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: Rate controlled transdermal nicotine delivery systems are disclosed which utilize an in-line adhesive to maintain the systems on the skin. The initial equilibrated concentration of nicotine in the nicotine reservoir and the adhesive is below saturation, preferably at a thermodynamic activity no greater than 0.50, and the reservoir comprises the nicotine dissolved in a material with respect to which the rate controlling element of the device is substantially impermeable. In preferred embodiments the initial loading of nicotine in the reservoir is sufficient to prevent the activity of the nicotine in the reservoir from decreasing by more than about 75% and preferably no more than about 25% during the predetermined period of administration; and the thickness of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and, preferably at least 75% of the initial equilibrated nicotine loading is in the reservoir layer.

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 material which is permeable to the drug but which prevents convective loss of the IV fluid. A transdermal-type drug delivery device is adhered to the semipermeable/microporous wall portion. Drug is delivered by the delivery device through the wall portion 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. The rate of drug delivery from the device into the IV fluid is controlled by either the wall portion or a membrane layer in the drug delivery device.

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: 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 a fluid flow path extending from the semipermeable wall portion toward the delivery orifice.

Abstract: An agent dispenser of the fluid imbibing type having a flexible bag within a membrane and in which a wicking or wetting device is in contact with the outer surface of the membrane to keep such outer surface wet at all times for all attitudes of a containment vessel housing the bag and the membrane. The wicking device is in the form of a fabric tube, such as a stretch knit fabric, or a preformed hydrophilic polymeric sleeve, which can be mounted on the outer surface of the membrane and remain in contact with it so long as there is any liquid in the containment vessel. Since the amount of water drawn by the wicking device is controlled by the membrane porosity and the amount of a solute composition in an intermediate layer between the bag and the membrane, the wicking device provides for a continuous controlled delivery of agent from the inner bag of the dispenser.

Abstract: A transdermal delivery device having a release-rate controlling-adhesive is disclosed having improved delivery characteristics. The device employs a polyisobutylene/mineral oil adhesive formulation and an ethylene/viny acetate (EVA) drug reservoir formulation. The device is useful in delivering a wide variety of transdermally administrable drugs, particularly those which are moderately soluble in mineral oil. Preferred embodiments deliver timolol base and atropine base from an EVA (40% VA) reservoir formulation.

Abstract: A patient-care apparatus comprising a container for receiving a biological fluid, and a delivery device on the outside of the container, which device comprises a biocide that is released to the container for preventing the multiplication of and/or eliminating the presence of unwanted pathogens in the container.

Abstract: An improved imbibing agent dispenser having a snap-on closure which is highly reliable, is simple to assemble on one end of the agent dispenser, and can be made at minimum expense without requiring heat or an adhesive to bond the closure to the dispenser. The closure is held in place on the dispenser by a locking feature formed by a shoulder on the end of the dispenser and a ledge on an outer, annular wall of the closure, the ledge being removably hooked beneath and biased toward the shoulder to releasably lock the closure to the dispenser. An important aspect of this closure is that the design provides for the complete containment of a solute component within the dispenser.

Abstract: A diffusional drug delivery device is described which can provide shelf life stability of the system components, elimination of the initial burst of drug and hence irritation, delayed onset of therapeutic effect and delivery of a therapeutic agent at an optimum rate. A metal layer and an activating means are inert when dry. Moisture activates the system whereby the activating means provides release of an eroding agent which erodes the metal layer through which the therapeutic agent diffuses and is subsequently delivered.

Abstract: An agent dispenser of the fluid imbibing type wherein the dispenser has a closure, such as a plug, closing an open end of the dispenser. The closure has a catheter coupled with it, and the catheter is in agent communication with the interior of the agent receiving means of the dispenser when the closure is put into place in closing relationship to the dispenser. Thus, when the agent receiving portion (reservoir) of the agent receiving means is filled, such as by a needle passing through a septum at the outer end of the closure, not only will the reservoir be filled, but also the catheter will be filled and thereby be primed, so that the catheter will be ready for use after it has been completely primed. The present invention, therefore, permits the filling of the reservoir and the priming of the catheter in a single step.

Abstract: Rate-controlled transdermal delivery devices are disclosed which utilize an in-line adhesive to maintain the device on the skin and deliver an agent which is a solvent for the in-line adhesive. The initial equilibrated concentration of the agent in the agent reservoir and the adhesive is below saturation and the reservoir comprises the agent dissolved in a solvent with respect to which the rate controlling element of the device is substantially impermeable. In preferred embodiments the initial loading of the agent in reservoir is sufficient to prevent the activity of the agent in the reservoir from decreasing by more than about 50% and preferrably no more than about 25% during the predetermined period of administration; and the thicknesses of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and, preferrably at least 75% initial equilibrated agent loading is in the reservoir layer.

Abstract: A diffusional drug delivery device is described which can provide for stability of the adhesive and system components, elimination of the initial burst of drug and hence irritation, and to provide for delayed onset of therapeutic effect along with delivery of a therapeutic agent at an optimum rate. The therapeutic agent in a first form which is suitable for storage, and the anhydrous activating means are inert when in an anhydrous environment. Moisture activates the system whereby the activating means provides an acidic or basic solution and the first form of the therapeutic agent is converted to a second form which is suitable for absorption through the skin or mucosa.

Abstract: A transdermal delivery system for the administering of ethinyl estradiol and levonorgestrel, in combination, utilizing a polymer matrix having the drug formulation along with a permeation enhancer dispersed throughout.

Abstract: A diffusional drug delivery device is described which can provide for stability of the adhesive and system components, elimination of the initial burst of drug and hence irritation, and to provide for delayed onset of therapeutic effect along with delivery of a therapeutic agent at an optimum rate. The therapeutic agent in a first form which is suitable for storage, and the anhydrous activating means are inert when in an anhydrous environment. Moisture activates the system whereby the activating means provides an acidic or basic solution and the first form of the therapeutic agent is converted to a second form which is suitable for absorption through the skin or mucosa.

Abstract: Transdermal delivery systems for delivery of fentanyl and its analgetically effective derivatives for extended periods of time are disclosed which deliver the base form of the drug at a rate of from 0.5 to 10 .mu.g/cm.sup.2 /hr for a substantial portion of their useful life. The systems can be from 5-100 cm.sup.2 in releasing surface and preferably employ an in-line amine resistant adhesive. Preferred rate controlled systems utilize an aqueous ethanolic gel to minimize drug content.

Abstract: A formulation dispenser is disclosed for use in a parenteral delivery system. The dispenser comprises an inlet for admitting fluid into the dispenser and an outlet for letting fluid leave the dispenser. A beneficial agent is housed in a formulation chamber in the dispenser and a membrane permeable to fluid and agent defines one boundary of the formulation chamber. A piston is slideably disposed in the dispenser for governing the flow of fluid through the dispenser, or for permitting fluid to contact the membrane and enter the formulation chamber for forming a solution containing agent that flows through the outlet into the parenteral system.

Abstract: A formulation dispenser is disclosed for use in a parenteral delivery system. The dispenser comprises an inlet for admitting fluid into the dispenser and an outlet for letting fluid leave the dispenser. A beneficial agent is housed in a formulation chamber in the dispenser and a membrane permeable to fluid and agent defines one boundary of the formulation chamber. A piston is slideably disposed in the dispenser for governing the flow of fluid through the dispenser, or for permitting fluid to contact the membrane and enter the formulation chamber for forming a solution containing agent that flows through the outlet into the parenteral system.