Incyte Corporation

Sanofi-aventis

Sanofi-synthelabo

Sanofi Pharmaceuticals, Inc.

William L Rocco

Francis X Muller

Sharon M Laughlin

Nancy M Franson

John D Higgins

Mei Li

Irwin C Jacobs

Tanvi Mitesh Shah

Ying Liu

Khawla Abdullah Abu-Izza

Huifang Wu

Micael A Guillot

Micael Guillot

John D c/o Sanofi-Aventis Département De Brevets Higgins

The present application relates to pharmaceutical formulations and dosage forms of an AXL/MER inhibitor, or a pharmaceutically acceptable salt, solvate, or hydrate thereof, including methods of preparation thereof, which are useful in the treatment of AXL/MER mediated diseases such as cancer.

Formulations of an AXL/MER inhibitor

The present application relates to pharmaceutical formulations and dosage forms of a lysine specific demethylase-1 (LSD1) inhibitor, or a pharmaceutically acceptable salt, solvate, or hydrate thereof, including methods of preparation thereof, which are useful in the treatment of LSD1 mediated diseases such as cancer.

Formulations of an LSD1 inhibitor

Disclosed are amorphous solid dispersion formulations comprising 7-chloro-N,N,5-trimethyl-4-oxo-3-phenyl-3,5-dihydro-4H-pyridazino[4,5-b]indole-1-acetamide.

Amorphous solid dispersions

Disclosed are a novel crystalline form of 7-chloro-N,N,5-trimethyl-4-oxo-3-phenyl-3,5-dihydro-4H-pyridazino[4,5-b]indole-1-acetamide, processes of preparing said crystalline form of 7-chloro-N,N,5-trimethyl-4-oxo-3-phenyl-3,5-dihydro-4H-pyridazino[4,5-b]indole-1-acetamide, compositions comprising said form in admixture with one or more pharmaceutically acceptable excipients, and uses for the same.

Crystalline form

A method for preparing pharmaceutical formulations of poorly soluble drug substances in the form of concentrated solutions for filling soft gelatin capsules and solid dispersions and suspensions for filling hard gelatin capsules and compressing into tablets is provided. Pharmaceutical formulations of poorly soluble drug substances are also disclosed. The formulations include the sodium salt of the poorly soluble drug substance, a conversion aid such as PEG, polysorbate, a sugar alcohol (e.g. mannitol or xylitol), propylene glycol or transcutol, and, in some cases an excipient, such as dicalcium phosphate dihydrate, lactose monohydrate, or microcrystalline cellulose.

Pharmaceutical formulations containing poorly soluble drug substances

A pharmaceutical suspension formulation comprising 0.1 to 40% by weight ##STR1## as the active ingredient; 0.1 to 40% by weight Transcutol; 0.1-99% by weight starch; 0-40% by weight polyethylene glycol, NaOH and water,

Pharmaceutical suspension formulation

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Reading, PA, United States of America

William L Rocco