Abstract: Pharmaceutical compositions and methods are described comprising at least a parathyroid hormone peptide (PTH) preferably PTH1-34 and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of PTH, for treating or preventing osteoporosis or osteopenia in a mammalian subject, preferably a human.

Abstract: A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum×100) to at least about 1.

Abstract: Pharmaceutical compositions and methods are described comprising at least one Y2 receptor-binding peptide, such as peptide YY(PYY), Neuropeptide Y (NPY) or Pancreatic Peptide (PP) and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of the peptide YY, for treating a variety of diseases and conditions in mammalian subjects, including obesity.

Abstract: Pharmaceutical compositions and methods are described comprising at least one Y2 receptor-binding peptide, such as peptide YY(PYY), Neuropeptide Y (NPY) or Pancreatic Peptide (PP) and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of the peptide YY, for treating a variety of diseases and conditions in mammalian subjects, including obesity.

Abstract: Pharmaceutical compositions and methods are described comprising at least one Y2 receptor-binding peptide, such as peptide YY(PYY), Neuropeptide Y (NPY) or Pancreatic Peptide (PP) and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of the peptide YY, for treating a variety of diseases and conditions in mammalian subjects, including obesity.

Abstract: Pharmaceutical compositions and methods are described comprising at least one peptide YY compound and one or more intranasal delivery-enhancing agents for enhanced nasal mucosal delivery of the peptide YY, for treating a variety of diseases and conditions in mammalian subjects, including obesity. In one aspect, the intranasal delivery formulations and methods provide enhanced delivery of peptide YY to the blood plasma or central nervous system (CNS) tissue or fluid, for example, by yielding a peak concentration (Cmax) of the peptide YY in the blood plasma or CNS tissue or fluid of the subject that is 20% or greater compared to a peak concentration of the peptide YY in the blood plasma or CNS tissue or fluid of the subject following administration to the subject of a same concentration or dose of the peptide YY to the subject by subcutaneous injection.

Abstract: Pharmaceutical compositions and methods are described comprising at least one Y2 receptor-binding peptide, such as peptide YY(PYY), Neuropeptide Y (NPY) or Pancreatic Peptide (PP) and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of the peptide YY, for treating a variety of diseases and conditions in mammalian subjects, including obesity.

Abstract: Non-invasive methods are provided for obtaining biological samples of mammary fluid or mammary fluid components by administering oxytocin to a patient to stimulate expression of mammary fluid. During or after mammary fluid expression, a biological sample is collected in the form of whole mammary fluid, whole cells or cellular components, other selected liquid or solid fractions of the mammary fluid, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired constituents of mammary fluid. Methods and kits are also provided for determining the presence or amount of a breast disease marker in biological samples of mammary fluid or mammary fluid components obtained according to the above sample collection methods. Also provided within the invention are novel breast pump and breast pump adapter devices which incorporate a solid phase sample collection medium integrated within the breast pump or adapter or otherwise fluidly connected therewith.

Abstract: A method of making an emulsion of tocopherol incorporating a co-solvent and, stabilized by biocompatible surfactants, as a vehicle or carrier for therapeutic drugs, which is substantially ethanol free and which can be administered to animals or humans by various routes, is disclosed. Also included in the emulsion is PEGylated vitamin E. PEGylated ?-tocopherol includes polyethylene glycol subunits attached by a succinic acid diester at the ring hydroxyl of vitamin E and serves as a primary surfactant, stabilizer and a secondary solvent in emulsions of ?-tocopherol.

Abstract: An emulsion of ?-tocopherol, stabilized by biocompatible surfactants, as a vehicle or carrier for therapeutic drugs, which is substantially ethanol free and which can be administered to animals or humans via various routes is disclosed. Also included in the emulsion is PEGylated vitamin E. PEGylated ?-tocopherol includes polyethylene glycol subunits attached by a succinic acid diester at the ring hydroxyl of vitamin E and serves as a primary surfactant, stabilizer and a secondary solvent in emulsions of ?-tocopherol.

Abstract: Methods and compositions are provided for prophylaxis and treatment of breast cancer involving administration of a therapeutically effective amount of carbetocin and/or other long-acting oxytocin analogues. 1-Butanoic acid-2-(O-methyl-L-tyrosine)-1-carbaoxytocin (carbetocin) and/or other long-acting oxytocin analogues are formulated with a pharmaceutically acceptable carrier and administered in an amount sufficient to inhibit initiation or growth of breast cancer in the patient. The carbetocin and/or other long-acting oxytocin analogues may also be formulated with a pharmaceutically acceptable carrier and administered in an amount sufficient to treat, prevent or alleviate the symptoms of a psychiatric disorder in the patient. Carbetocin may be administered prophylactically or to treat existing conditions in patients by a variety of administration modes, including intramuscular, intravenous, intranasal, intrapulmonary, subcutaneous, parenteral, oral, or transdermal delivery methods and formulations.

