探索用真空压缩成型法制备柔性剂量儿科药物可分散性薄膜

Pharmaceuticals Pub Date : 2024-07-12 DOI:10.3390/ph17070934
D. Hales, Cătălina Bogdan, L. Tefas, Andreea Cornilă, Maria-Andreea Chiver, I. Tomuțǎ, T. Casian, R. Iovanov, Gábor Katona, Rita Ambrus, Sonia Iurian
{"title":"探索用真空压缩成型法制备柔性剂量儿科药物可分散性薄膜","authors":"D. Hales, Cătălina Bogdan, L. Tefas, Andreea Cornilă, Maria-Andreea Chiver, I. Tomuțǎ, T. Casian, R. Iovanov, Gábor Katona, Rita Ambrus, Sonia Iurian","doi":"10.3390/ph17070934","DOIUrl":null,"url":null,"abstract":"In recent years, solid dosage forms have gained interest in pediatric therapy because they can provide valuable benefits in terms of dose accuracy and stability. Particularly for orodispersible films (ODFs), the literature evidences increased acceptability and dose flexibility. Among the various available technologies for obtaining ODFs, such as solvent casting, hot-melt extrusion, and ink printing technologies, the solvent-free preparation methods exhibit significant advantages. This study investigated Vacuum Compression Molding (VCM) as a solvent-free manufacturing method for the preparation of flexible-dose pediatric orodispersible films. The experimental approach focused on selecting the appropriate plasticizer and ratios of the active pharmaceutical ingredient, diclofenac sodium, followed by the study of their impacts on the mechanical properties, disintegration time, and drug release profile of the ODFs. Additional investigations were performed to obtain insights regarding the solid-state properties. The ODFs obtained by VCM displayed adequate quality in terms of their critical characteristics. Therefore, this proof-of-concept study shows how VCM could be utilized as a standalone method for the production of small-scale ODFs, enabling the customization of doses to meet the individual needs of pediatric patients.","PeriodicalId":509865,"journal":{"name":"Pharmaceuticals","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Exploring Vacuum Compression Molding as a Preparation Method for Flexible-Dose Pediatric Orodispersible Films\",\"authors\":\"D. Hales, Cătălina Bogdan, L. Tefas, Andreea Cornilă, Maria-Andreea Chiver, I. Tomuțǎ, T. Casian, R. Iovanov, Gábor Katona, Rita Ambrus, Sonia Iurian\",\"doi\":\"10.3390/ph17070934\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"In recent years, solid dosage forms have gained interest in pediatric therapy because they can provide valuable benefits in terms of dose accuracy and stability. Particularly for orodispersible films (ODFs), the literature evidences increased acceptability and dose flexibility. Among the various available technologies for obtaining ODFs, such as solvent casting, hot-melt extrusion, and ink printing technologies, the solvent-free preparation methods exhibit significant advantages. This study investigated Vacuum Compression Molding (VCM) as a solvent-free manufacturing method for the preparation of flexible-dose pediatric orodispersible films. The experimental approach focused on selecting the appropriate plasticizer and ratios of the active pharmaceutical ingredient, diclofenac sodium, followed by the study of their impacts on the mechanical properties, disintegration time, and drug release profile of the ODFs. Additional investigations were performed to obtain insights regarding the solid-state properties. The ODFs obtained by VCM displayed adequate quality in terms of their critical characteristics. Therefore, this proof-of-concept study shows how VCM could be utilized as a standalone method for the production of small-scale ODFs, enabling the customization of doses to meet the individual needs of pediatric patients.\",\"PeriodicalId\":509865,\"journal\":{\"name\":\"Pharmaceuticals\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-07-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmaceuticals\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3390/ph17070934\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceuticals","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3390/ph17070934","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

近年来,固体制剂在儿科治疗中越来越受到关注,因为它们能在剂量准确性和稳定性方面提供宝贵的益处。特别是对于口腔可分散薄膜(ODF),文献证明其可接受性和剂量灵活性都有所提高。在现有的各种获得 ODF 的技术中,如溶剂浇铸、热熔挤出和油墨印刷技术,无溶剂制备方法具有显著优势。本研究将真空压缩成型(VCM)作为一种无溶剂制造方法,用于制备灵活剂量的儿科口腔分散膜。实验方法的重点是选择适当的增塑剂和活性药物成分双氯芬酸钠的比例,然后研究它们对 ODF 的机械性能、崩解时间和药物释放曲线的影响。为了深入了解固态特性,还进行了其他研究。通过 VCM 获得的 ODF 在关键特性方面表现出了足够的质量。因此,这项概念验证研究显示了如何将 VCM 用作生产小规模 ODF 的独立方法,从而实现剂量定制,满足儿科患者的个性化需求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Exploring Vacuum Compression Molding as a Preparation Method for Flexible-Dose Pediatric Orodispersible Films
In recent years, solid dosage forms have gained interest in pediatric therapy because they can provide valuable benefits in terms of dose accuracy and stability. Particularly for orodispersible films (ODFs), the literature evidences increased acceptability and dose flexibility. Among the various available technologies for obtaining ODFs, such as solvent casting, hot-melt extrusion, and ink printing technologies, the solvent-free preparation methods exhibit significant advantages. This study investigated Vacuum Compression Molding (VCM) as a solvent-free manufacturing method for the preparation of flexible-dose pediatric orodispersible films. The experimental approach focused on selecting the appropriate plasticizer and ratios of the active pharmaceutical ingredient, diclofenac sodium, followed by the study of their impacts on the mechanical properties, disintegration time, and drug release profile of the ODFs. Additional investigations were performed to obtain insights regarding the solid-state properties. The ODFs obtained by VCM displayed adequate quality in terms of their critical characteristics. Therefore, this proof-of-concept study shows how VCM could be utilized as a standalone method for the production of small-scale ODFs, enabling the customization of doses to meet the individual needs of pediatric patients.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信