Abstract: The present invention is directed to an anti-adhesion patch, which is constructed using a tissue equivalent technique. The anti-adhesion patch comprises a collagenous material and at least one non-living cellular component. Also provided is a method for preventing tissue adhesions between organs and other tissues being operated upon during surgical procedures by utilizing the anti-adhesion patch disclosed herein.

Abstract: The present invention relates to a titratable dosage transdermal delivery system for systemic delivery of a therapeutic agent or drug. The system comprises a plurality of patch units that are connected along one or more borders. The plurality of patch units are divisible into units along the one or more borders having one or more lines of separation. Each patch unit is surrounded by a border. The therapeutic patch has at least a backing layer and a therapeutic agent comprising layer. The dosage of therapeutic agent delivered to a patient is proportional to the number of patch unit applied per treatment. The system enables systemic administration of a titratable dosage of therapeutic agent, adjustable by the patient under the direction of a physician, through the skin or mucosa. Moreover, the invention relates to a method of making the titratable dosage transdermal delivery system.

Abstract: A bioadhesive composition for use as a skin adhesive, the composition formed by polymerizing with cross-linking and/or entanglement an aqueous reaction mixture comprising effective amounts of at least one monomer dissolved or suspended therein and capable of forming a hydrogel on polymerization, optionally at least one cross-linking agent for the monomer, and water, said composition having an elastic modulus (G′) and a viscous modulus (G″), wherein the degree of polymerization and/or the degree of cross-linking and/or entanglement are selected to control the skin adhesion properties of the bioadhesive composition having regard to the rate of change of tan delta (G″÷G″) against frequency in a diagnostic portion of the frequency range 0.01 to 300 rad/s, typically the lower end of the said frequency range below about 100 rad/s.

Abstract: The present invention relates to a dry type tooth whitening patch comprising peroxide as a tooth whitening agent. In particular, disclosed is a dry type tooth whitening patch in which a peroxide is contained, as a teeth whitening agent, in a matrix type adhesive layer. The adhesive layer includes, as a base polymer thereof, a hydrophilic glass polymer which provides a strong adhesion to teeth while releasing the tooth whitening agent when hydrated on the enamel layers of teeth in the moist oral cavity. The dry type patch according to the present invention is convenient in use, as compared to wet type patches. Further, it exhibits a superior adhesion while being maintained in a state attached to the teeth for a lengthened period of time so as to assure an enough contact time between the whitening agent in the patch and stains on the teeth, thereby giving a sufficient whitening effect.

Abstract: An intraoral adhesive preparation is provided, which contains a support made of a nonwoven fabric mainly made of split type conjugated fibers, and an adhesive plaster layer containing a drug, which is formed on the support, wherein the split type conjugated fiber has an about triangular sectional shape after splitting, where the about triangle has the longest diameter (DL) of 5 &mgr;m-15 &mgr;m, and the longest line segment (DS) that vertically crosses the longest diameter of 2 &mgr;m-10 &mgr;m.

Abstract: A transdermal patch assembly includes a pressure sensitive carrier having a central opening, one side being provided with a clear liner thereon extending across the central opening, and an opposite side being provided with a first adhesive coating thereon, the carrier having a thickness such that when combined with the clear liner, a cell is defined by walls of the central opening and an inwardly facing surface of the clear liner, the cell holding a pharmaceutical composition therein. The transdermal patch also includes a pharmaceutical diffusing cover having an overlying side with an outer periphery attached by the first adhesive coating to an inner periphery of the carrier opposite side, and an underlying side having a pair of opposed portions attached to a peelable release liner removably secured to an outer periphery of the carrier opposite side by the first adhesive coating.

