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  • 1 Hacettepe University Department of Radiopharmacy, Faculty of Pharmacy Ankara Turkey
  • | 2 Hacettepe University Department of Physics Engineering, Faculty of Engineering Ankara Turkey
  • | 3 Hacettepe University Department of Pharmaceutical Microbiology, Faculty of Pharmacy Ankara Turkey
  • | 4 Hacettepe University Department of Radiopharmacy, Faculty of Pharmacy 06100 Sıhhiye-Ankara Turkey
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The use of gamma rays for the sterilization of pharmaceutical raw materials and dosage forms is an alternative method for sterilization. However, one of the major problems of the radiosterilization is the production of new radiolytic products during the irradiation process. Therefore, the principal problem in radiosterilization is to determine and to characterize these physical and chemical changes originating from high-energy radiation. Parenteral drug delivery systems were prepared and in vitro characterization, biodistribution and treatment studies were done in our previous studies. Drug delivery systems (liposomes, niosomes, lipogelosomes and niogelosomes) encapsulating diclofenac sodium (DFNa) were prepared for the treatment of rheumatoid arthritis (RA). This work complies information about the studies developed in order to find out if gamma radiation could be applied as a sterilization method to DFNa, and the raw materials as dimyristoyl phosphatidylcholine (DMPC), surfactant I [polyglyceryl-3-cethyl ether (SUR I)], dicethyl phosphate (DCP) and cholesterol (CHOL) that are used to prepare those systems. The raw materials were irradiated with different radiation doses (5, 10, 25 and 50 kGy) and physicochemical changes (organoleptic properties pH, UV and melting point), microbiological evaluation [sterility assurance level (SAL), sterility and pyrogen test] and electron spin resonance (ESR) characteristics were studied at normal (25 °C, 60% relative humidity) and accelerated (40 °C, 75% relative humidity) stability test conditions.

  • Bushell JA, Claybourn M, Wiliams HE, Murphy DM: An EPR and ENDOR study of γ- and β-radiation sterilization in poly (lactide-co-glycolide) polymers and microspheres. J Control Rel 110, 49–57 (2005)

    Murphy D.M. , 'An EPR and ENDOR study of γ- and β-radiation sterilization in poly (lactide-co-glycolide) polymers and microspheres ' (2005 ) 110 J Control Rel : 49 -57.

    • Search Google Scholar
  • Mohammed AR, Bramwell VW, Coombes AGA, Perrie Y: Lyophilisation and sterilization of liposomal vaccines to produce stable and sterile products. Methods 40, 30–38 (2006)

    Perrie Y. , 'Lyophilisation and sterilization of liposomal vaccines to produce stable and sterile products ' (2006 ) 40 Methods : 30 -38.

    • Search Google Scholar
  • Erdoğan S, Özer AY, Ekizoğlu M, Özalp M, Çolak Ş: Gamma irradiation of liposomal phospholipids. FABAD J Pharm Sci 31, 182–190 (2006)

    Çolak , 'Gamma irradiation of liposomal phospholipids ' (2006 ) 31 FABAD J Pharm Sci : 182 -190.

    • Search Google Scholar
  • Olguner Mercanoğlu G, Özer AY, Çolak Ş, Korkmaz M, Özalp M, Ekizoğlu M, Barbarin N, Tilquin B: Radiosterilization of sulfonamides I: Determination of the effects of gamma irradiation on solid sulfonamids. Rad Phys Chem 69, 511–520 (2004)

    Tilquin B. , 'Radiosterilization of sulfonamides I: Determination of the effects of gamma irradiation on solid sulfonamids ' (2004 ) 69 Rad Phys Chem : 511 -520.

    • Search Google Scholar
  • Botelho ML, Verde SC, Alves L, Balchior A, Reymao J, Trabulo S, Gaspar MM, Cruz MEM, Simoes S: Radiation sterilization of antibiotic liposome formulations: A case study. Rad Phys Chem 76, 1542–1546 (2007)

    Simoes S. , 'Radiation sterilization of antibiotic liposome formulations: A case study ' (2007 ) 76 Rad Phys Chem : 1542 -1546.

    • Search Google Scholar
  • Berk F, Özer AY: Radiation sterilization of medical devices. FABAD J Pharm Sci 24, 223–231 (1999)

    Özer A.Y. , 'Radiation sterilization of medical devices ' (1999 ) 24 FABAD J Pharm Sci : 223 -231.

    • Search Google Scholar
  • Berk F: Tek Kullanımlık tıbbi malzemelerin gama radyasyonu ile sterilizasyonu ve diğer yöntemlerle karşılaştırılması. MSci thesis, Institute of Health Science, Hacettepe Universty, Ankara, Turkey (2002)

    Berk F. , '', in MSci thesis , (2002 ) -.

