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BACKGROUND OF THE INVENTION
1. Field of the Invention
A hypocompatible biodegradable non-aqueous cold sterilant effective against
a wide range of pathogenic organisms including bacterial spores.
2. Description of the Prior Art
Sterilants are used in many areas, such as in the sterilization of
laboratory, surgical, dental and other equipment. It is customary in
hospital practice to sterilize instruments overnight, using chemical
sterilizing agents or other sterilizing methods.
The most common methods of sterilization involve either the use of
pressurized steam, dry heat or ethylene oxide. However, some of these
methods are cumbersome, tedious and time-consuming, often damage the
sterilized material and require expensive equipment and skilled
technicians.
Moreover, steam sterilization is impracticable for many plastic devices and
delicate instruments which are sensitive to elevated temperatures.
Many chemical sterilization methods have been developed as substitutes for
steam sterilization. Unfortunately most have shortcomings. Phenols and
formaldehyde compositions have considerable sporicidal activity but have
objectionable odors and extreme toxicity. Ethanol, isopropyl alcohol and
the quaternary ammonium compounds have been used, and though less odorous
and toxic, lack the activity of the phenols and formaldehyde compositions.
Compositions comprising saturated dialdehydes with alkalinating agents have
also been used. Though such compounds are satisfactory as chemical
sterilization agents their sporicidal activity is limited to certain pH
ranges, require up to ten (10) hours to work, and have certain limits on
stability.
U.S. Pat. No. 3,282,775 shows a sporicidal composition including saturated
dialdehydes containing from 2 to 6 carbon atoms and a cationic surface
active agent. More specifically, these compounds include malonaldehyde,
succinaldehyde, oxaldehyde (glyoxal), adipaldehyde and preferably,
glutaraldehyde. The quantity of saturated dialdehyde used may vary from
about 0.1 percent to about 2 percent depending upon which particular
dialdehyde is selected. Moreover, one may safely depart from this
concentration without seriously detracting from its effectiveness. For
example, if desired, the final concentration of dialdehyde may be
increased up to as much as 10 percent or decreased as low as 0.05 percent.
However, amounts in excess of 2 percent are unnecessary, extremely toxic
and wasteful. In actual practice a range of from 0.1 percent to about 2
percent is preferred. The compounds may be diluted either with water or
lower alkanols such as methanol, ethanol, isopropanol and the like, or
with combinations to form aqueous-alcohol solutions. The pH of the final
solution may be either on the acid side or the alkaline side and may be
varied over a wide range of from about 4.0 to about 9.0 though it is
preferred to have the pH in the range of from about 5.0 to 8.0.
U.S. Pat. No. 4,040,977 describes a preservative and disinfecting
composition for aqueous emulsions, suspensions and solutions which are
obtained by reaction in water of a haloacetamide or thiocyanoacetamide or
mixture thereof; an alcohol or mixture of alcohols; and formaldehyde.
U.S. Pat. No. 3,697,222 describes a sterilization process achieved by
contacting a contaminated object with an aqueous acid glutaraldehyde
solution at temperatures above about 45 degrees C. The sterilizing action
may be enhanced by ultrasonic energy. Sterilization also may be achieved
using ultrasonic energy and aqueous alkaline glutaraldehyde solution.
U.S. Pat. No. 4,093,744 teaches a means for killing spores on instruments
and the like utilizing the combination of glutaraldehyde and a detergent
selected from the group consisting of nonionic, anionic and ampholytic
surface active agents. The sporicidal kill activity of glutaraldehyde is
enhanced by the detergents.
U.S. Pat. No. 4,048,336 relates to a means for killing spores on
instruments and the like utilizing the combination of 18 glutaraldehyde
and a monoaldehyde, such as, for example, formaldehyde. The sporicidal
kill activity of the composition is more rapid than previously possible
and more effective than the use of either glutaraldehyde or monoaldehyde
alone. Unfortunately, this composition is far more toxic than without
glutaraldehyde.
U.S. Pat. No. 4,208,404 shows an aqueous solution of glutaraldehyde of acid
pH value with dissolved quantities of certain highly ionized salts to kill
dormant spores at room temperature.
U.S. Pat. No. 4,294,797 describes a composition to sterilize medical
instruments comprising an alcohol-aldehyde active substance combination in
a proportion of 5 to 15 percent by weight. The preferred alcohol is
isopropanol and the preferred aldehyde is formaldehyde or a succinic acid
dialdehyde complex and the preferred ratio of alcohol to aldehyde is 1:1.
U.S. Pat. No.2,889,243 shows a chemical composition having antiviral
activity comprising hydroxpyruvaldehyde ether.
U.S. Pat. No. 4,173,653 teaches an Oxydiacetaldehyde is used as an active
antimicrobial agent in an aqueous solution for disinfecting or
sterilizing. The activity against bacteria or spores can be improved by
adding alkalinating agents or alcohols such as isopropanol, or by raising
pH or by raising the temperature.
