{"title":"Extended Chemical and Microbial Stability of Various Hormones in Phytobase and HRT Heavy Cream Bases.","authors":"Sarah Taylor, Rodney Haselhorst","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 4","pages":"344-350"},"PeriodicalIF":0.0000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International journal of pharmaceutical compounding","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
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.
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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