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.

1 . A method of treating pain comprising administering to a patient in need thereof, an intravenous dosage form comprising an effective amount of meloxicam which provides an analgesic effect for up to 24 hours. 
     
     
         2 . The method of  claim 1 , wherein the effective amount of meloxicam in the dosage form is selected from the group consisting of 5, 7.5, 15, 30, and 60 mg. 
     
     
         3 . The method of  claim 1 , wherein the intravenous dosage form comprising meloxicam provides a time to first perceptible pain relief in a range selected from group consisting of less than 1, 1 to 30, 2 to 25, 5 to 20, 10 to 20 and 12 to 18 minutes. 
     
     
         4 . The method of  claim 1 , wherein the intravenous dosage form comprising meloxicam provides a time to first perceptible pain relief selected from group consisting of 30, 25, 20, 18, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, and less than 1 minute. 
     
     
         5 . The method of  claim 1 , wherein the intravenous dosage form comprising meloxicam provides a time to meaningful pain relief in a range selected from group consisting of less than 25, 25 to 300, 75 to 250, 100 to 200, and 115 to 125 minutes. 
     
     
         6 . The method of  claim 1 , wherein the intravenous dosage form comprising meloxicam provides a time to meaningful pain relief selected from group consisting of 300, 275, 250, 225, 200, 195, 185, 175, 165, 155, 150, 125, 100, 75, 50, 25, and less than 25 minutes. 
     
     
         7 . The method of  claim 1 , wherein the pain is moderate to moderately severe acute pain. 
     
     
         8 . A pharmaceutical dosage form comprising 15 mg of meloxicam in injectable form that has a mean AUC inf  within 80.00% to 125.00% of the mean AUC inf  of the oral meloxicam tablets containing 15 mg of meloxicam as approved under NDA 020938. 
     
     
         9 . A pharmaceutical dosage form comprising 30 mg of meloxicam in injectable form that has a mean AUC inf  within 80.00% to 125.00% of the mean AUC inf  of the oral meloxicam tablets containing 30 mg of meloxicam as approved under NDA 020938. 
     
     
         10 . A pharmaceutical dosage form comprising 60 mg of meloxicam in injectable form that has a mean AUC inf  within 80.00% to 125.00% of the mean AUC inf  of the oral meloxicam tablets containing 60 mg of meloxicam as approved under NDA 020938. 
     
     
         11 . A pharmaceutical dosage form comprising 15 mg of an injectable meloxicam when administered to a subject results in a mean AUC inf  within 80.00% to 125.00% of 57314.4 (ng*hr/mL) following a single dose exposure. 
     
     
         12 . A pharmaceutical dosage form comprising 30 mg of an injectable meloxicam when administered to a subject results in a mean AUC inf  within 80.00% to 125.00% of 107508.7 (ng*hr/mL) following a single dose exposure. 
     
     
         13 . A pharmaceutical dosage form comprising 60 mg of an injectable meloxicam when administered to a subject results in a mean AUC inf  within 80.00% to 125.00% of 171229.0 (ng*hr/mL) following a single dose exposure. 
     
     
         14 . An intravenous pharmaceutical dosage form comprising meloxicam, polyvinyl pyrrolidone, and sodium deoxycholate. 
     
     
         15 . The pharmaceutical dosage form of  claim 14 , wherein the meloxicam is present in a particle form having a particle size distribution with an effective average particle size of less than 110 nm. 
     
     
         16 . The pharmaceutical dosage form of  claim 14 , wherein the meloxicam is present in a particle form having a particle size distribution with a D 90  of less than 150 nm. 
     
     
         17 . The pharmaceutical dosage form of  claim 14 , when administered to a patient provides duration of analgesic effect for up to 24 hours. 
     
     
         18 . The pharmaceutical dosage form of  claim 14 , when administered to a patient provides a time to first perceptible pain relief in a range selected from group consisting of less than 1, 1 to 30, 2 to 25, 5 to 20, 10 to 20 and 12 to 18 minutes. 
     
     
         19 . The pharmaceutical dosage form of  claim 14 , when administered to a patient provides a time to first perceptible pain relief selected from group consisting of 30, 25, 20, 18, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, and less than 1 minute. 
     
     
         20 . The pharmaceutical dosage form of  claim 14 , when administered to a patient provides a time to meaningful pain relief in a range selected from group consisting of less than 25, 25 to 300, 75 to 250, 100 to 200, and 115 to 125 minutes. 
     
     
         21 . The pharmaceutical dosage form of  claim 14 , when administered to a patient provides a time to meaningful pain relief selected from group consisting of 130, 120, 110, 100, 90, 80, 70, 60, 50, 40, 30, 20, 10, 5, and less than 5 minutes. 
     
     
         22 . A method of treating pain comprising the steps of:
 providing an injectable dosage form comprising meloxicam polyvinyl pyrrolidone, and sodium deoxycholate; and   administering the pharmaceutical composition intravenously to a patient in need thereof, wherein the patient experiences a first perceptible pain relief within 30 minutes post administration of the dosage form and meaningful pain relief for up to 24 hours.   
     
     
         23 . A method of treating moderate to moderately severe acute pain comprising administering to a patient in need thereof, an intravenous dosage form comprising an effective amount of meloxicam which provides an analgesic effect for up to 24 hours.