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Int J Clin Pharmacol Ther. 2018 Feb;56(2):81-85. doi: 10.5414/CP203118.

Norbuprenorphine and respiratory depression: Exploratory analyses with new lyophilized buprenorphine and sublingual buprenorphine
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Abstract

OBJECTIVES:

To investigate plasma levels of buprenorphine and norbuprenorphine and their relationship to respiratory depression.

MATERIALS AND METHODS:

Opioid-dependent subjects were randomized 2 : 1 to novel lyophilized rapid-disintegrating tablet ("bup-lyo") or standard sublingual buprenorphine tablet ("bup-SL"). Measurements included oximetry scores and linked plasma buprenorphine and norbuprenorphine levels.

RESULTS:

Respiratory depression (cumulative duration of SpO<sub>2</sub> < 90% over 30-minute periods) increased with corresponding exposure levels (AUC<sub>30 min</sub>) of buprenorphine and particularly with norbuprenorphine. A lower buprenorphine/norbuprenorphine ratio was predictive of respiratory depression. The mean (SD) observed ratio was significantly higher for "bup-lyo" (3.4 (2.8)) compared to "bup-SL" (1.7 (0.77)), p < 0.0001.

CONCLUSION:

Exploratory investigation found respiratory depression more strongly associated with norbuprenorphine than with buprenorphine. This accords with animal studies.
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PMID:
29231163
DOI:
10.5414/CP203118
[Indexed for MEDLINE]

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