Abstract: A device for controlled release of pharmaceutical agents and a method for use of the device. The drug delivery device comprises a covered container with an aperture and an aperture cover, containing a pharmaceutical agent and an excipient formulation.

Abstract: A method for treating patients having calcium related disorders includes using di- or tripeptide derivatives of bisphosphonates to enhance oral bioavailability of such compounds.

Abstract: A pharmaceutical delivery vehicle includes a solid drug particle disposed within a diffusional boundary layer made up of a matrix and a solubilizing agent. The solubilizing agent is selected to substantially solubilize a drug particle in vitro.

Abstract: A device for controlled release of pharmaceutical agents and a method for use of the device. The drug delivery device comprises a covered container with an aperture and an aperture cover, containing a pharmaceutical agent and an excipient formulation.

Abstract: A drug delivery system (10) includes a first capsule half (12) having an inner chamber (16) containing a drug (18) therein. A plug (28) is disposed in a passageway (26) of the capsule half (12) for plugging the opening (24) thereof. The plug (28) is releasable from the passageway opening (24) upon the application of pressure from within the inner chamber (16). A pump mechanism, reactive with the external environment of the capsule half (12), causes an increase in pressure within the inner chamber (16) and forces the plug (28) out of the passageway (26) to release the drug (18) from the inner chamber (16) and out of the passageway (26). Thusly, after initial release of drug from a second capsule half (14) releasably mounted on the first capsule half (12), the first capsule half (12) provides a second pulse of drug release at a predetermined time after initial ingestion of the capsule.

Abstract: Proteins or peptidic substances, which may be prepared from naturally occurring proteins, enhance the bioavailability of proteolytically-labile therapeutic agents which, in the absence of the protein or peptidic substance would suffer enzymatic inactivation upon administration.

Abstract: A controlled release delivery system includes a functional gene vector in a biodegradable polymeric microsphere encapsulating the vector. The present invention further provides a method of making a controlled release delivery system by encapsulating the functional gene vector in a biologically degradable polymeric microsphere.

Abstract: A self-microemulsifying excipient formulation for increasing the bioavailability of a drug which includes an emulsion including an oil or other lipid material, a surfactant, and a hydrophilic co-surfactant. A method for making a drug delivery system for increasing the bioavailability of a drug by emulsifying at least one drug with a self-microemulsifying excipient comprising an oil or other lipid material, a surfactant, and a hydrophilic co-surfactant and drugs formulated thereby.

Abstract: A drug delivery system (10) includes a first capsule half (12) having an inner chamber (16) for containing a drug (18) therein. A plug (28) is disposed in a passageway (26) of the capsule half (12) for plugging the opening (24) thereof. The plug (28) is releasable from the passageway opening (24) upon the application of pressure from within the inner chamber (16). A pump mechanism, reactive with the external environment of the capsule half (12), causes an increase in pressure within the inner chamber (16) and forces the plug (28) out of the passageway (26) to release the drug (18) from the inner chamber (16) and out of the passageway (26). Thusly, after initial release of drug from a second capsule half (14) releasably mounted on the first capsule half (12), the first capsule half (12) provides a second pulse of drug release at a predetermined time after initial ingestion of the capsule.

Abstract: A method of making a pharmaceutical composition is disclosed. The method includes the steps of contacting at least one pharmaceutical ingredient with a mixture consisting essentially of gelatin and lecithin to increase the dissolution rate of water-insoluble pharmaceutical ingredients. A pharmaceutical excipient coating for increasing the dissolution rate of water-insoluble pharmaceutical ingredients is also disclosed. The coating consists essentially of gelatin and lecithin.

Abstract: A method of making a pharmaceutical composition is disclosed. The method includes the steps of contacting at least one pharmaceutical ingredient with a mixture consisting essentially of gelatin and lecithin to increase the dissolution rate of water-insoluble pharmaceutical ingredients. A pharmaceutical excipient coating for increasing the dissolution rate of water-insoluble pharmaceutical ingredients is also disclosed. The coating consists essentially of gelatin and lecithin.

Abstract: A method of making a pharmaceutical composition is disclosed. The method includes the steps of contacting at least one pharmaceutical ingredient with a mixture consisting essentially of gelatin and lecithin to increase the dissolution rate of water-insoluble pharmaceutical ingredients. A pharmaceutical excipient coating for increasing the dissolution rate of water-insoluble pharmaceutical ingredients is also disclosed. The coating consists essentially of gelatin and lecithin.