U.S. Pat. No. 4,923,899 describes an aqueous composition for killing
bacteria, spores, fungi and viruses on nonabsorbent surfaces comprising at
least one quaternary ammonium salt, at least one aliphatic dialdehyde
having from two to six carbon atoms, and at least one aliphatic hydroxyl
compound having from one to eight atoms. Optionally, a chelating agent and
an inorganic nitrite salt may be employed. This sterilant kills bacteria,
spores, fungi and viruses over a pH range from about pH 4 to about pH 9.
U.S. Pat. No. 3,968,250 describes a method for disinfecting or sterilizing
medical, surgical, dental instruments or other objects in liquid phase
with improved sporicidal compositions by combining nonionic and anionic
surfactants with aqueous or alcoholic glutaraldehyde solutions. The method
can be used also with ultrasonic irradiation over a wide frequency range
of from 10 to 850 kHz.
U.S. Pat. No. 3,968,248 and U.S. Pat. No. 3,912,450 teach similar methods.
U.S. Pat. No. 4,103,001 shows a room temperature aqueous sterilizing
composition comprising from 0.75 percent by weight of glutaraldehyde and
from 4-15 percent by weight of phenol and a metal phenate, preferably
sodium phenate. Optionally present are 1-5 percent by weight of sodium
tetraborate, 2-10 percent by weight of a humectant such as glycerol,
di-ethylene glycol or propylene glycol and a surfactant. A preferred pH
range is pH 7.0-7.4.
U.S. Pat. No. 4,004,024 describes a method for controlling bacteria, fungi
and spores which comprises applying thereto a bacterially, fungicidally
and sporicidally effective amount of a furan selected from 2-(R.sub.1
O)-5-(R.sub.20 O)-2,5-dihydrofuran and 2-(R.sub.1 O)-5-(R.sub.2 O)-
tetrahydrofuran or mixtures thereof; a process for preparing a
2,5-bis(-R.sub.1 O)-2.5-tetrahydrofuran and 2.5-bis((R.sub.1
O)-tetrahydrofuran and 2.5-bis(benzyloxy)-tetrahydrofuran.
U.S. Pat. No. 4,436,754 describes a disinfecting and sterilizing
composition comprising an aqueous solution containing a 2 to 6 carbon atom
dialdehyde and may also contain formaldehyde and a diol or monosubstituted
diol of the formula RO(CH.sub.2 YCH.sub.2 O).sub.n CH.sub.2 CH.sub.2 OH;
where R is H or CH.sub.3 and n is an integer from 1 to about 22 with a
wide range of pH from pH 2 to pH 9.
U.S. Pat. No. 4,937,072 a sporicide having a defined period of sporicidal
activity comprising three components including a peroxide or peroxide
generating material, a peroxidase and a salt of iodine which serves as a
donor molecule, storing the three components in a nonreacting state to
maintain the sporocide in an inactive state and admixing the three
components in an aqueous based carrier to cause a catalyzed reaction by
said peroxidase for generating free radicals and/or by-products from the
iodide salt (donor molecule) and contacting the surface or object to be
sterilized with the activated mixture. The concentration level of the
three components can be selected such that an active sporocidal state is
maintained for any desired period of time.
U.S. Pat. No. 4,122,192 describes a solid composition for producing a
disinfectant or sterilant comprising a disinfecting or sterilizing amount
of saturated dialdehyde having from 2 to 6 carbon atoms absorbed on an
inorganic or organic particulate carrier material and, in some cases, an
alkalinating agent.
U.S. Pat. No. 3,983,252 describes a disinfectant composition comprising a
dialdehyde and an alkali metal salt of a hydrocarbon carboxylic acid in
aqueous solution and, optionally, an alcohol and/or a diol and/or a triol,
and are as potent as, but substantially more stable than, known dialdehyde
containing disinfectant compositions.
U.S. Pat. No. 3,653,499 describes a germicidal, sporicidal and detergent
composition which prevents coagulated blood from adhering to instruments
during sterilization and used to decontaminate surgical items, such as
needles and sponges comprising paraformaldehyde having an average
molecular weight of about 360 free from polymer chains over a molecular
weight of 3,000, alkali metal tripolyphosphate and a water soluble buffer,
such as sodium carbonate, to give a final aqueous solution having a pH
between about 10 and 11. If the materials are substantially anhydrous, the
constituents can be mixed together in a powder and stored in a container
hermetically sealed against the entrance of moisture. If the constituents
or any of them are not substantially anhydrous, the composition must be in
a two-part package separately sealed in waterproof pouches, one containing
the paraformaldehyde and the other the polyphosphate and buffer.
