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布洛芬临时口服混悬液在“瓦格纳”基质中的物理化学稳定性。

Physicochemical Stability of the Extemporaneous Ibuprofen Oral Suspension in "Wagner" Base.

作者信息

Spennacchio Antonio, Lopedota Angela, la Forgia Flavia, Fontana Sergio, Franco Massimo, Denora Nunzio

机构信息

Department of Pharmacy - Pharmaceutical Sciences, University of Bari "Aldo Moro", Bari, Italy.

Centro Studi e Ricerche "Dr. S. Fontant 1900-1982", Farmalabor s.r.l., Italy.

出版信息

Int J Pharm Compd. 2023 Jan-Feb;27(1):72-77.

Abstract

This article discusses a new method for the preparation of extemporaneous ibuprofen-based suspensions for use in paediatric patients. This method allows the preparation of extemporaneous suspensions up to concentrations of 200 mg/5 mL by using a liquid base named "Wagner." A comprehensive physicochemical stability study was conducted on the formulation at a drug concentration of 200 mg/5 mL by performing high-pressure liquid chromatography and Turbiscan analyses. Chromatographic analyses of the samples demonstrated the chemical stability of the active pharmaceutical ingredient in the base for more than 90 days when the formulations were stored at 4°C and 25°C. Visual and optical analyses evidenced a reversible, slightly creaming phenomenon when the formulations were stored at 4°C or 25°C restoring the initial suspension by simply shaking.

摘要

本文讨论了一种制备用于儿科患者的布洛芬临时混悬液的新方法。该方法通过使用名为“瓦格纳”的液体基质,可制备浓度高达200mg/5mL的临时混悬液。通过高压液相色谱法和Turbiscan分析,对药物浓度为200mg/5mL的制剂进行了全面的物理化学稳定性研究。当制剂在4°C和25°C储存时,样品的色谱分析表明活性药物成分在基质中的化学稳定性超过90天。视觉和光学分析表明,当制剂在4°C或25°C储存时,会出现可逆的轻微分层现象,只需简单摇晃即可恢复初始混悬液状态。

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