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Technical Note

New immediate release formulation for deterring abuse of methadone

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Pages 535-543 | Received 08 Jan 2012, Accepted 19 Mar 2012, Published online: 27 Apr 2012

References

  • FDA, Guidance for Industry. Assessment of Abuse Potential of Drugs (DRAFT GUIDANCE). Guidance document distributed for comment purposes only, Rockville, MD, 2010.
  • Katz N. Abuse-deterrent opioid formulations: are they a pipe dream? Curr Rheumatol Rep 2008;10:11–18.
  • Webster L. Update on abuse-resistant and abuse-deterrent approaches to opioid formulations. Pain Med 2009;10 Suppl 2:S124–S133.
  • Shaw IF, Berk J. Orally administered drug composition for therapy in the treatment of narcotic drug addiction. US patent 3, 980,766. 1976.
  • Kumar V, Dixon D, Tewari D, Wadgaonkar D. Method and compositions for deterring abuse of opioid containing dosage forms. US Patent Application US 2007/0264327, 2007.
  • Raffa RB, Pergolizzi JV Jr. Opioid formulations designed to resist/deter abuse. Drugs 2010;70:1657–1675.
  • Vaghefi F, Liversidge GG, Ruddy SB, Cooper ER. Abuse-resistant pharmaceutical compositions. US Patent Application US 2006/0104909, 2006.
  • Andersen C, Jespersen L. Egalet® morphine, a once-a-day, abuse resistant opioid analgesics: a double-blind, randomized, cross-over efficacy study in cancer patients. Available at: http://www.egalet.com/multimedia/Morphine_PhaseII_Poster_final_2009-04-29.pdf.
  • Haahr AM, Lyhne-Iversen L, Ridderberg S, Nilsson M, Hemmingsen P. Drug abuse resistant, controlled release, using Egalet® dosage units. CRS Poster. 2006; 680.
  • Kaiko RF, Colucci RD. Opioid agonist/antagonist combinations. US Patent 6, 277, 384. 2001.
  • US Pharmacopeia (USP 33-NF 28). 2011.
  • FDA, Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Rockville, MD: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), 1997.
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Guideline Q 1 A (R2): Stability testing of new drug substances and products. Geneva, Switzerland: International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, 2003.
  • The Merck Index, 10th Ed., editor M., Windholz, Rathway, N.J.: Merck &Co., Inc., 1983.
  • Benson DW, Kaufman JJ, Koski WS. Theoretic significance of pH dependence of narcotics and narcotic antagonists in clinical anesthesia. Anesth Analg 1976;55:253–256.
  • Rowe RC, Sheskey PJ, Owen SC, eds. Handbook of pharmaceutical excipients. 5th ed., 2006.
  • Inactive Ingredient Search for Approved Drug Products. Database Last Updated: January 19, 2012. Available at: http://www.accessdata.fda.gov/scripts/cder/iig/getiigWEB.cfm.

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