Assessment of a formulation designed to be crush-resistant in prescription opioid abusers.
BACKGROUND
The extent of prescription opioid abuse has led to the development of formulations that are difficult to crush. The purpose of the present studies was to examine whether experienced prescription opioid abusers (individuals using prescription opioids for non-medical purposes regardless of how they were obtained) were able to prepare a formulation of oxymorphone hydrochloride ER 40 mg designed to be crush-resistant (DCR) for intranasal (study 1) or intravenous abuse (study 2), utilizing a non-crush-resistant formulation of oxymorphone (40 mg; OXM) as a positive control.


METHODS
No drug was administered in these studies. Participants were provided with DCR and OXM tablets in random order and asked to prepare them for abuse with tools/solutions that they had previously requested. The primary outcome for study 1 was particle size distribution, and the primary outcome for study 2 was percent yield of active drug in the extracts. Other descriptive variables were examined to better understand potential responses to these formulations.


RESULTS
Fewer DCR than OXM particles were smaller than 1.705 mm (9.8% vs. 97.7%), and thus appropriate for analyses. Percent yield of active drug in extract was low and did not differ between the two formulations (DCR: 1.95%; OXM: 1.29%). Most participants were not willing to snort (92%) or inject (84%) the tampered products. Participants indicated that they found less relative value in the DCR than the OXM formulation across both studies.


CONCLUSIONS
These data suggest that the oxymorphone DCR formulations may be a promising technology for reducing opioid abuse.
Division on Substance Abuse, New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons, Department of Psychiatry, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA. skv2001@columbia.edu
Suzanne K
SK
Vosburg
Jermaine D
JD
Jones
Jeanne M
JM
Manubay
Judy B
JB
Ashworth
Irma H
IH
Benedek
Sandra D
SD
Comer
D000281:Administration, Intranasal; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical; D003627:Data Interpretation, Statistical; D003692:Delayed-Action Preparations; D003710:Demography; D005079:Excipients; D005260:Female; D006245:Hardness Tests; D006801:Humans; D020100:Hydrogels; D008297:Male; D008875:Middle Aged; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D010111:Oxymorphone / Q000008:administration & dosage / Q000737:chemistry; D010316:Particle Size; D011134:Polysaccharides; D011208:Powders; D015819:Substance Abuse, Intravenous; D016896:Treatment Outcome; D055815:Young Adult
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D005079:Excipients; D020100:Hydrogels; D011134:Polysaccharides; D011208:Powders; D010111:Oxymorphone