• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

应用于辊压制带状物的气体在散射介质吸收光谱中的光学孔隙率测定法(GASMAS)

Optical porosimetry by gas in scattering media absorption spectroscopy (GASMAS) applied to roller compaction ribbons.

机构信息

Innovation Strategies & External Liaison, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden.

Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden.

出版信息

Int J Pharm. 2021 Jan 5;592:120056. doi: 10.1016/j.ijpharm.2020.120056. Epub 2020 Nov 5.

DOI:10.1016/j.ijpharm.2020.120056
PMID:33161035
Abstract

Currently, there is a need for new technology for in-line or fast at-line assessment of solid material porosity. One specific gap is a fast technology to be used in connection to roller compaction (RC) manufacturing, where the porosity of the RC ribbons is critical to the manufacturing of tablets of the right tensile strength and disintegration properties. In this paper, the development of an at-line technology for fast, non-destructive assessment of porosity of RC ribbons is reported. The technology is based on a diode laser spectroscopic technique called Gas in scattering media absorption spectroscopy (GASMAS). GASMAS measures the sample voids by laser light, giving the distance through air. The total distance the light travels is measured using time-of-flight spectroscopy (TOFS). The ratio of these measures gives an "optical porosity", which through theory relates to the porosity of the sample. We present a description of the technology, evaluations of measurement robustness and results from an experimental design where roller compactor, roll force, roll gap and formulation were varied. It is concluded that the data from two different pharmaceutical formulations is supported by the same calibration curve, which indicates that optical porosimetry is a general technique for pharmaceutical materials that does not require frequent calibrations.

摘要

目前,需要开发新的技术来在线或快速在线评估固体材料的孔隙率。一个具体的空白是一种用于与辊压(RC)制造相关的快速技术,其中 RC 带的孔隙率对于制造具有适当拉伸强度和崩解性能的片剂至关重要。本文报告了一种用于快速、非破坏性评估 RC 带孔隙率的在线技术的开发。该技术基于一种称为气体在散射介质中的吸收光谱(GASMAS)的二极管激光光谱技术。GASMAS 通过激光测量样品中的空隙,给出空气的距离。使用飞行时间光谱(TOFS)测量光传播的总距离。这些测量的比值给出了一个“光学孔隙率”,通过理论与样品的孔隙率相关。我们介绍了该技术的描述、测量稳健性的评估以及在不同的轧辊压力、轧辊间隙和配方变化的实验设计中的结果。结果表明,来自两种不同药物制剂的数据由相同的校准曲线支持,这表明光学孔隙率测量法是一种适用于药物材料的通用技术,不需要频繁校准。

相似文献

1
Optical porosimetry by gas in scattering media absorption spectroscopy (GASMAS) applied to roller compaction ribbons.应用于辊压制带状物的气体在散射介质吸收光谱中的光学孔隙率测定法(GASMAS)
Int J Pharm. 2021 Jan 5;592:120056. doi: 10.1016/j.ijpharm.2020.120056. Epub 2020 Nov 5.
2
Near-infrared chemical imaging (NIR-CI) as a process monitoring solution for a production line of roll compaction and tableting.近红外化学成像(NIR-CI)作为辊压和压片生产线的过程监测解决方案。
Eur J Pharm Biopharm. 2015 Jun;93:293-302. doi: 10.1016/j.ejpb.2015.04.008. Epub 2015 Apr 25.
3
Roller compaction scale-up using roll width as scale factor and laser-based determined ribbon porosity as critical material attribute.以轧辊宽度为比例因子、基于激光测定的带状孔隙率作为关键物料属性进行滚压压实放大。
Eur J Pharm Sci. 2016 May 25;87:69-78. doi: 10.1016/j.ejps.2015.11.001. Epub 2015 Nov 9.
4
The influence of API concentration on the roller compaction process: modeling and prediction of the post compacted ribbon, granule and tablet properties using multivariate data analysis.活性成分浓度对滚压过程的影响:使用多元数据分析对压实后带状物、颗粒和片剂性质进行建模与预测。
Drug Dev Ind Pharm. 2015;41(9):1470-8. doi: 10.3109/03639045.2014.958754. Epub 2015 Jul 21.
5
Predicting the critical quality attributes of ibuprofen tablets via modelling of process parameters for roller compaction and tabletting.通过对辊压和压片工艺参数的建模来预测布洛芬片剂的关键质量属性。
Int J Pharm. 2019 Jun 30;565:209-218. doi: 10.1016/j.ijpharm.2019.05.011. Epub 2019 May 7.
6
Characterisation of density distributions in roller-compacted ribbons using micro-indentation and X-ray micro-computed tomography.使用微压痕和X射线微计算机断层扫描对辊压条带中的密度分布进行表征。
Eur J Pharm Biopharm. 2009 May;72(1):173-82. doi: 10.1016/j.ejpb.2008.12.005. Epub 2008 Dec 24.
7
Combining experimental design and orthogonal projections to latent structures to study the influence of microcrystalline cellulose properties on roll compaction.结合实验设计和正交投影到潜在结构,研究微晶纤维素性质对辊压实的影响。
Int J Pharm. 2011 Sep 15;416(1):110-9. doi: 10.1016/j.ijpharm.2011.06.018. Epub 2011 Jun 17.
8
Prediction of in-vitro dissolution and tablet hardness from optical porosity measurements.从光学孔隙率测量预测体外溶出度和片剂硬度。
Int J Pharm. 2024 Jul 20;660:124336. doi: 10.1016/j.ijpharm.2024.124336. Epub 2024 Jun 12.
9
Instrumented roll technology for the design space development of roller compaction process.仪器化辊压技术在辊压工艺设计空间开发中的应用。
Int J Pharm. 2012 Apr 15;426(1-2):116-131. doi: 10.1016/j.ijpharm.2012.01.032. Epub 2012 Jan 25.
10
Roller compaction: application of an in-gap ribbon porosity calculation for the optimization of downstream granule flow and compactability characteristics.辊压:使用间隙式带状孔隙率计算方法优化下游颗粒流动和可压缩性特性的应用。
Pharm Dev Technol. 2010 Jun;15(3):223-9. doi: 10.3109/10837450903095342.

引用本文的文献

1
Gas in scattering media absorption spectroscopy as a potential tool in neonatal respiratory care.散射介质吸收光谱中的气体作为新生儿呼吸护理中一种有潜力的工具。
Pediatr Res. 2022 Nov;92(5):1240-1246. doi: 10.1038/s41390-022-02110-y. Epub 2022 May 23.