Tamper resistant co-extruded dosage form containing an active agent and an adverse agent and process of making same
AssigneePurdue Pharma L.P.
InventorsRobert P. Flath, John K. Masselink
Life of this patent
Estimating the term…
Abstract
The present invention relates to co-extruded pharmaceutical compositions and dosage forms including an active agent, such as an opioid agonist, and an adverse agent, such as an opioid antagonist. Such compositions and dosage forms are useful for preventing or discouraging tampering, abuse, misuse or diversion of a dosage form containing an active pharmaceutical agent, such as an opioid. The present invention also relates to methods of treating a patient with such a dosage form, as well as kits containing such a dosage form with instructions for using the dosage form to treat a patient.
Claims55
1-11. (canceled)
A co-extruded dosage form comprising:
- a core comprising an adverse agent;
- a sheath comprising a hydrophobic material which surrounds at least a portion of the core;
- and
- a shell comprising an active agent which surrounds at least a portion of the sheath.
A method of making a tamper-resistant dosage form comprising:
- a) forming a multilayer extrudate by co-extruding:
- a core comprising an adverse agent;
- and
- a shell comprising an active agent which at least partially surrounds the core;
- and
- b) rendering the multilayer extrudate to form at least one particle.
A method of making a tamper-resistant dosage form comprising:
- a) forming a multilayer extrudate by co-extruding
- a core comprising an adverse agent and a hydrophobic material;
- a sheath comprising a hydrophobic material which at least partially surrounds the core;
- and
- a shell comprising an active agent and a hydrophobic material which at least partially surrounds the sheath;
- b) using a rolling punch to form one more particles from the multilayer extrudate;
- and
- c) incorporating one or more particles into a dosage form.
Dependencies are inferred from the claim text.