Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
2000-07-28
2003-04-01
Jarvis, William (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
Reexamination Certificate
active
06541517
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable
BACKGROUND OF INVENTION
The milieu of the skin is normally of acidic pH, i.e. the stratum corneum layer of the human skin is normally acidic. The stratum corneum is the thin outer cornified lipophilic epidermal layer of the skin, which functions as a barrier to the external environment. It is now generally accepted that this outer layer of the skin has a natural pH in the range of 4.0 to 6.0, normally 5.0. Ten to fifteen micrometers below the stratum corneum, the pH quickly rises to a neutral pH of 7.0.
Within the thin stratum corneum resides a diverse array of hydrolytic, proteolytic, esterifying, and lipid active enzymes which all appear to function optimally in an acidic range of pH 4.5-6.0, which is typical of this layer. Disruption of the pH of this layer by a vast array of etiologies is associated with numerous well-described pathologic entities. In other words, abnormally high pH, or abnormal alkalization, of the skin is often associated with many pathologic dermatological states.
For example, abnormal alkaline surface pH has been noted in atopic dermatitis. Atopic dermatitis is a chronic, itching, superficial inflammation of the skin, frequently associated with related disorders, such as hay fever and asthma. Atopic dermatitis may begin in the first few months of life, with red, weeping, crusted lesions on the face, scalp, diaper area and extremities. In older children or adults, it may be more localized and chronic. Although the dermatitis often improves by age 3 or 4, exacerbations are common during childhood, adolescents or adulthood. Itching is a constant feature, and consequent scratching and rubbing lead to an itch-scratch-rash-itch cycle.
Another pathology generally associated with abnormally high alkalinity of the skin is ichthyosis. Ichthyosis is a symptom in several rare hereditary syndromes and in several systematic disorders. It usually occurs in the lower legs of middle aged or older patients, most often in cold weather and in patients who bathe frequently. Mild to moderate itching may exist in an associated dermatitis due to detergents or other irritants. Xeroderma is the mildest form of ichthyosis.
Another example is seborrheic dermatitis. Seborrheic dermatitis is an inflammatory scaling disease of the scalp, face and occasionally more generalized areas. Onset in adults is gradual, and the dermatitis usually is apparent only as dry or greasy diffused scaling of the scalp (dandruff) with variable itching. In severe disease, yellow-red scaling papules appear along the hairline, behind the ears, and external auditory canals, on the eyebrows, on the bridge of the nose, the nasolabial folds, and over the sternum. Dry yellow crusting and conjunctival irritation may also be present. Neonates under one month old may develop seborrheic dermatitis, with thick, yellow, crusted scalp lesions, fissuring and yellow scaling behind the ears and red facial papules. Newborns may also have an associated stubborn diaper rash, while older children may develop thick, tenacious, scaly plaques in the scalp that may measure 1 to 2 centimeters in diameter. Very rarely, in infants or adults, the condition may become generalized.
Contact dermatitis, another example of a skin disorder associated with abnormally basic skin, is characterized as an acute or chronic inflammation, produced by substance contact with the skin. Contact dermatitis may be caused by marginal irritants such as soap, detergents, acetone or even water. It may take several days of exposure to cause clinically recognizable changes. Strong irritants, for example, acids and alkalines, cause observable changes within a few minutes. More specifically, allergic contact dermatitis is a delayed hypersensitivity reaction. It takes between 6 and 10 days to years for individual to become sensitized. Often times, ingredients in topical drugs constitute a major cause of allergic contact dermatitis. Other commonly implicated substances include plants, many potential sensitisers used in the manufacture of shoes and clothing, p-phenylenediamine and other dyes and cosmetics. Contact dermatitis ranges from redness to severe swelling and itching. Any exposed skin surface in contact with the sensitizing or irritating substance may be involved.
Pemphigus is an uncommon, potentially fatal, autoimmune skin disorder characterized by bullae on apparently healthy skin and mucus membranes that has been demonstrated to have an abnormally high pH. The primary lesions associated with pemphigus often occur first in the mouth, where they soon rupture and remain as chronic, often painful, erosions for variable periods of time before the skin is affected. On the skin, the bullae typically arise from normal appearing skin to leave a raw, denuded area and crusting when they rupture later.
Dermatitis herpetiformis is a chronic eruption characterized by clusters of intensely pruritic vesicles, papules and urticaria-like lesions. With this dermatitis, itching and burning are severe, and scratching often obscures the primary lesions. This form of dermatitis is also associated with abnormally alkaline skin.
Psoriasis is a common, chronic, recurrent disease characterized by dry, well-circumscribed, silvery, scaling papules and plaques of various sizes that is associated with high alkaline skin surface conditions. Psoriasis varies in severity from one or two lesions to a widespread dermatitis with disabling arthritis or exfoliation. It is generally caused by increased epidermal cell proliferation from abnormally alkaline stratum corneum. Psoriasis characteristically involves the scalp, the extensor surfaces of the extremities, particularly at elbows and knees and the back. The nails, eye brows and other regions may also be affected. Occasionally the disease is generalized.
Candidiasis, or yeast infections, may also be related to an abnormally high pH in the skin or mucous membranes. The symptoms of candidiasis vary from the site of the infection. However, symptoms usually include itchiness and inflammation.
Other skin disorders or pathologies that may be linked with an abnormally basic stratum corneum are acne, dermatophytosis, diaper rash, eczema and skin damage from a variety of causes including wounds, burns and fecal and urinary incontinence. In addition, a more alkaline surface pH has been shown to promote Staphylococcal skin colonization and the invasion of Nector americanus, i.e. human hookworm. Alopecia, or baldness, may also result from abnormal alkaline surface skin pH.
Many of these skin disorders or pathologies are accompanied by pruritus, a condition involving localized or general itching. Although usually occurring in the skin, pruritus can also occur in non-cutaneous sites such as mucous membranes. A variety of causes for the condition of pruritus are known including external and endogenous causes, localized skin disorders and systemic diseases. As previously discussed, many systemic and skin diseases are accompanied by persistent or recurrent itch attacks. Itch can also be produced by a variety of chemical, mechanical, thermal and electrical stimuli.
Research into the etiology of and treatment of many skin pathologies including pruritis has been limited both by the lack of animal models and by patient populations that at present would not support the perceived research and development and clinical testing costs. Treatment involves diagnosis of the underlying condition that causes pruritus and these skin disorders and pathologies and intervening therapeutically to alleviate these conditions. For example, developments leading to drugs to threat these conditions have been, for the most part, a bonus of anti-inflammatory drugs. Such treatments are not considered to be direct treatments of these conditions and are of limited efficacy, only occasionally and indirectly relieving the itching. In many cases, however, either the underlying cause for the condition cannot be determined or cannot be eliminated. In such cases, the direct treatment of the pruritic condition or
Ahrens Edward R.
Murphy Donald M.
Barnes & Thornburg
Jarvis William
Kim Vickie
Martin Alice O.
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