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• W2113551978 abstract "The ease with which active ingredient can be extracted from a prescription opioid product has been considered important for abuse liability assessment, approval, and scheduling. However, the assessment of extractability has never been studied systematically. Our goal was to create standards around assessment of extractability. Procedures included consensus of experts (including prescription opioid abusers, ex-DEA and ex-FDA chemists, substance abuse specialists, scale developers, and a pain specialist) and Concept Mapping (a quantitative method for synthesizing qualitative input). Results of the study included expert consensus on a definition of extractability; four key dimensions were defined as Ease of extraction, Purity of the extract, Efficiency of the extraction, and Potency of the extract. A classification system for ease of extractability was derived from traditional regulatory approaches, empirically tested, and revised. An Extractability Rating System was produced that includes a Standard Extractability Battery (SEB) that consists of all the core tests that must be performed to rate extractability and a scoring method that reduces the SEB into a Scoring Table (“Extractability Profile”) for each drug. The expert panel agreed that definitive ratings of extractability require availability of complete laboratory tests. For the purposes of this study ratings of 5 opioid products (Oxycontin, Percocet, Talwin-NX, the fentanyl matrix patch, and the Duragesic fentanyl reservoir patch) were constructed based on available data by 5 experts. While inter-rater reliability was low, the relative ordering of extractability (from most to least extractable) was Oxycontin, fentanyl matrix patch, Percocet, Talwin-NX, and Duragesic patch. This effort has begun the process of creating standards around assessing the extractability of prescription opioid products. While more work needs to be done, the assessment of abuse liability of prescription opioid products will be illuminated by this effort. A research grant from Janssen Pharmaceutica, Inc. is gratefully acknowledged. The ease with which active ingredient can be extracted from a prescription opioid product has been considered important for abuse liability assessment, approval, and scheduling. However, the assessment of extractability has never been studied systematically. Our goal was to create standards around assessment of extractability. Procedures included consensus of experts (including prescription opioid abusers, ex-DEA and ex-FDA chemists, substance abuse specialists, scale developers, and a pain specialist) and Concept Mapping (a quantitative method for synthesizing qualitative input). Results of the study included expert consensus on a definition of extractability; four key dimensions were defined as Ease of extraction, Purity of the extract, Efficiency of the extraction, and Potency of the extract. A classification system for ease of extractability was derived from traditional regulatory approaches, empirically tested, and revised. An Extractability Rating System was produced that includes a Standard Extractability Battery (SEB) that consists of all the core tests that must be performed to rate extractability and a scoring method that reduces the SEB into a Scoring Table (“Extractability Profile”) for each drug. The expert panel agreed that definitive ratings of extractability require availability of complete laboratory tests. For the purposes of this study ratings of 5 opioid products (Oxycontin, Percocet, Talwin-NX, the fentanyl matrix patch, and the Duragesic fentanyl reservoir patch) were constructed based on available data by 5 experts. While inter-rater reliability was low, the relative ordering of extractability (from most to least extractable) was Oxycontin, fentanyl matrix patch, Percocet, Talwin-NX, and Duragesic patch. This effort has begun the process of creating standards around assessing the extractability of prescription opioid products. While more work needs to be done, the assessment of abuse liability of prescription opioid products will be illuminated by this effort. A research grant from Janssen Pharmaceutica, Inc. is gratefully acknowledged." @default.
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• W2113551978 date "2005-03-01" @default.
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• W2113551978 title "Development of an extractability rating system for prescription opioid analgesic products" @default.
• W2113551978 doi "https://doi.org/10.1016/j.jpain.2005.01.335" @default.
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