Process for the production of an abuse-proofed dosage form
The present invention relates to a process for the production of an abuse-proofed dosage form containing, apart from one or more active ingredients with potential for abuse and optionally physiologically acceptable auxiliary substances, at least one synthetic or natural polymer (C) with a breaking strength of at least 500 N, wherein the formulation mixture is combined with a solvent for the polymer (C) at least in quantities such that the formulation mixture is at least uniformly moistened, the at least moistened composition is optionally divided into sub-portions, dried and shaped to yield the dosage form.
1 . A process for the production of a solid dosage form with at least reduced potential for abuse where
a) a formulation mixture containing at least one active ingredient with potential for abuse (A) and at least one synthetic or natural polymer (C), which exhibits a breaking strength of at least 500 N is uniformly moistened with at least a sufficient quantity of a solvent for the polymer (C) to uniformly moisten the mixture,
b) optionally dividing the mixture from step a) into sub-portions,
c) drying the sub-portion(s) from step b) or the mixture from step a) and
d) shaping the dried sub-portion or mixture from step c) to yield the dosage form.
2 . A process according to claim 1 where the dried sub-portions in each case correspond to the mass of a unit of the dosage form.
3 . A process according to claim 1 where the formulation mixture is dispersed in a liquid dispersant in which the polymer component (C) is not soluble before addition of the solvent.
4 . A process according to claim 3 where the formulation mixture is divided into sub-portions in each case corresponding to the mass of a unit of the dosage form either before or after the formulation mixture is dispersed.
5 . A process according to claim 3 where the solvent and the dispersant are miscible with one another.
6 . A process according to claim 1 where the solvent is incorporated into the formulation mixture as a foam.
7 . A process according to claim 6 where the foam is stabilized with the assistance of foam stabilizers.
8 . A process according to claim 6 where the composition is dried in granular form.
9 . A process according to claim 8 where the dried, granulated composition is divided into sub-portions, which in each case correspond to the mass of a unit of the dosage form, and shaped to yield the dosage form.
10 . A process according to claim 1 where solvent is added to the formulation mixture in an amount such that a shapeable paste is obtained.
11 . A process according to claim 10 where before of after it is dried, the paste is divided into sub-portions and the dried portions, optionally after being further divided in each case into a portion corresponding to the mass of a unit of the dosage form, are shaped or converted into the dosage form.
12 . A process according to claim 11 where the sub-portions have the form of strands.
13 . A process according to claim 12 where the strands are produced with the assistance of a screen or strand former.
14 . A process according to claim 12 where the dried strands are singulated and shaped to yield the dosage form.
15 . A process according to claim 14 where shaping proceeds with the assistance of a tablet press.
16 . A process according to claim 12 where the dried strands are shaped with the assistance of shaping rollers or shaping belts equipped with rollers to yield the dosage form.
17 . A process according to claim 11 where the paste is converted into a planar structure, from which the dosage form is stamped.
18 . A process according to claim 10 where the process is performed with the assistance of an extruder.
19 . A process according to claim 1 where a quantity of solvent sufficient to dissolve at least the polymer component (C) is added to the formulation mixture.
20 . A process according to claim 19 where the solution is converted into a planar structure.
21 . A process according to claim 20 where the planar structure is obtained with the assistance of an extruder with a flat die or by casting the solution onto a level planar support.
22 . A process according to claim 19 where the dosage form is shaped by stamping from the dried planar structure or obtained by calendering.
23 . A process according to claim 19 where the solution is divided into portions such that, after drying, they correspond in each case to the mass of a unit of the dosage form.
24 . A process according to claim 23 where the portions are placed in moulds corresponding to the shape of a unit of the dosage form.
25 . A process according to claim 19 , where the solution is divided into any desired portions, which, after drying, are optionally recombined, and shaped to yield the dosage form.