Migration of diethylhexyl phthalate from PVC bags into intravenous cyclosporine solutions.
The migration of diethylhexyl phthalate (DEHP) from PVC bags into LVPS (0.9% NaCl) and LVPS with cyclosporine at concentrations of 2.5 and 0.5mg/ml was studied. PVC bags were placed in contact with these solutions and stored at 25+/-1 degrees 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.
Gotardo
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Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas, UNESP, CP 502, CEP 14801-902 Araraquara, São Paulo, Brazil.
Monteiro
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D002849:Chromatography, Gas; D002851:Chromatography, High Pressure Liquid; D016572:Cyclosporine / Q000008:administration & dosage / Q000737:chemistry*; D004051:Diethylhexyl Phthalate / Q000032:analysis*; D004349:Drug Packaging; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000737:chemistry*; D007262:Infusions, Intravenous; D007700:Kinetics; D019999:Pharmaceutical Solutions; D011143:Polyvinyl Chloride / Q000032:analysis*
D007166:Immunosuppressive Agents; D019999:Pharmaceutical Solutions; D016572:Cyclosporine; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate