Stability Evaluation of Compounded Multidrug Oral Liquids in a Dual-Vehicle Suspending System.

Q4 Medicine
Carolina Schettino Kegele, Sarah Taylor, Hudson Polonini
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引用次数: 0

Abstract

Extemporaneously compounded oral liquids are essential for patients unable to swallow solid dosage forms, although ensuring stability in aqueous systems remains challenging. This study evaluated the chemical, physical, and microbiological stability of formulations containing topiramate, omeprazole, gabapentin, ondansetron, and levofloxacin prepared in Flavor Sweet™ SF and Flavor Plus™, also known as Syra Sweet™ SF and Syra Plus™. Stability was assessed over 90 days at room temperature and under refrigeration using validated UHPLC methods, along with physical and microbiological analyses. Gabapentin, ondansetron, omeprazole, and topiramate remained stable for 90 days under both conditions, while levofloxacin was stable for 60 days at room temperature and 90 days refrigerated. All formulations showed consistent pH and acceptable microbiological quality, although precipitation in some samples led to discontinuation of analysis. These results support the suitability of the vehicle system and highlight the importance of formulation parameters in stability and beyond-use dating.

复合多药口服液在双载体悬浮体系中的稳定性评价。
临时复合口服液对于不能吞咽固体剂型的患者是必不可少的,尽管确保在水系统中的稳定性仍然具有挑战性。本研究评估了在Flavor Sweet™SF和Flavor Plus™(也称为Syra Sweet™SF和Syra Plus™)中制备的含有托吡酯、奥美拉唑、加巴喷丁、昂丹西琼和左氧氟沙星的配方的化学、物理和微生物稳定性。在室温和冷藏条件下,使用经过验证的UHPLC方法以及物理和微生物分析,评估了90天以上的稳定性。加巴喷丁、昂丹司琼、奥美拉唑、托吡酯在两种条件下均稳定90天,左氧氟沙星室温稳定60天,冷藏稳定90天。所有的配方都显示出一致的pH值和可接受的微生物质量,尽管一些样品的沉淀导致分析停止。这些结果支持了车辆系统的适用性,并强调了配方参数在稳定性和超使用日期中的重要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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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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