Abstract: The present invention provides a multi-release oral drug delivery system that initiates drug release following an initial drug-free release interval, after administration to a subject, and a second drug-free release period before release of another dose of drug. The system has (1) inner compartments enclosed within a semipermeable membrane, and (2) a drug coating on the exterior of the semipermeable membrane surrounded by a microporous membrane, which microporous membrane is permeable to fluid and drug. The drug coating is released after the initial drug-free release interval. An inner compartment drug is released after a second drug-free release interval provided by a drug-free inner compartment.

Abstract: A pump for pumping drugs, medicaments or other liquids is disclosed having suture loops co-extensive with the outside wall of the pump. At least one depression is formed in the outside wall of the pump to strengthen the wall.

Abstract: An osmotic delivery system flow modulator assembly, an osmotic delivery system with a flow modulator assembly, and a method of assembling an osmotic delivery system. The osmotic delivery system flow modular assembly includes a body having a hole located through the body and communicating two opposing ends of the body. The use of the osmotic delivery system flow modulator assembly lessens the chance that air or gas pockets will form in the enclosure of the osmotic delivery system during assembly of the system. Because less air is within the osmotic delivery system, performance of the system is enhanced. Use of the flow modulator assembly also lessens the chance that beneficial agent will be wasted during assembly of the osmotic delivery system.

Abstract: The present invention relates to devices that allow for linear, sustained-release of solutes with adjustable initial-release kinetics. In particular, the present invention relates to devices for delivering substances to the body of an animal. The present invention also relates to methods for delivering solutes in a constant, sustained-release fashion using the devices of the invention.

Abstract: An osmotic delivery system for controlled delivery of a beneficial agent includes an implant capsule having a beneficial agent reservoir, an osmotic agent which expands on contact with fluid imbibed through a permeable membrane retained by the implant capsule, a delivery port, and a valve for opening and closing the delivery port. When the osmotic agent expands, a pressure is exerted against a separating member positioned between the beneficial agent reservoir and the osmotic agent. The separating member moves within the capsule, thereby forcing the valve to move a distance such that the beneficial agent can exit the reservoir through the delivery port.

Abstract: An osmotic beneficial agent delivery system includes an implantable osmotic delivery device and a catheter for delivery of the beneficial agent from the delivery device to a delivery location. The beneficial agent delivery system includes a catheter and a docking station which are implanted in the patient with a distal end of the catheter positioned at a delivery site. The catheter and docking station are left in place while an implant containing the beneficial agent is removably connected to the catheter at the docking station and can be replaced as needed. The docking station provides a connection between a catheter and the implant allowing the implant to be replaced periodically while the catheter and the docking station remain in place.

Abstract: An implantable microbolus infusion pump is disclosed which includes an elastically deformable reservoir, an electrically activated microvalve, and a remotely activated control system. The control system includes a sensor that can be remotely activate, for example, magnetically or by infrared light. The pump can provide bolus infusion of pharmacologic agents. The pump is also capable of providing sequential release of a plurality of drugs.

Abstract: An osmotic delivery system having a space efficient piston. The capsule has an interior holding the piston, 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 moveable seal separates the osmotic agent from the beneficial agent. The piston has a recess that receives at least a portion of the osmotic agent. 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: The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain.

Abstract: A dosage form manufactured from an extruded polymer tube and method for manufacturing the dosage form are disclosed. The dosage form is preferably an osmotic dosage form and includes a therapeutic agent and an expandable composition contained within the lumen of the extruded polymer tube.

Abstract: An osmotic delivery system flow modulator assembly, an osmotic delivery system with a flow modulator assembly, and a method of assembling an osmotic delivery system. The osmotic delivery system flow modular assembly includes a body having a hole located through the body and communicating two opposing ends of the body. The use of the osmotic delivery system flow modulator assembly lessens the chance that air or gas pockets will form in the enclosure of the osmotic delivery system during assembly of the system. Because less air is within the osmotic delivery system, performance of the system is enhanced. Use of the flow modulator assembly also lessens the chance that beneficial agent will be wasted during assembly of the osmotic delivery system.

