The disclosure provides products configured for oral use, and methods of making the products. The products include a plurality of granules, the granules including at least one filler; at least one sugar alcohol; a cellulose ether, polyvinylpyrrolidone, or a combination thereof; and at least one active ingredient, at least one flavorant, or a combination thereof. The products may be in a granular form, or in the form of a tablet or pellet.

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.

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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The present invention relates to the use of sodium octenyl succinate starch as a binder in twin screw granulation, in particular for pharmaceutical solid dosage form and the granule obtainable by the method thereof.

A method for preparing a microsphere include steps of dissolving an active ingredient and a biodegradable polymer in an organic solvent to prepare a dispersed phase, dissolving a salt in water to prepare a continuous phase, mixing and stirring the dispersed phase and the continuous phase to form an emulsion, removing the organic solvent; and drying.

A solid dispersion of amorphous efinaconazole and a method for preparing the same are proposed. The solid dispersion includes an amorphous form of efinaconazole and at least one stabilization carrier selected from hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), ethyl cellulose (EC), hydroxypropyl methylcellulose acetate succinate (HPMC-AS), polyvinylpyrrolidone (PVP), polyacrylic acid (PAA), saccharin, and malonic acid. The solid dispersion undergoes minimal thermodynamic deformation when exposed to ambient temperature and humidity, achieving improved stability, while maintaining the inherent improved stability and bioavailability of amorphous efinaconazole.

The present invention relates to a method for granulating an amphiphilic active ingredient or a pharmaceutically acceptable salt thereof, comprising a step for coating the active ingredient in a polar aprotic solvent in the presence of a polymer binder to obtain a granule.

A process for producing a pharmaceutical formulation comprises the steps of: A) suspending a pharmaceutical active substance in an aqueous solution of a polymer; B) drying the mixture obtained in step A); wherein in step A) the pharmaceutical active substance is present in the form of particles having a d.sub.90 value in the particle size distribution of ≤1 μm and before step B) the pharmaceutical active substance is further contacted with an ionic surfactant.