Process for the production of an abuse-proofed dosage form
The present invention relates to a process for the production of abuse-proofed, thermoformed dosage forms 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 with a breaking strength of at least 500 N.
1 . A process for the production of a solid pharmaceutical dosage forms with at least reduced potential for abuse, characterised in that
a) a formulation mixture containing at least one active ingredient with potential for abuse, at least one synthetic or natural polymer (C), which exhibits a breaking strength of at least 500 N, and optionally auxiliary substances (B) is shaped into formed articles by application of force,
b) the formed articles are optionally singulated and optionally in each case graded by size and,
c) after or during heating at least to the softening point of the polymer (C), the formed articles are exposed to force until they have a breaking hardness of at least 500 N, they are optionally provided with a cover and all the formed articles are optionally mixed back together again.
2 . A process according to claim 1 , characterised in that it is performed continuously or discontinuously.
3 . A process according to claim 1 or claim 2 , characterised in that the formulation mixture consists to an extent of at least 30 wt. % of component (C).
4 . A process according to any one of claims 1 to 3 , characterised in that the formulation mixture consists to an extent of at least 50 wt. % of component (C).
5 . A method according to any one of claims 1 to 4 , charactersed in that a) shaping of the formulation mixture proceeds with application of a force of at least 0.5 kN and optionally with heating to less than 60° C.
6 . A process according to any one of claims 1 to 5 , characterised in that, according to c), the formed articles are heated to at least 60° C. before or during application of force of at least 0.1 kN, preferably of 1 kN to 120 kN.
7 . A process according to any one of claims 1 to 6 , characterised in that the application of force according to a) or c) is performed with the assistance of a press, preferably a tablet press, shaping rollers or with shaping belts equipped with rollers.
8 . A process according to any one of claims 1 to 7 , characterised in that shaping according to a) gives rise to tablets.
9 . A process according to any one of claims 1 to 7 , characterised in that shaping according to a) gives rise to a multiparticulate dosage form with a minimum size of 0.5 mm, preferably of 1 to 3.5 mm.
10 . A process according to any one of claims 1 to 9 , characterised in that opioid active ingredients are used as active ingredients.