially corresponding to the tonicity value of fluids of an eye.
  • the ophthalmic solution also includes an effective minor amount of a buffering agent.
  • the pH of the ophthalmic solution can be adjusted, if required, by addition of an acid or a base so that the ophthalmic solution has an acceptable physiological pH (i.e. a pH in the range of from about 6.8 to about 8) .
  • the present invention relates to a disinfectant composition for ophthalmic devices wherein the disinfectant composition comprises at least 0.02 weight/volume percent stabilized chlorine dioxide.
  • An object of the present invention is to provide a preservative for ophthalmic solutions.
  • Another object of the present invention while achieving the before-stated object, is to provide an ophthalmic solution wherein the solution has a pH and tonicity value substantially corresponding to such values of the fluids of the human eye.
  • Another object of the present invention while achieving the before-stated objects, is to provide an aqueous saline ophthalmic solution having incorporated therein a preserving agent such that the integrity of the saline solution is maintained.
  • Yet another object of the present invention, while achieving the before-stated objects is to provide an improved composition useful as a disinfectant for ophthalmic devices.
  • a preserving amount of stabi- lized chlorine dioxide into an ophthalmic formulation has been found to be an effective preservative for ophthalmic formulations.
  • the preserving amount of stabilized chlorine, dioxide incorporated into an ophthalmic formula ⁇ tion can vary widely but will generally be an amount sufficient to preserve the integrity of the formulation.
  • 3,271,242 discloses a form of stabilized chlorine dioxide and a method for producing same which can be used as a preservative for aqueous ophthalmic solutions or as a disinfectant for ophthalmic devices.
  • a commercially available stabilized chlorine dioxide which can be utilized in the practice of the present invention is the proprietary stabilized chlorine dioxide of Bio- Cide International, Inc. of Norman, Oklahoma.
  • the term "aqueous ophthalmic solution” as used herein is to be understood to mean a solution containing sterilized water as the vehicle and having at least one other component, such as an ophthalmically acceptable inorganic salt, which can be administered to or placed in the eye; and wherein the solution will not possess toxic properties or have a deleterious affect on the tissue of the eye.
  • ophthalmically acceptable inorganic salt as used herein is to be understood to mean any inorganic salt which is capable of providing the ophthalmic solution with the desired tonicity values and which does not irritate or cause damage to the tissue of the eye.
  • a preserving amount of stabilized chlorine dioxide in aqueous ophthalmic formulations particularly a saline ophthalmic solution
  • an ingredient in the formulation of an aqueous ophthalmic solution, particularly a saline solution is an ingredient in the formulation of an aqueous ophthalmic solution, particularly a saline solution.
  • ophthalmic devices contacted with an ophthalmic solution containing a pre ⁇ serving amount of stabilized chlorine dioxide do not have to be rinsed to remove residual solution prior to use.
  • the contact lenses can be placed in a wearer's eye, without rinsing, without irri ⁇ tation or adverse effects occurring to the tissue of the eye, and without discomfort.
  • the amount of stabilized chlorine dioxide incor- porated in the ophthalmic formulation as a preservative can vary widely provided that such amount effectively prevents microbial growth in the formulation.
  • microbial growth in the ophthalmic formulation can be prevented when the amount of stabilized chlorine dioxide introduced into the formulation is from about 0.0002 to about 0.02 weight/volume percent of the solution, desir ⁇ ably from about 0.004 to about 0.01 weight/volume percent.
  • the ophthalmic solution have a pH value of from about 6.8 to about 8 so that the pH of the ophthal ⁇ mic solution substantially corresponds to the pH value of the fluids in the eye, or which can be tolerated by the eye without causing any discomfort or irritation.
  • an effective minor amount of a buffering agent is incorporated into the ophthalmic solution.
  • the effective minor amount of buffering agent employed to buffer the ophthalmic solution at a pH of from about 6.8 to about 8 can vary widely and will depend to a large degree on the particular buffering agent employed, as well as the chemical composition of the ophthalmic solution.
  • desirable results have been obtained when the amount of buffering agent incorporated into the aqueous ophthalmic solution to stabilize the solution at the acceptable physiological pH is from about 0.05 to about 1 weight/volume percent of the buffering agent.
