US 9,808,468 B2
Formulation of meloxicam
H. William Bosch, Bryn Mawr, PA (US)
Assigned to iCeutica Pty Ltd., Iluka, WA (AU)
Filed by ICEUTICA PTY LTD., Balcatta, WA (US)
Filed on May 15, 2017, as Appl. No. 15/595,446.
Application 15/595,446 is a continuation of application No. 14/974,108, filed on Dec. 18, 2015, granted, now 9,649,318.
Application 14/974,108 is a continuation of application No. 14/675,410, filed on Mar. 31, 2015, granted, now 9,526,734, issued on Dec. 27, 2016.
Claims priority of provisional application 62/009,860, filed on Jun. 9, 2014.
Prior Publication US 2017/0246178 A1, Aug. 31, 2017
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/5415 (2006.01); A61K 31/00 (2006.01); A61K 9/16 (2006.01); A61K 9/14 (2006.01)
CPC A61K 31/5415 (2013.01) [A61K 9/145 (2013.01); A61K 9/1617 (2013.01); A61K 9/1623 (2013.01); A61K 9/1652 (2013.01)] 24 Claims
 
1. A method for treating osteoarthritis comprising administering a capsule form of a pharmaceutical composition comprising 5 mg of meloxicam having a median particle size, on a volume basis, between 100 nm and 1000 nm, wherein a single dose, upon oral administration to a population of healthy adults in the fasted state, provides a mean plasma AUC (0-∞) of 7500-20000 h*ng/ml and a mean plasma Cmax of 350-950 ng/ml, wherein the D(0.9) of the particles of meloxicam is less than 4000 nm and greater than 1200 nm, and wherein the dissolution rate is such that, when tested using USP Apparatus 1 (baskets) set to rotation speed of 100 RPM in 500 mL of pH 6.1 phosphate buffer with 0.1% sodium lauryl sulfate (SLS) at 37° C.±0.5° C., at least 80% of the meloxicam dissolves in 10 minutes or less.