Environmental risk assessment for the galenical formulation of solid medicinal products at roche basle, switzerland

Abstract

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.

Pollution from drug manufacturing: review and perspectives

“…Accordingly, publicly available, self-reported data from industry [ 32 ] or monitoring data from authorities are scarce. There are reports of low effluent concentrations of APIs based on theoretical mass balance calculations that assume a constant discharge rate over time, but without any chemical measurements [ 34 ]. Clearly, there is a need for wider monitoring of API emissions from manufacturing worldwide, and it is important to allow the publication of negative findings from adequately designed studies.…”

Occurrence and Abundance of Antibiotics and Resistance Genes in Rivers, Canal and near Drug Formulation Facilities – A Study in Pakistan

“…On the basis of contribution from such sources, one may categorize them as levels up to mg L −1 [15]–[18], >100 µg L −1 [19]–[21] and <1 µg L −1 [22]–[26]. The highest levels ever reported from BDMF is 31 mg L −1 for ciprofloxacin (fluoroquinolone) from WWTP effluent receiving polluted water from about 90 bulk drug manufacturers in Patancheru near Hyderabad, India [15].…”

Pharmaceutical Formulation Facilities as Sources of Opioids and Other Pharmaceuticals to Wastewater Treatment Plant Effluents

“…The discharges of facilities that manufacture pharmaceutical products are an under-investigated source of pharmaceuticals to the environment, with only limited data currently available worldwide. Pharmaceutical manufacturing facilities include pharmaceutical production facilities (PPF), which produce active pharmaceutical ingredients, and pharmaceutical formulation facilities (PFF), which formulate and package pharmaceutical products ( 22 ). Past studies of pharmaceutical sources to the environment have focused on consumer use and disposal and hospital waste ( 14 , 23 , 24 ).…”