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Drug compatibility with a new generation of visiv polyolefin infustion solution containers
Drug Compatibility with a New Generation of VISIV
Polyolefin Infusion Solution Containers
Vasileios Aloumanis, MSFS
Michel Ben, MS
A new generation of VISIV polyolefin intravenous solution containers,
Thomas C. Kupiec, PhD
made of a new and different proprietary polymer, were evaluated for sorp-
tion and leaching potential with a cadre of drugs known to exhibit those
phenomena with polyvinylchloride containers. Sorption potential was
evaluated for amiodarone hydrochloride, carmustine, regular human in-
Lawrence A. Trissel, BS, RPh,
sulin, lorazepam, nitroglycerin, sufentanil citrate, and thiopental sodium.
Leaching potential was evaluated for tacrolimus and teniposide as well as
the vehicles of docetaxel and paclitaxel. Representative concentrations of
the drugs in infusion solutions or undiluted were placed into the new gen-
eration of VISIV containers and left in contact for up to 24 hours at room
temperature. High performance liquid chromatography was used to deter-
mine drug concentrations and the presence of plasticizer or other plastic
components, if any. Only regular human insulin exhibited any substantial
from Hospira, Inc., Lake Forest, Illinois.
loss of concentration in the polyolefin containers that could be attributed
to sorption. Other drugs’ concentrations were consistent with their stabili-
ties over the test periods. No evidence of leaching of plasticizer or other
plastic components was observed.
adsorption onto surfaces or absorption into
polymer matrices, or leaching of plasticizer
from plastic containers and tubing has been
drug-free vehicles representing docetaxel,
drugs making them incompatible with these
paclitaxel, tacrolimus, and teniposide drug-
plastic containers and administration sets.1
free vehicles were evaluated for leaching of
A new generation of VISIV (Hospira, Inc.,
(Lot 54-063-JT; Hospira, Inc.) injections
plastic components (Table 1). Acetonitrile,
Lake Forest, Illinois) polyolefin infusion
mercially. For the sorption portion of the
nents were suitable for high-performance
released using a new and improved propri-
etary polymer from the original version.
Although a previous study2 documented the
compatibility of the earlier VISIV contain-
ers, the compatibility of drugs that have
regular human insulin (Lot SZF0177; Novo
polyolefin plastic containers made of the
to sorption or to leaching must also be de-
Nordisk, Princeton, New Jersey), lorazepam
new proprietary polymer for evaluation in
termined for the new generation of VISIV
(Lot 3922000; Hospira, Inc.), nitroglycerin
this study were provided by Hospira, Inc.
containers manufactured from this new and
(Lot 5116; American Regent Laboratories,
Inc.), sufentanil citrate (Lot 101276; Akorn,
Sample Preparation and Handling
The objective of this study was to deter-
Inc., Buffalo Grove, Illinois), and thio-
Sample solutions of each test admixture
described in Tables 2 and 3 were prepared
polyolefin infusion solution containers that
Inc.) were obtained commercially. For the
and were transferred into three of the new
were made from the new and different pro-
leaching portion of the study, diethylhexyl
prietary polymer with seven drugs that have
new polymer through the access port along
with a control solution in a glass container.
(PVC) containers and sets and an additional
four drugs that have exhibited leaching of
plasticizer or other polymer matrix compo-
leaching plasticizer is associated with the
exposed to fluorescent light while laying flat
surfactants present in formulations (rather
on laboratory counters to assure maximum
162 International Journal of Pharmaceutical Compounding
surface contact of the liquid contents. Samples for analysis were
Table 1. Components for Drug-Free Vehicle evaluated for
taken from the access port using a needle and syringe initially and
Diethylhexyl Phthalate Leaching.
after storage for 24 hours for all drugs except for carmustine. Due
to its limited stability, the carmustine storage was evaluated for only
Each test solution was evaluated using HPLC. The Hewlett-
N,N-Dimethylacetamide Spectrum Chemicala ND0084
Packard Series 1100 (Agilent Technologies, Palo Alto, California)
consisting of a multisolvent delivery pump, autosampler, and
photodiode array detector was used for analysis of the drugs. The
system was controlled and integrated by a personal computer with
Table 2. Drug Solutions evaluated for Sorption.