Abstract: Implantable osmotic pump devices and systems include multiple osmotic pumps and/or semipermeable membranes to extend the useful life cycle and functionality of the drug delivery system. Use of an implantable system including multiple implantable osmotic pumps allows different drugs to be administered from the same implanted system. One or more of the semipermeable membranes of the system may be initially sealed by an overlying impermeable membrane upon implantation of the system into the patient. When the patient develops a tolerance to a first drug or to a first dose of the first drug, the impermeable membrane may be breached, to expose the underlying semipermeable membrane to the osmotic pressure of the patient at the implant site. This causes the infusion rate to increase, thereby providing the patient with the needed relief and/or other desired therapeutic effect. In the case of a multiple pump system, breaching an impermeable membrane may cause the infusion of a second drug.

Abstract: A biosensor (10) has a hydrogel (30) in a rigid and preferably biocompatible enclosure (20). The hydrogel (30) includes an immobilized analyte binding molecule (ABM) and an immobilized analyte. The immobilized analyte competitively binds with free analyte to the ABM, thus changing the number of crosslinks in the hydrogel (30), which changes hydrogel swelling tendency (and thus the osmotic pressure) in its confined space in proportion to the concentration of free analyte concentration. By measuring the change in hydrogel pressure with a pressure transducer (40), the biosensor (10) is able to accurately measure the concentration of the free analyte molecule without the problem of oxygen limitations and interference encountered by prior art biosensors. A battery (64) powered telemeter (60) operably engaged to the pressure transducer (40) sends a radio data signal to a receiver (66) containing an alarm system operably attached to a computer (62).

Abstract: An implantable bioartificial active secretion system for providing a physiological secretion such as insulin necessary for functionality of a physiologic activity such as glucose metabolism of a living-being host. The system includes a housing implantable within the host in fluidic communication with tissue fluid indicative of secretion need. A chamber within the housing contains a plurality of physiologically active, autonomously functioning, live secretory cells for producing the physiological secretion. A periodically operating pump apparatus moves tissue fluid into contact with the secretory cells for pick up of the regulating physiological secretion for subsequent physiologically-effective dispensing into the host while avoiding immunorejection of the host body or of the host to the secretory cells.

Abstract: An osmotic delivery system for controlled delivery of a beneficial agent includes an implant capsule having a beneficial agent reservoir, an osmotic agent which expands on contact with fluid imbibed through a permeable membrane retained by the implant capsule, a delivery port, and a valve for opening and closing the delivery port. When the osmotic agent expands, a pressure is exerted against a separating member positioned between the beneficial agent reservoir and the osmotic agent. The separating member moves within the capsule, thereby forcing the valve to move a distance such that the beneficial agent can exit the reservoir through the delivery port.

Abstract: A fluid delivery device generally including: an electrochemical pump, wherein the electrochemical pump is capable of generating water; an electrochemical pump product chamber, wherein the electrochemical pump product chamber is capable of retaining water generated from the electrochemical pump; a displaceable member positioned between the electrochemical pump product chamber and a reservoir, wherein the displaceable member is controllably displaced upon generation of water from the electrical pump; a reservoir, wherein the reservoir is capable of containing a fluid which is delivered upon displacement of the displaceable member; and a housing for containing the electrochemical pump, the electrochemical pump product chamber, the displaceable member, and the reservoir.

Abstract: A dosage form manufactured from an extruded polymer tube and method for manufacturing the dosage form are disclosed. The dosage form is preferably an osmotic dosage form and includes a therapeutic agent and an expandable composition contained within the lumen of the extruded polymer tube.

Abstract: An implantable osmotic pump for delivering a pharmaceutical agent to a patient includes an osmotic engine, a substantially toroidal compartment disposed at least partially around the osmotic engine and a piston disposed within the compartment. The osmotic engine is configured to cause the piston to travel within the compartment and deliver a dose pharmaceutical agent contained within the compartment when the pump is implanted in an aqueous environment. A dose escalation assembly may be fitted to the pump, the dose escalation assembly being adapted to selectively increase the rate at which the pharmaceutical agent is delivered from the pump.