U.S. Pat. No. 4,978,530 describes a process for sanitizing, disinfecting
and killing spores involving providing a tangible object made from
polymeric material impregnated with an aqueous glutaraldehyde solution
packaged in an air-tight enclosure, removing the impregnated tangible
object from the enclosure and applying the impregnated tangible object to
the surface to be sterilized and/or sanitized and disinfected so as to
expose spores, bacteria, virus and other microorganisms present on the
surface to the action of the glutaraldehyde solution. A sanitary
attachment for a receiver or mouthpiece of a telephone made from plastic
material incorporating a glutaraldehyde solution. A fabric made from
cellulosic or plastic material having sporicidal and/or sanitizing and
disinfectant activity as a result of being impregnated with a
glutaraldehyde solution. A method for sanitizing and disinfecting and/or
rendering fabric sporicidal involves impregnating a fabric with an aqueous
glutaraldehyde solution prior to packaging the fabric in an air-impervious
container until ready for use.
Various spray germicides for sanitizing such surfaces is typified by U.S.
Pat. No. 3,445,564. U.S. Pat. No. 3,445,564 is directed to a method,
compositions and articles for sanitizing public or communal facilities
prior to individual use. The method consists of applying a thin layer of a
rapidly drying liquid germicidal composition to a surface such as a toilet
seat. The rapidly drying germicidal compositions consist essentially of a
lower aliphatic alcohol and at least about 5 percent of a volatizing agent
such as acetone. Isopropyl alcohol has excellent germicidal activity and
is sufficiently volatile to give a satisfactory drying rate when blended
with suitable proportions of a volatizing agent. Inasmuch as the lower
aliphatic alcohols are not sufficiently volatile to afford usefully short
drying times for practical purposes in the method and articles of the
Kirschner invention it was necessary to include a volatizing agent in the
germicidal composition. The proportion of volatizing agent to lower
aliphatic alcohol in the rapidly drying germicidal compositions employed
in the invention may vary widely depending upon a number of factors, which
include among others, the volatility of the alcohol employed, the
volatility of the volatilizing agent, the desired drying rate of the
germicidal composition, the amount of germicidal agent applied to the
surface to be treated and the method of application of the germicide, not
to mention the prevailing conditions of temperature and relative humidity
under which the product is to be employed.
Although the isopropyl alcohol-acetone composition of U.S. Pat. No.
3,445,564 has germicidal activity against bacteria, fungi and other lower
organisms, additional antibacterial, antifungal or other active
ingredients may be incorporated to enhance the overall germicidal
effectiveness. Suitable germicidal additives include the well known
antibacterial quaternary ammonium compound. In essence, U.S. Pat. No.
3,445,564 teaches the use of isopropyl alcohol to kill a limited number of
germs on a dry toilet seat with the addition of acetone to volatize an
already highly volatile chemical to rapidly dry the toilet seat for use
within 30 seconds.
The use of a dye in a bactericidal solution as disclosed in U.S. Pat. No.
2,449,274 is employed to provide a visual indication of the effectiveness
of such sprays.
U.S. Pat. No. 4,678,658 shows an aerosol spray for use in disinfecting a
surface for personal use such as a public restroom facility or telephone.
The composition and delivery of the compositions provides for the
placement of a spray of disinfectant which includes a dye that disappears
as the spray effects the germicidal activity of the disinfectant. The
composition is also rapidly drying, so that the dye disappears as well as
the disinfecting composition leaving the surface dry. However, the spray
is corrosive and environmentally unsafe.
U.S. Pat. No. 3,821,413 discloses a formulation of materials which permits
an effective, uniform rate of evaporation of glycols from an air
circulator device to reduce airborne bacteria in the surrounding
atmosphere. It was observed that the relative amounts and identities of
the components of the invention are critical to the attainment of the
desired continuous evaporation of glycols over a prolonged period of time.
The composition of U.S. Pat. No. 3,821,413 is a single phase liquid
composition especially adapted for volatilization at a substantially
uniform rate from the air circulator device. Generally speaking, the
composition includes three essential components (1) a glycol, (2) an
organic polar coupling compound for maintaining the homogeneity prevents
the glycol from separating from the mixture during evaporation of the
mixture into the atmosphere and (3) an organic, relatively non-polar
compound for forming hydrophobic micelles with the glycol molecules in the
resulting mixture for reducing the affinity of the glycol to atmospheric
moisture and thereby increasing the rate at which the glycol may be
evaporated into the atmosphere.
The composition contains the glycol germicide. If desired, other suitable
germicides or antiseptic agents can be added provided, however, that the
glycol concentration of the composition does not fall below 5 percent by
weight of the total mixture. Such germicides include quaternary ammonium
compounds, phenols, bisphenols, salicylanilides, carbanilides,
formaldehyde and chloride.
The required glycol evaporation rate for attaining the desired air
sanitizing performance depends on the satisfactory stability and uniform
nature of the liquid composition during evaporation from the mixture.
