Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Wearing apparel – fabric – or cloth
Reexamination Certificate
2001-10-26
2002-12-03
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Wearing apparel, fabric, or cloth
C424S402000, C424S736000, C514S556000, C514S642000, C514S724000
Reexamination Certificate
active
06488948
ABSTRACT:
This invention relates to a water-based composition having at least one of anti-bacterial or anti-fungal properties and use thereof for skin care and for fabric treatment. The composition is not only effective as an anti-bacterial and/or anti-fungal material when included in a skin care gel or lotion for topical use, such as in a sun screen composition, or in conjunction with sanitary elastic gloves as a coating therein, it is gentle to the user's skin and may include constituents which advantageously indicate its presence. The composition is not only effective as an anti-bacterial and/or anti-fungal material when used as a liquid to treat fabric employed for personal hygiene aids including disposable diapers for children and adults, sanitary napkins, and wipes, it is gentle to the skin and may be formulated to provide odor control. Users include humans and animals.
Since about May, 1997 the inventor began offering for sale a lotion, which is a water-based composition useful as an antiseptic barrier for pre- and post-milking, and dry period treatment of the teats of milk cows under the trade name tSHIELD™ (Quest Research, Inc.). This composition is formulated as a soothing dip or lotion for topical application or is impregnated in toweling used as a cleansing wipe. The lotion product shields the skin of the cow against bacterial penetration for up to four days and may be marked with a dye to indicate its presence and hence provide an effectiveness indicator.
The composition includes four anti-bacterially-active constituents known to target bacteria commonly found for this application, namely, in % by weight based on the weight of the total composition, 0.30% of a Quaternium 12 (C.T.F.A. name, i.e., a Cosmetic, Toiletries, and Fragrances Association name), such as BORDAC 2250 a disinfectant manufactured by Lonza, Inc.; 2.80% of a Cetrimonium chloride (C.T.F.A. name), which is cetyl trimethyl ammonium chloride, a disinfectant manufactured by Lonza, Inc, under the tradename CARSOQUAT CT-429; 2.80% of a combination of Behentrimonium metholsulfate & stearyl alcohol (C.T.F.A. name), which is a disinfectant manufactured by ISP Corporation; and 0.10% Cetylpyridinium chloride.
The composition additionally includes silicone fluids, i.e., 0.90% of SILICONE 344 and 0.70% of SILICONE 1401 (manufactured by Dow Corning) to improve adherence of the lotion to the cow's teats, as well as other ingredients including emulsifiers, colorants, such as about 0.0023% by weight of FD&C Red, fragrances, and diluents, such as from about 85 to about 90% deionized water.
In about May, 1998, the inventor began offering for sale a water-based gel composition useful as an anti-bacterial hand wash for humans, particularly in medical hygiene applications, under the trade name QUATRO-DERM™ (Quest Research, Inc.). This composition includes four active constituents, hence the name “quatro”, namely, in % by weight based on the weight of the total composition, 0.1% of a Quaternium 12 (C.T.F.A. name), such as BORDAC 2250 a disinfectant manufactured by Lonza, Inc.; 0.5% of Didecyl-imethyl ammonium chloride; 1.0% of a Cetrimonium Chloride (C.T.F.A. name), which is cetyl trimethyl ammonium chloride, a disinfectant manufactured by Lonza, Inc. under the tradename CARSOQUAT CT-429; and 0.04% of CHG 20% (a chlorohexidine gluconate manufactured by Degussa AG).
The composition additionally includes various other constituents, such as 1.25% of METHOCEL 40-101 (manufactured by Dow Chemical Corporation) as a thickening agent to provide a viscosity of about 4000 centipoise to the composition, and 0.5% GERMABEN II (manufactured by ISP Corporation) as a formaldehyde donor for the composition.
This composition was not as gentle to the user's skin as was desired, suffered from color instability, and, in any event, was not free of formaldehyde due to the presence of GERMABEN II.
It is an object of the present invention to provide an anti-bacterial composition, which is gentle, which can be used repetitively, and yet which is ant-bacterially effective for humans and animals.
It is another object of the present invention to provide an anti-bacterial composition, which is gentle, which can be used repetitively, and yet which is ant-bacterially effective for humans and animals, and which leaves no visible residue yet has a sustained functional activity.
It is a further object of the present invention to provide an anti-fungal composition, which is gentle, which can be used repetitively, and yet which is effective as an anti-fungal material for humans and animals.
It is another object of the present invention to provide a fabric hygiene article, such as a disposable diaper (child and adult), a feminine hygiene pad, and a wipe for men and women but having particular utility for women for use in the groin, rectum, inner ears, eyelids, and for makeup removal which also treats the skin, containing the anti-bacterial and/or antifungal composition of the present invention.
It is yet another object of the present invention to provide a sanitary elastic glove having a coating provided on at least the inner surface thereof comprising an anti-bacterial and/or anti-fungal composition of the present invention.
These and other objects are accomplished by the present invention which provides a composition which is a gel or lotion and which has at least one of ant-bacterial or anti-fungal properties, comprising from about 85 to about 90% by weight of pure water, such as deionized water, from about 0.80 to about 1.3% by weight of Cetrimonium chloride; and from about 0.07 to about 0.08% by weight of at least one substance selected from the group consisting of Benzalkonium chloride and Grapefruit seed extract; from about 0.15 to about 0.35% by weight of Didecyl-dimethyl ammonium chloride; and from about 0.08% to about 1.55% of Quaternium 22.
The gel or lotion composition is a non-toxic, non-flammable, nondrying, non-irritating cleanser. It is advantageously alcohol-free, pH balanced, and does not leave any residue on body parts such as the breasts of nursing mothers or in the mother's milk.
The compositions according to the invention contain no toxic metals, such as arsenic, and no formaldehyde, yet have a very long shelf life. The compositions are gentle enough for any skin type including, but not limited to, lips, breasts, groin, rectal, and eye areas, and may be used repetitively with no adverse effects.
The present invention additionally provides a fabric hygiene article selected from the group consisting of a disposable diaper, a feminine hygiene pad, and a wipe, comprising a fabric assembly; and a water-based composition comprised of from about 85 to about 90% by weight of water; from about 2.20 to about 3.00% by weight of a mixture of Behentrimonium methosulfate and stearyl alcohol; from about 0.15 to about 0.33% by weight of Quatemium 12; from about from about 0.80 to about 3.00% by weight of Cetrimonium chloride; and from about 0.08% to about 1.55% of Cetylpyridinium chloride present in an amount which is at least effective to provide anti-bacterial and/or anti-fingal properties to the surface of the fabric assembly which contacts the user. The amount of composition used may range up to an amount which does not substantially prevent moisture uptake by the fabric assembly. The wipe is preferably completely saturated by the water-based composition and is made of a non-woven fabric composed of a material such as a natural material, for example, a cotton pulp, or a synthetic material such as polyester fibers.
The present invention further provides a sanitary glove, comprising a glove comprised of an elastic material; and a coating provided on at least a part of the inner surface of the glove and being comprised of a water-based composition having at least one of anti-bacterial or anti-fungal properties and comprising from about 85 to about 90% by weight of water; from about 2.20 to about 3.00% by weight of a mixture of Behentrimonium methosulfate and stearyl alcohol; from about 0.15 to about 0.33% by weight of Quaternium 12; from a
Coe Susan D.
Frank Robert J.
Prats Francisco
Sintal International, Inc.
Venable
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