Abstract: A percutaneous agent delivery or sampling device comprising a sheet having a plurality of microblades for piercing and anchoring to the skin for increasing transdermal flux of an agent and for improving the attachment of the device to the skin.

Abstract: The present invention is related to methods for lowering peroxide levels in sucrose acetate isobutyrate formulations and to composition used in and formed by such methods.

Abstract: An improved method for the manufacture of transdermal drug delivery devices comprising liquid dispersions of a liquid in an aqueous or nonaqueous matrix is disclosed. More particularly, the invention relates to preventing the formation of a crystalline structure in such liquid dispersions by annealing films and laminates in-line immediately following film formation and/or lamination during the manufacture of these devices.

Abstract: Formulations and methods are provided for improving the stability upon exposure to aqueous media of polypeptides present in non-aqueous suspension vehicles. In particular aspects of the invention, formulations are provided that comprise a complex of a metal ion and a polypeptide suspended in a non-aqueous, biocompatible suspension vehicle. Aggregation of individual polypeptide molecules is reduced when aqueous media is introduced to such formulations, serving to stabilize the polypeptide.

Abstract: An osmotic delivery system for controlled delivery of a beneficial agent includes an implantable capsule containing a beneficial agent and an osmotic engine that swells on contact with water, thereby causing the release of the beneficial agent over time. The osmotic delivery system has a membrane material that allows a controlled amount of fluid to enter from an exterior of the capsule, while preventing the compositions within the capsule from passing out of the capsule. The osmotic delivery system is designed to meet at least the operating pressures of 1000 psi. The membrane material is cast, calendered or extruded followed by machining (i.e., die-cutting, stamping or otherwise cutting to shape) to provide a uniform nonribbed membrane material. The capsule also includes a membrane material-retaining means that is positioned at a fluid uptake end to retain the membrane material within the capsule, even under periods of high pressure.

Abstract: A liposome composition comprising small, surface-bound effector molecules is disclosed. The liposomes have a surface layer of hydrophilic polymer chains, for enhanced circulation time in the bloodstream. The effector molecules are attached to the distal ends of the polymer chains. In one embodiment, the effector is polymyxin B, for treatment of septic shock.

Abstract: A device for intraosseous drug delivery includes a first implant body having a delivery orifice at a distal end thereof. The first implant body is adapted for mounting in a jawbone such that the delivery orifice communicates with the jawbone. The device further includes a drug cartridge including a reservoir for a drug disposed in the first implant body. The device further includes a pump disposed in the first implant body for pumping the drug from the reservoir to the delivery orifice.

Abstract: A system for intraosseous drug delivery includes a reservoir containing a drug, an injection port which provides a route through which the drug can be delivered to a root of a tooth from an exterior of the tooth, and an injection needle in communication with the reservoir and adapted for insertion into the injection port. A portal for intraosseous drug delivery includes a prosthetic body adapted to mate with a tooth and a port formed in the prosthetic body such that when the prosthetic body mates with the tooth a route is formed through which a drug can be delivered from an exterior of the prosthetic body to a root of the tooth.

Abstract: An osmotic intraosseous drug delivery device includes an artificial crown having a cavity defined therein and at least one inlet port in communication with the cavity. The device also includes an osmotic module including an osmotic agent and a drug formulation. The osmotic module is adapted to be inserted in the cavity in order to allow fluid received in the cavity through the inlet port to activate the osmotic module. The osmotic module has an outlet port through which the drug formulation can be dispensed.

Abstract: The present invention provides a compressed gas cylinder that is capable of storing a compressed fluid at high pressures. The cylinder of the present invention includes a body terminating in an inwardly domed cap. The dome included in the cap of the compressed gas cylinder of the present invention is formed such that the material near the tip of the dome is relatively thinner than the material near the base of the dome. The tip of the dome, therefore, creates a pierce region in the cap that can be pierced through the application of a relatively low pressure.

Abstract: A liposome composition comprising small, surface-bound effector molecules is disclosed. The liposomes have a surface layer of hydrophilic polymer chains, for enhanced circulation time in the bloodstream. The effector molecules are attached to the distal ends of the polymer chains. In one embodiment, the effector is polymyxin B, for treatment of septic shock.

