Abstract: The present invention is concerned with improving the delivery of a drug from a ruminal delivery device to give a consistent delivery of drug to the ruminal environment. Thus, the invention is directed to an improved ruminal drug delivery device comprising a semipermeable membrane having an exit orifice and defining a compartment, the compartment containing a swellable osmotic agent expandable driving member, a drug to be dispensed, a density element and, optionally, a partition layer between the osmotic expandable driving member and the drug formulation, wherein the improvement comprises an essentially gas-impermeable barrier means that separates the density element from the other components within the delivery device for isolating gases evolved from the density element from the other components within the delivery device. The barrier means further includes a coupling to transfer osmotic pressure to the semipermeable wall.

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: A device and method are provided for reducing or preventing skin sensitization in electrotransport drug delivery. The method involves co-administration of a countersensitizing agent, comprising cis-urocanic acid or an analog thereof, with the drug delivered via electrotransport. Novel drug reservoirs and electrotransport drug delivery systems, formulated with a countersensitizing agent as described herein, are provided as well.

Abstract: A composition suitable for transdermal electrotransport delivery of an agent through a body surface comprises a free acid/base form of an agent to be delivered by transdermal electrotransport, and a salt form of the agent, and optionally a permeation enhancer. Methods of enhancing transdermal electrotransport delivery and of forming a composition for the enhancement of transdermal electrotransport drug delivery, and a transdermal electrotransport delivery device (10) utilizing the compositions of the invention are disclosed.

Abstract: An electrotransport device (10) for transdermal delivery of an agent through a body surface has a donor reservoir (16) which contains a compound formed of the agent and a transdermal permeation enhancer, the compound being able to dissociate into an agent ion and an enhancer counter ion. Methods of enhancing transdermal electrotransport drug delivery and methods of forming a composition exhibiting enhanced transdermal electrotransport drug delivery are also provided.

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 delivery system is disclosed for delivering a fluid-sensitive beneficial agent such as a somatotropin, or an analogue or derivative thereof, to an animal such as a bovine. The delivery system comprises a wall that surrounds an internal compartment, said wall comprising a first wall section that limits the passage of fluid into the system and a second wall section that permits the passage of fluid into the system. The wall may further comprise an end cap which may be adapted for ultrasonic welding to the first wall section and may maintain the beneficial agent in contact with an exit. The compartment comprises a beneficial agent and an expandable driving member. The delivery system comprises an exit for delivering the beneficial agent to the animal.

Abstract: This invention relates to stable non-aqueous protic formulations of peptide compounds. These stable formulations comprise peptide in non-aqueous protic 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 two-part electrotransport drug delivery device (20) is comprised of a controller (22) which has a plurality of different electronic outputs. The controller (22) is adapted to be mechanically and electrically coupled to a plurality of different drug-containing units (24). Each drug unit (24) includes a means (40, 42, Rx, Cx) for signaling the controller (22). The signal is read by the controller (22) and a predetermined electronic output is thereby selected and applied through the drug unit (24) in order to deliver the drug contained therein by electrotransport. The signal sent by the drug unit (24) to the controller (22) may be an optical signal (eg, reflected light), a signal sent by an electro-mechanical connector, an electrical signal (eg, resistance or capacitance), a magnetic signal or a metal detector sensing signal.

Abstract: The present invention provides improved compositions for improving the chemical and physical stability of peptides and proteins. The invention provides a liquid beneficial agent formulation containing a liquid suspension comprising at least 5% by weight beneficial agent and having a viscosity and beneficial agent size which minimizes settling of the agent in suspension over the extended delivery period.

Abstract: A method encompasses the substantially continuous electrotransport delivery of luteinizing hormone releasing hormone (LHRH), prologues, analogues, salts or mixtures thereof, preferably at a substantially constant rate, to a female mammal for the purpose of modifying its reproductive cycle. An electrotransport device substantially is suited for the continuous delivery of LHRH prologues, analogues, salts or mixtures thereof over an extended period of time to a mammal. The present technology may be successfully applied to the controlled breeding of mammals, such as thoroughbred race horses.

