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洞察长效注射悬浮剂的发展情况
Nilesh Malavia1, Diane J Burgess1
1University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT 06269, USA.
概括
长效注射 (LAI) 悬浮剂为慢性疾病提供持续的药物输送. 开发这些复杂的配方是具有挑战性的,但在表征和建模方面的进步正在为改进的疗法铺平道路.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 生物制药生物制药公司
背景情况:
- 长效注射剂 (LAI) 悬浮剂对于慢性疾病管理有价值,改善了依从性和减少了剂量频率.
- 尽管有好处,但LAI悬浮开发在理解复杂的释放机制,定义关键质量属性 (CQA) 和建立强大的体外-体内相关性 (IVIVC) 方面面临挑战.
研究的目的:
- 提供对LAI悬浮开发当前景观的全面审查.
- 突出最近的进展,并确定LAI暂停配方和监管批准的挑战和未来研究方向.
主要方法:
- 深入分析市场趋势,治疗用途,监管准则,制造工艺和关键配方CQAs.
- 对物理化学表征,体外释放试验,IVIVC和生理学基础的药物动力学 (PBPK) 建模方面的进展进行审查.
- 强调颗粒特征和沉积物形成对药物释放的影响以及新体外方法.
主要成果:
- 置LAI具有重要的制药机会,但由于复杂的释放和未定义的CQAs,在开发中面临障碍.
- 最近的进展包括增强的表征技术,新的体外释放试验,以及IVIVC和PBPK模型的开发.
- 颗粒大小,聚合和仓库形成是影响药物释放动态的关键因素.
结论:
- 克服监管和技术障碍需要创新的方法,包括生物相关的释放方法和机制建模.
- 了解和预测药物释放的进步对于成功开发和批准LAI暂停至关重要.
- 本综述为科学家和监管机构提供了洞察力,以推进LAI悬浮技术领域的发展.
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