Abstract: Compositions of and methods for formulating and delivering biologically active agent formulations having enhanced physical stability, and wherein deterioration from the presence of oxygen and/or water is minimized and/or controlled, to yield a stable formulation. The compositions of and methods for formulating and delivering biologically active agents of the present invention further facilitate their incorporation into a biocompatible coating which can be employed to coat a stratum-corneum piercing microprojection, or a plurality of stratum-corneum piercing microprojections of a delivery device, for delivery of the biocompatible coating through the skin of a subject, thus providing an effective means of delivering the biologically active agents.

Abstract: An applicator device (10) is provided for applying a patch (44) having an array of microprotrusions (90) to the stratum corneum. The applicator device (10) includes a device body (12) and a piston moveable within the device body (12). A cap (16) is provided on the device body (12) for activating the device (10) to impact the stratum corneum with a microprotrusion array (44,90). The device (10) is capable of being cocked by one handed operation of the user which allows the device (10) to be used by patients having neither the strength nor the manual dexterity to cock other types of applicator devices.

Abstract: Devices, systems and methods for controlling the application of current and/or voltage to deliver drug from patient contacts of an electrotransport drug delivery device by indirectly controlling and/or monitoring the applied current without directly measuring from the cathode of the patient terminal. In particular, described herein are electrotransport drug delivery systems including constant current delivery systems having a feedback current and/or voltage control module that is isolated from the patient contacts (e.g., anodes and cathodes). The feedback module may be isolated by a transistor from the patient contacts; feedback current and/or voltage control measurements may be performed at the transistor rather than at the patient contact (e.g., cathode).

Abstract: Electrotransport drug delivery devices, system and methods of using configured to determine if a current is present between the anode and cathode when drug is not intended to be delivered by the device. These devices/systems may include an off-current module to determine that any current (e.g., which may be inferred by measuring potential difference between the anode and cathode of the device) flowing between the anode and cathode is below a threshold value when the device is not supposed to be delivering drug, thereby preventing unintended delivery of drug and/or alerting a user that unintended delivery of drug may occur.

Abstract: Compositions of and methods for formulating and delivering biologically active agent formulations having enhanced physical stability, and wherein deterioration from the presence of oxygen and/or water is minimized and/or controlled, to yield a stable formulation. The compositions of and methods for formulating and delivering biologically active agents of the present invention further facilitate their incorporation into a biocompatible coating which can be employed to coat a stratum-corneum piercing microprojection, or a plurality of stratum-corneum piercing microprojections of a delivery device, for delivery of the biocompatible coating through the skin of a subject, thus providing an effective means of delivering the biologically active agents.

Abstract: A transdermal nicotine salt delivery system to an individual. The system has a high nicotine salt loading to effect therapeutic flux rate. Acrylate polymeric drug reservoir with the high nicotine salt dissolved therein provides desirable adhesive characteristics and effective transdermal therapeutic properties.

Abstract: A novel backing construction for a transdermal drug delivery system is disclosed. In particular, the invention relates to a system and method for labeling a transdermal drug delivery system, wherein the backing layer contains a writable medium capable of inkless printing.

Abstract: A transdermal nicotine salt delivery system to an individual. The system has a high nicotine salt loading to effect therapeutic flux rate. Acrylate polymeric drug reservoir with the high nicotine salt dissolved therein provides desirable adhesive characteristics and effective transdermal therapeutic properties.

Abstract: An applicator for applying a microprojection member to the stratum corneum of a patient having a housing, a piston moveable within the housing and a cap adapted to activate the applicator. The applicator is self-setting and auto-triggering, which allows the applicator to be used by patient's having neither the strength, nor the manual dexterity to pre-set and activate other types of applicator devices.

Abstract: A retainer (34) is provided for holding a microprotrusion member (44) for application of the microprotrusion member (44) to the stratum corneum with an impact applicator (10). The microprotrusion member (44) includes a plurality of microprotrusions (90) which penetrate the stratum corneum to improve transport of an agent across the stratum corneum.

Abstract: A switch operated therapeutic agent delivery device is described. The device comprises two parts, which are assembled by a user prior to use. A first part contains a power supply and circuitry for the device; and a second part comprises electrodes and reservoirs containing the therapeutic agent to be delivered. The action of combining the two parts of the device causes the two parts to be irreversibly coupled together, completes an electrical connection between the two parts, and closes one or more switches, thereby connecting a power source, such as a battery, into the device's circuitry, thereby powering the device on so that it is ready for use. The device can then be attached to a patient, who can operate the device by pressing a button in a proper sequence.

Abstract: A novel backing construction for a transdermal drug delivery system is disclosed. In particular, the invention relates to a system and method for labeling a transdermal drug delivery system, wherein the backing layer contains a writable medium capable of inkless printing.

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: A transparent transdermal delivery device for delivering nicotine which has an Opacity Index of less than 48.6%.

Abstract: A novel backing construction for a transdermal drug delivery system is disclosed. In particular, the invention relates to a system and method for labeling a transdermal drug delivery system, wherein the backing layer contains a writable medium capable of inkless printing.

Abstract: A polyacrylate formulation suitable for delivery of drug to through a body surface of an individual. By loading the drug and permeation enhancers at a high concentration into a polyacrylate proadhesive that has inadequate adhesive properties for typical adhesive application on the skin, a formulation with desirable adhesive characteristics and effective therapeutic properties can be made. The proadhesive has higher glass transition temperature than typical pressure sensitive adhesives.

Abstract: A transparent transdermal delivery device for delivering nicotine which has an Opacity Index of less than 48.6%.

Abstract: An applicator device (10) is provided for applying a patch (44) having an array of microprotrusions (90) to the stratum corneum. The applicator device (10) includes a device body (12) and a piston moveable within the device body (12). A cap (16) is provided on the device body (12) for activating the device (10) to impact the stratum corneum with a microprotrusion array (44, 90). The device (10) is capable of being cocked by one handed operation of the user which allows the device (10) to be used by patients having neither the strength nor the manual dexterity to cock other types of applicator devices.

Abstract: Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.

Abstract: A novel backing construction for a transdermal drug delivery system is disclosed. In particular, the invention relates to a system and method for labeling a transdermal drug delivery system, wherein the backing layer contains a writable medium capable of inkless printing.