Abstract: A dosage form is disclosed comprising a drug formulation that self-emulsifies in the drug formulation.

Abstract: An electrotransport agent delivery device (10) for delivering a therapeutic agent through intact skin, and a method of operating same, is provided. The device applies a pulsing electrotransport current wherein the length of the applied current pulses is at least 5 msec and preferably at least 10 msec. Most preferably, the current pulses have a magnitude above a critical level (Ic) at which the skin is transformed into a higher electrotransport delivery efficiency (E) state.

Abstract: A method and device are described for applying a microprotrusion member (44) including a plurality of microprotrusions (90) to the stratum corneum with impact. The method and device are used to improve transport of an agent across the skin for agent delivery or sampling. The applicator (10, 60, 80) causes the microprotrusion member (44) to impact the stratum corneum with a certain amount of impact determined to effectively pierce the skin with the microprotrusions (90). The preferred applicator (10, 60, 80) impacts the stratum corneum with the microprotrusion member (44) with an impact of at least 0.05 joules per cm2 of the microprotrusion member (44) in 10 msec or less.

Abstract: Reagents for use in preparing a therapeutic liposome composition sensitized to a target cell are described. The reagents include a liposomal composition composed of pre-formed liposomes having an entrapped therapeutic agent and a plurality of targeting conjugates composed of a lipid, a hydrophilic polymer and a targeting ligand. The therapeutic, target-cell sensitized liposome composition is formed by incubating the liposomal composition with a selected conjugate.

Abstract: An osmotic pump having a minimally compliant, volume-efficient piston positioned within a capsule is provided. The capsule has an interior surface, a beneficial agent, and an osmotic agent. The piston is movable with respect to an interior surface of the capsule, and defines a movable seal with the interior surface of the capsule. The movable seal separates the osmotic agent from the beneficial agent. The piston has a length-to-total-diameter ratio of about 1.1:1 and a core-diameter-to-total-diameter ratio of about 0.9:1. The piston enables greater beneficial agent and/or osmotic agent payload without increasing the size of the capsule. The osmotic agent imbibes liquid from a surrounding environment through a semipermeable body to cause the piston to move and, in turn, cause delivery of the beneficial agent from the capsule.

Abstract: A liposome composition for delivery of a nucleic acid in vivo or ex vivo is described. The liposomes in the composition are comprised of (i) a lipid that is neutral in charge at physiologic pH and positively charged at pH values less than physiologic pH and (ii) a lipid joined to a hydrophilic polymer by a dithiobenzyl linkage. The liposomes are associated with a nucleic acid for delivery to a cell.

Abstract: A liposomal composition and a method of using the same for achieving intracellular delivery of a liposome-entrapped agent is described. The liposomes are composed of a pH sensitive lipid and include a targeting ligand to direct the liposomes to a target cell. The liposomes also include a stabilizing component, such a polymer-derivatized lipid, where the polymer is attached to the lipid by a releasable linkage. Administration of the liposomes results in cellular internalization and destabilization of the liposome for intracellular delivery of the entrapped agent.

Abstract: The present invention includes an automatic injection device that reliably provides automatic needle retraction even when manufactured with part and assembly tolerances typical of low-cost and high-volume manufacturing processes. The injector of the present invention includes a body, a syringe cartridge, a drive mechanism, and a bias mechanism. The drive mechanism includes an energy source, a drive member, and a compound plunger with a releasable coupling. Significantly, the compound plunger included in the drive mechanism is designed to ensure needle retraction occurs after the automatic injection device has delivered the desired dose of medicament. Moreover, the design of the compound plunger included in the injector of the present invention can compensate for part and assembly tolerances typical of low-cost, high volume manufacturing processes, enabling the fabrication of a low cost automatic injection device providing reliable automatic needle retraction.

Abstract: An applicator for applying a microprojection member to the stratum corneum of a patient having a housing, a piston moveable within the housing and a cap adapted to activate the applicator. The applicator is self-setting and auto-triggering, which allows the applicator to be used by patient's having neither the strength, nor the manual dexterity to pre-set and activate other types of applicator devices.