Ready Biodegradability study and insights with UHPLC ‐qToF of a Metformin‐based drug and of Metarecod, a natural substance‐based medical device

AbstractDrugs are indispensable products with incontrovertible benefits to human health and lifestyle. However, due to their overuse and improper disposal, unwanted residues of Active Pharmaceutical Ingredients (APIs) have been found in different compartments of the environment and now are considered as Contaminants of Emerging Concern (CEC). Therefore, they are very likely to have a boomerang effect on human health, because they can enter into the food cycle. In the current legislation framework one of the test first used to evaluate biodegradation of APIs as well as chemical compounds is the ready biodegradability test (RBT). This test can be performed according to a series of protocols prepared by OECD (Organization for Economic Co-operation and Development) and usually is carried out on pure compounds. RBTs, largely used due to their relatively low cost, perceived standardization, straightforward implementation and interpretation, are known to have a number of well-documented limitations. In this work, following a recently reported approach, we propose to improve the evaluation of the RBT results applying advanced analytical techniques based on mass spectrometry, not only to the APIs but also to complex formulated products, as the biodegradability can potentially be affected by the formulation. We evaluated the ready biodegradability of two therapeutic products, ProductA- a drug based on Metformin- and ProductB- Metarecod a natural substance-based medical device - through...
Source: Journal of Mass Spectrometry - Category: Chemistry Authors: Tags: RESEARCH ARTICLE Source Type: research