Abstract: A topical patch having non-steroid antirheumatic agent as active substance, consisting of a backing layer inert to the active substance, a self-adhesive, active substance-containing matrix layer based on a polyacrylate adhesive, and a protective film to be removed prior to use, is characterized in that a. the non-steroid antirheumatic agent has a free carboxyl group, b. the active substance-containing matrix of the patch consists of a polyacrylate adhesive cross-linked with multivalent metal ions and having free carboxyl groups, and is free of hydroxyl groups, c. the matrix contains a fatty acid as plasticizer and permeation enhancer, and d. the backing layer consists of a material that is elastic in at least one direction.

Abstract: Methods are provided for enhancing the permeability of skin or mucosal tissue to topical or transdermal application of local anesthetic agents. The methods entail the use of a base in order to increase the flux of the agent through a body surface while minimizing the likelihood of skin damage, irritation or sensitization. The permeation enhancer can be an inorganic or organic base. Compositions and transdermal systems are also described.

Abstract: The invention provides a transdermal delivery system for treating diabetes and other pathologic systemic conditions, comprising an active ingredient selected from the group consisting of peptides and proteins having an S—S bond and mixtures thereof and a pharmaceutically acceptable oxidizing agent selected from the group consisting of iodine, povidine-iodine and sources thereof, said system being essentially free of reducing agents and said oxidizing agent enabling and facilitating the penetration of said active ingredient through the skin layers and into the blood stream.

Abstract: This invention relates to the field of transdermal drug delivery devices and more particularly to improved storage stability thereof. The invention comprises providing a transdermal drug delivery device with a non-occlusive backing or release liner in combination with a degradation protectant such as a desiccant or oxygen scavenger within the sealed pouch containing the device. The combination of the present invention provides increased shelf-life of these devices.

Abstract: A patch for topical application to the skin includes a charcoal based composition applied to an impervious backing sheet. In a preferred embodiment, the charcoal composition is provided in the form of a slice or layer of generally uniform thickness and includes activated charcoal combined with a host material.

Abstract: A biodegradable scaffold includes a protein, a cross-linking agent, 10 to 50 percent by volume porosity imparting polymeric beads and a modifying agent. A method for the use of the biodegradable scaffold is also provided.

Abstract: An active substance matrix patch for controlled delivery of nonsteroidal antirheumatics to the skin, comprising a flexible cover layer and a water insoluble, pressure sensitively adhesive active substance matrix, wherein said adhesive matrix is free from mineral oils and tackifier resins and is composed of a) from 25 to 90% by weight of synthetic framework polymers based on polyisobutylene, b) from 5 to 40% by weight of amorphous poly-&agr;-olefin, c) from 10 to 60% by weight of an insoluble hydrophilic filler having an average particle size of less than 100 &mgr;m, and d) from 0.001 to 20% by weight of a drug.

Abstract: A method is provided for increasing the permeability of skin or mucosal tissue to transdermally administered nonsteroidal anti-inflammatory drugs (NSAIDs). The method involves use of a specified amount of a hydroxide-releasing agent, the amount optimized to increase the flux of the NSAID through a body surface while minimizing the likelihood of skin damage, irritation or sensitization. Formulations and drug delivery systems for co-administering a hydroxide-releasing agent with an NSAID are provided as well.

Abstract: Methods for enhancing the condition of non-diseased skin by application of compositions containing adenosine or an adenosine analog are disclosed. Also disclosed are methods for increasing DNA synthesis or protein synthesis in dermal cells, and methods for increasing dermal cell size, by application of compositions containing adenosine.

Abstract: A non-invasive and non-systemic method for intradermal prevention OR amelioration of pain from a surgically closed wound is disclosed. The method comprises topical delivery of a local anesthetic to an exterior surface of a surgically closed wound.

Abstract: Topical compositions and methods for treating pain. The invention provides oil-in-water emulsions comprising an antidepressant; an NMDA-receptor antagonists; a lipophilic component; water; and a surfactant. The compositions induce a local-anesthetic effect when topically administered to intact skin thereby treating or preventing pain, for example, neuropathic pain.

