Effects of flow rate accuracy in two-day anticancer drug infusion with disposable pumps on plasma drug concentrations

Abstract

BACKGROUND:

Elastomeric pumps have a curved infusion rate profile over infusion time. Chemically driven pumps can overcome such limitations of elastomeric pumps and infuse constantly. However, studies on the pharmacokinetic benefit of chemically-driven pumps are insufficient.

OBJECTIVE:

This study aimed to determine effects of constant infusion with a chemically-driven pump on plasma drug concentrations compared to elastomeric pumps.

METHODS:

Infusion rate profiles of a chemically driven pump and two elastomeric pumps were measured in vitro tests under three height conditions of drug reservoir. Plasma drug concentrations were estimated using a pharmacokinetic model of 5-fluorouracil (5FU).

RESULTS:

The chemically-driven pump was more accurate than elastomeric pumps during the total infusion time (Root-mean-square-error (RMSE): 3% vs. 13%) which thus reduced its deviation of plasma 5FU concentration over time to one-fifth of that with an elastomeric pump. The chemically-driven pump had less than 5% of RMSE despite the influence of height difference.

CONCLUSION:

Although chemically-driven pumps maintained plasma 5FU concentration successfully and elastomeric pumps did not, both pumps were proper for 5FU infusion because the time-dependent changes in infusion rate did not affect the area under the curve. Chemically driven pumps would be more advantageous for drugs that are sensitive to their plasma concentrations.

Keywords

Infusion pumps disposable equipment 5-fluorouracil pharmacokinetics

1. Introduction

Nonelectric disposable pumps are widely used for chemotherapy, antibiotic regimen, and analgesia because they are relatively inexpensive and convenient [1, 2]. Unfortunately, disposable pumps do not have as much control over the rate of infusion rate as electronic pumps. Therefore, understanding the performance of a disposable pump in use is helpful for the safety and efficacy of treatment [3]. There have been experimental studies on various factors affecting flow rates of disposable pumps [4, 5, 6, 7]. In particular, many studies have focused on external factors such as vertical displacement and temperature. However, little research has been done on flow rate errors caused by intrinsic factors such as the pumpâ€™s driving force.

Disposable pumps have different characteristics depending on the driving force used [8]. An elastomeric pump is the most common type. Most elastomeric infusion pumps have a curved profile of time-infusion rate that rises at the initial and the end of the infusion. This is because it is hard to make an elastomeric reservoir providing constant elastic force regardless of how much it stretches [9]. To overcome such limitations of elastomeric pumps, a chemically-driven pump has been proposed. A chemically driven pump can pressurize a drug by a gaseous product from a chemical reaction. The gas pressure can be kept constant by a pressure-dependent relief valve [10]. Therefore, a chemically-driven pump can deliver drugs more accurately than an elastomeric pump. However, the effect of performance difference between a chemically-driven and an elastomeric pump on infusion therapies has not yet been studied.

We selected 5-fluorouracil (5FU) as the target drug of this study. 5FU is not only a commonly used anticancer drug for various cancers such as breast cancer, colorectal cancer, and colon cancer, but also has a well-validated nonlinear two-compartment model [11, 12]. In many cases, an intravenous infusion of 5FU continues for 46–48 hours. 5FU has side effects such as fatigue and nausea. Since it is infused over two days with a single charge, patients are sometimes outside the hospital during the treatment. Therefore, it could be dangerous when the infusion rate deviates from the target flow rate due to flow characteristics of the pump and/or environmental factors.

This study aims to evaluate effects of difference in flow rate accuracy between an elastomeric pump and a chemically-driven pump on plasma drug concentration by combining experimental data with a pharmacokinetic (PK) model. Among commercially available pumps, one product of a chemically-driven pump and two products of elastomeric pumps available for 5FU administration were tested. Although only one regimen for 5FU was simulated in this study, the method used in this study could be applied to other infusion regimens using a disposable pump. Clinicians could be selected an appropriate product depending on patients and drugs if the possible variation caused by a disposable pump was verified by PK simulation with the flow rate profile of the pump.

