Psoriasis patch

Details Psoriasis patch Psoriasis patch

2001-04-02

2004-12-14

Kunz, Gary (Department: 1616)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

C424S446000, C424S448000, C424S401000

Reexamination Certificate

active

06830758

ABSTRACT:

BACKGROUND OF THE INVENTION
Dermatitis is defined as an inflammation of the skin. Stedman's Medical Dictionary, 25
th
edition, pp.418-419, Williams & Wilkins, Baltimore. 1990. Among the types of dermatitis are contact dermatitis, atopic dermatitis (i.e., eczema), psoriasis, and seborrheic dermatitis. Stedman's Medical Dictionary, 25
th
edition, pp.418-419, Williams & Wilkins, Baltimore. 1990.
Contact dermatitis is an altered state of skin reactivity induced by exposure to an external agent. Substances that produce this condition can be an irritant or an allergen. Irritants cause direct tissue damage while allergens induce an immunologic reaction that causes inflammation and tissue damage. With the enormous number of artificial compounds in the human environment today that can be irritants or allergens, contact dermatitis is becoming more common. Over 2800 substances have been identified as contact allergens. Contact dermatitis is responsible for approximately 5.7 million physician visits per year in the U.S.
The term eczema is used to describe all kinds of red, blistering, oozing, scaly, brownish, and itching skin conditions. Examples include seborrheic eczema, nummular eczema, and allergic contact eczema. Eczema is also sometimes used to refer specifically to atopic dermatitis, which is a group of allergic or associated diseases that usually affect several members of a family. These families usually have allergies such as hay fever and asthma. Atopic dermatitis is very common throughout the world. Atopic dermatitis is typically recognized by an itching rash, along with a family history of allergies. It affects about 10% of infants and 3% of the overall U.S. population. The disease can occur at any age, but is most common in infants and young adults. The condition usually improves in childhood or sometime before the age of 25.
In infancy, atopic dermatitis is evidenced by an itching, oozing, and crusting condition that tends to occur mainly on the face and scalp. If the disease continues or occurs beyond infancy, the skin has less of a tendency to be red, blistering, oozing, and crusting. Instead, the lesions become dry, red to brown, and the skin may become scaly and thickened. An intense, almost unbearable itching can continue. Some patients scratch at their skin until it bleeds and crusts, which can lead to infection.
Seborrheic dermatitis is another type of eczema. It consists of a red, scaly, itchy rash in the areas of the body with the highest concentration of sebaceous glands. These include the navel, breasts, underarms, groin, and buttocks.
Psoriasis is a persistent skin disease in which the skin becomes inflamed, producing red, thickened areas with silvery scales, most often on the scalp, elbows, knees, and lower back. The FDA refers to psoriasis as a condition of the scalp or body characterized by irritation, itching, redness, and extreme excess shedding of dead epidermal cells. 21 C.F.R. Chapter 1, Section 358.703 (c). Psoriasis can be so mild that people do not know they have it, or it can be quite severe. The most common form begins with little red bumps that gradually grow larger and form scales. While the top scales flake off easily and often, scales below the surface stick together. When they are removed, the tender, exposed skin bleeds. These small red areas then grow, sometimes becoming quite large. Evidence suggest psoriasis may be caused by malfunctioning white blood cells, causing inflammation in the skin. The cells of the skin then divide too rapidly, causing the skin to shed itself every three to four days. Psoriasis afflicts 2% of the U.S. population and costs the nation between $2 billion and $3 billion each year.
FDA regulations (e.g., 21 C.F.R. Chapter 1, Section 358, Subpart H-Drug Products for the Control of Dandruff, Seborreic Dermatitis and Psoriasis; 21 C.F.R. Ch. 1, Section 348—External Analgesic Drug Products for Over-The-Counter Human Use, Feb. 8, 1983; and 21 C.F.R. Ch. 1, Section 348—External Analgesic Drug Products for Over-The-Counter Human Use, Feb. 27, 1990) regulate what components (i.e., “active ingredients”), in a specified amount, may be described as providing relief or controlling the symptoms of psoriasis, seborrheic dermatitis, or eczema (i.e., contains a topical psoriasis drug, a topical dermatitis drug, or a topical eczema drug). In order to follow FDA regulations, as defined in the over-the-counter (OTC) monograph, only a select number of active ingredients that are able to provide relief or to control the symptoms of psoriasis, dermatitis, or eczema, in a specified amount, may be included in an appropriate dosage form which is described as capable of providing relief or controlling the symptoms of psoriasis, dermatitis, and/or eczema. Consequently, it is difficult to manufacture an adhesive patch that includes a topical psoriasis, dermatitis, or eczema drug, while at the same time (a) maintaining the solubility and stability of the active ingredients in the therapeutic formulation, (b) maintaining the pressure sensitive adhesive properties of the therapeutic formulation such that the patch can effectively exfoliate the skin upon removal, and (c) following FDA regulations.
Several adhesive patches, drug dispensing devices, electrodes, and bandages have been disclosed for applying salicylic acid and/or hydrocortisone to skin. See, e.g., U.S. Pat. Nos. 6,096,334; 6,096,033; 5,741,510; 5,536,263; 4,675,009; 4,307,717; and 4,274,420; which are all commonly assigned to Lec Tec Corporation (Minnetonka, Minn.).
U.S. Pat. No. 4,274,420 discloses an electrode for use in monitoring and stimulation medical applications. The electrode includes a connector plug and a skin-interfacing substrate material. The substrate material can include salicylic acid in 17.8 wt. % (see, Example 2). The reference, however, does not disclose or suggest that the electrode can be used to provide relief or to control the symptoms of psoriasis, seborrheic dermatitis, or eczema. In addition, the reference does not disclose or suggest that salicylic acid can be present in the amount permitted by the FDA (e.g., 1.8 wt. % to 3.0 wt. % of the substrate) to provide relief or to control the symptoms of psoriasis or seborrheic dermatitis. As such, the amount of salicylic acid disclosed therein does not comply with FDA regulations for controlling or treating the conditions of psoriasis or seborrheic dermatitis. See, e.g., 21 C.F.R. Ch. 1, Section 358.710 (b)(4), Apr. 1, 2000 Edition. Additionally, the backing is not disclosed as being treated with a sizing agent. As such, the overall yield of product can be higher, the “holdout” of therapeutic formulation on the backing can be improved, and the degree of penetration of the therapeutic formulation in the backing can be decreased. In addition, the nature and amount of adhesive in the therapeutic formulations that include salicylic acid may not be sufficient to exfoliate the skin, upon removal of the adhesive patch.
U.S. Pat. No. 4,307,717 discloses a bandage that includes a backing element and a substrate attached to the backing element. The substrate includes a matrix that includes a medicament. The medicament can be a keratolytic agent such as salicylic acid (see, col. 3, lines 41-44) or an anti-inflammatory agent such as hydrocortisone (see, col. 3, lines 31-33). However, the amount of salicylic acid or hydrocortisone that can be employed in the matrix or substrate is not disclosed. The reference does not disclose or suggest that the bandage can be used to provide relief or control the symptoms of psoriasis, seborrheic dermatitis, or eczema. In addition, the reference does not disclose or suggest that salicylic acid or hydrocortisone can be present in the amount permitted by the FDA (e.g., 1.8 wt. % to 3.0 wt. % of the substrate for salicylic acid and 0.25 wt. % to 1.0 wt. % of the substrate for hydrocortisone) to provide relief or to control the symptoms of psoriasis, seborrheic dermatitis, or eczema. As such, the amount of salicylic acid and hydrocortisone disclosed therein does not comply with FDA regu

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