title: Influence of irradiation sterilization on poly(lactide-co-glycolide) microspheres containing anti-inflammatory drugs.
abstract: Gamma-irradiation is finding increasing use in the sterilization of pharmaceutical products. However, irradiation might also affect the performance of drug delivery systems. In this study, the influence of gamma-irradiation on the physicochemical properties of two commonly used non-steroidal anti-inflammatory drugs (NSAIDs) [naproxen sodium (NS) and diclofenac sodium (DS)] was investigated. The drugs were incorporated in poly(lactide-co-glycolide) (PLGA, 50:50; molecular weight 34000 or 88000 Da) microspheres. The biodegradable microspheres were irradiated at doses of 5, 15, 25 kGy using a 60Co source. Drug loading of irradiated and non-irradiated microspheres with both 34000 and 88000 Da polymers were essentially the same. A significant difference was noticed in the particle sizes of the irradiated as compared to the non-irradiated formulations. Notably, in release studies, the amount of active substance released from PLGA microspheres showed an increase with increasing irradiation dose. In DSC, the glass transition temperatures (Tg) of microspheres exhibited a slow increase with irradiation dose.
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, Hacettepe University, Ankara, Turkey. sucalis@tr.net
authors.forename: Sema
authors.initials: S
authors.lastname: Caliş
authors.forename: Sibel
authors.initials: S
authors.lastname: Bozdag
authors.forename: H Süheyla
authors.initials: HS
authors.lastname: Kaş
authors.forename: Melike
authors.initials: M
authors.lastname: Tunçay
authors.forename: A Atilla
authors.initials: AA
authors.lastname: Hincal
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000528:radiation effects*; D002152:Calorimetry, Differential Scanning; D004008:Diclofenac / Q000528:radiation effects*; D016503:Drug Delivery Systems; D009288:Naproxen / Q000528:radiation effects*; D011098:Polyglactin 910 / Q000528:radiation effects*; D013242:Sterilization / Q000379:methods*; D013678:Technology, Pharmaceutical
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D011098:Polyglactin 910; D009288:Naproxen