  • any suitable buffering agent can be employed which is compatible with the other ingredients of the ophthal ⁇ mic solution, and which does not have deleterious or toxic properties which could harm the eye.
  • suitable buffering agents are boric acid, sodium borate, sodium phosphates (including mono, di- and tri- basic phosphates, such as sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, and mixtures, thereof).
  • any other suitable buffering agent can be employed to stabilize the pH of the ophthalmic solution so that the ophthalmic solution is provided with an acceptable physiological pH, and the before-mentioned buffering agents are merely examples of such buffering agents.
  • buffering agents are well known in the art no further examples of such buffering agents which can be utilized in the ophthalmic solutions of the present invention are not believed necessary.
  • the pH of the aqueous buffered ophthalmic solution can be adjusted by the addition of an effective amount of either a base or an acid, as the case may be. Any suitable base or acid can be employed to adjust the pH of the aqueous buffered ophthalmic solution which does not provide the ophthalmic solution with toxic or deleter- ious properties which could harm either ophthalmic devices or the eye.
  • An example of a base which can be used to adjust the pH of the aqueous buffered ophthalmic solution is 1 N sodium hydroxide; and an example of an acid which can be used to adjust the pH of the aqueous buffered ophthalmic solution is 1 N hydrochloric acid.
  • the integrity of an ophthalmic solution can be enhanced by the incorporated of from about 0.0002 to about 0.02 weight/volume percent stabi ⁇ lized chlorine dioxide. That is, the presence of stabi ⁇ lized chlorine dioxide in an ophthalmic solution greatly enhances the useful or shelf life of the ophthalmic solution.
  • stabilized chlorine dioxide and an ophthalmically acceptable inorganic salt or other suitable tonicity imparting agent are admixed with sterile water to provide an ophthalmic solution having a tonicity value substantially corre ⁇ sponding to the tonicity value of fluids of the eye.
  • the amount of water employed as the vehicle in the ophthalmic solution will vary depending upon the amount of the stabilized chlorine dioxide and the ophthalmically acceptable inorganic salt and/or other suitable tonicity imparting agent employed in the formulation.
  • the amount of ophthalmically acceptable inorganic salt utilized can vary widely provided that the amount of the inorganic salt employed is sufficient to provide the ophthalmic solution with the desired tonicity value. Generally the ophthalmic solution will have the desired tonicity value when the amount of ophthalmically accept- able inorganic salt employed in the formulation of the ophthalmic solution is from about 0.5 to about 0.9 weight/volume percent.
  • ophthalmically acceptable inorganic salts are alkali metal chlorides and alkaline earth metal chlorides, such as sodium chloride, potassium chloride, calcium chloride and magnesium chloride. Because it is desirable that one not have to remove residual aqueous ophthalmic solution from the contact lenses after the soaking and cleansing procedure prior to use, the pH of the ophthalmic solution should substantially correspond with the pH of the fluids of the eye. When it is deter ⁇ mined that the pH of the ophthalmic solution is not within an acceptable physiological pH, (i.e.
  • the pH of the ophthalmic solution can be adjusted by the addition of a base or acid, such as 1 N hydrochloric acid or 1 N sodium hydroxide, so that the solution has an acceptable physio ⁇ logical pH.
  • a base or acid such as 1 N hydrochloric acid or 1 N sodium hydroxide
  • the stabilized chlorine dioxide can also be utilized as a disinfecting agent in a disinfectant composition.
  • a suitable vehicle such as steri ⁇ lized water
  • at least about 0.02 weight/volume percent stabilized chlorine dioxide is incorporated as the disinfecting agent.
  • the amount of stabilized chlorine dioxide employed as the disinfect ⁇ ing agent can vary widely, desirable results can be obtained when the stabilized chlorine dioxide utilized as the disinfecting agent is present in the disinfectant composition in an amount of from about 0.02 to 2.0 weight/volume percent, desirably from about 0.04 to about 0.1 weight/volume percent, and more desirably from about 0.05 to about 0.08 weight/volume percent.
  • aqueous ophthalmic solution containing stabilized chlorine dioxide for the cleansing of contact lenses
  • the con ⁇ tact lenses are placed in an appropriate container con ⁇ taining an amount of the aqueous saline ophthalmic solu ⁇ tion to substantially cover the contact lenses.
  • the contact lenses are maintained in contact with the solution for a period of at least fifteen minutes to allow the contact lenses to be thoroughly soaked in the solution. Because of the unique properties of the stabilized chlorine dioxide the contact lenses can be maintained in the solution for long periods of time, even days, without degradation of the polymeric materials from which the contact lenses are fabricated. Further, the stabilized chlorine dioxide functions as a disinfectant for other ophthalmic devices such as lens holders and containers, instruments (i.e.
