Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2001-01-19
2002-12-17
Dees, Jos′ G. (Department: 1619)
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
06495158
ABSTRACT:
BACKGROUND OF THE INVENTION
Acne vulgaris is a chronic disorder of the pilosebaceous follicles (apparatus) characterized by comedones (blackheads), papules, pustules, cysts, nodules, and often scars, that appear on the most visible areas of the skin (e.g., the face, chest, back, neck, and upper arms). The pilosebaceous apparatus is largely under the control of endogenous hormones (mainly androgens) which are present in unusually high concentrations in the blood during adolescence and puberty, giving rise to an excessive production of sebum. The condition may worsen by a simultaneous increase in the rate of keratinization of the skin's horny layer (the stratum comeum). As the horny cells proliferate, they can form an occlusive plug or comedone which coupled with the increased production of the sebum, represents an ideal medium for the proliferation of the skin resident strains, such as the Gram positive anaerobic bacterium, Propionibacterium acnes. Eventually, the plugged follicles rupture and allow the discharge of their contents, causing local swelling and inflammation. The exposed follicles may darken from the deposition of pigment from damaged cells in the deeper layer of skin. In severe cases, acne can lead to hospitalization of the patient, extensive discomfort, and long term scarring of the skin.
There are numerous treatments available for treating acne. Typically, acne is treated with topical formulations in the form of creams, gels, emulsions or lotions that contain selected agents. These agents include hormones or hormone agonists and antagonists (EP A1 0 563 813 and U.S. Pat. No. 5,439,923), antimicrobial agents (U.S. Pat. No. 4,446,145, GB 2,088,717, GB 2,090,135, GB 1,054,124, U.S. Pat. No. 5,409,917), salicylic acid (U.S. Pat. No. 4,514,385, U.S. Pat. No. 4,355,028, EP A1 0 052 705, FR-A 2,581,542, and FR-A 2,607,498). The problems associated with topical treatment of acne with creams, gels, emulsions and lotions include, e.g., the lack of precision of the application of the cream, gel, emulsion or lotions and the associated lack of control over precise doses to the target site. The application of a cream, gel, emulsion or lotion typically results in the exposure of an area considerably in excess of that covered by the acne, thereby exposing normal healthy skin to the anti-acne formulation. In addition, creams, gels, emulsions and lotions are messy and inconvenient.
Oral administration of anti-acne agents is currently provided for severe cases of acne. These are reviewed in “Acne, A Review of Optimum Treatment” by Sykes N. I. and Webster G. F in Drugs 48, 59-70 (1994). Numerous side-effects have been described using oral administration of anti-acne drugs. For example, isotretinoin, which is a derivative of vitamin A has associated risks of teratogenicity and may be a risk for women of childbearing age. Oral administration of antibiotics suited for treating acne may induce the appearance of adverse effects which include abdominal cramps, black tongue, cough, diarrhea, fatigue, irritation of the mouth and other undesirable symptoms.
Salicylic acid in the form of a tacky hydrophilic gel dressing (U.S. Pat. No. 5,258,421) and in combination with pantothenic acid or pantothenic acid derivative in a cleansing pad (PCT WO 93/21899) has been used for treating acne. In addition, a patch containing cephalosporin has been described in U.S. Pat. No. 5,409,917 for the treatment of acne using a method for making nicotine patches. Since the patch was not optimized for the special circumstances associated with acne including optimizing the anti-acne agent content and placement of the patch at multiple locations on exposed skin such as the face, the patch has not been adopted as an anti-acne formulation delivery modality.
FDA regulations (e.g., 21 C.F.R. Chapter 1, Section 333, Subpart D-Topical Acne Drug Products, Apr. 1, 2000 Edition) regulate what components (i.e., “active ingredients”), in a specified amount, may be described as treating acne (i.e., contains a topical acne drug). In order to follow FDA regulations, therefore, only a select number of active ingredients that are able to treat acne, in a specified amount, may be included in an adhesive patch when the patch is described as treating acne. Consequently, it is difficult to manufacture an adhesive patch that includes a topical acne drug, while at the same time maintaining (a) the solubility and stability of the active ingredients in the therapeutic formulation, (b) the pressure sensitive adhesive properties of the therapeutic formulation, and (c) following FDA regulations.
Several adhesive patches, drug dispensing devices, electrodes, and bandages have been disclosed for applying salicylic acid and/or sulfur 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. 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 treat acne. In addition, the reference does not disclose or suggest that salicylic acid can be present in the amount permitted by the FDA (e.g., 0.5 wt. % to 2.0 wt. % of the substrate). As such, the amount of salicylic acid disclosed therein does not comply with FDA regulations for topical acne drugs. See, 21 C.F.R. Chapter 1, Section 333, Subpart D- Topical Acne Drug Products, Apr. 1, 2000 Edition. Additionally, the backing is not disclosed as being treated with a sizing agent.
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. It is disclosed that the medicament can be a keratolytic agent such as salicylic acid or an antipruritic agent such as sulfur. However, the amount of salicylic acid or sulfur 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 treat acne. In addition, the reference does not disclose or suggest that salicylic acid or sulfur can be present in the amount permitted by the FDA (e.g., 0.5 wt. % to 2.0 wt. % of the substrate or 3.0 wt. % to about 10.0 wt. % of the substrate, respectively). See, 21 C.F.R. Chapter 1, Section 333, Subpart D- Topical Acne Drug Products, Apr. 1, 2000 Edition. Additionally, the backing is not disclosed as being treated with a sizing agent.
U.S. Pat. No. 4,675,009 discloses a drug dispensing device (e.g., an adhesive skin reservoir) for the transdermal delivery of a medicament. The drug dispensing device includes a backing element and a substrate attached to the backing element. The substrate includes a medicament wherein the medicament can be a keratolytic agent such as salicylic acid (see, col. 3, line 66) or an antipruritic agent such as sulfur. The salicylic acid can be present in 8-20% of the substrate (see, Example 20). The amount of sulfur that can be employed in the substrate is not disclosed. The reference does not disclose or suggest that the drug dispensing device can be used to treat acne. In addition, the reference does not disclose or suggest that salicylic acid or sulfur can be present in the amount permitted by the FDA (e.g., 0.5 wt. % to 2.0 wt. % of the substrate or 3.0 wt. % to about 10.0 wt. % of the substrate, respectively). See, 21 C.F.R. Chapter 1, Section 333, Subpart D- Topical Acne Drug Products, Apr. 1, 2000 Edition. Additionally, the backing is not disclosed as being treated with a sizing agent.
U.S. Pat. Nos. 5,536,263 and 5,741,510 disclose an adhesive patch for applying medication to the skin. The patch includes a backing and a hydrocolloidal gel located on and in the backing. The gel includes a pressure-sensitive adhesive and a medicament. The medicament can be a keratolytic agent such as sal
Buseman Teri
McWhorter Daniel M.
Rolf David
Dees Jos′ G.
Haghighatian Mina
Lec Tec Corporation
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