Abstract: A rotary mill for milling particulate material is described.

Abstract: A self-powered device is disclosed for delivering a useful agent. The device comprises (1) a housing member, (2) a variable volume chamber storing a useful agent and having a passageway for delivering the agent in the housing, and (3) a pressure generating member comprising a semipermeable polymer having a cross-linked hydrophilic polymer dispersed therein positioned between the housing and the chamber. In operation, when the device is in a fluid environment, fluid from the environment enters the housing and is imbibed by the hydrophilic polymer into the generator, causing the generator to enlarge and apply pressure against the chamber, thereby decreasing the volume of the chamber and simultaneously dispensing agent through the passageway from the device at a controlled rate over a prolonged period of time. An article of manufacture also is disclosed which consists of a pressure generating member manufactured as a film useful for making a dispensing device.

Abstract: A self-powered device for delivering drug is disclosed. The device comprises (1) a substantially rigid housing, (2) a collapsible container storing a drug and having a passageway for delivering the drug in the housing, and (3) an expandable laminate positioned between the housing and the container. The laminate comprises (a) a lamina formed of an absorbent material laminated to (b) a lamina placed adjacent to the container and formed of a swellable hydrophilic polymer. In operation, when the device is in a biological environment, fluid from the environment is imbibed by the laminate into the housing causing the laminate to expand and exert pressure on the container, thereby collapsing the container and concomitantly pumping drug through the passageway from the device at a correspondingly controlled rate over a prolonged period of time.

Abstract: Therapeutic system in the form of a skin patch that administers clonidine transdermally in an initial priming dose of 10 to 300 mcg/cm.sup.2 of skin that brings the concentration of clonidine in the blood to a level sufficient to elicit alpha-adrenergic stimulation without intolerable side effects, followed by a substantially constant continuous dosage in the range of 0.1 to 100 mcg/hr that maintains said level. The system is a four-layer laminate of, from the top: a protective backing; a gelled, mineral oil-polyisobutene-clonidine reservoir lamina that is the source of the clonidine for the continuous constant dosage; a microporous membrane that controls the constant dosage rate; and a gelled, mineral oil-polyisobutene-clonidine contact adhesive layer that is the source of the clonidine for the priming dose and the means by which the system is attached to the skin.

Abstract: An improvement in liquid dispensers, especially those used to infuse liquid drugs into patients, that dispense liquid under pressure from an expansible, elastomer bladder is disclosed. The improvement is that the bladder is made from synthetic vulcanized polyisoprene, especially polyisoprene that has 90% to 98% cis linkages and has been vulcanized with an organic peroxide, such as dicumyl peroxide, at a concentration of 5.5.times.10.sup.-3 to 7.5.times.10.sup.-3 moles of peroxide per 100 grams of polyisoprene.

Abstract: An osmotic system is disclosed for dispensing a beneficial agent. The system comprises (1) a first wall of a semipermeable material that surrounds a compartment containing a drug formulation, and has a passageway through the wall for releasing agent from the compartment, (2) a second wall positioned distant from the first wall, said second wall a microporous or hydrogel material that extends around the first wall, and (3) a distribution zone interposed between the first and second wall and initially housing a compound soluble in an external fluid that enters the system.In operation, agent is dispensed from the system by fluid passing through the second wall into the zone from which fluid is further being imbibed through the first wall into the compartment forming a solution that is released through the passageway into the zone, and then through the second wall to the exterior of the system.

Abstract: A patient-care apparatus housing a device for controlling the presence of pathogens is disclosed. The apparatus comprises a container with an inlet port and a device in the apparatus for controlling the presence of pathogens.

Abstract: A self-powered device for dispensing a medicament is disclosed. The device comprises (1) a rigid housing defining an internal space, (2) a container in the housing formed of a stretched polymer and having a passageway connecting the container with the exterior of the device, (3) a medicament in the container, and (4) an expandable laminate surrounding the container position between the interior of the housing and the exterior of the container. The laminate comprises (a) a lamina of an absorbent material laminated to (b) a lamina of a swellable, hydrophilic polymer. In operation, when the device is in a biological fluid environment, fluid therefrom is imbibed by the laminate into the housing, causing the laminate to expand and exert pressure on the container, thereby shrinking the container to an unstretched state, which decreases its volume and concomitantly pumps medicament through the passageway at a controlled rate over time.

Abstract: An ocular system is disclosed for dispensing a medication formulation to the eye. The system comprises a formulation consisting of a pilocarpine osmotic solute and an epinephrine osmotic solute dispersed in a polymer such that the formulation is surrounded substantially individually by the polymer. The system, when placed in the eye, dispenses the formulation at a controlled rate over time. A method also is disclosed for the management of intraocular pressure using the ocular system.

