Update on tamper-resistant drug formulations

Abstract An expert panel convened in 2005 by the College on Problems of Drug Dependence (CPDD) to consider strategies to reduce the risk of prescription medication abuse concluded that drug formulation plays a significant role in determining risk of abuse. Efforts on the part of the pharmaceutical i...

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Bibliographic Details
Published in:Drug and alcohol dependence 2013-06, Vol.130 (1), p.13-23
Main Authors: Romach, M.K, Schoedel, K.A, Sellers, E.M
Format: Article
Language:English
Subjects:
Abuse deterrent
Abuse liability
Analgesics, Opioid - chemical synthesis
Analgesics, Opioid - standards
Chemistry, Pharmaceutical - standards
Chemistry, Pharmaceutical - trends
Drug Compounding - standards
Drug Compounding - trends
Drug formulations
Humans
Opioid
Opioid-Related Disorders - prevention & control
Prescription Drugs - chemical synthesis
Prescription Drugs - standards
Prodrugs - chemical synthesis
Prodrugs - standards
Psychiatry
Tamper resistant
Tampering
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Summary:Abstract An expert panel convened in 2005 by the College on Problems of Drug Dependence (CPDD) to consider strategies to reduce the risk of prescription medication abuse concluded that drug formulation plays a significant role in determining risk of abuse. Efforts on the part of the pharmaceutical industry to develop drugs that deter abuse have focused primarily on opioid formulations resistant to common forms of tampering, most notably crushing or dissolving the tablet to accelerate release. Several opioid formulations developed to be tamper resistant have been approved, but the US Food and Drug Administration has not approved explicit label claims of abuse deterrence and has stated that any such claim will require substantial postmarketing data. Drug development efforts in this area raise questions about the relative impact of abuse-deterrent formulations, not only on individuals who might abuse a medication, but also on patients who are compliant with therapy. This review discusses progress since the 2005 CPDD meeting with an emphasis on opioids. Articles cited in the review were identified via a PubMed search covering the period between January 1, 2000, and October 5, 2011. Scientific work presented by the authors and their colleagues at meetings held through May 2012 also was included. Published literature suggests that development of abuse-deterrent products will require broad public health support and continued encouragement from regulatory authorities so that such products will become the expected standard of care for certain drug classes.
ISSN:0376-8716
1879-0046
DOI:10.1016/j.drugalcdep.2012.12.028