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At least 163 records · Page 9Linked to original sources

Leaching of diethylhexyl phthalate from polyvinyl chloride bags into intravenous etoposide solution.

OBJECTIVE: To compare the release of diethylhexyl phthalate (DEHP) from polyvinyl chloride (PVC) bags from four different manufacturers into intravenous etoposide solutions. METHOD: Etoposide solutions, 0.4 mg/mL, containing the vehicle polysorbate 80 were prepared in 5% dextrose or 0.9% sodium chloride injection PVC bags and stored at room temperature for 24 h. DEHP content was analysed by high-performance liquid chromatography. RESULTS: Substantial amounts of DEHP (up to 20 microg/mL at room temperature) leached into the etoposide solutions. However, no significant differences were found in the amounts of DEHP leached into the etoposide infusion solutions prepared using either 5% dextrose or 0.9% sodium chloride injection and stored in the four different containers. CONCLUSION: To minimize patient exposure o DEHP, etoposide solutions should ideally be stored in a glass or polyolefin container.

Antineoplastic Agents, Phytogenic↗

Storage of lorazepam in three injectable solutions in polyvinyl chloride and polyolefin bags.

The stability of lorazepam 0.1 mg/mL in three intravenous infusion solutions in polyvinyl chloride (PVC) and polyolefin bags at 37, 24, 4, and -20 degrees C was evaluated over seven days of storage. Triplicate test solutions of lorazepam 0.1 mg/mL in 50-mL PVC bags and 50-mL polyolefin bags containing 0.9% sodium chloride injection, 5% dextrose injection, and lactated Ringer's injection were prepared and stored at 37, 24, and 4 degrees C. Samples were removed initially and at various times over seven days and analyzed for lorazepam content. In addition, lorazepam 0.1 mg/mL in 5% dextrose injection in polyolefin bags was stored at -20 degrees C and samples were removed initially and after seven days and analyzed for lorazepam content. The rate of lorazepam sorptive loss to PVC bags was evaluated with lorazepam 0.1 mg/mL in 5% dextrose injection in PVC bags and stored at 24 degrees C. Samples were removed initially and after two, four, six, and eight hours. High-performance liquid chromatography was performed in duplicate on each sample for lorazepam quantitation. Rapid loss of lorazepam occurred in all samples stored in PVC bags. After seven days at 4 degrees C, 8-9% was lost from 0.9% sodium chloride injection and 5% dextrose injection. At 24 degrees C, 17% was lost in 24 hours; at 37 degrees C, 27-29% was lost in 24 hours. About 10% of the lorazepam was lost from the lactated Ringer's solution in PVC bags after three days at 4 degrees C; 25% was lost in 24 hours at 24 degrees C; and 25% was lost in eight hours at 37 degrees C.(ABSTRACT TRUNCATED AT 250 WORDS)

Child↗

The mechanism of particulate contamination in soft polyvinyl chloride infusion fluid bags.

In the seventies, it was shown that particles were generated in soft polyvinyl chloride (PVC) infusion fluid bags when they were shaken. In this investigation an exponentially modified log-normal distribution (EMLN) is fitted to the particle data. Using the formula for the volume of a sphere, the number-density distribution is converted into a volume-density distribution. The total particle load in the samples is estimated by integration for total particle volume. The results are expressed as volume concentration in plain SI-units (microliters/l). A four-factor analysis of variance demonstrates that the mechanism of the contamination process is most probably an emulsification of low molecular weight additives in the PVC plastic, i.e. di(2-ethylhexyl) phthalate (DEHP), epoxidized vegetable oils (EVO), and others.

Drug Contamination↗

[Pilot study on the biochemical treatment of mother liquid of polyvinyl chloride produced by suspension polymerization].

In the pilot study on the treatment of mother liquid of polyvinyl chloride produced by suspension polymerization (SPVC) by using a novel aerobic treatment system-4 cascade aerobic biofilm reactors with internal circulation, the removal efficiencies of the COD and turbidity at different HRT together with the resistance impact of the system were researched. The laws of the biological growth and the development were observed. Some primary factors (suspended solids, chironomidae larvae, nutrition) influencing the steady operation of the reactor were studied and their controlling methods were suggested. The experiment results show that the start-up period was very short and the total COD removal rate was over 75% at HRT of 14 h, the effluent less than 50 mg/L can steadily meet the requirement of wastewater discharge standard and also be reused after advanced treatment.

