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Pharmaceutical Regulatory Affairs: Open Access

Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

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Biotransformation Open Access

Biotransformation can be defined as the use of biological systems to produce chemical changes on compounds that are not their natural substrates [1]. To defend the body against xenobiotics, a set of biotransformation reactions (or metabolic reactions) is suffered. Due to biotransformation, the molecular structure of a the drug is usually changed to be more hydrophilic and the substances can be easily eliminated from the body [2]. In general, biotransformation reactions are divided into two broad categories called “phase I reaction” and “phase II”. Phase I reactions are functionalization reactions which introduce polar chemical groups either by inserting new polar functional groups, or by interchanging or unmasking existing functional groups by oxidation, reduction and hydrolytic reactions. Phase I reactions are mediated by enzymes such as CYP, FMO, esterases and amidases. CYP enzymes are by far the most important enzymes responsible for the pharmacological activation of many drugs. In phase II reactions, small endogenous polar molecules (e.g. glucuronic acid and sulfate) conjugate with the functional groups formed during phase I reactions. Direct conjugation of endogenous molecules can also occur if the compound already has appropriate functional groups. These conjugate reactions are caused by enzymes such as glucuronosyltransferase, sulfotransferase and N-acetyltransferase. In a traditional approach to drug discovery based on a prodrug, biotransformation reactions

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