甲化口服溶液的稳定性评估用于药物成中心的分发:物理化学和微生物学研究
Mª Antonia Meroño Saura1, Pablo Selvi Sabater2, Mª Pilar Sánchez Piñera3
1Reina Sofia University General Hospital, Murcia, Spain. Mariaa.merono@carm.es.
International journal of pharmaceutical compounding
|December 6, 2024
概括
这项研究证实,0.5%的甲口服溶液稳定60天,保持其化学,物理和微生物完整性. 这一发现支持延长保质期和改善药物依赖治疗的处方.
科学领域:
- 制药科学 制药科学
- 临床药房 临床药房
- 药物的稳定性 药物的稳定性
背景情况:
- 甲对于治疗阿片类药物依赖至关重要.
- 确保甲口服溶液的稳定性对于有效的患者治疗至关重要.
- 优化分发电路可以改善获得必需药物的机会.
研究的目的:
- 评估0.5%水性口服甲溶液的物理化学和微生物稳定性.
- 确定向药物依赖中心分发的甲口服溶液的适当到期日.
- 评估暴露于光线对甲溶液稳定性的影响.
主要方法:
- 制备六批0.5%的甲口服溶液.
- 在受控的室温下储存样品,有或没有光保护.
- 在60天内定期分析度,pH值,感官特性和微生物污染.
主要成果:
- 甲度保持稳定,在受保护和未受保护的样本中变化很小 (<2%).
- pH值保持在6.5以下,随着时间的推移略有增加.
- 没有检测到微生物生长,感官特征保持一致,符合口服液体配方标准.
结论:
- 0.5%的甲口服溶液在60天内在化学,物理和微生物学上保持稳定.
- 该研究支持延长这种配方的到期日期.
- 基于经过证明的稳定性,对甲到药物依赖中心的优化分发回路是可行的.
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