WO2007092350A1 - Wound care articles, drug delivery systems and methods of using the same - Google Patents

Abstract

A wound care article that includes a hot melt superabsorbent polymer composition that includes a thermoplastic polymer, superabsorbent polymer particles and optionally at least one physiologically active agent, a prodrug or a combination thereof, a liquid permeable layer, a first liquid permeable, superabsorbent particle impermeable barrier, a second liquid permeable superabsorbent particle impermeable barrier, and a liquid impermeable layer. A drug delivery system that includes a first hot melt superabsorbent polymer composition that includes thermoplastic polymer and superabsorbent polymer particles, and at least one physiologically active agent, prodrug or combination thereof.

Description

WOUND CARE ARTICLES, DRUG DELIVERY SYSTEMS AND METHODS OF

USING THE SAME CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Serial No. 60/765,121, filed on February 2, 2006, entitled, "Wound Dressing and Other Absorbent Articles Including Hot Melt Superabsorbent Polymer Composition," U.S. Provisional Application Serial No. 60/765,345, filed on February 2, 2006, entitled, "Hot Melt Superabsorbent Polymer Dermal Delivery System," and U.S. Provisional Application

Serial No. 60/803,941 , filed on June 5, 2006, entitled, "Wound Care Article That Includes A Physiologically Active Agent," all of which are incorporated herein.

BACKGROUND

The invention relates to absorbing exudates from the body and in particular wounds and delivering a physiologically active agent, pro drug, or a combination thereof. A variety of wound care articles are used to improve the health and appearance of dermal tissue. Wounds, either injury induced (e.g., cuts, abrasions and blisters) or surgically induced (e.g., surgical incisions), require localized treatment to remedy the affected area and to prevent further dermal damage. If wounds are not properly treated, further dermal irritation can occur resulting in secondary infections and further discomfort to the patient.

Hydrocolloid dressings are widely used in the area of wound care due their beneficial effects to the healing process. Hydrocolloid dressings are beneficial to wound healing because hydrocolloids absorb excess fluids, thereby removing them from the wound site, offer a controlled adhesion level to the wound bed, which allows a noninvasive dressing change without causing trauma to the wound, and facilitate the healing process.

Hydrocolloid dressings are used by hospital personnel, as well as the general public. Products designed for over the counter sale to the general public are often somewhat thinner in hydrocolloid mass and are not designed to provide a particularly high level of fluid absoiption capability. However, hydrocolloid dressings used for wound care applications require a high degree of absorbency, as well as good structural integrity of the hydrocolloid mass, but are often bulky and relatively inflexible and thus do not conform well to a body surface or movement of the body. In addition, the hydrocolloid and carrier composition typically require processing using a high temperature extrusion to form a film, which can be undesirable. Dermal administration of physiologically active compounds involves the direct application of a physiologically active formulation to the skin. In transdermal delivery systems the physiologically active agent is often contained in a formulation, such as a hydro-alcohol gel and may optionally include a rate limiting membrane. When the system is applied to skin, the active agent begins to transport out of the formulation, and across a rate limiting membrane (if present). The active agent then enters the skin, enters blood vessels and tissues under the skin, and is taken into the systemic circulation of the body by the blood. At least some systems have a certain amount of active agent in or on the skin side of the rate limiting membrane (if present) prior to use. Such administration has long been known in the practice of medicine and continues to be an important technique in the delivery of active physiologically active compounds.

Such dermal administration offers many important advantages over other delivery techniques such as injection, oral tablets and capsules. These advantages include being noninvasive (thus, less risk of infection), avoiding first pass metabolism (metabolism of the drug in the liver when the drug is taken orally and absorbed through the gastrointestinal tract), and avoiding of high peaks and low valleys of concentration of pharmaceutically active compounds in a patient's bloodstream. In particular, high peaks and low valleys of concentration are typical in injection and oral administrations and are often associated with undesirable side effects and/or less than satisfactory intended effects. Since the early 1970s the main focus of transdermal systemic drug delivery has been, and still is, on transdermal patch devices. These patch devices are like bandages which are attached to the surface of intact skin for prolonged periods of time to allow a desired systemic delivery of a drug or other physiologically active agent. These , transdermal patch devices occlude the skin and trap the drug, together with volatiles and vehicle excipients, between the skin and an outer impermeable backing membrane. The membrane prevents the evaporation or diffusion of vehicle excipients, volatiles and drug into an environment other than the target skin site. The prolonged length of time required for transfer of the drug and excipients From the patch into the skin can, and often does, result in local skin irritation. The irritation is caused by prolonged contact on the skin by the drug, volatiles, vehicle excipients, or the adhesive used to attach the patch device to the skin. The occlusive nature of the patch device also restricts the natural ability of the skin to "breathe", increasing the risk of irritation.

SUMMARY

In one aspect, the invention features a wound care article that includes a skin contacting surface, an exterior surface, a first liquid permeable, superabsorbent particle impermeable banner, a hot melt superabsorbent polymer composition that includes superabsorbent polymer particles and thermoplastic polymer, a first liquid impermeable layer, and a pressure sensitive adhesive composition disposed on the skin contacting surface, the hot melt superabsorbent polymer composition being disposed between the first liquid permeable, superabsorbent particle impermeable barrier and the liquid impermeable layer. In one embodiment, the wound care article further includes a liquid permeable layer, the first liquid permeable, superabsorbent particle impermeable barrier being disposed between the hot melt superabsorbent polymer composition and the liquid permeable layer. In another embodiment, the wound care article includes a second liquid permeable, superabsorbent particle impermeable barrier disposed between the hot melt superabsorbent polymer composition and the liquid impermeable layer. In some embodiments, the wound care article further includes at least one physiologically active agent, prodrug or combination thereof. In some embodiments the physiologically active agent, prodrug or combination thereof is incorporated into the hot melt superabsorbent composition, disposed on a surface of the hot melt superabsorbent polymer composition or a combination thereof. In other embodiments, the at least one physiologically active agent, prodrug or combination thereof is incorporated into the first liquid permeable, superabsorbent particle impermeable barrier, disposed on a surface of the first liquid permeable, superabsorbent particle impermeable barrier or a combination thereof.

In some embodiments, the physiologically active agent is selected from the group consisting of antibacterial agents, antifungal agents, antiviral agents, antiparasitic agents, anesthetic agents, analgesics, antipyretics, non-sterodial an ti -inflammatory agents, antihypertensives, antihistamines, beta-adrenergic blocking agents, antimicrobials, and combinations thereof. In one embodiment, the physiologically agent is selected from the group consisting of bacitracin, terbinafine hydrochloride, acyclovir, metronidazole, lidocaine, fentanyl, and combinations thereof. In one embodiment, the hot melt superabsorbent polymer composition is coextensive with the liquid impermeable layer.

In other embodiments, the wound care article further includes a release liner disposed on the pressure sensitive adhesive composition.

In another embodiment, the first liquid permeable, superabsorbent particle impermeable barrier includes fibers selected from the group consisting of cellulose, creped cellulose, comminuted wood pulp, modified crosslinked cellulose, cotton and combinations thereof. In some embodiments, the first liquid permeable, superabsorbent particle impermeable baπier includes synthetic fibers. In other embodiments, the wound care article further includes an exterior fibrous layer disposed on the liquid impermeable layer.

In some embodiments, the hot melt superabsorbent polymer composition includes a discontinuous layer. In one embodiment, the hot melt superabsorbent polymer composition is in contact with the liquid impermeable layer.

In another embodiment, the wound care article further includes a second liquid impermeable layer, the second liquid impermeable layer being disposed between the first liquid impermeable layer and the hot melt superabsorbent polymer composition.

In another aspect, the invention features a drug delivery system that includes a first hot melt superabsorbent polymer composition that includes superabsorbent polymer particles and thermoplastic polymer, and at least one physiologically active agent, prodrug or combination thereof. In one embodiment, the drug delivery system includes a liquid impermeable layer. In other embodiments, the drug delivery system includes a pressure sensitive adhesive composition disposed on the liquid impermeable layer. In one embodiment, the pressure sensitive adhesive composition is disposed along the perimeter of the liquid impermeable layer. In other embodiments, the drug delivery system includes a liquid permeable layer, and the hot melt superabsorbent polymer composition is disposed between the liquid permeable layer and the liquid impermeable layer.

In some embodiments, the drug delivery system includes a carrier disposed on the hot mell superabsorbent polymer composition, the carrier including at least one physiologically active agent, prodrug or combination thereof. In other embodiments, the carrier can be dispose between the first hot melt superabsorbent polymer composition and a second hot melt superabsorbent polymer composition.

In another aspect, the invention features a method of administering a physiologically active agent, the method including adhering a drug delivery system to the skin of a mammal, wherein the drug delivery system includes a hot melt superabsorbent polymer composition and physiologically active agent, and wherein the hot melt superabsorbent polymer composition includes thermoplastic polymer and superabsorbent polymer particles. In one embodiment, the drug delivery system further includes a liquid permeable, superabsorbent particle impermeable barrier, the hot melt superabsorbent polymer composition being disposed between the liquid permeable layer and the liquid permeable, superabsorbent particle impermeable barrier. In some embodiments, the hot melt superabsorbent polymer composition further includes a polar liquid. In another embodiment, the at least one physiologically active agent, prodrug or combination thereof is incorporated into the hot melt superabsorbent polymer composition, disposed on a surface of the hot melt superabsorbent polymer composition or a combination thereof.

In one embodiment, the drug delivery system further includes a carrier and a second hot melt superabsorbent polymer composition that includes thermoplastic polymer and superabsorbent polymer particles, the carrier being disposed between the first hot melt superabsorbent polymer composition and the second hot melt superabsorbent polymer composition. In some embodiments, the second hot melt superabsorbent polymer composition further includes at least one physiologically active agent, prodrug or combination thereof.

In other aspects, the invention features a method of administering a physiologically active agent, the method includes adhering a drug delivery system disclosed herein to the skin of a mammal. In one embodiment, the skin of the mammal is located on a part of the mammal selected from the group consisting of forehead, armpit and back.

In another aspect the invention features a method of treating a wound, the method includes adhering a wound care article disclosed herein to the skin of a mammal through the pressure sensitive adhesive composition.

In another embodiment, a wound care article disclosed herein is used in a method for absorbing moisture, the method including adhering the wound care article to the skin of a mammal through a pressure sensitive adhesive composition, the skin of the mammal being located on a part of the mammal selected from the group consisting of forehead, armpit and back.

The present invention features absorbent articles such as wound care articles and drug delivery systems that exhibit good flexibility and an ability to conform to the body surface with which they are in contact. The wound care articles that include an optional active agent, i.e., a physiologically active agent, a prodrug or a combination thereof, may deliver active agent, as well as absorb exudates from the wounds or protect the wound.

Other features and advantages will be apparent from the following description of the preferred embodiments, the drawings, where like reference numerals refer to like elements, and from the claims.

GLOSSARY In reference to the invention, these terms have the meanings set forth below:

The term "drug", as used herein, means any physiologically active compound including but not limited to compounds that treat diseases, injuries, undesirable symptoms, and improve or maintain health.

The term "liquid permeable" refers to the ability of a liquid, e.g., saline, water, or at least one wound exudate, e.g., blood, moisture, water serum, or mucous, to pass through.

The term "physiologically active agent", as used herein, means a broad class of useful chemical and therapeutic agents.

