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.

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: A reservoir and a family of reservoirs are provided which are designed to be used with a single controller to provide a wide range of therapeutic drug delivering regimens while maintaining many of the same reservoir configurations and drug formulations. A method of making a reservoir and a family of reservoirs and incorporating them into an electrotransport system is disclosed.

Abstract: A device and method for enhancing skin piercing by microprotrusions involves pre-stretching the skin to enhance pathway formation when the microprotrusions are pressed into the skin. An expandable device includes skin engaging opposite ends that contact the skin surface so that when the device is expanded the skin is stretched. The skin is placed under a tension of about 0.01 to about 10 megapascals, preferably about 0.05 to 2 megapascals. The device has a plurality of microprotrusions which penetrate the skin while the skin is being stretched by the expanded device. Another stretching device employs suction for skin stretching.

Abstract: The present invention is directed to an osmotic engine useful in an osmotic delivery system for delivery of a beneficial agent in a controlled manner over a preselected administration period. By including a flowable engine comprising at least one osmotic agent and at least one fluid vehicle, the resulting osmotic engine reaches a zero order push power or push rate quickly and provides steady delivery of the beneficial agent.

Abstract: An implant retention trocar includes a cannula for puncturing the skin of an animal and an obturator for delivering the implant beneath the skin of the animal. The implant retention trocar has a cannula distal tip design which causes a minimum of trama and tearing of tissue during implant insertion. A spring element received within the cannula prevents an implant which is to be inserted into an animal from falling out of the cannula during the implant insertion process. The spring element includes a longitudinal leg which is folded with a zig-zag shaped bend. When the spring element is inserted into the cannula the zig-zag shaped bend of the longitudinal leg retains the implant within the cannula.

Abstract: A composition is disclosed comprising a polymer and a surfactant in a solvent exhibiting a common solubility for the polymer and the surfactant. The composition provides a dosage form for administering a drug over time.

Abstract: A reservoir and a family of reservoirs are provided which are designed to be used with a single controller to provide a wide range of therapeutic drug delivering regimens while maintaining many of the same reservoir configurations and drug formulations. A method of making a reservoir and a family of reservoirs and incorporating them into an electrotransport system is disclosed.

Abstract: An electrotransport reservoir housing which contains, integrally formed therein, at least one region of conductive material which allows for a liquid and moisture tight barrier, while at the same time providing a means for conducting an electric current therethrough.

Abstract: An electrotransport device (20) for delivering one or more therapeutic agents through the skin includes electrodes (30,32) for contacting the skin (34), at least one electrode containing the agent, a power source (22) for generating electrical current (IL) for delivering the agent, a current generating and controlling means (24), and a disabling means (26) for permanently and irreversibly disabling the current. The disabling means (26) may include a timer means (66), a counter means (82), or a body parameter sensor (134) and limit comparator (132) to effect permanent disabling. The disabling means may be a permanent transition to a disabled logic state, a permanent discharge of a power supply source (22), or a permanent diversion of electrotransport current from the electrodes (30,32), or a combination of the above.

Abstract: The invention provides an improved electrotransport drug delivery system for analgesic drugs, namely fentanyl and sufentanil. The fentanyl/sufentanil is provided as a water soluble salt (e.g., fentanyl hydrochloride), preferably in a hydrogel formulation, for use in an electrotransport device (10). In accordance with the present invention, a transdermal electrotransport delivered dose of fentanyl/sufentanil is provided which is sufficient to induce analgesia in (e.g., adult) human patients suffering from moderate-to-severe pain associated with major surgical procedures.

Abstract: An implantable osmotically driven delivery system having a dynamic, two-way valve and a self-adjusting, variable geometry fluid flow channel. As pressure within the agent delivery system increases, the fluid channel narrows, thereby restricting flow. At exceptionally high pressures, the valve can be designed to close altogether at the orifice or delivery end, or it can provide a minimal leak path so that a maximum fluid flow is never exceeded. At zero or very low pressures, the valve will close completely at the beneficial agent reservoir end, isolating the beneficial agent formulation from external fluid infiltration and thereby eliminating diffusion of external fluid into the beneficial agent formulation.