2. Materials and methods

2.1 Pumps and infusion fluid

Three products of disposable pumps with a labeled flow rate of 2 mL/h and a nominal filling volume of 96–100 mL were used (Fig. 1 and Table 1). Anapa (Anapa^® NB1020, E-WHA Meditech Inc., Republic of Korea) is a chemically-driven pump. Autofuser (Autofuser^® PASB3000-2, Ace Medical Co. Ltd., Republic of Korea) and Infusor (Infusor^® SV2, Baxter International Inc., US) are elastomeric pumps. All tests used 0.9% sodium chloride solution as the infusion fluid, although Baxter used 5% dextrose solution to calibrate Infusor SV2. The manufacturer of Infusor SV2 indicates that its flow rate will increase by about 10% more than the nominal flow rate in the case of infusing 0.9% NaCl solution.

Table 1
Characteristics of infusion pumps

Products	Anapa^® NB1020	Autofuser^® PASB3000-2	Infusor^® SV2
Type	Chemically-driven pump	Elastomeric pump	Elastomeric pump
Manufacturer	E-WHA Meditech	ACE Medical	Baxter Healthcare
Country	Republic of Korea	Republic of Korea	USA
Flow rate	2 ml/h	2 ml/h	2 ml/h
Accuracy	$\pm$ 10%	$\pm$ 10%	$\pm$ 12.5%
Nominal Volume	100 ml	100 ml	96 ml
Residual Volume	1.4 ml	$\sim$ 3% of Nominal Volume	1 ml
Recommended diluent	0.9% NaCl	0.9% NaCl	5% Dextrose
Temperature	23 ${{}^{\circ}}$ C	25 ${{}^{\circ}}$ C	33.3 ${{}^{\circ}}$ C

Figure 1.

Photographs of tested infusion pumps: (a) Anapa, (b) Autofuser, and (c) Infusor SV2.

2.2 In vitro test

The infusion rate was measured gravimetrically at 6-minute intervals until the weight no longer increased. The infusion was started after filling up to the nominal filling volume of each pump. An 18-gauge needle was connected to the end of the pump tubing instead of the catheter. During the experiment, the temperature of the flow restrictor was adjusted to the optimum temperature according to instructions for each pump using a circulating water bath. In addition to the same height condition, experiments were conducted with drug reservoir placed 50 cm higher or 50 cm lower than the flow restrictor (Fig. 2). For Anapa and Autofuser, three trials were performed under each height condition. However, Infusor SV2 was tested twice per height due to a lack of a pump. In the case of Autofuser, an additional test was conducted under the 0-cm height condition because one of its results looked different from flow rate profiles of others. In a preliminary test collecting data for five days without a disposable pump, the average evaporation rate was 0.005 ml/h, which was negligibly low compared to the target flow rate of the pump.

Figure 2.

Schematics of in vitro test setup.

Figure 3.

Nonlinear two-compartment model.

2.3 Data analysis

Start and finish of an infusion were considered when the measured flow rate was above 0 ml/min and below 0.01 mL/min, respectively. Data in which the average infusion rate for the total infusion time was out of 5% of the average within the group were excluded from analysis. Due to intra-variability of the end time, time-related infusion rates were averaged over infusing volume-based intervals. The average infusion rate was obtained at 10% intervals until the percentage of infusing volume over the nominal filling volume reached 90%. Interval of 90–100% was excluded from the analysis because the residual amount remaining on the line was ambiguous. Flow rate error was calculated as percent error of the average infusion rate relative to the labeled infusion rate. Flow rate accuracy was compared using standard deviation (SD) and root-mean-square-error (RMSE) value during the entire infusion time.

2.4 Pharmacokinetic simulation

A nonlinear two-compartment model was used (Fig. 3). Pharmacokinetic parameters were determined according to the study of Terret et al. [11] (Table 2 and Eq. (1)). In Eq. (1), META means hepatic metastasis score, where 0 indicates no metastasis, 1 indicates 25% or less of tumor replacement, 2 indicates 50% or less of tumor replacement, and 3 indicates 75% or less of tumor replacement. Additionally, a patient with dihydropyrimidine dehydrogenase (DPD) deficiency was simulated using the maximum elimination rate ( $V_{\max}$ ) that was 40% lower than no liver metastasis [13].