Animals↗

Investigation of the release behavior of diethylhexyl phthalate from polyvinyl chloride tubing for intravenous administration based on HCO60.

The release behavior of diethylhexyl phthalate (DEHP) from polyvinyl chloride (PVC) tubing, which composes materials in an intravenous administration set (IAS), was investigated using polyoxyethylated hydrogenated castor oil (HCO60) in physiological saline (PS), distilled water for injection (DWI), and ribose, fructose, and glucose (TZ) solutions. The amount of DEHP released increased with increasing HCO60 concentration, and the cumulative amount of DEHP released after 4h increased in the following order: 50% TZ<DWI=PS. At HCO60 levels above and below critical micelle concentration, no significant increase in the amount of DEHP released was observed; the release of DEHP appeared due to molecular interactions between DEHP and HCO60 molecules rather than the solubilization of DEHP into micelles. The release behavior of DEHP was affected by the addition of sugars. The amount of DEHP released decreased with an increase in the mean numbers of equatorial OH groups n(e-OH) per molecule in the following order: glucose [n(e-OH);4.6]<fructose(3.0)<ribose(2.1). Molecular mobility of HCO60 was assumed to be restricted by interaction with the sugar molecule and/or the extent of microscopic viscosity. Interaction of HCO60 with the sugar, the difference in the mode, and/or the extent of molecular interaction between sugar and HCO60 appeared to induce the difference in release behavior, while the increase in the number of water molecules needed to hydrate sugar molecules seemed to decrease the amount of free water, thus allowing microscopic viscosity to increase and to restrict the mobility of HCO60. These results suggest that the release of DEHP from PVC tubing is closely associated with the interaction of DEHP with HCO60, and related to the molecular mobility of HCO60 in solution.

Castor Oil↗

[The amount of the loss of cyclosporine A dose correlated with the amount of leaching di (2-ethylhexyl) phthalate from polyvinyl chloride infusion tube].

An interaction between cyclosporine A (CyA) injection and infusion tubes were examined. We used polyvinyl chloride (PVC) and polybutadiene (PB) tubes. CyA injection (Sandimmun) was diluted (0.495 mg CyA/ml) with saline and dripped through infusion tubes. The amounts of unsolved substances, loss of CyA dose and leached di (2-ethylhexyl) phthalate (DEHP) during the drip study were compared. CyA was not lost into the PB tube and no DEHP was leached. Therefore, using PVC tube, 11.9 mg of CyA were lost with in 24 h after the beginning of the administration, and the concentration of leached DEHP amounted to 93.6 micrograms/ml at 12 h. We also investigated the effects of the component of the einfusion solution on the loss of CyA into PVC tube using saline, electrolyte maintenance solution, 5% glucose and 10% maltose. Sugar-containing solutions were found to have less effects than other solutions on the loss of CyA dose and DEHP leaching. The leaching of DEHP may be a major factor for the generation of unsolved substances and the loss of CyA dose. In the clinical use of CyA injection, PB tube is the best selection and the sugar-containing solution is a second selection when PB infusion tubes are hard to obtain.

Adsorption↗

Stability of meropenem in polyvinyl chloride bags and an elastomeric infusion device.

PURPOSE: The stability of meropenem in i.v. solutions stored in polyvinyl chloride (PVC) bags and an elastomeric infusion device at concentrations commonly used in home care was studied. METHODS: Vials of meropenem were reconstituted with sterile water for injection and mixed with 0.9% sodium chloride injection (NS) to yield concentrations of 4, 10, and 20 mg/mL. Six replicate solutions were prepared in PVC containers and six in the Homepump ECLIPSE elastomeric infusion device. All solutions were stored at an average temperature of 5 degrees C and sampled immediately after preparation and at intervals up to 120 hours (five days); the 4-mg/mL solution was also sampled at 144 and 168 hours (seven days). Samples were assayed for meropenem concentration by stability-indicating high-performance liquid chromatography. RESULTS: All solutions of meropenem retained over 90% of the initial drug concentration at five days. The 4-mg/mL solutions retained over 93% of the initial concentration at seven days. The rate of meropenem decay did not differ significantly between PVC and elastomeric infusion containers for the 4- and 20-mg/mL solutions; however, there was a difference for the 10-mg/mL solutions. CONCLUSION: Meropenem 4 mg/mL in NS was stable for at least seven days in PVC bags and elastomeric infusion containers when stored at 5 degrees C, and meropenem 10 and 20 mg/mL in NS was stable for at least five days in both containers at 5 degrees C.

