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, said dosage form exhibiting a breaking strength of at least 500 N, said process comprising:
a) producing a formulation mixture comprising at least one active ingredient with potential for abuse (A) and at least one synthetic or natural polymer (C);
b) moistening the mixture with at least a sufficient quantity of a solvent for the polymer (C) to uniformly moisten the mixture;
c) optionally dividing the mixture from step b) into sub-portions;
d) drying the sub-portion(s) from step c) or the mixture from step b); and
e) shaping the dried sub-portion or mixture from step d) to yield the dosage form.
2 . The 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 . The process according to claim 1 , which further comprises dispersing the formulation mixture in a liquid dispersant in which the polymer component (C) is not soluble before addition of the solvent.
4 . The process according to claim 3 , which further comprises dividing the formulation mixture 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 . The process according to claim 3 , where the solvent and the dispersant are miscible with one another.
6 . The process according to claim 1 , which further comprises incorporating the solvent into the formulation mixture as a foam.
7 . The process according to claim 6 , which further comprises stabilizing the foam with the assistance of foam stabilizers.
8 . The process according to claim 6 , which further comprises drying the sub-portion(s) or the mixture in granular form.
9 . The process according to claim 8 , which further comprises drying the mixture in granular form, and then dividing the dried, granulated mixture into sub-portions, which in each case correspond to the mass of a unit of the dosage form, and shaping to yield the dosage form.
10 . The process according to claim 1 , which further comprises adding solvent to the formulation mixture in an amount such that a shapeable paste is obtained.
11 . The process according to claim 10 , which further comprises drying the paste and, before or after it is dried, the paste is divided into sub-portions and shaping or converting into the dosage form the dried portions, optionally after further dividing each case into a portion corresponding to the mass of a unit of the dosage form.
12 . The process according to claim 11 , where the sub-portions have the form of strands.
13 . The process according to claim 12 , which further comprises producing the strands with the assistance of a screen or strand former.
14 . The process according to claim 12 , which further comprises singulating and shaping dried strands to yield the dosage form.
15 . The process according to claim 14 , where shaping proceeds with the assistance of a tablet press.
16 . The process according to claim 12 , which further comprises shaping dried strands with the assistance of shaping rollers or shaping belts equipped with rollers to yield the dosage form.
17 . The process according to claim 11 , which further comprises converting the paste into a planar structure, from which the dosage form is stamped.
18 . The process according to claim 10 , where the process is performed with the assistance of an extruder.
19 . The process according to claim 1 , which further comprises adding a quantity of solvent sufficient to dissolve at least the polymer component (C) to the formulation mixture.
20 . The process according to claim 19 , which further comprises converting the solution into a planar structure.
21 . The process according to claim 20 , which further comprises producing the planar structure with the assistance of an extruder with a flat die or by casting the solution onto a level planar support.
22 . The process according to claim 19 , which further comprises shaping the dosage form by stamping from the dried planar structure or by calendaring.
23 . The process according to claim 19 , where the mixture is divided into portions such that, after drying, the portions correspond in each case to the mass of a unit of the dosage form.
24 . The process according to claim 23 , which further comprises placing the portions in molds corresponding to the shape of a unit of the dosage form.
25 . The process according to claim 19 , which further comprises dividing the mixture into any desired portions, and, after drying, optionally recombining the portions, and shaping to yield the dosage form.