作为自动注射器固体配方的单克隆抗体的稳定性:试点研究
Fatima Garcia-Villen1,2,3, Idoia Gallego1,2,3, Myriam Sainz-Ramos1,2,3
1NanoBioCel Group, Laboratory of Pharmaceutics, Faculty of Pharmacy, University of the Basque Country UPV/EHU, 01006 Vitoria-Gasteiz, Spain.
Pharmaceutics
|August 26, 2023
概括
这项研究探讨了自动注射器的冷干燥单克隆抗体. 曼尼托尔改善了抗体稳定性,这是朝着更好的药物坚持性和患者友好的输送系统迈出的关键一步.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 药物输送系统 药物输送系统
背景情况:
- 药物坚持不佳是治疗类风湿性关节炎和牛皮性关节炎等慢性疾病的一个主要挑战.
- 亲肠道单克隆抗体是有效的治疗方法,但依附性可以通过输送方法来限制.
- 与传统注射器相比,自动注射器提供了更好的用户友好性和更少的不适,可能会提高粘附性.
研究的目的:
- 评估将单克隆抗体作为固体剂型在自动注射器中配制的可行性.
- 为了评估单克隆抗体在缩和冷干燥后的稳定性.
- 选辅助剂,以检查它们在固体配方中增强抗体稳定性的潜力.
主要方法:
- 单克隆抗体溶液的度,以减少体积.
- 缩抗体溶液的冷干燥 (溶解) 的方法.
- 差分扫描热量计 (纳米-DSC) 用于评估药物稳定性.
- 选辅助剂,包括曼尼托尔,以提高稳定性.
主要成果:
- 纳米DSC分析表明,曼尼托改善了缩,冷干燥单克隆抗体的稳定性.
- 即使使用曼尼托尔,也观察到抗体CH2域的轻微不稳定性,这表明需要进一步研究.
- 结果表明,自动注射器中固体抗体配方的潜力很大.
结论:
- 曼尼托尔是一种有前途的辅助剂,用于稳定缩,冷干燥的单克隆抗体,用于自动注射器应用.
- 需要进一步研究才能完全稳定抗体,特别是CH2域.
- 这项研究是向开发先进的药物输送系统的基本步骤,这些系统可以改善患者的坚持和体验.
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