Development of tamper deterrent formulations: State of the pharmaceutical industry

Current Drug Abuse Reviews

Volumn 3, Issue 3, 2010, Pages 139-146

  Hamed, Ehab ^a   Moe, Derek ^a  

^a CIMA Labs Inc Minnesota   (United States)

Author keywords

Abuse; Extended release; Formulations; Opioids; Tamper deterrent

Indexed keywords

AMPHETAMINE; BUPRENORPHINE PLUS NALOXONE; HYDROCODONE; MORPHINE; MORPHINE SULFATE PLUS NALTREXONE; NALOXONE; NALOXONE PLUS OXYCODONE; NALOXONE PLUS PENTAZOCINE; NICOTINIC ACID PLUS OXYCODONE; OPIATE; OPIATE ANTAGONIST; OXYCODONE; PENTAZOCINE; PSYCHOSTIMULANT AGENT; SEDATIVE AGENT; TAPENTADOL; TRANQUILIZER; UNCLASSIFIED DRUG; VALORON N; VYRANSE; CENTRAL DEPRESSANT AGENT; CENTRAL STIMULANT AGENT; NARCOTIC ANALGESIC AGENT; PRESCRIPTION DRUG;

ANALGESIC ACTIVITY; CHEMICAL BARRIER; DRUG ABUSE; DRUG CLASSIFICATION; DRUG DOSAGE FORM; DRUG EFFECT; DRUG FORMULATION; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG RELEASE; HUMAN; IN VITRO STUDY; IN VIVO STUDY; INJECTION; LOW DRUG DOSE; PATENT; PHYSICAL BARRIER; PHYSICAL PHENOMENA; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; TAMPER DETERRENT FORMULATION; ADDICTION; DELAYED RELEASE FORMULATION; DRUG CONTROL; DRUG DESIGN; LEGAL ASPECT; METHODOLOGY;

ANALGESICS, OPIOID; CENTRAL NERVOUS SYSTEM DEPRESSANTS; CENTRAL NERVOUS SYSTEM STIMULANTS; DELAYED-ACTION PREPARATIONS; DRUG AND NARCOTIC CONTROL; DRUG DESIGN; DRUG INDUSTRY; DRUG LABELING; HUMANS; PRESCRIPTION DRUGS; SUBSTANCE-RELATED DISORDERS;

EID: 79953768961     PISSN: 18744737     EISSN: 18744745     Source Type: Journal    
DOI: 10.2174/1874473711003030139     Document Type: Review

References (52)