Abstract: A biosensor (10) has a hydrogel (30) in a rigid and referably biocompatible enclosure (20). The hydrogel (30) includes an immobilized glucose-binding molecule such as concanavalin A (Con A) and an immobilized hexose saccharide such as a-D-mannopyranoside. The immobilized hexose saccharide competitively binds with free glucose to the glucose-binding molecules, thus changing the number of crosslinks in the hydrogel (30), which changes hydrogel swelling tendency and the pressure of the hydrogel in its confined space in proportion to the concentration of free glucose. By measuring the change in hydrogel pressure with a pressure transducer (40), the biosensor (10) is able to accurately measure the concentration of the tree glucose molecule without the problem of oxygen limitations and interference encountered by prior art biosensors.

Abstract: A human body implantable drug delivery pump comprises a housing including at least a first shield and a second shield. The housing defines an interior within the shields. The pump further includes a fluid reservoir within the housing, a fluid conduit also within the housing from the reservoir, an outlet from the fluid conduit to the exterior of the housing, and a pump member in the housing adapted to move fluid through the fluid conduit to the outlet. The fluid in the reservoir and fluid conduit is isolated from the pump interior. The pump further comprises a desiccant in the pump interior, the desiccant absorbent of moisture in the pump interior, and preferably absorbent of substantially all the moisture in the pump interior. The desiccant also preferably has a moisture absorbent property dependent on temperature, being lessened at higher temperatures, the desiccant being pre-baked to improve its moisture absorbent property before being placed in the pump.

Abstract: The present invention relates to a drug delivery device which is implantable within a mammal and adapted for long-term efficient drug delivery to surrounding tissue. The drug delivery device is part of a drug delivery system that includes a catheter and a drug feed system. The drug delivery device includes a support structure that defines a drug reservoir and a capillary interface which facilitates vascular ingrowth while inhibiting blockage of drug delivery openings in the reservoir.

Abstract: Implantable osmotic pump devices and systems include multiple osmotic pumps and/or semipermeable membranes to extend the useful life cycle and functionality of the drug delivery system. Use of an implantable system including multiple implantable osmotic pumps allows different drugs to be administered from the same implanted system. One or more of the semipermeable membranes of the system may be initially sealed by an overlying impermeable membrane upon implantation of the system into the patient. When the patient develops a tolerance to a first drug or to a first dose of the first drug, the impermeable membrane may be breached, to expose the underlying semipermeable membrane to the osmotic pressure of the patient at the implant site. This causes the infusion rate to increase, thereby providing the patient with the needed relief and/or other desired therapeutic effect. In the case of a multiple pump system, breaching an impermeable membrane may cause the infusion of a second drug.

Abstract: An implantable drug delivery device is provided with a passive flow control device is provided in the form of a valve which may assume two flow states. Flow control is achieved by duty cycling the valve using a control module which generates appropriate signals in response to an input telemetry signal corresponding to a desired flow rate. In another embodiment, a passively controlled bolus delivery device is provided to deliver a bolus of drug in addition to normal dosage.

Abstract: The present invention relates to an implantable infusion pump having a refillable infusate reservoir in fluid communication with a delivery site via a flow path. This flow path includes a flow resistance. The infusion pump includes a sensing device(s), positioned relative to the flow path, to provide data regarding a flow rate along the flow path. The infusion pump effects a division of a total flow period into at least a plurality of unit dose periods, each unit dose period effecting delivery of a unit dose of infusate. The cumulative effect of delivering the total number of unit dose periods is the delivery of a desired dose over the total flow period. The present invention permits a reservoir pressure to vary over any portion of total flow period but effects a constant-pressure state over each unit dose cycle.

