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논문 기본 정보

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학술저널
저자정보
진수언 (연세대학교) 박정우 (한국화학융합시험연구원) 백홍 (한국화학융합시험연구원) 전승호 ((주)폴리사이언텍) 박상욱 (한국화학융합시험연구원) 황성주 (연세대학교)
저널정보
한국약제학회 Journal of Pharmaceutical Investigation Journal of Pharmaceutical Investigation 제48권 제6호
발행연도
2018.11
수록면
665 - 672 (8page)
DOI
10.1007/s40005-017-0364-2

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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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