The invention provides compositions that contain pathogen-binding nanodiscs and methods of using such compositions to treat and prevent pathogen infections. The compositions include nanodiscs functionalized with receptors that bind a pathogen. Binding of a pathogen to the nanodiscs neutralizes the pathogen by interfering with one or more aspects of its reproductive cycle. The compositions and methods are useful for treating or preventing infections in the body and for disinfecting aqueous fluids that may contain pathogens.

The present invention relates to mixtures comprising: i) at least one lipid and/or at least one oil; and ii) an alkyl ammonium EDTA salt;
wherein the mixture has a water content in the range of 0 to 1.0 wt %.

The invention further relates to mixtures which are pre-formulations, methods of treatment comprising administration of such pre-formulations, to pre-filled administration devices and kits containing the formulations, to the use of an alkylammonium EDTA salt to reduce the decomposition of the lipid components and/or any active agent contained within the pre-formulation, and to alkyl ammonium EDTA salts as described herein.

Gels are formed based on generally recognized as safe (GRAS) low molecular weight amphiphilic molecules in a self-assembly process. Therapeutic or prophylactic agents, such as biological macromolecules, are loaded without exposure to temperatures and/or organic solvents which can degrade or destroy the biologic agents and/or their activity. The resulting self-assembled gel composition contains microstructures having pores and aqueous domains at their interior, rendering them permeable to hydrophilic and hydrophobic molecules. This permeability allows sequestration of the biological macromolecules. Once sequestered, the electrostatic, hydrophobic-hydrophobic etc. interactions between the biological macromolecules and the amphiphilic gelators keep the labile payload encapsulated with high stability until the microstructures are degraded.

The disclosure generally relates to lipid nanodiscs, in particular to lipid nanodiscs formed from polysaccharides. A lipid nanodisc according to the disclosure includes a lipid bilayer having a first hydrophilic face and a second hydrophilic face opposing the first hydrophilic face, and a hydrophobic edge between the opposing hydrophilic faces, and a polysaccharide encircling the hydrophobic edge of the lipid bilayer. The polysaccharide is modified with a hydrophobic group. Methods of making and characterizing the lipid nanodiscs are also disclosed.

The present invention relates to compositions forming a low viscosity mixture of: a) 20-50 wt. % of at least one diacyl glycerol; b) 20-54 wt. % of at least one phosphatidyl choline (PC); c) 5-15 wt. % of at least one biocompatible, organic mono-alcoholic solvent; d) 1 to 20 wt. % polar solvent e) 5 to 150 mg/ml of at least one peptide somatostatin receptor agonist comprising pasireotide; f) optionally at least one antioxidant;
wherein the ratio of components a:b is in the range 40:60 to 54:46;
wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with excess aqueous fluid.

The invention further relates to methods of treatment comprising administration of such compositions, and to pre-filled administration devices and kits containing the formulations.

Disclosed are compositions and methods for treating, amelioriating, reversing and/or preventing (acting as a prophylaxis): a respiratory condition involving an infection or an inflammation, or any lung condition involving inflammation or infection, e.g., of a respiratory mucosa, and/or an infection or an inflammation of an underlying muscle of the respiratory tract; or, an asthma; a bronchitis; a sinusitis or rhinosinusitis; an infection of a sinus; chronic obstructive airway disease; emphysema; chronic bronchitis; pneumonia; or, a bronchiectasis. In alternative embodiments, the therapeutic combination comprises an orally administered Amphotericin B or equivalent antifungal alone, or a combination of Amphotericin B and: one antibiotic; two antibiotics; three antibiotics; or, four or more antibiotics. In alternative embodiments, these compositions and methods are dosaged and administered to children in need thereof. In alternative embodiments, compositions and methods of the invention are dosaged, formulated and dosaged as tablet, capsule, liquid, powder or aerosol preparations or formulations, or preparations or formulations for oral delivery or inhalation.

The present invention relates to compositions forming a low viscosity mixture of: a) 20-80 wt. % of at least one diacyl glycerol and/or a tocopherol; b) 20-80 wt. % of at least one phosphatidyl choline (PC); c) 5-20 wt. % of at least one biocompatible, organic mono-alcoholic solvent; d) up to 20 wt. % polar solvent e) at least one peptide active agent; f) optionally at least one antioxidant; wherein the ratio of components a:b is in the range 40:60 to 54:46; wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with excess aqueous fluid. The invention further relates to methods of treatment comprising administration of such compositions, and to pre-filled administration devices and kits containing the formulations.

A cochleate composition is disclosed. Following oral administration of the cochleate composition, the pharmacologically active agent is found at higher concentrations in the tissue relative to plasma. Oral administration of these cochleate compositions also preferentially targets infected or inflamed tissue as compared to tissue in a healthy subject. The cochleate composition contains a size-regulating agent that reduces cochleate particle size, such as a lipid-anchored polynucleotide, a lipid-anchored sugar, a lipid-anchored polypeptide, or a bile salt (such as oxycholate or deoxycholate). Also disclosed are methods of treatment using the cochleate composition and methods of increasing the concentration of a pharmacologically active agent in an infected tissue relative to the concentration of the pharmacologically active agent in the plasma or the tissue of a healthy subject.

Fusion protein nanodisk compositions and methods of treating a variety of disorders by administration of the fusion protein nanodisk compositions to a patient in need are disclosed. The fusion protein nanodisks provide for the combined delivery of two different apolipoproteins to a subject in need. Fusion protein nanodiscs may include a phospholipid bilayer encompassed by a fusion membrane scaffold protein. The fusion membrane scaffold protein may include two different amphipathic alpha-helical proteins, such as apolipoproteins. Methods for treating a disorder by administering a therapeutic amount of the fusion protein nanodisc described above are also disclosed.

A self-assembled discoidal PNA delivery vehicle includes a zwitterionic short chain diacyl lipid, a zwitterionic long chain diacyl lipid, a charged long chain diacyl lipid, a PEGylated lipid of the formula distearoyl phosphoethanolamine (DSPE)-PEG.sub.n-TG, and an encapsulated PNA molecule with a defined molar ratio of the zwitterionic long chain diacyl lipid and the charged long chain diacyl lipid to the short chain diacyl lipid, the molar ratio of the charged long chain diacyl lipid to the zwitterionic long chain diacyl lipid, molar % of the PEGylated lipid to all lipids, and ratio of PNA to lipid. Also described are method of self-assembling the discoidal PNA delivery vehicle and methods of enhancing cellular uptake of PNA using the discoidal PNA delivery vehicle.