Abstract
Objective: The aim of this study was to highlight and sediment the necessary steps to be followed while conducting forced degradation studies to identify degradation products and to describe the Brazilian and international regulations associated with degradation studies of drugs and drug products. Methods: This review was conducted based on the Brazilian guidance tools as RDC 53/2015, Guide 4 and Question and Answer resource; references used as international guides; and articles in the field of degradation product analyses. Results: Characterization of the impurity profile for a substance, and development of indicative stability methods are essential criteria for compliance with current legislation, and address a legitimate health concern. As this matter falls under the purview of recently published regulation, many doubts remain regarding methods of conducting studies of forced degradation, and development of methods indicative of stability. Analytical conditions predict degradation after exposing them to thermal, humid, acidic, basic, oxidation, photolytic, and metal ion conditions. Conclusions: Although RDC 53/2015 outlines the parameters of degradation, the analytical conditions are not specified, as well as in other international standards. A well-designed forced degradation study is key to obtaining a good stability indicating method with peak purity and mass balance.
Highlights
The presence of impurities in drugs and/or drug products has been known to manufacturers for a long time
In view of this information, this review aims to highlight and sediment the necessary steps to be followed while conducting forced degradation studies to identify degradation products in drugs or drug products
Excipients contain impurities that are capable of initiating oxidation, such as organic hydroperoxides, which are generally found in excipients such as polysorbate 80, polyethylene glycol (PEG) 400, hydroxypropylmethylcellulose (HPMC), and polyvinylpyrrolidone (PVP)[28]
Summary
The presence of impurities in drugs and/or drug products has been known to manufacturers for a long time. Resolution of Executive Board (RDC) No 53/2015 of the Brazilian National Health Surveillance Agency (ANVISA) approving guidelines based on the International Conference on Harmonization (ICH) recommendations was legislated These guidelines established parameters for reporting, identification, and qualification of degradation products formed during the shelf-life of a drug product. Establishing exposure limits to impurities without any risk to human health has become a global concern because of the number of serious adverse events experienced around the world due to the presence of impurities in drug products, with some events having resulted in fatal outcomes[6] In view of this information, this review aims to highlight and sediment the necessary steps to be followed while conducting forced degradation studies to identify degradation products in drugs or drug products
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