  • the borate buffered saline solution had the following composition:
  • the pH of the buffered solution was adjusted by the addition of either hydrochloric acid NF or sodium hydroxide NF so that the pH of the saline solution was within the range of from about 7.7 to 7.9.
  • the stabilized chlorine dioxide was added to the borate buffered saline solution in the following concen ⁇ trations: Percent (Weight/Volume)
  • a preserving amount of stabilized chlorine dioxide having a raw material age of 54 months was utilized in one sample; and a similar preserving amount of stabilized chlorine dioxide having a raw material age of 2 months was utilized in a second sample.
  • Each of the samples of stabilized chlorine dioxide was the proprietary stabi ⁇ lized chlorine dioxide of Bio-Cide International, Inc. of Norman, Oklahoma, under the trademark Purogene. No aging effect was detected between the two samples and their use as a preservative for borate buffered saline solutions.
  • EXAMPLE III A preservative efficacy test was performed on a borate buffered saline solution having a composition similar to that of Example I wherein 0.005 weight/volume percent stabilized chlorine dioxide was added to the borate buffered solution and the resulting mixture stored for 90 days at 45 degrees Centigrade. At the end of the storage period the sample was examined and it was determined that the stabilized chlorine dioxide was an effective preservative for a borate buffered saline solu ⁇ tion.
  • EXAMPLE IV An experiment was conducted to determine if a borate buffered saline solution containing 0.005 weight/volume percent stabilized chlorine dioxide met the USP. Efficacy criteria for ophthalmics as set forth in the U.S. Pharma ⁇ copeia (USP. XXI, 1985). The stabilized chlorine dioxide . employed was the proprietary stabilized chlorine dioxide of Bio-Cide International, Inc. of Norman, Oklahoma. The criteria for preservatives requires that a 99.9% reduc ⁇ tion of microbes challenge occur within 14 days of con ⁇ tact with the product being tested; and that no growth of yeast and fungi occur.
  • borate buffered saline solution containing 0.005 weight/volume percent stabilized chlorine dioxide met the before-mentioned criteria for preservatives.
  • a control solution of the borate buffered saline solution which did not contain the stabilized chlorine dioxide present did not meet this USP Efficacy criteria for ophthalmics.
  • a 21 day subacute eye toxicity study in rabbits was conducted using a borate buffered saline solution con ⁇ taining 0.005 weight/volume percent stabilized chlorine dioxide.
  • the borate buffered saline solution containing the stabilized chlorine dioxide had the following composition:
  • the ocular effects of the buffered saline solution containing 0.005 weight/volume percent stabilized chlorine dioxide were evaluated in rabbit eyes in con ⁇ junction with Permalens soft contact lenses.
  • Test eye lenses were subjected to daily cleaning, rinsing, and overnight soaking with the borate buffered saline solu ⁇ tion containing stabilized chlorine dioxide.
  • Control eye lenses were subjected to the same regimen using preserved normal saline solution. Lenses were fit directly to the eye and worn daily for a minimum of eight hours for 21 consecutive days.
  • the ocular effects of the buffered saline * solution containing 0.005 weight/volume percent stabilized chlorine dioxide were evaluated in rabbit eyes in con- juction with Permalens soft contact lenses and multiple topical instillations.
  • Test eye lenses were subjected to overnight soaking in the borate buffered saline solution containing 0.005 weight/volume percent stabilized chlorine dioxide followed by direct fit to the eye and 8 hours of wear with topical instillations of the test solution performed at a rate of one drop every one-half hour. Eyes were observed for discomfort and/or gross ocular reactions at lens fit, at each instillation and at lens removal. Slit lamp biomicroscopy was performed following lens removal. Control eyes were subjected to the same regimen using preserved normal saline. No ocular reactions were noted in any rabbit.
  • the borate buffered saline solution containing the stabilized chlorine dioxide had the following composition:
  • the ocular effects of the buffered saline solution containing 0.005 weight/volume percent stabilized chlorine dioxide were evaluated in rabbit eyes following 1 day of multiple topical instillations performed at a rate of one drop every one-half hour for 8 hours. Test eyes were. treated with the borate buffered saline solu ⁇ tion containing 0.005 weight/volume percent stabilized chlorine dioxide and control eyes were treated with a preserved normal saline solution.

