Micronized Opioid Compositions, Formulations and Dosage Forms and Methods of Making Same

Abstract

Novel compositions, formulations and dosage forms comprising stabilized micronized opioid particles are disclosed. Exemplary opioids include oxycodone, oxymorphone, hydrocodone, and hydromorphone, including as free bases or as salts. Stabilized micronized opioid particles having a DV90 particle size distribution of less and or equal to 10μ or less than or equal to 20μ are disclosed. Methods for micronizing an opioid to provide stabilized micronized opioid particles are also disclosed.

1 - 39 . (canceled) 
     
     
         40 . A composition comprising stabilized micronized oxycodone particles, wherein the oxycodone particles have a DV 90  particle size distribution of less than or equal to 10 μm. 
     
     
         41 . The composition of  claim 40 , wherein the stabilized micronized oxycodone particles are in the form of a salt. 
     
     
         42 . The composition of  claim 41 , wherein the stabilized micronized oxycodone particles are stabilized micronized oxycodone HCl particles. 
     
     
         43 . The composition of  claim 40 , wherein the stabilized micronized oxycodone particles are stabilized micronized oxycodone freebase particles. 
     
     
         44 . The composition of  claim 40 , wherein ≤1% of the stabilized micronized oxycodone particles have a particle size ≤0.2 μm. 
     
     
         45 . The composition of  claim 40 , wherein the stabilized micronized oxycodone particles comprise less than or equal to 30 ppm of α,β-unsaturated ketones (ABUK). 
     
     
         46 . The composition of  claim 40 , wherein the composition comprises 5 mg of the stabilized micronized oxycodone particles. 
     
     
         47 . The composition of  claim 40 , wherein the composition comprises 10 mg of the stabilized micronized oxycodone particles. 
     
     
         48 . The composition of  claim 40 , wherein the composition comprises 20 mg of the stabilized micronized oxycodone particles. 
     
     
         49 . The composition of  claim 40 , wherein the composition comprises 30 mg of the stabilized micronized oxycodone particles. 
     
     
         50 . The composition of  claim 40 , wherein the composition comprises 40 mg of the stabilized micronized oxycodone particles. 
     
     
         51 . The composition of  claim 40 , wherein the composition is a non-aerosol composition. 
     
     
         52 . The composition of  claim 40 , wherein the composition is provided in a liquid suspension or a non-tablet dosage form. 
     
     
         53 . The composition of  claim 40 , wherein the composition is suitable for oral administration. 
     
     
         54 . The composition of  claim 40 , wherein the stabilized micronized oxycodone particles comprise less than or equal to 25 ppm of ABUK. 
     
     
         55 . The composition of  claim 40 , wherein the stabilized micronized oxycodone particles comprise less than or equal to 20 ppm of ABUK. 
     
     
         56 . The composition of  claim 40 , wherein the stabilized micronized oxycodone particles comprise less than or equal to 15 ppm of ABUK. 
     
     
         57 . The composition of  claim 40 , wherein the stabilized micronized oxycodone particles comprise less than or equal to 10 ppm of ABUK. 
     
     
         58 . The composition of  claim 40 , wherein the stabilized micronized oxycodone particles comprise less than or equal to 5 ppm of ABUK. 
     
     
         59 . The composition of  claim 40 , wherein the stabilized micronized oxycodone particles comprise less than or equal to 1 ppm of ABUK.