Sanofi Pharmaceuticals, Inc.

Sanofi-synthelabo

Sanofi Winthrop Inc.

Sharon M Laughlin

William L Rocco

Nancy M Franson

William Rocco

Micael A Guillot

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

A pharmaceutical formulation comprising ##STR1## as the active ingredient, polyethylene glycol, NaOH, and water, wherein the mole equivalents of NaOH per mole equivalent of active ingredient is at least about 1.1, is suitable for soft gelatin capsule filling.

Pharmaceutical formulation

Disodium tiludronate tetrahydrate is provided for use in pharmaceutical compositions for oral administration in the form of a tablet, effervescent composition, capsule and the like.

Growing community of inventors

Phoenixville, PA, United States of America

Sharon M Laughlin