尤德拉吉特® FS含有菌体的微粒,通过喷雾干燥制备,用于口服
Emilie Tabare1, Tiffany Dauchot1, Christel Cochez2
1Laboratory of Pharmaceutics and Biopharmaceutics, Faculty of Pharmacy, Université Libre de Bruxelles, 1050 Brussel, Belgium.
Pharmaceutics
|June 28, 2023
概括
这项研究开发了一种使用Eudragit® FS30D用于结肠向的口服菌体治疗输送系统. 优化的配方在制造和模拟胃肠道条件期间保护了菌体 (LUZ19),显示了6个月的稳定性.
科学领域:
- 微生物学 微生物学
- 制药科学 制药科学
- 药物输送系统 药物输送系统
背景情况:
- 抗生素耐药性需要替代治疗,如菌体治疗.
- 口腔菌体的输送面临来自胃肠道疾病的挑战.
- 欧德拉吉特®衍生物具有针对性胃肠道输送的潜力.
研究的目的:
- 开发和优化使用Eudragit® FS30D.使用菌体的口腔结肠向输送系统.
- 为了确保细菌 (LUZ19) 在配方和模拟胃肠道过境期间的活力和活性.
- 在模拟的结肠环境中评估菌体的释放特征.
主要方法:
- 基于Eudragit® FS30D的输送系统的配方,用于菌体 LUZ19.9.
- 对囊填充和片剂的粉末流动性的评估.
- 药片注射后对菌体活力的评估.
- 在人肠道微生物生态系统模拟器 (SHIME®) 中进行了体外释放研究.
- 在指定存储条件下对最终配方的稳定性测试.
主要成果:
- 一种优化的配方成功地在制造过程中保留了LUZ19的活性.
- 该配方保护了细菌体免受酸性条件和片制过程的影响.
- SHIME®模型证实了LUZ19在结肠中的向释放.
- 粉末配方在+5°C下至少保持6个月的稳定性.
结论:
- 尤德拉吉特 (Eudragit® FS30D) 是一种适合开发结肠向口服菌体输送系统的辅助剂.
- 开发的系统有效地保护菌体,并确保其可用于潜在的治疗用途的可行性.
- 这种方法为治疗抗生素耐药性感染的口腔菌体治疗提供了一个有希望的策略.
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