植物基和 HRT 重奶油基中各种激素的化学和微生物稳定性的扩展。

Q4 Medicine
Sarah Taylor, Rodney Haselhorst
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引用次数: 0

摘要

随着《美国药典》(USP)"危险药物 - 医疗机构中的处理 "一章的发布,以及《美国药典》(USP)"药物配制 - 非无菌制剂 "将于 2023 年进行重大修订,以前用于证明延长使用期限 (BUD) 的许多研究已不再充分。为了向配制商提供高质量的证据,以支持两种水性乳膏载体(Phytobase™ 和 HRT Heavy™)中激素制剂的物理、化学和微生物稳定性,我们按照美国药典的规定,对常见外用和透皮激素的高浓度和低浓度的 12 种不同组合(共 24 种测试配方)进行了稳定性指示测试和抗菌效果测试 (AET)。在本研究中,我们讨论了 Phytobase™ 和 HRT Heavy™ 是否适合用于复方激素疗法 (CHT),以及这些载体与雌三醇、雌二醇、睾酮、孕酮和脱氢表雄酮等激素单独或混合使用时的兼容性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Extended Chemical and Microbial Stability of Various Hormones in Phytobase and HRT Heavy Cream Bases.

The release of USP chapter <800> Hazardous Drugs -Handling in Healthcare Settings and the major revisions to USP <795> Pharmaceutical Compounding -Nonsterile Preparations in 2023 rendered many studies previously used to justify extended beyond use date (BUD) no longer sufficient. To provide compounders with high quality evidence to support physical, chemical, and microbial stability of hormone preparations in two aqueous cream vehicles, Phytobase™ and HRT Heavy™, we set out to perform stability indicating testing and antimicrobial effectiveness testing (AET) per USP <51> on 12 different combinations bracketed in high and low concentrations (for a total of 24 tested formulas) of common topical and transdermal hormones. In this study we discuss the suitability of Phytobase™ and HRT Heavy™ for compounded hormone therapy (CHT) and the compatibility of these vehicles with hormones including estriol, estradiol, testosterone, progesterone, and dehydroepiandrosterone both alone and in combination.

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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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