Miljöpåverkan
Miljöinformationen för buprenorfin är framtagen av företaget Camurus för Buvidal
Miljörisk:
Risk för miljöpåverkan av buprenorfin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Det kan inte uteslutas att buprenorfin är persistent, då data saknas.
Bioackumulering:
Buprenorfin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Environmental Risk Classification
Predicted Environmental Concentration (PEC)
PEC is calculated according to the following formula:
PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.37*10-6 *47.31*(100-0)
Where:
A = 47.31 kg (total sold amount buprenorphine and buprenorphine hydrochloride in Sweden year 2022, data from IQVIA).
R = % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available. (If R is not equal to 0 this should be justified under the degradation section)
P = number of inhabitants in Sweden = 10 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. I)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)
PEC = 0.0064 μg/L
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of buprenorphine is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) at the time of registration was below the action limit 0.01 µg/L.
Predicted No Effect Concentration (PNEC)
No data available
Environmental risk classification (PEC/PNEC ratio)
No data available.
Degradation
No data available.
Bioaccumulation
Partitioning coefficient: Log Dow = 3.7 at pH 7 (guideline OECD 107). (Ref II)
Justification of chosen bioaccumulation phrase: Since log Dow < 4 at pH 7, the substance has low potential for bioaccumulation.
Excretion (metabolism)
Buprenorphine is oxidatively metabolised by 14-N-dealkylation to N-desalkyl-buprenorphine (also known as norbuprenorphine) via cytochrome P450 CYP3A4 and by glucuroconjungation of the parent molecule and the dealkylated metabolite. Norbuprenorphine is a µ-opioid agonist with weak intrinsic activity.
As the main metabolite is pharmacologically active, no reduction of A in the PEC calculation has been made.
References
I. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
II. Volic, N., 2020. Determination of physico-chemical properties of Buprenorphine: partition coefficient at pH5 and pH7 using shake flask method; partion coefficient at pH 9 using slow-stirring method. Charles River Laboratories Den Bosch, Study No. 20186155