The term "physiologically active", as used in describing the agents contemplated herein, refers to agents having a direct pharmacological effect on the host, and an indirect or observable effect that is useful in the medical arts. The term a "prodrug" as used herein means a structurally related compound or derivative of an active compound that is converted to a desired physiologically active compound in the animal body. The prodrug itself may have little or none of the desired activity. The term "transdermal", as used herein, means being able to pass through unbroken skin.

The lerm "non-occlusive", as used herein, means closing the skin to the atmosphere for a prolonged length of time.

The term "skin", as used herein, includes stratum comeum covered skin and mucosal membranes.

The term "tackifier" means a component that imparts tack to a composition. The term "tack" means the property of a material that enables it to form a bond of measurable strength immediately on contact with another surface.

The term "transdermal", as used herein, means being able to pass through unbroken skin.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a plan view of a body facing side of a wound dressing according to one embodiment;

FIG. 2 shows a cross-sectional view of the wound dressing of FIG. 1, taken along view line A-A;

FIG. 3 shows a cross-sectional view of a wound dressing according to another embodiment;

FIG. 4 shows a plan view of a wound dressing according to another embodiment; FIG. 5 shows a cross-sectional view of the wound dressing of FTG. 4, taken along the view line B-B.

FIG. 6 shows a cross-sectional view of an absorbent article according to another embodiment.

FIG. 7 shows a cross-sectional view of a wound dressing according to another embodiment. FIG. 8 shows a cross-sectional view of a wound dressing according to another embodiment. FIG. 9 shows a plan view of a wound dressing according to another embodiment. FIG. 10 shows a plan view of a body facing side of a drug delivery system according to one embodiment of the invention;

FIG. 1 1 shows a cross-sectional view of the drug delivery system of FIG. 10, taken along view line C-C;

FIG. 12 shows a cross-sectional view of a drug delivery system according to another embodiment;

FIG. 13 shows a cross-sectional view of another embodiment of a drug delivery system; FIG. 14 shows a cross-sectional view of a drug delivery system according to another embodiment;

FlG. 15 shows a cross-sectional view of another embodiment of a drug delivery system.

DETAILED DESCRIPTION The wound care articles and drug delivery systems include a hot melt superabsorbent polymer composition that includes a blend of thermoplastic polymer, SLiperabsorbent polymer particles and, optionally, a physiologically active agent, prodrug or a combination thereof. For ease of reference, the term "physiologically active agent" will be used throughout this description, although it is to be understood that the active agent could be a physiologically active agent, a prodrug, or a combination of a prodrug and a physiologically active agent.

The wound care articles and drug delivery systems optionally include a variety of additional components and layers including, e.g., a pressure sensitive adhesive composition (for contacting a user's skin and adhering the article or system to the skin), a liquid permeable layer, a liquid impermeable layer, a liquid permeable, superabsorbent particle impermeable barrier and combinations thereof. The liquid permeable layer can provide a comfortable feel to the user's skin and aid in preventing the wound care articles and drug delivery systems from adhering to the user's skin. The liquid permeable, superabsorbent particle impermeable barrier assists in preventing the expanding wet superabsorbent polymer from being released and contacting the user's skin. Where present, the pressure sensitive adhesive helps maintain the wound care articles and drug delivery systems in a desired position.

WOUND CARE ARTICLES

The absorbent article in the form of a wound care article (e.g., wound dressing) 10 includes a hot melt superabsorbent polymer composition 16 that includes a thermoplastic polymer, superabsorbent polymer particles and optionally at least one physiologically active agent 1 1 , a prodrug or a combination thereof, a skin contacting layer 12 (i.e., a layer intended to be worn proximal the skin), a first liquid permeable, superabsorbent particle impermeable barrier 14, a second liquid permeable superabsorbent particle impermeable barrier 18, and a liquid impermeable layer 20, as illustrated in FIGS. 1 and 2. A pressure sensitive adhesive 22 extends along the perimeter of the skin contacting layer 12 and is available for contact with the user's skin so that the wound care article 10 can be adhered to the skin. A construction adhesive maintains the components of the wound care article in fixed relation with respect to one another through an adhesive bond. The skin contacting layer 12 is adhered to the first liquid permeable, superabsorbent particle impermeable barrier 14 through a construction adhesive 24b and the liquid impermeable layer 20 is adhered to the second liquid permeable, superabsorbent particle impermeable barrier 18 through construction adhesive 24a. The wound care article is flexible, preferably exhibits a flexibility similar to that of the nonwoven webs in the absence of the hot melt superabsorbent polymer composition, and preferably conforms to a surface (e.g., skin) and accommodates the movement of a body part.

The wound care article 10 can also optionally include an exterior fibrous layer 26, an example of which is illustrated in FIG. 3. The exterior fibrous layer provides an appealing tactile sensation to the wound care article relative to an exterior impermeable plastic film. The liquid impermeable layer 20 and the exterior fibrous layer 26 can be separate components bonded to each other through a construction adhesive. Alternatively, the liquid impermeable layer 20 can be coated on and simultaneously bonded to the fibrous layer 26 using any suitable hot melt coating technique including, e.g., the noncontact coating techniques describe in U.S. Patent 5,827,252 (Werenicz et al.) and incorporated herein.

FIGS. 4-5 illustrate an embodiment of the wound dressing 40 that includes a skin contacting layer (e.g., liquid permeable layer) 42, a first liquid permeable, superabsorbent particle impermeable barrier layer 44 bonded to the skin contacting layer 42 through a discontinuous layer of construction adhesive 46, a hot melt superabsorbent polymer composition 48 in the form of three parallel stripes 48a-c disposed between the liquid permeable, superabsorbent particle impermeable barrier 44 and a second liquid permeable, superabsorbent particle impermeable barrier layer 50, and a liquid impermeable exterior layer 52 (which is intended to be distal to the skin when worn by a user) bonded to the second liquid, permeable superabsorbent particle impermeable barrier 50 through a construction adhesive 46. The hot melt superabsorbent polymer composition 48 is illustrated as including the optional physiologically active agent 51. A pressure sensitive adhesive 54 extends along the perimeter of the proximal surface of the dressing 40 (e.g., on the skin contacting layer 42) and is available for contact with a user's skin.

The wound care article can have a variety of other constructions. In one embodiment, the hot melt superabsorbent polymer composition is in direct contact with an liquid impermeable layer that includes an exterior surface. FIG. 7, for example, illustrates a wound care article 128 that includes a liquid impermeable layer 130, a hot melt superabsorbent polymer composition 132, a liquid permeable, superabsorbent particle impermeable barrier layer 134, and a skin contacting layer (e.g., a liquid permeable layer) 136. Other useful wound care articles are describe in U.S. Patent Application Serial No. 60/765,121 and incorporated herein.

In other embodiments, the wound care article includes a second liquid impermeable layer (e.g., a release coated paper) disposed between the hot melt superabsorbent polymer composition and a first liquid impermeable layer. In such an embodiment, the hot melt superabsorbent polymer composition can be coated, e.g., on liquid impermeable release paper and the release coated paper can be disposed on the first liquid impermeable exterior layer.

In use, the wound care article is placed over the wound to absorb the exudates of the wound (e.g., blood, serum, water, mucous, and other exudates) and to protect the wound from external contact. As the liquid exudates pass through the layers of the dressing to the hot melt superabsorbent polymer composition, the liquids are absorbed by the superabsorbent polymer, which then expands. As the hot melt superabsorbent polymer composition absorbs liquid from the wound, the physiologically active agent, where present, is released from the hot melt superabsorbent polymer composition and is available for transfer to the body. Over time, as additional moisture and other exudates are given off by the body more of the superabsorbent polymer is exposed, e.g., superabsorbent polymer located further in the depth of the hot melt superabsorbent polymer composition. As the additional superabsorbent polymer absorbs water and other exudates, additional active agent in the hot melt composition is exposed and made available for contact with and optionally transmission through one or more layers of tissue (e.g., skin). This mechanism creates a time release administration of the active agent. The wound care articles (e.g., wound dressings) can exhibit a variety of shapes and the dressing in its entirety or any component thereof can have any combination of height, width and depth.

Although the wound care articles disclosed herein have been described with respect to their use in conjunction with wounds, the articles are also well suited for use in other absorbent article applications including, e.g., surgical drapes, smocks, gowns, bed liners, examination table covers, mattress pads, breast pads, and arm pit pads.

The wound dressing construction is also well suited for use as an absorbent article by individuals in environments that produce perspiration including, e.g., hospital personnel functioning for extended durations under stressful situations including, e.g., surgeons, nurses, and aids during surgical operations, athletes and welders. The absorbent article is also well suited for use by individuals who wear a head covering including, e.g., athletes (e.g., football players, baseball players, and hockey players), hospital personnel, police and fire personnel, and welders. For such uses, the pressure sensitive adhesive of the wound dressing is adhered to the forehead, arm pit, back or any other area where perspiration accumulates on the individual, through the pressure sensitive adhesive.

For clothing including drapes and gowns, the absorbent article can be adhered to an area of the garment where perspiration accumulates including, e.g., the arm pit region and the lower back region. The absorbent article can also be in the form of a bed liner and used by placing the sheet on a bed either directly under the individual or under a bed covering such us a sheet or mattress pad. The absorbent articles can be used to treat wounds such as, for example, cuts, abrasions, bed sores, scrapes, blisters, surgical incisions and combinations thereof. FIG. 6 illustrates an alternative embodiment of an absorbent article 100 that includes a liquid permeable layer 112, a liquid permeable, superabsorbent particle impermeable barrier 114, a hot melt superabsorbent polymer composition 116 (which is illustrated as including the optional physiologically active agent 117), a second liquid permeable, superabsorbent particle barrier 118, and a exterior layer 120. A pressure sensitive adhesive 122 extends along the perimeter of the surface of the exterior layer 120 (e.g., a liquid impermeable layer, a nonwoven layer or a combination thereof) and is available for contact with the interior surface of a garment (e.g., head covering, smock, surgical gown, and bra) so that the absorbent article 100 can be adhered to the interior surface of the garment. With respect to a head covering, the pressure sensitive adhesive on the exterior surface of the absorbent article is available for adhesion to the interior head-contacting surface of the head covering including, e.g., the forehead contacting surface of such head coverings as welding helmets, baseball caps, football helmet, hats for golfing, police personnel and fireman, and visors, and the liquid permeable layer is available for contact with the individual when the head covering is worn. Likewise, the absorbent article can be adhered to the interior surfaces of other pieces of athletic gear including, e.g., shoulder pads, shin guards, gloves, and sweat bands for head and wrists.