1. Office of National Drug Control Policy (ONDCP) [homepage on the Internet]. Rockville, MD. [updated 2009 May 20; cited 2010 Feb 12]. Available from: http://www.ondcp.gov/news/press09/052009.html
2. U.S. Department of Health and Human Services (HHS), Substance Abuse and Mental Health Services Administration (SAMHSA), Office of Applied Studies (OPS) [homepage on the Internet]. [updated 2009 Sep 10; cited 2010 Feb12]. Available from: http://oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.pdf
3. United Nation office on Drug and Crime (UNODC) [homepage on the Internet]. Vienna, Austria: c2010. [cited 2010 Jun 7]. Available from: http://www.unodc.org/documents/wdr/WDR_2009/Executive_summary_LO-RES.pdf
4. U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control [homepage on the Internet]. Springfield, VA. [cited 2010 Feb 17]. Available from: http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf
5. Monitoringthefuture [homepage on the Internet]. Ann Arbor, MI: The Regents of the University of Michigan; c2010. [updated 2010 August 20, cited 2010 August 25]. Available from: http://www.monitoringthefuture.org/pubs/monographs/overview2006.pdf
6. U.S. Food and Drug Administration [homepage on the Internet]. Rockville, MD. [updated 2009 Nov 20; cited 2010 Jun 15]. Available from: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm187975.htm
7. U.S. Food and Drug Administration Draft Guidance for Industry. Format and content of proposed risk evaluation and mitigation strategies (REMS,REMS assessments, and proposed REMS modifications. September 2009.
8. Coleman JJ, Schuster CR, DuPont RL. Reducing the abuse potential of controlled substances. Pharm Med 2010; 24: 21-36.
9. Katz N. Abuse-deterrent opioid formulations: Are they a pipe dream? Curr Rheumatol Rep 2008; 10: 11-8.
10. Tufts Health Care Institute [homepage on the Internet]. Boston, MA: Tufts Health Care Institute; c2010 [cited 2010 Jun 7]. Available from: http://www.thci.org/Opioid/background.pdf
11. Webster LR, Bath B, Medve RA. Opioid formulations in development designed to curtail abuse: who is the target? Expert Opin Investig Drugs 2009; 18: 255-63.
12. Budman SH, Grimes Serrano JM, Buttler SF. Can abuse deterrent formulation make a difference? Expectation and speculation. Harm Red J [serial on the Internet]. 2009 May 2009; [cited 2010 June 7]; 6: 8. Available from: http://www.harmreductionjournal.com/content/pdf/1477-7517-6-8.pdf
13. Hays L, Kirsh KL, Passik SD. Seeking drug treatment for oxycontin abuse: A chart review of consecutive admissions to a substance abuse treatment facility in Kentucky. J Natl Comp Cancer Network 2003; 1: 423-8.
14. U.S. Drug Enforcement Administration [homepage on the Internet]. Springfield, VA [cited 2010 Jun 7]. Available from: http://www.justice.gov/dea/pubs/abuse/4-narc.htm#Hydromorphone
15. Katz NP, Buse DC, Budman SH, et al. Development and preliminary experience with an ease of extractability rating system for prescription opioids. Drug Dev Ind Pharm 2006; 32: 727-46.
16. Habib W, Hamed E, Moe D, inventors; CIMA LABS Inc., assigness. Abuse resistant drug formulation. United States Patent US 20080069891. 2008 March.
17. Hirsh J, Kibanov AM, Swager TM, et al., inventors; Collegium Pharmaceutical, Inc., assignee. Abuse-deterrent pharmaceutical compositions of opioids and other drugs. United States Patent US 7,399,488. 2008 July.
18. Morrison YV, inventor. Abuse resistant capsules. United States Patent US 2009123386. 2009 May.
19. Kumar V, Dixon D, Tewari D, Wadgaonkar DB, inventors; Acura Pharmaceuticals Inc., assignee. Methods and compositions for deterring abuse of opioid containing dosage forms. United States Patent 7,510,726. 2009 March.
20. Bastin RJ, Lithgow BH, inventors. Aventis Pharma Limited, assignee. Abuse resistant tablets. United States Patent 6,309,668. 2001 Oct.
21. Mannion RO, Mckenna WH, O'Donnell EP, et al., inventors; EURO-CELTIQUE S.A., assignee. Alcohol resistant dosage forms. United States Patent 20070259045. 2007 Nov.
22. Webster LR. PTI-821: Sustained-release oxycodone using gel-cap technology. Expert Opin Investig Drugs 2007; 16: 1-8.
23. U.S. Food and Drug Administration [homepage on the Internet]. Rockville, MD. [cited 2010 Jun 16]. Available from: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4395b1-02-PAIN.pd
24. Pain Therapeutics Inc. [homepage on the Internet]. San Mateo, CA: PAIN THERAPEUTICS, INC; c2002-2007 [cited 2010 May 20]. Available from: http://investor.paintrials.com/releasedetail.cfm?Rel easeID=354003
25. Pain Therapeutics Inc. [homepage on the Internet]. San Mateo, CA: PAIN THERAPEUTICS, INC; c2002-2007 [cited 2010 may 20]. Available from: http://investor.paintrials.com/releasedetail.cfm?Rel easeID=394485
26. U.S. Food and Drug Administration [homepage on the Internet]. Rockville, MD. [cited 2010 Jun 16]. Available from: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4356b1-02-Purdue.pdf
