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Details for Patent: 8,114,384

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Details for Patent: 8,114,384

Title:Process for the production of an abuse-proofed solid dosage form
Abstract: The present invention relates to a process for the production of an abuse-proofed solid dosage form containing at least one active ingredient with potential for abuse and a synthetic or natural polymer with a breaking strength of =500 N, characterized in that a corresponding mixture is processed by melt extrusion with the assistance of a planetary-gear extruder.
Inventor(s): Arkenau; Elisabeth (Aachen, DE), Bartholom us; Johannes (Aachen, DE)
Assignee: Gruenenthal GmbH (Aachen, DE)
Filing Date:Jul 14, 2004
Application Number:10/890,704
Claims:1. A process for the production of an abuse-proofed solid dosage form with a breaking strength of at least 500N, said dosage form comprising at least one opioid active ingredient with potential for abuse and 50-99.9 wt%, relative to the total weight of the dosage form, of polyethylene oxide having a molecular weight of at least one million Daltons, said process comprising heating a mixture comprising the at least one opioid active ingredient with potential for abuse and the polyethylene oxide in a planetary-gear extruder at least until the polyethylene oxide has softened, and thereafter compacting and extruding the mixture with the planetary-gear extruder into formed articles, which are optionally subjected to singulation and shaping to yield a nonmultiparticulate dosage form with a breaking strength of at least 500 N.

2. A process according to claim 1, wherein the active ingredient is selected from the group consisting of oxycodone, morphine, hydromorphone, tramadol and the physiologically acceptable salts thereof.

3. A process according to claim 1, wherein the mixture additionally comprises further auxiliary substances.

4. A process according to claim 1, wherein the planerary-gear extruder has at least three planetary spindles.

5. A process according to claim 1, wherein the planetary-gear extruder has a feed screw and a central spindle with planetary spindles.

6. A process according to claim 1, wherein the formed articles are finally formed and optionally singulated.

7. A process according to claim 1, wherein the formed articles are formed into tablets.

8. A process according to claim 7, wherein the tablets are formed with press molding with the assistance of two counter-rotating rolls with mutually opposing recesses, the construction of which recesses determines the tablet shape.

9. A process according to claim 7, wherein the tablets are in each case formed with the assistance of a die and at least one shaping punch.

10. An abuse-proofed dosage form with a breaking strength of at least 500N obtainable by a process according to claim 1.

11. A process according to claim 2, where the active ingredient is the hydrochloride of oxycodone, morphine, hydromorphine, or tramadol.

12. A process according to claim 3, where the further auxiliary substances are one or more substances selected from the group consisting of waxes (D), antioxidants and plasticizers.

13. A process according to claim 1, where the opioid is in a form selected from the group consisting of physiologically acceptable enantiomers, stereoisomers, diastereomers, racemates and derivatives thereof.

14. A process of claim 13, where the physiologically acceptable derivatives thereof are selected from the group consisting of ethers, esters and amides.
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