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 and a non-rate controlled, monolithic, subsaturated patch for transdermally administering fentanyl and analogs thereof, for analgetic purposes, to a subject through skin over an extended period of time are disclosed.

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: This invention provides rate controlling membranes for controlled drug delivery devices that are stable over time and exhibit more predictable and consistent membrane functionality. According to another aspect, the membranes have enhanced permeability. According to the invention, the rate controlling membrane of a controlled drug delivery device is subjected to a pre-treatment annealing process wherein it is subjected to an elevated temperature for a predetermined time period and subsequently cooled to ambient conditions before incorporation into a controlled drug delivery device.

Abstract: This invention provides rate controlling membranes for controlled drug delivery devices that are stable over time and exhibit more predictable and consistent membrane functionality. According to another aspect, the membranes have enhanced permeability. According to the invention, the rate controlling membrane of a controlled drug delivery device is subjected to a pre-treatment annealing process wherein it is subjected to an elevated temperature for a predetermined time period and subsequently cooled to ambient conditions before incorporation into a controlled drug delivery device.

Abstract: This invention relates to the field of transdermal drug delivery devices and more particularly to improved storage stability thereof. The invention comprises providing a transdermal drug delivery device with a non-occlusive backing or release liner in combination with a degradation protectant such as a desiccant or oxygen scavenger within the sealed pouch containing the device. The combination of the present invention provides increased shelf-life of these devices.

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 polymer 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 thicknesses of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and, preferably at least 75% initial equilibrated nicotine loading is in the reservoir layer.

Abstract: A composition for the treatment of impotence via delivery to the urethra comprises a vasoactive prostaglandin and a polyethylene glycol dispersant having sufficient viscosity to be retained without spillage from a urethra receivable insert. The composition can additionally contain an .alpha.-blocker. Suppositories can be formulated that are small enough for administration to the male urethra, and that dissolve, melt or bioerode within the urethra to release the active agent(s). The suppositories can contain vasodilators other than prostaglandins as the active for the treatment of impotence. Suppositories can also be formulated that contain active agents useful in the treatment of priapism or Peyronie's syndrome.

Abstract: Erectile dysfunction, particularly impotence, priapism and Peyronie's disease is treated by the transurethral administration of a therapeutically effective agent. The agents are administered to the urethra by means of a penile insert (1) having a rapidly releasing coating (4) containing the agent on its exterior surface or by means of an inserter (27) carrying an agent containing dose of agent (31) which can be displaced into the urethra.

Abstract: A composition of matter for application to a body surface or membrane to administer oxybutynin by permeation through the body surface or membrane, the composition comprising, in combination, the oxybutynin to be administered, in a therapeutically effective amount; and a permeation-enhancing mixture comprising a monoglyceride or a mixture of monoglycerides, and a lactic ester or a mixture of lactate esters; present in specific concentrations.

Abstract: Compositions, devices, and methods for transdermal administration of an active agent are disclosed using a novel dual permeation enhancer mixture comprising lauryl acetate and a monoglyceride, preferably glycerol monolaurate. The dual permeation enhancer mixture comprising lauryl acetate is a potent permeation enhancer and provides stable systems which are more readily characterized.

Abstract: A device for the transdermal administration of a drug to a sensitive body area such as the scrotum. Devices according to the invention provide an improved quality of adhesion to the body area while also providing patient comfort during use and upon removal of the device. Also disclosed are methods of transdermal delivery such as the transcrotal delivery of testosterone to hypogonadic males.

Abstract: Erectile dysfunction, particularly impotence, priapism and Peyronie's disease is treated by the transurethral administration of a therapeutically effective agent. The agents are administered to the urethra by means of a penile insert (1) having a rapidly releasing coating (4) containing the agent on its exterior surface or by means of an inserter (27) carrying an agent containing dose of agent (31) which can be displaced into the urethra.

Abstract: A composition of matter for application to a body surface or membrane to administer oxybutynin by permeation through the body surface or membrane, the composition comprising, in combination the oxybutynin to be administered, in a therapeutically effective amount; and a permeation enhancing mixture comprising a monoglyceride or a mixture of monoglycerides, and a lactic ester or a mixture of lactate esters, present in specific concentrations.

Abstract: A device for the transdermal administration of a drug comprising a microporous tie layer located between the drug reservoir and the contact adhesive. The tie layer eliminates blooming and delamination and has no appreciable adverse effect on either the drug flux or release rate from the device.

Abstract: A method of administering nicotine transdermally in which a nicotine patch, capable of administering nicotine for at least 16 hours at rates that are efficacious in smoking cessation therapy, is applied in the morning upon waking and removed prior to sleep. This method is effective even though nicotine is not essential during sleep and many smokers experience morning craving.

Abstract: A device for the transdermal administration of oxybutynin comprising a microporous tie layer located between the oxybutynin reservoir and the contact adhesive. The tie layer eliminates blooming and delamination and has no appreciable adverse effect on either the oxybutynin flux or release rate from the device.

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: Erectile dysfunction, particularly impotence, priapism and Peyronie's disease is treated by the transurethral administration of a therapeutically effective agent. The agents are administered to the urethra by means of a penile insert (40) having a shaft with a deformable distal end which forms a dose receiving cavity when an internal piston is retracted relative to the shaft.

Abstract: Diffusional delivery devices are constructed in two or more compartments, each containing a separate drug or other beneficial agent, and each arranged to permit diffusion of the agent out of the device through an individually-characterized agent-permeable wall segment. The diffusion rates of the various agents relative to one another are set and controlled by the parameters of the individual wall segments, such as the surface area of the wall segment, the average thickness of the wall segment, and the permeability of the wall segment for the particular agent. The permeability may be varied by variations in the chemical composition of the wall segment. Using these parameters rather than blending the agents at calculated ratios in a single formulation for diffusion through a single wall permits a wider range of, and greater flexibility in, variation between the diffusion rates of the different agents. This is of value when the simultaneous administration of agents at a specified ratio is desired.