WO2000054594A1 - Composition sterilisante - Google Patents

Composition sterilisante Download PDF

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Publication number
WO2000054594A1
WO2000054594A1 PCT/GB2000/000922 GB0000922W WO0054594A1 WO 2000054594 A1 WO2000054594 A1 WO 2000054594A1 GB 0000922 W GB0000922 W GB 0000922W WO 0054594 A1 WO0054594 A1 WO 0054594A1
Authority
WO
WIPO (PCT)
Prior art keywords
iodine
potassium iodide
composition
sterilant
sterilant composition
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/GB2000/000922
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English (en)
Inventor
Mary Viktoria Kelemen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Salter Roy
Original Assignee
Salter Roy
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 Salter Roy filed Critical Salter Roy
Priority to AU31788/00A priority Critical patent/AU3178800A/en
Publication of WO2000054594A1 publication Critical patent/WO2000054594A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION 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
    • A01N59/00Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
    • A01N59/12Iodine, e.g. iodophors; Compounds thereof

Definitions

  • This invention relates to a sterilant composition which is particularly suitable for use in single-stage "cold" sterilization of instruments for use for example in surgery such as endoscopes which are heat sensitive, and dentistry, where the instruments require rapid turnover.
  • a simple relatively low cost sterilising fluid for use in particular in the above mentioned fields where steam sterilization may be inappropriate for a number of reasons .
  • Cold sterilizing procedures are of course already known. However, they have a number of disadvantages relating mainly to the nature of the chemicals used and there has been a need for some time for a cold sterilant which is non-toxic, non-carcinogenic, non- flammable and non-irritant.
  • Such a composition should of course primarily be able to perform as an effective sterilant which means that in addition to destroying bacteria and other living life forms it must also be a rapid acting sporicide.
  • An accepted definition of a sterilant is a solution which will reduce both the bacterial and the spore concentration by 5 log cycles. Additionally, for the sterilant composition to be useful as a cold sterilant this level of sporicidal action has to be achieved within a period of the order of thirty minutes.
  • the sterilant composition should be relatively low-cost, easily prepared and should also have a satisfactory shelf life. It should ideally be of such low cost that it can also be used in many situations as a more general application germ killer, i.e. a disinfectant.
  • a disinfectant i.e. a disinfectant.
  • An aqueous solution made from 5% iodine and 10% potassium iodide in water has been known for many decades as Lugol ' s Solution for use as a disinfectant and also, in well diluted form, has been prescribed for oral administration for the treatment of thyro- toxicosis.
  • JP-A-3 127 706 describes the use of a 0.1 iodine solution corresponding approximately to a four-fold diluted Lugol' s solution (I 2 1.27% and KI 2.50%) for killing living spores.
  • Lugol ' s solution only reduces the spore count by about 4 log cycles within thirty minutes and never kills all the spores, and after a week there is a significant reversion, i.e. appearance of additional colonies. Accordingly, Lugol ' s Solution does not appear to be a promising starting point for producing an effective fast acting cold sterilant composition. It has also been believed that an acidic pH, for example pH4 , is desirable to enhance sporicidal activity.
  • iodophors have been described for use as disinfecting agents but none are effective as sterilizing agents. Quoting from Goodman and Gilman' s "The Pharmacological Basis of Therapeutics" : "An iodophor is a loose complex of elementary iodine with a carrier that serves not only to increase the solubility of iodine but also to provide a sustained-release reservoir of the element.”
  • iodophor polyvinylpyrrolidone (povidone) .
  • a 10% solution contains 1% of available iodine, but the free iodine concentration is less than 1 ppm.
  • GB 1,472,408 describes an iodophor solution containing polyvinyl alcohol, boric acid, iodine and potassium iodide. From a compositional point of view none of the examples use an excess of iodine over potassium iodide. Moreover, although the compositions have anti-bacterial properties, even though stated otherwise in the specification they are not effective sterilants; hat is they are not effective against spores within a short period of time.
  • EP 0,487,066 describes a disinfectant composition
  • a disinfectant composition comprising a solution of hydroxypropyl cellulose which acts as an iodophor, iodine and an iodide, which may be potassium iodide. Similarly, this is a disinfectant and is not a sterilant.
