Patent ID: 12220490

DETAILED DESCRIPTION

Backing Layer

The backing layer comprises may comprise any suitable material known for use in the preparation of wound dressings and includes, but is not limited to, a foam, a polyurethane, a polyethylene, a polyester, a polyamide, polycellulose, cotton, or any mixture thereof. In an exemplary embodiment, the backing is flexible, pliable, and/or stretchable. In an exemplary embodiment, the backing contains two sides, a front side and a back side. In an exemplary embodiment, the backing layer is vapor or moisture permeable and able to achieve a MVTR>300 g/m2/24 h, but is liquid impermeable. In an exemplary embodiment, the backing layer is continuous (e.g., no holes, perforations or indentations) or is discontinuous (e.g., containing holes, perforations or indentations). In an exemplary embodiment, the backing contains a hydrophobic sizing agent.

The backing layer has a suitable thickness for the intended use. In an exemplary embodiment, the backing layer has a thickness of 0.02 to about 1.0 mm, such as 0.03 to about 0.8 mm, such as about 0.05 to about 0.6 mm, such as about 0.07 to about 0.5 mm, such as about 0.1 to about 0.5 mm.

Therapeutic Adhesive Composition

The therapeutic adhesive composition of the present invention comprises or consists of any skin-friendly adhesive composition known for use in medical articles which contact mammalian (e.g., human) skin. Exemplary adhesive compositions may suitably be, but are not limited to, the types disclosed in U.S. 2013/0152944; 2011/0105977; U.S. Pat. Nos. 6,495,158; and 9,078,948.

In an exemplary embodiment, the therapeutic adhesive composition is a pressure sensitive therapeutic adhesive composition and may comprise one or more of a polyacrylamide, xanthum gum, guar gum, a hydrocolloid, a starch, a vinyl acetate copolymer, polyvinyl pyrrolidone, polyvinyl alcohol, polyethylene oxide, a polyacrylate, polymaleic acid, polymaleic anhydride, a polyurethane, a polyurea, maltodextrin, carboxymethyl cellulose, polyisobutylene, rubber, polybutene, carboxypropyl cellulose, polydimethylsiloxane, polystyrene-polybutadiene-polystyrene, polystyrene-polyisoprene-polystyrene, polystyrene-poly(ethylene-butylene)-polystyrene block polymers or any combination thereof.

In an exemplary embodiment, the therapeutic adhesive composition comprises a topical acne agent, such as but not limited to, salicylic acid, resorcinol, resorcinol acetate, benzoyl peroxide, sulfur, retinol, retinal, retinoic acid, an alpha hydroxy acid, vitamin C, vitamin A, hyaluronic acid, vegetable oils, coconut oil, jojoba oil, avocado oil, olive oil, hemp oil, peptides (such as glycyl-histidyl-lysine (GHK)-Cu and palmitoyl KTTKS), corticosteroids, pharmaceutically acceptable salts of any of the preceding, or any combination thereof. In an exemplary embodiment, the topical acne agent is salicylic acid or a pharmaceutically acceptable salt thereof. In an exemplary embodiment, the salicylic acid or the pharmaceutically acceptable salt thereof is present in an amount of about 0.05 to about 10 wt. % of the adhesive composition, including the more specific ranges described herein.

In an exemplary embodiment, the adhesive composition comprises a solvent, which includes but is not limited to, an alcohol (such as a polyhydric alcohol), water, or a combination thereof. In an exemplary embodiment, the polyhydric alcohol is propylene glycol, ethylene glycol, glycerol or a combination thereof. In an exemplary embodiment, the solvent is present in an amount of about 0.5 to about 25 wt. %, such as about 1 to about 15 wt. %, such as about 5 to about 15 wt. %, such as about 10 to about 25 wt. %, of the adhesive composition.

In an exemplary embodiment, the adhesive composition is positioned on an entire side of the backing. In an exemplary embodiment, the adhesive composition is positioned on only a portion of an entire side of the backing. In an exemplary embodiment, the adhesive composition is affixed or coated only on the surface of the backing. In an exemplary embodiment, the adhesive composition is partially embedded in at least a portion of the backing in a range of about 50 to 100%, such as about 60 to 100%, such as about 70 to 100%, such as about 80 to 100%, such as about 90 to 100%.

