Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug.

IF 5.7 3区医学 Q2 CHEMISTRY, MEDICINAL Pharmaceuticals Pub Date : 2025-01-13 DOI:10.3390/ph18010086

Clément Boisseillier, Lucas Demange-Labriet, Dulanjalee Kariyawasam, Pauline Marchadour, Anne-Sophie Fauqueur, Maxime Annereau, Lucas Denis, Camille Cotteret, Salvatore Cisternino, Arnaud Schweitzer-Chaput

{"title":"Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug.","authors":"Clément Boisseillier, Lucas Demange-Labriet, Dulanjalee Kariyawasam, Pauline Marchadour, Anne-Sophie Fauqueur, Maxime Annereau, Lucas Denis, Camille Cotteret, Salvatore Cisternino, Arnaud Schweitzer-Chaput","doi":"10.3390/ph18010086","DOIUrl":null,"url":null,"abstract":"Orodispersible thin film (ODF) is an innovative dosage form that allows for adjustable dosing and improved patient compliance. It is administered by mouth, where it dissolves, making it suitable for children.Objectives: The aim of the study was to develop and characterize an optimal ODF formulation containing equivalent hydrocortisone at 0.5 mg/cm2 using the solvent-casting method. A stability-indicating assay for the simultaneous quantification of hydrocortisone and hydrocortisone 21-hemissucinate (HMS) was developed. ODFs were characterized by organoleptic properties and by testing for uniformity of mass, content, stability, thickness, and dissolution.Results: When optimized, ODF is thin, flexible, and transparent, making it suitable for production in hospital pharmacies using standard equipment. In contrast to the water-insoluble hydrocortisone, the HMS-loaded cast gel successfully satisfied the tests, including content uniformity. Disintegration appeared acceptable as compared to the commercial grade ondansetron ODF (Setofilm®). The physicochemical stability of the active ingredients (i.e., HMS, hydrocortisone) contained in the ODF at 0.5 mg/cm2 is demonstrated for at least 84 days at 23 °C.Conclusion: The ODF formulated with the water-soluble hydrocortisone prodrug HMS allows accurate drug level to be achieved, thus opening up new opportunities for use in pediatric patients.","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 1","pages":""},"PeriodicalIF":5.7000,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11768698/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceuticals","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/ph18010086","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}

引用次数: 0

Abstract

Orodispersible thin film (ODF) is an innovative dosage form that allows for adjustable dosing and improved patient compliance. It is administered by mouth, where it dissolves, making it suitable for children.

Objectives: The aim of the study was to develop and characterize an optimal ODF formulation containing equivalent hydrocortisone at 0.5 mg/cm² using the solvent-casting method. A stability-indicating assay for the simultaneous quantification of hydrocortisone and hydrocortisone 21-hemissucinate (HMS) was developed. ODFs were characterized by organoleptic properties and by testing for uniformity of mass, content, stability, thickness, and dissolution.

Results: When optimized, ODF is thin, flexible, and transparent, making it suitable for production in hospital pharmacies using standard equipment. In contrast to the water-insoluble hydrocortisone, the HMS-loaded cast gel successfully satisfied the tests, including content uniformity. Disintegration appeared acceptable as compared to the commercial grade ondansetron ODF (Setofilm^®). The physicochemical stability of the active ingredients (i.e., HMS, hydrocortisone) contained in the ODF at 0.5 mg/cm² is demonstrated for at least 84 days at 23 °C.

Conclusion: The ODF formulated with the water-soluble hydrocortisone prodrug HMS allows accurate drug level to be achieved, thus opening up new opportunities for use in pediatric patients.

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

含琥珀酸前药的氢化可的松可分散薄膜的研制。

孔分散薄膜（ODF）是一种创新的剂型，允许调整剂量和提高患者的依从性。它是口服的，在那里它溶解，使它适合儿童。目的：本研究的目的是利用溶剂铸造法开发和表征含有等效氢化可的松0.5 mg/cm2的最佳ODF配方。建立了同时定量氢化可的松和21-半发酸氢化可的松（HMS）的稳定性指示法。odf通过感官特性和质量、含量、稳定性、厚度和溶出度的均匀性测试来表征。结果：优化后的ODF薄、柔韧、透明，适合在医院药房使用标准设备生产。与水不溶性氢化可的松相比，hms负载的铸型凝胶成功地满足了测试，包括含量均匀性。与商业级ondansetron ODF （Setofilm®）相比，崩解似乎是可以接受的。ODF中含有的活性成分（即HMS，氢化可的松）在0.5 mg/cm2下的物理化学稳定性在23°C下至少84天。结论：采用水溶性氢化可的松前药HMS配制的ODF可实现准确的药物水平，为儿科患者的应用开辟了新的机遇。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Pharmaceuticals Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

6.10

自引率

4.30%

发文量

1332

审稿时长

6 weeks

期刊介绍： Pharmaceuticals (ISSN 1424-8247) is an international scientific journal of medicinal chemistry and related drug sciences.Our aim is to publish updated reviews as well as research articles with comprehensive theoretical and experimental details. Short communications are also accepted; therefore, there is no restriction on the maximum length of the papers.