Study of the technological properties of excipients in the development of the composition of orally dispersible tablets

Q3 Pharmacology, Toxicology and Pharmaceutics
I. D. Kasymov, A. V. Basevich
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引用次数: 1

Abstract

Introduction. The article presents the results of studying the technological properties of individual excipients widely used in the compositions of existing orally dispersed tablets (ODT) for subsequent planning a multifactorial experiment. Samples of excipients were analyzed according to such pharmacopoeial indicators as description, flowability, bulk density, compressibility, fractional composition, solubility in water.Aim. The aim of the work is to create a list and study the technological properties of candidate substances for the role of auxiliary substances in the composition being developed by the ODT.Materials and methods. The technological properties of excipient samples were studied according to the methods of the State Pharmacopoeia of the XIV edition using the flowability tester GTL (ERWEKA, Germany), the bulk density tester SVM 221 (ERWEKA, Germany), the tablet press PGR-10 (LabTools, Russia) and the tablet hardness tester TBH 125 TDP (ERWEKA, Germany).Results and discussion. As a result of the study, experimental data on the technological properties of excipient samples were collected, and the selected samples were compared according to pharmaceutical and technological indicators.Conclusion. In the course of the study, a list of auxiliary substances for the development of the composition of ODT was formed and studies of their technological properties were carried out. The obtained experimental data will allow to develop an optimal matrix of a multifactorial experiment for the development of the composition of ODT and justify the choice of excipients.
口服分散片剂中辅料的工艺性能研究
介绍。本文介绍了对现有口服分散片(ODT)中广泛使用的单个赋形剂的工艺特性的研究结果,为后续的多因子实验计划提供依据。根据描述、流动性、容重、压缩性、组分、水溶性等药典指标对辅料样品进行分析。这项工作的目的是创建一个清单,并研究候选物质的技术特性,以供ODT正在开发的组合物中辅助物质的作用。材料和方法。采用流动性测试仪GTL (ERWEKA,德国)、容重测试仪SVM 221 (ERWEKA,德国)、压片机PGR-10 (LabTools,俄罗斯)和片剂硬度计TBH 125 TDP (ERWEKA,德国),按照《国家药典》第十四版的方法研究辅料样品的工艺性能。结果和讨论。根据研究结果,收集了辅料样品工艺性能的实验数据,并根据药学指标和工艺指标对所选样品进行了比较。在研究过程中,形成了发展ODT成分的辅助物质清单,并对其工艺性能进行了研究。获得的实验数据将允许开发一个多因素实验的最佳矩阵,用于开发ODT的组成,并证明辅料的选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Drug Development and Registration
Drug Development and Registration Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
1.20
自引率
0.00%
发文量
61
审稿时长
8 weeks
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