syspend®SF PH4中心血管药物混悬液的抗菌稳定性、pH值和物理外观:一项补充性评价

Q4 Medicine
Carolina Schettino Kegele, Eli Dijkers, Hudson Polonini
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引用次数: 0

摘要

临时口服液制剂的复合对于个性化药物治疗至关重要,特别是对于需要量身定制剂量和灵活剂型的儿科、老年和吞咽困难患者。然而,不含防腐剂的液体运输工具需要彻底的评估,以确保抗菌安全性和物理化学完整性随着时间的推移。本补充研究旨在评估用syspend®SF PH4液体制备的心血管药物制剂的抗菌效果、pH稳定性和物理外观,以支持符合美国药典(USP)标准的过期使用日期(BUD)。在室温(25±2°C)和冷藏(5±3°C)储存条件下,在预定义的时间间隔内监测pH值和外观,并在此期间结束时根据USP协议评估抗菌有效性。7种心血管药物混悬液的9个口服剂型为:氨氯地平(苯磺酸盐)1.0 mg/mL、马来酸依那普利1.0 mg/mL、氢氯噻嗪2.0、5.0 mg/mL、赖诺普利(二水合物)1.0 mg/mL、酒石酸美托洛尔10.0 mg/mL、己酮茶碱20.0 mg/mL、螺内酯2.0、2.5 mg/mL。所有配方都符合USP抗菌有效性标准,同时在整个研究过程中保持稳定的pH值,并且物理外观没有相关变化。这些结果,结合先前证明的化学稳定性(HPLC),证实了syspend®SF PH4是一种强大而可靠的无防腐剂临时口服液配方载体,支持其在符合usp的BUD限制内安全使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Antimicrobial Stability, pH, and Physical Appearance of Cardiovascular Drug Suspensions in SyrSpend® SF PH4: A Complementary Evaluation.

The compounding of extemporaneous oral liquid formulations is essential for personalized pharmacotherapy, particularly for pediatric, geriatric, and dysphagic patients who require tailored doses and flexible dosage forms. However, preservative-free liquid vehicles require thorough evaluation to ensure antimicrobial safety and physicochemical integrity over time. This complementary study aimed to assess the antimicrobial effectiveness, pH stability, and physical appearance of cardiovascular drug formulations prepared with SyrSpend® SF PH4 liquid, in order to support beyond-use dating (BUD) in compliance with United States Pharmacopeia (USP) standards. The pH and appearance were monitored at predefined intervals over 90 days under room temperature (25 ± 2°C) and refrigerated (5 ± 3°C) storage conditions, and the antimicrobial effectiveness was evaluated following the USP <51> protocol at the end of this period. Nine oral formulations of seven cardiovascular drug suspensions were included: amlodipine (as besylate) 1.0 mg/mL, enalapril maleate 1.0 mg/mL, hydrochlorothiazide 2.0 and 5.0 mg/mL, lisinopril (as dihydrate) 1.0 mg/mL, metoprolol tartrate 10.0 mg/mL, pentoxifylline 20.0 mg/mL, and spironolactone 2.0 and 2.5 mg/mL. All formulations met USP criteria for antimicrobial effectiveness, while maintaining stable pH values and no relevant changes in physical appearance throughout the study. These results, when combined with previously demonstrated chemical stability (HPLC), confirm that SyrSpend® SF PH4 is a robust and reliable vehicle for preservative-free extemporaneous oral liquid formulations, supporting its safe use within USP-compliant BUD limits.

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来源期刊
CiteScore
0.40
自引率
0.00%
发文量
62
期刊介绍: The International Journal of Pharmaceutical Compounding (IJPC) is a bi-monthly, scientific and professional journal emphasizing quality pharmaceutical compounding. IJPC is the only publication that covers pharmaceutical compounding topics relevant and necessary to empower pharmacists to meet the needs of today"s patients. No other publication features hands-on, how-to compounding techniques or the information that contemporary pharmacists need to provide individualized care.
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