Opioid extended-release tablets with improved tamper-resistant properties

Expert Opinion on Drug Delivery

Volumn 9, Issue 8, 2012, Pages 879-891

  Bartholomaeus, Johannes H ^a   Arkenau Marić, Elisabeth ^b   Galia, Eric ^b  

^a Pharmakreativ Consulting   (Germany)

^b GRÜNENTHAL GMBH   (Germany)

Author keywords

Abuse; Controlled release; Mechanical properties; Misuse; Opioids; Tamper resistant

Indexed keywords

CAPSAICIN; EMETIC AGENT; NALOXONE; NALTREXONE; NICOTINIC ACID; OPIATE; OXYMORPHONE; TRAMADOL;

ARTICLE; DRUG ISOLATION; DRUG RELEASE; IN VITRO STUDY; TABLET FORMULATION;

ANALGESICS, OPIOID; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DRUG COMPOUNDING; HUMANS; OXYMORPHONE; POLYETHYLENE GLYCOLS; SECURITY MEASURES; TABLETS; TRAMADOL;

EID: 84864253851     PISSN: 17425247     EISSN: 17447593     Source Type: Journal    
DOI: 10.1517/17425247.2012.698606     Document Type: Article

References (29)

1. Substance Abuse and Mental Health Services Administration. Results from the 2010 national survey on drug use and health: Summary of national findings. Substance Abuse and Mental Health Services Administration; Rockville, MD: 2011. Report No.: NSDUH Series H-41, HHS Publication No. (SMA) 11-4658
2. Dhalla IA, Mamdani MM, Sivilotti ML, et al. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone. CMAJ 2009;181:891-6
3. Butler SF, Black RA, Cassidy TA, et al. Abuse risks and routes of administration of different prescription opioid compounds and formulations. Harm Reduct J 2011;8:29
4. Osgood ED, Eaton TA, Trudeau JJ, Katz NP. A brief survey to characterize oxycodone abuse patterns in adolescents enrolled in two substance abuse recovery high schools. Am J Drug Alcohol Abuse 2012;38:166-70
5. EMBEDA (morphine sulfate and naltrexone hydrochloride). Full Prescribing Information. King Pharmaceuticals; Bristol, TN: 2009
6. OxyContin (oxycodone HCl controlled-release tablets). Full Prescribing Information. Purdue Pharma L.P.; Stamford, CT: 2010
7. OXECTA (oxycodone HCl, USP). Full Prescribing Information. King Pharmaceuticals; Bristol, TN: 2011
8. NUCYNTA ER (tapentadol). Full Prescribing Information. Janssen Pharmaceuticals, Inc., Titusville, NJ: 2011
9. OPANA ER (oxymorphone hydrochloride). Full Prescribing Information. Endo Pharmaceuticals; Chadds Ford, PA, USA: 2012
10. Bartholomaus J, Geissler A, Bertram U, Griessmann K. Tamper-resistant dosage form for oxidation-sensitive opioids. WO2011009603; 2011
11. Katz N. Abuse-deterrent opioid formulations: Are they a pipe dream? Curr Rheumatol Rep 2008;10:11-18
12. McKenna WH, Mannion RO, O'Donnell EP, Huang HH. Tamper resistant dosage forms. US20090081290A1; 2009
13. Mastropietro DJ, Omidian H. Current approaches in tamper-resistant and abuse-deterrent formulations. Drug Dev Ind Pharm 2012. [Epub ahead of print]
14. Dowwolff Cellulosics. POLYOX physical properties. 2011. Available from: Http://dowwolff.custhelp.com/app/answers/detail/a-id/1377/-/polyox-physical- properties [Last accessed January 24 2012]
15. Bartholomaus J, Kugelmann H, Arkenau-Maric E. Form of administration secured against misuse. EP1658055B1; 2007
16. Bartholomaus J, Arkenau-Maric E. Method for the production of an administration form which is secured against misuse. EP1699440B1; 2009
17. Bartholomaus J, Arkenau-Maric E. Method for the production of an abuse-proof, solid form of administration. EP1740156B1; 2011
18. Bartholomaus J, Kugelmann H, Arkenau-Maric E. Dosage form that is safeguarded from abuse. EP1658054B1; 2007
19. Arkenau-Maric E, Bartholomaus J, Schateikis D. Form of administration secured against misuse. WO20088145334; 2008
20. International Conference on Harmonisation. Stability Testing: Photostability Testing of New Drug Substances and Products (Q1B): International Conference on Harmonisation; 1996. Report No.: CPMP/ICH/279/95
21. International Conference on Harmonisation. Stability Testing for New Dosage Forms (Q1C): International Conference on Harmonisation; 1996. Report No.: CPMP/ICH/280/95
22. International Conference on Harmonisation. Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (Q1D): International Conference on Harmonisation; 2002. Report No.: CPMP/ICH/4104/00
23. International Conference on Harmonisation. Stability Testing of New Drug Substances and Research (Q1A): International Conference on Harmonisation; 2003. Report No.: CPMP/ICH/2736/99
24. International Conference on Harmonisation. Evaulation of Stability Data (Q1E): International Conference on Harmonisation; 2003. Report No.: CPMP/ICH/420/02
25. Benedek IH, Jobes J, Xiang Q, FiskeWD. Bioequivalence of oxymorphone extended release and crush-resistant oxymorphone extended release. Drug Des Devel Ther 2011;5:455-63
26. Butler SF, Black R, Grimes Serrano JM, et al. Estimating attractiveness for abuse of a not-yet-marketed "abuse-deterrent" prescription opioid formulation. Pain Med 2010;11:81-91
27. SokolowskaM, Comer SD, Sullivan MA, Ashworth JB. Can increasing mechanical stability of controlled release tablets decrease drug preference and the street value of the drug? [abstract PM 387]. 13th Congress of the International Association for the Study of Pain; 2010 August 29-September 2; Montreal, QC, Canada. Available from: Http://www.abstractsonline.com/Plan/ ViewAbstract.aspx?sKey=61f3d88d-52e8- 404a-8e7a-ef29e654ada1&cKey=76cd0256- aba8-467c-a7ec-6b1d02acec8a&mKey=% 7B3F846F23-E219-40A0-B790- DBC3F75684FD%7D [Last accessed 23 May 2012]
28. Vosburg SK, Jones JD, Manubay JM, et al. Assessment of a formulation designed to be crush-resistant in prescription opioid abusers. Drug Alcohol Depend 2012; In press 29. Black R, Coplan P, Cassidy T, et al. Effects of reformulated OxyContin among patients assessed for substance abuse treatment in the NAVIPPRO sentinal surveillance network. J Pain 2012;13:S58
29. Mitchell JF. Oral dosage forms that should not be crushed. 2011. Available from: Http://www.ismp. org/Tools/DoNotCrush.pdf [Last accessed 24 January 2012]