  • US 4,526,751 describes the use of a iodophor solution of the povidone type referred to above which additionally contains potassium iodide and potassium bromide and which is a disinfectant. As in the case of other iodophor solutions it does not act as a sterilant .
  • JP 56,077,209 A describes an iodophor solution using an amino acid as a solubilising agent. Again this acts as a disinfectant but not as a sterilant.
  • selection of the proportion of the iodine to potassium iodide content in a simple aqueous solution of those two components results in a solution which is a very effective sporicide, typically reducing the spore concentration by 7 log cycles within thirty minutes, maintaining this activity down to a five-fold dilution and moreover having a good shelf life and without the necessity of any additives such as a buffer in the solution to reduce the pH. Shelf life is particularly important as the less frequently the solution has to be prepared the more economical it becomes in terms of the cost of materials and manpower hours used in its preparation.
  • a sterilant composition which consists essentially of an aqueous solution of from 0.2% to 1.0% w/v of potassium iodide (KI) and an amount of iodine (I 2 ) in % w/v excess of the % w/v amount of the potassium iodide up to the maximum solubility of iodine in the potassium iodide solution.
  • the ratio of potassium iodide to iodine used to make the solution is substantially
  • a packaged composition can conveniently be supplied for use in cold sterilising surgical and dental instruments comprising potassium iodide and iodine in a weight ratio of 1:1:5, either as an aqueous solution or in a form suitable for mixing with sterile water to form the sporicidal solution.
  • compositions of the present invention are that it is simple to make, its materials are relatively inexpensive, it requires no additions such as pH buffers, it has a good shelf life, and it does not have many of the health and environmental disadvantages of prior chemical "cold” sterilants.
  • Specific examples of compositions within the scope of the present invention will now be described.
  • laboratory grade iodine and potassium iodide were employed.
  • sporicidal activity the spore suspension was "Spordex” and was a suspension of Bacillus subtilis spores 2.8 x 10 8 per ml supplied by Steris.
  • a sodium acetate buffer solution two possible buffers are exemplified, namely a 0.2M sodium acetate buffer (pH4.0) prepared from 0.2M sodium acetate (27.22 g/L) 180 ml plus 0.2M acetic acid (12ml/L) 820 ml and a 1.0M sodium acetate buffer (pH 4.0) prepared from 1.0M sodium acetate (136.1 g/L) 180 ml + 1.0M acetic acid (60 ml/L) 820 ml.
  • pH4.0 0.2M sodium acetate buffer
  • 1.0M sodium acetate buffer prepared from 1.0M sodium acetate (136.1 g/L) 180 ml + 1.0M acetic acid (60 ml/L) 820 ml.
  • the potassium iodide was first dissolved either in sterile distilled water or the buffer solution in the appropriate w/v amount and then the iodine was dissolved in the potassium iodide solution. Although the iodine dissolves readily the solution is stirred at room temperature for a minimum of two hours or overnight as appropriate. As controls corresponding solutions of potassium iodide but with no iodine were used.
  • a viable count of the commercial Bacillus subtilis spore suspension was carried out. Plates were prepared with nutrient agar . A 0.1ml sample was withdrawn and diluted m nutrient broth. A viable count by spread- plate method was carried out m duplicate using 0.1ml of 10 5 and 10 5 dilutions.
  • Tests were also performed with solutions of the iodine and potassium iodide in 0.2M sodium acetate buffer giving pH 4.0 and also the 1M sodium acetate buffer referred to above. Generally, it was found that the buffer had little or no effect on the sporicidal activity.
  • cor. tamir.a tec TABLE 5 Sporicidal activity of 1.5% w/v iodine dissolved in 1% w/v potassium iodide in water - twofold, five-fold and ten-fold dilutions.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Agronomy & Crop Science (AREA)
  • Inorganic Chemistry (AREA)
  • Pest Control & Pesticides (AREA)
  • Plant Pathology (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Environmental Sciences (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une composition stérilisante constituée essentiellement d'une solution aqueuse d'iodure de potassium (KI), (de 0,2 à 1,0 poids/volume), et d'une quantité d'iode (I2), supérieure en pourcentage à celle d'iodure de potassium jusqu'à la solubilité maximale d'iode dans la solution d'iodure de potassium. Le rapport en poids iodure de potassium sur iode est de préférence 1/1,5. Cette composition convient pour la stérilisation à froid d'instruments chirurgicaux et dentaires.
PCT/GB2000/000922 1999-03-15 2000-03-14 Composition sterilisante Ceased WO2000054594A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU31788/00A AU3178800A (en) 1999-03-15 2000-03-14 Sterilant composition

