Granted Patent B2

US 8,114,383 · App. 10/718,112 · Granted Feb 14, 2012

Abstract

Claims (14)

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° 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.

Assignments (9)