Abstract: A dosage form for delivery of a therapeutic agent to a subject is described. The dosage form contains: (a) an outer wall defining an interior compartment; (b) within the interior compartment, a therapeutic agent; (c) at least one exit orifice formed by laser ablation of the outer wall for release of the agent therethrough, and (d) a barrier layer disposed between the outer wall and the interior compartment in at least a region corresponding to the exit orifice. The barrier layer comprises a material that allows the barrier layer to remain intact during laser-formation of the at least one exit orifice in the outer wall. Also disclosed is a method for controlling the depth of laser ablation of a dosage form during laser formation of an exit orifice in an outer wall of the dosage form.

Abstract: The present invention provides a syringe cartridge that is sufficiently robust to be used in autoinjectors that generate injection forces sufficient to deliver viscous medicaments. The syringe cartridge of the present invention includes a syringe, a bias mechanism, and a casing. The casing of the syringe cartridge of the present invention includes a collapsible portion and a fixed portion. Advantageously, the collapsible portion of the casing collapses within the fixed portion of the casing as the syringe is driven through its stroke within the syringe cartridge. As the collapsible portion collapses within the fixed portion, the length of the syringe cartridge is effectively reduced, which, in turn, allows the use of a shorter plunger and thereby facilitates the construction of a more compact autoinjector.

Abstract: Composition of matter for application to a body surface or membrane to administer fluoxetine by permeation through the body surface or membrane, the composition comprising fluoxetine to be administered, at a therapeutically effective rate, alone or in combination with a permeation enhancer or mixture. A preferred embodiment is directed to the transdermal administration of fluoxetine at reduced skin irritation levels wherein fluoxetine, preferably provided as fluoxetine acetate, is coadministered with a corticosteroid such as hydrocortisone. Also disclosed are drug delivery devices containing the fluoxetine or fluoxetine and enhancer composition and methods for the transdermal administration of the fluoxetine and fluoxetine/enhancer composition.

Abstract: A method of preparing lipid particles having an asymmetric lipid coating is described. The lipid composition of the outer lipid coating of the particles varies from the inner to outer surfaces. The asymmetric lipid particles are formed by preparing a lipid composition containing a charged lipid and a therapeutic agent, where the particles each have an outer lipid coating with an external lipid leaflet and an internal lipid structure. The particles are then incubated under conditions effective to remove the charged lipid from the external lipid leaflet, thus rendering the lipid coating asymmetric. The particles have the ability to their regain surface charge via translocation of the lipids.

Abstract: An osmotic delivery system having a space-efficient piston is provided. The enclosure has an interior holding the piston, a beneficial agent, and an osmopolymer including a tablet. 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 osmopolymer from the beneficial agent. The piston has a recess that receives at least a portion of the osmopolymer. The osmopolymer 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: Conjugates of a hydrophobic moiety, such as a lipid, linked through a cleavable dithiobenzyl linkage to a therapeutic agent are described. The dithiobenzyl linkage is susceptible to cleavage by mild thiolysis, resulting in release of the therapeutic agent in its original form. The linkage is stable under nonreducing conditions. The conjugate can be incorporated into liposomes for administration in vivo and release of the therapeutic agent in response to endogeneous in vivo reducing conditions or in response to administration of an exogeneous reducing agent.

Abstract: A reservoir and a family of reservoirs are provided which are designed to be used with a single controller to provide a wide range of therapeutic drug delivering regimens while maintaining many of the same reservoir configurations and drug formulations. A method of making a reservoir and a family of reservoirs and incorporating them into an electrotransport system is disclosed.

Abstract: An osmotic delivery system has a membrane plug retention mechanism which can also be used to control the delivery rate of a beneficial agent from the osmotic delivery system. The osmotic delivery device includes an implant capsule containing a beneficial agent and an osmotic agent. Holes are formed along a side wall of the implant capsule at an open end of the capsule. When the membrane plug is inserted into the open end of the capsule, the membrane material swells into the holes in the capsule side wall creating a large frictional force which prevents expulsion of the membrane plug. A beneficial agent delivery rate of the osmotic delivery system is controllable by varying the size and number of the holes to change the amount of exposed surface area of the membrane plug. An increase in the surface area of the membrane plug exposed to the exterior environment causes a corresponding increase in the liquid permeation rate of the membrane and thus, increases the beneficial agent delivery rate.