Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump
March 11th, 2017
We report a method for drug sorption evaluation using a pump and model drugs (diazepam and tacrolimus). After drug analysis using high-performance liquid chromatography, drug concentrations and sorption levels in the tubes of administration sets are calculated.
The overall goal of this protocol is to evaluate the drug sorption of tubes in administration sets using an infusion pump. This method can help answer key questions in the quality evaluation field to help develop the tubes in administration sets suitable for injectable drug formulations. Though this method can provide insight into the sorption evaluation of drug to tubes in administration sets.
It can also be applied to other systems, like accessorized tubes of administration sets. Demonstrating the procedure will be Dr.Su-Eon Jin, a research professor from my laboratory. To begin this procedure, label the tube type on the end of each tube.
Then, remove all detachable accessories, such as connectors and needle coverings. Using a sharp razor, cut the tube to one meter in length from the connection of the drip chamber. Next, in labeled one liter glass bottles, dilute the drug injections with a five percent dextrose solution.
Gently swirl the bottles to mix each drug solution. Transfer the diluted solution to an amber vial. It is important to mix the drug solution gently to prevent the generation of bubbles in bottles.
First, confirm the tube depending flow rate using a pump, as outlined in the text protocol. Then, connect the end of one tube to a syringe. Immerse the other end in a bottled drug injection.
Pull back on the syringe plunger until the tube is completely filled with drug solution. Next, open the door of the infusion pump and push the release lever. Insert the preloaded tube into the infusion pump.
Removing the bubbles from tubes in administration sets is a required technique after loading the drug solution. After this, remove the syringe. Place a chemically-resistant borosilicate glass graduated cylinder over the end of the tube to collect the drug solution after it passes through.
Set the flow rate, as outlined in the text protocol. Using amber vials, collect sample at room temperature at various time points. To begin, prepare standard drug solutions, as outlined in the text protocol.
After this, inject ten microliters of each standard into an HPLC system with UV detection equipped with a C18 column. Confirm the specificity and linearity, and obtain calibration curves, as outlined in the text protocol. Next, dilute the drug samples as needed to fall within the calibration range.
Directly inject ten microliters of each diluted sample into the HPLC system. Then, calculate the drug concentration and sorption level, as outlined in the text protocol. In this study, drug absorption to PVC and non-PVC based tubes were evaluated using a pump and model drugs.
High performance liquid chromatography is then used to calculate drug concentrations and sorption levels in the tubes. A chromatogram of diazepam shows the drug peak at eight point two minutes, with interfering peaks that did not overlap. Sorption levels are then determined by calculating the percentage of remaining drug content after passage through the tubes.
Sorption is seen to be the highest in PVC-based tubes, and lowest in PO based tubes, during the initial phase of the kinetic sorption test. The tacrolimus chromatogram shows a drug peak at six point eight minutes, with no interfering peaks. The determined sorption levels shows a similar trend with sorption being highest in PVC based tubes and lowest for PO based tubes.
Once mastered, this technique can be done in one to four hours if it is performed properly. While attempting this procedure, it's important to remember to use glass-based containers, except on tubs of administration sets. After its development, this technique paved the way for researchers in the field of quality evaluation of administration sets, depending on the injectable drug formulations to explore physicochemical phenomena of drug sorption in tubes of administration sets during intravenous infusion.
After watching this video, you should have a good understanding of how to perform a sorption kinetic study using a pump, and how to evaluate a drug sorption levels in tubes of administration sets. When the drug loss due to sorption in PVC-based tubes is found, we recommend using non-PVC-based tubes, such as polyolefin-based ones to minimize unwanted sorption.
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Overview
This article presents a protocol for evaluating drug sorption to tubes in administration sets using an infusion pump and high-performance liquid chromatography (HPLC). The method is designed to assess the compatibility of different tubing materials, such as PVC and non-PVC polymers, with injectable drug formulations, focusing on safety and efficacy during intravenous drug delivery.
Key Study Components
Area of Science
- Pharmaceutical sciences
- Analytical chemistry
- Medical device evaluation
Background
- Administration sets are used for direct drug delivery into the body and consist of various components including tubes and connectors.
- Drug sorption to tubing can reduce drug efficacy and compromise patient safety.
- There are currently no standardized methods for evaluating drug sorption in administration sets.
- Material composition of tubes (e.g., PVC vs. non-PVC) can influence drug sorption rates.
