Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
2002-04-30
2003-07-22
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C514S861000
Reexamination Certificate
active
06596284
ABSTRACT:
BACKGROUND OF INVENTION
The present invention relates to prevention and treatment of eczema and atopic dermatitis. More particularly, the present invention relates to the prevention and treatment of atopic dermatitis and other eczematous disorders by the application of a combination of topical isotonic saline OCEAN® and topical nasal mast cell stabilizers.
Atopic dermatitis is a chronic inflammatory skin disorder, also known by terms used to describe the disorder as neurodermatitis, disseminated lichen simplex chronicus, or atopic eczema. The prevalence of atopic dermatitis among persons one year to seventy four years of age ranges from seven to twenty four cases per one thousand. Atopic dermatitis is most prevalent in infancy and childhood, less prevalent in puberty, and often persists into adulthood. Horan R F, Schneider L C, Sheffer A L, JAMA 268:2858(1992).
Atopic dermatitis is not a primary allergic disorder per se but appears to be inherited in association with certain allergic disorders. Environmental stimuli can trigger the disease in genetically predisposed individuals. The increased prevalence of atopic dermatitis since the 1990s has been attributed to environmental irritants, infections, previous exposure to allergic foods, and airborne allergens such as dust, mites, animal dander and pollens.
Atopy is characterized by physiologic, immuno pathologic, and pharmacological abnormalities that involve the skin. These abnormalities include: 1) a lowered threshold to itch stimuli, 2) a hypersensitivity to alpha-adrenergic agonists and to cholinergic agents, 3) a very dry hyperkeratotic skin which has decreased water-holding capacity, 4) a marked tendency to produce lichenification in response to friction and scratching, and 5) a tendency for the skin to be colonized with bacteria. Immunopathologic abnormalities involve interaction of many cells (mast cells, basophils, eosinophils, keratinocytes, Langerhans cells, and helper T cells) and cell products (histamine, leukotrienes, prostaglandins and cytokines) that participate in the inflammatory cascade. Karmali R A, Safai B. Prostaglandins Leukotrienes & Medicine 15: 277-286 (1984). Enhanced production of serum IgE in conjunction with the binding of IgE to epidermal Langerhans cells may induce an eczematous reaction in the skin via allergen-specific T cell responses. Dysregulation of IgE synthesis in the pathogenesis of atopic dermatitis points to abnormalities of cell-mediated as well as of humoral immunity. Bos J D, Wierenga E A, Smitt J H S, et al. Arch Dermatol 128: 1509 (1992).
Mast cells are also implicated in the pathogenesis of IgE-mediated food hypersensitivity. Histamine activation of Hl receptors increases vascular permeability, which results in passage of serum factors and leukocytes into the skin, where mediators of inflammation are released. It is likely that the release of mast cell mediators, including histamine, is responsible for the pruritus and subsequent eczematous skin findings in patients with atopic dermatitis.
CLINICAL FEATURES
Itching is the primary symptom of atopic dermatitis. The pruritus may be generalized or localized, seasonal and often worse in winter, and has a diurnal rhythm in which itching is minimal at midday and maximal in the evening. Emotional stress can also provoke and aggravate itching and scratching.
Excoriations, papules, eczema, and lichenification are the lesions of atopic dermatitis.
CLINICAL COURSE
The clinical course of atopic dermatitis is divided into three stages: the infantile stage, the childhood stage and the adolescent/adult stage. The diagnosis of atopic dermatitis is usually clinically evident. Secondary skin infections may result due to localized immunosuppression in the skin. For example, in atopic dermatitis, there is increased susceptibility to herpes simplex, herpes zoster, staphylococcal impetiginization, and infection with human papillomavirus.
A severe complication of atopic dermatitis, Kaposi's varicelliform eruption is characterized by hemorrhagic vesicles, high fever, and severe prostration. The etiologic agents are herpes simplex virus (eczema herpeticum), vaccinia virus (eczema vaccinatum) and coxsackievirus A16.
Lesions of atopic dermatitis occasionally progress to generalized erythroderma, usually seen in adults, and accounts for 4.5 percent of exfoliative dermatitis cases.
A much less common but serious complication is the development of cataracts in patients with long-standing atopic dermatitis. The long-term application of topical corticosteroids to the eyelids and periorbital skin can also increase the risk of ocular cataract. Regular eye examinations are recommended in children with atopic dermatitis.
Currently, mast cell stabilizers are employed to treat allergic rhinitis and asthma. In response to a challenge by an allergen, mast cells release mediators which include, histamine, leukotrienes, prostaglandins, serotonin, proteases and others, which induce vasodilatation, smooth muscle contraction, glandular secretion of stimulation of irritant nerve receptors among other symptoms. These mediators are also implicated as mediators for symptoms of atopic dermatitis and/or infections of wounds or skin lesions. Since mast cell stabilizers inhibit the release of the mediators from the mast cells, the present invention proposes a new use for the mast cell stabilizers in the treatment of atopic eczema and/or some infections of wounds or skin lesions. Suitable mast cells used include cromolyn sodium, nedocrormil and lodoxamide. Each of these mast cell stabilizers may be combined with a physiological solution, preferably an isotonic saline OCEAN® , alone and/or as mixtures in various combinations, and may be topically applied.
SUMMARY OF INVENTION
There is provided by the present invention a topical spray or topical drops for the treatment of atopic dermatitis, said topical preparations comprising an effective amount of a topical mast cell stabilizer to inhibit release of mast cell mediators, wherein the topical mast cell stabilizer is selected from the group consisting of cromolyn sodium, nedocromil and lodoxamide, and topical preparation includes sterile isotonic saline OCEAN®.
There is also provided by the present invention a topical spray for the treatment of other eczematous disorders, herpes simplex, herpes zoster, vaccinia virus or coxsackievirus, said topical spray comprising an effective amount of a mast cell stabilizer selected from the group consisting of cromolyn sodium, nedocromil and lodoxamide, and OCEAN®.
There is also provided by the present invention a topical spray to prevent wound formation and promote wound healing involving the repair or replacement of damaged tissues including, but not limited to, skin, vascular tissue or soft tissues.
DETAILED DESCRIPTION
Reduction of various factors that may incite or exacerbate an episode of atopic dermatitis and associated disorders, is of utmost importance. Some of these triggers are physical or chemical irritants, psychological stress, infections, overheating and allergens.
The prime objectives of treatment are to reduce inflammation and to prevent and relieve itching. Itching leads to scratching and to trauma of the skin, resulting in infection, lichenification, and eczematization. Three different therapeutic approaches are used systemic, phototherapy and topical therapy. For example, systemic therapy may include use of papaverine hydrochloride, antihistamines (hydroxyzine or diphenydramine), antibiotics, glucocorticoids, interferon gamma, or cyclosporine. Phototherapy usually involves use of UVB or UVA. Topical therapy includes corticosteroids, antihistamines, or emollients The present invention provides a topical preparation comprising an effective amount of a mast cell stabilizer, selected from a group consisting of cromolyn sodium, nedocromil and lodoxamide. This preparation may be used alone or optionally, in combination with any one or more conventional therapeutic approaches which use systemic, phototherapy and other topical therapies.
The topical mast cell stabilizers used herein,
Feller Theodore H.
Fleming Thomas E.
George Konata M.
Hartley Michael G.
Karmali Rashida A.
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