Abstract: An intrauterine system for releasing beneficial agent to the uterus at a controlled and continuous rate for a prolonged period of time is disclosed. The system is shaped, sized and adapted for insertion and retention in the uterus. The system contains a beneficial agent and it is formed of a copolymeric material permeable to the passage of agent by diffusion. The material is an ethylene-vinyl ester polymer of the general formula: ##STR1## wherein R is hydrogen, alkyl of 2 to 7 carbons, or aryl, m is (4 to 80)% by weight and n is (100-m)% by weight.

Abstract: This invention concerns polymeric orthoesters having a repeating mer comprising a hydrocarbon radical and an orthoester functionality of the general formula: ##STR1## wherein R.sub.1 is a monovalent radical, R.sub.2 is a hydrocarbon radical, a is 2 to 3, and n is at least 10. The polymers are useful for making articles of manufacture and as coatings for beneficial agents.

Abstract: A method for administering a drug to a preselected tissue compartment of the eye for advantageously controlling the concentration of drug in the tissue compartment is disclosed. The method comprises (1) placing an ocular therapeutic system in the eye, and (2) orienting the drug releasing portal of the system towards the preselected tissue compartment for controlled administration of drug thereto.

Abstract: Means for administering an amphipathic medicament by micelle solubilization is disclosed. The micelle consists of a nonionic surfactant medicament adduct. The adduct is coated onto an osmotically effective solute and housed in an osmotic therapeutic system for administering the medicament in a therapeutically effective amount over a prolonged period of time.

Abstract: The invention concerns orthoester and orthocarbonate polymers having a repeating mer comprising a hydrocarbon radical and a symmetrical dioxycarbon unit of the general formula: ##STR1## wherein R.sub.1 is a multivalent hydrocarbon radical, R.sub.2 and R.sub.3 are hydrocarbon radicals with at least one of R.sub.2 or R.sub.3 bonded to the dioxycarbon through an oxygen linkage, and which polymers are synthesized by reacting a polyol with an orthoester or orthocarbonate. The polymers are useful for making articles of manufacture, including devices and coatings for delivering beneficial agents.

Abstract: A device for the controlled continuous administration of an active agent to an environment of use is disclosed. The device comprises a body of erodible agent release rate controlling material containing an agent dispersed therethrough; the rate controlling material is a hydrophobic poly(carboxylic acid) having one ionizable carboxylic hydrogen for each 8 to 12 carbon atoms, which material erodes at a controlled and continuous rate over a prolonged period of time in response to the environment by a process of carboxylic hydrogen ionization, thereby releasing the dispersed agent at a controlled rate over a prolonged period of time.

Abstract: A self-powered device for delivering drug is disclosed. The device comprises (1) a substantially rigid housing, (2) a collapsible container storing a drug and having a passageway for delivering the drug in the housing, and (3) an expandable laminate positioned between the housing and the container. The laminate comprises (a) a lamina formed of an absorbent material laminated to (b) a lamina placed adjacent to the container and formed of a swellable hydrophilic polymer. In operation, when the device is in a biological environment, fluid from the environment is imbibed by the laminate into the housing causing the laminate to expand and exert pressure on the container, thereby collapsing the container and concomitantly pumping drug through the passageway from the device at a correspondingly controlled rate over a prolonged period of time.

Abstract: A drug delivery for administering drug to an aqueous body environment at a substantially constant rate. The devices consist essentially of a mixture of drug of specific average particle size dispersed in a polymer of specific water permeability, tensile strength, and Young's modulus in specific volume proportions such that the particles are surrounded substantially individually by the polymer. The constancy of the release rate of drug from the devices is governed by the drug particle size and volume proportion of drug in the mixture.

Abstract: An ophthalmic bioerodible dosage form for ophthalmic drugs is disclosed. The dosage form comprises particles of 10 to 300 microns made of drug dispersed within a drug release rate controlling material which bioerodes in the environment of the eye.

Abstract: An osmotic therapeutic system for delivering a beneficial drug is disclosed. The system comprises a drug delivery module which module comprises a rate controlling laminated wall surrounding a reservoir and has a portal for delivering drug from the system. The laminated wall comprises a semipermeable lamina in laminar arrangement with a microporous lamina to provide a wall that is permeable to an external fluid, impermeable to drug and maintains its integrity during the delivery of drug. The reservoir contains a drug, or a mixture of drug and solute which drug or solute is soluble in the fluid and exhibits an osmotic pressure gradient across the wall against the fluid.

Abstract: An osmotic device is disclosed for delivering an active agent. The device comprises a wall surrounding a compartment with a passageway through the wall for releasing the agent. The wall comprises a material permeable to an external fluid and substantially impermeable to agent and at least one additional material independently selected from materials that impart stability to the wall, enhance the permeability of the wall to fluids, or aid in forming the wall. The compartment contains an agent that exhibits an osmotic pressure gradient across the wall against an external fluid, or the agent is mixed with an osmotically effective compound that exhibits an osmotic pressure gradient against the fluid. Agent is released from the device by fluid being imbided through the wall into the compartment at a rate controlled by the permeability of the wall and the osmotic pressure gradient across the wall, thereby producing a solution containing agent that is released through the passageway at a controlled rate over time.