Abstract: The present invention relates to methods for terminal sterilization of solid forms of nanoparticulate active agent compositions via gamma irradiation. The nanoparticulate active agent has an effective average particle size of less than about 2 microns, prior to incorporation into a solid form for sterilization. The resultant sterilized compositions exhibit excellent redispersibility, homogeneity, and uniformity. Also encompassed are compositions made via the described method and methods of treating animals and humans using such compositions.

Abstract: The present invention relates to liquid dosage forms of nanoparticulate active agents having very low viscosities.

Abstract: A system for milling at least one material, e.g., a drug. The system includes a milling apparatus and at least one milling medium. The milling apparatus includes a chamber having a rotary milling head located in it. The milling head is rotated within the chamber by a magnetic drive system.

Abstract: The present invention is directed to nanoparticulate compositions comprising benzoyl peroxide. The benzoyl peroxide particles of the composition have an effective average particle size of less than about 2 microns.

Abstract: The present invention relates to a drug delivery device for mixing and delivering a drug by injection. The device includes a housing having a first port or opening therein that receives a first container that contains a fluid or powdered drug, for example a lyophilized drug. The housing can also include a second port or opening that receives a second container that contains a fluid to be mixed with the drug to form an injectable fluid. The device includes a manifold having a channel that fluidly connects the first and second containers. A penetrating membrane such as a needle is used to inject the drug into a patient which is in fluid communication with the first container. The needle is movable from a storage position in the housing to an injection position extending through the housing.

Abstract: A spike for facilitating the introduction of liquid under pressure into a container containing a substance is provided which includes an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, where the distal end has a sharp, pointed tip. An introduction channel is located within the spike shaft for receiving liquid into the container where a portion of the introduction channel is angled to cause liquid to travel out of the introduction channel in a direction non-parallel to the longitudinal axis of the spike shaft. An extraction channel may be included within the spike shaft for removing liquid from the container, where the extraction channel extends through the elongate spike shaft towards the proximally located end portion.

Abstract: Disclosed is a rapidly disintegrating solid oral dosage form of a poorly soluble active ingredient and at least one pharmaceutically acceptable water-soluble or water dispersible excipient, wherein the poorly soluble active ingredient particles have an average diameter, prior to inclusion in the dosage form, of less than about 2000 nm. The dosage form of the invention has the advantage of combining rapid presentation and rapid dissolution of the active ingredient in the oral cavity.

Abstract: A device for measuring a volume of liquid drug. The device includes a first chamber containing liquid drug, a measurement chamber in liquid communication with the first chamber, and a measurement assembly.

Abstract: Disclosed is a rapidly disintegrating or dissolving (fast melt) solid dosage form of at least one active agent and at least one pharmaceutically acceptable water-disintegrable or water-soluble excipient, wherein the dosage form has two opposed double-convex surfaces. The dosage form of the invention has the advantage of exhibiting low friability with a very low disintegration time.

Abstract: The present invention relates to a drug delivery device for mixing and delivering a drug by injection. The device includes a housing having a first port or opening therein that receives a first container that contains a fluid or powdered drug, for example a lyophilized drug. The housing can also include a second port or opening that receives a second container that contains a fluid to be mixed with the drug to form an injectable fluid. The device includes a manifold having a channel that fluidly connects the first and second containers. A penetrating membrane such as a needle is used to inject the drug into a patient which is in fluid communication with the first container. The needle is movable from a storage position in the housing to an injection position extending through the housing.

Abstract: The present invention relates to a drug delivery device for mixing and delivering a drug by injection. The device includes a housing having a first port or opening therein that receives a first container that contains a fluid or powdered drug, for example a lyophilized drug. The housing can also include a second port or opening that receives a second container that contains a fluid to be mixed with the drug to form an injectable fluid. The device includes a manifold having a channel that fluidly connects the first and second containers. A penetrating membrane such as a needle is used to inject the drug into a patient which is in fluid communication with the first container. The needle is movable from a storage position in the housing to an injection position extending through the housing.