  • Liman V, Özer AY, Çolak S, Korkmaz M, Kılıç E, Özalp M: The effects of gamma radiation sterilization on cefazolin sodium. FABAD J Pharm Sci 30, 124–132 (2005)

    Özalp M. , 'The effects of gamma radiation sterilization on cefazolin sodium ' (2005 ) 30 FABAD J Pharm Sci : 124 -132.

    • Search Google Scholar
  • Naki N: Kozmetikler ve kozmetik hammaddelerinin gama radyasyonla sterilizasyonu/dekontaminasyonu üzerinde çalışmalar. MSci thesis, Institute of Health Science, Hacettepe University, Ankara, Turkey (2003)

    Naki N. , '', in MSci thesis , (2003 ) -.

  • Olguner G: Radiation sterilization of sulfonamides and comparison with the other sterilization techniques. MSci thesis, Institute of Health Science, Hacettepe University, Ankara, Turkey (2000)

    Olguner G. , '', in MSci thesis , (2000 ) -.

  • Türker S, Erdoğan S, Özer AY, Ergün EL, Tuncel M, Bilgili H, Deveci S: Scintigraphic imaging of radiolabelled drug delivery systems in rabbits with arthritis. Int J Pharm 296, 34–43 (2005)

    Deveci S. , 'Scintigraphic imaging of radiolabelled drug delivery systems in rabbits with arthritis ' (2005 ) 296 Int J Pharm : 34 -43.

    • Search Google Scholar
  • Zuidam NJ, Gouw HK, Barenholz Y, Crommelin DJ: Physical (in) stability of liposomes upon chemical hydrolysis: The role of lysophosphalipids and fatty acids. Biochim Biophys Acta 22, 101–110 (1995)

    Crommelin D.J. , 'Physical (in) stability of liposomes upon chemical hydrolysis: The role of lysophosphalipids and fatty acids ' (1995 ) 22 Biochim Biophys Acta : 101 -110.

    • Search Google Scholar
  • Barbarin N, Tilquin B: Study of nonvolatile degradation compounds produced by radiosterilization of cefatoxime. Radiat Phys Chem 60, 359–367 (2001)

    Tilquin B. , 'Study of nonvolatile degradation compounds produced by radiosterilization of cefatoxime ' (2001 ) 60 Radiat Phys Chem : 359 -367.

    • Search Google Scholar
  • Gibella M, Crucq AS, Tilquin B, Stocker P, Lesgards G, Raffi Y: ESR studies of some irradiated pharmaceuticals. Radiat Phys Chem 58, 69–76 (2000)

    Raffi Y. , 'ESR studies of some irradiated pharmaceuticals ' (2000 ) 58 Radiat Phys Chem : 69 -76.

    • Search Google Scholar
  • Olguner Mercanoğlu G, Özer AY, Özalp M, Ekizoğlu M: Radiosterilization of sulfonamides II: Determination of the effects of gamma irradiation on commercial sulfanomide preparations. Turkish J Pharm Sci 4, 159–170 (2007)

    Ekizoğlu M. , 'Radiosterilization of sulfonamides II: Determination of the effects of gamma irradiation on commercial sulfanomide preparations ' (2007 ) 4 Turkish J Pharm Sci : 159 -170.

    • Search Google Scholar
  • British Pharmacopoeia (2004): University Press, Cambridge

  • Kantaglu O (2004): Endüstride sterilizasyon kursu, TAEK, Ankara

    Kantaglu O. , '', in Endüstride sterilizasyon kursu , (2004 ) -.

  • Phillips GO, Power DM, Sewart MCG: Effects of gamma irradiation on sodium sulphacetamide. Radiat Res 46, 236–250 (1971)

    Sewart M.C.G. , 'Effects of gamma irradiation on sodium sulphacetamide ' (1971 ) 46 Radiat Res : 236 -250.

    • Search Google Scholar
  • Amin GAM, Spyrou NM: Study of gamma-radiation-induced optical effects in Ge-Se-Cd for possible industrial dosimetric applications. Rad Phys Chem 72, 419–422 (2007)

    Spyrou N.M. , 'Study of gamma-radiation-induced optical effects in Ge-Se-Cd for possible industrial dosimetric applications ' (2007 ) 72 Rad Phys Chem : 419 -422.

    • Search Google Scholar
  • Pandey BN, Lathika KM, Mishra KP: Radiation induced oxidative damage modification by cholesterol in liposomal membrane. Rad Phys Chem 54, 481–489 (1999)

    Mishra K.P. , 'Radiation induced oxidative damage modification by cholesterol in liposomal membrane ' (1999 ) 54 Rad Phys Chem : 481 -489.

