Abstract: The present application discloses devices and methods for delivering a therapeutic compound to the olfactory epithelium of an animal or human. The device having one or more channels for imparting a circumferential and axial velocity to the discharged fluid, and an outlet that discharges an aerosol spray having a circumferential and axial velocity as it enters the nasal cavity of a user. The device is designed to displace the air in the upper nasal cavity in order to specifically deposit a therapeutic agent on the olfactory epithelium while minimizing pressure and discomfort experienced by the user.

Abstract: A compound delivery device for delivering a plume derived from a propellant and a drug formulation. The drug formulation is in an intranasal dosage form in the form of powder, suspension, dispersion or liquid. The propelled intranasal dosage form is deposited within the olfactory region of the nasal cavity. The drug deposited within the olfactory region is delivered to the brain avoiding the blood-brain-barrier. Hydrofluoroalkane propellant from a pressurized canister is channeled to a diffuser and drug-containing chamber where the intra-nasal dosage form is aerosolized. The aerosolized intra-nasal dosage form passes through a nozzle thus delivering a plume to the olfactory region of a user's nasal cavity.

Abstract: Methods of delivering a pharmaceutical compounds directly to the olfactory epithelium of a mammal by providing a pharmaceutical aerosol suspension comprising an aerosol and the pharmaceutical compound; aerosolizing the suspension to generate a stream of droplets, the stream having a rotational component, and, delivering the droplets directly to the olfactory epithelium, wherein at least 15% of the droplets are delivered directly to the olfactory deposition. The pharmaceutical compound may be encapsulated within a liposome nanoparticle.

Abstract: The present application is directed to lipid-drug complexes and related methods for producing stable lipid-drug complexes at or near the neutral pH range and administering pharmaceutical lipid-drug complexes to patients. In certain examples, the lipid-drug complex has a lipid-to-drug molar ratio of approximately 3:1. In certain examples, the lipid-drug complex may have lipid-to-drug molar ratios of less than 3:1 to 10:1 or higher. The present application is also directed to methods of administering a drug to a patient though subcutaneous injection of the lipid-drug complexes into particular tissues to effect higher localized concentrations of the at least one drug.

Abstract: Lipid nanoparticles expressing metal ions and methods for using the compositions for magnetic resonance imaging.

Abstract: The present application discloses devices and methods for delivering a therapeutic compound to the olfactory epithelium of an animal or human. The device having one or more channels for imparting a circumferential and axial velocity to the discharged fluid, and an outlet that discharges an aerosol spray having a circumferential and axial velocity as it enters the nasal cavity of a user. The device is designed to displace the air in the upper nasal cavity in order to specifically deposit a therapeutic agent on the olfactory epithelium while minimizing pressure and discomfort experienced by the user.

Abstract: Disclosed is a test method of bioavailability or bioequivalence for xenobiotics, comprising selection of test subjects (human or animal) based on the genetic information for metabolic enzymes or transporters that influence pharmacodynamics or pharmacokinetics for xenobiotics, and testing bioavailability or bioequivalence of the same. Consideration of this method for applying genetic profiling information to improve analysis of a result from the bioavailability or bioequivalence test after the clinical test is also provided.

Abstract: Provided are compositions relating to novel MDR1 polymorphisms, including nucleic acids, polypeptides, and recombinant cells, as well as methods for detection of MDR1 polymorphisms in biological samples and elucidation of the influence of MDR1 polymorphisms on MDR1 protein function. Also provided are a rat MRP1 cDNA and protein, stable cell lines expressing the rat MRP1 protein, and methods of assessing drug penetration or disposition in a cell line expressing a recombinant mammalian MRP1 or MDR1 protein, or a homolog thereof.

Abstract: Provided are compositions relating to novel MDR1 polymorphisms, including nucleic acids, polypeptides, and recombinant cells, as well as methods for detection of MDR1 polymorphisms in biological samples and elucidation of the influence of MDR1 polymorphisms on MDR1 protein function. Also provided are a rat MRP1 cDNA and protein, stable cell lines expressing the rat MRP1 protein, and methods of assessing drug penetration or disposition in a cell line expressing a recombinant mammalian MRP1 or MDR1 protein, or a homolog thereof.

Abstract: Various embodiments of the present invention are directed to lipid-pharmaceutical compositions and related methods for producing a lipid-drug complex under conditions near the neutral pH range. Optimal pH range is provided for the efficient incorporation of various lipid-drug complexes. A lipid-drug complex, such as a liposome, readily encapsulates drugs having low aqueous solubility within a neutral pH range. In some embodiments, the lipid-drug complex comprises a lipid bilayer and a lipid-soluble drug having a range of molar ratio values of lipid-to-drug from about 3:1 to about 100:1 or higher for relatively toxic drugs. Lipid-drug complexes can also be formed within a range of molar ratios from about 3:1 to about 10:1, and a range of molar ratios from about 5:1 to about 7:1. In various embodiments, biomolecules, such as nucleic acids and proteins, that can have pharmacological activities may also be incorporated within lipid vesicles.

Abstract: This invention is directed to a new membrane lytic immunoassay. In one embodiment of this assay, an antigen is first covalently coupled with lipids and this antigen-lipid complex is mixed with a hexagonal phase forming lipid to form bilayer liposome vesicles additionally containing a self-quenching fluorescent dye. When this antigen-containing liposome is brought into contact with a solid surface coated with antibody molecules, binding occurs between the antigen and the antibody, disrupting the liposome and releasing the dye. To assay a biological fluid for free antigen the fluid is first contacted with the solid surface-antibody complex, to saturate the bound antibody. Binding by the liposomes is thereby inhibited, leading to reduced dye release. Comparing dye release against a standardized curve of dye release versus known antigen concentrations allows for rapid determination of the unknown antigen concentration in the biological fluid. Similarly, antibodies and other entities, e.g., enzymes, drugs, etc.