Abstract: An apparatus and method are provided for selectively applying an agent-containing liquid coating to extremely tiny skin piercing microprojections (10). The coating solution is applied to the skin piercing microprojections (10) using a coating technique which selectively coats only the skin piercing microprojections (10) and not the substrate (12) from which the microprojections (10) extend, and then dried. The coating method includes providing an agent-containing coating liquid and conveying the liquid to a liquid holding surface having a coating transfer region. The depth of the coating liquid at the coating transfer region is precisely controlled. The microprojections are then immersed to a predetermined level in the coating liquid. The liquid that coats the microprojections (10) is then dried to form a solid agent-containing coating on the microprojections (10).

Abstract: The invention provides for a formulation for coating one or more microprojections which reduces or minimizes the loss of counterions from the coating in order to achieve a pH-stabilized formulation.

Abstract: An agent delivery or sampling device (2) comprising a member (6) having a plurality of blades (4) for piercing the skin and a connecting medium (65) covering at least a part of the skin contacting side (48) of the member (6) for increasing transdermal flux of an agent.

Abstract: An expandable skin stretching device includes skin engaging opposite ends that contact the skin surface on opposite sides of an area of the skin surface having micropathways therein. When the skin stretching device is expanded the skin between the opposite ends is placed under tension, i.e., stretched. The skin is placed under a tension of about 0.01 to about 10 megapascals, preferably about 0.05 to about 2 megapascals. The skin stretching can be unidirectional or multi-directional. Alternative embodiments of skin stretching devices use suction or normal force to stretch the skin. Stretching the skin helps keep the micropathways open for enhanced agent (e.g., drug) delivery through the micropathways. The stretching also delays micropathway closure.

Abstract: A minimally invasive transdermal nucleic acid sampling method comprises piercing through the outermost layer of the skin and into the underlying epidermis with a plurality of microprojections. Living skin cells in the underlying epidermis are disrupted, causing them to release their contents including their nucleic acids (i.e., DNA, RNA, fragments thereof or other polynucleic acid material found in the nucleii and/or mitochondria of cells). The nucleic acid is collected on the surfaces of the microprojections and/or in a separate nucleic acid collection reservoir. The collected nucleic acid is then analyzed using standard polymerase chain reaction (PCR) techniques. Optionally a suction device applies a partial vacuum through openings in the microprojection member to the microcuts in the skin for enhanced efflux of intracellular and extracellular (i.e., body) fluids containing the nucleic acid.

Abstract: A minimally invasive transdermal nucleic acid sampling method comprises piercing through the outermost layer of the skin and into the underlying epidermis with a plurality of microprojections. Living skin cells in the underlying epidermis are disrupted, causing them to release their contents including their nucleic acids (i.e., DNA, RNA, fragments thereof or other polynucleic acid material found in the nucleii and/or mitochondria of cells). The nucleic acid is collected on the surfaces of the microprojections and/or in a separate nucleic acid collection reservoir. The collected nucleic acid is then analyzed using standard polymerase chain reaction (PCR) techniques. Optionally a suction device applies a partial vacuum through openings in the microprojection member to the microcuts in the skin for enhanced efflux of intracellular and extracellular (i.e., body) fluids containing the nucleic acid.

Abstract: A device and method are provided for percutaneous transdermal delivery of a immunologically active agent. The agent is mixed with appropriate surfactants and dissolved in water to form an aqueous coating solution having the appropriate concentration for coating extremely tiny skin piercing elements. The coating solution is applied to the skin piercing elements using known coating techniques and then dried. The device is applied to the skin of a living animal, causing the microprotrusions to pierce the stratum corneum and deliver a immunologically effective dose of the immunologically active agent to the animal.

Abstract: Methods are provided for preparation of a coating on one or more microprojections of a microprojection array using wetting agents either as a pretreatment of the microprojection surfaces or incorporated in the coating formulation along with the active agent.

Abstract: A transdermal analgesic system having reduced potential for abuse, wherein the system provides for the controlled release of the antagonist at a rate sufficient to provide an abuse limiting release rate ratio of the antagonist to the analgesic when the dosage form is subject to abuse is disclosed.

Abstract: A device comprising of a plurality of microprojections for piercing the outermost layer of skin is provided for increasing transdermal agent flux. The device includes penetration depth limiters for ensuring uniform depth of piercing by the microprojections, thereby preventing over penetration and undesirable bleeding and pain. The microprojections have a length (L1) which is substantially greater than the intended penetration depth (L2). The microprojection penetration depth limiters allow for more uniform penetration for optimum agent delivery or fluid sampling.

Abstract: Composition of matter for application to a body surface or membrane to administer fluoxetine by permeation through the body surface or membrane, the composition comprising fluoxetine to be administered, at a therapeutically effective rate, alone or in combination with a permeation enhancer or mixture. A preferred embodiment is directed to the transdermal administration of fluoxetine at reduced skin irritation levels wherein fluoxetine, preferably provided as fluoxetine acetate, is coadministered with a corticosteroid such as hydrocortisone. Also disclosed are drug delivery devices containing the fluoxetine or fluoxetine and enhancer composition and methods for the transdermal administration of the fluoxetine and fluoxetine/enhancer composition.