$\displaystyle V_{\max}=751\times\textit{BSA}\times({1+0.068\times\textit{META}})$ (1)

Table 2

Pharmacokinetic parameters

Parameter	Value
BSA, Body surface area (m²)	1.7
$V_{1}$ (L)	12.7
$k_{12}({h^{-1}})$	5.35
$k_{21}({h^{-1}})$	5.69
$K_{m}$ (mg/L)	5.57

An average infusion rate profile over time for each pump was obtained from experimental data and used as input for PK simulations. Due to intra-variability of the end time, average time-dependent infusion rate profiles were estimated with the method that averaged the infusion rate data based on infusion volume and then reconverted the volume-related average infusion rate into a time-related one. Unmeasured data necessary for this process were obtained through linear interpolation. For Infusor SV2, infusing volume-related infusion rate profile was divided by 2.2 ml/h and multiplied by 2.0 ml/h to correct the flow rate increase due to using saline. In all simulations, the drug concentration filled in each disposable pump was kept at a dose of 2400 mg/m² of body surface area (BSA). Since the therapeutic window of 5FU was determined by the area under curve (AUC) of the drug concentration in the blood [14], the AUC for the total infusion time was also calculated in the result of a virtual patient with neither liver metastasis nor DPD deficiency.

3. Results

3.1 Flow rate accuracy

Anapa was more consistent in flow rate during the total infusion period than Autofuser and Infusor SV2. Although the infusion rate of Anapa decreased with time, the standard deviation of Anapa was not as high as those of elastomeric pumps, resulting in a flat profile (Fig. 4 and Table 3). On the other hand, Autofuser had a U-shaped profile with infusion rates 12.3–25.3% higher than the labeled infusion rate at the beginning and end of the infusion. In Infusor SV2, the infusion rate started to increase from the middle of the infusion time and peaked with a flow rate error of 31% when 80–90% of the drug was infused.

Figure 4.

Infusion rate error profiles of Anapa, Autofuser, and Infusor SV2. Mean and standard deviation of each point are presented.

Table 3

Flow rate error

	Anapa^®	Autofuser^®	Infusor^®
$\Delta$ H $=$ 0 cm
RMSE (%)	2.81	13.3	13.7
Mean error rate (%)	$-$ 1.64	11.72	7.70
SD of error rate (%)	2.42	6.69	11.21
$\Delta$ H $=$ 0 cm, and $\pm$ 50 cm
RMSE (%)	4.74	15.83	13.52
Mean error rate (%)	$-$ 0.89	13.28	7.61
SD of error rate (%)	4.96	11.73	11.71

Anapa infused the entire drug with a smaller flow rate error than Autofuser and Infuser SV2. Autofuser and Infuser SV2 showed about 10% higher RMSE than Anapa (Table 3). Moreover, when the height of the drug reservoir affected the infusion rate of the pump, Anapa infused the drug at a more accurate rate than elastomeric pumps. Although the height manipulation had a similar effect on the flow rate change for the three pumps, the RMSE of Anapa was so small in the 0-cm height condition that the height-affected Anapa showed lower RMSE than elastomeric pumps (Table 3).

Figure 5.

Infusion profiles used as an input of pharmacokinetic simulations.

3.2 Pharmacokinetic effect

The average infusion rate profile used for the PK simulation is shown in Fig. 5. In the case of Autofuser, the drug infusion finished earlier than other pumps, maintaining an infusion rate higher than the nominal infusion rate over the entire infusion time. The total infused dose of Autofuser was smaller than that of Anapa with the same filling volume, which seemed to be due to the residual drug volume (Fig. 5). Although the infusion rate of Infusor SV2 was slower than that of Anapa in the first half of drug infusion, there was little difference in infusion amount (Fig. 5). This was because the infusing drug concentration of Infusor SV2 was set to be higher than that of Anapa due to their nominal filling volume differences.

