Abstract: An electrotransport delivery device utilizing reservoir buffering at a select pH ranges in order to reduce skin irritation and skin resistance is provided. Cathodic reservoirs are buffered to a pH of less than about 4, preferably to a pH in the range of about 2 to 4, while anodic reservoirs are buffered to a pH above about 4, preferably to a pH in the range of about 4 to 10. Another electrotransport delivery device utilizes a potassium sensor to monitor potassium efflux from the skin. Potassium efflux above a certain predetermined level has been found to be a precursor to skin irritation/erythema. Operation of the device is modified (eg, terminated) when the predetermined potassium efflux level is sensed.

Abstract: The present invention is directed to an active agent dosage form which is useful for the prolonged delivery of an active agent formulation to a fluid environment of use. The active agent dosage form is a matrix that has on its surface two or more insoluble bands. The invention is also directed to the method for making the active agent dosage form.

Abstract: A dry-state iontophoretic drug delivery device (10, 30) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. In one embodiment of the invention, a sealed liquid-containing pouch (21, 22) is provided in each electrode assembly (8, 9). Water or other liquid (20) is released from the pouch (21, 22) by pulling a tab (27, 28) attached to a portion (25, 26) of the pouch (21, 22) which is capable of being torn or ripped in order to hydrate the drug and electrolyte reservoirs (15, 16) and activate the device (10, 30). In another embodiment, the device (30) is held in a package (32). The device (30) has pouches (21, 22) which release their liquid contents automatically upon removal of the device (30) from the package (32). In yet another embodiment, the device (40) is held in a package (42) having a compression zone (46). The pouches (21, 22) must be moved through the compression zone (46) when removing the device (40) from the package (42).

Abstract: The present invention is directed to a fluid-imbibing dispensing device for the initially delayed delivery of an active agent to a fluid environment of use and to a method of using the dispensing device. The dispenser comprises a housing having a first wall section and a second wall section in reversibly sliding telescopic arrangement with each other, which housing maintains its integrity in the environment of use; an internal compartment surrounded and defined by the housing; at least one active agent formulation in the compartment; and expansion means and a push plate in the compartment for separating apart the first and second wall sections of the housing after exposure to the environment of use to expose the active agent formulation to the environment of use.

Abstract: A method of treating inflammatory disease of the mouth by locally delivering beclomethasone dipropionate and related compounds to the oral cavity of a patient over an extended period of time is disclosed. In one embodiment, beclomethasone dipropionate is delivered by an osmotic device (10), in another embodiment, it is delivered by an erosion controlled device (110) and in yet another embodiment, it is delivered by a diffusion controlled device (310).

Abstract: The present invention provides compositions and methods for the transdermal administration of a contraceptively effective amount of gestodene and estrogen, such as ethinyl estradiol, in combination, together with a suitable permeation enhancer. The amount of the estrogen codelivered is kept at an about constant and contraceptively effective rate while the amount of gestogen codelivered varies depending on the phase of the menstrual cycle but remains at a contraceptively effective rate. The size of the system may also vary depending on the amount of gestogeno be delivered.

Abstract: This invention pertains to a sustained release delivery device for delivering a beneficial agent into the oral cavity of a patient. More particularly, the invention relates to a device comprising about 0.1% to about 20% by weight beneficial agent, about 40% to about 95% by weight ethylene vinyl acetate copolymer having a vinyl acetate content of about 4% to about 80% and about 1% to about 60% by weight polyvinyl pyrrolidone.

Abstract: The present invention is directed to the transdermal administration of melatonin together with a suitable permeation enhancer. The invention includes a transdermal drug delivery device (10) comprising a matrix (12) adapted to be placed in melatonin- and permeation enhancer-transmitting relation with the skin site (18). The matrix (12) contains sufficient amounts of a permeation enhancer and of melatonin, in combination, to continuously administer to the skin (18) for a predetermined period of time the melatonin to provide an effective therapeutic result. The invention is also directed to a method for the transdermal administration of a therapeutically effective amount of melatonin together with a skin permeation-enhancing amount of a suitable permeation enhancer. The invention further includes methods for time- and rate-patterned transdermal delivery of melatonin to simulate the natural circadian rhythmic profile of melatonin in mammals.

