Environmental Risk Assessment for the Galenical Formulation of Solid Medicinal Products at Roche Basle, Switzerland
| Autor: | Benno Dörr, Jürg Oliver Straub, Corinne C Hoerger, Claude Schlienger |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Drug Industry
Drug Compounding Geography Planning and Development Industrial Waste Sewage Waste Disposal Fluid Rivers Risk Factors Water Pollution Chemical Significant risk General Environmental Science Environmental risk assessment Active ingredient Waste management business.industry General Medicine Pulp and paper industry Pharmaceutical Preparations Wastewater Environmental science Sewage treatment Ecotoxicity business Risk assessment Switzerland Environmental Monitoring |
| Zdroj: | Integrated Environmental Assessment and Management. 5:331 |
| ISSN: | 1551-3793 1551-3777 |
| DOI: | 10.1897/ieam_2008-049.1 |
| Popis: | An environmental risk assessment for losses to wastewater from galenical manufacturing at solid medicinal products at F. Hoffmann-La Roche in Basle, Switzerland, was performed based on an annual total materials balance. This balance resulted in a loss factor of 0.2% relative to the sum of all starting materials, which was later confirmed as valid by analysis for 1 specific active pharmaceutical ingredient (API). The initial risk assessment for all 25 different APIs formulated resulted in no evident risk for the wastewater treatment plant, based on biodegradation no-effect data. However, based on acute ecotoxicity data, potential risk to the local receiving water, the River Rhine, was identified from 1 single API, the antibiotic sulfamethoxazole (SMX). A refinement of the risk assessment for SMX, based on chronic ecotoxicity data, or the predicted no-effect concentration (PNEC), and documented sewage works degradability, or the predicted environmental concentration (PEC), led to a significant decrease of the initial PEC/PNEC ratio to well below 1. In view of this refinement, the final conclusion is that the galenical production investigated poses no significant risk to the environment. |
| Databáze: | OpenAIRE |
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