The effect of radiation on a variety of pharmaceuticals and materials containing polymers

PDA Journal of Pharmaceutical Science and Technology

Volumn 66, Issue 2, 2012, Pages 184-199

  Silindir, Mine ^a   Özer, A Yekta ^a  

^a HACETTEPE UNIVERSITY   (Turkey)

Author keywords

Methods for preventing harmful radiation effects; Radiation effects on pharmaceuticals; Radiation effects on polymers; Radiosterilization methods

Indexed keywords

ACICLOVIR; AMLODIPINE BESYLATE; BUPIVACAINE; CIPROFLOXACIN; DOXORUBICIN; ETHYLENE OXIDE; FORMALDEHYDE; FREE RADICAL; IBUPROFEN; LEVONORGESTREL; MACROGOL; MALARIA VACCINE; METOCLOPRAMIDE; PENTETATE INDIUM IN 111; POLYGLACTIN; POLYLACTIDE; RECOMBINANT SOMATOMEDIN C; SOMATOMEDIN; BIOMATERIAL; POLYMER;

AQUEOUS SOLUTION; ATOMIC FORCE MICROSCOPY; BRUCELLA OVIS; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DELIVERY SYSTEM; ELECTRON SPIN RESONANCE; ELECTRON THERAPY; FREEZE DRYING; GAMMA IRRADIATION; GAMMA RADIATION; HUMAN; IONIZING RADIATION; MICROEMULSION; NONHUMAN; POLYMERIZATION; RADIATION; RADIATION DOSE; RADIATION STERILIZATION; RADIOLYSIS; REVIEW; ROOM TEMPERATURE; SCANNING ELECTRON MICROSCOPY; STENT; SUSPENSION; ULTRAVIOLET RADIATION; X RAY; X RAY DIFFRACTION; INSTRUMENT STERILIZATION; RADIATION RESPONSE;

BIOCOMPATIBLE MATERIALS; GAMMA RAYS; HUMANS; POLYMERS; RADIATION EFFECTS; RADIATION, IONIZING; STERILIZATION;

EID: 84862131807     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: 10.5731/pdajpst.2012.00774     Document Type: Review

References (80)

