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Assessment of Physicochemical Parameters of Tubing's of Intravenous Infusion sets

Author Affiliations

  • 1 Department of Chemistry, Faculty of Applied Sciences, Integral University, Lucknow, INDIA
  • 2 Analytical Chemistry Division, Indian Institute of Toxicology Research, M.G. Marg, Lucknow, INDIA

Res. J. of Pharmaceutical Sci., Volume 1, Issue (4), Pages 1-9, December,30 (2012)

Abstract

The main objectives of study were to evaluate the physicochemical test of the leachates of Intravenous infusion sets of seven brands used in thepresent study were purchased from different medical shops in Lucknow. At 60±2°C for 2 hours condition, the maximum global migration residue was found from IV-6 sample in 5% sodium carbonate (6.2 mg/100 ml) while the minimum was in IV-5 sample in 3% acetic acid (0.2 mg/100 ml) (Fig.1). The results also showed that at 25±2°C for 24 hours condition, the maximum global migration residue was found from IV-6 sample in 0.9% sodium chloride (5.2 mg/100 ml) while the minimum was in IV-5 sample in 3% acetic acid (0.14 mg/100 ml) (Fig.2). The results revealed that at 60±2°C for 2 hours condition, the maximum migration of oxidizable matters was from the leachates of IV-3 sample in double distilled water (3 ml; difference in the volume of sodium thiosulphate consumed) while the minimum migration of oxidizable matters was observed in IV-4 and IV-5 sample in sodium carbonate (0.1 ml) (Fig 3). At 25±2°C for 24 hours condition, the maximum migration of oxidizable matters was from the leachates of IV-3 sample in double distilled water (2.3 ml; difference in the volume of sodium thiosulphate consumed) while the minimum migration of oxidizable matters was observed in IV-2, IV-4, IV-5 and IV-7 sample in sodium carbonate (Fig. 4). At 60±2°C for 2 hours condition, the maximum migration of UV absorbing materials was from IV-1 sample in 0.3% acetic acid (OD – 0.206) whiles the minimum was from IV-5 sample in 0.9% sodium chloride (OD – 0.035). The migration was below the permissible limit (OD – 0.3) (Fig. 5). At 25±2°C for 24 hours condition, the maximum migration of UV absorbing materials was from IV-1 sample in 0.3% acetic acid (OD – 0.161) whiles the minimum was from IV-5 sample in 0.9% sodium chloride (OD – 0.031). The migration was below the permissible limit (OD – 0.3) (Fig. 6). The results showed that the leaching of additives used in plastic biomedical devices is temperature dependent i.e. high at higher temperature. These additives are not chemically bound to the matrix of the polymeric materials and leach out during normal use.

