Abstract: A process for preparing ultrafine powders of biological macromolecules comprises atomizing liquid solutions of the macromolecules, drying the droplets formed in the atomization step, and collecting the particles which result from drying. By properly controlling each of the atomization, drying, and collection steps, ultrafine dry powder compositions having characteristics particularly suitable for pulmonary delivery for therapeutic and other purposes may be prepared.

Abstract: The invention provides a method for forming particles of a target substance (26), involving: (a) preparing a solution or suspension of the substance in a vehicle (21) which is or includes either a near-critical fluid (21) or a first supercritical fluid; (b) introducing the solution or suspension into a particle formation vessel (32); and (c) contacting the solution or suspension, in the particle formation vessel, with a second super-critical fluid, under conditions which allow the second supercritical fluid to cause precipitation of particles of the target substance from the solution or suspension; wherein the second supercritical fluid is miscible or substantially miscible with the vehicle and is a fluid in which the target substance is insoluble or substantially insoluble.

Abstract: The invention relates to a process for the production of morphologically uniform microcapsules that contain peptides, proteins or other water-soluble biologically active substances as active ingredients as well as microcapsules that are produced according to this process with a degree of concentration of between 3 to 30% by weight and a diameter ≦8 &mgr;m. According to the invention, biodegradable polymers are dissolved in a halogen-free solvent or solvent mixture, and the buffered active ingredient solution, which has a pH of between 6.0 to 8.0, is dispersed into this solution. Then, an aqueous solution that contains a surfactant (W/O/W-emulsion) is added to this W/O-emulsion, and the solvent is removed. The microcapsules that are produced with this process do not show any tendency toward agglomeration. The encapsulation efficiency of the process is approximately 90 to 95%.

Abstract: Methods for preparing dry powders having hydrophobic and hydrophilic components comprise combining solutions of the components and spray drying them simultaneously in a spray dryer. The hydrophilic and hydrophobic component are separately dissolved in separate solvents and directed simultaneously through a nozzle, usually a coaxial nozzle, into the spray dryer. The method provides dry powders having relatively uniform characteristics.

Abstract: Spray drying methods for forming powder compositions for pharmaceutical applications are disclosed. According to one aspect of the invention, the spray drying feed stock comprises a bioactive agent, surfactant, and a blowing agent. Another aspect of the invention is directed to spray drying a feed stock comprising a phospholipid and calcium chloride.

Abstract: The present invention provides therapeutic formulations for solutions of &Dgr;9-tetrahydrocannabinol (&Dgr;9 THC) to be delivered by metered dose inhalers. The formulations, which utilize non-CFC propellants, provide a stable aerosol-deliverable source of &Dgr;9 THC for the treatment of various medical conditions, such as: nausea and vomiting associated with chemotherapy; muscle spasticity; pain; anorexia associated with AIDS wasting syndrome; epilepsy; glaucoma; bronchial asthma; and mood disorders.

Abstract: The invention relates to a process for the production of gaseous microparticles for ultrasonic diagnosis, whose wall material is built up from polyesters of &agr;-, &bgr;- or &ggr;- hydroxycarboxylic acids, particles that are produced according to this process, as well as their use in medical diagnosis.

Abstract: The invention provides a method and apparatus for forming particles of a substance, comprising (a) introducing into a particle formation chamber, the temperature and pressure in which are controlled, a first supercritical fluid (SCF) and a solution or suspension of the substance in a vehicle; (b) simultaneously introducing an impinging flow of a second supercritical fluid (SCF), at an angle to, and directed at, the direction of flow of the first supercritical fluid, so as to increase the amount of kinetic energy transferred to the solution or suspension; and (c) using either or both of the first and the second supercritical fluids to disperse the solution or suspension, and to extract the vehicle from it, substantially simultaneously and substantially immediately on introduction of the fluids into the particle chamber.

Abstract: A process for preparing ultrafine powders of biological macromolecules comprises atomizing liquid solutions of the macromolecules, drying the droplets formed in the atomization step, and collecting the particles which result from drying. By properly controlling each of the atomization, drying, and collection steps, ultrafine dry powder compositions having characteristics particularly suitable for pulmonary delivery for therapeutic and other purposes may be prepared.

Abstract: Methods for preparing dry powders having hydrophobic and hydrophilic components comprise combining solutions of the components and spray drying them simultaneously in a spray dryer. The hydrophilic and hydrophobic component are separately dissolved in separate solvents and directed simultaneously through a nozzle, usually a coaxial nozzle, into the spray dryer. The method provides dry powders having relatively uniform characteristics.

Abstract: Stabilized dispersions are provided for the delivery of a bioactive agent to the respiratory tract of a patient. The dispersions preferably comprise a plurality of perforated microstructures dispersed in a suspension medium that typically comprises a hydrofluoroalkane propellant. As density variations between the suspended particles and suspension medium are minimized and attractive forces between microstructures are attenuated, the disclosed dispersions are particularly resistant to degradation, such as, by settling or flocculation. In particularly preferred embodiments, the stabilized dispersions may be administered to the lung of a patient using a metered dose inhaler.

Abstract: The invention relates to a process for the production of morphologically uniform microcapsules that contain peptides, proteins or other water-soluble biologically active substances as active ingredients as well as microcapsules that are produced according to this process with a degree of concentration of between 3 to 30% by weight and a diameter≦8 &mgr;m. According to the invention, biodegradable polymers are dissolved in a halogen-free solvent or solvent mixture, and the buffered active ingredient solution, which has a pH of between 6.0 to 8.0, is dispersed into this solution. Then, an aqueous solution that contains a surface-active substance (W/O/W-emulsion) is added to this W/O-emulsion, and the solvent is removed. The microcapsules that are produced with this process do not show any tendency toward agglomeration. The encapsulation efficiency of the process is approximately 90 to 95%.

Abstract: The invention relates to gaseous microparticles for ultrasonic diagnosis, whose wall material is built up from block copolymers of polyesters of &agr;-, &bgr;- or &ggr;-hydroxycarboxylic acids with linear or star-shaped polyethylene glycols and optionally liquid crystals or whose wall material is built up from polyesters of &agr;-, &bgr;- or &ggr;-hydroxycarboxylic acids and liquid crystals, media that contain these particles for ultrasonic diagnosis, as well as a process for the production of the media and particles.

Abstract: A dosage form and a method are disclosed and claimed for administering a drug in a sustained and constantly ascending rate per unit time to provide an intended therapeutic effect while concomitantly lessening the development of unwanted effects.

Abstract: The present invention is directed to the transdermal administration of at least one drug together with a suitable amount of a permeation enhancer comprising monoalkyl ethers of polyethyleneglycol and their alkyl or aryl carboxylic acid esters and carboxymethyl ethers. 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 the 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 at least one drug together with a permeation enhancer of this invention, alone or in combination with other enhancers.

Abstract: Composition of matter for application to a body surface or membrane to administer pergolide by permeation through the body surface or membrane, the composition comprising pergolide to be administered, at a therapeutically effective rate, alone or in combination with a permeation enhancer or mixture. Also disclosed are drug delivery devices containing the pergolide or pergolide and enhancer composition and methods for the transdermal administration of the pergolide and pergolide/enhancer composition.

Abstract: This invention pertains to a dosage form for the management of epilepsies wherein the dosage form comprises administering valproic acid or a valproic acid derivative at a continuous rate over an extended time.

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: A dosage form is disclosed for delivering an antiepileptic drug, which dosage form comprises a laminated wall for maintaining the integrity of the dosage form and of the antiepileptic drug.

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.