1. Harrison, J. D.; Stather, J. W. The assessment of doses and effects from intakes of radioactive particles. J. Anat. 1996, 189 (Pt. 3), 521-530. (Pubitemid 27011005)
2. Gopal, N. G. S. Radiation sterilization of pharmaceuticals and polymers. Radiat. Phys. Chem. 1977, 12 (1-2), 35-50.
3. Guillard, V.; Mauricio-Iglesias, M.; Gontard, N. Effect of novel food processing methods on packaging: structure, composition, and migration properties. Crit. Rev. Food Sci. Nutr. 2010, 50 (10), 969-988.
4. Ari, İ. G. Radyasyonun Madde ile Etkileşimi ve Polimerler. Endüstride Radyasyonla Sterilizasyonda Kalite Kontrolüve Kalite Temini Uygulamalari Kursu, Türkiye Atom Enerjisi Kurumu Ankara Nükleer Araştirma ve Eǧitim Merkezi, Gama Işinlama Tesisi, Sarayköy, Ankara, 20-24 November 1995.
5. Morrissey, R. F.; Herring, C. M. Radiation sterilization: past, present and future. Radiat. Phys. Chem. 2002, 63 (3- 6), 217-221.
6. International Atomic Energy Agency, Directory of Gamma Processing Facilities in Member States; IAEA-DGPF-CD; IAEA: Vienna, 2004.
7. Chmielewski, A. G.; Berejka, A. J. Radiation Sterilization Centres Worldwide. In Trends in Radiation Sterilization of Health Care Products; IAEA: Vienna, 2008; pp 49-61.
8. Başgül, M. Radyasyonun Farmasötikler Üzerine Etkileri. Endüstride Radyasyonla Sterilizasyonda Kalite Kontrolüve Kalite Temini UygulamalariKursu, Türkiye Atom Enerjisi Kurumu Ankara Nükleer Araştirma ve Eǧitim Merkezi, Gama Işinlama Tesisi, Sarayköy, Ankara, 20 -24 November 1995.
9. Jefferson, S. Manual on Radiosterilization of Medical and Biological Materials, Technical Reports Series No. 149; IAEA: Vienna, 1973; pp 89-95.
10. Ishigaki, I.; Yoshii, F. Radiation effects on polymer materials in radiation sterilization of medical supplies. Int. J. Radiat. Appl. Instrument. 1992, 39 (6), 527-533.
11. Gürsoy, A. Z. Farmasötik Teknoloji-Temel Konular ve Dozaj Şekilleri, KontrollüSalim Sistemleri Derneg&caroni: İstanbul, 2004; pp 101-115.
12. Jacobs. G. P. Radiation sterilization of parenterals. 2007. http://pharmtech.findpharma.com/pharmtech/ Aseptic-processing/Radiation- Sterilization-of- Parenterals/ArticleStandard/Article/detail/423948.
13. Al-Mohizea, A. M.; El-Bagory, I. M.; Alsarra, I. A.; Al-Jenoobi, F. I.; Bayomi, M. A. Effect of gamma radiation on the physicochemical properties of ciprofloxacin in solid state. J. Drug Del. Sci. Technol. 2007, 17 (3), 211-215. (Pubitemid 47057015)
14. Maquille, A.; Jiwan, J. L. H.; Tilquin, B. Radiosterilization of drugs in aqueous solutions may be achieved by the use of radioprotective excipients. Int. J. Pharm. 2008, 349 (1-2), 74-82.
15. Polat, M.; Korkmaz, M. Effect of gamma radiation on amlodis and its potential for radiosterilization. J. Pharm. Biomed. Anal. 2006, 40 (4), 882-888. (Pubitemid 43257891)
16. Maksimenko, O.; Pavlov, E.; Toushov, E.; Molin, A.; Stukalov, Y.; Prudskova, T.; Feldman, V.; Kreuter, J.; Gelperina, S. Radiation sterilisation of doxorubicin bound to poly(butyl cyanoacrylate) nanoparticles. Int. J. Pharm. 2008, 356 (1-2), 325-332.
17. Mukherjee, R. N. Radiation: A Means of Sterilization. www.iaea.org/Publications/Magazines/ Bulletin/. . ./17605882837.pdf.
18. Guidelines for Validation, Radiation Sterilization, Sterigenics. www.sterigenics.com.
19. Lambert, B. J. Sterilisation: material compatibility challenges and guidance for combination products. 2010. http://www.emdt.co.uk/article/ sterilisation-material-compatibility-challenges.
20. Association for the Advancement of Medical Instrumentation (AAMI) TIR33:2005, Sterilisation of Healthcare Products, Radiation, Substantiation of a Selected Dose, Method VDmax.
21. Association for the Advancement of Medical Instrumentation (AAMI) TIR17:2008, (Revision of AAMI TIR17:1997), Technical Information Report, Compatibility of Materials Subject to Sterilization.
22. Association for the Advancement of Medical Instrumentation (AAMI) TIR17:1997, Technical Information Report, Radiation Sterilization-Material Qualification.