HOT MELT SUPERABSORBENT POLYMER COMPOSITION

The hot melt superabsorbent polymer composition can be any suitable hot melt superabsorbent polymer composition that includes a blend of thermoplastic polymer and superabsorbent polymer particles including, e.g., a hot melt adhesive composition that includes superabsorbent polymer particles. In some embodiments, the superabsorbent polymer particles are additionally present on a surface of the hot melt superabsorbent polymer composition. The hot melt superabsorbent polymer composition can be tacky or nontacky. Useful thermoplastic polymers include, e.g., styrenic block copolymers, polyolefins (e.g., amorphous and crystalline polyolefins including homogeneous and substantially linear ethylene/alpha-olefin interpolymers), interpolymers and copolymers of ethylene including, e.g., ethylene-vinyl acetate, ethylene-vinyl acetate ethylene-acrylic acid, ethylene-methacrylic acid, ethylene-methyl acrylate, ethylene-ethyl acrylate and ethylene n-butyl acrylate and derivatives (e.g., incorporating at least two comonomers), polyacrylic acids, polymethacrylic acids, polyacrylates, polyvinyl acetates, polylactic acids, polylactides, caprolactone polymers, poly (hydroxy-butyrate/hydroxyvalerate), polyvinyl alcohols, polyesters, copolyesters (e.g., biodegradable copolyesters), poly(ethylene oxide)polyether amide, polyester ether block copolymers, polyvinyl pyrrolidone, polyvinyl pyrrolidone-vinyi acetate copolymer, polyetheroxazoline, polyvinyl ethers (e.g., polyvinyl methyl ether), polyamides, polyacrylamide, and combinations thereof. A wide variety of block copolymers are useful including, e.g., A-B-A triblock copolymers, A-B diblock copolymers, and (A-B)n radial block copolymers, and branched and grafted versions thereof, wherein the A blocks are non elastomcric polymer blocks , typically comprising polystyrene, and the B blocks are unsaturated conjugated diene or hydrogenated version thereof. Suitable B blocks include, e.g., isoprene, butadiene, ethylene/butylene (hydrogenated butadiene), ethylene/propylene (hydrogenated isoprene), and combinations thereof. Useful block copolymers are commercially available under the KRATON D and G series of trade designations from Shell Chemical Company (Houston, Texas), EUROPRENE Sol T trade designation from EniChem (Houston, Texas), and Vector© series of trade designations from Exxon (Dexco) (Houston, Texas). Useful commercially available polyolefins include, e.g., AFFINITY substantially linear ethylene polymers polyolefin plastomers from The Dow Chemical Company (Midland, Michigan) and EXACT homogeneous linear ethylene polymers from Exxon Chemical Company (Houston, Texas). Useful amorphous polyolefins and amorphous polyalphaolefins include homopolymers, copolymers, and terpolymers Of C₂-Cs alphaolefins. Useful commercially available amorphous polyalphaolefins include, e.g., REXTAC and REXFLEX propylene based homopolymers, ethylene-propylene copolymers and butene-propylenc copolymers available from Rexene (Dallas, Texas), VESTOPLAST alpha-olefin copolymers available from Hϋls (Piscataway, New Jersey). Any suitable superabsorbent polymer can be included in the composition. Superabsorbent polymers are also referred to as water-insoluble absorbent hydrogel- forming polymers, "hydrogel-forming" polymers, and "hydrocolloids." Superabsorbent polymers are able to absorb many times their own weight in water. Useful superabsorbent polymers include at least partially crosslinked, at least partially neutralized polymers that gel when contacted with water and are preferably substantially water insoluble. Suitable superabsorbent polymers include, e.g., polysaccharides (e.g., carboxymethyl starch, carboxymethyl cellulose, and hydroxypropyl cellulose), polyvinyl alcohol, polyvinyl ethers, polyvinyl pyridine, polyvinyl morpholinione, N,N-dimethylarninoethyl, N,N- diethylaminopropyl, acrylates, methacrylates, and the quaternary salts thereof. The superabsorbent polymer preferably includes a plurality of functional groups, e.g., sulfonic acid groups, carboxy groups and combinations thereof. Suitable superabsorbent polymers are prepared from polymerizable, unsaturated, acid-containing monomers including, e.g., olefinically unsaturated acids and anhydrides having at least one carbon-carbon olefinic double bond including, e.g., olefinically unsaturated carboxylic acids and acid anhydrides, olefinically unsaturated sulfonic acids and combinations thereof. Useful olefinically unsaturated carboxylic acid and carboxylic acid anhydride monomers include, e.g., acrylic acid, methacrylic acid, ethacrylic acid, chloroacrylic acid, cyanoacrylic acid, crotonic acid, phenylacrylic acid, acrytoxypropionic acid, sorbic acid, chlorosorbic acid, angelic acid, cinnamic acid, p-chlorocinnamic acid, stearylacrylic acid, itaconic acid, citraconic acid, mesaconic acid, glutaconic acid, aconitic acid, maleic acid, fumaric acid, tncarboxyethylene acid anhydride, maleic acid anhydride, and combinations thereof.

Useful olefinically unsaturated sulfonic acid monomers include aliphatic and aromatic vinyl sulfonic acids (e.g., vinylsulfonic acid, allyl sulfonic acid, vinyl toluene sulfonic acid and styrene sulfonic acid), acrylic and melhacrylic sulfonic acids (e.g., sulfoethyl acrylate, sulfoethyl methacrylate, sulfopropyl acrylate, sulfopropyl methacrylate, 2-hydroxy-3-methacryloxypropyl sulfonic acid and 2-acrylamide-2- methylpropane sulfonic acid), and combinations thereof.

Useful superabsorbent polymers that include carboxy groups include, e.g., hydrolyzed starch-acrylonitrile graft copolymers, partially neutralized hydrolyzed starch- acrylonitrile graft copolymers, starch-acrylic acid graft copolymers, partially neutralized starch-acrylic acid graft copolymers, saponified vinyl acetate-acrylic ester copolymers, hydrolyzed acrylonitrilc or acrylamide copolymers, slightly network crosslinked polymers of any of the foregoing copolymers, partially neutralized polyacrylic acid, and slightly network crosslinked polymers of partially neutralized polyacrylic acid. These polymers are disclosed, e.g., in U.S. Patent Nos. 4,076,663, 4,093,776, 4,666,983 and 4,734,478 and incorporated herein. The absorbent gelling particles can have any suitable property including, e.g., size, shape, morphology and combinations thereof. The superabsorbent particles preferably are spherical or substantially spherical and preferably have an average particle size no greater than about 400 μm, no greater than about 350 μm, no greater than about 200 μm, no greater than about 150 μm, no greater than about 100 μm, no greater than about 100 μm, no greater than about 50 μm, no greater than about 40 μm, at least about 10 μm, at least, about 20 μm, or even about 20 μm to about 30 μm.

Useful commercially available superabsorbent particles include, e.g., sodium polyacrylate superabsorbent particles available under the AQUA KEEP series of trade designations including, e.g., particles having a median particle size of from about 20 μm to about 30 μm available under the trade designation AQUA KEEP JOSH-NF, particles having an average particle size of from 200 μm to 300 μm available under the trade designation AQUA KEEP 10SH-P, particles having an average particle size of from 320 μm to 370 μm available under the trade designation AQUA KEEP SA60S, particles having an average particle size of from 35Oμm to 390 μm available under the trade designations AQUA KEEP SA60SX, SA55SX II and SA 60SL II, and particles having an average particle size of from 250 μm to 350 μm available under the trade designation AQUA KEEP SA60N TYPE II from Sumitomo Seika Chemicals CoI, Ltd. (Japan). Useful superabsorbent polymer forms include, e.g., particles, granules, flakes, pulveruients, interparticle aggregates, interparticle crosslinked aggregates, fibers, foams, and combinations thereof.

The hot melt superabsorbent polymer composition preferably includes superabsorbent polymer particles in an amount of at least about 30 % by weight, at least about 40 % by weight, at least about 50 % by weight, no greater than about 70 % by weight, or even no greater than about 60 % by weight. The hot melt superabsorbent polymer composition can also include other additives including, e.g., plasticizers, tackifiers, waxes, antioxidants, biocides, chitosan, antimicrobial agents, zeolites, carbon black, pigments, fillers (e.g., titanium dioxide and hydrophilic fillers), surfactants, phosphites (e.g., IRGAFOS 168), antiblock additives, and combinations thereof.

Useful plasticizers include phthalate plasticizers (e.g., dioctyl phthalate and butyl benzyl phthalate (e.g., Santicizer 160 from Monsanto)), liquid polyesters (e.g., Dynacol 720 from HuIs, liquid polymeric plasticizer an example of which is commercially available from C. P. Hall, benzoate plasticizers (e.g., 1,4-cyclohexane dimethanol dibenzoate (e.g., BENZOFLEZ 352 commercially available from Velsicol), diethylene glycol/dipropylene glycol dibenzoate (e.g., BENZOFLEZ 50 commercially available from Velsicol), and diethylene glycol dibenzoate (e.g., commercially available 2-45 High Hydroxyl (Velsicol)), phosphite plasticizers (e.g., t-butyl diphenyl phosphate (e.g., SANTICIZER 154 from Monsanto)), liquid rosin derivatives having Ring and Ball softening points below about 60°C including, e.g., methyl esters of hydrogenated rosin (e.g., Hercoyn D from Hercules), vegetable oils, and animal oils (e.g., glycerol esters of fatty acids and polymerizable products thereof, citric acid esters (e.g., citric acid esters commercially available under the CITROFLEX series of trade designations), and toluene sulfonamide.

Useful water soluble or water dispersible plasticizers include polyethylene glycol having a molecular weight less than about 2000, derivatives of polyethylene glycol including Pycal 94, the phenyl ether of PEG available from ICI; ethoxylated bis phenol A (e.g., Macol 206 EM from PPG Industries) and dionyl phenol ethyloxylates (e.g., Surfonic DNP from Huntsman Chemical Corp.).

Other useful plasticizers include hydrocarbon oils (paraffinic oils, naphthenic oils and oils having low aromatic content) , polybutene, liquid tackifying resins and liquid elastomers. Plasticizer oils are preferably low in volatility, transparent and have as little color and odor as possible.

Useful waxes include 12-hydroxystearamide, N-(2-hydroxy ethyl 12-hydroxy stearamide (Paricin 220 and 285 from CasChem), stearamide (Kemamide S from Witco), glycerin monostearate, sorbitan monostearate, and 12-hydroxy stearic acid. Other useful waxes include paraffin waxes, microcrystalline waxes, Fischer-Tropsch, polyethylene and by-products of polyethylene. Also useful in combination with the above waxes are waxes such as N,N'-ethylene-bis stearamide (Kemamide W-40 from Witco), hydrogenated castor oil (castor wax), oxidized synthetic waxes, and functionalized waxes such as oxidized polyethylene waxes (Petrolite E-1040).

Waxes are usefully employed to reduce viscosity as well as increase the blocking resistance at concentrations ranging from about 2 % by weight to about 25 % by weight, or even from about 10 % by weight to about 20 % by weight.

Useful tackifying agents include, e.g., resins derived from renewable resources such as rosin derivatives including wood rosin, tall oil and gum rosin, as well as rosin esters, natural and synthetic terpenes and derivatives thereof, aliphatic, aromatic and mixed aliphatic-aromatic petroleum based tackifiers. Examples of useful hydrocarbon resins include alpha-methyl styrene resins, branched and unbranched C₅-C10 resins and styrenic and hydrogenated modifications thereof. Useful tackifying resins range from being a liquid at 37°C to having a ring and ball softening point of about 135^υC. The composition can include tackifying resin in an amount from 0 % by weight to about 50 % by weight, from about 5 % by weight to about 40 % by weight, or even from about 10 % by weight to about 20 % by weight.

Useful antioxidants include, e.g., hindered phenolics (e.g., IRGANOX 1010, IRGANOX 1076).

Hydrophilic fillers are a preferred class of additives, which are useful to alter the surface properties and/or increase the rate of absorption. Hydrophilic fillers include calcium carbonate, hydroxyethyl cellulose, hydroxypropyl cellulose, starch and cellulose esters (e.g., acetates), attagel clay, guargum, bentonite, hectonite, diatomaceous earth, talc, and combinations thereof.

Suitable surfactants include nonionic, anionic, and silicone surfactants. The composition can include surfactant in an amount from 0 % by weight to about 25 % by weight, or even from about 5 % by weight to about 15 % by weight.

