新型口服LAAM即时释放囊用于治疗阿片类药物使用障碍
Zixuan Zhen1, Hadi Sudarjat2, Katherine Pierce1
1School of Pharmacy, Department of Pharmaceutical Sciences, University of Connecticut, 06269, USA.
International journal of pharmaceutics
|August 4, 2025
概括
一个新的口服囊Levo-alpha-acetylmethadol (LAAM) 已开发用于阿片类药物使用障碍治疗. 稳定,立即释放的LAAM囊为每日甲治疗提供了一个有希望的替代方案.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物输送系统 药物输送系统
背景情况:
- 阿片类药物使用障碍 (OUD) 是一个重要的公共卫生问题.
- 像甲这样的当前治疗需要每天去诊所,这给患者的坚持带来了挑战.
- 利沃-α-乙甲 (LAAM) 提供了更长的作用时间,为OUD管理提供了潜在的优势.
研究的目的:
- 开发和描述一种新的口服立即释放囊配方Levo-alpha-acetylmethadol (LAAM).
- 为阿片类药物使用障碍治疗提供每日甲剂量的一种方便的替代方案.
- 评估开发的LAAM囊的质量,稳定性和药物动力学特征.
主要方法:
- 使用VIVAPUR® MCC Spheres 700作为核心和优化的涂层解决方案,准备了LAAM固体分散涂层颗粒.
- 使用流体床涂层技术,设计实验 (DoE) 用于优化关键过程参数.
- 质量控制测试包括囊重量变化,含量均性,体外释放和储存稳定性研究.
- 在子中进行了药理动力学 (PK) 研究,以比较开发的囊与口服LAAM溶液.
主要成果:
- 优化涂层过程导致药物加载效率提高,涂层时间缩短.
- 开发的LAAM囊显示出与USP指导方针一致的即时释放特征.
- 6个月的稳定性研究证实了药物含量和释放性质的完整性.
- 在子PK研究中,与口服溶液相比,LAAM囊表现出更长的Tmax和更高的Cmax,AUC类似.
结论:
- 开发的LAAM即时释放囊是稳定的,具有理想的药物特性.
- 这种新的配方为阿片类药物使用障碍提供了一个潜在的更方便和更有效的治疗选择.
- 拉姆囊适用于进一步的临床研究,作为每日甲治疗的替代品.
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