研磨参数对晶体形态,热行为和美沙胺纳米晶体溶解的影响
Sakshi Kunjir1, Prajakta Pathare1, Sonam Sharma1
1Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur, Export Promotion Industrial Park (EPIP), Zandaha Road, NH322, Hajipur, Bihar, 844102, India.
Pharmaceutical research
|July 23, 2025
概括
用干式球磨来制造梅沙胺纳米晶体 (NCs),以提高药物的溶解性和溶解性. 优化的参数产生了板状NCs (435nm) 在60分钟内溶解84%,提高了治疗潜力.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 药物运输 药物运输 药物运输
背景情况:
- 像梅沙胺 (MES) 这样的药物分子的低水溶性限制了治疗疗效,需要高剂量.
- 由于结肠溶解不良,梅萨拉需要高剂量 (高达4.8g/天) 用于治疗炎症性肠病.
研究的目的:
- 为了提高梅萨拉胺的溶解速度和溶解度.
- 设计和开发梅沙胺纳米晶体 (NCs),用于增强药物输送.
主要方法:
- 梅萨拉胺纳米晶体是通过干球磨粉 (BM) 工艺制造的.
- 使用Soluplus作为稳定剂,并优化磨参数 (时间,速度,稳定剂度).
- 分析了纳米晶体的特性,包括粒子大小,形态和溶解.
主要成果:
- 优化的磨削参数产生了多样化的MES NC形态.
- 第29批 (40/1/400) 产生板状MESNC (435nm,PDI 0.39),溶解明显改善 (60分钟内84%) 的结果.
- 球磨机有效地影响了MES的溶解性,溶解率,颗粒大小和晶体习惯.
结论:
- 干球研磨是一种可行的平台技术,用于生产mesalamine纳米晶体.
- 开发的MESNCs显示了增强的溶解,为改善治疗结果提供了潜力.
- 研究结果支持使用干BM技术扩展和商业化药物产品.
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