a Department of Radiopharmacy, Faculty of Pharmacy , Hacettepe University , Ankara , Turkey.
b Department of Pharmaceutical Microbiology, Faculty of Pharmacy , Hacettepe University , Ankara , Turkey.
Pharm Dev Technol. 2017 Sep;22(6):775-784. doi: 10.3109/10837450.2016.1163393. Epub 2016 Apr 6.
In recent years, drug delivery systems such as liposomes and microparticles have been used in clinic for the treatment of different diseases and from a regulatory point of view, a parenterally applied drug and drug delivery systems must be sterile and pyrogen free. Radiation sterilization is a method recognized by pharmacopoeias to achieve sterility criteria of parenterals. It has the ability to kill microorganisms in therapeutic products. The ability of, however, irradiation might also affect the performance of drug delivery systems. One of the most critical points is irradiation dose, because certain undesirable chemical and physical changes may accompany with the irradiation, especially with the traditionally applied dose of 25 kGy. Its ionizing property may cause fragmentation of covalent bond. The care must be paid to the applied dose. In this research, the effects of gamma irradiation on different drug delivery systems such as chitosan microparticles, liposomes, niosomes and sphingosomes were investigated. According to the experimental data, it can be concluded that gamma irradiation can be a suitable sterilization technique for liposome, niosome and sphingosome dispersions. When all irradiated drug carrier systems were taken into consideration, chitosan glutamate microparticles were found as the most radioresistant drug delivery system among the others.
近年来,脂质体和微粒等药物传递系统已在临床上用于治疗各种疾病,从监管的角度来看,用于注射的药物和药物传递系统必须是无菌且无热原的。辐照灭菌是一种被药典认可的方法,可达到注射剂的无菌标准。它具有杀死治疗产品中微生物的能力。然而,辐照的能力也可能会影响药物传递系统的性能。其中最关键的一点是辐照剂量,因为伴随着辐照,可能会发生某些不良的化学和物理变化,尤其是传统应用的 25kGy 剂量。其电离特性可能会导致共价键的断裂。因此必须注意辐照剂量。在这项研究中,研究了γ辐照对壳聚糖微粒、脂质体、非离子体和神经酰胺体等不同药物传递系统的影响。根据实验数据,可以得出结论,γ辐照可以作为脂质体、非离子体和神经酰胺体分散体的一种合适的灭菌技术。当考虑所有辐照药物载体系统时,发现谷氨酸壳聚糖微球是所有药物传递系统中对辐照最具抗性的。