Abstract: A transdermal agent sampling device is provided. The sampling device is comprised of a microblade array and a device for applying a partial vacuum. The microblade array comprises a sheet having a plurality of microblades for piercing the skin to a very shallow depth (i.e., 25 &mgr;m to 400 &mgr;m) to create microslits in the outermost stratum corneum layer of the skin. The partial vacuum applying device applies a partial vacuum in the range of about 0.1 to about 0.8 atm, and preferably about 0.3 to about 0.7 atm, for sampling a body analyte such as glucose in interstitial fluid. The partial vacuum is applied for a period of about 2 to about 30 seconds, and preferably about 5 to about 15 seconds. The interstial fluid is analyzed for body analyte (e.g., glucose) content or concentration.

Abstract: A minimally invasive transdermal agent sampling device (2, 10) comprises a sheet (6) having a plurality of openings (8) and a plurality of microblades (4) for piercing the skin (20). A suction device (10) applies a negative pressure through the openings (8) to the microslits in the skin (20) for enhanced efflux of interstitial fluid. The device (2, 10) can be used for transdermal sampling of body analytes such as glucose for measuring/estimating blood glucose concentration.

Abstract: A minimally invasive transdermal nucleic acid sampling method comprises piercing through the outermost layer of the skin and into the underlying epidermis with a plurality of microprojections. Living skin cells in the underlying epidermis are disrupted, causing them to release their contents including their nucleic acids (i.e., DNA, RNA, fragments thereof or other polynucleic acid material found in the nucleii and/or mitochondria of cells). The nucleic acid is collected on the surfaces of the microprojections and/or in a separate nucleic acid collection reservoir. The collected nucleic acid is then analyzed using standard polymerase chain reaction (PCR) techniques. Optionally a suction device applies a partial vacuum through openings in the microprojection member to the microcuts in the skin for enhanced efflux of intracellular and extracellular (i.e., body) fluids containing the nucleic acid.

Abstract: Composition of matter for application to a body surface or membrane to administer fluoxetine by permeation through the body surface or membrane, the composition comprising fluoxetine to be administered, at a therapeutically effective rate, alone or in combination with a permeation enhancer or mixture. A preferred embodiment is directed to the transdermal administration of fluoxetine at reduced skin irritation levels wherein fluoxetine, preferably provided as fluoxetine acetate, is coadministered with a corticosteroid such as hydrocortisone. Also disclosed are drug delivery devices containing the fluoxetine or fluoxetine and enhancer composition and methods for the transdermal administration of the fluoxetine and fluoxetine/enhancer composition.

Abstract: A transdermal electrotransport drug delivery device having an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode. At least one of the anode and the cathode includes an electrode and a reservoir comprised of a housing composed of a polymeric material and an aqueous medium in contact with the housing. The aqueous medium includes (i) a drug or an electrolyte salt or a mixture thereof, (ii) propylene glycol, and (iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium. The propylene glycol prevents the antimicrobial agent from being adsorbed by other materials used in the construction of the delivery device. A process for preparing a transdermal electrotransport drug delivery device is also provided.

Abstract: Skin patches (20) having a microprojection array (10), a reservoir (18) containing an antigenic agent and an immune response augmenting adjuvant, and methods of using same to vaccinate animals (e.g., humans) is disclosed. In a preferred embodiment, the microprojection arrays (10) are composed of a photoetched and micro-punched titanium foil (14). The microprojections (12) are coated with a liquid formulation containing a vaccine antigen and an adjuvant such as glucosaminyl muramyl dipeptide, dried, and applied to skin of the animal to be vaccinated using an impact applicator. The microprojections (12) create superficial pathways through the stratum corneum to facilitate permeation of antigenic agent and adjuvant. Antigen dose and depth of penetration can be controlled. This technology has broad applicability for a wide variety of therapeutic vaccines to improve efficacy, and convenience of use.

Abstract: The device including a plurality of stratum corneum-piercing microprojections, and a solid coating disposed upon the microprojections, wherein the solid coating includes at least one beneficial agent and a biocompatible carrier is provided. The device is applied to the skin of a living animal (e.g., a human), causing the microprojections to pierce the stratum corneum and deliver an effective dose of the agent to the animal.

Abstract: An apparatus and method are provided for selectively applying an agent-containing liquid coating to extremely tiny skin piercing microprojections (10). The coating solution is applied to the skin piercing microprojections (10) using a coating technique which selectively coats only the skin piercing microprojections (10) and not the substrate (12) from which the microprojections (10) extend, and then dried. The coating method includes providing an agent-containing coating liquid and conveying the liquid to a liquid holding surface having a coating transfer region. The depth of the coating liquid at the coating transfer region is precisely controlled. The microprojections are then immersed to a predetermined level in the coating liquid. The liquid that coats the microprojections (10) is then dried to form a solid agent-containing coating on the microprojections (10).

Abstract: A device (12) and method are provided for percutaneous transdermal delivery of a potent pharmacologically active agent. The agent is dissolved in water to form an aqueous coating solution having an appropriate viscosity for coating extremely tiny skin piercing elements (10). The coating solution is applied to the skin piercing elements (10) using known coating techniques and then dried. The device (12) is applied to the skin of a living animal (e.g., a human), causing the microprotrusions (10) to pierce the stratum corneum and deliver a therapeutically effect dose of the agent to the animal.