Accordingly, the compositions of the invention include from about 2
percent to about 40 percent by weight of an organic polar coupling
compound for maintaining the homogeneity of the mixture to prevent the
glycol from separating from the mixture during the evaporation process.
The affinity of glycols to attract atmospheric moisture significantly
reduces their volatility and impairs their evaporation rate. Accordingly,
the compositions of the invention include from about 5 percent to about 80
percent by weight of an organic, relatively non-polar compound for forming
hydrophobic micelles surrounding the glycol molecules in the mixture for
reducing the affinity of the glycol to atmospheric moisture and thereby
increase the rate of evaporation of the glycol. Without this micelle
formation, it was found that the glycol or mixture of glycols in the
mixture cannot evaporate appreciably in an air circulator device
containing a wick immersed in the liquid composition.
U.S. Pat. No. 3,806,593 is directed to an acne treatment medication applied
to the skin for preventing the formation of acne or decreasing already
established ache. An important factor for the occurrence of ache is the
presence of bacteria in the sebaceous glands in the skin. It is known that
the bacteria in the sebaceous glands form esterases which hydrolyze the
sebum fats to alcohols and free fatty acids.
The medicinal ache-preventing or ache-diminishing composition of U.S. Pat.
No. 3,806,593 is based on the bacterial esterase activity in the sebaceous
glands which together with the water already present in the skin can
hydrolyze an ester having a good penetration capacity into the sebaceous
glands to form one and preferably two antibacterially active components,
viz. an acid and an alcohol, which are harmless to the skin. The active
compound in the composition is one or more esters chosen from the group
consisting of ethyl lactate, isopropyl lactate and/or glycerol mono or
dilactate. The esters hydrolyze in the sebaceous glands due to the
esterases present in the glands to form the corresponding acids and
alcohols. Lactic acid and the lower alcohols and also glycerol to a
certain extent exert a good antibacterial activity when formed in situ in
the sebaceous glands. The esters are lipophilic and can thus penetrate
into the said glands. Even if a beneficial action can be achieved by
application of the ester or esters per se, it, has been found to be
suitable to apply the ester in the form of a solution in ethyl alcohol or
isopropyl alcohol. The alcohol prevents hydrolysis of the ester already in
the composition, the alcohol moves the hydrolysis equilibrium towards
ester formation. The alcohol can also facilitate the penetration of the
ester into the skin.
As is well-known alcohol in high concentrations may cause a drying-out of
the skin. To counteract this effect, the composition may include a
moisture-retaining agent such as a lower, suitably water-free polyol, viz.
propylene glycol or glycerol. The content of propylene glycol or glycerol
in the composition according to the invention may be up to 25 percent,
suitably not more than 10 percent by weight and preferably 1-5 percent.
High levels of polyol tend to make the composition smeary upon application
on the skin and should thus be avoided.
The preferred composition according to the invention consists of about 15
percent by weight of ethyl lactate, about 2 percent by weight of propylene
glycol, the remainder being ethyl alcohol.
In summary, U.S. Pat. No. 3,806,593 relates to acne medication comprising
esters that hydrolize in the sebaceous glands in combination with an
alcohol to prevent hydrolysis of the esters as well as to facilitate the
penetration of the ester into the skin, and propylene glycol or glycerol
to prevent drying of the skin. The preferred ratio of the constituents is
15 percent to 83 percent to 2 percent respectively.
U.S. Pat. No. 4,664,909 discloses a stable, fast drying pituitous powder
deodorant suspension in an alcohol media containing a minimal amount of
water and a critical amount of the essential hydroxyethyl cellulose as the
suspending agent.
The fast drying pituitous suspension of particulate material in an aqueous
alcohol media contains hydroxyethyl cellulose at levels above its normal
solubility limit by the polyhydric alcohol.
More specifically, U.S. Pat. No. 4,664,909 relates to stable pituitous
suspensions of particulate material, preferably about 1-20 percent,
uniformly suspended in alcohol/aqueous media containing a high alcohol
content and a lower water content. The alcohol media may be a lower
monohydric alcohol selected from the group consisting of methanol,
ethanol, isopropanol and mixtures thereof. The use of polyhydric alcohols
such as propylene glycol, butylene glycol and polyols thereof, and
glycerin decreases the critical water level required in the hydroxyethyl
cellulose-containing alcohol media.
It has been unexpectedly found that powders can be suspended in
alcoholic/aqueous media containing a high alcohol content and a lower
water content by using the water soluble polymer hydroxyethyl cellulose at
critical levels above its ethanol solubility range which may be broadened
by specified polyhydric alcohols. This polymer is unique in its property
to form stable suspensions.