Abstract: An implantable osmotic pump system includes a rigid pump housing defining an opening adapted to receive a catheter; one or more membrane assemblies fitted to the pump housing; an osmotic engine within the rigid pump housing and a flexible pharmaceutical agent compartment disposed within the pump housing. The flexible pharmaceutical agent compartment is adapted to enclose a volume of a pharmaceutical agent and to cause the pharmaceutical agent to be infused through the opening as water crosses the membrane assembly or assemblies and increases the volume of the osmotic engine. The flexible pharmaceutical agent compartment may include polyethylene teraphthalate (PET), for example, and/or may include a metallic layer such as gold, silver, platinum and/or aluminum, for example, to inhibit the transfer of gas or liquid across the compartment. A catheter may be bonded to the opening of the pump housing and to a corresponding opening in the flexible pharmaceutical agent compartment.

Abstract: The present invention provides medical devices such as medication infusion pumps having internal surfaces that are treated to inhibit protein denaturation. In accordance with the invention, hydrophilic internal surfaces and related coating methods are provided to reduce or eliminate accumulation of medication deposits which can otherwise occur when handling complex protein-based medications. Preferred hydrophilic pump surfaces include hydrophilic surfactants (PEO) or (PEG) coatings which exhibit very low protein adsorption characteristics. Several methods are disclosed for producing such treated surfaces including the covalent attachment of hydrophilic surfactants.

Abstract: Implantable devices and osmotic pump and catheter systems for delivering a pharmaceutical agent to a patient at selectable rates include an impermeable pump housing and a moveable partition disposed within the housing, the partition dividing the housing into an osmotic driving compartment having an open end and a pharmaceutical agent compartment having a delivery orifice. A plurality of semi permeable membranes may be disposed in the open end of the osmotic driving compartment and a number of impermeable barriers may seal selected ones of the plurality of semi permeable membranes from the patient until breached. Breaching one or more of the impermeable barriers increases the surface area of semi permeable membrane exposed to the patient and controllably increases the delivery rate of the pharmaceutical agent through the delivery orifice and catheter.

Abstract: The present invention provides a simple and improved osmotic device (1) that is capable of providing a controlled release of active agent contained in the core (4) through a preformed passageway (5) into an environment of use. The preformed passageway (5) increases in size during use of the osmotic device (1) thereby increasing the release rate of the active agent, enabling the release of large particles containing active agent, and enabling the release of active agents that are substantially insoluble in the environment of use.

Abstract: An implantable infusion pump to deliver stored infusate to a desired fluid delivery site. The pump includes a collapsible fluid chamber. The pump can include a multi-stage filtration system to filter micro-emboli as well as larger particles that are inadvertently introduced into the pump system. An external member can receive the pump and provide a medium to include additional, interactive components, e.g., a bolus port, as well as provide a versatile suture structure to enable the pump to be properly secured within an implantation site. To improve volumetric efficiency, the pump can further incorporate an outlet flow passage within a movable wall of the fluid chamber.

Abstract: Controlled release, multi-step drug dosage forms comprising a plurality of dose units and a plurality of separators that control release of drug from the dose units. In one embodiment, a dose unit is a single dosage amount of a drug that is electrostatically deposited onto a substrate. The dosage forms are designed to deliver a drug to exhibit a desired pharmacokinetic profile.

Abstract: An implantable infusion pump possesses operational functionality that is, at least in part, controlled by software operating in two processor ICs which are configured to perform some different and some duplicate functions. The pump exchanges messages with an external device via telemetry. Each processor controls a different part of the drug infusion mechanism such that both processors must agree on the appropriateness of drug delivery for infusion to occur. Delivery accumulators are incremented and decremented with delivery requests and with deliveries made. When accumulated amounts reach or exceed, quantized deliverable amounts, infusion is made to occur. The accumulators are capable of being incremented by two or more independent types of delivery requests. Operational modes of the infusion device are changed automatically in view of various system errors that are trapped, various system alarm conditions that are detected, and when excess periods of time lapse between pump and external device interactions.