Useful hot melt superabsorbent polymer compositions are described in, e.g., U.S. Patent Nos. 6,534,572, and 6,458,877, and U.S. Patent Application Serial Nos. 10/050,375 (published as U.S. Publication No. 2003/0134552), and 11/007,470, and incorporated herein. Useful hot melt superabsorbent polymer compositions are commercially available under the HYDROLOCK series of trade designations from H. B. Fuller Company (Vadnais Heights, Minnesota). Useful hot melt superabsorbent polymers compositions that include a physiologically active agent are described in U.S. Patent Application Serial No. 60/765,345, filed on February 2, 2006, and incorporated herein.

The hot melt superabsorbent polymer composition can be provided in a variety of forms including, e.g., a coating (e.g., a continuous or discontinuous coating), a film (e.g., a continuous or discontinuous film), a spray pattern, a mass, and combinations thereof, using any suitable technique including, e.g., contact coating, noncontact coating, spraying (e.g., spiral spraying and random spraying), extrusion (e.g., single screw extrusion and twin screw extrusion), slot coating, melt blown, foaming, engraved roller, gravure, screen printing, flexographic and compositions thereof.

The configuration, location and amount of the hot melt superabsorbent polymer composition present in the dressing is selected to optimize the absorbent properties of the dressing including, e.g., penetration time, penetration rate, wet back, absorbent capacity, fluid retention, and combinations thereof. The hot melt superabsorbent polymer composition can be present in the dressing in a variety of configurations including, e.g., random, pattern, stripes, dots having a variety of shapes (e.g., round, oval, square, diamond, and triangle), wavy lines, spiral spray, fanciful forms (e.g., leaves, flowers, and petals), and combinations thereof. The hot melt superabsorbent polymer composition is preferably in the form of a discontinuous layer. One useful configuration includes a number of stripes of hot melt superabsorbent polymer composition, which can exist in a variety of configurations including, e.g., single or multiple stripes (e.g., one, two, three, four, and five), and continuous or discontinuous stripes. Where multiple stripes of hot melt superabsorbent polymer are present any suitable spacing between the individual regions can exist including, e.g., constant (e.g., equal spacing distances) or variable spacing distances. The stripes can also be positioned in any orientation including, e.g., along the length of the article, the width of the article, at any angle to the longitudinal axis of the article, at any angle to the latitudinal axis of the article, and combinations thereof. The width and length of the stripes can also be constant or variable. The spacing between the regions of hot melt superabsorbent polymer composition is preferably sufficient to allow the superabsorbent polymer freedom to expand as it would when contacted with water. The configuration can also be selected to optimize leakage control, e.g., to prevent wound exudates from extending beyond a certain location. FIG. 9, for example, illustrates a wound dressing 150 that includes a configuration of hot melt superabsorbent polymer composition in the form of a border 152 surrounding a random arrangement 154 of spaced dots 156. The borderl52 functions to maintain wound exudates within the area defined thereby.

Any amount of hot melt superabsorbent polymer composition can be present in the article. Preferably the wound dressing includes hot melt superabsorbent polymer composition in an amount of at least about 10 grams per square meter (g/m²), at least about 20 g/m², at least about 50 g/m², at least about 100 g/m², at least about 150 g/m², at least about 250 g/m², at least about 500 g/m², or even from about 50 g/m² to about 500 g/m².

PHYSIOLOGICALLY ACTIVE AGENTS The absorbent article (e.g., wound care articles) and drug delivery systems can include a variety of physiologically active agents, prodrugs and combinations thereof. The physiologically active agent preferably is able to permeate the skin of the wearer. Suitable physiologically active agents can be dissolved or suspended in the thermoplastic polymer of the composition. The physiologically active agent can be mixed into a hot melt superabsorbent polymer composition, applied to the surface thereof, and combinations thereof. The physiologically active agent also can be introduced into the composition by adding the physiologically active agent in a variety of forms including, e.g., a powder form, a water suspension, an oil, a lipid, and combinations thereof, by adding a physiologically active agent carried on a powder support to the composition, and combinations thereof.

The physiologically active agent preferably is able to permeate a tissue or skin. The physiologically active agent can be incorporated into any suitable layer of the wound care article or drug delivery system. For example, the physiologically active agent can be incorporated into the hot melt superabsorbent polymer composition, coated on a surface of the hot melt superabsorbent polymer composition, and combinations thereof. Where the physiologically active agent is incorporated into the hot melt superabsorbent polymer composition, the physiologically active agent must be able to withstand the temperatures experienced by the hot melt superabsorbent polymer composition as a whole during the application process. Preferably the active agent is able to maintain its integrity and effectiveness after having been exposed to temperatures of at least 200°F, at least 22O⁰F, or even at least 250⁰F during the coating process.

In other embodiments, the physiologically active agent is incorporated in or coated on the surface of a component of the absorbent article including, e.g., a liquid permeable (e.g., skin contacting) layer, a first liquid permeable, superabsorbent particle impermeable barrier, a hot melt superabsorbent polymer composition, a second liquid permeable, superabsorbent particle impermeable barrier and combinations thereof. The physiologically active agent can be incorporated into a desired layer or structure of the absorbent articles by, for example, mixing the physiologically active agent with the other components of the layer during formation of the layer. Additionally or alternatively, the physiologically active agent can be coated onto desired surfaces of a layer or structure by any appropriate coating method. Where the physiologically active agent is incorporated into the hot melt superabsorbent polymer composition, the physiologically active agent must be able to withstand the temperatures experienced by the hot melt superabsorbent polymer composition as a whole during the application process. Preferably, the physiologically active agent is able to maintain its integrity and effectiveness after having been exposed to temperatures of at least 200⁰F, at least 220⁰F, or even at least 250⁰F during the coating process.

In embodiments where the physiologically active agent is incorporated into the hot melt superabsorbent polymer composition, a polar liquid (e.g., water, saline, glycols including, e.g., polyethylene glycol and polypropylene glycol, alcohol or a combination thereof) can be added to the hot melt superabsorbent polymer composition. The presence of a polar liquid such as water in the hot melt superabsorbent polymer composition can facilitate the release (e.g., immediate) of the physiologically active agent upon contact with the user's skin. The polar liquid can be added to the hot melt superabsorbent polymer composition during the manufacture of the drug delivery system using any suitable technique including, e.g., blending, coating, spraying, painting, printing, and brushing. The polar liquid can also cause at least a portion of the hot melt superabsorbent polymer composition to gel, whereupon it can exhibit properties including, e.g., being stretchable, resilient, pliable, moldable and combinations thereof. If the physiologically active agent is incorporated into another component of the absorbent article, e.g., the skin contacting layer, the first liquid permeable, superabsorbent particle impermeable barrier, the second liquid permeable, superabsorbent particle impermeable barrier and combinations thereof, a polar liquid can be added to that component to facilitate release (e.g., immediate) of the physiologically active agent.

The system can include a locally or systemically physiologically active agent that can be delivered through the skin, optionally with the assistance of a dermal penetration enhancer including, e.g., chitin, glyceryl trinitrate and isosorbide dinitrate.

Active agents (grouped by therapeutic class) include, for example:

Alimentary System: antidiarrhoeals (e.g., diphenoxylate, loperamide, and hyoscyamine).

Cardiovascular System: antihypertensives (e.g., hydralazine, minoxidil, captopril, enalapril, clonidine, prazosin, debrisoquine, diazoxide, guanethidne, methyldopa, reseipine, trimetaphan); calcium channel blockers (e.g., diltiazem, felodopine, amlodipine, nitrendipine, nifedipine, and verapamil), antiarrhyrthmics (e.g., amiodarone, flecainide, disopyramide, procainamide, mexiletene, and quinidine); antiangina agents (e.g., glyceryl trinitrate, erythritol tetranitrate, pentaerythritol tetranitrate, mannitol hexanitrate, perhexilene, isosorbide dinitrate, and nicorandil); beta-adrenergic blocking agents (e.g., alprenolol, atenolol, bupranolol, carteolol, labetalol, metoprolol, nadolol, nadoxolol, oxprenolol, pindolol, propranolol, sotalol, timolol, and timolol maleate); cardiotonic glycosides (e.g., such as digoxin and other cardiac glycosides and theophylline derivatives); adrenergic stimulants (e.g., adrenaline, ephedrine, fcnoterol, isoprenaline, orcipienaline, rimeterol, salbutamol, salmeterol, terbutaline, dobutamine, phenylephrine, phenylpropanolamine, pseudoephedrine, and dopamine); vasodilators (e.g., cyclandelate, isoxsuprine, papaverine, dipyrimadole, isosorbide dinitrate, phentolamine, nicotinyl alcohol, co-dergocrine, nicotinic acid, glyceryl trinitrate, pentaerythritol tetranitrate, and xanthinol); antimigraine preparations (e.g., ergotamine, dihydroergotamine, methysergide, pizotifen and, sumatriptan); Drugs Affecting Blood and Haemopoietic Tissues;

Anticoagulants and thrombolytic agents (e.g, warfarin and dicoumarol); low molecular weight heparins (e.g., enoxapaiϊn); streptokinase and its active derivatives; and haemostatic agents (e.g., aprotinin, tranexamic acid, and protamine).

