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: Compositions and dosage forms for administering abusable substances are disclosed which have a reduced potential for abuse without diminishing the therapeutic or beneficial effects of the abusable substance. Topical compositions for application to the skin or mucosa contain the abusable substance in a form which is permeable to the skin or mucosa to which it is to be applied and an antagonist for the abusable substance is present in the composition in an abuse negating amount and in a form that is impermeable to the skin or mucosa to which the composition is to be applied. Controlled release dosage forms which release the abusable substance from a drug reservoir composition confined behind a release rate controlling barrier have the abusable substance and its antagonist in the drug reservoir. The abusable substance is present in a form that is releasable from the dosage form and the antagonist is present in an abuse negating amount in a form that is not releasable from the dosage form.

Abstract: An improved osmotic engine is disclosed. The osmotic engine is adapted to be used with an osmotically driven syringe which can be used to deliver a beneficial agent, such as a drug, at a pre-determined rate over an extended period of time. The osmotic engine has an exterior wall defining a compartment which contains an osmotic solute. The wall comprises a thin permeable and/or microporous material which is permeable to an external fluid such as water but is impermeable to the solute. The wall also has a delivery orifice drilled therethrough. A rigid non-dissolving ring-shaped wall support is provided for maintaining the shape of the engine during use. The wall support also provides an open fluid flow path extending from the semipermeable wall portion toward the delivery orifice. The open fluid flow path minimizes the time required for the engine to begin pumping.

Abstract: An adhesive composition suitable for use as an in-line contact adhesive for electrotransport drug delivery systems.

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 corrosion resistent density element for use in ruminal delivery devices which fragments upon contact with the blades in grinding machinery without damage to the blades. The density element has density of at least about 1.5 g/ml and a transverse rupture strength no greater than about 30,000 psi.

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: An osmotic device (10) for delivering a beneficial drug, such as an anti-microbial drug, into the mouth of a human patient is disclosed. The device (10) has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device comprises a thin semipermeable membrane wall (12) surrounding a compartment (13) housing a beneficial agent (14) that has at least some degree of solubility in aqueous biological fluids, e.g., saliva, and a fibrous support material (15) composed of hydrophilic water-insoluble fibers. A passageway (17) in the wall (12) connects the agent 14) with the exterior of the device (10). The wall (12) is permeable to the passage of aqueous biological fluid but substantially impermeable to the passage of the fibrous support material (15).

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

Abstract: A membrane capable of controlling the rate at which an agent is released from an iontophoretic delivery device is provided. The membrane inhibits agent release from the delivery device when no electrical current is flowing and yet provides minimal impedance to electrically-assisted agent delivery. The membrane is useful both as a control membrane in an iontophoretic agent delivery device and as a test membrane for testing the performance characteristics of an iontophoretic agent delivery device in vitro.

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: An improved method for delivering a drug or beneficial agent transdermally to humans by iontophoresis is provided. The method includes selecting and iontophoretically delivering the drug through a skin site which optimizes the transdermal delivery rate of the drug while minimizing inter-patient variability in skin resistance.

Abstract: A transdermal therapeutic system which utilizes electrical current to facilitate drug delivery.

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: An agent formulator (30, 60) for an intravenous administration set (14) is provided. The intravenous administration set (14) includes a container (12) of an IV fluid (13), a drip chamber (22), an agent formulator (30, 60) and an adapter-needle assembly (28). The agent formulator (30, 60) has a fluid inlet (23) and a fluid outlet (25) for maintaining a flow of IV fluid (13 ) therethrough. A portion (36) of the formulator wall (32) is comprised of a window material which allows the agent to diffuse therethrough but which prevents convective loss of the IV fluid (13). A flow distributor (38, 68) is provided within the chamber for distributing the flow of IV fluid (13) along the interior surface of the window (36). A transdermal-type drug delivery device (40) is adhered to the exterior surface of the window (36). Drug is delivered by the delivery device (40) through the window (36) and into the flowing IV fluid (13).

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: 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.o to t.sub.1 and t.sub.1 to t.sub.2).

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: An osmotic device (10) for the controlled systemic delivery of nicotine through an oral mucosal membrane of a human patient is disclosed. The device (10) has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device (10) comprises a semipermeable wall (12) surrounding a compartment (13) containing a nicotine salt (14) and optionally an alkaline salt which is capable of reacting with the nicotine salt in the presence of water to form nicotine base. The conversion of nicotine salt to nicotine base may take place within the device (10) and/or outside the device and in the patient's mouth. Nicotine base and/or salt is delivered from the compartment (13) through a passageway (17) in the wall (12). The nicotine salt exhibits good stability and shelf life while the nicotine base exhibits excellent absorption through oral mucosal membranes.

Abstract: An electrically powered iontophoretic delivery device is provided. The device utilizes electrodes composed of a polymeric matrix containing about 5 to 40 vol % of a conductive filler which forms a conductive network through the matrix, and about 5 to 40 vol % of a chemical species which is able to undergo either oxidation or reduction during operation of the device. Preferably, the conductive filler is carbon or graphite fibers. For the anode electrode, the chemical species should be able to undergo oxidation and is preferably either silver or zinc. For the cathode electrode, the chemical species should be able to undergo reduction and is preferably silver chloride.