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Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
Published on: July 23, 2016
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在眼科预装注射器中对托波特干进行稳定性研究,用于静脉内输送
William Bello1,2,3, Camille Hosotte1,2,3, Camille Stampfli1
1Pharmacy Department, Lausanne University Hospital, Lausanne, Switzerland.
European journal of hospital pharmacy : science and practice
|January 21, 2025
概括
预填注射器中的托波特干 (TPT) 在5°C和-20°C稳定12个月,为视网膜母细胞瘤治疗提供了安全的选择. 这种稳定性支持有效地为患者准备和管理TPT.
科学领域:
- 眼科医生 眼科 眼科
- 在瘤学瘤学.
- 制药科学 制药科学
背景情况:
- 内和室内托波特干 (TPT) 在视网膜母细胞瘤治疗中显示出有效性.
- 由于水解,梅尔法兰需要快速施用,与TPT不同.
- 由于其稳定性和降低毒性,TPT为预填注射器提供了潜在的潜力.
研究的目的:
- 在预装注射器中评估TPT的稳定性.
- 在各种存储条件下,评估TPT在20微克/毫升和200微克/毫升的稳定性.
- 确定TPT对于预填注射器生产的适用性.
主要方法:
- 使用二极管阵列检测的逆相液态色谱.
- 在30°C,5°C和-20°C12个月的预填注射器中评估的物理化学稳定性.
- 进行了视觉检查和pH值测量.
主要成果:
- TPT溶液 (20微克/毫升和200微克/毫升) 在5°C和-20°C稳定12个月.
- 在建议的储存温度下,没有观察到沉物或pH/度的显著变化.
- 在3个月后,只有在30°C时检测到轻微的降解剂 (8-甲基-TPT) (<0.5%).
结论:
- 在BBraun Omnifix注射器中的TPT溶液在5°C保存时稳定12个月.
- 这种稳定性支持TPT对患者的安全和可靠的管理.
- 预填TPT注射器是用于视网膜母细胞瘤治疗的可行选择.
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