与OrPhylloTM准备使用的基础组合的个性化口膜:API兼容性和基于证据的过时使用日期
Carolina Schettino Kegele1, Bruna Marianni1, Hudson Polonini1
1Fagron BV, Rotterdam, The Netherlands.
International journal of pharmaceutical compounding
|December 16, 2025
概括
该OrPhylloTM薄膜基支持稳定的口腔可分散薄膜 (ODF) 长达180天,具有各种活性药物成分 (API). 这证实了它对个性化复合药物的可靠性.
科学领域:
- 制药复合剂 制药复合剂
- 药物输送系统 药物输送系统
- 物理药房 物理药房
背景情况:
- 口腔可分散薄膜 (ODF) 提供了一种替代的剂量形式来管理活性药物成分 (API).
- 开发稳定的ODF配方需要一个强大的薄膜形成基.
- OrPhylloTM是一种新的薄膜形成基,用于组合个性化的ODF.
研究的目的:
- 用OrPhylloTM基来评估ODF与七种不同的API复合的物理化学稳定性.
- 为了确定每个API装载的ODF配方的超值使用日期 (BUD).
- 评估OrPhylloTM作为一种多功能复合基的适用性.
主要方法:
- 使用OrPhylloTM.将七种APIs (咖啡因,叶酸,黄素,皮里多克素化物,维生素B12,5-HTP,DHEA) 合成ODF.
- 使用经过验证的分析方法,评估在环境条件下180天内的稳定性.
- 超出使用日期 (BUDs) 基于在90-110%范围内的回收值 (USP <795>) 建立.
主要成果:
- 含有5-HTP (100 mg/mL),黄素 (50-100 mg/mL),DHEA (10 mg/mL) 和胺 (5 mg/mL) 的配方在整个180天内表现出稳定性.
- 其他配方表现出不同的稳定性,BUDs从60天到150天不等.
- 在不同的API和度中,OrPhylloTM表现一致.
结论:
- OrPhylloTM是一款可靠且坚固的薄膜形成基材,用于组合个性化的ODF.
- 该基础支持多个API的延长过期使用日期,证明了其实际价值.
- 对OrPhylloTM的全面稳定性数据加强了其在制药化合物中的适用性.
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