Extended Release Abuse Deterrent Liquid Fill Dosage Form
AssigneePharmaceutical Manufacturing Research Services, Inc.
InventorsEdwin R. Thompson, Eric R. Thompson, Nicholas R. Myslinski, Steven F. Kemeny, Matthew N. Hart
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Abstract
The present disclosure relates to an oral, extended release, abuse deterrent dosage form containing a controlled release agent, a second agent and/or polyethylene glycol, and at least one active pharmaceutical ingredient susceptible to abuse. The dosage form is stable at high temperatures and abuse deterrent to oral and parenteral administration via dose dumping, extraction, and purification. The present disclosure also relates to processes of preparing the dosage form.
Claims30
An extended release, abuse deterrent capsule comprising:
- (a) an active substance susceptible to abuse;
- (b) a controlled release agent that has a melting temperature less than or equal to about 70° C.;
- and
- (c) a second agent that has a melting temperature greater than or equal to about 100° C., or
- (d) a polyethylene glycol having an average molecular weight between about 3000 Daltons and about 4000 Daltons.
A process for the production of an extended 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 controlled release agent that has a melting temperature less than or equal to about 100° C.;
- and
- (iii) a second agent that has a melting temperature greater than or equal to about 100° C.;
- or
- (iv) a polyethylene glycol having an average molecular weight between about 3000 Daltons and about 4000 Daltons;
- and
- (b) dispensing the homogenized suspension into a capsule body to produce the capsule.
Dependencies are inferred from the claim text.