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Stability of intravenous famotidine stored in polyvinyl chloride syringes.

The stability of intravenous famotidine in dextrose 5% injection (D5W), NaCl 0.9% injection (NS), and sterile water for injection stored in polyvinyl chloride (PVC) syringes at 4 degrees C for 14 days was studied. The concentration of famotidine samples was determined at time 0, 7 days, and 14 days by reverse-phase high-performance liquid chromatography. Samples were inspected for visual changes and tested for changes in pH. Results of the HPLC analysis indicated that the famotidine samples remained within 94-100 percent and 99-103 percent of the time 0 concentrations at 7 and 14 days, respectively. Repeated measures analysis of variance demonstrated a significant time effect on famotidine concentration as concentrations changed over time (p less than 0.01). This change was small in magnitude, however, and concentrations decreased at 7 days and increased at 14 days. Famotidine is stable at a concentration of 2 mg/mL in D5W, NS, and sterile water for injection stored in PVC syringes at 4 degrees C for 14 days.

Chromatography, High Pressure Liquid↗

In vivo percutaneous absorption of [14C]DEHP from [14C]DEHP-plasticized polyvinyl chloride film in male Fischer 344 rats.

These studies investigated the migration of di(2-ethylhexyl) phthalate (DEHP) contained as a plasticizer in polyvinyl chloride (PVC) from plastic film and its absorption through rat skin in iivo. Sheets of PVC film (15 cm2) plasticized with [14C]DEHP were applied to the shaved backs of eight male rats in two separate experiments. For Study I, the PVC film was removed after 24 hr, the animals were rewrapped to prevent them from ingesting any residual DEHP at the exposure site, and urine and faeces were collected at regular intervals for 7 days. For Study II, the PVC film was removed after 24 hr, and the animals were immediately killed by CO2 inhalation. Urine and faeces were collected at 24 hr, and the exposure site was washed and rinsed to remove residual [14C]DEHP. In both studies, the amounts of radioactivity transferred from the film were extremely small, amounting to 0.0643% (Study I) and 0.126% (Study II) of that applied. The transferred radioactivity was found to be in three separate fractions. Radioactivity readily removed from the skin (mean 75% of the transferred radioactivity), radioactivity remaining at the application site at sacrifice. and absorbed radioactivity, that is, that distributed systemically or eliminated. The mean absorption rates for DEHP, calculated from the sum of the quantities absorbed plus that present in the exposure site, were: Study I, 0.239, and Study II, 0.242 microg/cm2/hr.

Animals↗

Pulmonary toxicity of polyvinyl chloride particles after a single intratracheal instillation in rats. Time course and comparison with silica.

Our previous in vitro studies indicated that emulsion polyvinyl chloride (PVC) particles (PVC-E3), with a mean diameter of 2 microm, exhibited a moderate toxicity in different pulmonary cell cultures. The in vitro cytotoxicity and pro-inflammatory potential of PVC-E3 particles were reduced when the additives had been "washed off" (PVC-W3), indicating that PVC-particle associated toxicity is probably related to the residual additives. In the present study, male Wistar rats (230 +/- 18 g) received a single intratracheal instillation of vehicle, crystalline silica particles [Min-U-Sil, 10 mg/kg body weight (BW)], PVC-E3 (10 or 50 mg/kg BW), or PVC-W3 (10 or 50 mg/kg BW). After 2, 7, 28, or 90 days, the rats were sacrificed (n = 6) and pulmonary injury and inflammation were determined by measuring lung weight, lactate dehydrogenase (LDH) activity and protein concentrations in bronchoalveolar lavage fluid (BALF), differential BALF cell count, and histopathology. Silica exposure resulted in pulmonary inflammation and damage at all time points with a progressive deterioration. Exposure to high concentrations of PVC particles caused pulmonary inflammation and damage, which were similar to the silica-exposed group at 2 days, but at 90 days, most parameters had returned to the control level, except for minor histopathological lesions. PVC-E3 did not induce more damage than PVC-W3. Two days after exposure, PVC-W3 caused less neutrophil but more eosinophil influx than PVC-E3. Although the pulmonary toxicity of both PVC-E3 and PVC-W3 appeared limited, this in vivo study has not confirmed the conclusion from the in vitro toxicity tests that removal of residual additives reduces the toxicity of PVC-E3 particles.