Specifically, polyhydric alcohols can be partially substituted for the
monohydric alcohol, not to exceed the monohydric alcohol content. The
monohydric alcohol content, such as ethanol, must exceed the upper
solubility level for the water soluble polymer hydroxyethyl cellulose in
ethanol or other lower alkanol. The reported upper solubility level of
this water soluble polymer in ethanol is 70 percent. Below this level and
within normal soluble use ranges, a uniformly viscous liquid is obtained
which pours evenly. Although, it appears aesthetically desirable, it will
not support suspended powder and segregation occurs. However, at ethanol
concentrations above its solubility range, the polymer becomes less
soluble and forms the desired pititious type liquid. If ethanol is further
increased resulting in very low water levels the polymer will precipitate
out and its suspending properties are again lost. Accordingly, a 70:30
ratio of ethanol-water is optimum. However, it was found that this problem
can be eliminated by the sufficient addition of a polyhydric alcohol such
as glycerin, propylene glycol, butylene glycol and polyglycols thereto.
Accordingly, it has been found that the monohydric alcohol constitutes
about 55-85 percent; and the water content may be as low as 5 percent if
at least 10 percent polyhydric alcohol is also present in the suspension.
The combined water and polyhydric alcohol content is at least 15 percent
and may be up to about 25 percent. Thus, it is apparent that the
proportions of monohydric alcohol, water and polyhydric alcohol are
interdependent.
In summary, U.S. Pat. No. 4,664,909 teaches a fast-drying deodorant
comprising a critical amount of hydroxyethyl cellose as the deodorant to
encapsulate or isolate bacteria to prevent growth of the bacteria,
suspended in a solution of monohydric alcohol to provide the fast drying
characteristics and polyhydric alcohol to improve the overall solubility
of the solution to allow the use of increased levels of monohydric
alcohol. The relative proportions of the monohydric alcohol, water and
polyhydric alcohol are driven or determined by the desired solubility and
therefore are interdependent.
U.S. Pat. No. 3,966,902 disclosed various polymer complex carriers such as
propylene glycol for use with an active ingredient such as a disinfectant
or fragrance.
U.S. Pat. No. 4,690,779 refers to the use of propylene glycol in
combination with alcohol and fragrances. This composition is both toxic
and non-biodegradable.
U.S. Pat. No. 4,209,500 teaches a composition suitable for use in aerosol
sprays including an anhydrous alcohol and fragrance or perfume. This
composition is corrosive, non-biodegradable and non-evaporative.
U.S. Pat. No. 4,689,168 describes a hard surface cleaning composition
suitable for glass, chrome, plastic, enamel and other hard surfaces. The
composition is applied to the hard surface as an emulsion of an aqueous
phase and an oil phase. The bubbling action is caused by the evaporation
of volatile constituents from the film or layer of applied compositions,
as well as the desire for the aqueous and oil phase components to reform.
The bubbling action, characterized by small bubbles of volatile components
erupting from the surface of the composition film aids in lifting soil
from the hard surface. As an apparent consequence, the rate of cleaning is
accelerated. The composition comprises a polar organic solvent or mixture
of solvents, a nonvolatile surfactant, a volatile surfactant such asn an
acetylenic alcohol or diol, a volatile organosiloxane oligomer and water.
U.S. Pat. No. 4,983,317 teaches a liquid composition for cleaning a wide
variety of hard surfaces, particularly metallic, plastic, tile, porcelain,
glass and mirrored surfaces comprising a polyacrylic acid or a
polyacrylate resin builder in combination with a hydrotrope which is an
alkali metal salt of a C.sub.21 dicarboxylic acid. The organic solvent may
be selected from the group consisting of alkylene and polyalkylene glycols
of from 2 to 6 carbon atoms and lower alkyl ethers of alkylene and
polyalkylene glycols of from 3 to 8 carbon atoms, the alkyl ether having
from 1 to 4 carbon atoms. A lower aliphatic alcohol of from 2 to 4 carbon
atoms may also be included in the composition to adjust evaporation rate
of the composition.
U.S. Pat. No. 5,064,635 describes a mixture of one or more surfactants
(detergents) with the pH sensitive dye. The surfactant can be diluted with
water to give the desired cleaning strength. The surfactant can be an
anionic, nonionic, amphoteric or mixtures of the three types. Typical
anionic surfactants used are petroleum sulfonates, such as sodium
dodecylbenzene sulfonate, alcohol sulfates such as sodium lauryl sulfate
and ethoxylated higher fatty alcohol sulfates such as sodium lauryl ether
sulfate. Typical nonionic surfactants are primary alcohol ethoxylates,
secondary alcohol ethoxylates, alkyl phenol ethoxylates and alkanolamides.
The amphoteric surfactants include a number of types of carboxylates
derived from fatty imidazolines such as sodium dicarboxyethylcoco
phosphoethyl imidazoline or fatty proprionates such as
cocoamphoproprionate or cocoamphodipropionate. The composition of a basic
cleaner includes the surfactant or mixture of surfactants at about 0.1
percent to about 20.0 percentage by weight. This range of surfactant is
for usage in a nondiluted product for household use. Thymolphthalein in
the range of about 0.01 percent to about 1 percent by weight will give a
broad range of blue color when varying intensity using an alkali system to
adjust the pH of the composition.