23. Igartua, M.; Hernandez, R. M.; Rosas, J. E.; Patarroyo, M. E.; Pedraz, J. L. Gamma-irradiation effects on biopharmaceutical properties of PLGA microspheres loaded with SPf66 synthetic vaccine. Eur. J. Pharm. Biopharm. 2008, 69 (2), 519-526.
24. Phillips, G. O. Manual on Radiosterilization of Medical and Biological Materials, Technical Reports Series No. 149; IAEA: Vienna, 1973; pp 207-228.
25. Garcia, R.; Howard, B.; LaRue, R.; Parton, G.; Walker, J. Sterilization, Strategies for gamma sterilization of pharmaceuticals. Pharmaceutical & Medical Packaging 2004, 1, 1- 4. http:// www.pmpnews.com/.
26. Razèm, D.; Katusin-Razèm, B. The effects of irradiation on controlled drug delivery/controlled drug release systems. Radiat. Phys. Chem. 2008, 77 (3), 288-344. (Pubitemid 350297979)
27. Da Costa Martins, R.; Gamazo, C.; Irache, J. M. Design and influence of γ-irradiation on the biopharmaceutical properties of nanoparticles containing an antigenic complex from Brucella ovis. Eur. J. Pharm. Sci. 2009, 37 (5), 563-572.
28. Dorati, R.; Colonna, C.; Serra, M.; Genta, I.; Modena, T.; Pavanetto, F.; Perugini, P.; Conti, B. Gamma-irradiation of PEGd, IPLA and PEGPLGA multiblock copolymers: I. Effect of irradiation doses. AAPS PharmSciTech. 2008, 9 (2), 718 -725.
29. Puthli, S.; Vavia, P. Gamma irradiated micro system for long-term parenteral contraception: An alternative to synthetic polymers. Eur. J. Pharm. Sci. 2008, 35 (4), 307-317.
30. Martinez-Sancho, C.; Herrero-Vanrell, R.; Negro. S.; Study of gamma-irradiation effects on aciclovir poly(D,L-lactic-co-glycolic) acid microspheres for intravitreal administration. J. Control. Release. 2004, 99 (1), 41-52.
31. Bozdag, S.; Dillen, K.; Vandervoort, J.; Ludwig, A. The effect of freeze-drying with different cryoprotectants and gamma-irradiation sterilization on the characteristics of ciprofloxacin HClloaded poly(D,L-lactide-glycolide) nanoparticles. J. Pharm. Pharmacol. 2005, 57 (6), 699-707. (Pubitemid 40694877)
32. Shameem, M.; Lee, H.; Burton, K.; Thanoo, B. C.; Deluca, P. P. Effect of gamma-irradiation on peptide-containing hydrophilic poly(d,l-lactideco- glycolide) microspheres. PDA J. Pharm. Sci. Technol. 1999, 53, 309-313. (Pubitemid 30100068)
33. Maquille, A.; Habib Jiwan, J. L.; Tilquin, B. Cryo-irradiation as a terminal method for the sterilization of drug aqueous solutions. Eur. J. Pharm. Biopharm. 2008, 69 (1), 358-63.
34. Laufman, H.; Rubel, T. Synthetic absorbable sutures. Surg. Gynecol. Obstet. 1977, 145 (4), 597-608. (Pubitemid 8202480)
35. Sintzel, M. B.; Merkli, A.; Tabatabay, C.; Gurny, R. Influence of irradiation sterilization on polymers used as drug carriers: a review. Drug Dev. Ind. Pharm. 1997, 23 (9), 857-878. (Pubitemid 27406361)
36. El Maghraby, G. M.; Bosela, A. A. Investigation of self-microemulsifying and microemulsion systems for protection of prednisolone from gamma radiation. Pharm. Dev. Technol. 2010, 16 (3), 237-242.
37. Harrington, K. J.; Rowlinson-Busza, G.; Syrigos, K. N.; Uster, P. S.; Vile, R. G.; Peters, A. M.; Stewart, J. S. The effect of irradiation on the biodistribution of Radiolabeled PEGylated liposomes. Int. J. Radiat. Oncol. Biol. Phys. 2001, 50 (3), 809-820. (Pubitemid 32515336)
38. Fernández-Carballido, A.; Puebla, P.; Herrero- Vanrell, R.; Pastoriza, P. Radiosterilization of indomethacin PLGA/PEG-derivative microspheres: protective effects of low temperature during gamma- irradiation. Int. J. Pharm. 2006, 313 (1-2), 129-135.
39. Fernández-Carballido, A.; Herrero-Vanrell, R.; Molina-Martinez, I. T.; Pastoriza, P. Sterilized ibuprofen-loaded poly(D,L-lactide-co-glycolide) microspheres for intra-articular administration: effect of gamma-irradiation and storage. J. Microencapsul. 2004, 21 (6), 653-665. (Pubitemid 40069059)
