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Conference Presentations - 2011 AIChE Annual Meeting

Quality by Design for DPIs -A Regulatory Perspective

Oct 19, 2011
Prasad Peri
Inhalation Powders have become an important dosage form in developing products for delivery to the lungs. Since the approval of the first DPI in the US in the late 1990’s there has been a rapid surge in the number of drug development programs involving Dry Powder Inhalers. The draft MDI/DPI...

Green and High Efficient Enzyme Hydrolysis Process for Sweet Sorghum Bagasse

Oct 19, 2011
Xinshu Zhuang
In order to improve enzymatic hydrolysis efficiency, several approaches including liquid hot water (LHW) pretreatment, adding surfactant, magnetic stirring and fed-batch hydrolysis were investigated, in which Sweet sorghum bagasse (SSB) was chosen as the feedstock. The experiment results showed...

Dynamic Design Space As An Integrated Component of Quality by Design

Oct 19, 2011
Carl A. Anderson
The Food and Drug Administration requires from pharmaceutical companies the development of extensive knowledge databases regarding the control of the manufacturing process of a drug product. Through development and validation, drug manufacturers discover their process boundaries and identify a...

Modeling of Asphaltene Deposition In a Vertical Tubing

Oct 19, 2011
Dmitry Eskin
Asphaltene deposition phenomena are investigated both theoretically and experimentally. A Couette device, where the inner cylinder rotates and particles deposit on the outer wall, is used for laboratory studies of the deposition process. The modeling approach, recently proposed by the authors (...

QbD In Dry Powder Inhaler Development

Oct 19, 2011
David Morton
Summary Developing products comprising un-bound fine cohesive powders throws up significant challenges. Dry powder inhalers present a prime example. Why? Because the behaviour of fine cohesive particle behaviour is notoriously complex, and notably more so than any single phase solid, liquid or...

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