Central Nervous System: analgesics, antipyretics including the opiod analgesics (e.g., buprenorphine, dextromoramide, dextropropoxyphene, fentanyl, alfentanil, sufentanil, hydromorphone, methadone, morphine, oxycodone, papaveretum, pentazocine, pethidine, phenoperidine, codeine, dihydrocodeine); acetylsalicylic acid (aspirin), paracetamol, and phenazone; hypnotics and sedatives (e.g., the barbiturates, amylobarbitone, butobarbitone, and pentobarbitone); other hypnotics and sedatives (e.g., choral hydrate, chlormethiazole, hydroxyzine, and meprobamate); antianxiety agents (e.g., the benzodiazepines, alprazolam, bromazepam, chlordiazepoxide, clobazam, chlorazepate, diazepam, flunitrazepam, flurazepam, lorazepam, nitrazepam, oxazepam, temazepam, and triazolam); neuroleptic and antipsychotic drugs (e.g., the phenothiazines, chlorpromazine, fluphenazine, pericyazine, perphenazine, promazine, thiopropazate, thioridazine, and trifluoperazine); the butyrophenones (droperidol and haloperidol) and the other antipsychotic drugs (e.g., pimozide, thiothixene, and lithium); antidepressants (e.g., the tricyclic antidepressants amitryptyline, clomipramine, desipramine, dothiepin, doxepin, imipramine, nortriptyline, opipramol, protriptyline and trimipramine); the tetracyclic antidepressants (e.g., mianserin); the monoamine oxidase inhibitors (e.g. isocarboxazid, phenelizine, tranylcypromine, and moclobemide); selective serotonin re-uptake inhibitors (e.g., fluoxetine, paroxetine, citalopram, fluvoxamine, and sertraline); CNS stimulants (e.g. caffeine); anti-alzheimer's agents (e.g. tacrine); antiparkinson agents (e.g., amantadine, benserazide, carbidopa, levodopa, benztropine, biperiden, benzhexol, procyclidine); dopamine-2 agonists (e.g., S(-)-2-(N-propyl-N-2-thienylethylamino)-5- hydroxytetralin (N-0923)); anticonvulsants (e.g., phenytoin, valproic acid, primidone, phenobarbitone, methylphenobarbitone and carbamazepine, ethosuximide, methsuximide, phensuximide, sulthiame, and clonazepam); antiemetics, antinauseants (e.g., the phenothiazines, prochloperazine, and thiethylperazine); 5HT-3 receptor antagonists (e.g. ondansetron and granisetron); and others such as dimenhydrinate, diphenhydramine, metoclopramide, domperidone, hyoscine, hyoscine hydrobromide, hyoscine hydrochloride, clebopride, and brompride). Musculoskeletal System: non-steroidal an ti -inflammatory agents including their racemic mixtures or individual enantiomers where applicable (e.g., ibuprofen, flurbiprofen, ketoprofen, aclofenac, diclofenac, aloxiprin, aproxen, aspirin, diflunisal, fenoprofen, indomethacin, mefenamic acid, naproxen, phenylbutazone, piroxicam, salicylamide, salicylic acid, sulindac, desoxysulindac, tenoxicam, tramadol, and ketoralac); additional non-steroidal antiinflammatory agents which can be formulated in combination with the dermal penetration enhancers (e.g., salicylamide, salicylic acid, flufenisal, salsalate, triethanolamine salicylate, aminopyrine, antipyrine, oxyphenbutazone, apazone, cintazone, flufenamic acid, clonixeril, clonixin, meclofenamic acid, flunixin, colchicine, demecolcine, allopurinol, oxypurinol, benzydamine hydrochloride, dimefadane, indoxole, intrazole, mimbane hydrochloride, paranylene hydrochloride, tetrydamine, benzindopyrine hydrochloide, fluprofen.ϊbufenac, naproxol, fenbufen, cinchophen, diflumidone sodium, fenamole, flutiazin, metazamide, letimide hydrochloride, nexeridine hydrochloride, octazamide, molinazole, neocinchophen, nimazole, proxazole citrate, tesicam, tesimide, tolmetin, and triflumidate); antirheumatoid agents (e.g., penicillamine, aurothioglucose, sodium aurothiomalate, methotrexate, and auranofiπ); muscle relaxants (e.g., baclofen, diazepam, cyclobenzaprine hydrochloride, dantrolene, methocarbamol, orphenadtϊne, and quinine); and agents used in gout and hyperuricaemia (e.g., allopurinol, colchicine, probenecid, and sulphinpyrazone). Hormones and Steroids: oestrogens (e.g., oestradiol, oestriol, oestrone, ethinyloestradiol, mestranol, stilboestrol, dienoestrol, epioestriol, estropipate, and zeranol); progesterone and other progestagens (e.g., allyloestrenol, dydrgesterone, lynoestrenol, norgestrel, norethyndrel, norethisterone, norethisterone acetate, gestodene, levonorgestrel, medroxyprogesterone, and megestrol); antiandrogens (e.g., cyproterone acetate and danazol); antioestrogens (e.g., tamoxifen and epitiostanol and the aromatase inhibitors, exemestane and 4-hydroxy-androstenedione and its derivatives); androgens and anabolic agents (e.g., testosterone, methyltestosterone, clostebol acetate, drostanolone, furazabol, nandrolone oxandrolone, stanozolol, trenbolone acetate, di hydro-testosterone, 17-.alpha.- methyl-19-nortestosterone, and fluoxymesterone); 5-alpha reductase inhibitors (e.g., finasteride, turosteride, LY-191704, and MK-306); corticosteroids (e.g., betamethasone, betamethasone valerate, cortisone, dexamethasone, dexamethasone 21-phosphate, fludrocortisone, flumethasone, fluocinonide, fluocinonide desonide, fluociriolone, fluocinolone acetonide, fluocortolone, halcinonide, halopredone, hydrocortisone, hydrocortisone 17-valerate, hydrocortisone 17-butyrate, hydrocortisone 21-acetate methyl prednisolone, prednisolone, prednisolone 21-phosphate, prednisone, triamcinolone, and triamcinolone acetonide); further examples of steroidal antiinflammatory agents for use in the instant compositions (e.g., cortodoxone, fluoracetonide, fludrocortisone, difluorsone diacetate, flurandrenolone acetonide, medrysone, amcinafel, amcinafide, betamethasone and its other esters, chloroprednisone, clorcortelone, descinolone, dcsonide, dichlorisone, difluprednate, flucloronide,flumethasone, flunisolide, flucortolone, fluoromcthalone, fluperolone, fluprednisolone, meprednisone, methylmeprednisolone, paramethasone, cortisone acetate, hydrocortisone cyclopentylpropionate, cortodoxone, flucetonide, fludrocortisone acetate, flurandrenolone acetonide, medrysone, amcinafal, amcinafide, betamethasone, betamethasone benzoate, chloroprednisone acetate, clocortolone acetate, descinolone acetonide, desoximetasone, dichlorisone acetate, difluprednate, flucloronide, flumethasone pivalate, flunisolide acetate, fluperolone acetate, fluprednisolone valerate, paramethasone acetate, prednisolamate, prednival, triamcinolone hexacetonide, cpitivazol, formocortal, and nivazol); pituitary hormones and their active derivatives or analogs (e.g., corticotrophin, thyrotropin, follicle stimulating hormone (FSH)₁ luteinising hormone (LH), and gonadotrophin releasing hormone (GnRH)); hypoglycaemic agents (e.g., insulin, chlorpropamide, glibenclamide, gliclazide, glipizide, tolazamide, tolbutamide, and metformin); thyroid hormones (e.g., calcitonin, thyroxine and liothyronine and antithyroid agents such as carbimazole, and propylthiouracil); other miscelaneous hormone agents (e.g., octreotide); pituitary inhibitors (e.g., bromocriptine); and ovulation inducers (e.g., clomiphene). Genitourinary System: diuretics (e.g., the thiazides, related diuretics and loop diuretics, bendrofluazide, chlorothiazide, chlorthalidone, dopamine, cyclopenthiazide, hydrochlorothiazide, indapamide, mefruside, methycholthiazide, metolazone, quinethazone, bumetanide, ethacrynic acid and frusemide and pottasium sparing diuretics, spironolactone, amiloride, and triamterene); antidiuretics (e.g., desmopressin, lypressin, and vasopressin including their active derivatives or analogs); obstetric drugs including agents acting on the uterus (e.g., ergometrine, oxytocin, and gemeprost); and prostaglandins (e.g., alpvostadil (PGEl), prostacyclin (PGI2), dinoprost (prostaglandin F2- alpha), and misoprostol).

Antimicrobials: antimicrobials including silver ions, silver sulfadiazine, benzalkonium chloride, cetalkonium chloride, methylbenzethonium, neomycin sulfate, hexachlorophene, eosin, camphor, cephalosporins (e.g., such as cephalexin, cefoxytin, and cephalothin); penicillins (e.g., amoxycillin, penicillin G, amoxycillin with clavulanic acid, ampicillin, bacampicillin, benzathine penicillin, benzylpenicillin, carbenicillin, cloxacillin, methicillin, phenethicillin, phenoxymethylpenicillin, flucloxacillin, mezlocillin, piperacillin, ticarcillin, and azlocillin); tetracyclines (e.g., minocycline, chlortetracycline, tetracycline, demeclocycline, doxycycline, methacycline and oxytetracycline, and other tetiacycline-type antibiotics); aminoglycosides (e.g., amikacin, gentarnicin, kanamycin, neomycin, netilmicin, and tobramycin); antifungals (e.g., amorolfine, isoconazole, clotrimazole, econazole, miconazole, nystatin, terbinafine (e.g., terbinafine hydrochloride, a useful example of which is available under the trade designation LAMISIL from Novartis (East Hanover, New Jersey), bifonazole, amphotericin, griseofulvin, ketoconazole, fluconazole and flucytosine, salicylic acid, fezatione, ticlatone, tolnaftate, triacetin, zinc, pyrithione, and sodium pyrithione); quinolones (e.g., nalidixic acid, cinoxacin, ciprofloxacin, enoxacin, and norfloxacin); Sulphonamides (e.g., phthalylsulphthiazole, sulfadoxine, sulphadiazine, sulphamethizole, and sulphamethoxazole); sulphones (e.g., dapsone); other miscellaneous antibiotics (e.g., chloramphenicol, clindamycin, erythromycin, erythromycin ethyl carbonate, erythromycin estolate, erythromycin glucepate, erythromycin ethylsuccinate, erythromycin lactobionate, roxithromycin, lincomycin, natamycin, nitrofurantoin, spectinomycin, vancomycin, aztreonam, colistin IV, metronidazole (a useful example of which is commercially available under the FLAGYL trade designation from Sanofi Aventis (Bridgewater, New Jersey), tinidazole, fusidic acid, and trimethoprim); 2-thiopyridine N-oxide; halogen compounds, particularly iodine and iodine compounds (e.g., iodine-PVP complex and diiodohydroxyquin); hexachlorophene; chlorhexidine; chloroamine compounds; benzoyl peroxide; antituberculosis drugs (e.g., ethambutol, isoniazid, pyrazinamide, rifampicin, and clofazimine); antimalarials (e.g., primaquine, pyrimethamine, chloroquine, hydroxychloroquine, quinine, mefloquine, and halofantrine); antiviral agents (e.g., acyclovir (a useful example of which is commercially available under the ZOVIRAX trade designation from Biovail Pharmaceuticals, Inc. (Bridgewater, New Jersey) and acyclovir prodrugs, famciclovir, zidovudine, didanosine, stavudine, lamivudine, zalcitabine, saquinavir, indinavir, ritonavir, n-docosanol, tromantadine, and idoxuridine), anthelmintics (e.g., mebendazole, thiabendazole, niclosamide, praziquantel, pyrantel embonate, and diethylcarbamazine); and cytotoxic agents (e.g., plicamycin, cyclophosphamide, dacarbazine, fluorouracil and its prodrugs [described, for example, in International Journal of Pharmaceutics 1 11, 223-233 (1994)], methotrexate, procarbazine, 6-mercaptopurine, and mucophenolic acid). The amount of antimicrobial agent should be sufficient to provide an effective antimicrobial concentration or dose rate of the material to the skin surface. Typical concentrations of standard antimicrobials range from about 0.01 % by weight to 5 % by weight based on the weight of the composition.

Respiratory System: antitussives (e.g., ethylmorphine, dextromethoiphan, and pholcodine); expectorants (e.g., acetylcysteine, bromhexine, emetine, guaiphenesin, ipecacuanha, and saponins); decongestants (e.g., phenylephrine, phenylpropanolamine, and pseudoephedrine); and bronchospasm relaxants (e.g., ephedrine, fenoterol, orciprenaline, rimiterol, salbutamol, sodium cromoglycate, cromoglycic acid and its prodrugs (which are described, for example, in International Journal of Pharmaceutics 7, 63-75 (1980)), terbutaline, ipratropium bromide, salmeterol and theophylline, and theophylline derivatives).

