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复合克隆丁化口服液剂型的物理化学和微生物学稳定性 在PCCA基,SuspendIt®中
Yashoda V Pramar1, Tarun K Mandal1, Levon A Bostanian1
1College of Pharmacy, Xavier University of Louisiana, New Orleans, Louisiana. yvpramar@xula.edu.
International journal of pharmaceutical compounding
|August 2, 2024
概括
在PCCA Suspend中组合克洛尼丁化 (HCl) 口服悬浮剂,它提供了一个稳定的液体剂型. 冷悬浮液保持稳定182天,而室温稳定性延长到119天.
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:
- 克隆丁化是一种α-agonist低血压剂,通常以口服药片形式提供.
- 现有的剂量强度缺乏灵活性,无法准确地对患者进行定位.
- 需要一种可定制,稳定的克隆尼丁化液体配方.
研究的目的:
- 为了评估随时组合的克洛尼丁化悬浮液的物理化学和微生物稳定性.
- 为了确定PCCA SuspendIt中克洛尼丁化的稳定性数据,PCCA SuspendIt是一种无糖,无素的载体.
- 为复合药剂制造商提供一种可行的液体替代克隆尼丁化.
主要方法:
- 克洛尼丁化悬浮剂是在PCCA SuspendIt中以20mcg/mL和100mcg/mL的剂量制备的.
- 稳定性在5°C和25°C的182天内使用验证的HPLC试验进行了评估.
- 进行了物理参数 (pH,粘度,外观) 和微生物学测试.
主要成果:
- 克隆丁化悬浮剂在冷藏下保持了超过94.6%的初始度182天.
- 在室温下,20mcg/mL悬浮液在119天后显示药物度低于90%.
- 没有观察到微生物生长;物理性质保持一致.
结论:
- 在PCCA SuspendIt中随时组合的克洛尼丁化悬浮液在冷藏时稳定182天.
- 在研究的两种度下,室温稳定性被证明为119天.
- 这为克隆尼丁化治疗提供了一种灵活而稳定的复合液体替代品.
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