Abstract: A complex of a double stranded (ds) ribonucleic acid and a peptide produced by a method comprising dissolving the nucleic acid in an aqueous solution, dissolving the peptide in an aqueous solution, mixing the solubilized ds nucleic acid and the solubilized peptide, and treating the mixture by freezing and thawing, heating and cooling, or salting and desalting.

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: What is described is an aqueous Y2 receptor-binding peptide formulation for enhanced intranasal delivery of a Y2 receptor-binding peptide, comprising said Y2 receptor-binding peptide, a buffer salt, and having a pH between about 3.0 and about 6.0, wherein said buffer salt comprises a net single ionogenic moiety with a pKa within two pH units of the pH of the formulation.

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) wherein the formulations have increased resistance to microbial contamination and is comprised of a Y2 receptor-binding peptide, water, a cyclodextrin and sodium benzoate.

Abstract: Compositions and methods are provided for intranasal delivery of interferon-? yielding improved pharmacokinetic and pharmacodynamic results wherein the composition is free of a stabilizer that is a protein or a polypeptide. In certain aspects of the invention, the interferon-? 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-? and/or a substantially decreased time to maximal concentration of interferon-? in a tissue of a subject as compared to controls where the interferon-? is administered to the same intranasal site alone or formulated according to previously disclosed reports. The enhancement of intranasal delivery of interferon-? 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 formulation for intranasal delivery of a neuroprotective peptide, comprising an aqueous mixture of a peptide having the sequence NAPVSIPQ or a pharmaceutically acceptable salt thereof, a solubilizing agent, a chelator, and a surface active agent. The formulation can contain a peptide salt or mucosal delivery-enhancing agent which increases the amount of neuroprotective peptide reaching the therapeutic target.

Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

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: 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: 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: Methods and compositions containing oxytocin or an oxytocin analog, specifically carbetocin, are provided for the prevention and treatment of autism spectrum disorders, related disorders and symptoms of such disorders. The methods and compositions of the invention are effective in the treatment of social withdrawal, eye contact avoidance, repetitive behaviors, anxiety, attention deficit, hyperactivity, depression, loss of speech, verbal communication difficulties, aversion to touch, visual difficulties, comprehension difficulties, and sound and light sensitivity. Additional compositions and methods are provided which employ oxytocin or an oxytocin analog in combination with a secondary or adjunctive therapeutic agent to yield more effective treatment tools against autism spectrum disorders and related disorders.

Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide, a sugar and a salting-out salt.

Abstract: Methods for treating metabolic diseases are described for intranasal delivery of an exenatide, comprising an aqueous mixture of exendin, and a delivery enhancer selected from the group consisting of a solubilizer, a chelator, and a surfactant, and the pharmaceutical formulations used therein.

Abstract: A parathyroid hormone (1-34) (PTH) dosage form is described that is suitable for multi-use administration. A dosage form of parathyroid hormone (1-34) (PTH) comprising an aqueous pharmaceutical formulation for aerosolized intranasal delivery of PTH having a bioavailability of about 5% or greater, wherein the formulation comprises a therapeutically effective amount of PTH and polysorbate, and wherein least 90% of the PTH can be recovered after storage for 24 weeks at 5° C.

Abstract: What is described is a method of delivering PTH to a human, comprising exposing a layer of mucosal cells to a mixture of PTH and an enhancer, wherein the enhancer is capable of modulating the barrier function of a cellular tight junction. Specifically, the method of delivering PTH to a human by intranasal administration comprises use of an aqueous solution of growth and excipients in a bottle and a droplet-generating actuator attached to the bottle and fluidly connected to the PTH solution in the container, wherein the actuator produces a spray of the PTH solution through a tip of the actuator when the actuator is engaged, wherein the spray of PTH solution has a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip.

Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

Abstract: What is described is a pharmaceutical formulation for intranasal delivery of glucagon-like protein-1 (GLP-1), comprising an aqueous mixture of GLP-1, a solubilizing agent, a chelator, and a surface active agent.

Abstract: Pharmaceutical compositions and methods are described comprising at inactive forms or parathyroid hormone peptide (PTH) or PTH analogs wherein the inactive forms are activated upon administration into the systemic circulation. Also described is a method of preventing local reaction to a biologically active agent, preparing a formulation comprising said biologically active agent, a solubilizing agent and a surfactant, and administering such formulation by contacting said formulation with a mucosal surface.

Abstract: What is described is a method for treating osteoporosis in a mammal comprising administering intranasally a therapeutically effective amount of a PTH formulation to the mammal wherein the PTH formulation is an aqueous formulation comprised of a PTH peptide and one or more excipients selected from the group consisting of a water-miscible polar organic solvent, a surface active agent, and a chelating agent for cations.

Abstract: What is described is an aqueous pharmaceutical composition for intranasal delivery of PTH, comprising a PTH molecule, and one or more excipients selected from the group consisting of a chelating agent, an alcohol, and a surface active agent, wherein the PTH molecule selected from the group consisting of SEQ NO: 1, SEQ NO: 2, and SEQ NO: 3.