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: A transdermal delivery system having a microprojection array with one or more voids configured to allow an adhesive backing to attach to a user's skin and, hence, improve retention of the system thereto. Radial voids can be configured to enhance compliance of the array to conform more readily to non-flat areas of the skin.

Abstract: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or assembly) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the VEGF-based agent is contained in a biocompatible coating that is applied to the microprojection member.

Abstract: A transdermal agent delivery apparatus and system having a low infection potential comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the microprojection member includes a biocompatible coating having at least one biologically active agent and at least one antimicrobial agent disposed therein. In another embodiment, the microprojection member includes a hydrogel formulation having at least one biologically active agent and at least one antimicrobial agent. In yet another embodiment, the microprojection member includes a hydrogel formulation having at least one antimicrobial agent and a solid film having at least one biologically active agent.

Abstract: A system and method for transdermally delivering a biologically active agent comprising one or more electrodes having stratum corneum-piercing projections and a circuit that delivers an electrical signal to the electrodes to electroporate a cell membrane. Preferably, the system is configured to generate homogeneous electrical fields and, more preferably, to generate spherically or semispherically symmetrical electric fields. Methods of the invention include applying a first electric signal to facilitate transdermal transport of the agent and applying a second electric signal to facilitate intracellular transport of the agent.

Abstract: An apparatus and method for transdermally delivering an immunologically active agent comprising a delivery system having a microprojection array that includes a plurality of microprojections that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers, the microprojection array having a plurality of array regions, each of the array regions having a different biocompatible coating disposed thereon, wherein at least one of the array region coatings includes an immunologically active agent. In one embodiment, each coating on the array regions includes a different immunologically active agent. In another embodiment, the biocompatible coating on a first array region includes an immunologically active agent and the biocompatible coating on a second array region includes an immune response augmenting adjuvant.

Abstract: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the PTH-based agent is contained in a biocompatible coating that is applied to the microprojection member.

Abstract: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the fentanyl-based agent is contained in a biocompatible coating that is applied to the microprojection member. In a further embodiment, the delivery system includes a gel pack having a fentanyl-based agent-containing hydrogel formulation that is disposed on the microprojection member after application to the skin of a patient. In an alternative embodiment, the fentanyl-based agent is contained in both the coating and the hydrogel formulation.

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: 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: Buffered drug formulations for transdermal electrotransport delivery are disclosed. The formulations utilize a dipeptide as a buffer and allow for more efficient electrotransport delivery of drugs, e.g., polypeptide drugs, via the transdermal route.

Abstract: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers, a formulation containing the biologically active agent and an oscillation inducing device. In one embodiment, the biologically active agent is contained in a biocompatible coating that is applied to the microprojection member. In a further embodiment, the delivery system includes a gel pack having an agent-containing hydrogel formulation that is disposed on the microprojection member after application to the skin of a patient. In an alternative embodiment, the biologically active agent is contained in both the coating and the hydrogel formulation.

Abstract: Methods for preparing compositions for use in electrotransport delivery systems. The method includes providing a drug solution comprising drug ions and associated counterions; adjusting the pH of the drug solution by contacting the drug solution with a ion exchange material first; separating the ion exchange material from the pH-adjusted drug solution; and buffering the pH-adjusted drug solution with a buffer. A peptidic buffer is preferably used. The methods result in compositions suitable for use in electrotransport delivery systems.

Abstract: The invention provides for a formulation for coating one or more microprojections using a non-volatile counterion to improve solubility of a biologically active agent. The invention also includes formulations having a volatile counterion to reduce the solubility of a portion of the biologically active agent.

Abstract: A system and method for transdermally delivering a vaccine to a patient including an iontophoresis delivery device having a donor electrode, a counter electrode, and electric circuitry for supplying iontophoresis energy to the electrodes, and a non-electroactive microprojection member having a plurality of stratum corneum-piercing microprojections extending therefrom. The vaccine can be contained in a hydrogel formulation in an agent reservoir disposed proximate the donor electrode, in a biocompatible coating that is disposed on the microprojections or in both.

Abstract: An apparatus and method for transdermally delivering a vaccine comprising a delivery system having (i) a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers and (ii) an ultrasonic device. In one embodiment, the vaccine is contained in a biocompatible coating that is applied to the microprojection member. In a further embodiment, the delivery system includes a gel pack having a vaccine-containing hydrogel formulation that is disposed on the microprojection member after application to the skin of a patient. In an alternative embodiment, the vaccine is contained in both the coating and the hydrogel formulation.

Abstract: A formulation for coating a transdermal delivery device having a plurality of stratum corneum-piercing microprojections, the formulation including a biologically active agent and at least one viscosity-enhancing counterion. Preferably, the formulation has a viscosity in the range of about 20-200 cp.

Abstract: A drug delivery system for delivering a biologically active agent through the skin of a patient comprises (i) a pretreatment patch adapted to be placed on the patient's skin, the pretreatment patch having a backing membrane and a microprojection array, the microprojection array being adhered to the backing membrane, the microprojection array including a plurality of microprojections adapted to pierce the stratum corneum of the patient, the pretreatment patch including a skin template that remains on the patient's skin after the pretreatment patch is applied to and removed from the patient's skin, and (ii) a gel patch having a top and bottom surface, the gel patch including a reservoir containing a hydrogel formulation, the gel patch having a skin contact area in the range of approximately 0.5-30 cm2.

Abstract: An apparatus for transdermally delivering a nicotine-based agent to a tobacco or nicotine user comprising a microprojection member having a plurality of microprojections that are adapted to pierce the stratum corneum of the tobacco user, the microprojection member having a biocompatible coating disposed thereon that includes a nicotine-based agent.

Abstract: An apparatus for transdermally delivering a biologically active agent comprising (i) a gel pack containing a hydrogel formulation and (ii) a microprojection member having top and bottom surfaces, a plurality of openings that extend through the microprojection member and a plurality of stratum corneum-piercing microprotrusions that project from said bottom surface of the microprojection member, the microprojection member being adapted to receive the gel pack whereby the hydrogel formulation flows through the microprojection member openings. Preferably, the hydrogel formulation comprises a water-based hydrogel.