Chromatography, High Pressure Liquid↗

Storage of platelets in a new plastic container. Polyvinyl chloride plasticized with butyryl-n-trihexyl citrate.

The effect of storage of platelets in a new polyvinyl chloride (PVC) plastic material with a butyryl-n-trihexyl citrate (BTHC) plasticizer (PL 2209) was evaluated. The PL 1240 container, i.e. PVC plastic with a different plasticizer, tri-(ethylhexyl)-tri-mellitate, was used as a reference. Measurements of pH, pO2, pCO2, glucose, lactate, adenosine triphosphate, total adenine nucleotide content, lactate dehydrogenase and platelet factor 4 (PF4) were made during 5 days of storage. Similar results were noted comparing PL 2209 and PL 1240. Differences in pO2 and pCO2 indicate greater gas permeability in PL 2209 than in PL 1240. Significantly higher PF4 levels were found in PL 2209, but the difference could not be attributed to the PL 2209 container itself. Paired autologous reinfusion studies (111Indium) of 6 normal donors gave mean recovery values after 5-day storage of 41.1 +/- 7.4% (PL 2209) and 45.5 +/- 7.7% (PL 1240), t1/2 66 +/- 13 and 75 +/- 5 h, survival time (linear model) 6.3 +/- 1.0 and 6.8 +/- 0.7 and survival time (multiple-hit model) 6.0 +/- 0.7 and 6.5 +/- 0.4 days, respectively. Only the difference in survival time (multiple-hit) was significantly higher in PL 1240. The corrected count increments at 12-24 h following transfusion were 13,300 +/- 10,800 (PL 2209) and 13,600 +/- 11,600 (PL 1240) with no statistically significant difference found. These results indicate PL 2209 as an equivalent alternative to PL 1240 for the 5-day storage of platelets.

Blood Component Transfusion↗

Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components.

The extent of leaching of diethylhexyl phthalate (DEHP) from polyvinyl chloride (PVC) bags by several organic solvents and surfactants used as formulation components and by 12 drug products containing these solvents and surfactants was studied. The organic solvents ethanol, polyethylene glycol, and propylene glycol, the surfactants polysorbate 80 and polyoxyethylated castor oil, and the 12 drugs were admixed separately in PVC bags of 5% dextrose injection. At the time of preparation and after 4, 8, and 24 hours at 24 degrees C, the concentration of DEHP in duplicate samples was determined in duplicate by high-performance liquid chromatography. Ethanol, polyethylene glycol, and propylene glycol at concentrations of 25% and the drugs containing these components did not leach DEHP within the study period. Polysorbate 80 1% to 25% leached detectable amounts of DEHP in as little as one hour at the high concentration and within four hours at the lower concentrations; at 24 hours, DEHP concentrations ranged from 36 micrograms/mL for 1% polysorbate 80 to 237 micrograms/mL for 25% polysorbate 80. Similar results were observed for polysorbate 80 plus ethanol and for polyoxyethylated castor oil plus ethanol. Drug products containing surfactants, including cyclosporine, miconazole, and teniposide, and the vehicles used in formulating taxol and taxotere, leached relatively large amounts of DEHP in 24 hours. Smaller amounts were leached by chlordiazepoxide hydrochloride and etoposide. DEHP was leached from PVC containers by a variety of surfactants and drug products containing these surfactants. Drugs that leach DEHP should be prepared in non-PVC containers and administered through non-PVC tubing.

Chemistry, Pharmaceutical↗

The covariation of chemical contamination, particulate matter and turbidity in soft polyvinyl chloride infusion fluid bags.

