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用于口腔结核病治疗的德拉曼尼德纳米颗粒通过乳化进行配方和扩展

Nicholas J Caggiano¹, Madeleine S Armstrong¹, Joanna S Georgiou¹

¹Department of Chemical and Biological Engineering, Princeton University, Princeton, New Jersey 08544, United States.

Molecular pharmaceutics

|August 14, 2023

概括

通过乳化进行德拉曼胺 (DLM) 的纳米封装可提高溶解动力学和稳定性,用于治疗耐药结核病 (DR-TB). 这种方法克服了无形固体分散的局限性,提供了更好的口服生物可用性.

科学领域:

制药科学制药科学
药物输送系统药物输送系统
纳米技术纳米技术

背景情况:

德拉曼尼德 (DLM) 对于治疗耐药结核病 (DR-TB) 是至关重要的.
DLM的疏水性导致溶解性差,限制了口服生物可用性.
现有的无形固体分散 (ASD) 在恶劣条件下面临稳定性问题 (相分离,再结晶).

研究的目的:

开发一种稳定的DLM纳米封装配方,以增强溶解动力学和口服生物可用性.
为了克服ASD和基于降水的纳米封装方法对DLM的局限性.
用一种乳化方法研究DLM纳米封装,以提高稳定性和有效性.

主要方法:

通过乳化研究了DLM纳米封装,保持DLM在分散阶段溶解.
选稳定剂 (莱西和HPMC) 和优化配方使用探头超声波.
扩大了生产规模,使用高压均质化和喷雾干燥得到的乳液.
使用固态NMR和体外溶解研究评估物理稳定性和溶解动力学.

主要成果:

优化的配方实现了250nm稳定的乳液滴,使用1:1莱西:HPMC比率,具有40%的DLM负载.
高压均质化使得可扩展的生产和一致的滴滴大小.
与晶体DLM相比,喷雾干燥的DLM纳米颗粒显示出显著增强的溶解动力学.
乳液粉在加速测试 (50°C/75%RH) 中表现出良好的物理稳定性.

结论:

乳化是DLM纳米封装的一个可行的策略,克服了先前的配方挑战.
纳米封装的DLM显示显著改善的溶解速度和增强的物理稳定性.
这种配方方法有望改善DLM在治疗DR-TB的口服生物可用性和疗效.

关键词:

乳液乳液是一种乳液.封装的封装方式纳米颗粒是一种纳米粒子.在口服交付口服交付.结核病是一种肺结核病.

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