在PCCA基,SuspendIt®中提前复合的水合物口服液剂型的物理化学和微生物学稳定性
Yashoda V Pramar1, Courtaney Davis2, Kendice Ip2
1College of Pharmacy, Xavier University of Louisiana, New Orleans, Louisiana. yvpramar@xula.edu.
International journal of pharmaceutical compounding
|December 6, 2024
概括
在PCCA SuspendIt中,一种新的复合口服液体化 (镇静剂) 配方显示了180天的稳定性. 这为儿童和成人患者提供了一个灵活的,可定制的替代品,而不是固定的强度的商业产品.
科学领域:
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
- 复合药房 复合药房 复合药房
背景情况:
- 酸盐是一种常用的镇静剂,催眠剂和焦虑缓解剂药物,特别是在儿科牙科手术和各种患者群体的夜间镇静中使用.
- 现有的商业化水合物配方提供了有限的剂量灵活性,特别是对于儿科患者,需要开发定制的替代品.
- 需要适合年龄的,灵活的化水合物剂量选择,突出了即时复合制剂的重要性.
研究的目的:
- 开发和验证用于分析化的稳定性指示试验.
- 为了确定PCCA SuspendIt.It中化化合物的物理化学和微生物学稳定性.
- 为灵活,即时复合的口服液体化水合物配方提供稳定性数据.
主要方法:
- 一种稳定性指示的超高性能液态染色学 (UPLC) 试验被开发和验证用于化酸盐分析.
- 在PCCA SuspendIt中,以25 mg/mL和100 mg/mL的剂量制备了水合物溶液,这是一种无糖,无的载体.
- 样品在5°C和25°C的温度下储存在珀色塑料瓶中,并在180天内测试化学稳定性,pH值,外观和微生物生长.
主要成果:
- 在确定PCCA SuspendIt中化酸盐的化学稳定性方面,UPLC试验被证明是可靠的.
- 没有观察到任何显著的降解;在两种温度下,药物度在整个180天的研究期间保持在标记量的96%或以上.
- 复合化水合物配方没有微生物生长,并保持一致的pH和外观,符合稳定性标准.
结论:
- 酸盐在PCCA SuspendIt中在冷藏和室温下保持180天的物理,化学和微生物稳定性.
- 这项研究验证了一种稳定,即时复合的口服液体化水合物配方,提供了一个可行的替代品,延长了使用期限.
- 该复合制剂为儿科和成人患者提供灵活,可定制的剂量选择,解决商业产品的局限性.
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