Provided herein are methods of administering a once-nightly dosage of gamma-hydroxybutyrate after a high-fat meal.

A composition comprises a therapeutically effective oral pharmaceutical dosage form. The dosage form includes an aqueous carrier material having an acidic pH and a plurality of individual pellets having a first dose of melatonin therein. The individual pellets comprises (i) a solid core; (ii) an active coating over the solid core, the active coating including melatonin and a hydrophilic binder; and (iii) an enteric coating over the active coating. A dissolution pH of the enteric coating is higher than the acidic pH of the aqueous carrier material.

Disclosed herein are pharmaceutical formulations comprising verinurad or a pharmaceutically acceptable salt thereof that are resistant to alcohol-induced dose dumping and may be used in therapeutic and/or prophylactic methods.

The present application discloses pharmaceutical compositions and methods of treating neurological disorders and seizure disorders with the high dose modified release compositions of huperzine. The pharmaceutical compositions and methods described herein, allow for higher dosing of huperzine, while avoiding rapid peak plasma levels, thereby avoiding the dose-limiting adverse events associated with the immediate release formulations.

Method of treating sexually transmitted infection in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above. Pharmaceutical compositions and uses thereof are included herein.

This invention provides, in part, various compositions and methods for protecting the gastrointestinal microbiome from antibiotic disruption.

The present disclosure provides methods and compositions for modified delivery of mycophenolic acid active agents, including sodium mycophenolate, in veterinary subjects. Presently disclosed methods and compositions are useful, for example, to treat autoimmune diseases, blood disorders associated with IMPDH activity, and immune rejection related to transplant or graft procedures.

The present invention provides, in part, formulations comprising an alkaline phosphatase. Particularly, modified-release formulations comprising an alkaline phosphatase are provided, which release a substantial amount of the alkaline phosphatase in the intestines. Therapeutic uses of the alkaline phosphatase formulations are also provided.

Disclosed are formulations for providing a therapeutic bioactive polypeptide to injured tissue. Formulations include mineral coated microparticles wherein a polynucleotide is adsorbed to the mineral layer. Other formulations include a carrier including mineral coated microparticles wherein mineral coated microparticles include a polynucleotide. Also disclosed are methods for sustained delivery of a bioactive polypeptide and methods for treating chronic wounds using a formulation for providing sustained delivery of the bioactive peptide.

Methods are provided for coating particles characterised by the addition of a powdered excipient, typically during coating. Typically, the coating method comprises Wurster fluidized bed coating. The method provides for coating particles in a coater comprising a coating processing chamber, wherein the particles comprise an active pharmaceutical ingredient. The coated particles are preferably for use in a method of administering an active pharmaceutical ingredient or for use in a method of treating or preventing a disease or condition. The invention further provides a pharmaceutical composition comprising coated particles obtainable by the method of the invention, preferably as part of a liquid formulation for oral administration.