Astellas Pharma Gmbh

Bend Research, Inc.

Medivation Prostate Therapeutics, Inc.

Ben Research, Inc.

Sanjay Konagurthu

Randy J Wald

Dwayne Thomas Friesen

Koji Nishimura

Douglas Alan Lorenz

Leah Elizabeth Appel

Yuuki Takaishi

Toshiro Sakai

Shinsuke Oba

Edward Dennis LaChapelle

Hiroyasu Toyota

Jason A Everett

Atsushi Kanbayashi

Ryousuke Irie

Sheila Matz

Joshua R Shockey

Richard Frank Falk

Joseph P Reo

Joshua Richard Shockey

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

Formulations of enzalutamide

A pharmaceutical composition comprises multiparticulates comprising a melt-congeal core and a solid amorphous dispersion layer of a poorly water soluble drug and polymer. The multiparticulates are suitable for improving bioavailability of poorly water soluble drugs. The melt-congeal cores facilitate application of the solid amorphous dispersion layer, and allow incorporation of additional optional components to the core so as to adjust the release of drug from the multiparticulate.

Multiparticulates of spray-coated drug and polymer on a meltable core

An exemplary method comprises providing a spray-dried dispersion comprising particles, the particles comprising an active agent and a polymer, the dispersion particles having an average particle diameter of less than 50 &#x3bc;m. An ordered mixture is formed by high-shear mixing the dispersion with a powdered glidant, wherein the average particle diameter of the glidant is less than or equal to one fifth the average particle diameter of the dispersion after high-shear mixing. The dosage forms are formed by at least one of directly compressing the ordered mixture to form a tablet and encapsulating the ordered mixture to form a capsule.

Methods for making pharmaceutical solid dosage forms of spray-dried dispersions

A pharmaceutical composition comprises multiparticulates comprising a drug, a matrix material, and swelling agent. In one aspect, the multiparticulates comprise a core comprising a drug, and a coating surrounding the core. The coating is selected from the group consisting of (i) a water-permeable, substantially drug-impermeable coating, and (ii) an anti-enteric coating.

Taste-masked drugs in rupturing multiparticulates

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Bend, OR, United States of America

Sanjay Konagurthu