Buprenorphine

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

Assessment report for Zubsolv

Assessment report for Zubsolv (buprenorfin, naloxon) 14 September 2017, EMA/659116/2017.

Hazard

Persistence: However, both buprenorphine and naloxone meet the persistence label criteria. ...

OECD 308:
DT_{50, water} =1.5–1.8 d
DT_{50, whole system} = 1.7–1.8 d
% shifting to sediment = 92–97 at day 100.

Bioaccumulation: Log K_ow 3.40 (pH 7).

Chronic toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 240 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC = 0.086 microg/L.

PNEC = Lowest NOEC, 240 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 24 microg/L

PEC/PNEC = 0.0036.

The data for calculating risk in assessment reports for a medicinal product do not necessarily represent the total emission of all products with the same active substance during use.

Assessment report for Suboxone, Sixmo and Buvidal

Assessment report for Suboxone (buprenorphine, naloxone) 30 April 2020, EMA/302500/2020. There is similar information in the assessment report for Sixmo (buprenorphine) 26 April 2019, EMA/CHMP/266482/2019 and Buvidal (buprenorphine) 20 September 2018, EMA/693347/2018.

The environmental risk assessment can stop in Phase I. Naloxone and buprenorphine hydrochloride PEC_surfacewater values are below the action limit of 0.01 μg/L and both active substances are not a PBT substance as log Kow does not exceed 4.5. Therefore, naloxone and buprenorphine hydrochloride are not expected to pose a risk to the environment.

Fass environmental information

Fass environmental information for Buvidal from Camurus (downloaded 2023-04-24).

Hazard

Persistence: No data.

Bioaccumulation: Log Dow = 3.7 at pH 7 (guideline OECD 107).

Toxicity: No data.

Risk

Risk of environmental impact of buprenorphine cannot be excluded, due to the lack of environmental toxicity data.

Manufacturer has on fass.se stated that data is missing for the substance so that the environmental risk cannot be calculated. It is voluntary for manufacturers to provide information on the environmental impact on fass.se.

Pharmaceuticals residues in the aquatic environment in Sweden

Buprenorphine has been found in the water environment in the Stockholm Region and nationally in Sweden.