Abstract: The present disclosure relates to pharmaceutical compositions comprising a gonadotropin-releasing hormone (GnRH) antagonist and methods of preparing and using such compositions. The disclosure also relates to methods of facilitating release of a GnRH antagonist from a pharmaceutical composition.

Abstract: Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.

Abstract: Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.

Abstract: Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.

Abstract: Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.

Abstract: Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.

Abstract: The present disclosure relates to pharmaceutical compositions comprising a gonadotropin-releasing hormone (GnRH) antagonist and methods of preparing and using such compositions. The disclosure also relates to methods of facilitating release of a GnRH antagonist from a pharmaceutical composition.

Abstract: The invention comprises a novel process for the spheronization of charged resins. Spherical multiparticlates are produced which range in size from 0.3 mm to 3 mm in diameter. The spherical particle product is microcrystalline-free. The process consists of the steps of mixing followed by wet granulation, spheronization and drying.

Abstract: A controlled release drug delivery device, comprised of swellable polymers, whose degree of swelling in an environment of use is controlled by swelling modulators blended within the polymers, is disclosed. The swelling modulators can include buffers, osmagents, surfactants or combinations thereof surrounded by a microporous coating or interspersed within individual matrices. The combination of controlled release swelling modulators with swellable polymers may be applied to regulate patterns of beneficial agent (typically a drug) release.

Abstract: A solubility modulated drug delivery device for controlled release of a therapeutically active ingredient into an environment of use is disclosed. The device comprises a core composition of a solubility modulating agent consisting of a complexing agent or a surfactant and a diffusible, water soluble, therapeutically active agent. The core composition is surrounded by a water insoluble semipermeable wall which is substantially impermeable to the core composition and permeable to the fluids in the environment of use and contains apertures through which active agent is released.

Abstract: The instant invention relates to a drug-delivery device for the controlled release of HMG-CoA reductase inhibitor salts, as the therapeutically active ingredient, into an environment of use which comprises:(A) a core composition comprising(1) a water insoluble, non-diffusible, charged resin entity, and(2) a diffusible, water soluble ionizable therapeutically active HMG-CoA reductase inhibitor salt carrying the same charge as said resin entity; and(B) an imperforate water insoluble wall surrounding said core composition and prepared from a semipermeable material substantially impermeable to core composition and permeable to the passage of an external fluid in the environment of use, with said wall having a means for release of the therapeutic agent through the water insoluble wall; or(C) a water insoluble wall surrounding said core composition and prepared from (1) a polymer material that is permeable to water but substantially impermeable to solute and (2) 0.

Abstract: A drug delivery device for the controlled release of a therapeutically active ingredient into an environment of use is disclosed which comprises:(A) a core composition comprising(a) a plurality of controlled release solubility modulating units comprising solubility modulating agents each of which is a complexing agent or a surfactant and which is either (i) surround by a water insoluble cost containing at least one pore forming additive dispersed throughout said coat, or (ii) dispersed in an individual matrix substrate, and(b) A therapeutically active ingredient; and(B) a water insoluble microporous wall surrounding said core composition comprising:(i) a polymer material that is permeable to water but substantially impermeable to solute and(ii) 0.1 to 75% by weight, based on the total weight of (i) and (ii), of at least one water leachable pore forming additive dispersed throughout said wall.