The present invention aims to provide a preparation containing a compound of the formula [I] or a pharmaceutically acceptable salt thereof or a hydrate thereof having improved pharmacokinetics, and a manufacturing method thereof. The present invention relates to a solid dispersion containing (1) an amorphous compound represented by the following formula [I]:

##STR00001##

or a pharmaceutically acceptable salt thereof or a hydrate thereof, and

(2) one to four kinds of pharmaceutically acceptable polymers selected from the group consisting of hydroxypropylmethylcellulose acetate succinate, methylcellulose, hypromellose and polyvinyl alcohol, and a manufacturing method thereof.

The present invention relates to pharmaceutical formulations to treat gout by managing uric acid content in human body by control of making of uric acid in the body and/or removing uric acid from the body. Further, such formulations for treatment of gout are fast available for pharmacological action. Pharmaceutical formulation of the present invention is orally disintegrating solid pharmaceutical dosage form of febuxostat for treating hyperuricemia.

A tablet for oral suspension formulation suitable for reconstitution is disclosed. The tablet contains a disintegrant, a wetting agent, a lubricant and other excipients in selected amounts to provide fast disintegration and dissolution in water. Also disclosed is a method of treating a disease by administering to a subject in need thereof a tablet disclosed herein.

A product and process of manufacturing an edible soft-chewable dosage form for the delivery of pharmaceutically active ingredients or nutritional agents orally to an animal or human subject, by forming a granulated soft-chew mass by appropriate mixing and sifting steps, and forming tablets with a compression press. Such soft-chew dosage forms have hardness of less than about two kilopond (2 kp) and friability of less than about one percent (1%) at three-hundred (300) rotations when measured according to the United States Pharmacopeia (USP) test. The process for manufacturing such compressed soft-chew tablets employs compression (tablet) pressing equipment to produce soft-chew tablets of consistent weight and texture.

Provided herein are pediatric formulations comprising 2 methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate, and methods for treating, preventing and managing cancer using the same.

The present disclosure provides a pharmaceutical composition comprising a solid dispersion having a mass median diameter of about 75 μm to about 400 μm, and one or more pharmaceutically acceptable excipients, wherein the solid dispersion comprises (R)-2-(1-(6-amino-5-chloropyrimidine-4-carboxamido)ethyl)-N-(5-chloro-4-(trifluoromethyl)pyridin-2-yl)thiazole-5-carboxamide, or a pharmaceutically acceptable salt thereof, and a vinylpyrrolidone-vinyl acetate copolymer.

Provided herein are fixed-dose combination formulations of a pharmaceutically effective amount of eflornithine together with a pharmaceutically effective amount of sulindac. Also provided are methods of use and of methods of manufacture of these formulations.

A dry granulation process using a twin-screw extruder for granulating a powder mixture which includes at least one active ingredient and at least one carrier. The process includes steps of kneading the powder mixture in the screw barrel of the twin-screw extruder at a barrel temperature below a melting point of the at least one active ingredient and a melting point or a glass transition temperature of the at least one carrier to provide a kneaded powder mixture, and extruding the kneaded powder mixture to form granules. Granules and tablets produced using the dry granulation process in the twin-screw extruder are also provided.

The invention relates to pharmaceutical compositions comprising a GLP-1 agonist, an SLGT2 inhibitor, a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, and a hydrotrope. The invention further relates to processes for the preparation of such compositions, and their use in medicine.

The present invention concerns tablet formulations of fosfomycin trometamol, methods of manufacturing and using thereof. More specifically, it relates to an oral pharmaceutical composition in tablet form comprising or consisting of: a. fosfomycin trometamol; b. a low moisture diluent selected from the group consisting of anhydrous calcium hydrogen phosphate, anhydrous microcrystalline cellulose and combinations thereof; c. optionally, a lubricant; and d. optionally, other pharmaceutically acceptable excipients.