chromatography management software (HPLC ChemStation
Version A.09.03; Agilent Technologies). The specific parameters of
each of the analytical methods for the drugs evaluated in the sorp-
tion portion of the study are cited in Table 4. These methods were
demonstrated to be stability indicating by accelerated degradation
of the drug exposed to heat, 0.1 N hydrochloric acid, 0.1 N sodium
hydroxide, and 3% hydrogen peroxide to intentionally degrade the
subject drugs. The decomposition product peaks for each of the
aAll drug solutions were prepared in 5% dextrose injection and evaluated over 24
drugs did not interfere with the peaks of the respective intact drugs.
hours contact time in the new VISIV polyolefin bags, except where noted otherwise.
The initial concentrations of the drugs were defined as 100%,
Evaluated for only 6 hours due to inherent drug instability.
cPrepared in 0.9% sodium chloride injection.
and subsequent sample concentrations were expressed as percent-
age of the initial concentration. Compatibility was defined as not
less than 90% of the initial drug concentration remaining in the
Table 3. Drug Solutions evaluated for Leaching of
The analyses for leached plastic components were performed
Docetaxel vehicle equivalent to 0.74 mg/mL
using an HPLC analytical method based on that of Waugh et al,3
Paclitaxel vehicle equivalent to 1.2 mg/mL
with minor modifications to assure DEHP separation from the
Tacrolimus vehicle equivalent to 0.02 mg/mL
peaks of the drug product components. The liquid chromatograph
Teniposide vehicle equivalent to 0.1 mg/mL
Table 4. High-Performance Liquid Chromatographic Analytical Methods for Analysis of Drug Concentrations.
a30% mobile phase B 0 minutes to 3 minutes, 90% mobile phase B 6 minutes to 9 minutes, 30% mobile phase B 9.1 minutes
bMetacresol preservative eluted at 9.7 minutes.
dBenzyl alcohol eluted at 3.3 minutes.
International Journal of Pharmaceutical Compounding
Table 4. (Continued)
Table 5. Drug Content Remaining in Test Solutions after
0.9999. The limits of quantitation and detection were 5.32 and 1.56
24-hour Contact Periods with the New VISIV Polyolefin
ng, respectively. The relative standard deviation from nine injec-
tions of DEHP for each drug admixture was 0.2% or less. Absence
of detectable plastic components such as DEHP plasticizer was
RESULTS AND DISCUSSION
Of the seven drugs tested that exhibited sorption to PVC, only
insulin demonstrated a substantial loss in the new VISIV polyolefin
containers (Table 5). About 45% of the insulin was lost after 24
hours. A control solution in a glass container exhibited a similar loss
Carmustine exhibited about 10% loss in 6 hours, which is
consistent with previous reports of the drug’s chemical instability,4-6
indicating that the new VISIV polyolefin container does not accel-
erate carmustine decomposition or result in sorption. In addition,
was also a Hewlett-Packard Series 1100 (Agilent Technologies). A
a control solution in a glass container exhibited a similar loss of
Phenomenex Luna C18 reverse-phase analytical column (Phenom-
enex, Torrance California) was used, along with a guard column of
Thiopental sodium concentration in the test samples declined
the same material. The mobile phase consisted of methanol, water,
about 5% in 24 hours, which is nearly identical to the loss that
and glacial acetic acid (1800:198:2). The flow rate was 1.4 mL/min
occurred in the thiopental sodium control solution in a glass bottle
and the run time was 20 minutes. Sample injection volume was 10
in the same time period. This result again indicates that the new
microliters for each of the drugs. Detection was performed at 225
VISIV container does not accelerate thiopental sodium decomposi-
nm. The retention time for DEHP under these analytical condi-
tions was about 7.5 minutes. The surfactant peaks did not interfere
In this study of the new VISIV polyolefin containers, none of
with the DEHP peak. The standard curve was over the range of
the surfactant-containing vehicles for drugs that are known to
6.2 to 310 mcg/mL. The correlation coefficient was greater than
leach plastic components, such as DEHP plasticizer from PVC
164 International Journal of Pharmaceutical Compounding
equipment,1,3,7,8 exhibited any leached components in the new poly-
10. Xu QA, Trissel LA. Compatibility of paclitaxel injection diluent
olefin containers. This is consistent with previous research involv-
with two reduced-phthalate administration sets for the Acclaim
ing similar non-PVC devices and equipment.2,8-11
1998; 2(5): 382–384.
