Degradation-Driven Implications for the Pharmacology and Risk Profile ofFexofenadine

Introduction/Objective: Introduction/Objective: Understanding a drug’s degradation profile is essential for ensuring its stability, efficacy, and safety. This minireview summarizes the pharmacological characteristics of fexofenadine and predicts its degradation pathways, with an emphasis on quality assessment and regulatory implications. Methods: To build on the outlined objectives, a systematic search was conducted in PubMed and Scopus using keywords related to fexofenadine’s pharmacology, chemical structure, and degradation mechanisms. Of 368 records identified, 52 studies met the inclusion criteria and were critically analyzed. Results: Following this analysis, it was found that fexofenadine is susceptible to photolysis, hydrolysis, and N-nitrosation processes. Discussion: Fexofenadine’s vulnerabilities, which are corroborated by forced degradation studies, may compromise its stability and lead to nitrosamine formation. Notably, the drug is primarily excreted unchanged, indicating minimal metabolic transformation. Predicted metabolic routes include aromatic hydroxylation, Ndealkylation, and piperidine ring opening; however, its high polarity favors renal elimination. Phase II conjugation, particularly glucuronidation, may further contribute to its clearance and the absence of detectable metabolites. In addition, nanoformulations have been shown to enhance fexofenadine’s stability, bioavailability, and therapeutic performance Conclusion: Further investigation into fexofenadine’s stability is critical for optimizing formulation strategies, guiding quality control, and mitigating degradation-related risks. Theoretical and experimental insights can strengthen regulatory compliance and ensure sustained drug safety.