40. Çolak, S.; Korkmaz, M. Investigation of radiosterilization and dosimetric features of sulfacetamide sodium. J. Pharm. Biomed. Anal. 2004, 36 (4), 791-798. (Pubitemid 39469419)
41. Carrascosa, C.; Espejo, L.; Torrado, S.; Torrado, J. J. Effect of gamma-sterilization process on PLGA microspheres loaded with insulin-like growth factor-I (IGF-I). J. Biomater. Appl. 2003, 18 (2), 95-108.
42. Montanari, L.; Cilurzo, F.; Selmin, F.; Conti, B.; Genta, I.; Poletti, G.; Orsini, F.; Valvo, L. Poly- (lactide-co-glycolide) microspheres containing bupivacaine: comparison between gamma and beta irradiation effects. J. Control. Release 2003, 90 (3), 281-290. (Pubitemid 36859960)
43. Oliveira, A. L.; Mano, J. F.; Román, J. S.; Reis, R. L. Study of the influence of beta-radiation on the properties and mineralization of different starch-based biomaterials. J. Biomed. Mater. Res. B Appl. Biomater. 2005, 74 (1), 560 -569.
44. Powell, D. B. Manual on Radiation Sterilization of Medical and Biological Materials, Technical Reports Series No.149; IAEA: Vienna, 1973; pp 111-129.
45. Soliman, E. A.; Mohy Eldin, M. S.; Furuta, M. Biodegradable zein-based films: influence of gamma- irradiation on structural and functional properties. J. Agric. Food Chem. 2009, 57 (6), 2529-2535.
46. Radiation Effects on Polymers for Biological Use; Kausch, H., Ed.; Advances in Polymer Science 162; Springer-Verlag: Berlin, 2003; pp 63-93.
47. Saçak, M. Polimer Kimyasi; Gazi Kitapevi: Ankara, Türkiye, 2002; pp 228 -299.
48. Sawyer, L. C.; Grubb, D. T.; Meyers, G. F. Polymer Microscopy, 3rd ed.; Springer: New York, 2008; pp 1-25.
49. Matthews, I. P.; Gibson, C.; Samuel, A. H. Sterilisation of implantable devices. Clin. Mater. 1994, 15 (3), 191-215. (Pubitemid 24127787)
50. Denizli, K. F. Medikal cihaz üretiminde kullanilan polimerlere radyasyon etkisi. Türkiye Atom Enerjisi Kurumu (TAEK), Ankara Nükleer Tarim ve Hayvancilik Araştirma Merkezi Gida Işinlama ve Sterilizasyon Bölümü, Endüstride Radyasyonla Sterilizasyon Kursu, Sarayköy, Ankara, 21-25 October 2002.
51. Sobhi, H.; Matthews, M. E.; Grandy, B.; Masnovi, J.; Riga, A. T. Selecting polymers for medical devices based on thermal analytical methods. J. Therm. Anal. Calorim. 2008, 93 (2), 535-539.
52. Introduction to Biopolymers. http://www.burdica. com/Medical-Biopolymers. html.
53. Fried, J. R. Polymer Science and Technology, 2nd ed.; Prentice Hall Professional Technical References (PTR), Pearson Education, Inc.: Upper Saddle River, NJ, 2003; pp 1-22, 153-205, 263-282, 353-388, 518 -521.
54. Bruck, S. D.; Mueller, E. P. Radiation sterilization of polymeric implant materials. J. Biomed. Mater. Res. 1988, A2 Suppl., 133-144.
55. An, Y. H.; Alvi, F. I.; Kang, Q.; Laberge, M.; Drews, M. J.; Zhang, J.; Matthews, M. A.; Arciola, C. R. Effects of sterilization on implant mechanical property and biocompatibility. Int. J. Artif. Organs 2005, 28 (11), 1126 -1137.
56. Bertrand, O. F.; Sipehia, R.; Mongrain, R.; Rodés, J.; Tardif, J. C.; Bilodeau, L.; Côté, G.; Bourassa, M. G. Biocompatibility aspects of new stent technology. J. Am. Coll. Cardiol. 1998, 32 (3), 562-571. (Pubitemid 28435237)
57. Vasita, R.; Shanmugam, I. K.; Katt, D. S. Improved biomaterials for tissue engineering applications: surface modification of polymers. Curr. Top. Med. Chem. 2008, 8 (4), 341-353.
58. Reichmanis, E.; Frank, C. W.; O'Donnell, J. H.; Hill, D. J. T. Irradiation of Polymeric Materials; American Chemical Society: Washington, DC, 1993; pp 1-8.
59. Tissue Engineering: The Nuts and Bolts. http://www. medicaldevice- network.com/features/feature386/.
60. Carvalho, F. G.; Fucio, S. B.; Pascon, F. M.; Kantovitz, K. R.; Correr-Sobrinho, L.; Puppin- Rontani, R. M. Effect of gamma irradiation on fluoride release and antibacterial activity of resin dental materials. Braz. Dent. J. 2009, 20 (2), 122-126.
61. DiCicco, M.; Compton, R.; Duong, T.; Jansen- Varnum, S. A. Electron paramagnetic resonance analyses of surface radical chemistries of gammasterilized orthopedic materials: Implications pointing to cytotoxicity via wear debris-induced inflammation. J. Biomed. Mater. Res. B Appl. Biomater. 2005, 75 (1), 6-17.
