New abuse deterrent formulation (ADF) technology for immediate-release Opioids

Drug Development and Delivery

Volumn 13, Issue 8, 2013, Pages 76-81

  Bartholomäus, Johannes ^a   Schwier, Sebastian ^b   Brett, Martin ^c   Stahlberg, Hans Jürgen ^d   Galia, Eric ^e   Strothmann, Kai ^b  

^a TECHNICAL UNIVERSITY OF BRAUNSCHWEIG   (Germany)

^b UNIVERSITY OF MÜNSTER   (Germany)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d GRÜNENTHAL GMBH   (Germany)

^e GOETHE UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

MACROGOL; OXYCODONE; OXYMORPHONE; TAPENTADOL;

ABUSE DETERRENT FORMULATION; DRUG BIOAVAILABILITY; DRUG DELIVERY DEVICE; DRUG FORMULATION; DRUG MARKETING; DRUG RELEASE; MEDICAL TECHNOLOGY; NOTE; PARTICLE SIZE; TABLET;

EID: 84885718205     PISSN: 15372898     EISSN: 1944818X     Source Type: Trade Journal    
DOI: None     Document Type: Note

References (11)

1. CDC: Prescription Drug Overdose: An American Epidemic. http://www.cdc.gov/about/grandrounds/archives/2011/pdfs/PHGRRx17Feb2011.pdf. (assessed July 3rd, 2013).
2. National Association of Attorneys General letter (signed by 48 state & territorial Attorney Generals) to the FDA, March 2013.http://www.hpm.com/pdf/blog/20130311.Final%20FDA%20Letter.pdf. (assessed July 3rd, 2013).
3. FDA Draft Guidance for Industry Abuse- Deterrent Opioids - Evaluation and Labeling http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf. (assessed July 3rd, 2013).
4. Butler SF, Cassidy TA, Chilcoat H et al. Abuse rates and routes of administration of reformulated extended-release oxycodone: initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain. 2012;14: 351-358.
5. Endo Health Solutions Inc, Press Release. Nov. 13, 2012. http://phx.corporate-ir.net/phoenix.zhtml?c=123046&p=irol-newsArticle_print&ID=1758228&highlight=. (assessed July 3rd, 2013).
6. FDA News Release. April 16, 2013. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348252.htm. (assessed July 3rd, 2013).
7. Throckmorton DC. The science of abuse-deterrence - progress toward creating safer opioids. FDA Voice. April 16, 2013. http://blogs.fda.gov/fdavoice/index.php/2013/04/the-science-of-abuse-deterrence-progress-toward-creating-safer-opioids/. (assessed July 3rd, 2013).
8. Cassidy T. Impact of tamper resistant opioid formulations: findings from NAVIPPRO. http://www.navippro.com/uploadedFiles/TamperResistant.pdf. (assessed July 3rd, 2013).
9. Bartholomaeus JH, Arkenau-Marić E, Galia E. Opioid extended-release tablets with improved tamper-resistant properties. Expert Opinion on Drug Delivery. 2012;9(8):879-891.
10. Bartholomaeus JH, Ashworth JB, Stahlberg HJ, Galia E, Strothmann K. Innovative formulation technology protecting intended drug action. Drug Development & Delivery. 2012;12(8): 69-75.
11. Stahlberg HJ, Brett M, Ossig J, Schwier S, Philipp A. Bridging from conventional marketed immediate release formulations to new tamper resistant alternatives. J Pain. 2013;14(4, Suppl 1):S70.