In an exemplary embodiment, the adhesive composition comprises at least one of glycerin, pectin, a skin conditioner (such as vitamin E, aloe, lanolin, calamine or any combination thereof), an antimicrobial agent (such as antifungal agent), an antiseptic agent (such as iodine, triclosan, silver, chlorhexidine, chlorhexidine salts, PHMB and/or octenidine), an antibiotic agent (such as erythromycin, tetracycline or cephalosporin), a carotenoid, an analgesic and a hemostyptic in an amount of about 0.01 to about 50 wt. %, such as about 0.1 to 50 wt. %, such as about 1 to 50 wt. %, such as about 5 to about 50 wt., such as about 10 to about 50 wt. %, such as about 20 to about 50 wt. %, of the adhesive composition.

In an exemplary embodiment, the adhesive composition has a thickness in an amount of 0.01 mm to about 1.5 mm, such as about 0.10 to about 0.60 mm, such as about 0.20 to about 0.50 mm, including other ranges described herein.

In an exemplary embodiment, more than one adhesive patch (such as 2 or 4 or 6 or 8 or 10 or 12 or 16) can be affixed to or mounted on the release liner. In an exemplary embodiment, the adhesive patch is crescent-shaped or rectangular or circular or oval.

In an exemplary embodiment, the adhesive patch or the backing has a diameter of about 0.1 to about 5 inches, such as about 0.2 to about 2 inches, such as about 0.3 to about 1 inch, such about 0.3 to about 0.5 inches, including other ranges described herein.

In an exemplary embodiment, the present invention also provides for a method for treating or preventing acne, dermatitis or warts in a mammal (e.g., a human) in need or risk thereof by applying to the targeted skin surface of the mammal an adhesive patch of the present invention for an period of time effective to treat or prevent acne, dermatitis or warts. In an exemplary embodiment, the targeted skin surface of the mammal is the face, neck, shoulder, chest, back, or any combination thereof. In an exemplary embodiment, the effective period of time is about 10 minutes to about 72 hours, including the more specific ranges described herein.

In an exemplary embodiment, the adhesive patch according to the invention is applied to the lip(s) of a mammal for preventing or treating cold sores. Application of the adhesive path to the lip(s) includes the region of the lip(s) alone or a portion of the patch can be applied to the lip (such as the edge of the lip) and the remaining portion of the patch can be applied to the surrounding skin.

The thickness of the adhesive composition layer of the patch of the present invention may be substantially constant over the surface or the adhesive composition layer or alternatively, the adhesive composition layer may have a thicker portion at the center of the composition compared to the edges of the composition layer—i.e., a beveled edge, where in various particular embodiments, the thickness of the edge is 10% or 20% or 50% or 75% of the thickness of the center.

Any suitable amount of a pressure sensitive adhesive can be present in the therapeutic adhesive composition, provided the amount of pressure sensitive adhesive effectively provides the requisite adhesiveness to the backing and/or the liner and remains stable in the therapeutic adhesive composition over a prolonged period of time. Typically, the therapeutic adhesive composition can include a pressure sensitive adhesive in an amount of about 0.01 to about 99.99 wt. % of the therapeutic adhesive composition, such as about 0.1 to about 99.9 wt. %, such as about 1 to about 99 wt. %, such as about 2 to about 98 wt. %, such as about 3 to about 97 wt. %, such as about 5 to about 95 wt. %, such as about 10 to about 90 wt. %, such as about 15 to about 85 wt. %, such as about 20 to about 80 wt. %, such as about 25 to about 75 wt. %, such as about 30 to about 70 wt. %, such as about 40 to about 60 wt. %.

As used herein, “acne” refers to an inflammatory follicular, papular, or pustular eruption involving the sebaceous glands. The types of acne include acne conglobata, chloracne, and rosacea. See, e.g., Stedman's Medical Dictionary, 25th Ed., illustrated, Williams & Wilkins, Baltimore, Md., pp. 15-16 (1990).

The adhesive patch of the present invention can be applied to any suitable skin surface of the subject in need thereof. Suitable skin surfaces in which the patch can be applied include the face, neck, shoulder, chest, elbow, inner elbow and back. In an exemplary embodiment, the adhesive patch of the present invention is applied to the face (including lips) of the subject.

