Abstract: An iontophoretic agent delivery device having donor and counter electrodes comprised of either metal or a hydrophobic polymer loaded with a conductive filler is provided. The agent reservoir in the donor electrode assembly contains about 10 to 60 wt. % hydrophobic polymer, about 10 to 60 wt. % hydrophilic polymer, and up to 50% agent. Similarly, the electrolyte reservoir contains about 10 to 60 wt. % hydrophobic polymer, about 10 to 60 wt. % hydrophilic polymer, and up to 50% electrolyte. The agent reservoir, the electrolyte reservoir and the electrodes are preferably in the form of films which are laminated to one another. The hydrophobic polymer component in the agent/electrolyte reservoir prevents the reservoir from delaminating from the metal/hydrophobic polymer based electrode, even after hydration of the reservoirs.

Abstract: A membrane capable of inhibiting agent release from a delivery system when no electrical current is flowing and yet provide minimal impedance to electrically-assisted agent delivery, useful both for incorporating into electrotransport agent delivery systems and for use in measuring agent release rates in in vitro testing.

Abstract: A dry-state iontophoretic drug delivery device (10, 70, 80) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. A liquid-containing pouch (21, 22) is provided. In certain embodiments the liquid is contained in breakable capsules within the pouch. Water or other liquid can be released from the capsules in the pouch by squeezing or flexing the pouches (21,22). Alternatively, the liquid can be released from the pouches (21,22) using pouch piercing pins (36,37). The liquid released from the pouches (21,22) hydrates the drug and electrolyte reservoirs (15, 16) and activates the device. In another embodiment, the device (20, 20a) has liquid-containing gel layers (31,32) which are initially separated from their respective electrode assemblies (8, 9). Liquid-wicking pathways (27,28) are provided to carry the liquid from the gel layers (31,32) to the drug and electrolyte layers (15, 16).

Abstract: The present invention provides compositions and methods for the transdermal administration of a therapeutically effective amount of a synthetic 19-nor-progesterone (ST-1435) together with, optionally, a suitable permeation enhancer.

Abstract: The present invention provides compositions and methods for the transdermal administration of a therapeutically effective amount of a synthetic 19-nor-progesterone (ST-1435) and an estrogen, in combination, together with, optionally, a suitable permeation enhancer.

Abstract: An osmotically driven syringe (20, 60) is disclosed which can be used to deliver a beneficial agent such as a drug, at varying pre-determined rates over multiple periods of time. The syringe (20, 60) is driven by an osmotic engine (10) having a shaped wall (12) containing an osmotic agent (17) and/or a gas generating means (19), such as an effervescent couple. The wall (12) is composed of a semipermeable and/or microporous material which is permeable to an external liquid (e.g., water) but which is substantially impermeable to the osmotic agent (17) and the gas generated by the gas generating means (19). The wall (12) has a passageway (13) therethrough to provide a flow path for the driving fluid generated by the engine (10). The osmotic agent(s) (17) and/or the gas generating means (19) are placed in the engine (10) in such a way as to drive engine (10) at different pumping rates (R.sub.1, R.sub.2) over sequential periods of time (t.sub.0 to t.sub.1 and t.sub.1 to t.sub.2).

Abstract: A dry-state iontophoretic drug delivery device (10, 30) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. In one embodiment of the invention, a sealed liquid-containing pouch (21, 22) is provided in each electrode assembly (8, 9). Water or other liquid (20) is released from the pouch (21, 22) by pulling a tab (27, 28) attached to a portion (25, 26) of the pouch (21, 22) which is capable of being torn or ripped in order to hydrate the drug and electrolyte reservoirs (15, 16) and activate the device (10, 30). In another embodiment, the device (30) is held in a package (32). The device (30) has pouches (21, 22) which release their liquid contents automatically upon removal of the device (30) from the package (32). In yet another embodiment, the device (40) is held in a package (42) having a compression zone (46). The pouches (21, 22) must be moved through the compression zone (46) when removing the device (40) from the package (42).

Abstract: Delivery devices which include a beneficial agent and an activating mechanism in separate compartments separated by a moveable partition are designed to deliver the beneficial agent in a pulsatile manner through an orifice. The pulsatile delivery is achieved by a band of resilient material which is placed over the orifice. The resilient material is sufficiently tight to substantially seal the orifice when the pressure within the device is below a threshold level while at the same time being capable of being stretched when the internal pressure exceeds the threshold.

Abstract: A method and means for reducing sensitization or irritation caused by transdermally delivered drugs, wherein one or more metabolic modulators is coadministered with a sensitizing or irritating drug.

Abstract: An iontophoretic agent delivery device, having a layered structure and peripheral insulation, wherein ion transport occurs through two opposing surfaces of said device. The device is especially suited to agent delivery through body surfaces exposed to body fluids. A method of delivering an agent through a body surface exposed to body fluids is also disclosed.