Abstract: This invention relates generally to an implantable containment apparatus made of selectively permeable material. In particular, the implantable containment apparatus is used to contain a therapeutical device, such as a drug delivery device, a cell encapsulation device, or a gene therapy device. A therapeutical device can be easily placed and replaced in an apparatus of the present invention without damaging tissues associated with the selectively permeable material of the apparatus.

Abstract: An osmotic beneficial agent delivery system includes an implantable osmotic delivery device and a catheter for delivery of the beneficial agent from the delivery device to a delivery location. The beneficial agent delivery system includes a catheter and a docking station which are implanted in the patient with a distal end of the catheter positioned at a delivery site. The catheter and docking station are left in place while an implant containing the beneficial agent is removably connected to the catheter at the docking station and can be replaced as needed. The docking station provides a connection between a catheter and the implant allowing the implant to be replaced periodically while the catheter and the docking station remain in place.

Abstract: A coating composition for use in coating implantable medical devices to improve their ability to release bioactive agents in vivo. The coating composition is particularly adapted for use with devices that undergo significant flexion and/or expansion in the course of their delivery and/or use, such as stents and catheters. The composition includes the bioactive agent in combination with a mixture of a first polymer component such as poly(butyl methacrylate) and a second polymer component such as poly(ethylene-co-vinyl acetate).

Abstract: An osmotic device for the controlled release of active compounds into the fluid of the gastrointestinal tract through an outlet opening arranged in the outer membrane of the device is characterized in that the outlet opening, compared with areas of the device designed to maintain a distance relative to the surface of the mucous membrane, is arranged in a position of the external membrane at a distance from the surface of the mucous membrane which, relatively thereto, is further away.

Abstract: A microfabricated, fully integrated drug delivery system capable of secreting controlled dosages of multiple drugs over long periods of time (up to a year). The device includes a long and narrow shaped implant with a sharp leading edge for implantation under the skin of a human in a manner analogous to a sliver. The implant includes: 1) one or more micromachined, integrated, zero power, high and constant pressure generating osmotic engine; 2) low power addressable one-shot shape memory polymer (SMP) valves for switching on the osmotic engine, and for opening drug outlet ports; 3) microfabricated polymer pistons for isolating the pressure source from drug-filled microchannels; 4) multiple drug/multiple dosage capacity, and 5) anisotropically-etched, atomically-sharp silicon leading edge for penetrating the skin during implantation. The device includes an externally mounted controller for controlling on-board electronics which activates the SMP microvalves, etc. of the implant.

Abstract: The invention is directed to a device for delivering an active agent formulation for a predetermined administration period. An impermeable reservoir is divided into a water-swellable agent chamber and an active agent formulation chamber. Fluid from the environment is imbibed through a semipermeable plug into the water-swellable agent chamber and the active agent formulation is released through a back-diffusion regulating outlet. Delivery periods of up to 2 years are achieved.

Abstract: Osmotic delivery system semipermeable body assemblies that control the delivery rate of a beneficial agent from an osmotic delivery system incorporating one of the semipermeable body assemblies. A semipermeable body assembly or plug includes a semipermeable body which is positionable in an opening of an osmotic delivery system. The semipermeable body has a hollow interior portion having a size selected to obtain a predetermined liquid permeation rate through the semipermeable body. Because the beneficial agent in the osmotic delivery system is delivered at substantially the same rate the osmotic agent imbibes liquid which has permeated through the plug from a surrounding environment, the liquid permeation rate through the plug controls the delivery rate of the beneficial agent from the osmotic delivery system.

Abstract: A compact, small-volume, very low flow rate fluid dispensing device for precisely dispensing medicinal fluids into a patient at a very low, controlled flow rate over long periods of time. The dispensing device is readily implantable into the patient's body and includes a novel heat stimulatable polymer gel material which uniquely functions as an internal energy source for controllably expelling the medicinal fluids from the device.

