Abstract: Applicators for a microprojection array and methods of using the applicators are described.

Abstract: In an aspect of the invention, a composition for making a patch for the transdermal delivery of tamsulosin is provided. The composition comprises (a) at least about 1 wt % tamsulosin or a pharmaceutically acceptable salt of tamsulosin, (b) at least about 40 wt % polyisobutylene adhesive or hydrophobic synthetic rubber adhesive, (c) about 1-20 wt % of an aprotic solvent in which tamsulosin dissolves readily, (d) about 1-20 wt % of an unsaturated fatty acid or an alpha-hydroxy acid or a mixture of unsaturated fatty acids or alpha-hydroxy acids or of both unsaturated fatty acids and alpha-hydroxy acids, (e) a lipophilic permeation enhancer, and (f) a matrix modifier.

Abstract: In an aspect of the invention, an array of microprotrusions is formed by providing a mold with cavities corresponding to the negative of the microprotrusions, casting atop the mold a first solution comprising a biocompatible material and a solvent, removing the solvent, casting a second solution atop the first cast solution, removing the solvent from the second solution, and demolding the resulting array from the mold. The first solution preferably contains an active ingredient.

Abstract: Applicators for a microprojection array capable of multiple impacts and methods of using the applicators are described.

Abstract: A composition is provided, wherein the composition comprises a water-swellable, water insoluble polymer, a blend of a hydrophilic polymer and a complementary oligomer capable of hydrogen bonding to the hydrophilic polymer, and a whitening agent, preferably a peroxide. The composition finds utility as a tooth whitening composition and is applied to the teeth in need of whitening, and then removed when the degree of whitening has been achieved. In certain embodiments, the composition is translucent. Methods for preparing and using the compositions are also disclosed.

Abstract: A method for delivering a therapeutic agent to a subject from a transdermal delivery system is described, where the therapeutic agent (i) has a half-life in the blood when delivered orally of greater than about 48 hours and (ii) is for the treatment of a chronic condition. The transdermal delivery system achieves transdermal delivery of the therapeutic agent at steady state that is bioequivalent to administration of the therapeutic agent orally, wherein bioequivalency is established by (a) a 90% confidence interval of the relative mean Cmax and AUC of the therapeutic agent administered from the transdermal delivery system and via oral delivery between 0.70 and 1.43 or between 0.80 and 1.25, or (b) a 90% confidence interval of the ratios for AUC and Cmax of the therapeutic agent administered from the transdermal delivery system and via oral delivery between 0.70 and 1.43 or between 0.80 and 1.25.

Abstract: A transdermal delivery system for systemic delivery of donepezil is described, where the system comprises an adhesive matrix drug reservoir layer comprised of a copolymer of acrylic acid/vinyl acetate, triethyl citrate, and donepezil base generated in situ by reaction of donepezil HCl and an alkaline salt. The system is provided for treatment of Alzheimer's disease, and achieves transdermal delivery of the therapeutic agent at steady state that is bioequivalent to administration of the therapeutic agent orally.

Abstract: Devices and methods for using and manufacturing microstructure arrays are described.

Abstract: Formulations for topical application of aripiprazole are provided. The formulations, when applied topically to the skin of a subject, provide a therapeutic amount of aripiprazole in the blood for a sustained period of time for treatment of conditions responsive to aripiprazole including but not limited to depression, schizophrenia, and bipolar disorder.

Abstract: An adhesive device used as a wound dressing, ingredient delivery device or IV hold-down in which inadvertent edge release of these devices along the periphery of the polymeric film layer is minimized when the handling layer, which is adhered to the polymeric film layer, is removed after application of the polymeric film layer to the patient.

Abstract: A method and a drug delivery system for transdermally administering parathyroid hormone (PTH) in a pulsatile fashion are provided, where the drug delivery system comprises an array of microprojections each comprising PTH.

Abstract: An applicator for a microprojection array is described. In one embodiment, the applicator comprises an energy-storing element. Application of force causes the compressed energy-storing element to extend or transition from first and second configurations, releasing stored energy to deploy a holding member in the application which is configured to hold an array of microprojections. In another embodiment, the applicator comprises an energy storing element with two stable configurations, a first stable configuration and second stable configuration. Application of force causes the energy-storing element to transition from the higher energy first stable configuration to the lower energy second stable configuration, releasing the difference in energies of the two states to deploy a holding member in the application which is configured to hold an array of microprojections.