Abstract: A drug delivery device having a housing having an internal reservoir in communication with a drug delivery outlet via a fluid path. An expandable chamber disposed adjacent to the reservoir forces drug from the reservoir to the outlet when supplied with a gas. A flow regulating chamber, in communication with the fluid path, is capable of volumetric changes in response to temperature and/or pressure changes. An increase in the volume of the flow regulating chamber increases flow resistance to the outlet and thereby counteracts the corresponding increase in delivery rate resulting from the expansion of the expandable chamber due to the same volumetric changes in response to temperature and/or pressure. In a preferred embodiment, an electrical circuit has a current stabilizing element in electrical communication with an electrolytic cell which supplies the gas. A throttling device maintains a higher pressure in the device to reduce possible clogging of the fluid path.

Abstract: A system adapted to be disposed between a rigid or semi-rigid device and human skin for reliably attaching the device to the skin for an extended period of time. The system includes a skin-contacting surface for adhering to human skin, and an opposed surface for attachment to a rigid or semi-rigid device. The system is attached along its opposed surface to a portion of the total area of the adjacent surface of the device. When the device is subjected to external stress, the stress is transmitted through the area of attachment and distributed to the unattached area. This minimises stress on the skin and reduces the chance of detachment from the skin.

Abstract: A system and method for delivering drug solutions to a user, the system having a housing with a drug reservoir therein. The system also includes an activation assembly having a delivery needle and an activation device for activating delivery. The system further includes a pump, associated with the drug reservoir and a flow restrictor. When activated, the pump moves the drug out of the drug reservoir through the delivery needle and into the skin of the user. The pump may be in the form of a spring.

Abstract: An injector is automatic in that the needle is injected automatically into the injection site (e.g., a patient's skin), delivery is initiated upon activation of the injector, and the needle is retracted after the end of delivery. Preferably the needle is not seen by the user prior to, during or after injection. Prior and to and after injection, the needle is withdrawn into the device so as to avoid any potential injury or health risk to the user or health care provider. The injector includes a housing and a control unit arranged to slide within the housing to move a piston rod during drug delivery and to pivot within the housing for needle retraction. The injector may also include a back rod that moves the piston rod before activation of the injector for titration and reconstitution and automatically disengages from the piston rod upon activation of the injector. A needle-locking device can be used in any number of pen-like injectors or other types of injectors or syringes.

Abstract: Improved electrolytic cells are described. The cells comprise the novel electrolyte K2HPO4, or a less alkaline phosphate buffer solution, electrodes having a modified composition, or a combination of the new electrolyte and a modified composition electrode. The K2HPO4 electrolyte, or less alkaline phosphate buffer solution, and modified electrodes can be used in liquid delivery devices which deliver a liquid agent at a constant rate or a controlled variable rate over a period of time.

Abstract: Nanoparticulate insulin compositions having effective an average particle size of less than about 5 microns are described. The compositions exhibit retention of insulin bioactivity, increased bioavailability, and increased consistency of bioavailability as compared to prior macro-sized insulin compositions. Methods of making nanoparticulate insulin compositions, dosage forms containing them, and the use of such formulations in insulin therapy are also described.

Abstract: The present invention is directed to a high throughput screening (HTS) method, comprising reducing the particle size of a poorly soluble candidate compound to about 1 micron or less using a small scale mill or microfluidics. The product produced from this process is a dispersion of a nanoparticulate candidate compound having one or more surface stabilizers adsorbed onto the surface of the compound. The reduction in particle size results in an increase in the solubility and/or dispersibility of the compound, thus increasing the effectiveness of HTS conducted in conjunction with the particle size reduction process. The particle size reduction process can be conducted before HTS to make screening compounds soluble and/or dispersible, or after HTS to validate an insoluble or poorly compound determined to be active after screening.

Abstract: Particulate crystalline therapeutic substances are formulated with stabilizers to enhance contact between the crystalline therapeutic substances and the mucosal membranes to provide extended therapeutic effect.

Abstract: A drug delivery device having a housing having an internal reservoir in communication with a drug delivery outlet via a fluid path. An expandable chamber disposed adjacent to the reservoir forces drug from the reservoir to the outlet when supplied with a gas. A flow regulating chamber, in communication with the fluid path, is capable of volumetric changes in response to temperature and/or pressure changes. An increase in the volume of the flow regulating chamber increases flow resistance to the outlet and thereby counteracts the corresponding increase in delivery rate resulting from the expansion of the expandable chamber due to the same volumetric changes in response to temperature and/or pressure. In a preferred embodiment, an electrical circuit has a current stabilizing element in electrical communication with an electrolytic cell which supplies the gas. A throttling device maintains a higher pressure in the device to reduce possible clogging of the fluid path.