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Review ArticleReview

Advice on Degradation Products in Pharmaceuticals: A Toxicological Evaluation

Sâmia Rocha de Oliveira Melo, Maurício Homem-de-Mello, Dâmaris Silveira and Luiz Alberto Simeoni
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 221-238; DOI: https://doi.org/10.5731/pdajpst.2014.00974
Sâmia Rocha de Oliveira Melo
Faculty of Health Sciences, University of Brasilia, Brasília, Brazil
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  • For correspondence: samiamelo@gmail.com
Maurício Homem-de-Mello
Faculty of Health Sciences, University of Brasilia, Brasília, Brazil
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Dâmaris Silveira
Faculty of Health Sciences, University of Brasilia, Brasília, Brazil
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Luiz Alberto Simeoni
Faculty of Health Sciences, University of Brasilia, Brasília, Brazil
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Abstract

Degradation products are unwanted chemicals that can develop during the manufacturing, transportation, and storage of drug products and can affect the efficacy of pharmaceutical products. Moreover, even small amounts of degradation products can affect pharmaceutical safety because of the potential to cause adverse effects in patients. Consequently, it is crucial to focus on mechanistic understanding, formulation, storage conditions, and packaging to prevent the formation of degradation products that can negatively affect the quality and safety of the drug product. In this sense, databases and software that help predict the reactions involving the pharmaceutically active substance in the presence of degradation conditions can be used to obtain information on major degradation routes and the main degradation products formed during pharmaceutical product storage. In some cases, when the presence of a genotoxic degradation product is verified, it is necessary to conduct more thorough assessments. It is important to consider the chemical structure to distinguish between compounds with toxicologically alerting structures with associated toxic/genotoxic risks and compounds without active structures that can be treated as ordinary impurities. Evaluating the levels of degradation products based on a risk/benefit analysis is mandatory. Controlling critical variables during early development of drug products and conducting a follow-up study of these impurities can prevent degradation impurities present at concentrations greater than threshold values to ensure product quality. The definition of the impurity profile has become essential per various regulatory requirements. Therefore, this review includes the international regulatory perspective on impurity documents and the toxicological evaluation of degradation products. Additionally, some techniquesused in the investigation of degradation products and stability-indicating assay methods are highlighted.

LAY ABSTRACT: Degradation products are impurities resulting from chemical changes that occur during drug manufacturing. They can also form during storage and transportation in response to changes in light, temperature, pH, and humidity, or due to inherent characteristics of the active pharmaceutical substance, such as their reaction with excipients or on contact with the packaging. The presence of these chemicals can affect product safety and quality. Therefore, it is necessary to know and follow the guidelines and standards regarding degradation products and existing regulatory environments to assess the toxicity and risk related to their presence in pharmaceutical products.

  • Degradation products
  • Toxicity
  • Regulatory guides and standards
  • Safety
  • Quality
  • © PDA, Inc. 2014
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PDA Journal of Pharmaceutical Science and Technology: 68 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 3
May/June 2014
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Advice on Degradation Products in Pharmaceuticals: A Toxicological Evaluation
Sâmia Rocha de Oliveira Melo, Maurício Homem-de-Mello, Dâmaris Silveira, Luiz Alberto Simeoni
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 221-238; DOI: 10.5731/pdajpst.2014.00974

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Advice on Degradation Products in Pharmaceuticals: A Toxicological Evaluation
Sâmia Rocha de Oliveira Melo, Maurício Homem-de-Mello, Dâmaris Silveira, Luiz Alberto Simeoni
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 221-238; DOI: 10.5731/pdajpst.2014.00974
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