基于凝的布卡粘合剂双层配方尼菲迪平的开发和表征
M Alagusundaram1, Nem Kumar Jain2, M Yasmin Begum3
1Department of Pharmaceutics, School of Pharmacy, ITM University, Gwalior 474001, Madhya Pradesh, India.
Gels (Basel, Switzerland)
|September 27, 2023
概括
开发了一种使用聚合物双层配方的新型nifedipine口腔输送系统. 这种稳定,可控释放的系统证明了有效的药物捕获和最小的刺激,显示了针对药物输送的前景.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 生物材料科学 生物材料科学
背景情况:
- 尼菲迪平是一种通道阻塞剂,用于高血压和胸痛.
- 传统的尼菲迪平口服配方可能会受到第一通代谢和可变生物利用性的影响.
- 口腔药物递送提供了一种潜在的替代途径,可以提高治疗疗效.
研究的目的:
- 开发和表征一种新型的聚合物布科粘合双层配方,用于控制的尼菲迪平输送.
- 评估开发系统的药物捕获,稳定性和释放动力学.
- 通过ex vivo和in vivo研究来评估配方的安全性和有效性.
主要方法:
- 使用水友性聚合物 (HPMC,SCMC,CP) 和不透的支持层 (EC) 制备双层药片.
- 使用DSC,热重力测量分析,预制剂研究和ex vivo测试 (粘,pH,胀,透) 的表征.
- 在体外和体内释放药物的研究,在人类唾液中进行稳定性测试,并对粘膜组织进行组织学检查.
主要成果:
- DSC证实了无相互作用的尼菲迪平捕获;预配方研究显示了良好的成分特性.
- 优化的配方 (NT5) 呈现出极好的口粘强度和受控的药物释放 (R2=0.9966).
- 实验室和体内释放概况与相关性很好,没有显著的降解或粘膜刺激.
结论:
- 开发的nifedipine buccoadhesive双层配方是一种用于向药物输送的新,稳定和有效系统.
- 该配方确保了单向药物释放,并为传统的注射途径提供了有希望的替代方案.
- 该系统在唾液中的稳定性和缺乏粘膜刺激支持其临床适用性.
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