Abstract
We report the sorption evaluation method for injectable drugs administered using set tubes to evaluate the quality of the administration sets. The evaluation method using a peristaltic pump, so called pump method, was used for the kinetic sorption study. Nitroglycerin (NTG) and cyclosporin A (CSA) were selected as model drugs. The parameters of drug-diluted concentrations and flow rates were adapted to the clinically relevant values. Polyvinylchloride (PVC)- and non-PVC (PU and PO)-based tubes were cut to a fixed length of 1 m after removing the accessories in the administration sets. NTG and CSA were analyzed using high-performance liquid chromatography (HPLC) methods with ultraviolet (UV) detection. After the drug analyses, NTG and CSA sorption levels were calculated from the percentage values of the subtracted drug concentrations in samples from those in the diluted solutions. The average sorption levels and each sorption level at each sampling point were considered to compare the sorption levels in all administration set tubes. Both drugs showed high sorption levels in PVC- and PU-based administration set tubes. However, the drugs showed a minimum sorption potential of < 10% on PO-based tubes, which could be clinically acceptable. This suggests that the sorption evaluation methods for NTG and CSA could be promising standards for endorsing administration set tubes and for evaluating newly developed or designed polymeric alternatives. Additionally, PO could be an alternative and next-generation polymeric material for manufacturing administration set tubes.
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This work was supported by the Korea Ministry of Environment through “The Advancement of Scientific Research and Technological Development in Environmental Science Program” (E315-00015-0414-2).
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SEJ designed the study and wrote the paper, JWP performed the experiments and analyzed the data, HB and SWP designed the study and provided comments, SJ designed the study and provided the administration sets, and SJH designed the study as a principal investigator and confirmed the written paper.
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Jin, SE., Park, J.W., Baek, H. et al. Evaluation of nitroglycerin and cyclosporin A sorption to polyvinylchloride- and non-polyvinylchloride-based tubes in administration sets. J. Pharm. Investig. 48, 665–672 (2018). https://doi.org/10.1007/s40005-017-0364-2
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DOI: https://doi.org/10.1007/s40005-017-0364-2