Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2001-08-30
2003-11-11
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S059000, C424S078060, C424S078070, C424S078020, C424S078030, C424S484000, C424S485000
Reexamination Certificate
active
06645510
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to skin products, and particularly to emulsion-based skin products that can be applied to the skin to provide continuing antimicrobial, antiviral, antiseptic, and skin protecting or healing properties.
BACKGROUND OF THE INVENTION
People often use soaps and bactericides to remove and exterminate undesirable contaminants such as dirt and bacteria from the skin, especially the hands. These products are typically applied to the skin while washing the hands under running water. The products have a limited temporal effect, however, because they are washed from the skin along with the dirt and bacteria during the washing process. Conventional soaps and bactericides do not, therefore, provide any lasting effect after they have been used. However, in many occupations, such as the medical profession, it is important to minimize and destroy harmful bacteria and viruses immediately when they contact the skin. A skin product that provided continued protection against contaminants with which the skin comes into contact, after being applied to the skin, would therefore be highly desirable. Such skin products should be specifically formulated for the special demands of particular applications.
In some applications, the need for rapid and anti-bacterial and anti-viral activity is particularly important. For example, surgeons and medical care practitioners require surgical scrub products that sanitize their hands before surgery or like procedures. FDA requires these products to have increasing efficacy the longer they are used. That is, regulations require that surgical scrub products improve their performance versus basic soaps with repeated use.
Prior art surgical scrub products are harsh to the hands. A typical surgical scrub product contains over 60% ethyl alcohol. Those products are very effective at killing microorganisms, but are equally effective at removing skin oils that make the skin soft and substantially crack-free. When hands are cracked and sore, it is more difficult to perform delicate surgery.
A product that matched the rapid anti-microbial behavior of high-alcohol surgical scrubs, by use of formulations containing aggressive anti-microbial agents, but which simultaneously coated and protected the medical practitioner's hands would be especially valuable.
Nevertheless, some skin is so damaged that aggressive anti-microbial active ingredients are too irritating for use in skin-care products. People who have developed a latex intolerance are typical of this group, because allergic reactions to the proteins or other irritants in latex products make their hands red and sore to the point of bleeding. Such allergies can threaten the careers of health care practitioners. If a skin-care product could be formulated to form a layer that coated, soothed, and protected the skin, yet could serve as a protective base layer for additional layers containing anti-microbial active agents, health care practitioners could protect themselves from harmful latex proteins, yet protect their patients from pathogenic organisms.
A different special situation is presented for skin products formulated for children younger than six years old. This population has a well documented history of frequent infections, many of which are transmitted via the hands. Children often have fingers and such in their mouths, so special formulations are required to make a safe and effective skin protectant product for children. A product that could protect and simultaneously disinfect the hands of young children, but be safe for them to occasionally ingest would improve the health of this special population.
Another special situation is baby's bottoms. Babies are prone to diaper rash and the like. A product that was gentle to baby's skin, yet protected this tender skin from the bacteria of feces and urine would be of particular advantage.
A skin-care product could also be adapted to topically deliver active agents, such as drugs, continuously to wounded, burned or ulcerated skin, or skin otherwise lacking in normal integrity. For example, preparations for removing warts might purposefully deliver toxic or irritating agents to selected areas of wounded skin.
Yet another set of special situations is presented by skin-care products formulated to topically deliver medicinally active agents to burns and wounds. Optimum wound or burn care products should (1) reduce inflammation by delivering anti-inflammatory agents or biological precursors of anti-inflammatory agents, (2) provide necessary nutrients and building block precursors for the biologically produced prostaglandin, leucotriene, and thromboxane compounds which regulate inflammation and promote tissue healing or new skin growth at a burn site which may have impaired blood supply, (3) promote normal and/or healing microbial activity at the wound surface, yet inhibit outside infections caused by external pathogenic bacteria or viruses, and (4) optionally modify electrical charge density in and around the wound so as to attract biologically provided nutrients and building block precursors to the wound site, which may have a deficient blood supply.
It would be especially desirable to formulate products for the treatment of wounds, or thermal, chemical, or radiation bums, to accomplish the above-described functional objectives. It would be desirable to formulate a composition which promotes increased levels of biosynthesized prostaglandin hormones such as PGE1, PGE3, PGI2, which promote healing of damaged skin and tissue, and caused decreased levels of prostaglandin PGE2, which produces undesirable inflammatory responses at a wound site. It would also be desirable to provide building block precursors of the hormones and other necessary cellular components, such as vitamins, minerals, sulfur compounds, saturated and unsaturated fatty acids, neurotransmitters, anti-oxidants, and other compounds which promote healing.
Prior art products provide anti-inflammatory compounds, necessary nutrients, or antiseptic treatments followed by non-sterile conditions, but none of the prior art teaches combining all the above functions in one stable salve.
Of particular importance is the healing of wounds and decubitus ulcers. A decubitous ulcer often begins as a bed shearing force abrasion on an immobilized patient. Body pressure restricts blood flow where the skin is in contact with the mattress. Necrosis ensues within 30 minutes, and a Level 1 ulcer (bed sore) develops. In more severe cases, the epidermal layer is disrupted (for example by scratching) and bacteria enter the site. As the ulcer severity increases, a deep sore opens up in a conical fashion. In a Level 4 decubitous ulcer, the bone is often visible.
Prior art treatments of Level 4 decubitous ulcers first require sanitizing the wound to kill pathogenic micro-organisms, as well as normally benign or beneficial micro flora. Medicines were subsequently applied to the sanitary wound, or heavy debridement of damaged tissue was repeatedly applied during prior art treatments. Healing is problematic using such treatments, typically taking 6 months, and is successful less than half the time.
Improved compositions and methods for successfully treating such ulcers within 1-2 months would substantially advance the art. Indeed, improved compositions and methods for treating thermal burns, radiation bums, surface wounds, deep wounds or ulcers, warts, or diaper rash would substantially advance the medical arts.
SUMMARY OF THE INVENTION
In accordance with the purpose(s) of this invention, as embodied and broadly described herein, this invention, in one aspect, relates to a method of treating or preventing ailments of the skin, comprising applying to the surface of animal skin or tissue an effective amount of a composition capable of forming a film that ionically bonds to the skin or tissue comprising the residue of: one or more active agents; a nonionic or substantially nonionic first film forming component; one or more cationic surfactants comprising one or more fatty moieties
Bettle Griscom
Coury William S.
Pettersson Berno I.
American Medical Research, Inc.
Di Nola-Baron Liliana
Needle & Rosenberg P.C.
Page Thurman K.
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