27. MedicalNewsToday [homepage on the Internet]. East Sussex, United Kingdome: MediLexicon International Ltd; c2010 [cited 2010 Jun 7]. Available from: http://www.medicalnewstoday.com/articles/129330.php
28. Intellipharmaceutics [homepage on the Internet]. Toronto, ON, Canada: Intellipharmaceutics International; c [cited 2010 May 21]. Intellipharmaceutics announces significant advance in its abusedeterrent oxycodone program. Available from: http://www.intellipharmaceutics.com/releases.cfm
29. Egalet [homepage on the Internet]. Vaerlose, Denmark: Egalet Ltd.;c [cited 2010 May 21]. Available from: http://www.egalet.com/index.dsp?area=6
30. Mickle T, Krishnan S, Bishop B, et al., inventors; Shire LLC; assignee. Abuse-resistant amphetamine prodrugs. United States Patent 7,718,619. 2010 May.
31. Mickle T, Krishnan S, Moncrief JS, Lauderback C, Mickle C, inventors; Shire LLC, assignee. Pharmaceutical compositions for prevention of overdose or abuse. United States Patent 7,375,083. 2008 May.
32. Mickle T, Krishnan S, Moncrief JS, Mickle C, Lauderback C, Piccariello T, inventors; Shire LLC, assignee. Abuse-resistant hydrocodone compounds. United States Patent 7,375,082. 2008 May.
33. Shafer JA, Telyatnikov VV, Guo Z, inventors, Controlled Chemicals, Inc., assignee. Compounds and methods for lowering the abuse potential and extending the duration of action of a drug. United States Patent 7,230,005. 2007 June.
34. U.S. Food and Drug Administration [homepage on the Internet]. Rockville, MD. [cited 2010 Jun 15]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021977s010s015lbl. Pdf
35. Hughes L, Bellamy SA, inventors. Pharmaceutical formulation including a resinate and an aversive agent. United States Patent US 20040126428. 2004 July.
36. Maloney AM, inventor. Opioid sustained-released formulation. United States Patent US 20020164373. 2002 Nov.
37. Collegium Pharmaceutical Inc. [homepage on the Internet]. Cumberland, RI: Collegium Pharmaceutical; c2007 [cited 2010 May 21]. Available from: http://www.collegiumpharma.com/news/ 20100630.html
38. Kumar V, Dixon D, Tewari D, Wadgaonkar DB, inventors; Acura Pharmaceuticals, Inc., assignee. Methods and compositions for deterring abuse of opioid containing dosage forms. United States Patent US 20090004292. 2009 Jan.
39. Anderson KA, Hoch JM, Liversidge G, Duvall JM, Slavitt JR, inventors; Elan Corporation plc, assignee. Pharmaceutical composition. United States Patent US 20030125347. 2003 July.
40. Acura Pharmaceuticals, Inc. [homepage on the Internet]. Palatine, IL: Acura Pharmaceuticals; c1998-2010 [cited 2010 Jun 15]. Acura Pharmaceuticals receives preliminary review letter from FDA regarding Acurox®. Available from: http://acurapharm.com/investors/press-releases
41. Acura Pharmaceuticals, Inc. [homepage on the Internet]. Palatine, IL: Acura Pharmaceuticals; c1998-2010 [cited 2010 Jun 15]. Acura and King receive FDA complete response letter regarding Acurox®. Acura Pharmaceuticals. Available from: http://acurapharm.com/investors/press-releases
42. Acura Pharmaceuticals, Inc. [homepage on the Internet]. Palatine, IL: Acura Pharmaceuticals; c1998-2010 [cited 2010 May 21]. King Pharmaceuticals and Acura Pharmaceuticals announce plans to submit an NDA for Acurox® tablets without niacin. Available from: http://acurapharm.com/investors/press-releases
43. Baum C, Hsu J P, Nelson RC. The impact of the addition of naloxone on the use and abuse of pentazocine. Public Health Rep 1987; 102: 426-9.
44. Reed DA, Schnoll SH. Abuse of pentazocine-naloxone combination. JAMA 1986; 256: 2562-4
45. Lahmeyer HW, Craig RJ. Pentazocine-naloxone: Another "addiction-proof drug of abuse". Substance Use Misuse 1987; 22: 1163-6
46. Alho H, Sinclair D, Vuori E, Holopainen A. Abuse liability of buprenorphine-naloxone tablets in untreated IV drug users. Drug Alcohol Depend 2007; 88: 75-8.
47. U.S. Food and Drug Administration [homepage on the Internet]. Rockville, MD. [cited 2010 Jun 15]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022321s000lbl.pdf
48. Kaiko RF, Colucci RD, inventors; Purdue Pharma L.P., assignee. Opioid agonist/antagonist combinations. United States Patent 7,172,767. 2007 Feb.
49. Mehta AM, inventor; ELITE LABORATORIES, INC, assignee. Abuse-resistant oral dosage forms and method of use thereof. United States Patent US 20100098771. 2010 April.
50. Caruso FS, Kao H-H, inventors; Endo Pharmaceuticals, Inc., assignee. Abuse-resistant controlled-release opioid dosage form. U.S. Patent Application 20080069881. 2008 March.
51. U.S. Food and Drug Administration Draft Guidance for Industry. Assessment of abuse potential of drugs. January 2010.
52. Health Canada Guidance Document. Clinical assessment of abuse liability for drugs with central nervous system activity, June 2007.