Effect of gamma-irradiation on cladribine and cladribine-containing biodegradable copolymers.
The aims of this study were to assess the effects of sterilization with gamma-irradiation on (i). bulk cladribine and (ii). cladribine-containing biodegradable copolymers. The stability of cladribine upon irradiation was confirmed by TLC, HPLC, UV, IR, DSC, rentgenography and electron microscopy. The stability of copolymers containing cladribine upon irradiation was assessed by IR, DSC and EPR. In vitro kinetics of nucleoside release from the copolymers before and after irradiation were compared, and only slight changes were found. Results of our study indicate that gamma-irradiation can be safely applied for the sterilization of cladribine or cladribine-containing copolymers for medical purposes.
Kryczka
Tomasz
T
Medical Research Centre, Polish Academy of Sciences, Pawińskiego 5, 02-106 Warsaw, Poland. tkryczka@cmdik.pan.pl
Marciniec
Barbara
B
Popielarz-Brzezinska
Maria
M
Bero
Maciej
M
Kasperczyk
Janusz
J
Dobrzyński
Piotr
P
Kazimierczuk
Zygmunt
Z
Grieb
Paweł
P
D001673:Biodegradation, Environmental / Q000528:radiation effects; D017338:Cladribine / Q000032:analysis / Q000528:radiation effects*; D005720:Gamma Rays; D011108:Polymers / Q000032:analysis / Q000528:radiation effects*; D013242:Sterilization / Q000379:methods*
D011108:Polymers; D017338:Cladribine