Abstract: A dispenser for use in a fluid environment of use which is capable of the delivery of one or a plurality of discrete active agent-containing units in any desired delivery pattern or profile. It also can provide for the initially delayed delivery of an active agent to the environment of use and for high accuracy in the timing of delivery of the active agent.

Abstract: A delivery system is disclosed for delivering a fluid-sensitive active agent such as a somatotropin, or an analogue or derivative thereof, to an animal such as a bovine. The delivery system comprises a first wall section, a second wall section and a locking coupling therebetween. The coupled wall sections define a compartment, enclosing an active agent and an expandable driving member. Various embodiments of the locking coupling are disclosed.

Abstract: A device (10) for the electrically assisted delivery of a therapeutic agent is described. The device (10) has rigid zones or regions (12, 14) which are physically connected by a flexible means (16) such as a web. The flexible means (16) permits the rigid zones (12, 14) to move independently with respect to each other while remaining physically connected or coupled. In a preferred embodiment, the rigid zones are physically and electronically coupled by the flexible means. In another embodiment, the device (500) comprises one or more rigid zones, the skin side of the rigid zone having a radius of curvature (520) which approximates that of the body site to which the device (500) is to be attached. A method of increasing the body surface conformability of an electrotransport device (50, 150, 170) is described. The method involves the step of intentionally placing rigid subcomponents (58, 36, 37) of the device in physically separate zones (52, 54; 152, 154, 156, 158; 172, 174, 176, 178) within the device.

Abstract: The present invention provides improved compositions for improving the chemical and physical stability of peptides and proteins. The invention provides a liquid beneficial agent formulation containing a liquid suspension comprising at least 5% by weight beneficial agent and having a viscosity and beneficial agent size which minimizes settling of the agent in suspension over the extended delivery period.

Abstract: The present invention is concerned with improving the delivery of a drug from a ruminal delivery device to give a consistent delivery of drug to the ruminal environment. Thus, the invention is directed to an improved ruminal drug delivery device comprising a semipermeable membrane having an exit orifice and defining a compartment, the compartment containing a swellable osmotic agent expandable driving member, a drug to be dispensed, a density element and, optionally, a partition layer between the osmotic expandable driving member and the drug formulation, wherein the improvement comprises an essentially gas-impermeable barrier means that separates the density element from the other components within the delivery device for isolating gases evolved from the density element from the other components within the delivery device. The barrier means further includes a coupling to transfer osmotic pressure to the semipermeable wall.

Abstract: The present invention is directed to a fluid-imbibing drug delivery device which is useful for the initial delayed delivery of an active agent formulation to a fluid environment of use, the initial delay period to startup or activation of the device being of a predetermined length of time. The delivery of the agent formulation from the dispensing device is continued until essentially all of the active agent formulation is delivered as a result of the fluid inhibition into a fluid flow path in the housing of the device and the expansion of an expansion agent in the active agent delivery chamber.

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: An electrotransport composition comprises at least one C.sub.2 -C.sub.4 lower alcohol, unsaturated derivatives thereof, or mixtures thereof, and at least one C.sub.8 -C.sub.14 higher alcohol, unsaturated derivatives thereof, or mixtures thereof. An electrotransport device and a method of increasing transdermal electrotransport flux utilize the composition of the invention for delivering pharmaceutically-acceptable agents across a body surface such as skin.

Abstract: The present invention is directed to the transdermal administration of a drug together with a suitable amount of an acyl lactylate permeation enhancer. The invention includes a transdermal drug delivery device comprising a matrix adapted to be placed in drug- and- permeation enhancer-transmitting relation with a skin site. The matrix contains sufficient amounts of an acyl lactylate permeation enhancer and drug, in combination, to continuously administer drug to the systemic circulation of a patient at a therapeutically effective rate. The invention is also directed to compositions and methods for transdermal administration of a drug together with an acyl lactylate permeation enhancer, alone or in combination with other enhancers.