Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Wearing apparel – fabric – or cloth
Reexamination Certificate
1999-09-15
2002-06-25
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Wearing apparel, fabric, or cloth
C424S402000, C514S844000, C514S938000
Reexamination Certificate
active
06410039
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to topical compositions that are therapeutic to or protect skin. Particularly, the present invention relates to topical compositions that include an emulsion of silicone oil in water and to wet wipes including the topical compositions. More particularly, the present invention relates to topical compositions having non-ionic surfactants that suspend silicone oil in water, to wet wipe products including the topical compositions, and to methods of applying the topical compositions to skin.
2. State of the Art
Skin treatment and protection products, such as body lotions and washing compositions, are used to clean skin, to treat adverse conditions of the skin, such as dermatitis, and to prevent irritations to and adverse conditions of the skin. Some of these skin treatment and protection products contain ingredients that protect the skin, such as oils. In water-based, or aqueous skin treatment and protection products that include oils, the oils are typically suspended in an aqueous carrier solution with surfactants, or emulsifiers, by way of an emulsion.
Babies, incontinent adults, and bedridden patients are particularly susceptible to irritations in the perineal area, such as contact dermatitis, which is typically referred to as “diaper rash”. Perineal dermatitis is thought to be caused by contact with bodily waste, such as urine and feces. Symptoms of perineal dermatitis include erythema, swelling, oozing, vesiculation, crusting and scaling, with the possibility of excoriation, thickening, and hyperpigmentation over time. One of the best ways to treat and prevent perineal dermatitis is to apply a protective barrier to the skin to protect it from bodily waste.
There are many commercially available protective barrier materials or compositions that can be topically applied to skin. These protective barrier materials or compositions can be in the form of powders, lotions, creams and ointments. Protective barrier materials or compositions can be sprinkled onto the skin, rubbed into the skin, or wiped onto the skin with a material impregnated with the protective barrier material or composition, such as a wet wipe towelette. Wet wipe towelettes are typically formed from combinations of cellulosic fibers, synthetic polymeric fibers, such as polyester, polypropylene, and binders. Wet wipe towelettes are generally premoistened with a composition that contains water with lesser amounts of ingredients such as moistening agents or humectants, emollients, surfactants, emulsifiers, antimicrobial agents, skin protectants, pH adjusting agents, fragrances, and powders.
In order to effectively treat and protect skin, the protective barrier material or composition must prevent prolonged exposure of the skin to irritants, such as body waste, without substantially reducing the rate at which moisture is lost through the skin. In addition, an effective amount of an effective barrier material or composition must be applied to the skin. It is known in the art that homogeneous compositions that contain protective barrier materials or compositions facilitate the homogeneous distribution of the protective barrier materials or compositions on the wipe. Upon applying a homogenous composition to the skin with such a wipe, the homogeneous distribution of protective barrier materials or compositions on the wipe facilitates the application of an effective amount of the protective barrier materials or compositions to the skin.
When a skin treatment and protection product is an oil-in-water emulsion of an oil-based protective barrier material or composition in water, the product will typically include surfactants, or emulsifiers, to suspend the protective barrier material or composition in the water in a manner that forms a homogenous emulsion. Surfactants, which typically include lipophilic (i.e., “fat loving”) tails and hydrophilic (i.e., “water loving”) heads, reduce the surface tension at the interface between particles of oil-based materials or compositions and water.
It is also known to include a preservative in oil-in-water emulsions of skin treatment and protection products to minimize unwanted microbial growth. A wide variety of preservatives are commercially available, including the mixture of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one, available under the trade names KATHON® and ISOCIL®, other chlorinated and non-chlorinated methylisothiazolinones, sorbic acid or a salt thereof, parabens, as well as other known preservatives.
Topical care compositions including water, a silicone oil, and an emulsifier to suspend the silicone oil in the water are known. Exemplary topical compositions including these constituents are disclosed in U.S. Pat. No. 5,648,083 (hereinafter “the '083 Patent”), issued to Blieszner et al. on Jul. 15, 1997, and in U.S. Pat. No. 5,043,155 (hereinafter “the '155 Patent”), issued to Puchalski et al. on Aug. 27, 1991.
The '083 Patent discloses a silicone oil-in water emulsion composition and a wipe product including the emulsion composition. The disclosed amounts of silicone oil that are useful in the emulsion composition of the '083 Patent are from about 0.5% to less than about 3% of the total weight of the emulsion composition. The '083 Patent also discloses the use of carboxylic acid polymeric emulsifiers to suspend the silicone oil in the water. As those of skill in the art are aware, carboxylic acid polymeric emulsifiers are ionic surfactants and, in particular, anionic surfactants. Due to the ionic nature of carboxylic acid polymeric emulsifiers, their use is somewhat undesirable since the ability of these emulsifiers to suspend a droplet of hydrophobic material in an aqueous solution depends upon the pH of the aqueous solution. If the pH of the solution drops or increases outside of the effective pH range for an ionic emulsifier, the hydrophobic material will no longer be suspended in the aqueous solution. As a result, the emulsion will separate.
Alternative emulsifiers that may be used in the emulsion composition of the '083 Patent are disclosed in the '155 Patent, the disclosure of which is incorporated by reference into the '083 Patent.
The '155 Patent discloses an emulsion composition that includes water, silicone oil, and an amphipathic emulsifier. The emulsifier comprises about 0.02-2.0% of the weight of the emulsion composition. The silicone oil comprises about 3-40% of the emulsion composition by weight.
Since the emulsion composition of the '155 Patent comprises such a high concentration of silicone oil, the emulsion composition must be manufactured using high shearing processes. First, the silicone oil and the emulsifier are blended by high shear mixing processes. Next, as the high shear mixing processes continue, water is gradually added in small volumes to the silicone oil and emulsifier mixture. As the water is added, the silicone oil and the emulsifier molecules form micelles that are suspended in the water.
The high concentration of silicone oil in the emulsion composition disclosed in the '155 Patent is somewhat undesirable since, after applying the emulsion composition to the skin and upon evaporation of the water of the emulsion composition and the resultant release of the silicone oil from the micelles, the silicone oil will leave a greasy or oily residue on the skin.
Moreover, the use of a maleic anhydride and octadecene polymer, the non-ionic amphipathic emulsifier disclosed as being useful in the emulsion composition of the '155 Patent, is somewhat undesirable in a topical composition since maleic anhydride is irritating to tissues such as skin. The other emulsifiers that are disclosed in the '155 Patent as being useful in the emulsion composition thereof are acidic, or anionic, emulsifiers and include different carbomers, which are polymers of acrylic acid crosslinked with allyl sucrose, and C
12
-C
22
alkyl-substituted acrylic acid copolymers. Due to the ionic nature of these emul
First Scientific, Inc.
Page Thurman K.
Sheikh Humera N.
TraskBritt
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