Extruded Immediate Release Abuse Deterrent Pill
First Claim
1. A directly-formed oral, immediate release, abuse deterrent dosage form comprising an active substance susceptible to abuse, a matrix agent and a plasticizer, wherein the dosage form is directly formed from an extrusion process.
1 Assignment
0 Petitions
Accused Products
Abstract
The present disclosure relates to an oral, immediate release, abuse deterrent pill containing at least one active pharmaceutical ingredient susceptible to abuse which is homogenously spread throughout a carrier matrix used to deter abuse. The pill is prepared using hot melt extrusion and a forming unit through a continuous process. The formed pill is abuse deterrent to parenteral administration due at least to particle size, viscosity, or purity limitations.
-
Citations
39 Claims
- 1. A directly-formed oral, immediate release, abuse deterrent dosage form comprising an active substance susceptible to abuse, a matrix agent and a plasticizer, wherein the dosage form is directly formed from an extrusion process.
-
2-3. -3. (canceled)
-
4. An oral, immediate release, abuse deterrent dosage form comprising:
-
(i) an active substance susceptible to abuse; (ii) a matrix agent, wherein the matrix agent has an average molecular weight between about 50K Daltons and 300K Daltons; and (iii) a plasticizer, wherein the active substance susceptible to abuse has an immediate release profile, and wherein the composition includes a physical barrier to reduce abuse. - View Dependent Claims (5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, 19)
-
-
15-17. -17. (canceled)
-
20. An oral, immediate release, abuse deterrent dosage form comprising:
-
(i) about 0.5 Wt % to about 30 Wt % of an active substance susceptible to abuse; (ii) about 10 Wt % to about 90 Wt % of a matrix agent having an average molecular weight of about 50K Daltons to about 300K Daltons; and (iii) about 5 Wt % to about 60 Wt % of a plasticizer.
-
-
21-26. -26. (canceled)
-
27. An oral, immediate release, abuse deterrent dosage form comprising an active substance susceptible to abuse, wherein less than about 95% of the active substance is released from the dosage form within 20 minutes following administration, and wherein greater than or equal to 75% of the active substance is released from the dosage form within 45 minutes following administration.
-
28. A process for the production of an oral, immediate release, abuse deterrent dosage form containing at least one active substance susceptible to abuse comprising:
-
(i) processing a uniform blend of the at least one active substance susceptible to abuse, a matrix agent and a plasticizer by hot melt extrusion using an extruder to make an extrudate; and (ii) forming the extrudate using a forming unit into the dosage form.
-
-
29-34. -34. (canceled)
-
35. A process for the production of an oral, immediate release, abuse deterrent dosage form, comprising:
(i) processing an analytically determined uniform blend of at least one active substance susceptible to abuse, a matrix agent and a plasticizer by hot melt extrusion using an extruder to make an extrudate and forming the dosage form.
-
36-37. -37. (canceled)
-
38. A process for the production of an oral, immediate release, abuse deterrent pill containing at least one active substance susceptible to abuse comprising:
-
(i) combining the at least one active substance susceptible to abuse, a matrix agent and a plasticizer in a hopper to form a mixture; (ii) blending the mixture in the hopper until a uniform blend is achieved; (iii) monitoring the mixture during blending using a process analytical technique to determine when a uniform blend is achieved; (iv) feeding the uniform blend into an extruder; (v) processing the uniform blend by hot melt extrusion in the extruder to make an extrudate; (vi) transferring the extrudate to a forming unit using a transfer unit capable of controlling the temperature, pressure, environment or shape of the extrudate; (vii) forming the extrudate using the forming unit into the pill; and (viii) determining the quality, volume and weight of the pill using an optical inspection technique.
-
Specification