Abstract: An agent detecting device comprising a plate (6) having a plurality of microprotrusions (4) for piercing the skin of a patient. Each of the microprotrusions (4) having an electrode (14, 16 and 18) thereon for detecting the presence of an agent in the patient's interstitial fluid.

Abstract: The present invention comprises a composition comprising a matrix adapted to be placed in drug-and permeation-enhancing mixture-transmitting relation to a selected skin or other body site. The matrix contains sufficient amounts of drug, permeation enhancer(s) and poly-N-vinylamide to continuously administer to the site, the drug, in a therapeutically effective amount, and the permeation-enhancing mixture, in an amount effective to enhance the permeation of the skin to the drug. The device shows increased transdermal flux, as compared to the transdermal flux of the drug from a device containing no poly-N-vinyl amide. Incorporating poly-N-vinyl amide into the transdermal system also improves the adhesion and stability of the system.

Abstract: This invention relates to fluid-imbibing delivery devices for delivering a beneficial agent to a biological environment of use. In particular, the devices include a rigid housing defining an internal compartment comprising a substantially impermeable first wall section and a second wall section permeable to fluid in the environment of use. The first wall section may be shape-retaining, with exit means and an open end, and extend for at least 85% of the entire length of the device to define the internal compartment.

Abstract: An electrotransport delivery device (10) with a display (14) having only on and off states, and a method of operating the display (14), are provided. Preferably, the display 14 is a light (e.g., a light emitting diode) with lit and unlit states or an audible alarm (e.g., a beeper) with sounding and silent states. The device (10) counts and stores the number of events (e.g., patient initiated drug delivery or sensed patient condition) which occur over a predetermined period of time (e.g., the period of time over which the device is worn by the patient). The event count is displayed by cycling the display (14) between on and off states according to a predetermined regimen which correlates the number of on/off cycles to the number of events. The device and method permit the use of a simple and inexpensive means (e.g., an LED) to display (e.g., to a medical technician) the number of e.g., patient initiated doses delivered over a previous period of therapy.

Abstract: Compositions, devices, and methods for transdermal administration of an active agent are disclosed using a novel dual permeation enhancer mixture comprising lauryl acetate and a monoglyceride, preferably glycerol monolaurate. The dual permeation enhancer mixture comprising lauryl acetate is a potent permeation enhancer and provides stable systems which are more readily characterized.

Abstract: A device for the transdermal administration of a drug to a sensitive body area such as the scrotum. Devices according to the invention provide an improved quality of adhesion to the body area while also providing patient comfort during use and upon removal of the device. Also disclosed are methods of transdermal delivery such as the transcrotal delivery of testosterone to hypogonadic males.

Abstract: The present invention relates to an improvement in an osmotic delivery device wherein the device comprises a semipermeable wall comprising cellulose acetate butyrate and surrounding an internal compartment containing a beneficial agent or medicament formulation, a fluid-activated expandable driving member, optionally a partition layer between the agent formulation and the driving member, and, optionally a density member, and exit means in the semipermeable wall; and wherein the improvement comprises the cellulose acetate butyrate component of the semipermeable wall having a differential scanning calorimetry ("DSC") profile wherein the main or primary DSC peak has a minimum temperature peak above 228.degree. C. and the secondary DSC peak area is equal to or less than about 30% of the total combined areas of the primary and secondary DSC peaks.

Abstract: An electrotransport system (20) for delivering a therapeutic agent (36) through a body surface (40) (eg, skin) of a patient includes a pair of electrodes (34, 38) for contacting the body surface, at least one of which contains the therapeutic agent (36). The system (20) is physically separated into a control unit (22) and a delivery unit (24) connected by a radiated energy signal-based telemetry link. The telemetry link may be radio frequency, ultrasonic, optical, infrared or inductively coupled. Signals from the control unit may be transmitted to the delivery unit by the telemetry link, or vice versa. The delivery unit may control electrotransport current on the signal transmitted. The radiated energy signal may be encoded to improve immunity to extrinsic interference. The delivery unit (24) may be configured with sensor means for detecting a condition such as a body or system parameter reaching some predetermined limit.

Abstract: An improved cathodic iontophoresis electrode assembly (8, 38) is provided having a reducible cathodic electrode (12,22) and a drug reservoir (14, 24) containing an anionic drug. The cathodic electrode (12, 22) is separated from the drug reservoir (14, 24) by means of a layer (30) of a cation exchange material. The cation exchange material is loaded with cations which are able to react with anions produced during reduction of the electrode (12, 22) to form an electrically neutral or substantially insoluble (eg, water insoluble) compound. The cathodic electrode (12, 22) is preferably composed of silver chloride which produces chloride ions during reduction. The cation exchange material is preferably loaded with silver or copper cations which react with the chloride ions to produce a neutral and relatively insoluble metal chloride salt.

Abstract: The present invention is directed to a fluid-imbibing dispensing device for the extended or protracted delivery of an active agent following an initially delayed startup of the delivery to a fluid environment of use.

Abstract: A transdermal drug delivery device (20) is provided having both an active drug reservoir (24) and a passive drug reservoir (26). Drug is actively delivered by iontophoresis from the active drug reservoir (24) by an electric field generated by a power source (21). Simultaneously, drug is delivered from passive reservoir (26) by passive (i.e., non-electrically assisted) diffusion. In one embodiment, the passive drug reservoir (26) is electrically insulated from the active drug reservoir (24). In a second embodiment, both the active and the passive drug are contained in the same reservoir (34). In the second embodiment, the active drug is ionizable while the passive drug is non-ionizable. Most preferably, the active drug is an ionizable form (i.e., a salt form) of the passive drug.

Abstract: Improved methods of ionophoretic drug delivery are described. By the intentional selection of drug(s) with specific characteristics, of ionotophoresis device, components or both permits the efficiency of drug delivery is increased.

Abstract: The present invention is directed to the transdermal administration of oxybutynin together with a suitable permeation enhancer. The invention includes a transdermal drug delivery device comprising a matrix adapted to be placed in oxybutynin- and permeation enhancer-transmitting relation with the skin site. The matrix contains sufficient amounts of a permeation enhancer and of oxybutynin, in combination, to continuously administer to the skin for a predetermined period of time the oxybutynin to provide an effective therapeutic result. The invention is also directed to a method for the transdermal administration of a therapeutically effective amount of oxybutynin together with a skin permeation-enhancing amount of a suitable permeation enhancer.

Abstract: A delivery system is disclosed for delivering a beneficial agent to an animal. The delivery system comprises a wall that surrounds a lumen, said wall comprising a composition that limits the passage of fluid into the system and a composition that permits the passage of fluid into the system. The lumen comprises a beneficial agent and an expandable member. The delivery system comprises an exit means for delivering the beneficial agent.

Abstract: It has been found that the following materials act as catalysts for the conversion of PETC to PETA by the ammonolysis of PETC in methanolic ammonia: (a) amine acid addition salts and quaternary ammonium halides and hydroxides, (b) tertiary amines, (c) olefin epoxides, (d) 8-hydroxyquinolines, (e) amine phenoxides, (f) quaternary hydroxyalkyl ammonium hydroxides, and (g) glycidyl halides and ethers. The preferred catalysts, according to this invention, include tetramethyl ammonium chloride, benzyl dimethylamine, dodecyl dimethylamine and 1,2-epoxy decane.