Diazepam sorption to PVC- and non-PVC-based tubes in administration sets with quantitative determination using a high-performance liquid chromatographic method

Jin, Su Eon; You, Siwon; Jeon, Seung-Ho; Hwang, Sung Joo

doi:10.1016/j.ijpharm.2016.04.040

Cited by 18 publications

(23 citation statements)

References 23 publications

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“…Our results showed that the mean plasma concentration of nitroglycerin in the PO administration set group over time was higher than those in the PU or PVC administration set group. These findings are in agreement with those of prior studies, [ 9 , 12 – 14 ] suggesting that the tube material influences the nitroglycerin concentration due to drug sorption. This phenomenon can be explained by several theories.…”

Section: Discussionsupporting

confidence: 93%

A comparison of the pharmacokinetic and pharmacodynamic properties of nitroglycerin according to the composition of the administration set

Kim

Song²,

Min

et al. 2018

Medicine

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Background:There is a risk of drug sorption into an intravenous administration set composed of polyvinyl chloride (PVC), polyurethane (PU), or polyolefin (PO). This has implications on the dose of the active ingredient the patient receives, and thus therapeutic success. This study aimed to determine the plasma concentration of nitroglycerin and the effect of nitroglycerin on patients based on the composition of the administration set.Methods:Using a randomized, open-labeled, 3 × 3 crossover method, 9 volunteers were assigned to 3 groups. In period I, nitroglycerin (100 μg/mL) was infused via a PVC- (group A), PU- (group B), or PO-based (group C) administration set. In period II, PU- (group A), PO- (group B), and PVC-based (group C) administration sets were used, and in period III, PO- (group A), PVC- (group B), and PU-based (group C) administration sets were used. The rate of drug administration in all periods was 12 mL/hour for 30 minutes using an infusion pump. Blood samples were collected, and the plasma concentrations of nitroglycerin were analyzed using validated high-performance liquid chromatography coupled with tandem mass spectrometry. Blood pressure was determined using a sphygmomanometer applied to the other upper arm at an interval of 5 minutes.Results:We observed that the mean plasma concentration of nitroglycerin over time when administered using a PO-based tube was higher than that when using a PU- or PVC-based tube. When the percent change of the mean arterial pressure from baseline at each time point was compared among groups, there were statistically significant differences between PU and PO or PVC at most points during nitroglycerin infusion.Conclusion:Our results showed higher nitroglycerin plasma concentration and lower arterial pressure when a PO-based administration set was used than when a PVC- or PU-based administration set was used. PO-based administration sets may be more appropriate for nitroglycerin administration compared to those composed of PVC or PU.

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Section: Discussionsupporting

confidence: 93%

A comparison of the pharmacokinetic and pharmacodynamic properties of nitroglycerin according to the composition of the administration set

Kim

Song²,

Min

et al. 2018

Medicine

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“…Other accessories, such as an airway check valve, a regulating clamp, an in-line filter, a Y-tube with cap (an injection port), and a needle, can also be attached to administration sets. Drug sorption to tubes is a critical issue in the delivery of injectable drugs 1 . Sorption describes the adsorption of a drug to the polymer surface and the absorption of a drug into the polymeric matrix 2 .…”

Section: Introductionmentioning

confidence: 99%

“…The levels of drug sorption to tubes in administration sets have been reported using various evaluation methods 1,2,3,4,5 . Test methods and model drugs are key factors in sorption evaluation.…”

Section: Introductionmentioning

confidence: 99%

“…Test methods and model drugs are key factors in sorption evaluation. The pump method 1,3 and drip method 4,5 have been widely used for sorption tests. In general, the pump method should be used in the case of drugs with low concentrations and low flow rates as the infusion conditions.…”

Section: Introductionmentioning

confidence: 99%

“…In general, the pump method should be used in the case of drugs with low concentrations and low flow rates as the infusion conditions. Using various evaluation methods, many studies of drug sorption have been reported for polyvinyl chloride (PVC)-and non-PVC-based tubes in administration sets 1,2,3,5 . Many sorptive drugs can be selected to investigate whether the tubes of the administration sets have drug sorption potential or not.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump

Jin

You

Jeon³

et al. 2017

JoVE

Self Cite

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Administration sets are delivery tools for the direct application of drugs into the body and are composed of a spike, a drip chamber, tubes, Luer adapters (connectors), a needle cover for protection, and other accessories. Drug sorption to tubes of administration sets is a critical issue in terms of safety and efficacy. Although drug sorption is an important factor in the quality of an administration set, there are no standard evaluation methods for the regulation of drug sorption to the tubes. Here, we describe an evaluation protocol for drug sorption to tubes of administration sets. Tubes made of polyvinyl chloride (PVC)- and non-PVC-based polymeric materials were cut to 1 m in length. Diazepam and tacrolimus were used as model drugs. In the kinetic sorption study, we selected the drug concentration and flow rate based on the clinical usage of these drugs. After the dilution of each drug in a glass bottle, the diluted drug solution was delivered through tubes of administration sets using a pump. Samples were collected in amber vials at appropriate time points and the drugs were analyzed using high-performance liquid chromatography. Drug concentrations and sorption levels to tubes of the administration sets were calculated. Acceptable criteria to ensure the quality of administration sets are recommended.

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To what extent do the storage conditions of polyether‐based polyurethane have an impact on diazepam delivery?

Maiguy-Foinard

Masse

Degoutin

et al. 2020

J of Applied Polymer Sci

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Interactions between medical device material and the drug itself have been evoked for polyurethane and may lead to underdosing. Polyurethane, sterilization mode, and the crosslinking level of the polymer have an influence on sorption. The aim here is to evaluate the impact of polyurethane conservation time and conditions as well as sterilization mode. Two polyurethane extension tubes were tested, one sterilized by ethylene oxide and the second by gamma radiation. Forced degradation experiments were performed. After 3 and 6 months of incubation, thermal properties, diazepam delivery and cytotoxicity of leachates were assessed. Diazepam delivery differs significantly according to the version of polyurethane. Sterilization however has no impact on diazepam delivery. No cytotoxicity was observed whatever the infusion tube and the aging conditions. In conclusion, sterilization procedures do not induce polyurethane degradation, but high temperature/relative humidity/time storage conditions lead to a slight degradation in polyurethane.

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Diazepam sorption to PVC- and non-PVC-based tubes in administration sets with quantitative determination using a high-performance liquid chromatographic method

Cited by 18 publications

References 23 publications

A comparison of the pharmacokinetic and pharmacodynamic properties of nitroglycerin according to the composition of the administration set

A comparison of the pharmacokinetic and pharmacodynamic properties of nitroglycerin according to the composition of the administration set

Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump

To what extent do the storage conditions of polyether‐based polyurethane have an impact on diazepam delivery?

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