Abstract: A method of making a drug delivery system (10) includes the steps of filling a first water permeable capsule half with a drug and an osmotic agent and plugging an open-end (24) of the capsule (12). The method further includes the steps of disposing a water permeable film (30) over the capsule (12) and plug (28), filling a second capsule half (14) with a drug (18), and releasably mounting an open end (34) of the second capsule half (14) over the plugged end (24) of the first capsule half (12).

Abstract: A pharmaceutical formulation comprising a polymeric resin having bile acid binding properties in combination with at least one bile acid binding material which enhances the bile acid binding affinity and/or capacity of the formulation, methods for preparing the formulations and methods for using the formulations.

Abstract: An improved bioactive agent delivery composition and method of application are described. The composition comprises a bioactive agent, a hydrophilic polymer in an incompletely hydrated state and a substantially water-miscible solvent system. The agent and polymer are essentially dissolved in the solvent system to form a sprayable composition having a viscosity of less than 350 cP. Upon dilution with water, the viscosity of the composition increases to in excess of 1000 cP to produce a retentive coating at the site of application which provides enhanced bioavailability of the agent.

Abstract: A drug delivery system includes a first capsule half having an inner chamber for containing a drug therein. A plug is disposed in a passageway of the capsule half for plugging the opening thereof. The plug is releasable from the passageway opening upon the application of pressure from within the inner chamber. A pump mechanism causes an increase in pressure within the inner chamber and forces the plug out of the passageway to release the drug from the inner chamber and out of the passageway thereby providing a second pulse of drug release at a predetermined time after initial ingestion of the capsule. The invention further provides a method of manufacturing the drug delivery system and method by which the drug delivery system provides the drug to the body.

Abstract: A drug delivery system for administering a drug in controlled pulse doses to an aqueous environment in the body of a living being has one or more, and preferably less than ten, individual drug-containing subunits in a unitary drug depot, such as a tablet or capsule. The individual subunits are designed to dissolve at different sites and/or times in the gastrointestinal tract to release pulse doses of drug into the portal system in an analogous manner to the rate of release from an immediate release dosage form administered according to an appropriate dosing schedule. The dissolution time of the individual subunits can be controlled by several methods including the provision of pH-sensitive enteric coatings and permeability-controlled coatings. The drug delivery system has significant advantages for the oral administration of first-pass metabolized drugs which exhibit a non-linear relationship between input rate of the drug into the portal system and bioavailability.

Abstract: An improved bioactive agent delivery composition and method of application are described. The composition comprises a bioactive agent, a hydrophilic polymer in an incompletely hydrated state and a substantially water-miscible solvent system. The agent and polymer are essentially dissolved in the solvent system to form a sprayable composition having a viscosity of less than 350 cP. Upon dilution with water, the viscosity of the composition increases to in excess of 1,000 cP to produce a retentive coating at the site of application which provides enhanced bioavailability of the agent.

Abstract: A dosage system for administering drugs and conducting gastric flow studies is configured in the form of a multiplicity of substantially spherical subunits which have advantageously preselected particle diameter and density to customize the flow rate of the subunits with respect to the rate of flow of at least certain portions of the chyme. The diameter and density are related to one another in accordance with a relationship: ##EQU1## where N.sub.V is a dimensionless group having a predetermined value representing gastric residence time, g is the gravitational constant, .DELTA.p is the difference in density between the subunits and the chyme, and <v> is the linear velocity of the chyme. The flow rate of the subunits can be made slower, faster, or substantially equal to that of the chyme, as required to treat certain disease states. Also, the subunits can be provided with an enteric coating which permits more precise administration of certain drugs, such as those used in enzyme supplementation therapy.

Abstract: The instant invention is directed to a lipid osmotic pump, comprising:(A) a core, comprising:(i) a beneficial amount of at least one substantially water insoluble active agent which is lipid soluble and/or lipid wettable;(ii) a sufficient amount of at least one water immiscible lipid carrier, which is liquid at the temperature of intended use, to dissolve and/or suspend said active agent; and(iii) a sufficient amount of at least one osmotic agent to ensure release of said lipid carrier from the pump; and(B) surrounded by a water insoluble wall:(i) having a thickness of about 1 to 1000 microns;(ii) which is preferentially wetted by said lipid carrier over an aqueous solution of said osmotic agent;(iii) having a water permeability of about 1.times.10.sup.-18 to 4.times.10.sup.-15 cm.sup.