Tag Archives: AAPS

2010 Fall Meeting Highlights

Now that the busy fall meeting season has come to an end, I wanted to take the opportunity to quickly revisit some highlights that my colleagues and I noted: Continue reading

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

Improving Global Health Through Advances in Pharmaceutical Sciences

Here is an introductory video that discusses the 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting which will take place November 14 to 18 in New Orleans:

AAPS Meeting : 2010 from Nem Perez on Vimeo.

From AAPS 2009: How To Improve Roller Compaction Processes

At the 2009 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting in Los Angeles, Gerald Burke presented a case study on how Patheon Pharmaceuticals improved roller compaction processes.  Specifically, the case study focused on the influence of roller compactor settings on Critical Quality Attributes (CQAs) and the early prediction and control of granule porosity. Continue reading