Abstract: Tablet treating system 10 treats a series of pharmaceutical tablets 50T with pulses of laser energy 24P within at least one predetermined treatment site 50S on each tablet. A tablet conveyer 12 continuously moves individual tablets along a tablet path 10P. A Laser 14 provides the pulses of laser energy along a stationary laser path which crosses the tablet path defining a stationary intersection zone 14Z common to both paths. The tablet path has periodic treatment windows 20W during which the treatment sites 50S on the moving tablets pass through the stationary intersection zone. The operation of the laser has periodic laser ready windows 24W during which the laser may be fired. A controller 16 is responsive to the movement of the tablet conveyer and to the operation of the laser for activating the laser and treating the tablets. The controller activates the laser when a tablet is passing through the intersection zone and the tablet treatment window coincides with the laser ready window.

Abstract: A dry-state iontophoretic drug delivery device (10, 70, 80) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. A liquid-containing pouch (21, 22) is provided. In certain embodiments the liquid is contained in breakable capsules within the pouch. Water or other liquid can be released from the capsules in the pouch by squeezing or flexing the pouches (21,22). Alternatively, the liquid can be released from the pouches (21,22) using pouch piercing pins (36,37). The liquid released from the pouches (21,22) hydrates the drug and electrolyte reservoirs (15, 16) and activates the device. In another embodiment, the device (20, 20a) has liquid-containing gel layers (31,32) which are initially separated from their respective electrode assemblies (8, 9). Liquid-wicking pathways (27,28) are provided to carry the liquid from the gel layers (31,32) to the drug and electrolyte layers (15, 16).

Abstract: A method of preventing sensitization in transdermal drug delivery by the inclusion of a corticosteroid, which will be coextensively coadministered with the sensitizing agent.

Abstract: A dispenser is disclosed for delivering a beneficial agent in a hydrophilic carrier formulation to an animal in a rate-controlled manner. The dispenser comprises (1) a semipermeable housing defining an internal space, (2) at least one composition comprising a beneficial agent and a pharmaceutically acceptable hydrophilic carrier in the space, (3) an expandable hydrophilic driving member in the space, (4) a density member in the space, and (5) one exit passageway or a multiplicity of exit passageways in the housing for delivering the beneficial agent from the dispenser, the diameter of each exit passageway being of a size to maximize release of the beneficial agent by osmotic pumping and to minimize release of the beneficial agent by diffusion or erosion to substantially avoid mechanical agitation-dependent release of the beneficial agent.

Abstract: The invention herein pertains to methods and materials for producing a nicotine maintenance pouch. Laminates comprising a nicotine barrier layer and a nicotine degradation agent barrier layer are disclosed. In a preferred embodiment, the nicotine barrier layer comprises a nitrile rubber modified acrylonitrilemethyl acrylate copolymer. An especially preferred nicotine barrier material comprises, by weight percent, 75% acrylonitrile, and 25% methyl acrylate with 10% butadiene (AN-MA/B). The nicotine degradation agent barrier layer is preferably aluminum foil. In an especially preferred embodiment, the laminate comprises a layer of AN-MA/B adhered to a layer of aluminum foil, which in turn is adhered to a layer of paper stock.Pouches comprising a self-sealed nicotine barrier layer and a nicotine degradation agent barrier layer are disclosed. These pouches are preferably formed from the laminates above.

Abstract: Erectile dysfunction, particularly impotence, priapism and Peyronie's disease is treated by the transurethral administration of a therapeutically effective agent. The agents are administered to the urethra by means of a penile insert (1) having a rapidly releasing coating (4) containing the agent on its exterior surface or by means of an inserter (27) carrying an agent containing dose of agent (31) which can be displaced into the urethra.

Abstract: The present invention is directed to a long-term dispensing device for the controlled delivery of a beneficial agent in a hydrophilic carrier, which device quickly and continuously delivers an effective amount of agent followed by a continuous and sustained delivery of agent in a controlled and uniform amount over a prolonged period of time, thus providing for delivery of beneficial agent to an environment of use at two different rates and having a fast startup.

Abstract: A two phase adhesive matrix for use in an electrically powered iontophoretic delivery device is provided. The adhesive matrix comprises an adhesive hydrophobic polymer phase and about 15 to 60 wt % on a dry weight basis of a hydrophilic polymer phase distributed through the hydrophobic polymer phase. The hydrophilic phase forms upon hydration an interconnecting network of aqueous pathways for passage of the agent through the adhesive. The adhesive can be used to adhere an electrode assembly of an iontophoretic delivery device to a body surface such as skin or a mucosal membrane. Alternatively, the adhesive can be used to adhere together two or more elements of an iontophoretic delivery device.

Abstract: A formulation chamber is disclosed comprising a wall surrounding a lumen containing a device for delivering a beneficial agent. The chamber has an inlet for admitting a fluid into the chamber and an outlet for letting an agent formulation leave the chamber. The chamber is adapted for use in an intravenous delivery system for delivering an agent formulation to a patient.