62. Mcgovern, T. F.; Ammeen, D. J.; Collier, J. P.; Currier, B. H.; Engh, G. A. Rapid polyethylene failure of unicondylar tibial components sterilized with gamma irradiation in air and implanted after a long shelf life. J. Bone Joint Surg. Am. 2002, 84-A (6), 901-906.
63. Briganti, E.; Al Kayal, T.; Kull, S.; Losi, P.; Spiller, D.; Tonlorenzi, S.; Berti, D.; Soldani, G. The effect of gamma irradiation on physicalmechanical properties and cytotoxicity of polyurethane- polydimethylsiloxane microfibrillar vascular grafts. J. Mater. Sci. Mater. Med. 2010, 21 (4), 1311-1319.
64. Bruck, S. D. Long-term stability of intraocular lenses: literature review, assessment, and testing protocol. J. Long Term Eff. Med. Implants 1993, 3 (4), 333-350. (Pubitemid 24032966)
65. Denizli, K. F. Test Yöntemleri-Radyasyonun Malzemeye Etkisinin Ölçülmesi ve Deǧerlendirilmesi. Endüstride Radyasyonla Sterilizasyonda Kalite Kontrolüve Kalite Temini Uygulamalari Kursu, Türkiye Atom Enerjisi Kurumu Ankara Nükleer Araştirma ve Eǧitim Merkezi, Gama Işinlama Tesisi, Sarayköy, Ankara, 20-24 November 1995.
66. Denizli, K. F. Iyonlaştirici isinlarla işinlanmiş polikarbonatin biyouyumluluǧu. PhD Dissertation, Hacettepe University, Ankara, Turkey, 1999.
67. Ohki, Y. Radiation effects on polymers. IEEE Transactions on Electrical Insulation 1986, 21 (6), 919-922.
68. Bennet, J. Material Considerations: Irradiation Processing. Sterigenics, 1- 4. Accessible at http:// www.sterigenics.com/services/medical-sterilization/ contract-sterilization/material-consideration-- irradiation-processing.pdf.
69. Hegazy, E. A.; Abdel-Rehim, H.; Diaa, D. A.; El-Barbary, A. Controlling of Degradation Effects in Radiation Processing of Polymers, IAEA-TECDOC- 1617; IAEA: Vienna, 2009; pp 67-84.
70. Chapiro, A. Radiation Chemistry of Polymeric Systems, High Polymers; Wiley-Interscience: New York, 1962; pp 64 -75.
71. Rabek, J. F. Experimental Methods in Polymer Chemistry; John Wiley: New York, 1980; p 527.
72. Simha, R.; Wall, L. Mechanism of high energy radiation effects in polymers. J. Phys. Chem. 1957, 61 (4), 425-430.
73. Zündorf, J.; Kremer, S.; Grüger, T. Formation of hydrogen fluoride by gamma and beta sterilisation in medical devices containing perfluoroheptane. Toxicology 2008, 243 (3), 284-293. (Pubitemid 350256868)
74. Kanjickal, D.; Lopina, S.; Evancho-Chapman, M. M.; Schmidt, S.; Donovan, D. Effects of sterilization on poly(ethylene glycol) hydrogels. J. Biomed. Mater. Res. A 2008, 87 (3), 608-617.
75. Jayabalan, M.; Lizymol, P. P. Effect of γ-radiation sterilization on the stability of polyurethane potting compounds based on castor oil/SMDI and caprolactone polyol/SMDI, used for hollow fibre haemodialyzer. Bull. Mater. Sci. 1997, 20 (5), 727-735. (Pubitemid 127577868)
76. Hemmerich, K. J. Polymer Materials Selection for Radiation-Sterilized Products. MDDI, 2000. Accessible at http://www.mddionline.com/article/ polymer-materials-selection-radiation-sterilizedproducts.
77. Killian, P.; Rabe, R.; Blackmore, J. Effect of gamma sterilization on select TPE materials, RTP Company Imagineering Plastics, 1-12, 2008. (http://medicaldesign.com/Whitepapers/ TPE-Gamma-Sterilization-White-Paper.pdf).
78. Fengmei, L. Dianhua, C. Effect of radiation on structure and properties of material made from oxpericardium. Radiat. Phys. Chem. 1998, 52 (1-6), 323-326.
79. Czvikovszky, T. Degradation effects in polymers. In Advances in Radiation Chemistry of Polymers, IAEA-TECDOC-1420; IAEA: Vienna, 2003; pp 91-102.
80. Kantoǧlu, Ö . Alternatif Sterilizasyon Yöntemlerinin Malzemeye Etkisi. Türkiye Atom Enerjisi Kurumu (TAEK), Ankara Nükleer Tarim ve Hayvancilik Araştirma Merkezi Gida Işinlama ve Sterilizasyon Bölümü, Endüstride Radyasyonla Sterilizasyon Kursu, Sarayköy, Ankara, 21-25 October 2002.