About 200 samples of normal saline, isotonic glucose and Ringer acetate infusions in soft polyvinyl chloride (PVC) bags obtained from three manufacturers have been analyzed by conductometric particle counting, turbidimetry and gas liquid chromatography (GLC). The particle counts were fitted to an exponentially modified log-normal model and integrated for total particle-volume. Di(2-ethylhexyl) phthalate (DEHP) and epoxidized vegetable oils (EVO), which are the main water insoluble contaminants in PVC fluid bags, were determined by GLC. There was a strong linear correlation between turbidity and GLC results. The correlation between particle-volume concentration and the DEHP and EVO concentrations was fairly good. The results seem to verify that an emulsion of plastic additives is formed when soft PVC infusion fluid bags are shaken.

Chromatography, Gas↗

[Determination method of tricresyl phosphate in polyvinyl chloride].

A simple and rapid method using HPLC was developed for the determination of tricresyl phosphate (TCP) in polyvinyl chloride (PVC) articles. A test sample was extracted with acetonitrile at 37 degrees C overnight. The extract solution diluted with an equivalent amount of water was applied to a Sep-Pak C18 cartridge, and TCP was eluted with acetonitrile-water (2:1) mixture. The eluate was analyzed by HPLC with an Inertsil Ph-3 column, using 65% acetonitrile/water as the mobile phase, with UV detection (264 nm). The calibration curve was rectilinear from 0.5 to 100 micrograms/mL. The recoveries of TCP added to various kinds of PVC articles at the level of 1,000 micrograms/g were 84.7-98.6%. The determination limit of TCP was 50 micrograms/g in samples. This method was applied to products including 3.1, 6.6 and 8.8% TCP and the recoveries of TCP were 87.3-91.4%. This method is very simple, and it seems suitable for a regulatory test.

Chromatography, High Pressure Liquid↗

Polyvinyl chloride matrix membrane electrodes for manual and flow injection analysis of chloroquine in pharmaceutical preparations.

Two types of polyvinyl chloride (PVC) matrix membrane electrodes responsive to the antimalarial drug chloroquine have been constructed, electrochemically evaluated, compared and used in pharmaceutical analysis. Type 1 is the classic PVC model with chloroquine-tetraphenylborate (TPB) sensor; Type 2 is a coated silver disk without internal filling solution. Both electrode types exhibited rapid linear potentiometric response to the logarithmic concentration of diprotonated chloroquine cation in the 10(-1) - 10(-6)M range with calibration slopes 28-30 mV/concentration decade over the pH range 1.8-6.2. These electrodes were sensitive enough to permit determination of chloroquine phosphate at concentrations as low as 5 microgram/mL with good accuracy and precision. Determination of chloroquine in various pharmaceutical preparations using direct potentiometry and potentiometric titration with NaTPB gave an average recovery of 98.8% of the nominal values (SD 0.5%). The Type 2 electrode was also assessed in a flow-through sandwich cell for flow injection analysis. Results were compared with data obtained by the U.S. Pharmacopeia method.

Chloroquine↗

Determination by gas-liquid chromatography of trace amounts of soft polyvinyl chloride plastic additives in aqueous solutions. I. Epoxidized vegetable oils.

A gas-liquid chromatographic method for the determination of epoxidized vegetable oils (EVO), such as epoxidized soybean oil and epoxidized linseed oil, in aqueous solutions is described. The EVOs are extracted with n-hexane and transesterified to the methyl esters by sodium methoxide in methanol. 3% OV-210 is used as the stationary phase. The weakest standard solution corresponds to 5 micrograms/l (5 ppb) of EVO in an aqueous sample. The reproducibility of a single analysis is 5%. The method is used for the determination of EVO in intravenous fluids stored in flexible polyvinyl chloride bags.

Chromatography, Gas↗

Pulmonary toxicity of polyvinyl chloride particles after repeated intratracheal instillations in rats. Elevated CD4/CD8 lymphocyte ratio in bronchoalveolar lavage.

