Provided herein are oral dosage forms comprising a) a core tablet comprising (i) a drug layer comprising apremilast and hypromellose acetate succinate (HPMCAS) in an amorphous solid dispersion; and (ii) a swellable layer comprising one or more swellable polymers; and b) a coating layer disposed on the core tablet, wherein the oral dosage form surface comprises at least one drug release orifice. The disclosed oral dosage forms provide once-a-day dosing of apremilast and are suitable for treating diseases or disorders ameliorated by inhibiting phosphodiesterase subtype IV (PDE4).

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.

The present invention is related to the discovery of new oral dosage formulations and combination therapies for 1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide, or a pharmaceutically acceptable salt thereof, for treating conditions ameliorated by inhibition of IRAK4.

Methods of improving visual endpoints related to retina-associated disease with CCR3 modulating agents are provided. An example of such an endpoint is visual acuity. Retina-associated diseases upon which visual acuity and other visual endpoints may be improved include retinopathy of prematurity, age-related macular degeneration, central retinal vein occlusion, and diabetic retinopathy.

The present invention relates to a pharmaceutical composition for oral administration, particularly in the form of a tablet, comprising darolutamide or a pharmaceutically acceptable salt thereof as an active ingredient. Darolutamide is a potent androgen receptor (AR) modulator useful in the treatment of cancer, particularly AR dependent cancer such as prostate cancer, and other diseases where AR antagonism is desired.

This invention relates to novel implant drug delivery systems for long-acting delivery of antiviral drugs. These compositions are useful for the treatment or prevention of human immunodeficiency virus (HIV) infection.

The present invention relates to pharmaceutical compositions containing one or more compounds of formula 1 ##STR00001##
wherein R.sup.1 is H, C.sub.1-6-alkyl, C.sub.0-4-alkyl-C.sub.3-6-cycloalkyl, C.sub.1-6-haloalkyl; R.sup.2 is H, C.sub.1-6-alkyl; X is an anion selected from the group consisting of chloride or ½ dibenzoyltartrate; j is 1 or 2; and
processes for the preparation thereof, and their use to treat diseases connected with the CCR3 receptor.

The invention provides an oral extended release formulation for the treatment of treatment-resistant depression, treatment-resistant anxiety, and phobia.

Provided herein are tablet formulations comprising a core comprising omecamtiv mecarbil, a pharmaceutically acceptable salt thereof, or a pharmaceutically acceptable hydrate of a pharmaceutically acceptable salt thereof; a filler; a binder; a glidant; and a lubricant; and a film coating on the core, the film coating comprising a modified-release polymer and a pore former. Also provided is a process for making a tablet formulation and a method of treating cardiovascular conditions, such as heart failure, using the tablet formulation.

The invention provides an oral extended release formulation for the treatment of treatment-resistant depression, treatment-resistant anxiety, and phobia.