Purpose of Study
- To establish a reproducible protocol for assessing drug sorption to administration set tubes.
- To compare sorption characteristics of PVC and non-PVC tubing materials.
- To provide recommendations for minimizing drug loss during intravenous infusion.
Methods Used
- Tubes of 1 meter length were prepared from PVC and non-PVC materials.
- Model drugs (diazepam and tacrolimus) were diluted in 5% dextrose solution and delivered through the tubes using an infusion pump.
- Samples were collected at various time points in amber vials to prevent light degradation.
- Drug concentrations were analyzed using HPLC with UV detection and C18 columns.
- Sorption levels were calculated based on the percentage of drug remaining after passage through the tubes.
Main Results
- PVC-based tubes exhibited the highest levels of drug sorption for both diazepam and tacrolimus.
- Polyolefin (PO)-based tubes showed the lowest drug sorption.
- Chromatograms confirmed clear drug peaks with minimal interference.
- The protocol can be completed in 1–4 hours and is adaptable to various administration set configurations.
Conclusions
- The described protocol enables reliable evaluation of drug sorption in administration set tubes.
- Non-PVC-based tubes, such as PO, are recommended to minimize drug loss due to sorption.
- This method supports quality assurance and safer clinical practice in intravenous drug administration.
Frequently Asked Questions
Executive Industry Relevance
Drug sorption to administration set tubing poses a significant risk to dose accuracy and therapeutic efficacy in intravenous drug delivery. This protocol enables biopharma R&D teams to quantitatively assess and compare sorption profiles of PVC and non-PVC tubing, supporting material selection and risk mitigation at the device-drug interface. Standardized evaluation of sorption informs both early formulation development and late-stage quality assurance, reducing variability and enhancing patient safety.
Strategic Applications in Biopharma R&D
Early Discovery & Target Validation
- Enables mechanistic de-risking by quantifying drug loss due to tubing-material interactions.
- Supports target validation by ensuring observed pharmacological effects are not confounded by device-related drug loss.
- Facilitates predictive confidence in preclinical dosing studies involving infusion delivery.
Screening & Assay Development
- Provides a standardized workflow for evaluating tubing compatibility with candidate compounds.
- Delivers reproducible, quantitative sorption data to inform assay design and downstream screening reliability.
- Enables selection of administration set materials that minimize compound loss during in vitro and in vivo studies.
Translational & Preclinical Research
- Aligns device selection with translational biomarker studies by controlling for drug delivery variability.
- Supports continuity from discovery through preclinical validation by standardizing infusion system performance.
- Reduces risk of false negatives in efficacy or toxicity studies due to unrecognized drug loss.
Pipeline & Workflow Integration
This protocol integrates into the discovery-to-preclinical continuum, informing both formulation development and device compatibility assessments for lead compounds delivered intravenously.
- Discovery Biology: Quantifies drug-tubing interactions to clarify true pharmacological exposure.
- Screening: Establishes assay readiness by validating tubing materials for minimal sorption.
- Analytics: Provides HPLC-based quantitative readouts for direct comparison of tubing performance.
- Translational Research: Ensures dosing fidelity in preclinical models by selecting low-sorption tubing.
- Enterprise Reuse: Offers a reproducible, adaptable protocol for ongoing device-drug compatibility testing across programs.
Operational & Enterprise Impact
- Scientific Value: Increases predictive confidence and reduces mechanistic ambiguity in drug delivery studies.
- Operational Value: Standardizes sorption evaluation, improving reproducibility and scalability across R&D teams.
- Strategic Value: Enables informed go/no-go decisions for device and formulation selection, reducing late-stage risk.
- Portfolio Impact: Supports risk-adjusted prioritization by identifying and mitigating device-related drug loss early.
Implementation Considerations
- Requires expertise in analytical chemistry and HPLC operation.
- Needs access to infusion pumps, validated HPLC systems, and controlled sample handling infrastructure.
- Demands cross-team standardization of tubing preparation and sample collection protocols.
- Adaptable to various tubing materials and drug formulations with appropriate validation.
- Dependent on accurate calibration and control of flow rates and sampling intervals.
Biopharma FAQs
Chapters in this video
0:05
Title
0:56
Preparation of Tubes and Drug Injections
1:41
Kinetic Sorption Study Using an Infusion Pump
2:45
Analysis of Drug Using High-performance Liquid Chromatography
3:32
Results: Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes
4:33
Conclusion
