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.