Abstract: Compositions and methods for the transdermal delivery of active agents up to a period of seven days or more at substantially a zero-order release rate comprising a pharmaceutically acceptable adhesive matrix and a polymeric plastic material that provides a release rate regulating effect on the active agents.

Abstract: This invention relates to a method for producing an adherable biomaterial patch. The subject patch is capable of being joined onto a tissue substrate. The invention is also directed to the patch per se, and to a method for producing the adherable biomaterial patch which is joined onto a tissue substrate. A preferred patch can even function in a highly acidic environment. The method of the present invention comprises providing a biomaterial patch consisting essentially of elastin or an elastin-based biomaterial having at least one outer surface. Next, at least one outer surface of the biomaterial patch is treated with a selected cyanoacrylate adhesive to produce a adherable biomaterial patch.

Abstract: A cosmetic, pharmaceutical, or dermatological patch includes a composition including a hydrophilic gelling system in an aqueous phase. The hydrophilic gelling system includes at least one gellan gum and at least one other hydrocolloid.

Abstract: The conductive adhesive of the present invention has a multi-layer structure comprising a hydrophobic phase containing an adhesive polymer, and a hydrophilic phase containing an electrolyte. This conductive adhesive is superior in anti-drying effect (moisturizing effect) because a humectant is effectively contained in the hydrophilic phase. The present invention also relates to a biomedical electrode using such a conductive adhesive. In the biomedical electrode according to the present invention, an adhesive layer to be applied to the skin surface of the human body contains the conductive adhesive described above and an electrode terminal connected with the adhesive layer is provided.

Abstract: Device for transdermal administration of N-Acetyl-L-cysteine, optionally encompassing salts, prodrugs and metabolites thereof, optionally together with pharmaceutically acceptable carrier(s) to a human being or an animal in order to achieve a mucolytic effect. Use of a mucolytic compound comprising N-Acetyl-L-cysteine, optionally encompassing salts, prodrugs and metabolites thereof, optionally together with pharmaceutically acceptable carrier(s), for the manufacture of a composition for achieving a mucolytic effect in a human being or an animal. Method for achieving a mucolytic effect in a living body by transdermal administration of a compound comprising N-Acetyl-L-cysteine, optionally encompassing salts, prodrugs and metabolites thereof, optionally together with pharmaceutically acceptable carrier(s).

Abstract: A plaster comprising a styrene-isoprene-styrene block copolymer 10-40 wt %, a rosin-based resin 5-30 wt %, a plasticizer 20-70 wt %, polyisobutylene 6-40 wt %, an antioxidant 0.1-5 wt %, and felbinac as a medicinally effective component 1.1-10 wt %, wherein the plaster does not contain crotamiton which is a solubilizer for the felbinac, the felbinac is uniformly dispersed in a semi-solubilized state in the plaster, wherein solubilized felbinac and microcrystalline felbinac coexist in the plaster, and a thickness of the plaster is 50-300 &mgr;m.

Abstract: A process for manufacturing transdermal systems comprising free active substance bases is characterized in that the free active substance base is liberated, during the manufacture of the system, from active substance salts by conversion with a basic alkaline metal salt.

Abstract: A first aid adhesive plaster comprising a pad on an upper surface of which an ointment is laid, an adhesive sheet of rectangular and an ointment protect cover formed to be a blister having a dome section by making its central portion project upwardly to form a gentle arc. The pad is covered with the blister by applying the ointment protect cover onto the adhesive sheet separably while leaving a gap between the ointment on the pad and an undersurface of the blister.

Abstract: A dressing for use with ostomy devices. The dressing has a dressing layer covered by protective cover layer and a release sheet. The dressing has an adhesive composition on a skin-contacting surface. The dressing layer has a thick center portion surrounded by a flange portion with a hole to accommodate the ostomy device. The thick portion has a thickness of less than 2.0 mm. and preferably a thickness of 0.91 mm. The flange portion has a thickness of 0.15 to 1.80 mm. and extends no more than 5.0 mm. from the edge of the thick portion. The configuration of the dressing layer, particularly when used with a hydrocolloid adhesive provides a dressing having wrinkle resistant edges allowing the dressing to be used in areas of the body having high mobility.

