Generated: April 24, 2017
|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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.