Animals↗

Reducing the migration of di-2-ethylhexyl phthalate from polyvinyl chloride medical devices.

We attempted to determine the processing conditions for decreasing the migration of phthalate esters, particularly di-2-ethylhexyl phthalate (DEHP), from polyvinyl chloride (PVC) products using a drug solvent after dilution based on the package insert. PVC sheets and PVC tubing were subjected to optical irradiation (ultraviolet (UV), visible light irradiation) and heat treatment to determine whether they are deteriorated by these treatments. UV irradiation to one side of the PVC sheet decreased the levels of DEHP migration from the sheets by almost 50%, although the amount of DEHP content in PVC sheet was observed no significant change. On the other hand, the levels of DEHP migrating from the inner surface of PVC tubing UV-irradiated from the outer surface were not decreased compared with the control. Therefore, the surface structure was examined by conducting Fourier transform infrared spectroscopy (FT-IR), electron spectroscopy for chemical analysis (ESCA) and static angle of contact measurement. In FT-IR analysis, we found that the UV-irradiated PVC sheets were exhibited broadened absorption bands with time. In ESCA analysis, the chlorine content was decreased and the oxygen content was increased with time in UV-irradiated PVC sheets. Moreover, the other treated PVC sheets shows no significant change compared with the non-UV-irradiated PVC sheet. Therefore, the surface structure of the UV-irradiated PVC sheet was changed. As a result, the migration of DEHP from PVC products can be decreased with simple treatment, such as UV-irradiation. This could be a useful method to develop novel PVC products.

Cyclosporine↗

Assessment of control strategies for reducing volatile organic compound emissions from the polyvinyl chloride wallpaper production industry in Taiwan.

This study attempts to assess the effectiveness of control strategies for reducing volatile organic compound (VOC) emission from the polyvinyl chloride (PVC) wallpaper production industry. In Taiwan, methyl ethyl ketone, TOL, and cyclohexanone have comprised the major content of solvents, accounting for approximately 113,000 t/yr to avoid excessive viscosity of plasticizer dioctyl phthalate (DOP) and to increase facility in working. Emissions of these VOCs from solvents have caused serious odor and worse air quality problems. In this study, 80 stacks in five factories were tested to evaluate emission characteristics at each VOC source. After examining the VOC concentrations in the flue gases and contents, the VOC emission rate before treatment and from fugitive sources was 93,000 and 800 t/yr, respectively. In this study, the semiwet electrostatic precipitator is recommended for use as cost-effective control equipment.

Air Pollutants↗

Uptake of polychlorinated biphenyls (PCBs) from an aqueous medium by polyethylene, polyvinyl chloride, and polystyrene films.

The sorption of selected polychlorinated biphenyl (PCB) congeners (from tri to deca chlorinated) by three food-packaging plastic films [polyethylene, polyvinyl chloride (PVC), and polystyrene] from an aqueous solution was investigated. From the data generated, PCB uptake, partition, and diffusion coefficients were calculated for the various films. Polyethylene exhibited the highest PCB uptake, diffusion, and partition coefficients when compared to the other materials. Although PVC indicated larger sorption diffusion and partition coefficients for the lower chlorinated congeners than polystyrene, a reversal of this trend was observed for the higher congeners. For polyethylene and PVC, the PCB uptake decreased as the chlorine numbers in the congeners increased, confirming the correlation between increasing chlorination and increasing cohesive density within the PCB molecules. For polystyrene, the uptake decreased from tri to penta congeners, but showed an increase for the hexa, and then a decreased uptake until the deca chlorination. A comparison of the molecular sizes of the PCB congeners showed that the partition (Ke) and sorption diffusion (Ds) coefficients generally decreased with their increasing molar volumes. The resulting Ke values were used to determine the extent of sorption because these values indicate the affinity of PCBs for the plastic films. Results from this study can be of practical importance for cases of product quality related to the transfer of contaminants from the product to the packaging materials.

