Development and Preliminary Experience with an Ease of Extractability Rating System for Prescription Opioids

Author: Katz N. P.   Buse D. C.   Budman S. H.   Wing Venuti S.   Fernandez K. C.   Benoit C.   Bianchi R.   Cooper D.   Jasinski D. R.   Smith D. E.   Butler S. F.  

Publisher: Informa Healthcare

ISSN: 0363-9045

Source: Drug Development and Industrial Pharmacy, Vol.32, Iss.6, 2006-06, pp. : 727-746

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Abstract

One important factor in the abuse potential of an opioid product is the ease with which active drug can be extracted. There are currently no standards for testing or reporting extractability. This article describes the development of an Extractability Rating System for use by the pharmaceutical industry and regulators. Despite several limitations, this effort serves as a call for standardized testing and reporting so that products can be accurately rated, and should help establish goals for drug developers who wish to develop “abuse-resistant” opioid products.