Presence of phthalate esters in intravenous solution evaluated using gas chromatography-mass spectrometry method (original) (raw)
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Phthalate esters (PAEs) are plasticizers associated with multiple toxicities; however, no strict regulations have been implemented to restrict their use in medical applications in Lebanon. Our study aimed at assessing the potential risks correlated with phthalate exposure from IV bags manufactured in Lebanon. GC–MS analysis showed that di-(2-ethylhexyl) phthalate (DEHP) is the predominant phthalate found in almost all samples tested with values ranging from 32.8 to 39.7% w/w of plastic. DEHP concentrations in the IV solutions reached up to 148 µg/L, as measured by SPME-GC–MS/MS, thus resulting in hazard quotients greater than 1, specifically in neonates. The toxicity of DEHP is mainly attributed to its metabolites, most importantly mono-(2-ethylhexyl) phthalate (MEHP). The IV bag solution with the highest content in DEHP was therefore used to extrapolate the amounts of urinary MEHP. The highest concentrations were found in neonates having the lowest body weight, which is concerning,...
Environmental Health Perspectives, 2005
Di(2-ethylhexyl) phthalate (DEHP) is an aromatic diester used primarily to soften and plasticize the rigid polymer polyvinyl chloride (PVC); DEHP may represent between 20 and 40% of the finished weight of the plastic (Jaeger and Rubin 1973). Among other properties, DEHP imparts to PVC flexibility, strength, optical clarity, and resistance to broad-range temperature variations (Shea 2003). In its pure form, DEHP is a clear, oily liquid, which is highly lipophilic (fat soluble) and poorly soluble in water. In PVC plastic, DEHP resides in the PVC matrix as a semisolid and readily migrates out of the plastic into blood or other lipid-containing solutions in contact with the plastic, a phenomenon observed with blood stored in PVC bags (Peck and Albro 1982; Rock et al. 1984). Because of its versatile properties, DEHP is also found in many commercial and household products such as vinyl floor and wall coverings, furniture,
Determination of di(2-ethylhexyl) phthalate in plastic medical devices
Chemical Industry, 2016
The presence of DEHP in dialysis and infusion sets for peritoneal dialysis and parenteral nutrition, which are made of PVC and other plastic polymeric materials, were investigated. Phthalate determination was carried out by gas chromatography - mass spectrometry method (GC-MS). The results showed that the peritoneal dialysis set (bag and tubing) made of PVC contains DEHP in significant amount, about 31 - 34%. Solution for peritoneal dialysis which was stored in the investigated PVC bag, contains low amount of DEHP, about 3.72 ?g dm-3. Infusion bottles which are made of LDPE, also contain DEHP but in lower amount than PVC bags. LDPE bottle for packaging physiological saline solution (0.9% NaCl) showed higher amount of DEHP than LDPE bottle for packaging Ringer?s solution. In contrast, solution stored in bottle with lower DEHP level, i.e. Ringer?s solution contained about three times higher concentration of DEHP than physiological saline solution stored in bottle with higher DEHP leve...
Leaching and Exposure of Phthalates from Medical Devices; Health Impacts and Regulations
Environmental Contaminants Reviews, 2019
Phthalates (PAEs) are widely used as plasticizers in medical devices to make polyvinyl chloride flexible and soft. However, PAEs can be leached out from plasticizers undesirably and can migrate within the material and end up with direct exposure to humans. Therefore, a number of studies have been conducted globally focusing on their leaching from medical devices like blood bags, infusion tubing, peritoneal dialysis bags and tubing, catheters etc. In current review an attempt is made to gather information related to leaching, exposure, health implication of PAEs along with the regulation used in different countries. Toxic health effects with the exposure of PAEs includes neurological effects, DNA damage, oxidative stress, asthma with negative impact on lungs, effects on reproductive system, liver impairment and gastrointestinal effects. In addition, leaching studies has shown the presence of DEHP about 31-34 % in peritoneal dialysis set like bags and tubing. DEHP leached out from medical apparatus depends upon temperature, storage time, amount of DEHP present in devices and shaking of device while in touched with medical solution. The exposure of plasticizers for pregnant hospitalised women and infants has also highlighted. In addition, PAEs alternates introduced in market are also discussed like Trioctyltrimellitate/tri-(2-ethylhexyl) trimellitate) along with various regulations regarding the use of PAEs in medical devices and other products. was poor.
Journal of Pharmaceutical and Biomedical Analysis, 2003
Health Canada reported recently that medical devices containing di(2-ethylhexyl) phthalate (DEHP) should not be used in the clinical treatment of infants, young boys, pregnant women, and nursing mothers. The risk assessment of DEHP released from PVC medical devices is an important issue for hospitalized patients. In this study, a simple, accurate, low-contamination and high-throughput analytical technique for the determination of DEHP in intravenous (IV) solution was developed using column-switching liquid chromatography/mass spectrometry (LC/MS) with an extraction mini-column. The sample preparation for on-line extraction involved simply mixing IV solution with internal standard as DEHP-d 4 in LC glass vials. The IV fat emulsion drug sample cannot be analyzed directly, hence this sample spiked with DEHP-d 4 solution was extracted by hexane and measured by column-switching LC/MS yielding an average recovery of 92.2% (C.V. 0/7.8%, n 0/5). A linear response was found for a variety of drugs tested within the validated range of 0.1 or 0.5 Á/10 mg/ml with correlation coefficients (r ) greater than 0.99. These results suggest that this method can assay background exposure to DEHP released from PVC medical devices in the patients. The method was applied to various IV solution samples to establish the first screening method for DEHP released from medical devices with respect to their safety. #
Migration of diethylhexyl phthalate from PVC bags into intravenous cyclosporine solutions
Journal of Pharmaceutical and Biomedical Analysis, 2005
The migration of diethylhexyl phthalate (DEHP) from PVC bags into LVPS (0.9% NaCl) and LVPS with cyclosporine at concentrations of 2.5 and 0.5 mg/ml was studied. PVC bags were placed in contact with these solutions and stored at 25 ± 1 • C. They were taken for analysis each 30 min during 6 h and after this period at each 1 h until 12 h of contact. Water was used as reference, and exposed and analyzed under the same conditions. After contact, the solutions were submitted to extraction with hexane and analyzed by GC-FID. The results showed that DEHP did not migrate into water and LVPS during all the time. Also, no measurable amount of DEHP was detected during the first 3 h of contact between the PVC bag and the diluted cyclosporine solution. However, the amount of released DEHP reached a detectable level after 4 h of contact, increased until 6 h, stabilized, and increased again after 9-10 h. The 12 h of contact showed the highest DEHP levels for both cyclosporine concentrations. The DEHP migrated was 0.02-0.08% of that present in the bag.
