Development And Implementation Of A Drying Process For An Amorphous Api Solid
Yao-En (David) Li1, Alex Coles2, Gerrie Liaw1 and Stephen Tyler1, (1)Global Pharmaceutical Operations, Manufacturing Science and Technology, Dept 045B, Building R13-2,, Abbott Laboratories, 1401 Sheridan Road, North Chicago, IL 60064, (2)Abbott Laboratories, Queenborough, Kent ME11 5EL, United Kingdom

An amorphous solid is a solid in which there is no long-range order of the positions of the atoms. It is normally difficult to remove the residual solvents during drying stage, mainly due to the formation of sticky, agglomerated solids.

In this paper, authors will discuss in detail on the development of a drying process based upon its glass transition temperature for amorphous API solids in an agitated dryer. This amorphous API compound is characterized by its low thermal degradation temperature, and the drying temperature of removing trapped solvents is very close to its thermal degradation temperature. There are several operational parameters that strongly effect the glass transition temperature during drying. The authors will present an industrial agitated drying model for such an amouphous compound in a production scale.

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Advances in Api Process Development

The Preliminary Program for 2007 Annual Meeting