Food Packaging↗

Pulmonary effects of polyvinyl chloride dust exposure on compounding workers.

Spirometry, chest radiography, environmental measurements, and a questionnaire on respiratory symptoms were used to evaluate the effects of exposure to polyvinyl chloride (PVC) dust on 171 Chinese and Malay PVC compounding workers in comparison with an unexposed reference group. Workers with high cumulative PVC dust exposure had a lower forced expiratory volume in 1 s and forced vital capacity, and a higher prevalence of radiological profusion of small opacities. Wheezing or chest tightness was also significantly more frequent in this group. Unlike previous studies, the PVC compounding workers in this study were exposed to only negligible amounts, if any, of vinyl chloride monomer or thermal degradation products of PVC such as hydrogen chloride, phosgene, or chlorine. The conclusion was drawn that a low grade of pneumoconiosis and a small degree of lung function impairment is associated with PVC dust exposure. Reversible airways obstruction is also likely and warrants further investigation.

Adult↗

A comparison of prelubricated hydrophilic and non-hydrophilic polyvinyl chloride catheters for urethral catheterization.

OBJECTIVE: To evaluate whether patients performing clean intermittent self-catheterization (CISC) for a short period preferred a prelubricated, hydrophilic, disposable polyvinyl chloride (PVC) catheter or a non-hydrophilic PVC catheter which could be used several times and that had to be lubricated by the patient. PATIENTS AND METHODS: In a prospective cross-over study, 32 patients used each type of catheter for 3 weeks. After each 3-week period, the patients completed a questionnaire to assess comfort and preference, and urine specimens were obtained for culture. RESULTS: There was no significant difference between the groups in the frequency of CISC, discomfort when used, opinion on handling the catheters, preference toward one of the catheters, or of infection. CONCLUSION: Non-hydrophilic PVC catheters may be used safely and with no discomfort to the patient. In addition it may be possible for the healthcare system to save money, as the non-hydrophilic PVC catheters are much cheaper.

Aged↗

The effects of polyvinyl chloride and polyolefin blood bags on red blood cells stored in a new additive solution.

BACKGROUND AND OBJECTIVES: Red blood cells (RBCs) must be stored in polyvinyl chloride (PVC) bags plasticized with di-2-ethylhexyl phthalate or a similar plasticizer to achieve their full storage life with conventional storage solutions. Improved storage solutions might remove this requirement and allow blood storage in other plastics. Experimental Additive Solution-61 (EAS-61), which maintains RBCs for 9 weeks with reduced haemolysis and satisfactory 51Cr 24-h recovery, is an appropriate candidate improved RBC storage solution. MATERIALS AND METHODS: Twenty-four units of packed RBCs were pooled in groups of four units, each pool was realiquoted into four units and stored, six pooled units per arm, in one of the following: 100 ml of EAS-61 in PVC; 200 ml of EAS-61 in PVC; 100 ml of EAS-61 in polyolefin (PO); and 200 ml of EAS-61 in PO. Haemolysis, RBC morphology indices, RBC ATP concentrations, and other measures of RBC metabolism and function were measured weekly. RESULTS: RBC haemolysis exceeded 1% by 7 weeks in PO bags containing 100 ml or 200 ml of EAS-61. In PVC bags, haemolysis was less than 1% at 11 weeks. RBC ATP concentrations were 1 mol/g of haemoglobin (Hb) higher at 2 weeks in the PVC-stored units. CONCLUSIONS: RBCs stored in PVC had markedly less haemolysis and higher RBC ATP concentrations than those stored in PO. Haemolysis would limit RBC storage in PO bags to a duration of 6 weeks, even with EAS-61.

