Abstract: A method for manufacturing a transdermal drug delivery device (10) is disclosed wherein a component (32) and/or a subassembly (20) are intentionally adapted to be separable from the rest of the device for disposal which is more medically or environmentally acceptable. In one embodiment, device 10 comprises upper and lower housings (16, 20), with lower housing (20) being separable from upper housing (16) and foldable upon itself to minimize medically unacceptable contact with, e.g., a drug reservoir (26 or 28) contained therein. A device (10) made in accordance with the invention is included.

Abstract: An electrotransport apparatus using dispersed ion exchange material (19,93) is disclosed. The ion exchange material (19,93) may be dispersed in either the donor electrode assembly (10), the counter electrode assembly (10) or both electrode assemblies. The dispersed ion exchange material (93) comprises mobile ionic species (C2) and substantially immobile ionic species (P). The dispersed ion exchange material (93) is consumed during electrotransport of drug or agent (A) in an electrotransport process in which substantially no species which compete with the drug or agent for electrotransport are generated. Electrotransport devices exhibiting reduced polarization are also disclosed.

Abstract: An osmotic device (10) for delivering a beneficial drug, such as an anti-fungal, into the mouth of a human patient is disclosed. The device (10) has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device (10) comprises a wall (12) surrounding a compartment (13) housing a layer of an agent (14) that is insoluble to very soluble in aqueous biological fluids, e.g., saliva, and a layer (16) of a fluid swellable, hydrophilic polymer. A passageway (17) in the wall (12) connects the agent (14) with the exterior of the device (10). The wall (12) is permeable to the passage of aqueous biological fluid but substantially impermeable to the passage of the hydrophilic polymer (16). In one embodiment the beneficial agent (14) has a different color than the hydrophilic polymer (16). The wall (12) is sufficiently translucent to permit the patient to see the amount of drug/beneficial agent (14) remaining to be delivered.

Abstract: The invention is directed to a composition and product for use in an electrotransport device. The composition includes an ionized drug, an anti-inflammatory agent and a solvent. Preferably, the anti-inflammatory agent is hydrocortisone or esters thereof, and the solvent is an alcohol, a glycol, a glycerol, a cyclodextrin, a nonionic surfactant or mixtures thereof. The composition preferably further includes a gel matrix that is a swellable, hydrophilic polymer, a water soluble hydrophilic polymer or a solid polymer. A hydrophobic polymer and/or additives may also be included.

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 method is provided for preparing drug formulations suitable for electrotransport drug delivery. The drug to be delivered, present in salt form, is contacted with an ion exchange material prior to incorporation into the reservoir (26) of an electrotransport delivery system (10). In this way, the drug salt is partially or completely neutralized. This technique is useful for adjusting the pH of the drug formulation without incorporating extraneous materials, e.g., competing ions or the like, into the reservoir (26).

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

Abstract: Compression forces (F) in a rotary tablet compressing machine (40) are monitored and controlled to provide enhanced accuracy in determining peak compression value and continuous validation of a compression waveform. The compression waveform is repetitively sampled under computer control at a sampling frequency that is many times the frequency of the compression events. The samples are stored in a computer memory (26) until at least one complete compression event is recorded. Identification of beginning and ending samples of an individual tablet compression event are obtained from the waveform itself by locating minimum amplitude samples, or by use of a separate signal that is derived from a transducer which is responsive to the angular position of a rotating turret. Stored samples representing the compression waveform as time and amplitude data are passed to a processor (23) that statistically fits the data to an equation form which represents the ideal shape of a compression event.

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 being of a predetermined length of time. The dispensing device is formed of a first and second housing that are in reversibly sliding telescoping arrangement with each other. The first housing contains the active agent formulation and has an aspect ratio less than 1. The housings are preferably. ovoloid in shape.

Abstract: The present invention is directed to a pharmaceutical formulation of a therapeutic polypeptide together with a permeation-enhancing mixture of sodium 3-nitrobenzoate and an oil to provide enhanced absorption of the polypeptide through the wall of the gastrointestinal tract, and particularly of the colon, after oral administration.

Abstract: An electrotransport drug-containing composition is provided. The composition includes a drug to be delivered through a body surface (eg, skin) of a patient, and a permeation enhancer which is solid or semisolid at temperatures typically encountered during storage of pharmaceuticals (eg, temperatures up to at least about 25.degree. C). The composition of the invention may be applied from a device 10 suitable for electrotransport delivery. A method for increasing electrotransport agent delivery rate and reducing body surface resistance relies on applying the composition of the invention to the body surface, and applying an electric current through the composition and the body surface.

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 expansion of an expansion agent in the active agent delivery chamber.

Abstract: Osmotically driven drug delivery devices with walls of porous hydrophobic material as the sole diffusion-limiting wall component are disclosed. Despite pores which are considerably larger than the molecular dimensions of osmotically active species in the interior of the device, despite pores which by their hydrophobic character do not permit the passage of liquid water, and despite the absence of a cellulosic semi-permeable membrane, the devices absorb water by osmosis without loss of the osmotically active species, and function in a manner analogous to osmotic pumps of the prior art. By permitting the use of hydrophobic substances as the wall material, the invention permits the device to be constructed entirely from biodegradable materials.

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: The present invention is directed to a material which can be used to deliver a drug, such as an antibiotic, into a diseased tissue pocket, such as a periodontal pocket. The material is preferably a bioerodible oligomer or polymer. The oligomer or polymer containing the drug is heated and is then delivered, preferably by injection, into the tissue pocket at a physiologically compatible elevated temperature. Once the bioerodible material is injected into the pocket, the material cools to the body temperature of the pocket. As it cools, the material hardens and remains in place in the tissue pocket. The hardened material bioerodes in the pocket and releases the drug over a period of several days.

Abstract: The present invention is directed to an oral active agent delivery system and method for delivering discrete units of an active agent formulation to a patient. An active agent formulation chamber (10) containing the active agent formulation and having a fluid passing active agent formulation retainer (14) is placed at one end (16) into a fluid and at a second end (18) into a patient's mouth. The active agent is delivered when the patient sips on the end of the chamber.

Abstract: An osmotic device (10) for delivering a beneficial drug, such as an anti-fungal, into the mouth of a human patient is disclosed. The device (10) has a size and shape adapting it to be comfortably retained in the mouth for extended periods of time. The device (10) comprises a wall (12) surrounding a compartment (13) housing a layer of an agent (14) that is insoluble to very soluble in aqueous biological fluids, e.g., saliva, and a layer (16) of a fluid swellable, hydrophilic polymer. A passageway (17) in the wall (12) connects the agent (14) with the exterior of the device (10). The wall (12) is permeable to the passage of aqueous biological fluid but substantially impermeable to the passage of the hydrophilic polymer (16). In one embodiment the beneficial agent (14) has a different color than the hydrophilic polymer (16). The wall (12) is sufficiently translucent to permit the patient to see the amount of drug/beneficial agent (14) remaining to be delivered.

Abstract: A composition of matter for application to a body surface or membrane to administer a drug by permeation through the body surface or membrane, the composition comprising, in combination the drug 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 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.