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KMID : 1142220160110010033
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 1 p.33 ~ p.41
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Consideration and Recommendation of Guideline for Evaluation of Drug Sorption to Administration Sets
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Jin Su-Eon
Jeon Seung-Ho
Park Jung-Woo
Baek Hong
Park Dang-Wook
Byon Hyo-Jin
Hwang Sung-Joo
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Abstract
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Administration sets are sterilized disposable medical devices without syringes that are used to deliver bulk intravenous injectable drug solutions to the human body. They consist of a spike, drip chamber, tubes, luer adapter (connector), and needle cover for protection. An airway check valve, regulating clamp, in-line filter, Y-tube with cap (injection port), and needle can also be attached to administration sets. The safety of administration sets is very important because of their clinical use in directly transferring intravenous injection solutions to the human body. Recently, sorption of drugs to administration sets has been reported due to the plasticizer in PVC-based administration sets. Thus, guidelines regarding drug sorption is considered to be necessary to ensure drug efficacy and safety. In this review, we analyzed cases of drug sorption to polyvinylchloride (PVC)- or non-PVC-based tubes in administration sets and recommended guideline for the evaluation of drug sorption to administration sets, specifically tubes in administration sets. In particular, we investigated drug sorption cases from scientific databases and list of the most commonly prescribed drugs of injections in clinic. Furthermore, the mechanism of drug sorption to administration sets and the physicochemical properties of sorptive drugs were confirmed.
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KEYWORD
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PVC, non-PVC, administration set, tube, drug sorption, guideline
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