Abstract: Methods and apparatus for improving administration of drugs through the use of heat and other physical means. The present invention relates to the use of heat and other physical means in conjunction with specially designed dermal drug delivery systems, conventional commercial dermal drug delivery systems, or drugs delivered into a sub-skin depot site via injection and other methods to alter, mainly increase, the drug release rate from the dermal drug delivery systems or the depot sites to accommodate certain clinical needs.

Abstract: Disclosed is a method of treating a non-topical infection selected from the group consisting of ear infections, skin and soft tissue infections, acne, infected wounds, bacteremia, in a useful warm blooded mammal who is in need of such treatment which comprises topical administration of a pharmaceutical formulation containing a transdermally effective amount of an Oxazolidinone.

Abstract: Intermediate release nicotinic acid formulations having unique biopharmaceutical characteristics, which are suitable for oral administration once per day as a single dose preferably administered during the evening or at night for treating hyperlipidemia without causing drug-induced hepatotoxicity to such a level that requires the therapy to be discontinued, are disclosed. The intermediate nicotinic acid formulations can be administered as tablets in dosage strengths of, for example, 375 mg, 500 mg, 750 mg and 1000 mg. The 375 mg, 500 mg and 750 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F2 of at least about 79, and the 1000 mg nicotinic acid tablets of the present invention have a dissolution curve similarity fit factor F2 of at least 44.

Abstract: An adhesive composition having dispersed therein a broad spectrum antimicrobial agent for use in medical applications, such as an adhesive for surgical drapes, wound dressings and tapes. The adhesive is composed of acrylic polymers, tackifiers and a preferred antimicrobial agent, diiodomethyl-p-tolylsulfone. The adhesive composition is essentially solventless and capable of application in a hot melt process while maintaining stability at elevated temperatures in the range of 275° F. to 350° F., which not only allows hot melt application, but allows for ethylene oxide sterilization under heat stress.

Abstract: An adhesive composition includes a polymerizable adhesive monomer and at least one antioxidant stabilizer, and/or a container for storing said monomer composition that includes an antioxidant stabilizer. The antioxidant stabilizer provides superior stabilization and shelf-life of the composition and/or the container, and may enhance wound healing properties of the monomer composition.

Abstract: The present invention is directed to an anti-adhesion patch, which is constructed using a tissue equivalent technique. The anti-adhesion patch comprises a collagenous material and at least one non-living cellular component. Also provided is a method for preventing tissue adhesions between organs and other tissues being operated upon during surgical procedures by utilizing the anti-adhesion patch disclosed herein.

Abstract: The dressings of the invention comprise at least two components: an absorbent substrate having a first skin-facing surface and a second opposing surface; and a discontinuous coating of a semi-solid composition having an ointment-like feel overlying a portion of the first surface of said absorbent substrate. The absorbent substrate is useful as a passive dispenser of at least one active ingredient that may be contained therein. The discontinuous coating is essentially non-adherent to the skin and is useful as an active dispenser of at least one active ingredient that may be contained therein. In preferred embodiments the dressing of the invention contains at least one and more preferably at least two active ingredients intended to provide therapeutic benefit to the skin.

Abstract: A pharmaceutical composition is characterized by: an active principle selected from one or more components of the group consisting of R(−)-propylnorapomorphine hydrochloride, S(+)-propylnorapomorphine hydrochloride, derivatives of R(−)-propylnorapomorphine hydrochloride and derivatives of S(+)-propylnorapomorphine hydrochloride, in pharmaceutically acceptable and effective doses, and further comprising components selected from the group consisting of stabilizers, solubilizers and permeation activators to facilitate the passage of the active principle through the skin. A transdermal patch that includes the pharmaceutical composition is also disclosed as well as a method of treatment for Parkinson's disease, hemicrania, sexual impotence, and psychotic disorders using the pharmaceutical composition or a transdermal patch that includes the pharmaceutical composition are described.