Occupational exposure to polyvinyl chloride (PVC) particles has been associated with interstitial lung disease. Our previous study showed that a single intratracheal instillation of emulsion PVC particles, with or without residual additives, induces acute but transient alveolitis in a dose-dependent manner in rats. The aim of the present study was to investigate the pulmonary response after the administration of the same PVC particles (PVC-E3 and PVC-W3) given in the same cumulative doses (10 and 50 mg/kg BW), but fractionated as seven intratracheal instillations (7 x 1.4 and 7 x 7.1 mg/kg BW) in the course of 3 weeks (day 0 to day 21). Pulmonary response was characterized by analysis of lung weight, bronchoalveolar lavage (BAL) fluid for lactate dehydrogenase (LDH), total protein, and cell cytology, and a microscopic evaluation of lung tissue. BAL T lymphocyte phenotypes (CD3 + CD4 +, CD3 + CD8+) were analyzed by flow cytometry. On day 28, lung weights, BAL-LDH, cell numbers in BAL, and CD4/CD8 ratios in BAL T lymphocytes were higher in rats that had received the high dose of PVC-E3 or PVC-W3 than in rats that had received the low dose of PVC particles and control rats. On day 90, the pulmonary response had partially regressed towards control values, but there were still microscopically evident lesions in the lungs and greater CD4/CD8 ratio in the high dose groups. There were significant positive correlations between the CD4/CD8 ratio and a histopathology score of the lung (r = 0.36, P = 0.038 on day 28, and r = 0.46, P = 0.006 on day 90). In conclusion, repeated intratracheal instillations of PVC particles yielded similar results as single instillations. The examined PVC particles have the potential of inducing a limited and transient acute inflammatory reaction in the lung, and possibly a more persistent alteration of pulmonary T lymphocyte subsets towards a high CD4/CD8 ratio.

Animals↗

Squamous cell carcinoma of the buccal mucosa associated with chronic oral polyvinyl chloride exposure: report of a case.

The following case report describes a 22-year-old healthy man, non-smoker, non-drinker, who developed a squamous cell carcinoma of the buccal mucosa. The appearance of this unusual tumor in an unexpected clinical setting was unexplained until it was discovered that the patient had a lifetime habit of chewing plastic materials containing polyvinyl chloride (PVC). The extent and chronicity of his intense oral exposure to PVC is believed to be related to his subsequent development of an oral neoplasm. Attention is again focused on PVC as an important environmental toxin and carcinogenic agent. Clarification of the content of PVC in consumer products is urged. Physicians must remain aware of possible environmental carcinogens in patients presenting with unexpected or rare malignancies. Detection of such exposure may well prevent subsequent development of additional unexplained neoplasms.

Administration, Oral↗

[Loss of intravenous nitroglycerin administered with polyvinyl chloride infusion systems].

To evaluate the consequences of the interaction between intravenous nitroglycerin (NTG) and infusion systems made of polyvinyl chloride (PVC), 20 dilutions of NTG were prepared in glass bottles with an initial concentration of 200 micrograms/ml, which were infused through 20 infusion systems at a rate of 20 ml/hour during 12 hours. NTG concentrations collected at the terminal part of the infusion systems were evaluated after 5 minutes, 6 hours and 12 hours. The results showed a substantial loss of NTG through PVC systems. The loss was 20% after 5 minutes and up to 32% after 12 hours. These results, obtained with a preparation similar to that used in clinical practice, may be helpful to estimate the real dose of the infused drug.

Infusion Pumps↗

The 24-hour shelf-life of cytapheresis platelet concentrates stored in polyvinyl chloride containers should be extended only with caution.

A recent publication suggested that the 24-hour allowable shelf-life of apheresis platelet concentrates collected by open-system techniques be extended to 48 hours because platelets collected in this fashion usually remain sterile for that length of time. The current studies, however, show that the quality of platelet concentrates deteriorates rapidly after storage for more than 24 hours in the relatively small-volume, polyvinyl chloride containers of currently marketed, open-system software, as evidenced by the falling pH, the disintegration of platelets, and the inability of platelets to recover from hypotonic shock. Platelets were markedly defective within 48 hours. Thus, it seems unwise to extend the shelf-life of such platelet concentrates beyond 24 hours solely because they are likely to remain sterile. Collection techniques and software must also be modified to ensure satisfactory platelet quality before the period of storage should be extended.

Blood Component Removal↗