Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2002-02-22
2003-12-09
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S405000, C424S745000, C514S455000, C514S556000, C514S729000
Reexamination Certificate
active
06660304
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a novel powder composition. More particularly, this invention relates to a novel powder composition having improved anti-microbial, cooling and skin soothing properties.
2. Description of the Prior Art
Miliria Rubra, commonly known as “prickly heat”, is a skin condition that results from an obstruction of the sweat gland ducts. More specifically, keratin plugs are formed due to the maceration of the stratum corneum accompanied by the distension of the sweat gland ducts. Prickly heat may be identified by the development of an intensely itchy rash on the skin that is composed of small vesicles, and may also be accompanied by a secondary bacterial infection. Babies often develop prickly heat, in particular during periods of warmer weather.
Several known methods exist for treating prickly heat and the symptoms thereof. One such method is the application of a powder mixture consisting of talc with one or more antibacterial agents such as boric acid, salicylic acid, and chlorphenesin. Disadvantageously, such treatments are inappropriate for use on babies' skin because the antibacterial agents tend to irritate the skin and because of the concern over the toxicity effects that may be associated with the use of such antibacterial agents.
It would be desirable to develop a powder composition that was effective in treating the symptoms of prickly heat, but that was also safe for use on babies' skin.
SUMMARY OF THE INVENTION
In accordance with this invention, there is provided a novel powder composition comprised of, consisting of, and/or consisting essentially of, based upon the weight of the composition, a skin irritation reducing agent comprising 1-Carboxy-N,N,N-trimethylmethanaminium hydroxide inner salt,
Scutellaria baicalensis
extract, bisabolol, or mixtures thereof.
Another embodiment of the invention is directed to a method for treating prickly heat comprised of, consisting of, and/or consisting essentially of topically applying an effective amount of a powder comprised, consisting of, and/or consisting essentially of a skin irritation reducing agent comprising 1-Carboxy-N,N,N-trimethylmethanaminium hydroxide inner salt, scutellaria baicalensis extract, bisabolol, or mixtures thereof.
The powders of this invention exhibit one or more beneficial properties. Not only do the powders relieve the symptoms of prickly heat by providing antimicrobial, soothing, and cooling benefits to the skin, but they also do so without the use of harsh antimicrobial agents which tend to irritate sensitive skin.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The main component of the powder composition of the present invention is a skin irritant reducer. Suitable skin irritant reducers include, but are not limited to 1-Carboxy-N,N,N-trimethylmethanaminium hydroxide inner salt, which is also known as trimethylglycine (betaine), scutellaria baicalensis extract, bisabolol, and mixtures thereof. One suitable mixture includes bisabolol, soybean oil, and chamomile extract and is available from Dragoco, Ltd. under the tradename, “Phytoconcentrol Chamomile.”1-Carboxy-N,N,N-trimethylmethanaminium hydroxide inner salt, which is an amino acid extracted from sugar beets that is commercially available from Cultor Ltd. (Finnsugar Bioproduct) under the tradename, “Betafin BPP”, may be used in the powder composition of the present invention in an amount, based upon the total weight of the composition, from about 0.005% to about 50%, preferably from about 0.05% to about 10.0%, and more preferably from about 0.1% to about 5.0%.
Scutellaria baicalensis
extract, which is derived from the root of the
Scutellaria Baicalensis
Georgi plant and is commercially available from Ichimaru Pharcos Co., Ltd. under the tradename, “Ougon extract powder,” may be used in the powder composition of the present invention in an amount, based upon the total weight of the composition, from about 0.00001% to about 0.10%, preferably from about 0.0001% to about 0.08%, and more preferably from about 0.001% to about 0.05%.
Bisabolol, which is available from Dragoco, Ltd. under the tradename “Dragosantol,” may be used in the powder composition of the present invention in an amount, based upon the total weight of the composition, from about 0.1% to about 2.0%, preferably from about 0.15% to about 1.5%, and more preferably from about 0.2% to about 0.5%.
Several other components may be present in the powder composition of the present invention such as a base including, but not limited to talc, cornstarch, and mixtures thereof. Talc is preferred. Preferably the base is sterilized via methods well known in the art such as via steam sterilization, before it is combined with the other ingredients of the powder of the present invention. Suitable amounts of talc may range from, based upon the total weight of the powder composition, about 50% to less than about 100%, preferably from about 70% to about 99%, and more preferably from about 80% to about 99%.
Another component that may be present in the powder composition of the present invention is a cooling agent that includes but not is not limited to menthol; eucalyptus oil; peppermint oil; cyclohexanol, 5-methyl-2-(1-methylethenyl)-, available from Takasago International Corporation, Tokyo under the tradename, “Coolact P”; 6-Isopropyl-9-methyl-1,4-dioxaspiro-(4,5)-decane-2-methanol,I-menthone glycerol ketal (Menthone Glycerin Acetal) available from Haarmann & Reimer (“H&R”) under the tradename, “Frescolat MGA”; 5-methyl-2-(1-methyl ethyl)-cyclohexyl-2-hydroxypropionate,I-menthyl lactate, acid/-menthyl ester (Menthyl Lactate) available from H&R under the tradename, “Frescolat ML”; menthyl pyrrolidone carboxylate (Menthyl PCA) available from Quest International UK Limited under the tradename, “Questice”, and mixtures thereof. The cooling agent may be used in an amount, based upon the total weight of the powder composition, of from about 0.01% to about 0.50%. Preferably, the menthol may be used in an amount, based upon the total weight of the composition, from about 0.01% to about 0.50%, more preferably from about 0.05% to about 0.30%, and most preferably from about 0.10% to about 0.20% and the eucalyptus oil and peppermint oil, respectively, may be used in an amount, based upon the total weight of the composition, from about 0.01% to about 0.50%, more preferably from about 0.05% to about 0.40%, and most preferably from about 0.20% to about 0.30%. The menthol and the eucalyptus oil provide a fresh, cooling feeling to the user. A mixture of menthol and eucalyptus oil is the preferred coolant.
Another component that may be used in the powder composition of the present invention is an astringent. Suitable astringents include, but are not limited to zinc oxide, glyoxyl diureide available from Sutton Laboratories under the trade name, “Allantoin,” and mixtures thereof. The astringents may be used in an amount, based upon the total weight of the composition, from about 0.10% to about 10.0%, preferably from about 0.5% to about 5.0%, and more preferably from about 0.5% to about 3.0%. Zinc oxide is preferred due to its mild antiseptic and astringent properties.
Another component of the present invention may be an antimicrobial agent comprised of benzethonium chloride, (-p-Chloro-3, 5-m-xylenol)(“PCMX”) (also known as “chloroxylenol”), and mixtures thereof. The preferred antimicrobial agent is PCMX. In one preferred embodiment, PCMX is used in combination with bisabolol skin irritant reducing agent. The amount of antimicrobial agent used in the composition of the present invention may range from about 0.10% to about 5.0%, preferably from about 0.2% to about 3.0%, and more preferably from about 0.3% to about 1.0%. Chloroxylenol (-p-Chloro-3, 5-m-xylenol), which is commercially available from Nipa Laboratories Ltd. under the tradename, “Nipacide PX,” is preferred for its unique combination of nontoxic antimicrobial and preservative properties.
In addition to the above components for the powder composition, the composition may inc
Hopkins John
Khaiat Alain V.
Nitikhunkasem Attaya
Berman Alysia
Harriman Erin M.
Johnson & Johnson Consumer Companies, Inc
Travers Russell
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