Allergy and Immune System: antihistamines (e.g., meclozine, cyclizine, chlorcyclizine, hydroxyzine, brompheniramine, chlorpheniramine, clemastine, cyproheptadine, dexchlorpheniramine, diphenhydramine, diphenylamine, doxylamine, mebhydrolin, pheniramine, tripolidine, azatadine, diphenylpyraline, methdilazine, terfenadine, astemizole, loratidine, and cetirizine); local anaesthetics (e.g., bupivacainc, amethocuine, lignocaine, cinchocaine, dibucaine, mepivacaine, prilocaine, and etidocaine); stratum comeum lipids (e.g., ceramides, cholesterol, and free fatty acids for improved skin barrier repair [Man, et al. J. Invest. Dermatol., 106(5), 1096, 1996]); neuromuscular blocking agents (e.g., suxamethonium, alcuronium, pancuronium, atracurium, gallamine, tubocurarine, and vecuronium); smoking cessation agents (e.g., nicotine, bupropion, and ibogaine); insecticides and other pesticides which are suitable for local or systemic application; dermatological agents (e.g., vitamins A and E, vitamin E acetate, and vitamin E sorbate); allergens for desensitisation (e.g., house dust mite allergen); nutritional agents (e.g., vitamins, essential amino acids, and essential fats); keratolyses (e.g., the alpha- hydroxy acids, glycollic acid, and salicylic acid); psychicenergisers (e.g., 3-(2- aminopropyl)indole, 3-(2-aminobutyl)indole, and the like); anti-acne agents (e.g., containing isotretinoin, tretinoin, and benzoyl peroxide); anti-psoriasis agents (e.g., containing etretinate, cyclosporine, and calcipotriol); anti-itch agents (e.g., capsaicin and its derivatives, e.g., nonivamide [Tsai, et al. Drug. Dev. Ind. Pharm., 20(4), 719, 1994]); anticholinergic agents, which are effective for the inhibition of axillary sweating and for the control of prickly heat, the antiperspiirant activity of agents (e.g., methatropine nitrate, propantheline bromide, scopolamine, methscopolamine bromide, and the new class of soft antiperspirants, quaternary acyloxymethyl ammnonium salts [described, for example, by Bodor et al, J. Med. chem. 23, 474 (1980) and also in United Kingdom Specification No. 2010270, published 27 Jun. 1979]). Other physiologically active peptides and proteins, small to medium-sized peptides, e.g., vasopressin and human growth hormone.

Particular active agents include dimenhydrinate, insulin, salicylic acid, acetylsalicylic acid, steroids and other hormone derivatives, more preferably testosterone, oestradiol, ethinyloestradiol, progesterone, norethisterone acetate and gestodene; and non- steroidal anti-inflammatory drugs, preferably ibuprofen, ketoprofen, flurbiprofen, naproxen and diclofenac; and opioid analgesics, preferably fentanyl and buprenorphine; and antinauseants, preferably prochlorperazine, metochlopramide, ondansetron and scopolamine; and antioestrogens, preferably tamoxifen and epitiostanol and the aromatase inhibitors, preferably exemestane and 4-hydroxy-androstenedione and its derivatives; and 5-alpha reductase inhibitors, preferably finasteride, turosteride, LY191704 and MK-306; and anxiolytics, preferably alprazolam; and prostaglandins, preferably alprostadil and prostacylcin and their derivatives; and melatonin; and anti-virals, preferably n-docosanol, tromantadine and lipophilic pro-drugs of acyclovir; and low molecular weight heparin, preferably enoxaparin; and anti-migraine compounds, preferably sumatriptan; and antihypertensives, preferably clonidine, amlodipine and nitrendipine; and anti-malarials, preferably primaquine; and minoxidil and minoxidil pro-drugs; and pilocarpine; and bronchodilators, preferably salbutamol, terbutaline, salmeteroi; and anti -depressants, preferably ibogaine, bupropion and rolipram; and anti-alzheimer's agents, preferably flLiphenazine and haloperidol; and anti-parkinson agents, preferably N-0923; and antiandrogens, preferably cyproterone acetate; and anorectic agents, preferably mazindol. Diseases or conditions that may be treated by using the absorbent articles and methods of the present invention include, but are not limited to, male hormone replacement in testosterone deficient hypogonadal men, female hormone replacement therapy for postmenopausal women, androgen replacement therapy for females lacking libido, male contraception, female contraception, soft tissue injury, narcotic withdrawal, severe post-operative pain, motion sickness, oestrogen dependent breast cancer, prostatic enlargement and/or prostatic cancer, alopecia and acne, anxiety disorders, male impotence, Raynauds syndrome and varicose veins, sleep disorders such as jetlag, herpes virus infections, deep vein thrombosis, migraine, high blood pressure, malaria, diagnosis of cystic fibrosis and asthma, particularly nocturnal asthma, smoking cessation, psychotic disorders, severe postnatal depression, virilisation and obesity.

The foregoing lists are by no means intended to be exhaustive and any physiologically active agent that is compatible with the absorbent articles and/or the hot melt superabsorbent polymer composition can be used.

CARRIER

Useful carriers include, e.g., the thermoplastic polymers disclosed herein, hydrogels including, e.g., polyurethane hydrogels, xanthan gum, alkylcellulose, a hydrophobic cellulosic material, copolymers of acrylic and methacrylic acid esters, shellac, waxes, polyvinyl pyrrolidone, and polyvinyl alcohol, and water-based lotions. Useful hydrogels are described, e.g., in U.S. Patent Nos. 6,905,700, 5,846,563 and 6,039,977.

SKIN CONTACTING LAYER

The skin contacting layer is a layer that is available for contact with the skin of a user. The skin contacting layer is exposed or can be exposed upon the removal of a release liner, where present. Useful skin contacting layers for the wound care article include, e.g., liquid permeable layers, liquid permeable, superabosrbent particle impermeable barrier layers, and combinations thereof. A useful skin contacting layer is a liquid permeable fibrous media that includes fibers, which can be made from a variety of polymers including, e.g., synthetic polymers, natural polymers and combinations thereof. Suitable synthetic polymers include, e.g., polyolefins (e.g., polyethylene and polypropylene), polyesters, polyacrylates, ethylene vinyl acetate, and copolymers and blends thereof, biodegradable polymers (e.g., biodegradable polyester), and combinations thereof. Suitable natural polymers include cellulose (e.g., cotton and wood pulp fibers), and treated natural fibers including, e.g., treated cellulose fibers (e.g., cellulose acetate), and combinations thereof.

The skin contacting layer can be in a variety of forms including, e.g., woven webs, nonwoven webs, knits, and combinations thereof. Useful methods of making nonwoven webs include, e.g., air laid, wet laid, meltblown, spunbonded, carded, thermally bonded, air-through bonded, powder bonded, latex bonded, solvent bonded, spunlaced, and combinations thereof.

The skin contacting layer can optionally be in the form of an apertured formed film. Apertured formed films are pervious to wound exudates and, if properly apertured, have a reduced tendency to allow liquids to pass back through and recontact the user's skin. Thus, the surface of the formed film that is in contact with the body remains dry. Suitable formed films are described in, e.g., U.S. Patent Nos. 3,929,135, 4,324,246,

4,342,314, 4,463,045, 4,637,819, 4,7S0,352, 5,006,394, and 6,180,052, and incorporated herein. A variety of apertured formed films suitable for skin contacting sheets are commercially available from Ahlstrom (Windsor Lock, Connecticut) and First Quality Nonwoven (Greatneck, New York) and under the SOFTSKIN trade designation from BBA Nonwovens (Nashville, Tennessee).

The skin contacting layer can optionally be made from a non-stick media. Nonstick media include apertured films that are liquid permeable and can be made from a variety of polymers including, e.g., polyurethane, polyethylene, polypropylene, polyamide, polyester polypropylene, polyethylene, polyether-amide, chlorinated polyethylene, styrene/butadiene block copolymers and polyvinyl chloride. The non-stick media may be in the form of moisture vapor permeable films, apertured films, woven-, non-woven and knit webs, and scrims.

The skin contacting surface of the skin contacting layer is preferably hydrophilic to allow liquids to transfer more readily there through, which improves the ability of the wound exudates to flow into and be absorbed by the absorbent components. The skin contacting surface of the skin contacting layer optionally can be made hydrophilic by treatment with a surfactant. Suitable methods of treating a sheet with a surfactant are described in, e.g., U.S. Patent No. 4,950,254, and incorporated herein. Alternately, surfactant can be incorporated into the polymer of the skin contacting layer as described in, e.g., in PCT Publication No. WO93/09741, and incorporated herein.

Useful skin contacting layers can have any suitable thickness including at least about 12 microns (μm), at least about 25 μm, at least about 100 μm, at least about 150 μm, or even no greater than about 200 μm. In the case where the skin contacting layer is a nonwoven, useful nonwovens have a basis weight of from 10 g/m² to 200 g/m².

LIQUID PERMEABLE, SUPERABSORBENT POLYMER PARTICLE IMPERMEABLE BARRIER

Useful liquid permeable, superabsorbent particle impermeable barriers include tissues, nonwoven webs, woven webs, apertured films or sheets, and combinations thereof. Preferably the liquid permeable, superabsorbent particle impermeable barrier is a tissue, e.g., a sheet that includes fibers, suitable examples of which include cellulose fibers, creped cellulose, comminuted wood pulp, modified crosslinked cellulose fibers, cotton (e.g., woven cotton), and combinations thereof. Useful commercially available tissues include those tissues available under the 1-PL YTISSUE series of trade designations from CityForest Corp. (Ladysmith, Wisconsin).

The woven and nonwoven webs can be made from a variety of fibers including natural fibers (e.g., cellulose fibers (e.g., cotton fibers and wood pulp fibers), creped cellulose fibers, comminuted wood pulp fibers, modified crosslinked cellulose fibers, and combinations thereof), and synthetic fibers made from a variety of polymers including, polyolefins (e.g., polyethylene and polypropylene), styrene, polyethylene terephthalate, ethylene-vinyl acetate, ethylene-vinyl acetate ethylene-acrylic acid, ethylene-methacrylic acid, ethylene-methyl acrylate, ethylene-ethyl acrylate and ethylene n-butyl acrylate and derivatives thereof (e.g., incorporating at least two comonomers), polyacrylic acids, polymethacrylic acids, polyacrylates, polyvinyl acetates, polylactic acids, polylactides, caprolactone polymers, poly (hydroxy-butyrate/hydroxyvalerate), polyesters, copolyesters (e.g., biodegradable copolyesters), poly(ethylene oxide)polyether amide, polyester ether block copolymers, polyvinyl pyrrolidone, polyvinyl pyrrolidone-vinyl acetate copolymer, polyetheroxazoline, polyvinyl ethers (e.g., polyvinyl methyl ether), polyamides, polyacrylamide, and combinations thereof, and combinations thereof, and combinations thereof. The liquid permeable, superabsorbent particle impermeable barrier can be prepared using any suitable method including, air laid, wet laid, meltblown, spunbonded, carded, spunlaced, and combinations thereof. Preferred tissues include wet laid tissues.

Apertured films can also be formed from the above-described polymers and formed into an apertured film using any suitable technique including those methods described in, e.g., U.S. Patent Nos. 5,980,814, 5,916,462, and 5,824,352, and incorporated herein.

The liquid permeable, superabsorbent particle impermeable barrier can also include multiple layers. Any suitable method can be used to join the various layers of the liquid permeable, superabsorbent particle impermeable barrier together including, e.g., thermal bonding, air-through bonding, powder bonding, latex bonding, solvent bonding, knurling, punching and embossing, and combinations thereof.

Where the liquid permeable, superabsorbent particle impermeable barrier media is sufficiently durable, the liquid permeable, superabsorbenl particle impermeable barrier can function as both the skin contacting layer and the liquid permeable, superabsorbent particle impermeable barrier, thereby eliminating the need for an additional skin contacting layer. FIG. 8, for example, illustrates a wound dressing 140 that includes a liquid impermeable backing 141 , a hot melt superabsorbent polymer composition 142, a liquid permeable, superabsorbent particle impermeable barrier layer 143 available for contact with the skin, and a pressure sensitive adhesive composition 22. The liquid permeable, superabsorbent particle impermeable barrier preferably exhibits a caliper thickness of no greater than about 500 μm, no greater than about 400 μm, at least 50 μm, at least 75 μm, or even from about 25 μm to about 500 μm.

