Abstract: Apparatus (11) for delivery of a medicament, drug or other therapeutic agent transdermally to a body by iontophoresis is provided. The apparatus (11) provides a means (13) for measuring and displaying the cumulative amount of the medicament delivered to the body by monitoring the amount of a metal, initially present at the anode (45), that is transferred to the cathode (41) in a subsidiary electrolyte cell (47) through which the drive current for the apparatus (11) passes. Optionally, the apparatus also provides a plurality of light emitting devices (63-1) that display a measure of the cumulative amount of medicament delivered, by use of visually distinguishable light colors or by use of binary encoding in the light display.

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 dispenser for use in a fluid environment which is capable of delivery of a plurality of discrete drug-containing units in any desired delivery pattern or profile.

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 dosage form is disclosed that comprises means inside the dosage form for providing a substantially drug-free interval before the dosage form delivers a drug from inside the dosage form. The dosage form in an embodiment comprises a drug on the exterior of the dosage form, which drug is available for immediate delivery.

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: A dosage form comprising (1) an immediately available dose of a beneficial drug followed by a timed delayed dose of drug, or (2) a timed delayed dose of drug.

Abstract: The present invention is directed to a fluid-imbibing drug delivery device having a first, low density such that it floats in the stomach contents for a predetermined prolonged period of time, during which prolonged period of time it dispenses a drug or other active agent to the stomach, and having a second, higher density such that the device exits the stomach at the end of the predetermined prolonged period of time.

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

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 dosage form is disclosed comprising a coat that surrounds a drug. The coat comprises a subcoat and an overcoat thermally annealed to provide a single unit coat around the drug.

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 dosage form is disclosed that comprises means inside the dosage form for providing a substantially drug-free interval before the dosage form delivers a drug from inside the dosage form. The dosage form in an embodiment comprises a drug on the exterior of the dosage form, which drug is available for immediate delivery.

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: A dosage form comprising (1) an immediately available dose of a beneficial drug followed by a timed delayed dose of drug, or (2) a timed delayed dose of drug.

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.