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|Title:||Abuse-proofed dosage form|
|Abstract:||The present invention relates to an abuse-proofed, thermoformed dosage form containing, in addition to one or more active ingredients with abuse potential optionally together with physiologically acceptable auxiliary substances, at least one synthetic or natural polymer with a breaking strength of at least 500 N and to a process for the production thereof.|
|Inventor(s):||Bartholomaus; Johannes (Aachen, DE), Kugelmann; Heinrich (Aachen, DE), Arkenau-Mari ; Elisabeth (Koln, DE)|
|Assignee:||Gruenenthal GmbH (Aachen, DE)|
1. A thermoformed dosage form comprising: i) one or more active ingredients with abuse potential (A) selected from the group consisting of opiates and opioids, ii) optionally
physiologically acceptable auxiliary substances (B), iii) at least 30% by weight of polyalkylene oxide (C) having a molecular weight of 1-15 million according to rheological measurements, and iv) optionally at least one wax (D), wherein said dosage form
has a breaking strength of at least 500 N and wherein the active ingredient with abuse potential (A) is present in a controlled release matrix of component (C).
2. The dosage form according to claim 1, which is in the form of a tablet.
3. The dosage form according to claim 1, wherein the wax (D) is at least one natural, semi-synthetic or synthetic wax with a softening point of at least 60.degree. C.
4. The dosage form according to claim 3, wherein the wax (D) is carnauba wax or beeswax.
5. A process for the production of a dosage form according to claim 1, said process comprising mixing components (A), the optionally present component (B), component (C) and the optionally present component (D) to form a mixture and, optionally after granulation, press-forming the mixture with preceding, simultaneous, or subsequent exposure to heat.
6. A process according to claim 5, wherein granulation is performed by means of a melt process.
7. A dosage form obtained by the process of claim 5.
8. The dosage form according to claim 1, wherein the active ingredient with abuse potential (A) is oxycodone or a physiologically acceptable salt thereof.
9. The dosage form according to claim 1, wherein the active ingredient with abuse potential (A) is oxymorphone or a physiologically acceptable salt thereof.