Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants
Reexamination Certificate
1999-03-15
2001-05-08
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Biocides; animal or insect repellents or attractants
C424S409000, C514S724000
Reexamination Certificate
active
06228385
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to liquid formulations for personal cleaning that have antimicrobial activity.
BACKGROUND
Alcohol is used to disinfect hands and body surfaces. In various forms, it is increasingly being used as hand antiseptics, both to supplement soap usage, as well as for situations where soap and water are not readily available. Ethanol and propanols exhibit broad spectrum antimicrobial activity and are non-allergenic, fast-acting, miscible in water, and relatively non-toxic.
These alcohols are effective against a wide variety of bacteria (Gram positive and Gram negative), yeast, molds, and viruses. Unfortunately, they are ineffective against bacterial spores, have no residual action, and are drying to the skin. Viscosity increasing agents (e.g., thickeners) are often added to alcohols to prevent runoff and to increase residence time on the skin. While longer residence time tends to enhance antimicrobial action it also tends to magnify certain undesirable side effects. Frequent use of alcohol gels may cause skin irritation and reduce the skin moisture level. This can be a problem for health care professionals, child care providers, food service workers and others who use alcohol gels to disinfect or sanitize their hands. Skin irritation from frequent use of alcohol gels may also be a problem for many persons suffering from temporary or chronic digestive tract disorders.
Some alcohol gel formulations contain skin moisturizers or conditioners. Unfortunately sufficiently high levels of some of these moisturizers and/or conditioners may cause instability in the alcohol gel over time and could cause the gel to lose viscosity. In addition, at sufficiently high levels these moisturizers and/or conditioners may provide unpleasant tactile sensations after application but before being absorbed by the skin. For example, high levels of moisturizers such as glycerin tend to provide an unpleasant tacky sensation until the glycerin is absorbed by the skin.
Thus, there is still a need for a liquid antimicrobial formulation that may be applied to the skin without causing drying and irritation. There is also a need for a liquid antimicrobial formulation that moisturizes skin. A need exists for a liquid antimicrobial formulation that includes an emollient or other component that counteracts or offsets any unpleasant tactile properties of the formulation.
Meeting these needs are important since it is desirable to disinfect and/or sanitize skin while maintaining good skin health with formulations that employ generally inexpensive, and readily available materials.
SUMMARY OF THE INVENTION
The problems described above are addressed by the present invention which provides a liquid antimicrobial, skin moisturizing formulation including: 1) an aqueous alcoholic base; 2) a humectant; 3) a delivery material adapted to release an emollient when the formulation is applied to the skin; and 4) an emollient imiscible in the aqueous alcoholic base and contained by the delivery material. Generally speaking, the delivery material encapsulates or entraps the emollient and then releases the emollient when the formulation is applied to the skin.
The emollient should be imiscible in the humectant as well as the aqueous alcoholic base. It is contemplated that the emollient may have some relatively low level of miscibility with the aqueous alcoholic base and/or humectant, depending on the type of emollients used.
The delivery material may be a particulate material and may be a finely divided material such as a powder-like material that may be readily dispersed in the aqueous alcoholic base. A feature of the invention is that the delivery material holds or contains the emollient and then releases the emollient when the formulation is applied to the skin. In an embodiment of the invention, the delivery material may encapsulate the emollient. For example, the delivery material may be gel capsules, small plastic beads or spheres and/or similar bubble like structures composed of a single or multiple layers that hold or surround the emollient.
In an embodiment of the invention, the delivery material should entrap the emollient. For example, the delivery material may be adsorbent or high surface area particulate materials such as certain starches, talcs, clays, metals, polymeric entrapment materials and the like.
Desirably, the particulate delivery material is a polymeric entrapment material formed from a variety of polymers such as, for example, polyolefins, nylons, polyacrylics and the like. Exemplary polymeric entrapment materials include one or more materials having the CTFA designation acrylates copolymers. Exemplary acrylates copolymers may be characterized as cross-linked methacrylates appearing as a white, free-flowing powder. Suitable acrylates copolymers may be obtained from Advanced Polymer Systems of Redwood City, Calif., under the trademarks Microspong® and Polytrap®.
Generally speaking, the formulation will contain from about 0.1 to about 5 percent, by weight, of the delivery material containing the emollient. Relatively small amounts of delivery material may be used if it is capable of containing and delivering relatively large amounts of emollient. On the other hand, relatively large amounts of delivery material may be needed if it is capable of containing and delivering relatively small amounts of emollient.
The emollient may be one or more liquid hydrocarbons (e.g., petrolatum), mineral oil and the like, vegetable and animal fats (e.g., lanolin, phospholipids and their derivatives) and/or a silicone materials such as one or more alkyl substituted polysiloxane polymers. More desirably, the emollient is dimethicone or dimethicone and one or more other alkyl substituted polysiloxane polymers.
In some embodiments of the present invention, it is contemplated that liquid hydrocarbon emollients and/or alkyl substituted polysiloxane polymers may be blended or combined with one or more fatty acid ester emollients derived from fatty acids or fatty alcohols.
According to an aspect of the present invention, the emollient reduces the undesirable tactile attributes of the formulation that may be caused by the humectant component. For example, a dimethicone emollient will reduce the level of tacky or sticky sensation that may be caused by the glycerin humectant in the formulation. It is contemplated that the delivery material may also help reduce undesirable tactile attributes of the formulation that may be caused by the humectant component.
While the loading of the emollient in the particulate delivery material will vary depending on the maximum liquid load for the particulate delivery material, particulate delivery materials may contain from about 10 to about 80 weight percent, based on the weight of the particulate delivery material, of the emollient. This level may be at the lower end of the range for starches and talcs and may be at the upper end of the range for acrylates copolymers. For example, when certain agglomerated acrylates copolymers are used, they may be loaded with from about 30 to about 75 weight percent, based on the weight of the particulate delivery material, of an emollient. As another example, the particulate delivery material may contain about 50 to about 70 weight percent, based on the weight of the particulate delivery material, of an emollient.
The humectant may be a water soluble polyhydric alcohol having from 2 to 3 hydroxyl groups and blends thereof. Desirably, the humectant is glycerin.
The amount of humectant in the formulation may vary depending on the level of moisturizing desired. Desirably, the level of humectant may range from about 1 to about 15 percent, by weight. For example, the formulation may contain from about 1 to about 5 percent, by weight, of the humectant (e.g., glycerin). As another example, the formulation may contain from about 4 percent, by weight, of the humectant (e.g., glycerin).
The aqueous alcoholic base contains water and an alcohol component. Generally speaking, the alcohol component may be selected from methanol, ethanol,
Jarvis William R. A.
Kim Vickie
Kimberly--Clark Worldwide, Inc.
Sidor Karl V.
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