Adenosine Triphosphate↗

[Sequential scintigraphy of liver and spleen in patients with polyvinyl chloride disease (author's transl)].

Occurence of severe liver damage including angiosarcoma in polyvinyl chloride production workers necessitates regular control investigations of liver and spleen. Radioisotope techniques with small irradiation doses which give valid results should be used. Investigations of 15 patients with PVC-induced liver disease showed that hepatic perfusion as demonstrated by 99mTc pertechnate does not correlate with the uptake of sulphide colloid in the hepatic reticuloendothelial system. This provides evidence that in VC disease specific damage of the reticuloendothelial system of the liver occurs. Sequential scintigraphy also proved that the liver perfusion quotient can be considered as a measure of portal pressure. In practice this may be used for follow-up controls. Vascularized tumours described in VC disease can also be demonstrated by scintigraphy.

Chemical and Drug Induced Liver Injury↗

Evaluation of various solvent systems for modeling solute sorption with plasticized polyvinyl chloride materials.

The partitioning behavior of 16 chemically diverse model solutes was determined for four model solvents (octanol, hexane, heptane, and chloroform) and two components of plasticized polyvinyl chloride [PVC; PVC resin and dioctyl phthalate (DOP) plasticizer]. Interactions between these model solutes and four plasticized PVC polymers, differing in their PVC-to-DOP weight ratio, were studied. The data were used to evaluate the utility of the solvents and components to act as PVC interaction models (correlating the interaction constant of the plastic with the solvent-water partition coefficients of the solute). The ability of any single solvent to model the material-solute interaction was limited because of the multiple mechanisms by which the PVC and the solute can interact. Several bimodal solvent systems, including octanol and hexane, DOP and PVC resin, and octanol and heptane, mimic the behavior of polymers studied with a higher degree of accuracy. The success of these pairings is directly related to their ability to target different potential material-solute interaction mechanisms. The interaction properties of the test plastics are strongly impacted by the amount of plasticizer in the material. The interaction properties of the materials studied could be effectively represented as a mass-related average of the interaction properties of the major components of the material.

Absorption↗

[Toxicity of chemicals produced by thermal destruction of synthetic materials based on polyvinyl chloride and used in coal mines].

The experiments on mongrel white rats studied toxicity of the products appearing during thermal destruction of conveyer tape TK-200 based on polyvinyl chloride and used in coal mines. The studies helped to define parameters of acute toxicity and the MACs for products of the conveyer tape burning, considering the main contents and the exposure intensity for 30-120 minutes; to determine jeopardy class; to calculate specific volatilization; to design recommendations for prevention of poisoning during fire in the mines.

Air Pollutants, Occupational↗

Managing milk leakage in breastfeeding women: a clinical trial evaluating a polyvinyl chloride device versus disposable nursing pads.

The object of this clinical trial was to evaluate the effectiveness and to investigate possible problems associated with the use of a polyvinyl chloride (PVC) device ("blis") compared to a disposable nursing pad, for controlling milk leakage among nursing mothers. Seventy-one women completed the single blind, paired comparison, randomized trial. Among the 28 women having a strong early preference, 21 opted for the PVC device (p = 0.01). Of the 37 women experiencing excessive milk leakage who preferred one of the devices, 24 preferred the PVC device (p = 0.05). There was no evidence that one device caused more problems or feeding complications than the other. This study is important in alleviating anxiety about device safety while promoting breastfeeding in mothers fearful of leaking at inopportune times.

Adolescent↗

Effect of orientation of a standard polyvinyl chloride tracheal tube on success rates during awake flexible fibreoptic intubation.

