{"title":"Stability of flucytosine 100 mg/mL suspension as an alternative to intravenous administration","authors":"Pamela Huang BPharm, Carmela Corallo BPharm, Cherie Chiang MBBS (Hons), FRACP, FRCPA, MAACB, MD, FFSc, Yoke Chee Leong BSc, MAACB, Bianca Tong BPharm (Hons)","doi":"10.1002/jppr.1924","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Flucytosine is an antifungal agent used in combination with other medicines for the treatment of fungal infections. It was available as intravenous (IV), oral tablet, and capsule formulations up until October 2021, when the IV product, Ancotil, was discontinued with no alternative brands available.</p>\n </section>\n \n <section>\n \n <h3> Aim</h3>\n \n <p>This study aimed to formulate a suitable formulation with appropriate stability data for medium to long-term nasogastric (NG) administration use.</p>\n </section>\n \n <section>\n \n <h3> Method</h3>\n \n <p>Flucytosine 500 mg tablets (Ancotil) were crushed and suspended in (1) Ora-Plus (OP) + Ora-Sweet (OS) and (2) Ora-Blend (OB) to produce 100 mg/mL suspensions (<i>n</i> = 3 for each suspending base) that were stored at 2–8°C in amber glass bottles until assayed. Appearance, odour and pH, and the concentrations of flucytosine in the suspensions were determined by high-performance liquid chromatography on days 1, 8, and 15. A subjective assessment of the ease of suspension for NG administration via a size 10fr nasogastric tube (NGT) was also tested. Ethics approval was not required for this research article as it was a stability study and did not contain human participants or human data.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>One of the three OB suspension bottles demonstrated significant suspension clumping resulting in all OB suspensions being excluded from further analysis. There was no change in appearance, odour or pH with the OP + OS based flucytosine suspensions and they extruded easily through a size 10fr NGT with minimal force. The three OP + OS bottles of flucytosine suspension were stable (>98% at all timepoints assessed) for 15 days at 2–8°C when stored in amber glass bottles.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>The OP + OS suspensions showed chemical stability for up to 15 days when stored under refrigerated conditions and protected from light, making this a suitable multidose enteral alternative to IV flucytosine.</p>\n </section>\n </div>","PeriodicalId":16795,"journal":{"name":"Journal of Pharmacy Practice and Research","volume":"54 4","pages":"323-327"},"PeriodicalIF":1.0000,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmacy Practice and Research","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/jppr.1924","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Flucytosine is an antifungal agent used in combination with other medicines for the treatment of fungal infections. It was available as intravenous (IV), oral tablet, and capsule formulations up until October 2021, when the IV product, Ancotil, was discontinued with no alternative brands available.
Aim
This study aimed to formulate a suitable formulation with appropriate stability data for medium to long-term nasogastric (NG) administration use.
Method
Flucytosine 500 mg tablets (Ancotil) were crushed and suspended in (1) Ora-Plus (OP) + Ora-Sweet (OS) and (2) Ora-Blend (OB) to produce 100 mg/mL suspensions (n = 3 for each suspending base) that were stored at 2–8°C in amber glass bottles until assayed. Appearance, odour and pH, and the concentrations of flucytosine in the suspensions were determined by high-performance liquid chromatography on days 1, 8, and 15. A subjective assessment of the ease of suspension for NG administration via a size 10fr nasogastric tube (NGT) was also tested. Ethics approval was not required for this research article as it was a stability study and did not contain human participants or human data.
Results
One of the three OB suspension bottles demonstrated significant suspension clumping resulting in all OB suspensions being excluded from further analysis. There was no change in appearance, odour or pH with the OP + OS based flucytosine suspensions and they extruded easily through a size 10fr NGT with minimal force. The three OP + OS bottles of flucytosine suspension were stable (>98% at all timepoints assessed) for 15 days at 2–8°C when stored in amber glass bottles.
Conclusions
The OP + OS suspensions showed chemical stability for up to 15 days when stored under refrigerated conditions and protected from light, making this a suitable multidose enteral alternative to IV flucytosine.
期刊介绍:
The purpose of this document is to describe the structure, function and operations of the Journal of Pharmacy Practice and Research, the official journal of the Society of Hospital Pharmacists of Australia (SHPA). It is owned, published by and copyrighted to SHPA. However, the Journal is to some extent unique within SHPA in that it ‘…has complete editorial freedom in terms of content and is not under the direction of the Society or its Council in such matters…’. This statement, originally based on a Role Statement for the Editor-in-Chief 1993, is also based on the definition of ‘editorial independence’ from the World Association of Medical Editors and adopted by the International Committee of Medical Journal Editors.