Radiosterilisation of indomethacin PLGA/PEG-derivative microspheres:: Protective effects of low temperature during gamma-irradiation
Radiosterilisation of indomethacin PLGA/PEG-derivative microspheres:: Protective effects of low temperature during gamma-irradiation
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DOI：
10.1016/j.ijpharm.2006.01.034
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发表时间：
2006-04-26
影响因子：
5.8
通讯作者：
Pastoriza, P
中科院分区：
文献类型：
--
作者：
Fernández-Carballido, A;Puebla, P;Pastoriza, P
目前，伽马辐照似乎是一种对由可生物降解聚合物制成的药物输送系统进行灭菌的好方法。微球的伽马辐照可以引起聚合物基质中的几个物理化学变化。这些修饰受温度、辐射剂量以及所包封药物和添加剂的性质的影响。本研究旨在评价温度对含有聚乙二醇衍生物的消炎痛PLGA微球在伽马辐照灭菌过程中的影响。采用溶剂挥发法制备了O/W乳状液微球，并对其进行了辐照处理。为了确保有效的灭菌，使用了25kGy的剂量。一些微球用干冰保护灭菌，保证了过程中的低温，而另一些微球在没有干冰保护的情况下灭菌。研究了辐照对未负载PLGA/聚乙二醇衍生物和吲哚美辛负载PLGA/聚乙二醇衍生物微球及其保护前后性能的影响。未保护的微球灭菌后，其表面形态、聚合物玻璃化转变温度、相对分子质量和吲哚美辛的释放速率均发生了变化。然而，经过保护灭菌的微球在伽马辐射暴露后并没有显示出显著的差异。将含有聚乙二醇衍生物的吲哚美辛微球置于低温伽马辐照下，灭菌方法令人满意。(C)2006爱思唯尔B.V.保留所有权利。
Currently, gamma-irradiation seems to be a good method for sterilising drug delivery systems made from biodegradable polymers. The gamma-irradiation of microspheres can cause several physicochemical changes in the polymeric matrix. These modifications are affected by the temperature, irradiation dose and nature of the encapsulated drug and additives. This study has aimed to evaluate the influence of temperature during the sterilisation process by gamma irradiation in indomethacin PLGA microspheres including a PEG-derivative. Microspheres were prepared by the solvent evaporation method from o/w emulsion and were then exposed to gamma-irradiation. A dose of 25 kGy was used to ensure effective sterilisation. Some microspheres were sterilised with dry ice protection that guaranteed a low temperature during the process whilst others were sterilised without such dry ice protection. The effects of gamma-irradiation on the characteristics of non-loaded PLGA/PEG-derivative and indomethacin loaded PLGA/PEG-derivative microspheres with and without protection were studied. Non-protected microspheres showed changes in their morphological surface, polymer glass transition temperature, molecular weight and release rate of indomethacin after sterilisation. However, microspheres sterilised with protection did not show significant differences after gamma-irradiation exposure. The sterilisation method was satisfactory when the indomethacin loaded microspheres including a PEG-derivative were exposed to gamma-irradiation at low temperature. (c) 2006 Elsevier B.V. All rights reserved.