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Miljöinformation
Bayer

KAPSLAR 10 mg
Avregistreringsdatum: 1997-04-30 (Tillhandahålls ej)

Aktiv substans:
ATC-kod: C08CA05
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöpåverkan (Läs mer om miljöpåverkan)

Nifedipin

Miljörisk: Risk för miljöpåverkan av nifedipin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Nifedipin bryts ned långsamt i miljön.
Bioackumulering: Nifedipin 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) = 1.5*10-6*A(100-R)
 = 1.5*10-6*53,8210[kg]*100

Where:

A = 53.8210 kg (total sold amount API in Sweden year 2015, data from IMS Health). R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9 *106 

V (L/day) = volume of wastewater per capita and day = 200 (1)

D = factor for dilution of wastewater by surface waterflow = 10 (1)

PEC = 0.0081 μg/L


Ecotoxicological studies

Crustacean (Daphnia magna):

Acute toxicity

EC50 /48 h (immobilization) = >3.88 mg/L (solubility limit) (guideline OECD202) (2)

Fish:

Acute toxicity (Zebrafish Danio rerio)

LC50 /96 h (mortality) = >5.77 mg/L (solubility limit) (guideline OECD 203) (2)


Environmental risk classification (PEC/PNEC ratio)

Risk of environmental impact of nifedipine cannot be excluded, since there is not sufficient ecotoxicity data available


Degradation

Biotic degradation

Ready degradability: not readily biodegradable

Manometric respiration test: Test results 3% degradation in 28 days (guideline OECD301F) (2)


The microbial degradation of nifedipine with environmental samples of coastal waters of 4 different sites (New York Bay, NY) was studied by Benotti et al (3). They incubated spiked nifedipine (1 µg/L) in mixtures with other pharmaceuticals and measured the disappearance from the water samples stored in the dark at 15ºC. Nifedipine was analyzed by LC-ToF-MS. Nifedipine 8 as parent compound) disappeared in 3 of 4 water samples with a half-life of 5.7 to 6.3 days, while in one sample the half-life was estimated to be >100 days. This sample originated from an oligotrophic region, while 2 of the others were more eutrophic. It is therefore likely that nifedipine is rapidly degraded in freshwater, since nifedipine as a human pharmaceutical will pass a waste water treatment plant after excretion from the patient, before it enters surface waters, and rivers are typically more eutrophic than marine or coastal areas, enhancing the degradation of nifedipine.


Abiotic degradation

Nifedipine is very light-sensitive. Photolytic degradation has been studied by several authors. In (4) the authors exposed samples of nifedipine in an ethanolic solution at 22ºC (pH not given) to monochromatic continuous irradiation with wave lengths between 223 and 390 nm. Rate constants for degradation were determined to be between 0.00009 to 0.00489 /s-1 dependent on wave lengths (low to high). The authors concluded that nifedipine is photolytically degraded at visible wave lengths, with maximum absorbance between 282 and 370 nm. Nitrosophenylpyridine was the main photolytic transformation product.

In (5) the degradation of nifedipine was studied using two different types of irradiation lamps (mercury vapor and fluorescence lamps with a light intensity of 5x104 J /m2) at wave lengths between 290 and 500 nm. Nifedipine was exposed to the different light sources as dry powder at room temperature. The irradiated samples were analyzed by HPLC-UV. Three degradation products were identified. The degradation half-life was a few minutes under the mercury vapor lamp and less than 3 hours under the fluorescence lamp.

The data on photo-stability of nipedipine suggest a high instability, with half-lives < 40 days.

The data on biological and abiotic degradation justify the phrase:
Nifedipine is slowly degraded in the environment.


Bioaccumulation

Partitioning coefficient:

Log POW 2.4 (calculated, method not known) (2).

Since log POW is 2.4, the substance has a low potential for bioaccumulation.


Excretion (metabolism)

Nifedipine is introduced mainly as oxidated metabolites and conjugated molecules (glucoronides).


References

  1. ECHA, European Chemicals Agency, 2016. Guidance on information requirements and chemical safety assessment.

    https://echa.europa.eu/documents/10162/13632/information_requirements_r16_en.pdf

  2. Bayer AG, Material Safety Data Sheet v4.0, 1.7.2011, Bayer AG, Leverkusen, Germany

  3. Benotti M.J., Brownawell B.J. 2009. Microbial degradation in marine and coastal waters. Environmental Pollution 157, 994-1002

  4. Maafi W., Maafi M. 2013. Modelling nifedipin photodegradation photostability and actinometric properties. Int J Pharmaceuiticals 456, 153-164

  5. Matsuda Y., Teraoka R., Sugimoto I. 1989. Comparative evaluation of photostability of solid state nifedipin under ordinary and intensive light irradiation conditions. Int J Pharmaceuiticals 54, 211-221

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