快速溶解的阿皮克萨班口服膜的设计和表征
Siva Prasad Sagili1, P Phani Deepika1, Eswaramma Pavuluri1
1Department of Pharmaceutics and Pharmaceutical Analysis, MNR College of Pharmacy MNR Nagar, Fasalwadi, Sangareddy, India.
概括
新的阿皮克萨班口服薄膜 (OTF) 为患有吞困难的患者提供快速释放药物. 这些快速溶解的薄膜提高了生物可用性,并有效地解决了血栓性问题.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
背景情况:
- 在COVID-19后出现的血栓性并发症需要有效的抗凝剂.
- 作为XA因子抑制剂的阿皮克萨班对于治疗深静脉血栓和动脉疾病至关重要.
- 对于患有食障碍的患者来说,常规剂量形式的挑战.
研究的目的:
- 开发快速分解的阿皮克萨班口服薄膜 (OTF).
- 提高药物释放动力学和患者的遵从性.
- 通过另一种输送途径改善阿皮克萨班的生物利用性.
主要方法:
- 用于OTF制造的溶剂造方法.
- 利用各种超级分解剂来优化膜的特性.
- 使用Design-Expert®软件,一个2^2的因数设计指导了配方开发.
主要成果:
- 优化的OTF表现出快速分解和增强的药物释放.
- 在60秒内达到93.47%的累积药物释放率.
- 评估优化的薄膜参数,包括pH值,药物含量,折叠耐久性和稳定性.
结论:
- 阿皮克萨班的OTF表现出第一阶段释放动力学.
- 菲克的扩散控制了药物释放机制.
- OTF提供了一种有前途的方法,用于快速系统吸收阿皮克萨班.
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