The adhesive patch of the present invention also serves to cosmetically cover noticeable skin blemishes such as acne and/or pimples. Many commercial products do not effectively cover the entire skin blemish for prolonged periods of time, but the adhesive patch of the present invention can accomplish this for over 4 hours, such as over 8 hours, such as over 12 hours, such as over 24 hours, such as over 48 hours while simultaneously therapeutically treating the skin blemish.

Release Liner

The release liner in the adhesive patch arrangement of the present invention is to coat and protect the adhesive composition of the adhesive patch to prevent the surface of the adhesive composition from being contaminated before attachment. The release liner is provisionally attached to the adhesive composition in a readily detachable state, typically requiring only a peeling force to detach.

Suitable compositions of the release liners of the present invention include those that are generally known to be used with skin-friendly adhesive compositions, such as release liners produced by subjecting a surface of a plastic sheet or a film of a polyolefin (such as polyethylene or polypropylene or a laminate of a plastic film and paper) to a silicone release treatment. In an exemplary embodiment, the thickness of the release liner has a thickness of about 0.01 to about 1.0 mm, such as about 0.03 to about 0.7 mm, such as about 0.07 to about 0.5 mm, such as about 0.1 to about 0.4 mm, including other ranges described herein.

In an exemplary embodiment, the area of the release liner is larger than the area of the adhesive patch—i.e., the area of the combined backing and the adhesive composition. In the exemplary embodiment where the release liner is larger than the adhesive patch, the portion of the release liner that extends beyond the adhesive patch may be held (gripped) by using the fingers of one hand and peeled away from the therapeutic adhesive composition to detach the release liner from the therapeutic adhesive composition. In an exemplary embodiment, the release liner covering the therapeutic adhesive composition contains a perforated pattern or a slit that allows for facile separation (peeling away) of the liner (in two portions) from the therapeutic adhesive composition. In this embodiment, the adhesive patch is attached to the skin of a mammal in need thereof in a two-step process where in the first step, one of the two portions of the liner is peeled away, exposing a portion of the therapeutic adhesive composition which is then attached (affixed) to the desired area of the skin of the mammal. In the second step, the second (remaining) portion of the liner is peeled away while the adhesive patch is still attached to the subject's skin via the previously exposed portion of the therapeutic adhesive composition, thus exposing the remaining portion of the therapeutic adhesive composition, which is then attached (affixed) to the subject's skin. This tandem mode of applying the adhesive patch of the present invention allows for a rapid and substantially error-free application of the patch to the subject's skin while minimizing mishaps such as having one portion of the adhesive composition undesirably attaching to another portion of the patch. This type of mishap prevents full contact of the therapeutic adhesive composition with the skin, which reduces the therapeutic benefit of the patch and also undesirably renders the patch less conspicuous on the surface of the subject's skin due to its lack of a completely flat surface.

Slit and/or Perforation

In an exemplary embodiment, the slit that forms the slit line in a single adhesive patch of the present invention partitions the release liner into two portions, thus allowing for a tandem (two-step) application of the adhesive patch on the skin of a mammalian subject. In an exemplary embodiment, the liner is cut to a depth in the range of at least 10%, such as 15% or 20% or 30% or 40% or 50% or 60% or 70% or up to 100% of the thickness of the liner to allow ready removal of the liner from the therapeutic adhesive composition.

In addition to a straight line, the slit line may be in any shape that allows for facile separation of the liner into multiple portions. For example, the shape may be a curve, a zigzag line, an arc shape, a wave shape or a saw-tooth shape.

In an exemplary embodiment, liner is perforated to also facilitate a tandem (two-step) application of the adhesive patch on the skin of a mammalian subject. In addition to a straight line, the perforation may be in any shape that allows for facile separation of the liner into multiple portions. For example, the shape may be a curve, a zigzag line, an arc shape, a wave shape or a saw-tooth shape.

In an exemplary embodiment, the improved release liner system contains a combination of one or more perforated lines and one or more slits.

The adhesive patch arrangement of the present invention is suitable for medical applications and cosmetic applications.