References

  1. Panda H., Plastic Additives Technology Hand Book107, 161, 162, 267-269 (1997)
  2. Maes D., Groeninckx G., Ravenstijn J. and Aerts L., A molecular model for structural changes during shear yielding and crazing in amorphous polymers, Poly Bull16(4), 363 (1986)
  3. Donnell J.H., ORahman N.P., Smith C.A., Winzor D.J., Chain scission and cross linking in the radiation degradation of polymers, Macromolecules,12(1), 113(1979)
  4. Viletti M.A., Crespo J.S., Soldi M.S., Pires A.T.N., Borsali R. and Soldi V.J., Thermal degradation of natural polymers , Therm Anal Calorim,67, 295 (2002)
  5. Deanin R.D., Additives in plastics, Environ Health Perspect11, 35 (1975)
  6. Arnold L.K., Introduction to plastics, 4th edition (1968)
  7. Anastas P.T., Bickart P.H., Kirchhoff M.M., Designing Safer Polymers (2000)
  8. Crompton T.R., ‘Additive migration from plastics into foods’, A Guide for the Analytical Chemist (2007)
  9. O.E.C.D., Emission scenario document on plastic additives (2004)
  10. Araujo P.H.H., Sayer C., Poco J.G.R., Giudici R., Techniques for reducing residual monomer content in polymers,Polym Eng Sci42, 1442-1468 (2002)
  11. Rijk R., Ehlert K., Migration of phthalate plasticizers from soft PVC toys and child care, Nutrition and Food Research, Zeist (2001)
  12. http://www.mst.dk/Publikationer/Publications/2010/12/978-87-92708-75-5.htm, Tonning K., Jacobsen E., Pedersen E., Nilsson N.H., Danish Technological Institute. Survey of chemical substances in consumer products, No.109210, Danish Ministry of the Environment and EPA (2010)
  13. Kim Y.J., Osako M., Sakai S.I., Leaching characteristics of polybrominated diphenyl ethers (PBDEs) from flame-retardant plastics, Chemosphere65, 506-513 (2006)
  14. Brede C., Fjeldal P., Skjevrak I. and Herikstad H., Increased migration levels of bisphenol A from polycarbonate baby bottles after dishwashing, boiling and brushingFood Addit and Contam, 20, 684-689 (2003)
  15. Geens T., Apelbaum T.Z., Goeyens L., Neels H. and Covaci A., Intake of bisphenol A from canned beverages and foods on the Belgian market, Food Addit Contam, Part , 27, 1627-1637 (2010)
  16. Sajiki J., Miyamotoa F., Fukatabc H., Mori C., Yonekubode J., Hayakawae K., ‘Bisphenol A (BPA) and its source in foods in Japanese markets, Food Addit Contam, Part A, 24, 103-112 (2007)
  17. Olea N., Pulgar R., Pérez P., Olea, Serrano F., Rivas A., Novillo-Fertrell A. et al, Estrogenicity of resinbased composites and sealants used in dentistry, Environ. Health Perspect, 104, 298–305 (1996)
  18. http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:235:0001:0439:en European Commission. 2009, (2011)
  19. http://ec.europa.eu/environment/docum/pdf/bkh_main.pdf, Groshart C.P., Okkerman P.C., (2000) list of substances for further evaluation of their role in endocrine disruption - preparation of a candidate list of substances as a basis for priority setting, Final Report, Annex 15 List of 66 substances with categorisation high, medium or low exposure concern (2011)
  20. http://ec.europa.eu/environment/endocrine/documents/bkh_report.pdf#page=1, Okkerman PC, van der Putte I, (2002) ,Endocrine disrupters, Study on 435 substances with insufficient data, Final Report. Annex 13, The summary profiles of (41) Category 1 chemical groups (2011)
  21. Rijk R., Ehlert K., Migration of phthalate plasticizers from soft PVC toys and child care, Nutrition and Food Research, Zeist (2001)
  22. http://www.mst.dk/Publikationer/Publications /2010/12/ 978-87-92708-75-5.htm, Tonning K., Jacobsen E., Pedersen E. and Nilsson N.H., Danish Technological Institute. Survey of chemical substances in consumer products, No.109210. Danish Ministry of the Environment and EPA (2010)
  23. Kim Y.J, Osako M. and Sakai S.I., Leaching characteristics of polybrominated diphenyl ethers (PBDEs) from flame-retardant plastics, Chemosphere65, 506-513, (2006)
  24. Brede C., Fjeldal P., Skjevrak I. and Herikstad H., Increased migration levels of bisphenol A from polycarbonate baby bottles after dishwashing, boiling and brushing,Food Addit and Contam,20, 684-689 (2003)
  25. Geens T., Apelbaum T.Z., Goeyens L., Neels H., Covaci A., Intake of bisphenol A from canned beverages and foods on the Belgian market, Food Addit ContamPart A 27, 1627-1637 (2010)
  26. Airaudo C.B., Gayte-Sorbier A., Momburg R. and Laurent P., Leaching of antioxidants and vulcanization accelerators from rubber closures into drug preparationsJ Biomater Sci Polym Ed1(4), 231-41(1990)
  27. Jenke D., A general strategy for the chemical aspects of the safety assessment of extractables and leachables in pharmaceutical drug products: the chemical assessment triad, PDA J Pharm Sci Technol,66(2), 168-83 (2012)
  28. Jenke D., Odufu A., Couch T., Chacko M., Strathmann S., Edgcomb E., Evaluation of the General Solution Compatibility of Polymer Materials Used in Medical Devices such as Syringes, PDA J Pharm Sci Technol, 66(4), 286-306 (2012)
  29. Jenke D., A general assessment of the physiochemical factors that influence leachables accumulation in pharmaceutical drug products and related solutions, PDA J Pharm Sci Technol,65(2), 166-76 (2011)
  30. Gill M., Garber M.J., Hua Y., Jenke D., Development and validation of an HPLC-MS-MS method for quantitating bis (2,2,6,6-tetramethyl-4-piperidyl) sebacate (Tinuvin 770) and a related substance in aqueous extracts of plastic materialsJ Chromatogr Sci.,48(3), 200 (2010)