Tag Archives: FBRM C35

视频:梅特勒-托利多FBRM C35获PowTech/TechnoPharm 2010创新奖

我早些时张贴过梅特勒-托利多颗粒系统特征分析组获得了PowTech/TechnoPharm 2010展会的创新奖, 得奖产品为用于实时测量高剪切力成粒过程及其它挑战性颗粒工艺过程的FBRM C35.

在这一视频中,颗粒系统特征分析的业务经理Carl Phillip通过简短的回顾解释了他们为什么获得了这一创新奖:

2010 AAPS 年会–特讯

上周我参加了在新奥尔良召开的2010 美国医药科学家协会(AAPS) 年会。这次AAPS会议将平行进行的技术报告和墙报分会于一大型贸易展会结合在一起。

粒径分布测量在医药制剂中的应用在这2010 AAPS会议上,热门议题有质量源于设计(QbD)、工艺过程分析技术(PAT)、以及趋向于药品实时放行的动力。FBRM和PVM技术得到很多壁报和报告的良好描述,主要反映它们在药品制剂过程中理解、优化、和控制颗粒大小分布上的应用。

两个注目的壁报来自Novartis和Bristol-Myers Squibb,集中介绍了FBRM C35在高剪切力湿式成粒过程中的应用。Novartis的文章–“评价用于高剪切力湿式成粒过程的监测和终点检定的PAT工具:NIR、FBRM、PVM、ARS” – 概述了一个用FBRM跟踪颗粒增长和细颗粒消失的研究案例。作者的结论:“FBRM对细颗粒群的灵敏性使变异的根源得到理解并得以消除。Bristol-Myers Squibb的文章–“用于高剪切力湿式成粒过程中实时测量玄长分布的FBRM C35 探头的分辨率和灵敏性、以及与其它粒径分布技术的关联”–显示了在一个干混和过程中FBRM怎样对不同级别的MCC之间的区别提供了充分的灵敏度,同时所得FBRM 数据是怎样与离线粒径测量技术良好关联的。BMS还介绍了描述FBRM数据的创新方法,即把玄长分布的变化视觉化为一个随时间变化的热图。

其它感兴趣的AAPS壁报有:

  • “工艺过程分析技术:用FBRM和PVM在线监测PLGA微粒形成过程” – 美国食品药品管理局 (FDA)
  • “质量源于设计(QbD) 案例研究:寻找实时PAT工艺过程监测与离线产品特征分析之间的关联” – 美国食品药品管理局(FDA)
  • “将QbD原理应用在为可持续性放行对各种级别的Hypromellose进行评价上” – GlaxoSmithKline
  • “预测制药固体在高剪切力研磨过程中的表现” – Pfizer
  • “用高分子来维持一个难溶药物分子的液充胶囊制剂在体外溶出超饱和的一个机理研究” – Amgen Inc.

从个人角度,我有幸被接受作一个壁报,集中介绍FBRM和PVM在改进液体制剂上的应用,像悬浮液、乳状液、和离散液。该壁报–“用原位颗粒和液滴特征分析改进液体制剂”–回顾了这个领域里近来的工作,包括FBRM如何能跟踪湿磨终点、改进乳化过程的放大、以及在变化的温度和搅拌条件下筛选悬浮稳定性条件。没能参加今年AAPS的人可在网上找到我壁报的内容- 请求即得网络研讨会:用在线颗粒和液滴测量来使液体制剂过程得以控制

新奥尔良为AAPS 大会提供了完美的背景,我幸运地得知了Creole与Cajun美食之间的区别!谁有兴趣的话,我喜欢Creole!

2010 AAPS Annual Meeting – Highlights

American Association of Pharmaceutical Scientists (AAPS) MeetingThis week, I was in New Orleans attending the 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting. The AAPS Meeting combines a large trade show with technical presentation and poster sessions running in parallel.