Abstract: An in-line adhesive, useful for transdermal delivery devices comprising a mixture of high and low molecular weighted polyisobutylene having a ratio HMW PIB:LMW PIB in the range of about 5-40:95-60 which is substantially free of plasticizers and tackifiers is disclosed. The adhesive finds particular use as a component of a transdermal delivery device for delivering oily non-polar agents such as nicotine, benztropine, secoverine, dexsecoverine, and arecoline.

Abstract: The present invention is directed to the transdermal administration of oxybutynin together with a suitable permeation enhancer. The invention includes a transdermal drug delivery device comprising a matrix adapted to be placed in oxybutynin- and permeation enhancer-transmitting relation with the skin site. The matrix contains sufficient amounts of a permeation enhancer and of oxybutynin, in combination, to continuously administer to the skin for a predetermined period of time the oxybutynin to provide an effective therapeutic result. The invention is also directed to a method for the transdermal administration of a therapeutically effective amount of oxybutynin together with a skin permeation-enhancing amount of a suitable permeation enhancer.

Abstract: A dispenser for use in a fluid environment which is capable of delivery of plurality of drugs in any desired delivery pattern or profile.

Abstract: A selectively permeable membrane (14) is positioned between the agent reservoir (15) and the electrode (11) of a donor electrode assembly (8) in an iontophoretic delivery device (10). Optionally, an electrolyte reservoir (13) is positioned intermediate the electrode (11) and the agent reservoir (15). In certain embodiments, the membrane (14) is permeable to species of less than a predetermined molecular weight and substantially less permeable to species of greater than the predetermined molecular weight. The agent is capable of dissociating into agent ions and counter ions.

Abstract: The present invention is directed to an improvement in a delivery system, the system comprising a wall that surrounds an internal lumen or compartment which contains a thermo-responsive beneficial agent formulation, an expandable driving member and an optional density member, and having an exit opening, and wherein the improvement comprises a) a viscosity-inducing amount of an inert viscosity-inducing agent in the thermo-responsive beneficial agent composition for increasing the viscosity of the beneficial agent composition, and/or b) a pressure-inducing exit member in the exit opening in the wall for increasing the pressure inside the lumen.

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 or a plasticizer 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 preferably 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 preferably at least 75% initial equilibrated agent loading is in the reservoir layer.

Abstract: Delivery devices which include a beneficial agent and an activating mechanism in separate compartments separated by a moveable partition are designed to deliver the beneficial agent in a pulsatile manner through an orifice. The pulsatile delivery is achieved by a band of resilient material which is placed over the orifice. The resilient material is sufficiently tight to substantially seal the orifice when the pressure within the device is below a threshold level while at the same time being capable of being stretched when the internal pressure exceeds the threshold.

Abstract: The present invention is directed to the transdermal administration of methyl nicotinate and an irritating or sensitizing drug. The invention includes a transdermal drug delivery device comprising a matrix adapted to be placed in irritating/sensitizing drug- and methyl nicotinate-transmitting relation with the skin site. The matrix contains sufficient amounts of irritating/sensitizing drug and of methyl nicotinate, in combination, to continuously administer to the skin for a predetermined period of time the drug to provide an effective therapeutic result. The invention is also directed to a method for either 1) preventing or reducing the irritation caused by an irritating drug or 2) preventing or reducing sensitization from occurring, as well as reducing or eliminating pain and discomfort occurring during the elicitation phase after sensitization has already been induced.

Abstract: Apparatus (11) for delivery of a medicament, drug or other therapeutic agent transdermally to a body by iontophoresis is provided. The apparatus (11) provides a means (13) for measuring and displaying the cumulative amount of the medicament delivered to the body by monitoring the amount of a metal, initially present at the anode (45), that is transferred to the cathode (41) in a subsidiary electrolyte cell (47) through which the drive current for the apparatus (11) passes. Optionally, the apparatus also provides a plurality of light emitting devices (63-1) that display a measure of the cumulative amount of medicament delivered, by use of visually distinguishable light colors or by use of binary encoding in the light display.

Abstract: An electrotransport drug delivery device (1) including a reusable component (2), a disposable component (4), and a removable liner (8) temporarily separating the mating surfaces of the components (2,4) during alignment and assembly of the components (2,4). At least one of the components (2,4) has an adhesive mating surface (11) facing the removable liner (8). Also disclosed are a disposable assembly (4) for an electrotransport device (1) and a method for assembling reusable and disposable components (2,4), the components (2,4) of the electrotranport device assembly (1) are adhesively mated.