Patent ID: 8735450

Claim:
A method for producing a composition comprising nanoparticles of diclofenac acid, comprising: dry milling a composition comprising diclofenac acid, lactose and sodium lauryl sulfate in a mill containing a plurality of milling bodies for a time period sufficient to produce a composition comprising nanoparticles of diclofenac acid having a median particle size on a particle volume basis between 1,000 nm and 25 nm; and processing the composition comprising nanoparticles of diclofenac acid into a unit dosage pharmaceutical composition containing 18 mg of diclofenac acid, wherein the unit dosage pharmaceutical composition, when tested in vitro by USP Apparatus I (Basket) method of U.S. Pharmacopoeia at 100 rpm at 37 °C. in 900 ml of 0.05% sodium lauryl sulfate in citric acid solution buffered to pH 5.75, has a dissolution rate of diclofenac acid such that at least 91%, by weight, is released by 45 minutes.