U.S. Pat. No. 4,965,063 and U.S. Pat. No. 5,057,303 teach compositions
similar to U.S. Pat. No. 5,064,635.
U.S. Pat. No. 4,329,334 shows a homogeneous liquid anionic-amphoteric based
antimicrobial conditioning shampoo which includes about 0.5 to 2.5 percent
of the antimicrobial agent, 1-imidazolyl-1-(4-chlorophenoxy)-3,
3-dimethylbutan-2, one, solubilized in an aqueous solution of critical
amounts of a mixture of the following specific ingredients: about 10-40
percent by weight of an anionic sulfate or sulfonate surface active agent;
about 0.1-7.5 percent by weight of an amphoteric surfactant selected from
the group consisting of cocobetaine, cocosulfobetaine,
cocoamidopropylbetaine, cocoamidopropylsulfobetaine or combinations
thereof; a nonionic surface active agent selected from the group
consisting of a tertiary amine oxide, a polyoxyethylene hexitan
mono-higher fatty acid ester and mixtures thereof; and about 0.5-2 percent
by weight of a lower aliphatic monohydric or polyhydric alcohol or
mixtures thereof in certain critical amounts to avoid precipitation of the
antimicrobial agent.
U.S. Pat. No. 3,654,165 teaches a cleaner-sanitizer for use on telephone
instruments including a fast-acting, penetrative, quick-drying
bacteriocidal detergent solution which leaves a safe, active residue of
selected proportions of sodium lauryl sulfate, dimethyl sulfone,
isopropanol and iodine in solution.
U.S. Pat. No. 4,793,988 describes a composition for disinfecting a surface,
such as a public restroom facility or telephone. The composition and
delivery of the composition provides for the placement of a thin layer of
disinfectant including a dye. The dye disappears as the thin layer effects
the germicidal activity of the disinfectant. A sample of the germicidal
composition was prepared with 400 mg of sodium dodecyl sulfate (SDS), 400
mg of octyl phenoxy polyethoxyethanol marketed as Triton X-100 and 100 mg
of blue dye thymophthalein. This composition was tested for germicide
effectiveness against Herpes simplex virus type 2, Neisseria gonorrhoeae,
Staphylococcus aureus, Escherichia coli 011K58, Shingela sonnei,
Salmonella typhimurium and Candida albicans.
U.S. Pat. No. 4,975,217 describes germicidal compositions for direct
application to human skin including an organic acid, e.g., malic acid, and
an anionic surfactant, e.g., a sodium alpha-olefin sulfonate, as active
ingredients, and can optionally include an alcohol, e.g., specially
denatured ethyl alcohol, as an additional active ingredient. When
formulated as soaps and lotions, the compositions have been found to
produce more than a 2.0 log reduction in bacteria applied to skin. Organic
acids and anionic surfactants, e.g., malic acid and a sodium alpha-olefin
sulfonate surfactant, are used as active ingredients in germicidal
products which are applied directly to the skin, such as hand-washing
soaps, skin-care lotions, soapy-lotions, or wipes containing these
materials. Optionally, the products can include an alcohol, such as,
specially denatured ethyl alcohol, ethyl alcohol and isopropyl alcohol as
an additional active ingredient. These formulations, in addition to
killing viruses, also effectively kill bacteria and yeasts. In particular,
the formulations have been found to kill a variety of microorganisms in
both in vitro experiments performed in test tubes and, even more
importantly, in in vivo experiments performed on human hands. Moreover,
notwithstanding their germicidal activity, the formulations have been
found to be non-irritating to human skin.
U.S. Pat. No. 4,046,706 shows a composition for cleaning contact lenses
comprising a poly(oxyethylene)-poly(oxypropylene) block copolymer having a
molecular weight between 1900 and 15,500, a water solubility in excess of
about 10 gms per 100 nl, a cloud point in 1 percent aqueous solutions
above about 30 degrees C., and a foam height in excess of 30 mm; a
microbial growth inhibitor; ethyl or isopropyl alcohol; an amphoteric
surfactant and water.
U.S. Pat. No. 3,578,499 teaches a powder composition containing a gelling
agent, a neutral diluent, a wetting agent and a dye or coloring additive.
The powder gelling composition when added to water forms a gel. Acid or
alkaline materials are added for cleaning, biocidal agents for sanitizing
or other materials to produce a desired effect. The significant advantage
of this method is the increased residence time and hence contact time
between agents in the gel and the surface to be acted on. A third
component included in the gelling composition is a wetting agent
exemplified by a linear alkyl benzene sulfonate type material wherein the
alkyl group may include from about 12 to 14 carbon atoms. The wetting
agent should be desirably characterized as a anionic agent although it is
recognized that nonionic surfactants may also be employed. One wetting
agent found useful herein is the commercially available sulfonate of
dodecylbenzene.