Abstract: Materials suitable for preparing components of flushable drug delivery systems are described. These components include drug impermeable and drug permeable materials, including materials that can be used to control the rate of release of drugs from the device, and pressure sensitive adhesive compositions which are drug compatible. Methods for fabricating these devices, including transdermal drug delivery patches, are described.

Abstract: A wound dressing having a metallic compound as an anti-microbial agent. The dressing includes a dressing layer that contacts a patient's skin at the wound bed. The composition of the dressing layer includes metallic compounds in which metallic ions, such as silver, are maintained in the dressing composition. The metallic compound is combined with a hydrocolloid adhesive to provide a highly absorbing dressing. As exudate is absorbed, contact with the metallic ions provides the anti-microbial effect. The metallic ions may be maintained in compounds such as zeolite and hydroxyl apatite mixed with a hydrocolloid adhesive.

Abstract: A gel-type adhesive composite bandage (10) is provided which can be used in the treatment of fungus-involved or discolored toe nails, or for general wound treatment. The bandage (10) includes a base (12) having a preformed recess (16), with a humectant-containing gel (18) within the recess (16). An adhesive-coated web (14) is applied over the base (12) and gel (18). The web (14) is strippable from the base (12) with the gel (18) adhered to the web (14). In the use, the web (14) is removed from the base (12), and the exposed gel (18) is applied directly to the affected toe mail or wound. The remaining portions of the adhesive-coated web (14) is then used to maintain the web (14) and gel (18) in place. The gel (18) preferably includes a polymeric matrix having a substantial quantity of water soluble humectant (for example, glycerin) entrapped within the matrix.

Abstract: Plaster for topical use having an analgesic activity and at the same time being able to re-absorb haematomas, comprising: a substrate layer; an adhesive layer in the form of a hydrogel matrix containing a pharmaceutically acceptable diclofenac salt, heparin or a heparinoid; a protective film which can be removed at the moment of use.

Abstract: A method is provided for increasing the permeability of skin or mucosal tissue to topically or transdermally administered pharmacologically or cosmeceutically active agents. The method involves use of a specified amount of a hydroxide-releasing agent, the amount optimized to increase the flux of the active agent through a body surface while minimizing the likelihood of skin damage, irritation or sensitization. Topically applied formulations and drug delivery devices employing hydroxide-releasing agents as permeation enhancers are provided as well.

Abstract: The present invention relates to a layered pharmaceutical delivery device for the administration of pharmaceuticals or other active compounds to mucosal surfaces. The device may also be used by itself without the incorporation of a therapeutic. The device of the present invention consists of a water-soluble adhesive layer, a non-adhesive, bioerodable backing layer and one or more pharmaceuticals if desired in either or both layers. Upon application, the device adheres to the mucosal surface, providing protection to the treatment site and localized drug delivery. The “Residence Time”, the length of time the device remains on the mucosal surface before complete erosion, can be easily regulated by modifications of the backing layer.

Abstract: A permeation enhancer composition is provided for increasing the permeability of skin or mucosal tissue to topically or transdermally administered pharmacologically or cosmeceutically active agents. The composition is comprised of a hydroxide-releasing agent and a lipophilic co-enhancer such as a fatty alcohol, a fatty ether, or a fatty acid ester, including fatty acid esters of polyols such as propylene glycol and glycerol. Also provided are pharmaceutical formulations containing a therapeutically effective amount of an active agent in addition to the aforementioned enhancer composition, methods for administering active agents topically or transdermally with enhanced permeation, and drug delivery systems for application to an individual's skin or mucosal tissue, wherein the systems are formulated so as to contain an active agent to be administered and an effective permeation enhancing amount of an enhancer composition of the invention.