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  • Health & Medical Sciences (AREA)
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Abstract

Une composition désinfectante pour dispositifs ophtalmiques comprend au moins 0,02 % en poids/volume de dioxyde de chlore stabilisé.
PCT/US1989/005292 1988-11-29 1989-11-22 Compositions desinfectantes pour dispositifs ophtalmiques WO1990006126A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US27779088A 1988-11-29 1988-11-29
US277,790 1988-11-29

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WO1990006126A1 true WO1990006126A1 (fr) 1990-06-14

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992015334A1 (fr) * 1991-03-04 1992-09-17 Allergan, Inc. Compositions et procedes de nettoyage pour lentilles de contact
EP0507837A1 (fr) * 1990-01-05 1992-10-14 Allergan, Inc. Procedes de desinfection de verres de contact
US5306440A (en) * 1989-10-02 1994-04-26 Allergan, Inc. Methods for generating chlorine dioxide and compositions for disinfecting
US5324447A (en) * 1989-10-02 1994-06-28 Allergan, Inc. Method and activator compositions to disinfect lenses
US5648074A (en) * 1993-05-25 1997-07-15 Allergan Compositions and methods for disinfecting contact lenses and reducing proteinaceous deposit formation
US5736165A (en) * 1993-05-25 1998-04-07 Allergan In-the-eye use of chlorine dioxide-containing compositions
WO2010009063A3 (fr) * 2008-07-15 2010-03-11 Basf Corporation Liquides à base de dioxyde de chlore non cytotoxique
US8343949B2 (en) 2004-06-09 2013-01-01 Allergan, Inc. Stabilized compositions comprising a therapeutically active agent, and an oxidizing preservative

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4654208A (en) * 1983-03-01 1987-03-31 Stockel Richard F Anti-microbial compositions comprising an aqueous solution of a germicidal polymeric nitrogen compound and a potentiating oxidizing agent
US4689215A (en) * 1984-07-30 1987-08-25 Ratcliff Perry A Method and composition for prevention and treatment of oral disease
US4696811A (en) * 1984-07-30 1987-09-29 Ratcliff Perry A Method and composition for prevention and treatment of oral disease

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4654208A (en) * 1983-03-01 1987-03-31 Stockel Richard F Anti-microbial compositions comprising an aqueous solution of a germicidal polymeric nitrogen compound and a potentiating oxidizing agent
US4689215A (en) * 1984-07-30 1987-08-25 Ratcliff Perry A Method and composition for prevention and treatment of oral disease
US4696811A (en) * 1984-07-30 1987-09-29 Ratcliff Perry A Method and composition for prevention and treatment of oral disease

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5306440A (en) * 1989-10-02 1994-04-26 Allergan, Inc. Methods for generating chlorine dioxide and compositions for disinfecting
US5324447A (en) * 1989-10-02 1994-06-28 Allergan, Inc. Method and activator compositions to disinfect lenses
US5338480A (en) * 1989-10-02 1994-08-16 Allegan, Inc. Compositions and methods to clean contact lenses
EP0507837A1 (fr) * 1990-01-05 1992-10-14 Allergan, Inc. Procedes de desinfection de verres de contact
EP0507837A4 (en) * 1990-01-05 1993-01-27 Allergan, Inc. Methods to disinfect contact lenses
WO1992015334A1 (fr) * 1991-03-04 1992-09-17 Allergan, Inc. Compositions et procedes de nettoyage pour lentilles de contact
US5648074A (en) * 1993-05-25 1997-07-15 Allergan Compositions and methods for disinfecting contact lenses and reducing proteinaceous deposit formation
US5736165A (en) * 1993-05-25 1998-04-07 Allergan In-the-eye use of chlorine dioxide-containing compositions
US8343949B2 (en) 2004-06-09 2013-01-01 Allergan, Inc. Stabilized compositions comprising a therapeutically active agent, and an oxidizing preservative
US8691802B2 (en) 2004-06-09 2014-04-08 Allergan, Inc. Stabilized compositions comprising a therapeutically active agent and an oxidizing preservative
WO2010009063A3 (fr) * 2008-07-15 2010-03-11 Basf Corporation Liquides à base de dioxyde de chlore non cytotoxique
US8518456B2 (en) 2008-07-15 2013-08-27 Basf Corporation Non-cytotoxic chlorine dioxide fluids
US8636987B2 (en) 2008-07-15 2014-01-28 Basf Corporation Tooth whitening compositions and methods

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Publication number Publication date
CA2004097A1 (fr) 1990-05-29
AU4658089A (en) 1990-06-26

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