Abstract: Biological samples of mammary fluid or components thereof are obtained using a breast pump device coupled with a solid phase sample collection medium, alternatively facilitated by administering oxytocin to the subject. The breast pump device stimulates expression of mammary fluid and provides for collection of diagnostic samples to evaluate breast disease, including cancer. The biological sample may include whole cells or cellular components, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired constituents comprising a breast disease marker. Methods, kits and adapter devices relating to the breast pump device are also provided. Yet additional methods, devices, accessories, and materials are provided for laboratory handling and processing of breast fluid samples and for related diagnostic methods.

Abstract: Disclosed herein are agents for enhancing the contrast in an ultrasound image. These agents are extremely small bubbles, or “microbubbles,” comprised of specially selected gases. The microbubbles described herein exhibit long life spans in solution and may be produced at a size small enough to traverse the lungs, thus enabling improved ultrasound imaging of the cardiovascular system and other vital organs. Also disclosed herein is a method for selecting gases from which contrast agents may be produced. The method is based on calculations using inherent physical properties of gases and describes a means to associate the properties of a gas with the time for dissolution of microbubbles comprised of the gas.

Abstract: Compositions and methods are provided for intranasal delivery of interferon-&agr; yielding improved pharmacokinetic and pharmacodynamic results. In certain aspects of the invention, the interferon-&agr; is delivered to the intranasal mucosa along with one or more intranasal delivery-enhancing agent(s) to yield substantially increased absorption and/or bioavailability of the interferon-&agr; and/or a substantially decreased time to maximal concentration of interferon-&agr; in a tissue of a subject as compared to controls where the interferon-&agr; is administered to the same intranasal site alone or formulated according to previously disclosed reports. The enhancement of intranasal delivery of interferon-&agr; according to the methods and compositions of the present invention allows for the effective pharmaceutical use of these agents to treat a variety of diseases and conditions in mammalian subjects.

Abstract: A method for treating cancer in a mammal comprised of administering a therapeutically effective amount of an agent that induces the expression of one or more claudins within a cancerous cell. Preferably the claudin is claudin-3, claudin-4 aor claudin-9. In a preferred method, a nucleic acid that encodes a claudin is administered to the mammal under conditions wherein the nucleic acid is transfected into the cancerous cell and the claudin is produced in the cell. Also disclosed is a method for diagnosing cancer comprising determining the presence of a claudin 3, 4 or 9 in a cell that normally expresses the protein. If the cell does not express the claudin, then it is cancerous.

Abstract: Disclosed are novel carboxylate salts of galantamine including galantamine gluconate, galantamine lactate, galantamine citrate and galantamine glucarate. These salts of galantamine have more than a 5 fold increase in solubility compared to galantamine hydrobromide. These galantamine salts can be administered to an individual to inhibit acetylcholinesterase in the treatment of such diseases as Alzheimer's disease, atony of the smooth muscle of the intestinal tract and urinary bladder, glaucoma, myasthenia gravis, and termination of the effects of competitive neuromuscular blocking drugs.

Abstract: Methods for treating migraine and cluster headaches by improving the transmucosal Tmax and Cmax of triptans are disclosed. The intranasal compositions are comprised of water, a triptan and an absorption enhancer, for example, &agr;-cyclodextrin.

Abstract: Methods and compositions are provided for prophylaxis and treatment of breast cancer involving administration of a therapeutically effective amount of carbetocin and/or other long-acting oxytocin analogues. 1-Butanoic acid-2-(O-methyl-L-tyrosine)-1-carbaoxytocin (carbetocin) and/or other long-acting oxytocin analogues are formulated with a pharmaceutically acceptable carrier and administered in an amount sufficient to inhibit initiation or growth of breast cancer in the patient. The carbetocin and/or other long-acting oxytocin analogues may also be formulated with a pharmaceutically acceptable carrier and administered in an amount sufficient to treat, prevent or alleviate the symptoms of a psychiatric disorder in the patient. Carbetocin may be administered prophylactically or to treat existing conditions in patients by a variety of administration modes, including intramuscular, intravenous, intranasal, intrapulmonary, subcutaneous, parenteral, oral, or transdermal delivery methods and formulations.

Abstract: An aqueous solution of calcitonin suitable for intranasal administration comprised of calcitonin, chlorobutanol at a concentration of less than 0.4% weight/weight, and water and having a pH of less than 4 with the proviso that benzalkonium chloride is not present in the solution. The aqueous solution of calcitonin can be used to treat osteoporosis, Paget's bone disease and hypercalcemia.

Abstract: Pharmaceutical compositions and methods are described comprising at least one Y2 receptor-binding peptide, such as peptide YY(PYY), Neuropeptide Y (NPY) or Pancreatic Peptide (PP) and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of the peptide YY, for treating a variety of diseases and conditions in mammalian subjects, including obesity.