Drug – bio-affecting and body treating compositions – Topical body preparation containing solid synthetic organic... – Anti-infective
Reexamination Certificate
1999-09-08
2001-12-18
Kulkosky, Peter F. (Department: 1615)
Drug, bio-affecting and body treating compositions
Topical body preparation containing solid synthetic organic...
Anti-infective
C424S404000
Reexamination Certificate
active
06331295
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to methods of prevention of skin irritation such as diaper rash and more particularly to prevention and treatment of diaper rash caused by fecal enzymes.
2. Brief Description of the Prior Art
Diaper rash is a form of contact dermatitis which afflicts infants whose wet and/or soiled diapers are not promptly changed. Because of the practical impossibility of attending promptly to all of an infant's needs, even those infants receiving a high level of care sometimes suffer from diaper rash.
It has recently come to be understood that the initial stages of some types of diaper rash are the result of skin irritation caused by contact with digestive enzymes present in infant feces, particularly trypsin, chymotrypsin and elastase. These enzymes are proteolytic enzymes produced in the gastrointestinal tract to digest food. In infants, the feces tend to be watery and they contain, among other materials such as bacteria, some amounts of undegraded digestive enzymes. These enzymes, if they remain in contact with the skin for any appreciable period of time have been found to cause an irritation that is uncomfortable in itself and can predispose the skin to infection by microorganisms.
Conventional methods of preventing or alleviating diaper rash have included application of powders to keep the skin dry and creams and ointments to protect the skin from contact with irritants. However diaper rash continues to be a problem for infants and parents.
Similar conditions conducive to skin irritation by proteolytic enzymes-present in feces are found in patients having colostomies and the like. Such patients also would benefit from improved treatments to prevent skin irritation due to fecal enzymes.
Accordingly, a need has continued to exist for additional methods of preventing and treating diaper rash and similar skin irritations.
SUMMARY OF THE INVENTION
The need for additional methods of preventing diaper rash has now been met by the method of this invention wherein fecal proteolytic enzymes are inactivated by contact with organophilic clays. A composition suitable for practicing the method of the invention comprises an amount of an organophilic clay effective to inactivate irritating fecal proteolytic enzymes dispersed in a pharmaceutically acceptable non-toxic dermatological vehicle.
In a further embodiment of the invention a composition containing organophilic clay, e.g, a superabsorbent polymer containing an organophilic clay, is incorporated into a fabric that is used to make garments, such as diapers, that may come into contact with feces containing skin-irritating enzymes.
Accordingly, it is an object of the invention to provide a method for preventing diaper rash.
A further object is to prevent contact dermatitis due to fecal enzymes.
A further object is to provide a composition for application to the skin that can prevent diaper rash.
A further object is to provide a composition for application to the skin that can prevent contact dermatitis due to proteolytic enzymes such as those present in feces.
A further object is to provide a method of inactivating skin-irritating fecal enzymes.
A further object is to provide a composition capable of inactivating skin-irritating fecal enzymes.
A further object is to provide a composition capable of inactivating skin-irritating fecal enzymes that can be incorporated into a fabric.
A further object is to provide a fabric incorporating a composition that is capable of inactivating skin-irritating fecal enzymes.
A further object is to provide a garment such as a diaper incorporating a composition that is capable of inactivating skin-irritating fecal enzymes.
Other objects of the invention will become apparent from the description of the invention which follows.
DETAILED DESCRIPTION OF THE INVENTION AND PREFERRED EMBODIMENTS
According to the method of the invention the irritating effects of fecal proteolytic enzymes are alleviated by contacting the enzymes with materials that inactivate the enzymes by adsorbing them or rendering them incapable of performing their native proteolytic activity. In particular, it has been found that organophilic clays can adsorb fecal enzymes, thereby preventing them from contacting the skin, and also inactivate such enzymes, thereby rendering them incapable of causing irritation to the skin.
According to the method of the invention feces containing irritating proteolytic enzymes are contacted with an amount of organophilic clay sufficient to reduce the activity of the enzymes and thereby decrease or eliminate their ability to cause irritation to the skin. In order to assure that the organophilic clay comes into contact with the proteolytic enzymes it is disposed in anatomical region likely to be contacted by feces, e.g., by applying it to the skin in those areas generally covered by an infant's diaper or by applying it to the diaper itself or incorporating it into the structure of the diaper.
In a preferred embodiment the organophilic clay is incorporated into a pharmaceutically acceptable skin coating material that is applied to the skin, e.g., of an infant, in the region which is subject to contact with feces. The organophilic clay-containing medium is applied sufficiently frequently, e.g., after each diaper change, and in sufficient amount to maintain an effective amount of the organophilic clay associated with the skin where it can adsorb and deactivate the fecal enzymes.
The amount of organophilic clay applied to the skin is evidently not critical, provided that enough is used to produce a substantial decrease in the irritation caused by the fecal enzymes. Typically, the amount of organophilic clay applied to the skin will be at least 0.25 milligrams per square centimeter
The organophilic clay used in the method of the invention is typically applied to the skin in a dermatological composition comprising a suspension of the organophilic clay in a pharmaceutically acceptable vehicle. Suitable vehicles include organic and aqueous liquid vehicles, lotions, creams, emulsions, gels or the like. The organophilic clay can also be applied in finely divided form as a mixture with a dusting powder, e.g., as a mixture with a talcum powder or a finely divided starch powder.
The protective composition also may act as a barrier to prevent the fecal enzymes from coming into contact with the skin. The vehicle may contain emollients to aid in healing irritated skin and dispersants if necessary to keep the organophilic clay in suspension. The vehicle should preferably be inert with respect to the organophilic clay, i.e., it should be devoid of materials that will themselves adsorb to the organophilic clay and thereby deactivate the adsorptive or inactivating properties of the organophilic clay which are the basis for its ability to for proteolytic fecal enzymes. In general, compounds having relatively long hydrocarbon chains, i.e., C-8 and longer, should be excluded from the protective composition because such hydrocarbon chains tend to interact with the organophilic clay and reduce or destroy its adsorptive properties for proteolytic fecal enzymes.
Accordingly, a dermatological composition incorporating the organophilic clay for use in the method of this invention might incorporate from about 3% to about 50% by weight of organophilic clay in a conventional dermatological vehicle. Preferably, the composition comprises from about 3% to about 20% by weight and more preferably from about 5% to about 10% by weight.
Suitable vehicles include hydrophobic vehicles such as petrolatum or mineral oil or mixtures thereof, or hydrophilic vehicles such as aqueous-base creams including emulsions of petrolatum and/or mineral oil in water, aqueous-based media thickened with viscosity-adjusting agents. Suitable thickening agents for aqueous-based vehicles include polyoxyethylenes, e.g., polyethylene glycols and derivatives having a molecular weight from about 3000 to about 20,000; polycarboxylic acids, e.g., polyacrylic acid and salts thereof; cellulose derivatives su
Enviroderm Pharmaceuticals Inc.
Kulkosky Peter F.
Vorys Sater Seymour and Pease LLP
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