Tag Archives: Benjamin Smith

What are Liquid Dosage Formulations?

Often, I hear questions surrounding what are liquid dosage formulations.  I thought I might take the opportunity to provide a short introduction to liquid dosage formulations.  Liquid dosage formulations may be in the form of suspensions or syrups, metered dosed inhalers (MDIs), or creams or lotions. All of these systems would typically have particles present or droplets present in their formulations. There could also be parentals, such as injections or intravenous infusions, which may be particle free. 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



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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上个月, 强生公司的Steve Mehrman做了一个“关于用流化床成粒作为溶解结果的一个预测方法”的报告. 如果您没能参加Steve在新泽西作的这一报告,他将在本月二十七日的网络研讨会上谈同一论题:配有在线FBRM C35的流化床:一个溶解质量预测法Continue reading

Predicting Dissolution Quality With Fluid Bed Granulation

Last month, Steve Mehrman of Johnson & Johnson gave a presentation on using Fluid Bed Granulation as a predictor of dissolution performanceContinue reading

Supersaturation Or the Crystal Size Distribution

Supersaturation or the Crystal Size DistributionWhich Measurement Is More Important?

In an ideal world, you may want to directly measure the crystal population within the crystallizer (a critical product quality attribute) and measure the supersaturation which is driving the process (a critical process parameter).  Today’s advanced Process Analytical Technology (PAT) allows you to measure both of these critical parameters in real time. But where should you begin – especially if budget constraints limit you to implementing only one advanced measurement. Continue reading

What Makes Crystallization Such a Complex Process?

As a follow-up on last week’s post regarding the implications of a well-designed crystallization process, including how Tim Bell of DuPont Engineering wrote: “Crystallization is notoriously difficult to scale-up…”, we will now address why crystallization is such a complex process. Continue reading

Implications of a Well-Designed Crystallization Process

well-designed crystallization processCrystallization is a critical process for the purification and isolation of chemical compounds in the manufacture of many fine chemical and pharmaceutical products. The results of the crystallization step have far reaching impacts on overall process efficiency and final product quality. Crystallization is also a very difficult process to effectively optimize and control. Crystallization is inherently complicated simply by being a process involving the creation and formation of solid particles.

Timothy A. Bell, of DuPont Engineering Research and Technology, wrote a review of the challenges of scaling-up particulate processes where he stated: Continue reading

Understanding Dissolution Inconsistency Through In Situ Particle Characterization and Root Cause Analysis


METTLER TOLEDO FBRM and Opt Diss Fiber Optic UV for Dissolution Testing in Distek Evolution 6100

USP tablet dissolution testing is recognized as the standard analytical method used in the pharmaceutical industry.

Traditionally, dissolution has been performed in the analytical laboratory and tests were conducted with the final product. But in recent years dissolution testing has become a development tool for Quality by Design (QbD), and testing has expanded to include dissolution and disintegration tests which screen product performance during drug product development.
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Advanced Energetic Materials: Improving Reaction Safety and Particle Size Distributions

In 1969, the USA Congressional Joint Committee on Atomic Energy held a hearing at the head of the Fermi National Accelerator Laboratory and was being questioned on why build a new $250 million particle collider.  What did a particle collider have to do with the security of the country?  Physicist Robert Wilson replied “It has nothing to do directly with defending our country except to make it worth defending.” 1

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