Abstract: A method for preparing hydrophilic pressure sensitive adhesive (PSA) compositions is provided, wherein the method enables preparation of adhesives having a particular, optimized degree of adhesion. That is, the hydrophilic PSA is comprised of a hydrophilic polymer and a complementary short-chain plasticizing agent, wherein the hydrophilic polymer and plasticizing agent are capable of hydrogen bonding or electrostatic bonding to each other and are present in a ratio that optimizes key characteristics of the adhesive composition, such as adhesive strength, cohesive strength and hydrophilicity. The adhesive is useful in a wide variety of contexts, e.g., as a biomedical adhesive for application to the skin or other body surface, and as such finds utility in the areas of drug delivery systems (e.g., topical, transdermal, transmucosal, iontophoretic), medical skin coverings and wound healing products and biomedical electrodes.

Abstract: The present invention features methods and compositions for transdermal administration. In one embodiment, the invention features methods and compositions for transdermal administration of an amine containing compound having biphasic solubility and/or an agent which enhances the activity of the amine containing compound having biphasic solubility, e.g., a muscle relaxant, to relieve pain.

Abstract: An improved silicone sheet for preventing or minimizing the appearance of scars impregnated with an antioxidant and/or an antimicrobial. The sheet is preferably self-adhering, and may be applied to an affected area of skin for at least 12 hours per day and for a time period sufficient to either prevent the formation of a scar or minimize the appearance of an existing scar.

Abstract: A composition, a method and an apparatus for transdermally delivering an effective amount of opioid antagonists derived from prodrugs for treatment of eating disorders, narcotic dependence and alcoholism. In addition, the present invention relates to a composition, a method and an apparatus for transdermally delivering an effective amount of an opioid and opioid antagonist derived from an opioid agonist and one of an opioid antagonist and a prodrug for treatment of pain.

Abstract: A method is provided for increasing the permeability of skin or mucosal tissue to a topically or transdermally administered pharmacologically or cosmeceutically active peptide, polypeptide or protein. The method involves use of a specified amount of a hydroxide-releasing agent, the amount optimized to increase the flux of the peptide, polypeptide or protein through a body surface while minimizing the likelihood of skin damage, irritation or sensitization. Formulations and drug delivery devices employing hydroxide-releasing agents as permeation enhancers are provided as well.

Abstract: A method is provided for increasing the permeability of skin or mucosal tissue to transdermally administered steroid drugs. The method involves use of a specified amount of a hydroxide-releasing agent, the amount optimized to increase the flux of the drug through a body surface while minimizing the likelihood of skin damage, irritation or sensitization. Formulations and drug delivery systems for co-administering a hydroxide-releasing agent with a steroid drug are provided as well. Optimally, the steroid drugs are a combination of an estrogen and progestin that may be administered in female hormone replacement therapy, to provide female contraception, and the like.

Abstract: Bioadhesive compositions in a flexible, finite form for topical application to skin or mucous membranes comprising a composition which results from an admixture of at least one PVP polymer, at least one bioadhesive, optionally a pharmaceutically acceptable solvent suitable for use with an active agent, and methods of administering active agents to a subject, are disclosed. The bioadhesive composition can either include an active agent incorporated directly in the composition, or a separate source of an active agent.

Abstract: A method is provided for increasing the permeability of skin or mucosal tissue to transdermally administered androgenic drugs. The method involves use of a specified amount of a hydroxide-releasing agent, the amount optimized to increase the flux of the androgenic drug through a body surface while minimizing the likelihood of skin damage, irritation or sensitization. Formulations and drug delivery systems for co-administering a hydroxide-releasing agent with an androgenic drug are provided as well.

Abstract: A transdermal therapeutic system for transcutaneous administration of sexual steroid hormones over long time periods, and a solvent-free method for the production thereof, is disclosed. The steroid hormones are subjected to as little thermal exposure as possible, thereby avoiding decomposition of the steroid hormones.