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Study of loss of the active principle capecitabine and cytotoxic activity in preparation intended for administration in liquid form

Eliezer C. Coelho Junior,Renata D. Daltoé,Klesia P. Madeira, Heberth Paula, Juliana A. Severi

crossref(2024)

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摘要
Abstract Purpose Despite the advantages for oral administration, some patients may encounter difficulty swallowing the Capecitabine (CAP) tablet, leading to its administration in the form of a solution prepared from crushed and dissolved tablets in water, thus constituting an off-label use. It was analyzed whether, from the dissolution of the tablet in water, there is a loss of the active ingredient and, consequently, a decrease in its cytotoxic effect. Methods The quantification of the active ingredient was carried out using Ultra Fast Liquid Chromatography, and the assessment of the cytotoxic effect of the solution was conducted using the MTT assay in breast cancer cell lines MCF-7 and MDA-MB-231. Additionally, the activity of the Thymidine phosphorylase enzyme was determined in the same cell lines by measuring the consumption of the substrate thymidine using the supernatant of the cell lysates through spectrophotometry. Results There was no significant change in the concentration of the active ingredient CAP in the solution prepared for up to 6 hours. A significant cytotoxic effect was observed after treatment in the cell lines, suggesting preserved cytotoxicity for at least 120 minutes after preparation. The activity of the Thymidine phosphorylase enzyme in the MDA-MB-231 cell line is 26.6% higher compared to the MCF-7 cell line. Conclusion It is suggested the safe use of the off-label form of CAP, adding greater treatment possibilities for patients with MBC. It is also suggested that the metabolic pathway for converting CAP to 5-FU may not be solely dependent on hepatic enzymes.
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