We conducted a randomised study in 70 patients to assess the effect of orientation of a standard polyvinyl chloride tracheal tube on the ease of railroading the tube during awake fiberoptic orotracheal intubation. Conventional orientation of the tube (with the bevel of the tube directed to the patient's left) was compared with orientation of the tube with the bevel facing posteriorly. The success rate of intubation at the first attempt was higher with the bevel oriented posteriorly (35/35; 100%) than with the conventional orientation (21/35; 60%; p = 0.0001), and the intubating time was shorter (median (range) 7 (5-11) s and 11 (5-60) s, respectively; p = 0.0001). We recommend that the tracheal tube should be aligned in this manner when railroading it over the fibrescope during awake fibreoptic orotracheal intubation.

Adult↗

Stability of fosphenytoin sodium with intravenous solutions in glass bottles, polyvinyl chloride bags, and polypropylene syringes.

OBJECTIVE: To determine the stability of fosphenytoin sodium admixtures with NaCl 0.9% injection and dextrose 5% (D5W) injection when stored in glass or polyvinyl chloride (PVC) containers, to evaluate the compatibility of fosphenytoin with 11 other intravenous solutions, and to determine the stability of fosphenytoin repackaged in polypropylene syringes. METHODS: Dilutions of fosphenytoin sodium 1, 8, and 20 mg phenytoin sodium equivalents (PE)/mL were prepared in NaCl 0.9%, D5W, and 11 other intravenous fluids. Aliquots of each solution in NaCL 0.9% or D5W were transferred to three glass bottles for storage at 25 degrees C and 21 PVC bags for storage at 25, 4, or -20 degrees C. Aliquots of each admixture with the other intravenous fluids were transferred to three PVC bags and stored at 25 degrees C for 7 days. In addition, 63 syringes were filled with fosphenytoin sodium 50 mg PE/mL (undiluted) and stored at 25, 4, or -20 degrees C. Samples of each solution from the three containers were analyzed for visual compatibility, pH, and fosphenytoin concentration initially and at 0.5, 1, 2, 3, 7, 14, and 30 days during storage at 25 and 4 degrees C and at 1, 7, 14, and 30 days during storage at -20 degrees C. Following removal of containers from the freezer, additional samples were obtained after 7 days at 4 or 25 degrees C, and 7 days at 25 degrees C, and then 7 days at -20 degrees C. RESULTS: No visible precipitation or change in color or clarity was observed in any of the fosphenytoin solutions during the study. The concentration of fosphenytoin at each sampling time remained within 97-104% of initial concentration, regardless of container, concentration, intravenous admixture, or storage temperature. CONCLUSIONS: Fosphenytoin sodium, either undiluted in polypropylene syringes or diluted with NaCl 0.9% or D5W in PVC bags, remains stable for at least 30 days at room temperature, under refrigeration, or frozen. After removal from the freezer, fosphenytoin can be thawed, kept at 4 or 25 degrees C for 7 days, and then returned to the freezer for another 7 days. Admixtures of fosphenytoin sodium in various other intravenous fluids are stable for at least 7 days at room temperature.

Chromatography, High Pressure Liquid↗

Pressure loss in elbow pipes of unplasticized polyvinyl chloride.

In the ductwork of local exhaust systems, 90 degrees elbow pipes (JIS K 6739) are commonly used to alter the direction of airflow; thus, are important components of polyvinyl chloride (PVC) ducts. Pressure loss in 90 degrees PVC elbow pipes was investigated by measuring static pressure, and the characteristics of airflow was determined. First, a linear decrease in static pressure was observed at points of the downstream side beyond a distance of 10 times the diameter (10d) from the flanged round opening of the smooth VU ducts (JIS K6741). The linear decrease was also observed at points of the downstream side located at distances of greater than 30d from the elbow pipe. Coefficients of loss in the PVC elbow pipes were found to be constant for the Reynolds numbers ranging from 3.38 x 10(4) to 5.96 x 10(5) for all diameters examined, and a chart of pressure loss was constructed with these coefficients. The coefficients of loss in PVC elbow pipes were not equivalent to those of metal stamped elbows for any R/d. However, the differences in the coefficients between the metal stamped elbow and the PVC elbow were smaller with larger R/d values.

Equipment Design↗