Abstract: The present invention is directed to the veterinary transdermal application of an active agent to an animal. More particularly, the invention is directed to an active agent dispenser or apparatus attachable to the ear of an animal for the transdermal delivery of an active agent to the animal. The dispenser comprises an ear tag component and a transdermal device component, wherein the transdermal component is held tightly in active agent-transmitting relation to the ear of an animal by the ear tag component.

Abstract: This invention relates to an active agent delivery device. More particularly, the invention relates to a delivery device that includes a sleeve to protect the delivery device from transient mechanical forces. The delivery device of the invention is robust and resistant to transient mechanical forces. The invention provides a fluid-imbibing delivery device comprising a housing enclosing an internal compartment, said housing having a first wall section that substantially restricts the passage of fluid into the delivery device, i.e. is substantially fluid-impermeable, and that contains a beneficial agent; a second wall section that permits the passage of fluid into the delivery device, i.e. is fluid-permeable, and that contains at least one expandable driving member; and exit means; with a protective sleeve means extending from the first wall section of the housing to cover and protect the second wall section of the housing and the junction of the first and second sections.

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 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 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: 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 dosage form is disclosed comprising means for delaying the delivery of drug from the dosage form following the administration of the dosage form to a patient in need of drug therapy.

Abstract: The present invention provides a method of reducing or preventing skin irritation of a weak base drug by inhibiting the accumulation of the drug in the lysosomes. The drug is irritating to humans, i.e., the drug is susceptible to inducing skin or mucosa irritation in a human when the drug is transdermally administered to the human at a therapeutically effective rate. Irritation reduction or prevention is induced by coadministering to the skin or mucosa of the human:(a) a therapeutically effective amount of a weak base drug which is irritating to humans, at a therapeutically effective rate over a predetermined period of time; and(b) an effective amount of an agent capable of inhibiting the lysosomal uptake of the drug to reduce or prevent irritation to the skin or mucosa.

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: The present invention is directed to a method of reducing or preventing skin sensitization by inhibiting the immunological processing of a sensitizing drug as an antigen. The drug is sensitizing to humans, i.e., the drug is susceptible to inducing skin or mucosa sensitization in a human when the drug is transdermally administered to the human at a therapeutically effective rate. Skin sensitization reduction or prevention is induced by coadministering to the skin or mucosa of the human:(a) a therapeutically effective amount of a sensitizing drug, at a therapeutically effective rate over a predetermined period of time; and(b) an antigen processing-inhibiting agent in an amount effective to inhibit the antigen processing of the drug.The system of the invention comprises a matrix adapted to be placed in sensitizing drug and antigen processing-inhibiting agent transmitting relation to the selected skin or mucosa site.

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.

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 diffusional drug delivery device is described which can provide for delayed onset of therapeutic effect and for delivery of the therapeutic agent in predetermined temporal patterns at optimum rates. Delay means are provided between the agent reservoir and the surface through which the agent is released by diffusion to delay the release of agent at a therapeutic rate for predetermined times after application. Suitable means include a delay membrane disposed between the releasing surface and the agent reservoir which membrane is preferably free of undissolved agent and/or is initially impermeable to the agent and thereafter becomes permeable. One or more agent chambers defined by one or more of such membranes may be provided, whereby agents are released in a predetermined temporal pattern at optimal release rates.

Abstract: The present invention is directed to an improved fluid-imbibing dispensing device for delivering a beneficial agent to a biological environment of use, the dispensing device being of the type having a housing which includes a fluid-impermeable first wall section with an open end and a fluid-permeable second wall section with an open end, an internal compartment formed by the first and second wall sections, exit means in the housing, a beneficial agent in that portion of the compartment formed by the first wall section, expandable driving means in that portion of the compartment formed by the second wall section, and a partition layer between the beneficial agent and the expandable driving means; wherein the improvement comprises the first wall section being comprised of an extremely fluid-impermeable material and the open end of each of the first wall section and the second wall section having reciprocally tapered edges one with the other to form a tapered lap joint for mating engagement, the tapered lap join

Abstract: The present invention provides a method of reducing or preventing skin irritation of a weak base drug by inhibiting the accumulation of the drug in the lysosomes. The drug is irritating to humans, i.e., the drug is susceptible to inducing skin or mucosa irritation in a human when the drug is transdermally administered to the human at a therapeutically effective rate. Irritation reduction or prevention is induced by coadministering to the skin or mucosa of the human:(a) a therapeutically effective amount of a weak base drug which is irritating to humans, at a therapeutically effective rate over a predetermined period of time; and(b) an effective amount of an agent capable of inhibiting the lysosomal uptake of the drug to reduce or prevent irritation to the skin or mucosa.