Claims for Patent: 10,709,713

Summary for Patent: 10,709,713

Title:	Nanoparticulate meloxicam formulations
Abstract:	The present invention is directed to nanoparticulate compositions comprising meloxicam particles having an effective average particle size of less than about 2000 nm.
Inventor(s):	Eugene R. Cooper, Tuula Ryde, John Pruitt, Laura Kline
Assignee:	Alkermes Pharma Ireland Ltd, DV Technology LLC
Application Number:	US16/550,239
Patent Claims:	1. A method of treating moderate to severe pain in an adult human in need thereof comprising: administering once a day to the adult human an intravenous bolus injection of a meloxicam formulation to achieve a mean AUCinf of 107508.7±34443.0 ng*hr/ml in the adult human, wherein the meloxicam formulation consists of 30 milligrams of nanoparticulate meloxicam, water, a surface stabilizer and a pharmaceutically acceptable excipient, wherein the nanoparticulate meloxicam has an effective average particle size of less than about 150 nm; wherein the meloxicam formulation comprises no more than 6,000 meloxicam particles that are greater than 10 μm in size and no more than 600 meloxicam particles that are greater than 25 μm in size; and wherein the surface stabilizer is adsorbed on the surface of the nanoparticulate meloxicam and is essentially free of intermolecular cross-linkages. 2. The method of claim 1, wherein the intravenous bolus injection of the meloxicam formulation provides pain relief to the adult human for up to 24 hours after administration. 3. The method of claim 1, wherein the intravenous bolus injection of the meloxicam formulation provides first perceptible pain relief to the adult human in about 30 minutes after administration. 4. The method of claim 1, wherein the intravenous bolus injection of the meloxicam formulation provides meaningful pain relief to the adult human in 100 to 200 minutes after administration. 5. The method of claim 1, wherein the meloxicam formulation is an aqueous dispersion. 6. A method of treating moderate to severe pain in an adult human in need thereof comprising: administering once a day to the adult human an intravenous bolus injection of a meloxicam formulation to achieve a mean AUCinf within 80% to 125% of 107508.7 ng*hr/ml in the adult human, wherein the meloxicam formulation consists of 30 milligrams of nanoparticulate meloxicam, water, a surface stabilizer and a pharmaceutically acceptable excipient, wherein the nanoparticulate meloxicam has an effective average particle size of less than about 150 nm; wherein the meloxicam formulation comprises no more than 6,000 meloxicam particles that are greater than 10 μm in size and no more than 600 meloxicam particles that are greater than 25 μm in size; and wherein the surface stabilizer is adsorbed on the surface of the nanoparticulate meloxicam and is essentially free of intermolecular cross-linkages. 7. The method of claim 6, wherein the intravenous bolus injection of the meloxicam formulation provides pain relief to the adult human for up to 24 hours. 8. The method of claim 6, wherein the intravenous bolus injection of the meloxicam formulation provides first perceptible pain relief to the adult human in about 30 minutes after administration. 9. The method of claim 6, wherein the intravenous bolus injection of the meloxicam formulation provides meaningful pain relief to the adult human in 100 to 200 minutes after administration. 10. The method of claim 6, wherein the meloxicam formulation is an aqueous dispersion.