For Anapa with infusion rate deviation over time of 2.4%, the standard deviation of plasma 5FU concentration during the entire infusion time was approximately 0.015 mg/L. For Autofuser and Infusor with infusion rate deviations over time of 6.7–11.2%, plasma 5FU concentration deviation was 0.056–0.067 mg/L. Plasma 5FU concentration depended on the drug infusion rate during the total infusion time (Fig. 5). A change of the maximum elimination rate ( $V_{\max}$ ) by hepatic metastasis score or DPD deficiency shifted the plasma 5FU concentration profile (Fig. 6). In the nonlinear model, the higher the plasma drug level, the faster the concentration decreased. Therefore, the plasma 5FU concentration due to the change in infusion rate was more deviated when the plasma drug level was higher (Fig. 6).

Figure 6.

Plasma 5FU concentration estimated from the pharmacokinetic model.

Figure 7.

Relation of total infusion amount and area under curve (AUC) loss in simulated results.

Compared to the AUC of an ideal infusion, Anapa and Infusor showed an error of about 2% and Autofuser had an error of 3.4%. Considering the therapeutic window of 5FU (AUC 20–30 mg $\cdot$ h/L), the effect of pump difference on AUC was insignificant. AUC was related to the total infusion amount, independent of time-variant plasma drug concentration (Fig. 7). It is reasonable that a disposable pump delivers less than the filling volume because of a residual volume.

4. Discussion

Flow rates during total infusion time were measured for chemically-driven pumps and elastomeric pumps. The chemically-driven pump was able to deliver the drug with a consistently low error rate (RMSE $=$ 2.8%, SD of error rate $=$ 2.4%) compared with elastomeric pumps, Autofuser (RMSE $=$ 13.3%, SD of error rate $=$ 6.7%) and Infusor (RMSE $=$ 13.1%, SD of error rate $=$ 11.2%). Moreover, the chemically-driven pump maintained a more accurate infusion rate over the entire infusion time even if the position of the drug reservoir was moved up or down by 50 cm, causing the flow rate to increase or decrease (RMSE $=$ 4.7%, SD of error rate $=$ 5.0%). The flow accuracy of the chemically-driven pump was as good as the allowable performance error of post-market electronic infusion pumps [15]. To investigate the pharmacokinetic effect of the improved flow rate accuracy of the chemically-driven pump, a PK model of 5FU was used to estimate the change in plasma 5FU concentration. This result was 5–6 times lower than the plasma 5FU concentration deviation when using elastomeric pumps. However, the infusion rate deviation over time did not affect the AUC of the plasma drug concentration profile. AUC was more related to the total drug infusion amount.

While most previous studies calculated the flow rate variability from the time-dependent flow rate samples [5, 6, 7, 16], this study obtained the flow rate consistency based on the flow rate data according to the infusing volume. The main reason for converting time-dependent data to infusion volume-based data was to avoid distortion of the flow rate profiles when averaging multiple trials, especially in the case of elastomeric pumps. By converting the infusion time into the volume, the flow rate profiles with different end times could be matched because the flow rate of elastomeric pumps was highly related to the fill volume. Nevertheless, the flow rate accuracy of Autofuser and Infusor SV2 were similar with the results of other elastomeric pumps [5, 16, 17].

The flow rate error caused by environmental factors such as the height of the drug reservoir or temperature has been studied as a drawback of disposable pumps. A chemically-driven pump also has this shortcoming. However, since the flow rate error of a chemically-driven pump was consistently low during the entire infusion time, the flow rate was within 10% of the set flow rate at all time points, even when height change caused flow rate error. On the other hand, elastomeric pumps had a curved infusion rate profile even in a well-controlled environment. It made the infusion rate deviate substantially from the set flow rate during the entire infusion time, even though the average flow rate was close to the set flow rate [18]. Therefore, characteristics of chemically-driven pumps could mitigate the risk of flow rate fluctuations due to external factors.

