Immediate Release Abuse Deterrent Liquid Fill Dosage Form

Abstract

The present disclosure relates to an oral, immediate release, abuse deterrent liquid filled capsule containing polyethylene glycol and at least one active pharmaceutical ingredient susceptible to abuse. The dosage form is abuse deterrent to parenteral administration. The present disclosure also relates to processes of preparing the dosage form.

1 . An immediate release, abuse deterrent capsule comprising:
 (a) an active substance susceptible to abuse;   (b) a first polyethylene glycol (PEG) having an average molecular weight between about 30,000 Daltons and about 40,000 Daltons; and   (c) a second PEG having an average molecular weight between about 3000 Daltons and about 4000 Daltons,   
       wherein the ratio of the first PEG to the second PEG is less than about 1:4 w/w. 
     
     
         2 . The capsule of  claim 1 , wherein the first PEG and the second PEG together are at least about 60 wt % of the dosage form. 
     
     
         3 . The capsule of  claim 1 , wherein at least 80% of the contents are soluble both water and alcohol. 
     
     
         4 . The capsule of  claim 1 , wherein the active substance is hydrocodone bitartrate. 
     
     
         5 . The capsule of  claim 1 , wherein the active substance is oxycodone HCl. 
     
     
         6 . The capsule of  claim 1 , further comprising a grey dye comprising FD&C Blue #1, FD&C Yellow #6, and FD&C Red #40. 
     
     
         7 . (canceled) 
     
     
         8 . The capsule of  claim 1 , wherein the ratio of the first PEG to the second PEG is between about 1:7 w/w and about 1:11 w/w. 
     
     
         9 . The capsule of  claim 1 , wherein the first PEG has an average molecular weight of about 35,000 Daltons and the second PEG has an average molecular weight of about 3350 Daltons. 
     
     
         10 . The capsule of  claim 1 , wherein the capsule comprises at least about 2.5 wt % of the active substance. 
     
     
         11 . The capsule of  claim 1 , wherein the capsule is prepared by filling a capsule body with a heated homogenized suspension comprising the active substance, the first PEG and the second PEG. 
     
     
         12 . An immediate release, abuse deterrent capsule comprising:
 (a) an active substance susceptible to abuse; and   (b) PEG with a weighted average molecular weight between about 6200 Daltons and about 7800 Daltons.   
     
     
         13 . The capsule of  claim 12 , wherein the capsule comprises at least about 60 wt % of the PEG. 
     
     
         14 . The capsule of  claim 12 , wherein the active substance is hydrocodone bitartrate. 
     
     
         15 . The capsule of  claim 12 , wherein the active substance is oxycodone HCl. 
     
     
         16 . An immediate release, abuse deterrent capsule comprising:
 (a) an active substance susceptible to abuse;   (b) a first PEG having a melting point greater than or equal to about 60° C.; and   (c) a second PEG having a melting point less than or equal to about 57° C.; wherein the contents of the capsule are solid at 40° C./75% relative humidity, and at least 75% of the active ingredient is released from the capsule within 45 minutes following administration or dissolution testing.   
     
     
         17 . The capsule of  claim 16 , wherein the first PEG and the second PEG together are at least about 60 wt % of the capsule. 
     
     
         18 . The capsule of  claim 16 , wherein the active substance is hydrocodone bitartrate. 
     
     
         19 . The capsule of  claim 16 , wherein the active substance is oxycodone HCl. 
     
     
         20 . A process for the production of an immediate release, abuse deterrent capsule comprising at least one active substance susceptible to abuse comprising:
 (a) preparing a homogenized suspension of:
 (i) the at least one active substance susceptible to abuse; 
 (ii) a first PEG having an average molecular weight between about 30,000 Daltons and about 40,000 Daltons; and 
 (iii) a second PEG having an average molecular weight between about 3000 Daltons and about 4000 Daltons; and 
 (b) filling the homogenized suspension into a capsule body to produce the capsule, wherein the ratio of the first PEG to the second PEG is less than about 1:4 w/w. 
   
     
     
         21 . The process of  claim 20 , wherein the first PEG and the second PEG together are at least about 60 wt % of the capsule. 
     
     
         22 - 25 . (canceled)