LIQUID IMPERMEABLE LAYER

The liquid impermeable layer prevents exudates and liquids absorbed by the dressing from escaping from the wound care article or drug delivery system. The liquid impermeable layer is liquid impervious (e.g., impervious to water-based exudates including, e.g., blood, serum, water, mucous, and other exudates) and flexible. The liquid impermeable layer can also exhibit elastic or extensible properties such that it can stretch in at least one direction and is preferably biodegradable. Useful methods of making a layer extensible using a mechanical operation include, e.g., pleating, corrugating, ring rolling, and those methods disclosed, e.g., in U.S. Patent 5,518,801, the relevant portions of which are incoiporated herein.

The liquid impermeable layer can be breathable or nonbreathable. The term "breathable" refers to the property of allowing vapors to transfer therethrough, while preventing the transfer of liquids including such liquids as blood, serum, mucous, water, and other wound exudates. Suitable breathable films include hydrophilic films including monolithic films. The breathability of a film is determined by its moisture vapor transmission rate. The liquid impermeable layer preferably exhibits a moisture vapor transmission rate of about 100 g/m²/day, at least about 500 g/m²/day, at least about 1000 g/m²/day or even at least about 2500 g/m²/day when measured according ASTM E96-95 Upright Cup Method entitled, "Standard Test Methods for Water Vapor Transmission of Materials," March 6, 1995.

Useful liquid impermeable layers include, e.g., polymeric films (e.g., thermoplastic films of polymers including e.g., polyethylene, polypropylene, polyester and ethylene vinyl acetate), composites including, e.g., film-coated woven and nonwoven webs, foams (e.g., polyurethane foams including, e.g., breathable polyurethane foams), and combinations thereof.

Useful liquid impermeable composites (e.g., laminates) include a fibrous web (e.g., a woven or nonwoven web) and a continuous film bonded thereto. The fibrous web provides a soft touch to the exterior surface of the liquid impermeable layer and therefore the dressing. Examples of useful methods for preparing composites are described in U.S. Patent Nos. 6,583,332, 5,827,252, and 6,843,874 and incorporated herein.

In some embodiments, the liquid impermeable layer can include a one-way liquid permeable layer, i.e., a layer that allows liquid to pass from a first surface (e.g., an exterior surface) to a second surface (e.g., an interior surface), and inhibits or preferably prevents liquids from moving from the second surface to the first surface. Examples of useful oneway liquid permeable layers are described in U.S. Patent No. 6,228,462, and incorporated herein. In use, the absorbent article can be applied to a wound and water can be applied to the exterior surface of the one-way liquid permeable layer of the absorbent article. The one-way water permeable layer can facilitate the delivery of water to the other components of absorbent article such as, for example, the hot melt superabsorbent polymer composition, which in turn can facilitate the release (e.g., immediate) of the physiologically active agent.

The liquid impermeable layer is preferably thin and conformable to the body. The liquid impermeable layer preferably has a thickness of from about 12 microns to about 200 μm, no greater than about 150 μm, no greater than about 100 μm, or even from about 12 μm to about 25 μm. Conformability is somewhat dependent on thickness, thus the thinner the film the more conformable the film.

Useful liquid impermeable materials can be made from polymers commercially available under the trade designation PEBAX from Arkema, Inc. (Pittsburgh, PA) and HYTREL from E. I. Du Pont de Nemours and Company (Wilmington, Deleware).

SKIN ATTACHMENT PRESSURE SENSITIVE ADHESIVE

Useful pressure sensitive adhesives that are suitable for application to the skin include pressure sensitive adhesive compositions in which the base polymer includes, e.g., block copolymer (e.g., styrene-isoprene-styrene, styrene-butadiene-styrene, styrene- ethylene-butylene-styrene, and styrene-ethylene-propylene-styrene), acrylic acid, acrylate, silicone, polyurethane, polyurethane elastomers, polyester, polyester elastomers (e.g., aliphatic-aromatic copolyesters, copolyestcr-copolyether and copolyether-copolyamide), polylactic acid, polyoxyalkanoates, and combinations thereof.

Useful adhesives for skin attachment include those adhesives described, e.g., in U.S. Patent No. 4,917,697, U.S. Patent Application Serial No. 10/934,266 filed August 1, 2002, and U.S. Patent Application Serial No. 10/211,162, filed September 3, 2004, and incorporated herein. Suitable commercially available skin attachment adhesives are available, e.g., under the trade designations LUNATAC D-1053, HL 2711 and HL 2539 from H.B. Fuller Co. (St. Paul, Minnesota). A useful commercially available styrene- isoprene-styrene skin attachment adhesive is available under the trade designation HM 1902 from H.B. Fuller Company (St. Paul, MN).

Other useful skin attachment adhesives are described, e.g., in U.S. Patent Nos. 5,614,310, 6,171,985, and 6,198,016, and PCT Publication Nos. WO 99/13866 and WO 99/13865, and incorporated herein.

The skin attachment adhesive can optionally include medicaments useful for enhancing wound healing and antimicrobial agents (e.g., iodine) to prevent infection.

RELEASE LINER The wound dressing can optionally include a release liner to protect the utility of the pressure sensitive adhesive prior to use and for ease of handling. Where present, the release liner is removed prior to using the wound dressing. Any suitable release liner can be used including, e.g., liners made of or coated with polyethylene, polypropylene and fluorocarbons, and silicone coated release papers and polyester films. Useful commercially available release liners include, e.g., silicone coated release papers available under the POLYSLIK trade designations including POLYSLIK S-8004 83 pound bleached silicone release paper from H. P. Smith Co. (Chicago, 111.) and 2-80-BKG-157 80 pound bleached two-sided silicone coated paper from Daubert Chemical Co., (Dixon, III.).

The components of the wound dressing can be joined together using any suitable mechanism including, e.g., adhesive bonding, stitching, heat bonding, pressure bonding, dynamic mechanical bonding, ultrasonic bonding, simultaneously or sequentially extruding at least two components of the wound dressing, and combinations thereof. Methods of attaching components of a wound dressing to each other are well known to the skilled artisan. CONSTRUCTION ADHESIVE

Where present, the construction adhesive can be any adhesive suitable for maintaining at least two of the components of the dressing in fixed relation to each other. The construction adhesive can be applied to the periphery of a layer, the major surface of the layer, the perimeter of the dressing and combinations thereof. When applied to the perimeter or periphery, the construction adhesive can be in the form of a continuous or discontinuous coating. When applied to a major surface of the layer, the construction adhesive is provided as a discontinuous coaling. The construction adhesive can be applied as a discontinuous coating using any suitable method that produces any suitable discontinuous coating including, e.g., a spiral spray, random spray, gravure, dot and random fibridization. Useful construction adhesives include, e.g., hot melt adhesives, pressure sensitive adhesives, hot melt pressure sensitive adhesives, and blends thereof. One example of a suitable commercially available construction adhesive is HL-1713 styrene-isoprene-styrene based construction adhesive from H.B. Fuller Company (St. Paul, Minnesota).

The components can be joined together in any suitable manner including, e.g., joining such that each component is directly secured to another component, a component is secured to an intermediate component, a component is integral with another component, and combinations thereof.

DRUG DELIVERY SYSTEM

The drug delivery system 210 includes a liquid impermeable backing 212, a hot melt superabsorbent polymer composition 214 in the form of three stripes 214a-c disposed on the backing 212 and a pressure sensitive adhesive composition 216 disposed along the perimeter of the backing 212, as illustrated in FIGS. 10-11. The hot melt superabsorbent composition includes a physiologically active agent 218, a thermoplastic polymer 220 and superabsorbent polymer particles 222.

The drug delivery system can be applied to the skin by contacting the skin with the pressure sensitive adhesive 216, preferably such that the hot melt superabsorbent polymer composition 214 is in contact with the skin. As the hot melt superabsorbent polymer composition absorbs moisture from the skin, the active agent is released from the hot melt superabsorbent polymer composition and is available for transfer to the body. Over time, as additional moisture is given off by the body more of the superabsorbent polymer is exposed, e.g., superabsorbent polymer located further in the depth of the hot melt superabsorbent polymer composition. As the additional superabsorbent polymer absorbs water, additional active agent is exposed and made available for contact with and optionally transmission through one or more layers of the skin. This mechanism creates a time release administration of the active agent.

FIG. 12 illustrates an embodiment of the drug delivery system 230 that includes a liquid impermeable, moisture vapor permeable backing 232a, a liquid permeable skin contacting layer 234, and a hot melt superabsorbent polymer composition 214a disposed between the liquid impermeable backing 232a and the skin contacting layer 234. A portion X of the liquid impermeable layer 232a extends beyond the hot melt superabsorbent polymer composition 214a and the skin contacting liquid permeable layer 234. A pressure sensitive adhesive composition 216a is disposed on the portion of the liquid impermeable backing 232a that extends beyond the other layers and is available for contact with a user's skin. The hot melt superabsorbent polymer composition 214a includes physiologically active agent 218a, thermoplastic polymer 220a and superabsorbent polymer particles 222a.

FIG. 13 illustrates another embodiment of the drug delivery system 240 that includes a liquid impermeable, moisture vapor permeable layer 232b, a liquid permeable layer 234b, a liquid permeable, superabsorbent particle impermeable barrier layer 236, a pressure sensitive adhesive composition 216b disposed on the liquid permeable, superabsorbent particle impermeable barrier 236, and a hot melt superabsorbent polymer composition 214b disposed between the liquid impermeable layer 234b and the liquid permeable, superabsorbent particle impermeable barrier layer 236. The hot melt superabsorbent polymer composition 214b includes a physiologically active agent 21 δb, thermoplastic polymer 220b and superabsorbent polymer particles 222b.

FIG. 14 illustrates an embodiment of the drug delivery system 250 that includes a liquid impermeable, moisture vapor permeable layer 232c, a hot melt superabsorbent polymer composition 214c that includes thermoplastic polymer 220c and superabsorbent polymer particles 222c, a pressure sensitive adhesive composition 216c disposed on the liquid impermeable, moisture vapor permeable layer 232c, and a carrier 219 that is coated on the surface of the hot melt superabsorbent polymer composition 214c. The carrier 219 includes physiologically active agent 218c.

FIG. 15 illustrates an embodiment of the drug delivery system 260 that includes liquid impermeable, moisture vapor permeable layer 232d, a first hot melt superabsorbent polymer composition 214d that includes thermoplastic polymer 22Od, superabsorbent polymer particles 222d and physiologically active agent 218d, a second hot melt superabsorbent polymer composition 244d that includes thermoplastic polymer 22Od and superabsorbent polymer particles 222d, and a carrier 219d that includes a physiologically active agent 218d that is disposed between the first hot melt superabsorbent polymer composition 214d and the second hot melt superabsorbent polymer composition 244d. A pressure sensitive adhesive composition 216d is disposed on the liquid impermeable, moisture vapor permeable layer 232d. The physiologically active agent 21Sd in the first hot melt superabsorbent polymer composition 214d can be the same as or different from the physiologically active agent 218d in the carrier 219d.

