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]:

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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.

Multilayer beads for pharmaceutical use having a drug-in-polymer layer are disclosed. The disclosed multilayer beads for pharmaceutical use have (a) a core particle; (b) an optional barrier layer coated on the surface of the core particle; (c) a drug-in-polymer layer coated on the surface of the core or the barrier layer, (d) an optional sealant layer coated on the surface of the drug-in-polymer layer; and (e) optionally one or more outer layers external to the drug-in-polymer layer or the sealant layer. The drug-in-polymer layer consists essentially of (i) a drug selected from the group consisting of a 15-keto prostaglandin drug, a 13,14-dihydro prostaglandin drug, and a 13,14-dihydro-15-keto prostaglandin drug; and (ii) a polymer selected from the group consisting of polyvinylpyrrolidone, vinylpyrrolidone-vinylacetate copolymer or a mixture thereof. The drug-in-polymer layer may be solid dispersion of the drug in the polymer. Pharmaceutical compositions comprising a plurality of multilayer beads and a pharmaceutically acceptable excipient and methods of treating a gastrointestinal disorder are also disclosed.

Pharmaceutical compositions comprising spray-dried oxalate decarboxylase crystals are disclosed. Methods to treat a disorder associated with elevated oxalate concentration using compositions comprising spray-dried oxalate decarboxylase crystals are also disclosed.

The present technology relates generally to dry powder formulations comprising leucine and trileucine in specific ratios that are suitable for pulmonary delivery. Also provided are methods of preparing the dry powder formulations, and methods of administration and treatment using the dry powder formulations.

The present disclosure relates to a process for preparing pitolisant hydrochloride of Formula-(I) and solid-state forms thereof.

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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 present invention relates to a pharmaceutical granulate composition comprising Palbociclib free base, having improved bioavailability.

The invention relates to solid particles containing solid primary particles that consist essentially of native cellulose and optionally a binder, to the production and use thereof.

A solid pharmaceutical composition comprising a quinazoline derivative or a medicinal salt thereof, and a preparation method therefor. Specifically, provided is a solid pharmaceutical composition comprising N.sup.6-(1-acryloylpiperidin-4-yl)-N.sup.4-(3-chloro-4-fluorophenyl)-7-methoxyquinazoline-4,6-diamine or a medicinal salt thereof, and a preparation method therefor and use thereof.

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An oral dissolving film containing nano- or micro-encapsulated bioactive material and methods of forming the film. The film may be prepared by dispensing a mixture of a film-forming agent, a crosslinking agent, a solution of nano- or micro-encapsulated bioactive material, and a photoinitiator into a plurality of wells in a tray using a 3D printer. The dispensed material is exposed to radiation in order to crosslink the material and form a film.