Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heavy metal containing doai
Reexamination Certificate
1999-09-23
2001-10-16
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heavy metal containing doai
C514S345000, C514S458000, C514S474000, C514S494000, C514S554000, C514S556000, C514S562000, C514S829000, C514S830000, C514S859000, C514S861000, C514S863000, C514S875000, C514S886000, C514S887000, C514S937000, C514S944000, C424S094400, C424S641000, C424S642000, C424S702000
Reexamination Certificate
active
06303651
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention deals with combinations of several synergistic antioxidants including enzymatic co-factors as adjunct to therapies of various mammals, particularly canine, feline and equine inflammatory conditions, including but not limited to thermal and chemical burns, various types of dermatitis, eczema infections and flea and mite induced cutaneous lesions, commonly known as “hot spots” and mange, respectively. These topical compositions are aimed at scavenging and neutralizing reactive oxygen species and other free radicals generated in the cutaneous inflammatory reactions being responsible for the animal's clinical symptoms and cutaneous lesions. These novel therapeutic compounds may be combined with other state of the art topical active ingredients such as zinc salts, anti-inflammatories (salicylates, non-steriodal anti-inflammatory drugs) corticosteroids, anti-microbials for the treatment of secondary bacterial or fungal infections and healing antioxidants such as zinc pyrithione and vitamins C and E.
BACKGROUND OF THE INVENTION
Canine eczema, clinically known as dermatitis rubric madidans, is one of the most difficult dermatologic problems to treat in veterinary medicine. Its pathogenesis is still rudimentary and multiple therapies are available to treat symptoms, while antibiotics quell secondary infections. Older literature refers to this entity as a moist and desquamating eczema or as infectious dermatitis, as the etiology was theorized to be Staphylococcus aureus as the putative pathogen. This Staph was cultured from early lesions, thus the term “infectious dermatitis.” Staph toxins or an “allergic id” reaction were postulated as etiologic. Contact dermatitis might also play a role in this condition.
Clinically, this eczema presents an acute discomfort, is persistent, and tends to recur. It is more frequent in the mature dog rather than in puppies. The lesions are of sudden onset and spread rapidly. The affected areas are very sensitive and extremely pruritic. The animal may have premonitory symptoms which include restlessness, anorexia, vomiting, and itching. Animals tend to persist in scratching, biting and rubbing the affected sensitive, moist lesions which become yellow to light red in color. Their efforts to obtain relief of the pruritus by scratching not only extends the depth and surface area of the dermatitis, but the excriations cause infection which extend to areas adjoining the original eczematoid site. Fever and lymph node enlargement may be noted. The course of this eczematoid reaction is variable, depending on the extent of the lesion, degree of destruction of the cutaneous tissues, severity of secondary infection and the animal's response to therapy.
Infections of the skin, so-called integumentary infections in dogs and cats, are most frequently caused by bacterial or fungal infectious agents. The cutaneous microbial flora comprises both resident and transient bacterial inhabitants. The former tends to be consistent in types and colonies within an anatomic area and is usually harmless. Resident bacteria have the usual characteristic of inhibiting the growth of skin pathogenic bacteria.
Other factors maintaining the resident communal micro-flora include skin pH and moisture, sebum production and the healthy status of the outer skin layer, the stratum corneum. Under adverse conditions to the aforementioned cutaneous factors which may disrupt the normal bacterial barriers, both the resident (usual) bacteria and the transient bacterial invaders may cause the cutaneous infectious lesion called pyoderma. In dogs, Staphylococcus aureus is a normal skin inhabitant but may increase its colony numbers in traumatized, inflamed or seborrheic animal skin conditions. Staph may reside in the hair, and these bacteria are apt to be the source of secondary infection causing pyoderma, with the classic symptoms of the animals' “hot spots”.
While Staph aereus is the major pathogen isolated from dogs' pyoderma, both local and systemic immune responses are probably involved in the pathogenesis of pyoderma. While specific anti-microbials are mandatory for the eradication of the pathogen causing pyoderma, both symptomatic and anti-inflammatory therapy to these cutaneous lesions is mandatory. The synergistic antioxidant compositions of the present invention are designed to scavenge and neutralize the reactive oxygen and other free radical species, which are present in the inflammatory reactions of these cutaneous primary and secondary infections and inflammatory reactions. Pustules, papules and furuncles require specific anti-microbial therapies, plus symptomatic therapies, including the reduction of inflammatory free radical reactions by the present antioxidant synergistic components to enhance the animal's cutaneous endogenous antioxidant defenses and promote the healing reparative processes.
Secondary skin lesions, the pyodermas, are characterized by excoriations, and ulcerations and crusting. Excoriations are self-inflicted lesious leading to ulcers, which are commonly referred to as “hot spots”. These “hot spots” are not truly pyoderma but are very bothersome and symptomatic to these domestic animals. Erosions and ulcers are secondary lesions, which result from the putative inflammatory process and/or from the victim's self-mutilation symptomatic response to the itching and pain. These are followed by classic signs of infection, namely, exudation, swelling and exaggerated redness and pus. The eroded and ulcerated tissues must be treated to alleviate the symptoms, and to reduce the inflammation. These remedies include compositions such as topicals containing the synergistic antioxidant complex of the present invention. Scarring needs to be prevented. Finally, if untreated, these secondary lesions, called “crusts” developing from dried exudates and keratin, must be carefully removed by the clinician in an effort to promote healing and avoid scarring of these tissues.
Infestation by fleas is common in domestic animals, particularly in dogs and cats, but fleas are not uncommon in other hairy mammals. Fleas are small, wingless bloodsucking external parasites, mainly of the species Ctenocephalides, genus
felis
for cats and genus
canis
for dogs. The adult flea spends most of its life on the body of the host. Eggs laid on the host or in the ground hatch into larvae feeding on organic matter. The larvae then spins a loose cocoon that within six days, under optimum conditions, becomes an adult then the insect emerges from the cocoon, and seeks the appropriate host, like these domestic animals, in order to feed on them and thereby continue their insect life cycle.
Adult fleas feed only on blood of the host animal. In this “nutrition and survival cycle”
0
of the fleas, they cause their hosts intense itching (pruritus) with consequent irritation to the host, which evokes a response to scratch and bite the affected irritated skin in an effort to control the pruritic and inflammatory site of the hypersensitive host skin.
The fleas cause the irritating symptoms due to their constant biting of the host's skin and from the flea's salivary secretion of toxic agents and allergens. Particularly in hypersensitive domestic host animals, fleabites produce intense pruritus and the animal then scratches and bites the putative skin surfaces. These mammals become restless from the cutaneous irritation and they continue biting and scratching in an attempt to relieve the irritating symptoms. By this mechanism, the host produces an acute, discrete dermatitis, which has also commonly been called a “hot spot”. Also, the biting and scratching may yield a chronic, nonspecific dermatitis, including ulceration and moist desquamation from the flea infested sites. The “hot spots” in the dog are usually subauricular, interscapular or adjacent to their rumps or thighs. In contrast, the chronic, non-specific flea induced dermatitis is more apt to be restricted to the lower back and to the perineum. Secondary infection from skin
Pak John
Thione INternational, Inc.
Wittenberg Malcolm B.
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