Abstract: Method of making an electrotransport device containing an analog of a parent polypeptide having one or more amino acid residues substituted relative to the parent polypeptide with an amino acid residue selected from the group consisting of proline, glycine and asparagine.

Abstract: Methods for modifying polypeptide agents to enhance their transdermal electrotransport flux are provided. The polypeptide is modified by reducing the potential of the polypeptide for forming &agr;-helical or &bgr;-sheet segments. In particular, amino acid residues known to stabilize &agr;-helical and &bgr;-sheet segments can be replaced with destabilizing residues and known helix breakers. Modified molecules and compositions including the molecules are also provided.

Abstract: An electrotransport apparatus using dispersed ion exchange material (19,83) is disclosed. The ion exchange material (19,83) may be dispersed in either the donor electrode assembly (10), the counter electrode assembly (10) or both electrode assemblies. The dispersed ion exchange material (83) comprises mobile ionic species (84-2) and substantially immobile ionic species (P). The dispersed ion exchange material (83, 84-2) interacts with competitive species (86) generated during electrotransport to render those species substantially immobile (87). Electrotransport devices exhibiting reduced polarization are also disclosed.

Abstract: An opiate analgesic composition and a non-opiate analgesic composition are disclosed for delivering an analgesic in either embodiment to a patient in need of relief from pain. The analgesics are present optionally with a nonionic surfactant and with an osmotic composition comprising a carbonate or bicarbonate for delivering the opiate analgesic and non-opiate analgesic from a dosage form.

Abstract: An inverter for reversing the orientation of a pharmaceutical dosage form at a discontinuity in a path of travel is described. The inverter receives dosage forms from an input path and delivers rectified dosage forms to an output path. In addition, a dosage form rectifier comprising an inverter is described. The dosage form rectifier receives randomly oriented dosage forms and delivers uniformly oriented dosage forms without recycling any of the dosage forms. In a repeating cycle for each dosage form supplied to the rectifier, the orientation of the dosage form is determined and dosage forms having a desired orientation are maintained in the desired orientation and delivered from the dosage form rectifier while dosage forms having an inverted orientation have their orientation rectified at the inverter before being delivered from the dosage form rectifier.

Abstract: The present invention relates to hydratable drug reservoir films for electrotransport drug delivery devices and to electrotransport drug delivery systems containing the hydratable drug reservoirs and to methods for manufacturing and using such systems. The hydratable reservoir films according to this invention are easily manufacturable and rapidly imbibe water and/or drug solution with good water retention and stability.

Abstract: This invention relates to stable non-aqueous formulations which are suspensions of proteinaceous substances or nucleic acids in non-aqueous, anhydrous, aprotic, hydrophobic, non-polar vehicles with low reactivity. More specifically, the present invention relates to stable protein or nucleic acid formulations wherein the compound remains in stable, dry powder form, yet the formulation is flowable and, therefore amenable to delivery to an animal via injection, transdermal administration, oral delivery or using an implantable device for sustained delivery. These stable formulations may be stored at elevated temperatures (e.g., 37° C.) for long periods of time and are especially useful as flowable formulations which can be shipped and/or stored at high temperatures or in implantable delivery devices for long term delivery (e.g., 1-12 months or longer) of drug.

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: A composition and a dosage form are disclosed comprising oxybutynin alone/or accompanied by another drug indicated for therapy. A method is disclosed for administering oxybutynin alone/or accompanied by a different drug or for administering oxybutynin and a different drug according to a therapeutic program for the management of incontinence alone, and for other therapy.

Abstract: The present invention comprises a composition comprising a matrix (12) adapted to be placed in drug- and permeation-enhancing mixture-transmitting relation to a selected skin (18) or other body site. The matrix (12) contains sufficient amounts of drug, permeation enhancer(s) and poly-N-vinyl amide to continuously administer to the site, the drug, in a therapeutically effective amount, and the permeation-enhancing mixture, in an amount effective to enhance the permeation of the skin (18) to the drug, the device (10) shows increased transdermal flux as compared to the transdermal flux of the drug from a device (10) containing no poly-N-vinyl amide. Incorporating poly-N-vinyl amide into the transdermal system also improves the adhesion and stability of the system.

Abstract: A dosage form comprising a composition comprising a drug surrounded by an interior and an exterior wall with an exit for administering the drug to a patient; and a method of using the dosage form are disclosed for an indicated therapy.

Abstract: A novel electrotransport drug delivery system (10) and therapeutic agent-containing reservoir (26, 28) for use therein are provided. An inert filler material effective to reduce the quantity of therapeutic agent otherwise present is incorporated in the reservoir (26, 28) along with the therapeutic agent to be delivered via electrotransport. Methods for making the reservoir (26, 28) and drug delivery system (10) are provided as well.

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: This invention relates to stable non-aqueous polar aprotic formulations of peptide compounds. These stable formulations comprise peptide in non-aqueous polar aprotic solvent. They may be stored at elevated temperatures for long periods of time and are especially useful in implantable delivery devices for long term delivery of drug.

Abstract: A percutaneous agent delivery or sampling device comprising a sheet having a plurality of microblades for piercing the skin for increasing transdermal flux of an agent. The microblades having a relatively sharp angled leading edge which transitions to a relatively gradually angled blade edge.

Abstract: A dosage form is disclosed comprising an anti-Parkinson's disease drug for administering to a patient in need of anti-Parkinson's disease therapy.

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: The present invention is an apparatus and method that maintains a constant drug delivery rate for an electrotransport delivery system, while the apparent transport efficiency of the system varies, by making adjustments to the output current of the system. More specifically, the constant drug delivery rate is maintained by the regulator of the electrotransport delivery system automatically adjusting the output current to compensate for the varying apparent transport efficiency.

Abstract: A percutaneous agent sampling device and method are provided. The device comprises a collector and a sheet having a plurality of microblades for piercing the skin for increasing transdermal flux of an agent.

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 as associated with major surgical procedures.