R.p.scherer Technologies, Inc.

Intermune, Inc.

Fmc Corporation

University of Mississippi

Biohaven Therapeutics Ltd.

Lupin, Inc.

Ariad Pharmaceuticals, Inc.

Ronald S Vladyka

David F Erkoboni

Ramachandran Radhakrishnan

Kenneth Sultzbaugh

Pamela R Stergios

Vladimir Coric

Michael Andrew Repka

Robert Berman

Roshan Vijay Tiwari

Hemlata Gunga Patil

Joseph Thomas Morott, Jr

Wenli Lu

Sampada Bhaskar Upadhye

Jun-Bom Park

Christopher A Sweriduk

Danny Yu

Amgad Saleh

David C Dalgarno

David Palling

Michael Augello

Sheila M Dell

Andrew Favara

Howard J Stamato

John D Iuliucci

Marc S Karetny

Joseph Amprey

Joseph Thomas Morott

A dry granulation process using a twin-screw extruder for granulating a powder mixture which includes at least one active ingredient and at least one carrier. The process includes steps of kneading the powder mixture in the screw barrel of the twin-screw extruder at a barrel temperature below a melting point of the at least one active ingredient and a melting point or a glass transition temperature of the at least one carrier to provide a kneaded powder mixture, and extruding the kneaded powder mixture to form granules. Granules and tablets produced using the dry granulation process in the twin-screw extruder are also provided.

Twin-screw dry granulation for producing solid formulations

Disclosed is sublingual administration of riluzole. In particular, a method for treating a neuropsychiatric disorder or symptom by administering a sublingual formulation of riluzole is provided. In addition, a method of relieving or reducing oral pain using the sublingual formulation of riluzole is disclosed.

Sublingual formulation of riluzole

Embodiments described herein are directed to novel pharmaceutical compositions comprising a plurality of microgranules comprising nitroimidazole compounds, and uses of these pharmaceutical compositions in the treatment of bacterial vaginosis.

Secnidazole formulations and use in treating bacterial vaginosis

A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.

Capsule formulation of pirfenidone and pharmaceutically acceptable excipients

A solid pharmaceutical composition containing AP23573 suitable for oral administration is disclosed.

Oral formulations

Granulate formulation of pirfenidone and pharmaceutically acceptable excipients

Granulation of microcrystalline cellulose with a granulating fluid consisting of water and a water-miscible, volatile, polar organic solvent yields porous granules which are comprised of particles that are larger than the ungranulated microcrystalline cellulose. This granulated microcrystalline cellulose is capable of cushioning controlled release particles and barrier coated particles from the compression forces used in tableting, thereby maintaining the physical integrity of the components of the tablet.

Microcrystalline cellulose cushioning granules

The present invention provides a method for preparing a spray-dried, compressible granular formulation for preparing pharmaceutical tablets in which essentially water-insoluble, acidic, amphoteric, and basic pharmaceutically active agents are converted to more water-soluble salts which are granulated with hydrolyzed cellulose, drug-containing slurries, the resulting granulations, capsules containing granulations, and pharmaceutical tablets compressed from such granules. In these formulations there is employed from 1% to 85% by weight of the pharmaceutically active agent and its salt form, from 5% to 99% of hydrolyzed cellulose, based on the dry weight of the granulation, and optionally, conventional granulation and/or tableting additives such as surfactants, disintegrants, and antiadherents/flow aids. Said tablets have significantly increased dissolution of the pharmaceutically active agent at the pH of the gastrointestinal tract in comparison with the unconverted free pharmaceutically active agent.

Hydrolyzed cellulose granulations of salts of drugs

A formulation of a sparingly water-soluble, crystalline pharmaceutically active agent wherein the active agent is converted to and stabilized in its amorphous form as a solid solution of a normally hydrophobic vehicle is described. The amorphous state is stabilized by the composition of the formulation, providing long shelf life of the improved composition. This stabilized formulation also provides increased solubility and bioavailability of the active agent. Solutions of the active agent are stabilized by the composition, preventing recrystallization and precipitation of the less soluble, crystalline form of the active agent from aqueous solutions thereof.

Aqueous solubility pharmaceutical formulations

Method of making granular pharmaceutical vehicle

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Somerset, NJ, United States of America

Ronald S Vladyka