Effect of Irradiation on Parathyroid Hormone PTH(1-34) Coated On a Novel Transdermal Microprojection Delivery System to Produce a Sterile Product-Adhesive Compatibility
Effect of Irradiation on Parathyroid Hormone PTH(1-34) Coated On a Novel Transdermal Microprojection Delivery System to Produce a Sterile Product-Adhesive Compatibility
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DOI：
10.1002/jps.21985
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发表时间：
2010-04-01
影响因子：
3.8
通讯作者：
Maa, Yuh-Fun
中科院分区：
文献类型：
--
作者：
Ameri, Mahmoud;Wang, Xiaomei;Maa, Yuh-Fun
通过伽马射线或电子束的最终灭菌和无菌处理作为生产涂在新型透皮微喷射输送系统上的甲状旁腺激素 1-34 无菌产品的方法进行了评估。两种方法的主要区别在于分别在最终灭菌和无菌加工过程中包含和排除用于辐照的包衣制剂。最终产品的伽马辐射和电子束都会导致 PTH(1-34) 氧化增加，可以通过降低辐射剂量或辐射温度来减少这种氧化。最大限度地减少初级包装内的水分和氧气含量可以有效限制 PTH 氧化
Terminal sterilization via gamma-irradiation or e-beam and aseptic processing were evaluated as a means to manufacture the sterile product of parathyroid hormone 1-34 coated on a novel transdermal microprojection delivery system. The main difference of the two methods is the inclusion and exclusion of the coated formulation for irradiation during terminal sterilization and aseptic processing, respectively. Both gamma-irradiation and e-beam of the final product resulted in increased PTH(1-34) oxidation, which could be reduced by lowering the irradiation dose or the irradiation temperature. Minimizing moisture and oxygen levels inside the primary packaging could effectively limit PTH oxidation to