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9905907.3 1999-03-15
GBGB9905907.3A GB9905907D0 (en) 1999-03-15 1999-03-15 Sterilant composition

Publications (1)

Publication Number Publication Date
WO2000054594A1 true WO2000054594A1 (fr) 2000-09-21

Family

ID=10849640

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2000/000922 Ceased WO2000054594A1 (fr) 1999-03-15 2000-03-14 Composition sterilisante

Country Status (3)

Country Link
AU (1) AU3178800A (fr)
GB (1) GB9905907D0 (fr)
WO (1) WO2000054594A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015157610A1 (fr) * 2014-04-11 2015-10-15 Microdermis Corporation Compositions sporicides de clostridium difficile

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3728449A (en) * 1972-05-01 1973-04-17 West Laboratories Inc Germicidal iodine compositions for application to skin tissue including teats of milk animals
JPS5677209A (en) * 1979-11-29 1981-06-25 Ise Kagaku Kogyo Kk Iodophor composition
JPS62185019A (ja) * 1986-02-10 1987-08-13 Ise Kagaku Kogyo Kk 動物用殺菌消毒剤並びに動物の殺菌消毒方法
WO1989000857A1 (fr) * 1987-08-03 1989-02-09 Mdt Corporation Composition germicide
WO1994023581A1 (fr) * 1993-04-15 1994-10-27 Ecolab Inc. Solution pour immerger les pis afin de constituer une barriere d'iode
GB2311222A (en) * 1996-03-18 1997-09-24 Mary Viktoria Kelemen Cold sterilant composition comprising an aqueous solution of lithium iodide and iodine

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3728449A (en) * 1972-05-01 1973-04-17 West Laboratories Inc Germicidal iodine compositions for application to skin tissue including teats of milk animals
JPS5677209A (en) * 1979-11-29 1981-06-25 Ise Kagaku Kogyo Kk Iodophor composition
JPS62185019A (ja) * 1986-02-10 1987-08-13 Ise Kagaku Kogyo Kk 動物用殺菌消毒剤並びに動物の殺菌消毒方法
WO1989000857A1 (fr) * 1987-08-03 1989-02-09 Mdt Corporation Composition germicide
WO1994023581A1 (fr) * 1993-04-15 1994-10-27 Ecolab Inc. Solution pour immerger les pis afin de constituer une barriere d'iode
GB2311222A (en) * 1996-03-18 1997-09-24 Mary Viktoria Kelemen Cold sterilant composition comprising an aqueous solution of lithium iodide and iodine

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
PATENT ABSTRACTS OF JAPAN vol. 12, no. 37 (C - 473) 4 February 1988 (1988-02-04) *
PATENT ABSTRACTS OF JAPAN vol. 5, no. 144 (C - 071) 11 September 1981 (1981-09-11) *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015157610A1 (fr) * 2014-04-11 2015-10-15 Microdermis Corporation Compositions sporicides de clostridium difficile
US9629875B2 (en) 2014-04-11 2017-04-25 Microdermis Corporation Clostridium difficile sporicidal compositions

Also Published As

Publication number Publication date
GB9905907D0 (en) 1999-05-05
AU3178800A (en) 2000-10-04

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