The current invention is based on the determination that a S1P receptor modulator compound of formula (I):

##STR00001##

decreases the heart rate of a subject to which it is administered by about 5 beats/min or less daily, or about 4 beats/min or less daily, or about 3 beats/min or less daily, or about 2 beats/min or less daily, wherein the S1P receptor modulator is administered at an initial daily dosage which is substantially the same as the standard daily therapeutic dosage.

What is described herein relates to a method for generating micro-particles comprising the steps of a) providing a homogenous supersaturated solution of a substance in a crystallization medium b) providing a seeding material characterized by a nano-particle size of a d50 between 10 nm and 999 nm comprising at least one stabilizer, wherein said seeding material is of the same substance as the substance of the homogenous supersaturated solution of step a) c) bringing the homogenous supersaturated solution in contact with the seeding material,
optionally isolating micro-particles.

The present disclosure relates to a composition for improving sleep quality, including γ-aminobutyric acid (GABA) or a salt, hydrate or solvate thereof; and at least one of arginine, niacin, and salts, hydrates and solvates thereof. The composition for improving sleep quality may improve the sleep quality by increasing melatonin secretion. In addition, in another aspect, the present disclosure provides a composition for alleviating stress, including γ-aminobutyric acid (GABA) or a salt, hydrate or solvate thereof; and at least one of arginine, niacin, and salts, hydrates and solvates thereof.

Provided herein are low impurity compositions comprising a compound represented by Formula (I): ##STR00001##
which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFRα kinases, and oncogenic forms thereof.

The present invention provides a pharmaceutical composition comprising a PDE9 inhibitor. Specifically, the PDE9 inhibitor is (S)-7-(2-methoxy-3,5-dimethylpyridin-4-yl)-1-(tetrahydrofuran-3-yl)-1H-pyrazolo[4,3-c]quin olin-4(5H)-one or pharmaceutically acceptable salts thereof.

The invention provides an oral solid formulation comprising (a) a controlled release component comprising a core comprising levodopa, wherein the core is coated with a layer of a muco-adhesive polymer and externally coated with a layer of an enteric polymer; and (b) an immediate release component comprising carbidopa and levodopa.

The present disclosure relates generally to rapid-release pharmaceutical dosage unit tablets containing a drug that is an inhibitor of the mitogen-activated protein kinase enzyme, a filler and a disintegrant, and to processes for forming the tablets. More specifically, the present disclosure relates to pharmaceutical dosage unit tablets containing cobimetinib, a least one filler, at least one lubricant and at least one disintegrant, and to methods for preparing the tablets from granules formed by dry granulation.

Disclosed herein are vaccine compostions and method to use the same. The compositions and methods disclosed herein provide means to prevent and/or treat a variety of cancers.

A drug delivery system comprises a porous, self-healing biodegradable polymer matrix having a ionic, charged, biopolymer and a pH modifying species disposed within the pores. An ionic macromolecule having the opposite charge binds the biopolymer and forms a nonsoluble polyelectrolyte complex. The molecular weight of the biopolymer, the self healing polymer matrix, the concentration of pore forming agent and the concentration of the pH modifying species are selected for optimal binding and release of the macromolecule.

Drug-loaded microbead compositions include microbeads of a water-swellable polymer material and a complex of a carrier and a therapeutic agent chemically bonded to the carrier. The complex is embedded in the polymer material. The therapeutic agent is not chemically bonded to the water-swellable polymer material. The drug-loaded microbead composition has a water content of less than 1% by weight, based on the total weight of the drug-loaded microbead composition. The drug-loaded microbead composition may be rehydrated to form an embolization composition for use in in embolization therapy. Methods for preparing the drug-loaded microbead compositions and the embolization compositions include loading a therapeutic agent into a water-swellable polymer material to form microbeads, then removing water from the microbeads.