In other embodiments, a polar liquid (e.g., water, saline, glycols including, e.g., polyethylene glycol and polypropylene glycol, alcohol or a combination thereof) is added to the hot melt superabsorbent polymer composition of the drug delivery system prior to use. The presence of a polar liquid such as water in the hot melt superabsorbent polymer composition can facilitate the immediate release of the active agent upon contact with the user's skin. The polar liquid can be added to the hot melt superabsorbent polymer composition during the manufacture of the drug delivery system using any suitable technique including, e.g., blending, coating, spraying, painting, printing, and brushing. The polar liquid can also cause at least a portion of the hot melt superabsorbent polymer composition to gel, whereupon the can exhibit properties including, e.g., being stretchable, resiliency, pliable, moldable and combinations thereof. In such a construction, a cover (e.g., a release liner) is placed over the moistened hot melt superabsorbent polymer composition to maintain the moisture therein.

The system can include any locally or systemically physiologically active agent that can be delivered through the skin, optionally with the assistance of a dermal penetration enhancer including, e.g., chitin, glyceryl trinitrate and isosorbide dinitrate. The invention will now be described by way of the following example.

EXAMPLES Test Procedures

Test procedures used in the examples include the following.

Bacteria Growth Test Method

Bacteria growth is evaluated per ASTM G22-76 entitled, "Standard Practice for Determining Resistance of Plastics to Bacteria," (1996), which is incorporated herein, with the following modifications: section 6.3, Nutrient-Salts Agar is replaced with Tryptic Soy Agar; section 8.3, incubation is seven days; and section 10.1, Procedure B is followed with the exception that the surface of the test specimen is observed for growth of bacterium or the absence of growth of bacterium.

Hot Melt Superabsorbent Polymer Compositions 1-4 Thermoplastic compositions 1-4 are prepared by combining the components (other than the superubsorbent particles) in the amounts specified in Table 1 in units of % by weight, and heating the composition to from 20O⁰F to 250°F while mixing.

Superabsorbent particles, in the amount specified in table 1 (% by weight), are then added to the molten thermoplastic composition with mixing.

3S Table 1

'Calsol 5555 naphthenic oil (Calumet Refining Co., Chicago, Illinois).

²Kralon G-1651 styrene-ethylene-butadiene-styrene block copolymer (Shell Chemical Company).

³Rhodacal DS-10 sodium dodecylbenzene sulfonate (Rhone Poulenc, Cranberry, New Jersey).

⁴AquaKeep 10SH-NF superabsorbent particles having an average diameter of 20 to 30 um (Sumitomo Seika, Osaka, Japan)

⁵Nyflex 222B naphthenic oil (Nynas Petroleum, Stockholm, Sweden).

Examples 1-4

A drug able to be delivered transdermally is then added to hot melt superabsorbent polymer compositions 1-4. Upon contact with skin, the composition is expected to absorb moisture from the skin and release the drug.

Control 1

NWI lOOA absorbent hot melt composition (H.B. Fuller Company, St. Paul, MN) is coated on a release paper to form a film having a thickness of approximately one mil to two mil. Example 5

Two percent Aglon Silver Antimicrobial Type AK (Aglon Technologies, Inc., Wakefield, MA) is added to molten NWl IOOA absorbent hot melt composition at 25O⁰F with stirring. The resulting composition is coated onto release paper to form a film having a thickness of approximately one mil to two mil.

The film of the Control 1 and Example 5 are each tested according to the Bacteria Growth Test Method. The film of Example 5 is expected to inhibit the growth of the test bacterium, Pseudomonas aeruginosa. The film of the Control 1 is expected to be unable to control or inhibit the growth of the test bacterium, Pseudomonas aeruginosa.

Control 2

A multilayer construction is prepared having a first layer of polyethylene film, an approximately 10 mil thick second layer of NWl IOOA absorbent hot melt composition disposed on the first layer, a third layer of tissue disposed on the second layer and a fourth layer of a nonwoven web disposed on the third layer. The multilayer construction is bonded together at its perimeter through HL1713 construction adhesive (H. B. Fuller Company, St. Paul, MN).

Example 6 A multilayer construction is prepared having a first layer of polyethylene film, an approximately 10 mil thick a second layer of NWI lOOA absorbent hot melt composition blended with 2 % Aglon Silver Antimicrobial Type AK (Aglon Technologies, Inc., Wakefield, MA) (prepared as described in Example 5) disposed on the first layer, a third layer of wet laid cellulose tissue disposed on the second layer and a fourth layer of a nonwoven spunbond polypropylene having a thickness of about 0.12 mm and a basis weight of about 15 g/m² disposed on the third layer. The multilayer construction is bonded together at its perimeter through HL1713 construction adhesive (H.B. Fuller Company, St. Paul, MN). Example 7

A multilayer construction is prepared having a first layer of polyethylene film, an approximately 10 mil thick second layer of NWI lOOA absorbent hot melt composition disposed on the first layer, Aglon Silver Antimicrobial Type AK (Aglon Technologies, Inc., Wakefield, MA) is sprinkled on the surface of ihe second layer, a third layer of wet laid cellulose tissue disposed on the second layer and over the antimicrobial, and a fourth layer of a nonwoven spunbond polypropylene having a thickness of about 0.12 mm and a basis weight of about 15 g/m² disposed on the third layer. The multilayer construction is bonded together at its perimeter through HL1713 construction adhesive (H.B. Fuller Company, St. Paul, MN).

The multilayer constructions of the Control 2 and Examples 6 and 7 are each tested according to the Bacteria Growth Test Method. The multilayer constructions of Example 6 and 7 are expected to inhibit the growth of the test bacterium, Pseudomonas aeruginosa. The multilayer construction of Control 2 is expected to allow the test bacterium, Pseudomonas aeruginosa to grow uninhibited.

All references disclosed herein are incoiporated herein by reference. Other embodiments are within the claims. Although the article and system has been described as including a hot melt superabsotbent polymer composition comprising a blend of thermoplastic polymer and superabsorbent polymer particles, in other embodiments the article and system include a thermoplastic composition and superabsorbent polymer particles disposed on at least one surface of the thermoplastic composition and optionally extending into the thermoplastic composition from the surface. What is claimed is:

Claims

1. A wound care article comprising: a. a skin contacting surface; b. an exterior surface; c. a first liquid permeable, superabsorbent particle impermeable barrier; d. a hot melt superabsorbent polymer composition comprising superabsorbent polymer particles and thermoplastic polymer; e. a first liquid impermeable layer, and f. a pressure sensitive adhesive composition disposed on said skin contacting surface, said hot melt superabsorbent polymer composition being disposed between said first liquid permeable, superabsorbent particle impermeable barrier and said liquid impermeable layer.

2. The wound care article of claim 1 further comprising a liquid permeable layer, said first liquid permeable, superabsorbent particle impermeable barrier being disposed between said hot melt superabsorbent polymer composition and said liquid permeable layer.

3. The wound care article of claim 2 further comprising a second liquid permeable, superabsorbent particle impermeable barrier disposed between said hot melt superabsorbent polymer composition and said liquid impermeable layer.

4. The wound care article of claim 2 further comprising at least one physiologically active agent, prodrug or combination thereof incorporated into said liquid permeable layer, disposed on a surface of said liquid permeable layer or a combination thereof.

5. The wound care article of claim 1 further comprising a release liner disposed on said pressure sensitive adhesive composition.

6. The wound care article of claim 1 further comprising at least one physiologically active agent, prodrug or a combination thereof.

7. The wound care article of claim 6, wherein said at least one physiologically active agent, prodrug or combination thereof is incorporated into said hot melt superabsorbent polymer composition, disposed on a surface of said hot melt superabsorbent polymer composition or a combination thereof.

8. The wound care article of claim 6, wherein said at least one physiologically active agent, prodrug or combination thereof is incorporated into said first liquid permeable, superabsorbent particle impermeable barrier, disposed on a surface of said first liquid permeable, superabsorbent particle impermeable barrier or a combination thereof.

9. The wound care article of claim 6, wherein said physiologically active agent is selected from the group consisting of antibacterial agents, antifungal agents, antiviral agents, antiparasitic agents, anesthetic agents, analgesics, antipyretics, non- sterodial anti-inflammatory agents, antihypertensives, antihistamines, beta-adrenergic blocking agents, antimicrobials, and combinations thereof.

10. The wound care article of claim 6, wherein said physiologically agent is selected from the group consisting of bacitracin, terbinafine hydrochloride, acyclovir, metronidazole, lidocaine, fentanyl, and combinations thereof.

1 1. The wound care article of claim 1, wherein said first liquid permeable, superabsorbent particle impermeable barrier comprises fibers selected from the group consisting of cellulose, creped cellulose, comminuted wood pulp, modified crosslinked cellulose, cotton and combinations thereof.

12. The wound care article of claim 1, wherein said first liquid permeable, superabsorbent particle impermeable barrier comprises synthetic fibers.

13. The wound care article of claim 1 further comprising an exterior fibrous layer disposed on said liquid impermeable layer.

14. The wound care article of claim 1 , wherein said hot melt superabsorbent polymer composition comprises a discontinuous layer.

15. The wound care article of claim 1, wherein said hot melt superabsorbent polymer composition is in contact with said liquid impermeable layer.

16. The wound care article of claim 1 further comprising a second liquid impermeable layer, said second liquid impermeable layer being disposed between said first liquid impermeable layer and said hot melt superabsorbent polymer composition.

17. A drug delivery system comprising: a first hot melt superabsorbent polymer composition comprising thermoplastic polymer and superabsorbent polymer particles; and at least one physiologically active agent, prodrug or combination thereof.

18. The drug delivery system of claim 17 further comprising a liquid impermeable layer.

19. The drug delivery system of claim 18 further comprising a pressure sensitive adhesive composition disposed on said liquid impermeable layer.

20. The drug delivery system of claim 19, wherein said pressure sensitive adhesive composition is disposed along the perimeter of said liquid impermeable layer.

21. The drug delivery system of claim 18 further comprising a liquid permeable layer, said hot melt superabsorbent polymer composition being disposed between said liquid impermeable layer and said liquid permeable layer.

22. The drug delivery system of claim 17, wherein said hot melt superabsorbent polymer composition further comprises a polar liquid.

23. The drug delivery system of claim 17 further comprising a carrier, said at least one physiologically active agent, prodrug or combination thereof being disposed in said carrier, said carrier being disposed on said hot melt superabsorbent polymer composition.

24. The drug delivery system of claim 23 further comprising a second hot melt superabsorbent polymer composition comprising thermoplastic polymer and superabsorbent polymer particles, said carrier being disposed between said first hot melt superabsorbent polymer composition and said second hot melt superabsorbent polymer composition.

25. The drug delivery system of claim 24, wherein said second hot melt superabsorbent polymer composition further comprises at least one physiologically active agent, prodrug or combination thereof.

26. A method of administering a physiologically active agent, said method comprising adhering a drug delivery system of claim 17 to the skin of a mammal.

27. The method of claim 26, wherein the skin of the mammal is located on a part of the mammal selected from the group consisting of forehead, armpit and back.

28. A method of treating a wound, said method comprising adhering the wound care article of claim I to the skin of a mammal through said pressure sensitive adhesive composition.

29. The method of claim 28, wherein said wound care article further comprises at least one physiologically active agent, prodrug or a combination thereof.

30. A method of using the wound care article of claim 1 for absorbing moisture, said method comprising adhering said wound care article to the skin of a mammal through said pressure sensitive adhesive composition, the skin of the mammal being located on a pan of the mammal selected from the group consisting of forehead, armpit and back.