Faculty of Pharmacy, Ahram Canadian University, Giza, Egypt.
Department of Pharmaceutics and Industrial Pharmacy Faculty of Pharmacy, Helwan University, Ain Helwan, Cairo, 11795, Egypt.
Daru. 2019 Jun;27(1):295-305. doi: 10.1007/s40199-019-00275-2. Epub 2019 Jun 7.
Oral administration of Iodine (I) solutions causes high risk of contamination for patients and dispensers. The objective of the study was to adapt hard gelatin capsules (HGCs) for filling with radiopharmaceutical solutions without deformation.
Polystyrene (PS) internally lining films with different thicknesses were used to protect HGCs. The insulated HGCs were evaluated for their physicochemical characteristics and rupturing time in different dissolution media. HGCs internally lined with PS were examined for withstand loading with different volumes and radioactivities of I solutions. Radioactivity release was studied in deionized water and acidic media. Quality control of released I was inspected for radiochemical purities.
There was a directly proportion between PS lining thickness and stability of HGCs after filling with 500 μl aqueous methylene blue solution. HGCs internally lined with PS 100 μm thickness withstand deformation for ˃ two months; however showed fast in-vitro rupturing time in different dissolution media. Internally lined HGCs loaded with different volumes and radioactivities of I solutions resisted for one week without radioactive leakage. Yet, revealed complete release of I after 20 min in dissolution media with great radiochemical purity.
The study promises safely I aqueous solution delivery via adapted HGCs. Graphical abstract Oral administration of radiopharmaceuticals.
口服碘（I）溶液会给患者和药剂师带来高度污染的风险。本研究的目的是开发一种方法，将硬胶囊（HGC）用于放射性药物溶液的填充，以避免变形。
使用不同厚度的聚苯乙烯（PS）内部衬膜来保护 HGC。对绝缘 HGC 的物理化学特性和在不同溶解介质中的破裂时间进行了评估。对 PS 内部衬里的 HGC 进行了不同体积和放射性碘溶液的承载能力测试。在去离子水和酸性介质中研究了放射性释放。对释放的 I 进行了放射化学纯度的质量控制检查。
在向 500μl 水性亚甲蓝溶液中填充后，PS 衬里厚度与 HGC 的稳定性之间存在直接比例关系。PS 厚度为 100μm 的 HGC 内部衬里可在不发生变形的情况下稳定保存˃两个月；然而，在不同的溶解介质中显示出快速的体外破裂时间。用不同体积和放射性碘溶液填充的内部衬里 HGC 可在一周内保持放射性泄漏，且无泄漏。然而，在溶解介质中，在 20 分钟后完全释放了 I，且具有很高的放射化学纯度。
本研究有望通过改良的 HGC 安全地输送放射性药物水溶液。
