Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Elemental chlorine or elemental chlorine releasing inorganic...
Reexamination Certificate
1999-10-21
2001-12-25
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Elemental chlorine or elemental chlorine releasing inorganic...
C205S500000, C252S187240, C252S187250, C252S187260, C252S187320, C422S029000, C422S037000, C424S663000, C424S665000, C424S680000, C510S370000, C510S380000, C514S769000, C514S770000, C514S949000
Reexamination Certificate
active
06333054
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to compositions for disinfecting substrates, including tissue, and methods of disinfection. The inventive compositions comprise an electrolytic chloroxidizing agent, a viscosity-enhancing agent, an electrolyte, and water.
BACKGROUND OF THE INVENTION
Superficial topical infections are typically a consequence of a primary disease source such as chronic urinary incontinence, or are directly related to a contagious nosocomial or endemic source. Prolonged moist or wet skin conditions often lead to maceration and other changes in skin integrity which provide the opportunity for normally saprophytic bacteria and fungi to invade the site and establish an infection.
The microorganism most prevalent in the moist environment of a skin infection is
Candida albicans,
a yeast-like fungus. This type of infection is usually characterized by erythema, edema and intense pruritus. Other localized, topical infections that are bacterial in origin may be the direct result of skin-to-skin contact with a contaminated vector. One of the most serious nosocomially acquired contagious bacterial infections is methicillin resistant
Staphlococcus aureus
which is often implicated in skin cellulitis, impetigo, boils and wound infections. On occasion, the etiological agent of the infection is a combination of bacteria and fungi. This is referred to as a mixed infection, wherein dissimilar microorganisms coexist to both the benefit of and the detriment to the host.
In more serious maladies of the dermis wherein the skin is breached, especially in chronic wounds and ulcers, a variety of micro-organisms, both pathogenic and non-pathogenic, contaminate the site of the breach. Non-pathogenic microorganisms constitute the normal flora of intact skin, but these can become pathogenic when their numbers overwhelm the natural host defenses in a wound environment, and subsequently cause infection.
Quantitatively, it has been shown by Kucan et al., that open wounds can maintain a bioburden of approximately 10
5
microorganisms per gram of tissue without the clinical manifestation of infection. “Comparisons of Silver Sulfadizine and Physiologic Saline in the Treatment of Chronic Pressure Ulcers.”
Amer. Ger. Soc.
29:232-235, 1981. However, a bioburden of greater than 10
5
is a significant challenge for the local wound tissue defenses. Consequently, a bioburden of 10
6
microorganisms per gram will often result in wound infection.
Wounds that are heavily contaminated by microorganisms, but not clinically infected, are often characterized by a prolonged period of inflammation, as well as a delay in wound repair and healing. Microorganisms that contaminate wounds have been implicated as an important factor in the retardation of wound healing by interfering with leucocyte phagocytosis, and by the depletion of nutrients and oxygen required for normal tissue granulation. Ree et al., “Cutaneous Tissue Repair: Practical Implication Of Current Knowledge, Part II.”
Jour. of the Amer. Academy of Dermatology
13(6):919-941, 1985.
DESCRIPTION OF RELATED ART
Historically, wounds have been cleansed and disinfected with a host of different types of antiseptic agents ranging from acetic acid to halogen-based solutions such as complexed iodine. Topical antiseptic agents have the recognized ability to either inhibit or destroy infection producing microorganisms; however, they also induce chemical trauma and necrosis of host defense cells, such as macrophages, when used directly in the wound site (Branemark et al., “Tissue Injury Caused by Wound Disinfectants”
Bone Joint Surg. Am.
49:48-62, 1967; Lineweaver et al., “Topical Antimicrobial Activity”
Arch. Surg.
120:267-70 1985). Furthermore, topical antiseptic agents, which are known to be severe cytotoxins, infringe dramatically upon wound-healing processes and greatly impair the hosts' defense mechanism. Viljanto, “Disinfection of Surgical Wounds without Inhibition of Normal Wound Healing”
Arch. Surg.,
115:253-6, 1980. Frequently, topical antimicrobials or antiseptics are used to decontaminate the intact skin site prior to surgical intervention. Antimicrobials used for this purpose are regarded as “Surgical Skin Preps” and are used in all standard protocols for skin disinfection ranging from venipuncture to major surgical procedures. Also, anti-microbials and antiseptics are routinely used as health-care personnel handwashes as a means of reducing the risk of cross-contamination.
U.S. Pat. No. 3,666,679 to Crotty relates to gelling compositions containing an anionic heteropolysaccharide biopolymer gelling agent, a linear alkyl benzene sulfonate, and various adjuvants. The gelling compositions may contain chlorine release additives such as chlorinated trisodium phosphate, chlorinated isocyanurates, sodium hypochlorite, and the like. However, such compositions require high concentrations of dilute solutions of chlorine release additives in order to achieve the desired results.
U.S. Pat. No. 4,035,483 to Bunyan is directed to antiseptic material comprising the reaction product of a protein, such as fibrin, collagen, or gelatin, and a hypochlorite. A preferred embodiment of the invention is one where the reaction product is impregnated in or coated on a sheet carrier. In another embodiment, a film is formed by reacting the hypochlorite with a substantial excess of protein. Such compositions do not possess the superior properties of the thixotropic gels.
U.S. Pat. No. 5,015,228 to Columbus et al. relates to a sterilizing device used with a needle, comprising a cover sheet and a gel medium. The preferred gel medium is a hydrogel comprising an interlaced network of agar and a copolymer of acrylamide crosslinked with the monomer N,N′-methylenebisacrylamide. Preferred sterilizing agents include sodium hypochlorite. Effective amounts of sodium hypochlorite must be highly diluted in order to achieve a desirable sterilizing effect.
Prior art chlorine-containing disinfectants are generally unsatisfactory for topical application. Common hypochlorite solutions (also called soda bleach solutions) are usually produced by bubbling chlorine in a concentrated solution of caustic soda. These bleach solutions must contain a considerable amount of sodium hydroxide in order to avoid decomposition. This gives common hypochlorite solutions a high, buffered pH as well as a corrosive nature when applied to skin or mucosa, and a cytotoxic effect upon tissue.
The common forms of topical disinfectant compositions tend to be inherently problematic. Such compositions are generally in the form of either a liquid or a gel, both of which have inherent disadvantages. Application of liquid products to intended treatment sites is difficult to control, as run-off, spillage, and poor containment are commonly encountered problems. Thick gels are not easily dispensed, and may not reach the entire surface area of wounds as easily as liquids.
SUMMARY OF THE INVENTION
It is therefore an object of this invention to overcome the problems of the prior art compositions by providing a disinfectant composition comprising an electrolytic chloroxidizing agent, a viscosity-enhancing agent, an electrolyte, and water. Such compositions are safe and effective, broad-spectrum topical antimicrobial agents and are in the form of a thixotropic, non-cytotoxic hydrogel. A related object is to provide a method for topically disinfecting a substrate, which comprises applying to said substrate an effective amount of a disinfectant composition comprising an electrolytic chloroxidizing agent, a viscosity-enhancing agent, an electrolyte, and water.
It is another object of this invention to provide a method of treating a topical infection, which comprises applying to a patient in need thereof an effective amount of a disinfectant composition comprising an electrolytic chloroxidizing agent, a viscosity-enhancing agent, an electrolyte, and water to the infected area and/or the surrounding infected area. A topical infection is understood by those of ordinary skill in the art to refer generally t
Amuchina S.p.A.
Choi Frank
Dees Jose′ G.
Finnegan Henderson Farabow Garrett & Dunner L.L.P.
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