Abstract: Osmotic delivery system semipermeable body assemblies that control the delivery rate of a beneficial agent from an osmotic delivery system incorporating one of the semipermeable body assemblies. A semipermeable body assembly or plug includes a semipermeable body which is positionable in an opening of an osmotic delivery system. The semipermeable body has a hollow interior portion having a size selected to obtain a predetermined liquid permeation rate through the semipermeable body. Because the beneficial agent in the osmotic delivery system is delivered at substantially the same rate the osmotic agent imbibes liquid which has permeated through the plug from a surrounding environment, the liquid permeation rate through the plug controls the delivery rate of the beneficial agent from the osmotic delivery system.

Abstract: Performance of delivery systems for delivering beneficial agents to an animal are monitored to determine the delivery rate of the beneficial agent and the proper operation of the beneficial agent delivery device. Performance monitoring can be achieved by monitoring the physical configuration of the implanted osmotic delivery device from the exterior of the body to determine the amount of beneficial agent delivered and/or the delivery rate of the beneficial agent. The monitoring of the physical configuration of the implanted osmotic delivery device may be performed in different manners such as by X-ray or fluoroscopic monitoring of the implant structure or magnetic determination of a piston location within the implant. Performance monitoring can also be achieved by use of a performance marker within the beneficial agent to produce a specifically detectable response which can be measured noninvasively in body fluids or by-products.

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.

Abstract: A biosensor (10) has a pH-sensitive polymeric hydrogel (30) in a rigid and preferably biocompatible enclosure (20). The hydrogel (30) includes an immobilized oxidoreductase enzyme such as glucose oxidase. The oxidoreductase enzyme catalyzes a chemical reaction consuming an organic molecule and producing a byproduct. The hydrogel (30) changes its osmotic pressure in proportion to the concentration of a byproduct. By measuring the change in osmotic pressure with a pressure transducer (40), the biosensor (10) is able to accurately measure the concentration of the organic molecule without the problem of interference encountered by prior art biosensors. A battery (64) powered telemeter (60) operably engaged to the pressure transducer (40) sends a radio data signal to a receiver (66) operably attached to a computer (62).

Abstract: A composition comprising oxybutynin, a device comprising oxybutynin, and a method for administering oxybutynin are disclosed for oxybutynin therapy.

Abstract: Transdermal administration of fenoldopam, both the racemic mixture and the active R-fenoldopam enantiomer, is described. Also described are transdermal patches for therapeutically effective transdermal administration of racemic fenoldopam and its active R-fenoldopam enantiomer to a subject in need of treatment for impaired renal function or hypertension.

Abstract: Disclosed is an implantable device for delivering a pre-selected molecule, for example, a hormone, into a mammal's systemic circulation. The device comprises a blood permeable element that can be anchored to an inner wall of an intact blood vessel The device also comprises a capsule that is held in place within the blood vessel by the anchored blood permeable element. The capsule encloses viable cells which produce and secrete the pre-selected molecule into blood passing the capsule. The invention also provides a minimally invasive method for percutaneously introducing into a preselected blood vessel the device of the invention.

Abstract: A delivery device having a first chamber containing an osmotic agent, a membrane forming a wall of the first chamber through which fluid is imbibed by osmosis, a second chamber containing a beneficial agent to be delivered, and a moveable piston separating the two chambers. In fluid communication with the second chamber is an orifice which comprises a slit valve. In the presence of pressure, the beneficial agent pushes through the slit, opening up a channel for delivery of the beneficial agent and creating flow. Because the slit remains closed in the absence of flow (or when the pressure is below the pressure required to open the slit), back diffusion of external fluids is eliminated when the slit is closed, which prevents contamination of the beneficial agent in the second chamber by external fluids. In addition, forward diffusion of the beneficial agent out of the capsule is prevented when the slit is closed.

Abstract: A dosage form is disclosed comprising a wall that defines an injection-molded compartment housing a capsule comprising a drug formulation.

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 improved process for manufacturing transdermal drug delivery devices and devices made therefrom. The invention provides a heat equilibration process for the manufacture of drug delivery devices which eliminates the need to preload the body contacting layer with a drug. The method has particular application in the manufacture of transdermal drug delivery devices including a drug reservoir comprising drug in excess of saturation.