Abstract: A composition is provided, wherein the composition comprises a water-swellable, water insoluble polymer, a blend of a hydrophilic polymer and a complementary oligomer capable of hydrogen bonding to the hydrophilic polymer, and a whitening agent, preferably a peroxide. The composition finds utility as a tooth whitening composition and is applied to the teeth in need of whitening, and then removed when the degree of whitening has been achieved. In certain embodiments, the composition is translucent. Methods for preparing and using the compositions are also disclosed.

Abstract: Adhesive devices used as wound dressings, ingredient delivery devices and IV hold-downs include a handling layer comprised of a layer of conductive material and at least one layer of non-conductive material, adhered to the non-adhesive coated side of an adhesive coated polymeric film layer, by an electrostatic charge, rather than by an adhesive.

Abstract: In an aspect of the invention, a composition for making a patch for the transdermal delivery of tamsulosin is provided. The composition comprises (a) at least about 1 wt % tamsulosin or a pharmaceutically acceptable salt of tamsulosin, (b) at least about 40 wt % polyisobutylene adhesive or hydrophobic synthetic rubber adhesive, (c) about 1-20 wt % of an aprotic solvent in which tamsulosin dissolves readily, (d) about 1-20 wt % of an unsaturated fatty acid or an alpha-hydroxy acid or a mixture of unsaturated fatty acids or alpha-hydroxy acids or of both unsaturated fatty acids and alpha-hydroxy acids, (e) a lipophilic permeation enhancer, and (f) a matrix modifier.

Abstract: A composition is provided, wherein the composition comprises a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer and a complementary oligomer capable of hydrogen bonding to the hydrophilic polymer, and a whitening agent, preferably a peroxide. The composition finds utility as a tooth whitening composition and is applied to the teeth in need of whitening, and then removed when the degree of whitening has been achieved. In certain embodiments, the composition is translucent. Methods for preparing and using the compositions are also disclosed.

Abstract: A microprojection array is provided, comprising an approximately planar base and a plurality of microprojections, wherein the array comprises a vaccine and a polymeric material. The array may have multiple layers. The vaccine may be placed in only one layer. In another embodiment of the invention, a method of preventing a disease is provided, comprising insertion into the skin of a patient an array of microprojections comprising a layer which comprises a vaccine for that disease and a polymer.

Abstract: In an aspect of the invention, an array of microprotrusions is formed by providing a mold with cavities corresponding to the negative of the microprotrusions, casting atop the mold a first solution comprising a biocompatible material and a solvent, removing the solvent, casting a second solution atop the first cast solution, removing the solvent from the second solution, and demolding the resulting array from the mold. The first solution preferably contains an active ingredient.

Abstract: Described here are methods, devices, and kits for microjet drug delivery. The devices described here may be modular or non-modular. The modular devices typically include a first module having a drug reservoir and a nozzle in fluid communication with the drug reservoir and a second module having an actuator and a power supply. The power supply provides power to the actuator and when the first and second modules are coupled, the actuator is capable of acting on a dispensing member causing it to dispense a drug in liquid form from the drug reservoir via the nozzle at a velocity sufficient to penetrate skin. Other devices described include a nozzle, a reservoir in fluid communication with the nozzle, a dispensing member, and an actuator. In these devices, the nozzle has at least one feature that enhances nozzle contact with the skin in order to reduce lateral drug leakage about the nozzle.

Abstract: Hydrogel compositions are provided (a) that have a continuous hydrophobic phase and a discontinuous hydrophilic phase, (b) that have a discontinuous hydrophilic phase and a continuous hydrophilic phase, or (c) that are entirely composed of a continuous hydrophilic phase. The hydrophobic phase, if present, is composed of a hydrophobic polymer, particularly a hydrophobic pressure-sensitive adhesive (PSA), a plasticizing elastomer, a tackifying resin, and an optional antioxidant. The discontinuous hydrophilic phase, if present, is composed of a crosslinked hydrophilic polymer, particularly a crosslinked cellulosic polymer such as crosslinked sodium carboxymethylcellulose. For those hydrogel compositions containing a continuous hydrophilic phase, the components of the phase include a cellulose ester composition or an acrylate polymer or copolymer, and a blend of a hydrophilic polymer and a complementary oligomer capable of hydrogen bonding thereto.