In 1968, Weisenfeld et al12 reported substantial loss of insulin
11. Faouzi MA, Dine T, Luyckx M et al. Leaching of diethylhexyl
to infusion solution containers and administration sets. At least 35
phthalate from PVC bags into intravenous teniposide solution.
additional published articles and research studies1 have also ad-
Int J Pharm
1994; 105: 89–93.
dressed this sorptive loss of insulin. The previous studies that have
12. Weisenfeld S, Podolsky S, Goldsmith L et al. Adsorption of
reported insulin adsorption to surfaces have reported losses as high
insulin to infusion bottles and tubing. Diabetes
as 80%, but losses are more commonly cited as around 30% to 40%
in a variety of glass and plastic container types.1 The current result
indicates that insulin sorptive loss also occurs to the new VISIV
Address correspondence to Lawrence A. Trissel, BS, RPh, FASHP, c/o
polyolefin containers to an extent that is consistent with previous
TriPharma Research, P.O. Box 265, Cashiers, NC 28717-0265.
studies of a variety of container types as well as the former VISIV
For drugs that are formulated using surfactants, the surfactants
have been found to leach the plasticizer DEHP from PVC contain-
ers and administration sets.3,4,7,8 The problem of plastic compo-
nent leaching has extended to other types of plastic bags as well.9
However, no plasticizer leaching was found using the new VISIV
Of the drugs tested, only insulin exhibited sorption to the new
VISIV polyolefin containers. No leaching of plastic components
such as plasticizer from the container was found with the vehicles of
1. Trissel LA. Handbook on Injectable Drugs
. 14th ed. Bethesda, MD:
American Society of Health-System Pharmacists; 2006: 113,
263, 942, 1024, 1218–1221, 1514, 1542.
2. Trissel LA, Xu QA, Baker MB. Drug compatibility with new
polyolefin infusion solution containers. Am J Health Syst Pharm
3. Waugh WN, Trissel LA, Stella VJ. Stability, compatibility, and
plasticizer extraction of taxol (NSC-125973) injection diluted in
infusion solutions and stored in various containers. Am J Hosp
1991; 48(7): 1520–1524.
4. Benvenuto JA, Anderson RW, Kerkof K et al. Stability and com-
patibility of antitumor agents in glass and plastic containers. Am
J Hosp Pharm
1981; 38(12): 1914–1918.
5. Benvenuto JA, Adams SC, Vyas HM et al. Pharmaceutical issues
in infusion chemotherapy stability and compatibility. In: Lokich
JJ, ed. Cancer Chemotherapy by Infusion
. Chicago, Illinois; Precept
6. Favier M, de Cazanove F, Coste A et al. Stability of carmustine
in polyvinyl chloride bags and polyethylene-lined trilayer plastic
containers. Am J Health Syst Pharm
2001; 58(3): 238–241.
7. Pearson SD, Trissel LA. Leaching of diethylhexyl phthalate
from polyvinyl chloride containers by selected drugs and formu-
lation components. Am J Hosp Pharm
1993; 50(7): 1405–1409.
8. Trissel LA, Xu Q, Kwan J et al. Compatibility of paclitaxel
injection vehicle with intravenous administration and extension
sets. Am J Hosp Pharm
1994; 51(22): 2804–2810.
9. Xu QA, Trissel LA, Davis MR. Compatibility of paclitaxel in
5% glucose and 0.9% sodium chloride injections in EVA mini-
bags. Aust J Hosp Pharm
1998; 28: 156–159.
International Journal of Pharmaceutical Compounding
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Community-driven research onHelicobacter pylori infection in theCanadian Arctic: the Old CrowH. pylori ProjectLaura Aplin1*, Janis Geary2, Sander Veldhuyzen van Zanten1,Brendan Hanley3, Diane Kirchgatter3, Karen J. Goodman1,2,The Old Crow H. pylori Project Planning Committee andThe CANHelp Working Group1Department of Medicine, University of Alberta, Edmonton, Canada; 2Department of Public Heal