The present disclosure provides pharmaceutical compositions prepared using an additive manufacturing process where the active pharmaceutical ingredient has been rendered into the amorphous form or prepared as an amorphous solid dispersion at a temperature below the melting point of the active pharmaceutical ingredient or the glass transition of the physical mixture or composition of the individual components. The present disclosure also provides methods of preparing these compositions by using properties such as the chamber and surface temperature and the electron laser density.

A solid oral immediate release formulation of LSD, wherein the composition is produced by lyophilization of a feedstock in a pre-formed mold to form an orally disintegrating tablet. A method of making a solid oral immediate release formulation of LSD by lyophilizing a flash frozen stock solution of LSD and excipients, including a non-gelling matrix former, filler, and binder in a pre-formed mold, and forming an orally disintegrating tablet. A method of treating an individual by administering a solid oral immediate release formulation of LSD, wherein the composition is produced by lyophilization of a feedstock in a pre-formed mold to form an orally disintegrating tablet and treating the individual.

The present invention to unit dosage forms which are capable of floating on gastric fluid and delivering the therapeutic agent over an extended period of time. Particularly the invention relates to Droxidopa sustained release gastroretentive dosage form for release of drug over period of 12 hrs. The gastroretentive dosage form of Droxidopa of the present invention comprises drug, polymer (Hydroxy propyl methyl cellulose K200M) as rate controlling polymer and the formulation maintains buoyancy on the gastric fluid for a period of 12 hrs, thus providing better patient compliance by providing reducing dosing frequency.

The present invention aims to provide a preparation expected to improve the bitter taste of an organic acid salt of vonoprazan and permit rapid dissolution of the organic acid salt of vonoprazan after administration. The present invention provides a preparation containing fine granules or granules containing (1) a core granule containing an organic acid salt of vonoprazan, (2) an intermediate layer containing the same organic acid as the organic acid forming the salt of vonoprazan in (1), or a salt thereof, and (3) a coating layer containing a water-insoluble polymer.

The present invention relates to modified release pharmaceutical compositions of riociguat or a pharmaceutically acceptable salt thereof. In particular, the compositions of the invention are stable, possess formulation characteristics and also provide extended therapeutically effective plasma levels over twenty four hour time period. The invention also relates to processes of preparing such compositions.

Disclosed herein are hemi-citrate salts of Compound 1, crystalline forms thereof, methods of their preparation, pharmaceutical compositions thereof, and methods of their use.

Formulations of mazindol having superior stability and methods of administering same are provided. The formulations may be immediate, enhanced, or otherwise delayed release formulations of mazindol.

This disclosure provides formulations of enzalutamide and their use for treating hyperproliferative disorders.

One aim of the present invention is to treat or prevent chronic kidney disease. Provided is a treatment or prophylactic pharmaceutical composition for chronic kidney disease, that contains an SGLTl-inhibiting compound or a pharmaceutically acceptable salt thereof.

A novel orally administrable dosage form including a drug/active layer for loading a therapeutic agent and an extension layer for retaining the API or drug dosage form in the stomach of a subject in need thereof. Also disclosed is a method of treating diseases with the dosage form.