Abstract: A process is provided for the production of bis-choline tetrathiomolybdate, the process comprising reacting a choline salt with ammonium tetrathiomolybdate, wherein the choline salt is a hydroxide, acetate, or halide choline salt, wherein the process comprises: combining the choline salt with a first mixture of ammonium tetrathiomolybdate in water, wherein a molar excess of choline salt to ammonium tetrathiomolybdate is used, for a first reaction period to provide a first reaction mixture; subjecting the first reaction mixture to a reduced pressure for a second reaction period to provide a second reaction mixture; and, isolating bis-choline tetrathiomolybdate from the second reaction mixture, wherein isolating bis-choline tetrathiomolybdate comprises adding ethanol to the second reaction mixture.

Abstract: The present invention relates to a film comprising an alginate salt of a monovalent cation or a mixture of alginate salts containing at least one alginate salt of a monovalent cation, and a compound of Formula (I), such as adrenaline, or a pharmaceutically acceptable salt thereof. The present invention further relates to methods for manufacturing such a film, and the use of such a film in the treatment of a human patient, in particular the use of such a film in the treatment of a condition selected from anaphylaxis, superficial bleeding and cardiac arrest.

Abstract: The present invention relates to bioavailable fill compositions containing one or more of a decongestant, an expectorant, an antitussive, an analgesic, and/or an antihistamine; capsules filled with the bioavailable fill compositions; and methods of making same.

Abstract: The invention provides formulations for oral delivery of a therapeutic agent wherein the formulation comprises a kappa opioid receptor agonist, an oligosaccharide stabilizing agent and an optional absorption enhancer. The kappa opioid receptor agonist may be coated with, embedded in or mixed with an oligosaccharide, such as trehalose. Also provided are capsules containing the oral formulations of the kappa opioid receptor agonists, the oligosaccharide and the absorption enhancer of the invention. The invention further provides methods of manufacture of the formulations and methods of their use for the prophylaxis, inhibition and treatment of variety of kappa opioid receptor-associated diseases and conditions such as pain, pruritus and inflammation. The methods of use include administering to the mammal the formulation of the kappa opioid receptor agonist, oligosaccharide and optional absorption enhancers.

Abstract: Enteric softgel capsules comprise a fill material and an enteric shell composition, characterized in that the enteric nature of the capsules may be achieved without an enteric coating or added conventional enteric polymers.

Abstract: A process prepares a polymer-coated hard shell capsule, suitable as container for pharmaceutical or nutraceutical biologically active ingredients. The hard shell capsule can include a body and a cap. In the closed state, the cap overlaps the body either in a pre-locked state or in a final-locked state. The hard shell capsule can be provided in the pre-locked state and spray-coated with a coating solution, suspension, or dispersion that includes a polymer or a mixture of polymers to create a coating layer which covers the outer surface of the hard shell capsule in the pre-locked state.

Abstract: Disclosed is the use of a water-soluble realgar solid dispersion in the preparation of an erythroid differentiation inducer for bone marrow hematopoietic stem cells and/or bone marrow hematopoietic progenitor cells. The water-soluble realgar solid dispersion is prepared from raw materials comprising 1 part by weight of realgar, 1-20 parts by weight of a polymer, and 0-5 parts by weight of a surfactant. The water-soluble realgar solid dispersion can induce bone marrow hematopoietic stem and/or progenitor cells to be differentiated into red blood cells, promote the accumulation of red blood cells in bone marrow cells, effectively alleviate the decrease in the number of red blood cells caused by the suppression of the erythroid differentiation of bone marrow hematopoietic stem and/or progenitor cells, improve anemia caused by hematopoietic failure, and protect bone marrow cells from the killing effect.

Abstract: Formulations of tegavivint, methods of making such formulations, and methods of treatment of cancer by administering the formulations.

Abstract: Pharmaceutical compositions comprising an immediate release component comprising 4-((L-valyl)oxy)butanoic acid and a modified release component comprising 4-((L-valyl)oxy)butanoic acid and the pharmacokinetics of 4-((L-valyl)oxy)butanoic acid and ?-hydroxybutyrate following oral administration of the pharmaceutical compositions is disclosed.

Abstract: The present application relates to a pregabalin sustained release composition, comprising: (a) an active ingredient; (b) a matrix-forming agent; (c) a swelling agent; (d) a gelling agent; and optionally a filler. The pregabalin sustained release composition provided in the present application can rapidly swell in volume when exposed to aqueous medium until exceeding the dimeter of human gastric pyloric (13 mm). It thereby prolongs the gastric emptying time to increase the retention time of pregabalin in the stomach and enhances absorption of pregabalin in the small intestine and ascending colon. Moreover, the pregabalin sustained release composition provided herein achieves a sustained release for 24 h, which allows QD (once a day) administration, reduces administration number, and improves patient compliance.

Abstract: Compositions, systems and methods of dispensing compositions for treating skin conditions, the compositions including an inorganic compound and having desirable viscosity, spreadability and foam drainage profiles.

Abstract: Pharmaceutical granulations having a functional coating surrounding a core containing 4-((L-valyl)oxy)butanoic acid are disclosed. The functional coatings provide for immediate release or modified release of 4-((L-valyl)oxy)butanoic acid. The pharmaceutical granulations can be used in oral pharmaceutical compositions.

Abstract: The present invention provides pharmaceutical composition of immunosuppressive agent in oral suspension dosage form. The oral suspension composition comprises of immunosuppressive agent with other pharmaceutical excipients such as vehicle, suspending agent, solvent or cosolvent, preservative, sweetener, antifoaming agent, wetting agent, buffering agent and flavouring agent. The present invention oral suspension having improved stability, palatability with high dose of active ingredient. The present invention provides oral suspension with flavor that has masked bitter taste of the drug and eliminates difficulty of administration. Further, the present invention also provides a convenient, easy process for preparation thereof.

Abstract: Provided herein are stable amlodipine liquid formulations. Also provided herein are methods of using amlodipine liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).

Abstract: A composition comprising particles formed of poly(diaminosulfide) and one or more leptospiral antigens, and methods of making and using the composition, are provided.

Abstract: Pharmaceutical compositions of 4-((L-valyl)oxy)butanoic acid and the pharmacokinetics of 4-((L-valyl)oxy)butanoic acid and ?-hydroxybutyric acid following oral administration of the pharmaceutical compositions to healthy subjects are disclosed.

Abstract: Compositions for forming porous materials and three-dimensional objects, including fibers, films and coatings made from the materials are provided. Also provided are methods for forming the porous objects from the compositions. The compositions include a solvent, a polymer binder that is soluble in the solvent, and solid particles that are insoluble in the solvent. The solid particles include water-soluble salt particles that can be selectively dissolved from objects made from the compositions to render the resulting structures porous.

Abstract: The present invention provides ingestible dosage form articles such as opaque capsules with reduced light transmittance.

Abstract: An insulin formulation and a method of preparing and using same. The insulin preparation includes insulin, oligosaccharide and sodium chloride at a ratio of 1:A:B (w:w:w respectively) with ranges of A and B are 1000-5000 and 10-50, respectively.

Abstract: Described are sustained-release solid dosage forms of epigallocatechin gallate (EGCG) or aminosterol compositions. In one aspect of the invention the sustained-release solid dosage forms of EGCG or an aminosterol are capsules comprising a plurality of coated solid particulates. Another aspect of the invention relates to methods of inhibiting, ameliorating, reducing the likelihood of, delaying the onset of, treating or preventing an amyloid disorder, comprising the step of administering to a subject in need a therapeutically effective amount of the solid dosage form. In certain aspects, the amyloid disorder is Parkinson's Disease.