Abstract: There is disclosed an insert for the orifice of a ruminal bolus. The insert fits within the exit orifice of the ruminal bolus such that the medicated paste being discharged passes through the insert creating a back pressure within the paste compartment of the bolus which improves the performance of the bolus. The insert also prevents foreign objects from becoming lodged in the orifice. The insert consists of a grid-like series of openings with insert members extending into the orifice for a significant portion of the total length. Integral with the insert is a flange which secures the insert within the orifice and prevents it from being removed from the orifice or from being driven into the orifice.

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

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: A method of inducing immune tolerance to a drug which is normally sensitizing to humans when applied to human skin or mucosa is provided. The sensitizing drug is continuously and co-extensively administered to a selected skin or mucosa site with the corticosteroid. Preferably, the corticosteroid is hydrocortisone or an ester thereof. The corticosteroid is administered to the selected skin or mucosa site at a rate and for a period of time sufficient to induce tolerance to the drug. Thereafter, the drug can be administered to the human, without administering any corticosteroid, without danger of inducing sensitization to the drug in the human.

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 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: 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 acrylonitrile-methyl 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: 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 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: A press is provided for simultaneously pressing and piercing an object. The piercing means moves from a sheathed to unsheathed position in response to compressive pressure. The piercing means are normally biased in the sheathed position by a bias means. Methods and apparatus for piercing an object are disclosed. The press can be used to produce a pierced dispensing device having a compression coating by (a) charging to a die mold a quantity of powder to be compressed; (b) delivering to the die mold an unpierced dispensing device core; (c) charging to the die mold an additional quantity of powder to be compressed; and (d) substantially simultaneously (i) compressing the elements within the die mold to produce a compression coating, and (ii) piercing the compression coating. The compression coating can comprise, for example, a loading dose or a semipermeable membrane.

Abstract: A parenteral delivery system and a formulation chamber are disclosed for administering a beneficial agent. The parenteral delivery system comprises a drip chamber and a formulation chamber. The formulation chamber comprises a wall surrounding an internal space and it has an inlet for admitting a liquid into the formulation chamber and an outlet for letting an agent formulation leave the formulation chamber. The chamber houses an agent delivery system for releasing a beneficial agent into a liquid that enters the chamber.

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: A dosage form is disclosed comprising a drug and a maltodextrin polymer for administering to a patient a drug in need of therapy.

Abstract: A method of inducing immune tolerance to a drug which is normally sensitizing to humans when applied to human skin or mucosa is provided. The sensitizing drug is continuously and co-extensively administered to a selected skin or mucosa site with the corticosteroid. Preferably, the corticosteroid is hydrocortisone or an ester thereof. The corticosteroid is administered to the selected skin or mucosa site at a rate and for a period of time sufficient to induce tolerance to the drug. Thereafter, the drug can be administered to the human, without administering any corticosteroid, without danger of inducing sensitization to the drug in the human.

Abstract: A drug formulation chamber for an intravenous administration set is provided. The intravenous administration set includes a container of an IV fluid, a drip chamber, a drug formulation chamber, and an adapter-needle assembly. The drug formulation chamber has a fluid inlet and a fluid outlet for maintaining a flow of IV fluid through the chamber. A portion of the chamber wall is comprised of a window material which allows the drug to diffuse therethrough but which prevents convective loss of the IV fluid. A flow distributor is provided within the chamber for distributing the flow of IV fluid along the interior surface of the window. A transdermal-type drug delivery device is adhered to the exterior surface of the window. Drug is delivered by the delivery device through the window and into the flowing IV fluid. The device delivers drug into the IV fluid at a rate that is independent of the flow rate of IV fluid through the formulation chamber.

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: A dosage form is disclosed comprising granule means for delivering soluble to insoluble drug to a warm-blooded animal.

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: An implantable osmotically driven syringe is disclosed which can be used to deliver a beneficial agent, such as a drug, at a predetermined rate over an extended period of time. A movable piston divides the syringe into a beneficial agent-containing compartment and a driving compartment. The piston is movable into a position wherein the driving compartment has a volume of essentially zero. The syringe is driven by an osmotic engine which has a shaped wall surrounding, and in contact with, an osmotic solute. The wall is comprised of a semipermeable and/or microporous material which is permeable to the external fluid (e.g., water) but is impermeable to the solute. The engine also has a passageway forming a fluid flow path between the osmotic solute and the driving compartment. A portion of the wall is exposed to a fluid-containing external environment. At least about 30% of the wall which contacts the solute also is exposed to the fluid in the external environment.