The invention relates to coated particles with a taste-masked drug substance. The particles comprise a core with a melt-agglomerated active pharmaceutical ingredient (API), optionally a thermolabile API, and a coating comprising a triglyceride and a surfactant. The particles exhibit immediate drug release and a storage-stable release profile. Moreover, the invention provides a hot-melt granulation and hot-melt coating method for manufacturing such coated particles, and pharmaceutical compositions comprising the coated particles. The method allows the granulation of APIs with small particle sizes (e.g., mean particle size below 150 μm, or even below 100 μm or 50 μm) into core particles, as well as coating said core particles, at moderate temperatures, thereby preventing the degradation of thermolabile active pharmaceutical ingredients.

A pharmaceutical composition comprising a small molecule EGFR inhibitor and a preparation method therefor, the composition comprising N-(5-((4-(1-cyclopropyl-1H-indol-3-yl)pyrimidin-2-yl)amino)-2-((2-(dimethylamino)ethyl)(methyl)amino)-4-methoxyphenyl)acrylamide, an isomer, solvate, hydrate, or pharmaceutically acceptable salt thereof, or a combination thereof that acts as an active ingredient, and at least one pharmaceutically acceptable excipient.

A novel and innovative method of fabricating nanoparticles with reproducible characteristics from batch-to-batch and during scale-up. The method is a dipolymerization-precipitation reaction facilitated by the inverse electron demand Diels-Alder (IEDDA) reaction.

The present invention relates to solid oral pharmaceutical compositions comprising dexamethasone or its pharmaceutically acceptable salts or solvates thereof. The present invention also relates to a process for preparing solid oral pharmaceutical compositions comprising dexamethasone or its pharmaceutically acceptable salts or solvates thereof. The preferred drug load in the compositions of the present invention is from about 0.01% to 15% by weight based on the total weight of the composition. The prepared compositions of dexamethasone as per the present invention exhibit desirable technical attributes.

The present invention relates to a process to prepare solid pharmaceutical forms comprising a quantity of mesalazine comprised between 75 and 95%, i.e. between 1000 and 1600 mg of drug per dosage unit. Furthermore, the present invention relates to a granulate and/or tablets obtained/obtainable with the process according to the invention, preferably coated to allow the controlled release of the drug. Finally, the present invention relates to the use of the granulate and/or the tablets as a medicament, preferably for the treatment of chronic inflammatory pathologies that preferably affect the intestinal tract.

Provided herein are pharmaceutical compositions (e.g., oral dosage formulations) comprising (S)-2-(2,6-dioxopiperidin-3-yl)-4-((2-fluoro-4-((3-morpholinoazetidin-1-yl)methyl)benzyl)amino)isoindoline-1,3-dione, or an enantiomer, mixture of enantiomers, tautomer, isotopolog, or pharmaceutically acceptable salt thereof, and a carrier or diluent. Also provided herein are methods of preparing and methods of using the pharmaceutical compositions.

The present invention relates to a composition in the form of a thermoformed extrudate comprising at least one triterpene and/or at least one triterpenoid and/or at least one of the glycosylated forms thereof and at least one polymer selected from the group consisting of natural or synthetic proteins, natural or synthetic oligosaccharides, natural or synthetic polysaccharides, the derivatives thereof and the mixtures thereof, said at least one triterpene and/or said at least one triterpenoid and/or said at least one of the glycosylated forms thereof comprising at least one first amorphous phase and optionally one second crystalline phase. The present invention also relates to the method for manufacturing by thermoforming such a composition and to the use thereof.

Provision of a granular preparation that contains edoxaban or a pharmacologically acceptable salt thereof, and has the property of being rapidly dissolved or suspended by the addition of water. A granular preparation comprising first granules containing (A) edoxaban or a pharmacologically acceptable salt thereof, (B) a sugar alcohol, and (C) a water-swelling additive, and second granules containing (D) 0.5 to 10% by weight of carmellose sodium with respect to the total weight of the preparation, and (E) 70 to 90% by weight of xylitol or sorbitol with respect to the total weight of the preparation.

The present invention includes compositions and methods for making and using a rapid dissolving, high potency, substantially amorphous nanostructured aggregate for pulmonary delivery of tacrolimus and a stabilizer matrix comprising, optionally, a polymeric or non-polymeric surfactant, a polymeric or non-polymeric saccharide or both, wherein the aggregate comprises a surface area greater than 5 m.sup.2/g as measured by BET analysis and exhibiting supersaturation for at least 0.5 hours when 11-15-times the aqueous crystalline solubility of tacrolimus is added to simulated lung fluid.

The present invention relates to a pharmaceutical formulation comprising at least one active pharmaceutical ingredient (API) having low aqueous solubility or a pharmaceutically acceptable salt thereof in the form of particles of a size between 1 and 800 nm, wherein said particles are encapsulated within a large microparticle of a size between 1 and 100 .Math.m formed by a matrix comprising at least an excipient. Therefore, the API is entrapped or encapsulated in the microparticles of excipients. This pharmaceutical formulation contains the pharmaceutical active ingredient having improved solubility and subsequently supra-bioavailability.