    • Search Google Scholar
  • Pandey BN, Lathika KM, Mishra KP: Modification of radiation-induced oxidative damage in liposomal and microsomal membrane by eugenol. Rad Phys Chem 75, 384–391 (2006)

    Mishra K.P. , 'Modification of radiation-induced oxidative damage in liposomal and microsomal membrane by eugenol ' (2006 ) 75 Rad Phys Chem : 384 -391.

    • Search Google Scholar
  • Plikk P, Odelius K, Hakkarainen M, Albertsson AC: Finalizing the properties of porous scaffolds of aliphatic polyesters through radiation sterilization. Biomaterials 27, 5335–5347 (2006)

    Albertsson A.C. , 'Finalizing the properties of porous scaffolds of aliphatic polyesters through radiation sterilization ' (2006 ) 27 Biomaterials : 5335 -5347.

    • Search Google Scholar
  • Sprinz H, Schwinn J, Naumov S, Brede O: Mechanism of thiyl radical-catalyzed isomerization of unsaturated fatty acid residues in homogeneous solution and in liposomes. BBA 1483, 91–100 (2000)

    Brede O. , 'Mechanism of thiyl radical-catalyzed isomerization of unsaturated fatty acid residues in homogeneous solution and in liposomes ' (2000 ) 1483 BBA : 91 -100.

    • Search Google Scholar
  • Varshney L, Dodke PB: Radiation effect studies on anticancer drugs, cyclophosphamide and doxorubicin for radiation sterilization. Rad Phys Chem 71, 1103–1111 (2004)

    Dodke P.B. , 'Radiation effect studies on anticancer drugs, cyclophosphamide and doxorubicin for radiation sterilization ' (2004 ) 71 Rad Phys Chem : 1103 -1111.

    • Search Google Scholar
  • Deeley CM: A basic interpretation of the technical language of radiation processing. Rad Phys Chem 71, 503–507 (2004)

    Deeley C.M. , 'A basic interpretation of the technical language of radiation processing ' (2004 ) 71 Rad Phys Chem : 503 -507.

    • Search Google Scholar
  • El-Ridy MS, Mostafa DM, Shehab A, Nasr EA, El-Alim SA: Biological evaluation of pyrazinamide liposomes for treatment of Mycobacterium tuberculosis. Int J Pharm 330, 82–88 (2007)

    El-Alim S.A. , 'Biological evaluation of pyrazinamide liposomes for treatment of Mycobacterium tuberculosis ' (2007 ) 330 Int J Pharm : 82 -88.

    • Search Google Scholar
  • Katusin-Razem B, Mihaljevic B, Razem D: Microbial decontamination of cosmetic raw materials and personal care products by irradiation. Rad Phys Chem 66, 309–316 (2003)

    Razem D. , 'Microbial decontamination of cosmetic raw materials and personal care products by irradiation ' (2003 ) 66 Rad Phys Chem : 309 -316.

    • Search Google Scholar
  • Dam AM, Gazso LG, Kaewpila S, Maschek I: Radiation treatment of pharmaceuticals. Radiat Chem 47, 515–517 (1996)

    Maschek I. , 'Radiation treatment of pharmaceuticals ' (1996 ) 47 Radiat Chem : 515 -517.

  • Da Costa ZM, Pontusehka WM, Campos LL: Study of the ESR signal of gamma irradiated hydroxyapatite for dose assessment. Nucl Instrum Meth B 218, 283–288 (2004)

    Campos L.L. , 'Study of the ESR signal of gamma irradiated hydroxyapatite for dose assessment ' (2004 ) 218 Nucl Instrum Meth B : 283 -288.

    • Search Google Scholar
  • Faucitano A, Buttafava A, Montanari L, Cilurzo F, Conti B, Genta I, Valvo L: Radiation-induced free radical reactions in polymer/drug systems for controlled release: An EPR investigation. Radiat Phys Chem 67, 61–72 (2003)

    Valvo L. , 'Radiation-induced free radical reactions in polymer/drug systems for controlled release: An EPR investigation ' (2003 ) 67 Radiat Phys Chem : 61 -72.

    • Search Google Scholar

2019  
Scimago
H-index
11
Scimago
Journal Rank
0,220
Scimago
Quartile Score
Medicine (miscellaneous) Q3
Scopus
Cite Score
155/133=1,2
Scopus
Cite Score Rank
General Medicine 199/529 (Q2)
Scopus
SNIP
0,343
Scopus
Cites
206
Scopus
Documents
23

 

Interventional Medicine and Applied Science
Language English
Size  
Year of
Foundation
2009
Publication
Programme
changed title
Volumes
per Year
 
Issues
per Year
 
Founder Akadémiai Kiadó
Founder's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Publisher's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Responsible
Publisher
Chief Executive Officer, Akadémiai Kiadó
ISSN 2061-1617 (Print)
ISSN 2061-5094 (Online)

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