In addition to the flow variations, the absence of sensing rapid injection or stagnation caused by pump failure was the most concerning part of disposable pumps. Therefore, weighing or visual monitoring of the drug reservoir was often recommended for patients [19]. In the case of a chemically driven pump, since it uses a cylindrical chamber rather than a balloon, the scale mark for the remaining drug amount is straightforward and accurate. This could be another advantage of a chemically-driven pump. Recently, there was an attempt to make a passive flow regulator using MEMS technology [20]. The excessive flow can be shut off according to driving pressure, reducing the risk of over-injection caused by the failure of non-electric pumps.

5FU is a drug having an AUC-based therapeutic window. It means that short-term high plasma drug concentrations are not considered dangerous. In practice, the concentration of 5FU in the blood often exceeds 30 mg/L after a bolus injection [11]. Instead, exceeding AUC of 30 mg $\cdot$ h/L is not recommended because the risk of side effects is greater than the therapeutic effect. Regardless of whether pumps were chemically-driven or elastomeric pumps, the AUC value depended on the total amount of injected drug rather than the instantaneous flow rate. Therefore, clinical effects of chemically-driven pumps and elastomeric pumps in 5FU infusion were expected to be equivalent. However, a chemically-driven pump would be a better choice for infusing drugs such as aminoglycosides antibiotics, where plasma drug concentration is critical [21, 22].

Martina et al. [23] have experimentally measured undesirable flow rate error that could occur at low infusion rates using syringe pumps and used it as an input value for a PK model to study how it affects epinephrine plasma concentration. However, to the best of our knowledge, no studies have investigated the effect of disposable pump flow performance on plasma drug concentration. Using the method presented in this study, it will be possible to review the safety and effectiveness of various disposable pumps for delivering a specific drug. It would increase the use of disposable pumps for infusion regimes where electronic pumps are usually used.

This study has several limitations. First, the number of in vitro experiments was small. However, it was enough to obtain the flow profile of each pump. Although the number of trials with Infusor was fewer than that for other pumps, experimental results did not differ from the flow profile provided by the manufacturer. Second, 5% dextrose was not used as the infusor’s diluent. However, as suggested by the manufacturer, the test result showed that the flow rate increased by 10%, indicating that it should not cause a problem. Lastly, this study did not address various drugs. Future studies should analyze low-volume disposable pump products used for antibiotic injection.

Improvements in the quality of life of cancer patients receiving home chemotherapy with disposable pumps have been reported [2, 24]. In the future, the spectrum enlargement of available disposable pumps, the development of microfluidic safety valves, and the validation of the infusion device through PK modeling would help to expand the use of disposable pumps for various infusion treatments and thus improve patients’ quality of life.

5. Conclusions

A chemically-driven pump can reduce the risk when flow rates change due to environmental influences for maintaining an accurate infusion rate for the entire infusion time. Chemically driven pumps and elastomeric pumps have similar clinical effects when it comes to infusing drugs that are not sensitive to plasma drug concentrations, such as 5FU. It may be advantageous to use a chemically-driven pump for some antibiotics where plasma drug concentration is critical since plasma drug concentration depends on changes of infusion rate. The method to check the safety through PK analysis combined with experimental data can help expand the use of disposable pumps in drug infusion regimes.

Footnotes

Acknowledgments

The authors would like to thank E-WHA Meditech Inc. for kind provisions of their pump products and experimental equipment.

Conflict of interest

The authors declare that they have no conflict of interest.

Funding

This work was supported by Korea Medical Device Development Fund grants funded by the Korean government (the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health & Welfare, the Ministry of Food and Drug Safety) (Project numbers: HW20C2066, RS-2022-00141157).

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Effects of flow rate accuracy in two-day anticancer drug infusion with disposable pumps on plasma drug concentrations

Abstract

BACKGROUND:

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSION:

Keywords

1. Introduction

2. Materials and methods

2.1 Pumps and infusion fluid

Table 1 Characteristics of infusion pumps

2.4 Pharmacokinetic simulation

3.1 Flow rate accuracy

5. Conclusions

Footnotes

Acknowledgments

Conflict of interest

Funding

References

Table 1
Characteristics of infusion pumps