Drug – bio-affecting and body treating compositions – Live hair or scalp treating compositions – Polymer containing
Reexamination Certificate
1999-07-12
2001-04-10
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Live hair or scalp treating compositions
Polymer containing
C424S480000, C514S635000, C514S728000, C514S731000
Reexamination Certificate
active
06214327
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to compositions and methods for protecting skin and preventing carryover of biohazardous substances from one material to another. In particular, the invention involves lotion compositions which are applied on skin to form a protective polymer coating while also being capable of rapidly killing a broad spectrum of microbial pathogens.
BACKGROUND OF THE INVENTION
There are many situations where people need to expose their hands to potentially hazardous materials including microorganisms, chemicals, etc., in connection with their work. A few examples of workers who manually encounter biohazards in their jobs include restaurant workers, food processors in meat and poultry plants, health care professionals such as physicians, nurses, emergency medical technicians, police, prison guards, fire fighters, mechanics, etc. In the food service and processing industries, workers hands frequently contact pathogenic organisms which can be dangerous to the worker or to the recipients of the processed food. In the past several years the public has been especially aware of this problem with respect to the handling of meat and poultry due to severe illness caused by the bacteria
E.coli
and Salmonella.
Workers' hands also come into contact with hazardous chemicals such as commercial solvents and petrochemicals which may damage the worker's skin and/or be absorbed through the skin possibly carrying other hazardous solutes and causing internal toxicity.
In coming up with a strategy for protecting people from manually encountered biohazards in the workplace, it is important to consider the need to protect the worker as well as the need to protect the consumer. For example, the most common approach for protecting a worker's hands from biohazardous organisms or chemicals is to wear gloves. However, even if a glove material is capable of acting as a complete barrier protecting the worker's hands, the gloves do not prevent carryover (cross contamination) of hazardous materials from one material to another. A worker wearing gloves may work with hamburger one minute and make a salad minutes later without changing gloves. This may result in carryover or cross-contamination of a hazardous substance or pathogen from one food to another. Accordingly, even if gloves protect the worker's skin, they do not adequately protect others who may be injured from carryover of hazardous materials in the workplace.
Another problem with gloves is that they reduce the worker's dexterity. This causes some workers not to wear gloves even in situations where there are dangerous chemicals or pathogens in the work environment. For example, machinists and mechanics frequently have to manipulate devices in small spaces or compartments where solvents and petrochemicals are present. The worker may not wear gloves in these situations because to do so would compromise the worker's agility or dexterity, thus slowing down or preventing the worker from carrying out his work. Gloves also significantly limit or prevent the worker from using his sense of touch which may be essential to the activity.
Accordingly, an important object of the present invention is to provide an alternative to wearing gloves which protects the users hands from biohazardous materials while also preventing cross contamination.
A further object of the invention is to provide a lotion for use on hands which is capable of broad spectrum bactericidal and antiviral activity within seconds of contact. The lotion should maintain its anti-microbial efficacy for at least several hours after application to the skin.
Another important object of the invention is to provide a polymer-based barrier on the skin which resists being washed-off and which prevents absorption through the skin of hazardous chemicals and commercial solvents.
Another goal of the invention is for the lotion's antibacterial and barrier functions to be relatively insensitive to the pH of the hazardous material.
Still another object is for the lotion to be nontoxic to humans.
The lotion should have a useful shelf-life of at least about two years. During that time the solution/emulsion should remain homogenous without any precipitation or separation of phases. The lotion's anti-microbial efficacy must also be maintained during the shelf-life period.
SUMMARY OF THE INVENTION
The present invention provides a lotion for application to skin for the purpose of protecting the skin from biohazardous materials such as solvents and petrochemicals which may damage the skin and/or be absorbed into the skin along with potentially toxic solutes, and for the purpose of preventing cross contamination of potentially hazardous pathogens such as bacteria and viruses from one material to another. One formula of the present invention includes a mire of polyvinylpyrrolidone (PVP) and hydroxyethylcellulose (HEC) in an aqueous solution, and an antibacterial agent dispersed in the solution. In another formula of the invention, the PVP and HEC polymer mixture is replaced by an aqueous carbomer solution. After application to the skin, the polymer material dries into a barrier film which resists being washed off and which prevents a variety of different chemicals and pathogens from contacting or penetrating the skin. The antibacterial agent kills bacteria upon contact or shortly thereafter. Different antibacterial agents are used such as 2,4,4′-trichloro-2′hydroxydiphenylether (“triclosan”) or chlorhexidine gluconate. The lotion may also include other materials such as antiviral agents, emulsifying agents, emulsion stabilizers, emollients, plasticizers, preservatives, aloe vera, glycerine and vitamin E.
The polymeric/antibacterial formulas of the present invention are unique and advantageous in their ability to provide a penetrant barrier which resists being washed off while providing broad spectrum anti-microbial efficacy for at least four hours after the lotion is applied to the skin. During that time period, bacteria which comes into contact with the antibacterial barrier is killed within seconds after contact.
Lotions of the present invention are typically produced by first dispersing and dissolving the polymers in water. The solution is then heated to approximately 75-80° C. In a second solution the emulsion, emollient and plasticizer components are mixed and heated to about 75-80° C. The second solution is then added to the first solution and mixed while cooling to about 40° C. A third solution including the antibacterial agent is then mixed into the batch. The solution is mixed while cooling to 35° C. and then the preservative is added. Finally, if necessary, the pH is adjusted to about 6.5-7.0.
DESCRIPTION OF THE INVENTION
The invention provides a number of lotion formulas, each of which, fundamentaly, includes a polymeric film-forming component and an antibacterial agent dispersed in the polymer material. The polymeric component must be selected and formulated so that after application on skin, it dries into a coating which is not easily washed or rubbed off and which serves as a barrier to prevent penetration of hazardous solvents and/or petrochemicals into the skin. The barrier is effective for at least several hours after application. We have discovered at least two different types of polymers which can be used for this purpose. Examples of these polymer formulas are detailed below. Three of the examples described include a mixture of polyvinylpyrrolidone (PVP) and hydroxyethylcellulose (HEC). The PVP preferably has a molecular weight in the range of about 20,000-40,000 daltons and is provided in the solution at a concentration of between approximately 0.10 to 2.00-percent (w/w). The HEC is provided in the solution at approximately 0.10 to 2.00-percent (wlw). In another formula, instead of using PVP and HEC, Carbopol™ 980 (an acrylic polymer) is used at a concentration of between approximately 0.05 to 2.00-percent (w/w). There are many different molecular weights available for these polymers, i.e., 12,000 to 2,800,000. T
Garruto John A.
Paler Lee L.
Steward Howard N.
Bio-Safe Enterprises, Inc.
Kolisch Hartwell Dickinson & McCormack & Heuser
Weddington Kevin E.
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