U.S. Pat. No. 2,333,124 describes a method for sterilizing air laden with
bacteria or other pathogenic organisms comprising contacting the air with
a mixture of glycols in vapor form in proportions to provide about 1 gram
of such glycols in vapor form to not more than about 5 to 7 million cubic
centimeters of air.
U.S. Pat. No. 2,857,315 shows a stable anti-perspirant stick having a base
comprising a sodium stearate-propylene glycol soap gel having an active
anti-perspirant agent sodium zirconium lactate. The sodium
stearate-propylene glycol soap gel may contain alcohol in an amount not
substantially greater than the propylene glycol by weight.
Additional examples of the prior art are found in U.S. Pat. No. 580,213;
U.S. Pat. No. 3,282,776; U.S. Pat. No. 4,201,764; U.S. Pat. No. 4,282,179;
U.S. Pat. No. 4,265,899; U.S. Pat. No. 4,283,421; U.S. Pat. No. 4,364,515;
U.S. Pat. No. 4,550,105, U.S. Pat. No. 4,105,431; U.S. Pat. No.
4,243,403; U.S. Pat. No. 4,278,206; U.S. Pat. No. 4,322,475; U.S. Pat. No.
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4,540,505; U.S. Pat. No. 4,675,397 and U.S. Pat. No. 4,915,934.
Examination of the prior art reveals most existing compositions available
are either toxic or non-biodegradable or both. Toxic chemicals that are
not biodegradable contaminate our environment, the soil and the water
supply.
In recognition of the dangers of existing disinfectants, health facilities
are required to notify employees that toxic chemicals are in use and
advise them of the possible hazards that result or could result as a
consequence of misuse or a spills. Such notices must also be given to the
community at large.
Other laws and regulations require users to document the use of toxic
chemicals and require that the excess, the waste, or the residue be
collected and properly stored. These materials must be collected by
licensed and approved toxic waste companies, taken to an authorized
disposal site and legally destroyed. The cost of disposing of such toxic
material is often more expensive than the initial purchase price.
Sterilants today should be non-toxic or low in toxicity and biodegradable
and capable of killing bacterial spores quickly and effectively. Further,
such disinfectants and sterilants should be chemically compatible with the
numerous aparatus and instruments found in modern healthcare facilities.
As described more fully hereinafter the instant invention is directed to an
environmentally safe composition capable of killing anaerobic and aerobic
bacteria, viruses including the HIV virus, mildew, mold, fungus and
bacterial spores. The principal complementary sporicidal ingredients of
the invention are selected from a group of monohydric alcohols, a group of
polyhydric alcohols, a group of saturated dialdehydes and a group of
cationic surface active agents.
In the past such alcohols have had limited use outside the laboratory due
to various undesirable characteristics of alcohol. For example, it has
been universally accepted that alcohol has very limited application as a
widely used disinfectant because alcohol is unable to penetrate protein
rich material, evaporates quickly, has limited stability and shelf life,
has a pungent odor and tends to form a glaze on hard surfaces possibly
hiding or covering visible contamination.
The instant invention has evolved from an extensive development program
involving the unexpected formulation of certain chemicals to reduce or
inhibit those undesirable features of alcohol and to make alcohol safe and
effective for use outside the laboratory.
SUMMARY OF THE INVENTION
The present invention relates to a hypocompatible biodegradable nonaqueous
cold chemical sterilant for use in manual bucket systems as well as
automated sterilizer systems to kill a wide range of pathogenic organisms
including bacterial spores.
The cold chemical sterilant comprises a composition including a monohydric
alcohol, a polyhydric alcohol, a saturated dialdehyde and a cationic
surface active agent.
The monohydric alcohol is selected from the group consisting of isopropyl,
methyl, ethyl, n-propyl, n-butyl, tert-butyl alcohol and allyl alcohol and
mixtures thereof. The polyhydric alcohol is selected from the group
consisting of propylene glycol; 1,3 propanediol; 1,2 butanediol,
polyethylene glycol with molecular weight of less than 800; glycerol and
1,4 butanediol and mixtures thereof.
The saturated dialdehyde is selected from the group consisting of
malonaldehyde, succinaldehyde, oxaldehyde (glyoxal), adipaldehyde and
glutaraldehyde. The cationic surface active agent is selected from the
group consisting of cetylpyridinium chloride, methylbenzethonium chloride,
dodecylamine, hexadecylamine, hexadecylamine hydrochloride, dodecyl
aniline, oleyl methylamine ethylene diethylamine methyl sulfate, oleyl
benzylamino ethylene diethylamine hydrochloride, sulfate of lauryl
pyridinium, octadecyl methylene pyridinium acetate, methyl sulfate of
dimethyloctadecyl sulfonium, betaine of diethyl aminoacetic acid,
cetylpyridinium bromide, dodecyltrimethylammonium bromide,
hexadecyltrimethylammonium bromide, tetradecyltrimethylammonium bromide,
benzalkonium chloride, benzethonium chloride,
benzyldimethyldodecylammonium bromide, benzyldimethyl- hexadecylammonium
chloride, benzyldimethyltetradecylammonium chloride,
benzyltrimethylammonium methoxide, cetyldimethylethylammonium bromide,
decamethonium bromide, dimethyldioctadecylammonium bromide,
methylbenzethonium chloride, methyl mixed trialkylammonium chloride,
methyltrioctylammonium chloride, 4-picoline dodecyl sulfate,
n,n,n'poloxyethylene (10)-n-tallow-1,3-diamino propane and octadecyl
chloromethyl ether.