At the 2010 AAPS meeting, hot topics included Quality by Design (QbD), Process Analytical Technology (PAT) and the drive towards real-time release for pharmaceutical products. FBRM and PVM technologies were well represented with numerous posters and presentations focusing on their use to understand, optimize and control particle size distribution during drug product formulation. Continue reading

怎样实时跟踪颗粒分布:AAPS 2010

2010 美国医药科学家协会(AAPS) 年会 即将于十一月十四至十八日在新奥尔良召开。本届AAPS年会与国际医药联邦(FIP)的医药科学国际协会 (PSWC)携手,将聚集来自全世界的数千医药科学家们。在此,我想点出会议上将要讨论的一些涉及怎样实时跟踪颗粒分布的报告:http://cn.mt.com/cn/zh/home/events/fairs/AAPS_2010.html?=US_AC_eAdv_zhBlog

  • SU9199  用非谱图式在线颗粒分布的确定作为高剪切力湿式成粒的终点;Purdue University, Sunday PM
  • T2124  评价用于高剪切力湿式成粒监测和终点确定的PAT 工具:NIR, FBRM, PVM, ARS Novartis, Tuesday AM
  • T2139  工艺过程分析技术:用FBRMPVM 在线监测PLGA 微米颗粒形成过程;FDA/CDER/OPS/DPQR, Tuesday AM
  • T3070 用高分子来维持溶解差的药物分子在液添胶囊制剂试管溶解时的超饱和机理研究;Amgen, Tuesday PM
  • W4256 实时颗粒分析:用聚光反射测量 (FBRM) 作为工艺过程分析技术 (PAT) Campbell University and GlaxoSmithKline, Wednesday AM
  • W5050  预测高剪切力湿式研磨药物固体的表现; Pfizer, Wednesday PM
  • W5423  质量源于设计 (QbD) 案例研究:寻找实时PAT工艺过程监测与离线产品定性分析之间的关联;FDA/CDER/OPS/DPQR, Wednesday PM
  • W5429  Lasentec FBRM C35 探头用于高剪切力湿式成粒过程中实时测量颗粒玄长分布的分辨率和灵敏度以及与其它颗粒分布技术的对比; Bristol-Myers Squibb (BMS), Wednesday PM
  • W5432  通过原位颗粒和液滴定性分析改进液体制剂; METTLER TOLEDO, Wednesday PM
  • R6266  应用QbD原理评价各种Hypromellose等级以确保可持续放行的制剂工艺;GlaxoSmithKline, Thursday AM

我期待在AAPS年会上见到您,并邀请您参观展示大厅的612展台。

您可能会感兴趣的类似贴文:

How To Track Particle Distribution in Real Time: AAPS 2010

The 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting will be held November 14 to 18 in New Orleans.  As thousands of pharmaceutical scientists from around the world prepare to gather for the AAPS conference that is being held in conjunction with the International Pharmaceutical Federation’s (FIP) Pharmaceutical Sciences World Congress (PSWC), I wanted to highlight some papers that will discuss how to track particle distribution in real-time:

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YouTube Video: PowTech/TechnoPharm 2010 Innovation Award for METTLER TOLEDO FBRM C35

Earlier I posted that the METTLER TOLEDO Particle System Characterization group won an Innovation Award at the PowTech/TechnoPharm 2010 Exhibition for their FBRM C35 product for real-time monitoring of high-shear granulation and other challenging particulate processes.

In this video, Carl Phillip, Business Area Manager for Particle System Characterization, gives a short interview explaining why they earned the Innovation Award:

httpv://www.youtube.com/watch?v=O0y1CvWFMig

Predictor of Dissolution Performance in Fluid Bed Granulation

In July, I announced that I would be chairing next week’s In Process Particle Forum  being held in Iselin, NJ.  Today, I want to highlight one of the papers that will be presented at In Process Particle ForumSteve Mehrman of Johnson & Johnson will present on using FBRM C35 during fluid bed granulation development and scale-up.

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METTLER TOLEDO receives POWTECH award for Top Innovation in Particle Characterization and Material Sciences

Powtech-FBRM-C35-METTLER-TOLEDO-innovation-award

Dr. Markus Adamczyk, representing METTLER TOLEDO, accepts the award for top innovation in particle characterization and material science from Frank Jablonski and Gerd Kielburger

A couple of weeks ago, I posted an article about my colleagues’ attendance at POWTECH in Nuremberg. I was recently informed that while in Nuremberg, they accepted an award for this year’s most outstanding innovation in the field of Particle Characterization and Material Science at POWTECH. I thought I would share some of the details with you:
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In Process Particle Forum: Liquid and Solid Dosage Formulations

I am excited to be chairing the upcoming In Process Particle Forum focused on Liquid and Solid Dosage Formulations on September 15 in Woodbridge, NJ. This will be the third year in a row that METTLER TOLEDO has brought together expert users of FBRM and PVM to present their cutting edge research to a group of their peers. This year, we have the best agenda yet with four industry papers from:

  • Bristol-Myers Squibb
  • Merck
  • Johnson and Johnson
  • GlaxoSmithKline

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