EXAMPLES

The following non-limiting exemplary formulations illustrate suitable adhesive compositions for use in combination with a therapeutic agent in the therapeutic adhesive compositions of the present invention.

Example 1

(a) 5 to 20 wt % or 5 to 15 wt % or 10 to 15 wt % of an elastomer;(b) 1 to 10 wt % or 2 to 10 wt % or 5 to 10 wt % of a mineral oil plasticizer;(c) 20 to 60 wt % or 25 to 55 wt % or 30 to 55 wt % or 35 to 50 wt % of a tackifier; and(d) 20 to 60 wt % or 25 to 50 wt % or 30 to 50 wt % or 30 to 45 wt % of an absorbent,where the total weight percent of components (a) through (d) is 100%.

In exemplary embodiments of the above formulation of Example 1, the elastomer is selected from the group consisting of Kraton SEBS, Kraton SIS, Kraton SBS and mixtures thereof; the mineral oil plasticizer is selected from the group consisting of mineral oil, plant oil, hydrogenated botanical oil and mixtures thereof; the tackifier is selected from the group consisting of acrylic resin, c5tackifier, hydrogenated hydrocarbon resin and mixtures thereof; and the absorbent is selected from the group consisting of carboxymethylcelluose, gelatin, SAP super absorbents and mixtures thereof. The therapeutic agent is one or more of benzoyl peroxide, salicylic acid, glycolic acid and sulfur.

Example 2

(a) 10 to 15 wt % of mineral oil;(b) 25 to 50 wt % or 30 to 40 wt % of carboxymethylcellulose;(c) 3 to 15 wt % or 5 to 10 wt % of KRATON° 1161; and(d) 25 to 45 wt % or 30 to 40 wt % of ARKON° P115,where the total weight percent of components (a) through (d) is 100%.

Example 3

(a) 3 to 10 wt % or 5 to 10 wt % of mineral oil;(b) 25 to 50 wt % or 30 to 40 wt % of carboxymethylcellulose;(c) 10 to 25 wt % or 15 to 20 wt % of KRATON° 1161; and(d) 25 to 55 wt % or 35 to 45 wt % of FORAL° 85,where the total weight percent of components (a) through (d) is 100%.

Example 4

(a) 35 to 65 wt % or 45 to 55 wt % of mineral oil; and(b) 35 to 65 wt % or 45 to 55 wt % of carboxymethylcellulose,where the total weight percent of components (a) and (b) is 100%.

Example 5

(a) 20 to 45 wt % or 30 to 40 wt % of alpha linolenic acid;(b) 15 to 40 wt % or 20 to 35 wt % of carboxymethylcellulose;(c) 20 to 45 wt % or 25 to 40 wt % of KRATON®; and(d) 10 to 25 wt % or 15 to 20 wt % of FORAL° 85,where the total weight percent of components (a) through (d) is 100%.

Example 6

(a) 1 to 15 wt % or 5 to 10 wt % of myristic acid;(b) 20 to 50 wt % or 30 to 40 wt % of carboxymethylcellulose;(c) 10 to 30 wt % or 15 to 25 wt % of KRATON®; and(d) 20 to 55 wt % or 35 to 50 wt % of FORAL° 85,where the total weight percent of components (a) through (d) is 100%.

Example 7

(a) 20 to 45 wt % or 25 to 40 wt % of a 1:1:1 mixture of mineral oil and alpha linolenic acid and myristic acid;(b) 10 to 35 wt % or 15 to 30 wt % of carboxymethylcellulose;(c) 15 to 40 wt % or 25 to 40 wt % of KRATON®; and(d) 10 to 30 wt % or 15 to 25 wt % of FORAL° 85,where the total weight percent of components (a) through (d) is 100%.

Example 8

(a) 35 to 65 wt % or 40 to 55 wt % of a 1:2:1 mixture of mineral oil and alpha linolenic and myristic acid;(b) 15 to 40 wt % or 20 to 35 wt % of carboxymethylcellulose;(c) 5 to 30 wt % or 5 to 20 wt % of KRATON®; and(d) 1 to 20 wt % or 10 to 15 wt % of FORAL° 85,where the total weight percent of components (a) through (d) is 100%.

All patents and other publications cited herein are incorporated by reference in their entireties.