The relative proportions by weight of each of the four constituents
compliment each other to reduce the surface tension of the bacterial spore
wall, penetrate the bacterial spore wall and kill the nuclei of the
bacterial spores and other target organisms without the need of removing
residue.
The hypocompatible biodegradable nonaqueous cold chemical sterilant in
liquid form may be used in manual bucket systems or automatic sterilizer
systems. Alternate systems may include a towelette or an absorbent wipe
containing the product in an airtight enveloping material such as sealed
foil or other wrapping material could be used for a single application.
The invention accordingly comprises the features of construction,
combination of elements, and arrangement of parts which will be
exemplified in the construction hereinafter set forth, and the scope of
the invention will be indicated in the claims.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Various sterilizing compositions and delivery devices have been developed
to kill various pathogenic organisms including bacterial spores. The wide
range of application or use is limited by the chemical and biological
effect of such compositions on the various surfaces and delivery means
exposed to such compositions.
The present invention relates to a hypocompatible organic or nonaqueous
cold chemical sterilant for application on medical instruments, and other
devices which is effective against a wide range of target organisms
including bacterial spores.
The cold chemical sterilant comprises a hypocompatible biodegradable
nonaqueous or organic composition including a monohydric alcohol,
polyhydric alcohol, saturated dialdehyde and a cationic surface active
agent combined in relative proportions by weight to sterilize medical and
dental instruments and other devices such as scopes and dental handpieces.
The application of the cold chemical sterilant is capable of killing a
challenge of the pathogenic or target organisms discussed herein within
ten minutes and without leaving an unacceptable residue.
The monohydric alcohol is selected from the group consisting of isopropyl,
methyl, ethyl, n-propyl, n-butyl, tert-butyl and allyl and mixtures
thereof. The preferred monohydric alcohol is isopropyl.
The polyhydric alcohol is selected from the group consisting of propylene
glycol; 1,3 propanediol; 1,2 butanediol, polyethylene glycol, glycerol and
1,4 butanediol and mixtures thereof. The preferred polyhydric alcohol is
polyethylene glycol with a molecular weight of 400 or less. The
polyethylene glycols suitable for use are well known and commercially
available. Polyethylene glycols, which are designated by a number that
represents the average molecular weight, range from clear viscous liquids
at room temperature, PEGs 200, 300, 400 and 600, to soft solids PEGs, 1000
and 1450, to waxy solids available in the form of flakes or powders, PEGs
3350, 8000 and 14000.
The saturated dialdehyde is selected from the group consisting of
malonaldehyde, succinaldehyde, oxaldehyde (glyoxal), adipaldehyde and
preferably, glutaraldehyde.
The cationic surface active agent is selected from the group consisting of
methylbenzethonium, dodecylamine, hexadecylamine, hexadecylamine
hydrochloride, dodecyl aniline, oleyl methylamine ethylene diethylamine
methyl sulfate, oleyl benzylamino ethylene diethyamine hydrochloride,
sulfate of lauryl pyridinium, octadecyl methylene pyridinium acetate,
methyl sulfate of dimethyloctadecyl sulfonium, betaine compound of diethyl
aminoacetic acid, octadecyl chloromethyl ether, cetylpyridinium bromide,
dodecyltrimethylammonium bromide, hexadecyltrimethylammonium bromide,
tetradecyltrimethylammonium bromide, benzalkonium chloride, benzethonium
chloride, benzyldimethyldodecylammonium bromide,
benzyldimethylhexadecylammonium chloride, benzyldimethyltetradecylammonium
chloride, benzyltrimethylammonium methoxide, cetyldimethylethylammonium
bromide, decamethonium bromide, dimethyldioctadecylammonium bromide,
methylbenzethonium chloride, methyl mixed trialkylammonium chloride,
methyltrioctylammonium chloride, 4-picoline dodecyl sulfate,
n,n,n'poloxyethylene (10)-n-tallow-1,3-diamino propane and preferably
cetylpyridinium chloride.
As used herein, target organisms refers to pathogenic organisms including
Staphylococcus areus, Pseudomonas aeruginosa and Salmonella coleraesuis
and viruses including HIV, tub | | |