Migration of phthalate-based plasticizers from PVC and non-PVC containers and medical devices
Journal of the Brazilian Chemical Society, 2012
A presença de cinco plastificantes derivados de ftalatos em equipamentos para administração intravenosa de soluções e em hemodialisadores (HD), que são feitos tanto de policloreto de vinila (PVC) quanto de outros materiais poliméricos, foi investigada. Destes ftalatos, o único autorizado por agências reguladoras é o di-(2-etilhexil) ftalato (DEHP) em equipamentos de PVC. A determinação foi feita por chromatografia líquida de alta eficiência (HPLC) com detecção UV. Os resultados mostraram que as bolsas para infusão que são feitas tanto de PVC quanto de etil vinil acetato (EVA) contêm apenas DEHP. Entretanto, as mangueiras dos equipos de infusão e dos HD, bem como as fibras capilares dos HD feitas de celulose, contêm não só DEHP, mas também ftalato de dibutila (DBP). Todos os cinco ftalatos investigados foram encontrados nos capilares dos HD feitos de polisulfona. A migração de DEHP para soluções (aminoácidos, glicose e salina) armazenadas em bolsas ocorreu com taxas diferentes para os dois polímeros. Enquanto que para as bolsas de PVC o DEHP foi encontrado em soluções já nos primeiros dias de contato, para as bolsas de EVA a migração iniciou após aproximadamente 6 meses de armazenamento. Como os dispositivos analisados, com exceção das bolsas, contém, além do DHEP, outros ftalatos, o risco posto aos pacientes deve ser motivo de preocupação. The presence of five plasticizer phthalates in bags and sets for intravenous administration and hemodialyzers (HD), which are made of polyvinyl chloride (PVC) and of other polymeric materials, was investigated. Di-(2-ethylhexyl) phthalate (DEHP) in PVC is the only authorized phthalate by regulatory agencies. Phthalate determination was carried out by high resolution liquid chromatograph (HPLC) with UV detection. The results showed that the infusion bags that are made of both PVC and ethylene vinyl acetate (EVA) contained only DEHP. In contrast, the tubing of infusion sets and of HD (as well as the cellulose capillaries of HD) contained not only DEHP but also dibutyl phthalate (DBP). Moreover, all five investigated phthalates were found in HD polysulfone capillaries. Migration of DEHP into the stored solutions (amino acids, glucose and saline) in bags occurred at different rates from one polymer to another. While DEHP from PVC bags was found in solutions within the first days of contact, the migration from EVA bags started only after approximately 6 months of solution storage. Since PVC and non-PVC devices (as well as capillaries of HD sets) contain DEHP and other phthalate-based plasticizers, the extent of the risk that they pose to patients remains a matter of concern.
Journal of Polymer Research, 2012
Towards a process development for the bioremediation of phthalic acid esters (PAE) blended in various plastics, we explored the type of PAE in commercially available PVC blood storage bags (BB), its solvent-and temperature-dependent migrations and coefficient of diffusion (D) behaviors at static condition by solvent extraction method. The PAE [about 34 % (w/w)] in BB was confirmed as DEHP by UV, TLC and GC-MS analyses. When effects of five solvents on the rate of migration of intact DEHP from BB tested (40°C), order of migration during the initial hrs was: n-hexane>methanol>t-butyl alcohol>isopropyl alcohol>ethanol. At 40°C, about 60 % (of total) DEHP in BB migrated into n-hexane, which rose to 80 % at 60°C and almost 95 % at boiling (69°C) in the first h. DEHP diffusion from BB was dependent on its concentration and nature of surrounding medium and temperature. Fickian approximation was used to calculate D values for DEHP migration, and in n-hexane average values were: 1.26×10 −7 , 1.92× 10 −7 and 2.18×10 −7 cm 2 sec −1 at 40, 50 and 60°C, respectively. This study shows that n-hexane is the preferred solvent to extract DEHP from used or waste medical and allied PVC products for small scale, especially screening studies. Briefly, DEHP and solvent were separated individually upon distillation of the extract; thus DEHP, microporous PVC BB sheet and solvent were recovered for reuse inexpensively without environmental contamination.
Journal of Oncology Pharmacy Practice, 2005
Etoposide intravenous solution is associated with leaching of diethylhexyl phthalate (DEHP) from bags and tubings made from polyvinyl chloride (PVC). Recent evidence suggests that this may be more substantial than previously found. Since DEHP is potentially hepatotoxic and carcinogenic, it is preferable to prepare and administer etoposide bags and tubings made from non-PVC materials. J Oncol Pharm Practice 155 Á 157. J Oncol Pharm Practice (2005) 11: 155 Á/157 -2005 Edward Arnold (Publishers) Ltd