3rd Annual Conference 2017
3rd – 5th October 2017
Crowne Plaza Hotel – Blanchardstown, Dublin, Ireland

Modeling the Physical Stability of Amorphous Solid Dispersions

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Modeling the Physical Stability of Amorphous Solid Dispersions

Modeling the Physical Stability of Amorphous Solid Dispersions

Rodney J. Ketner, Ph.D.
Bend Research, a division of Capsugel,
Bend, Oregan, USA

The use of amorphous solid dispersions to improve oral bioavailability has been known in the pharmaceutical industry for well over 40 years, with a large number of products advancing to commercialization in the past few years.  Driven by an increasing percentage of poorly soluble drugs in pharmaceutical industry pipelines, fundamental understanding and the application of solid-dispersion technology have advanced substantially. This presentation briefly describes the formulation of amorphous solid dispersions (“spray-dried dispersions” or SDDs) and related technologies that have been used successfully to improve the oral bioavailability of low-solubility drugs.  Stage-appropriate physical-stability models that have been developed and verified for the prediction of long term stability for SDD formulations are described, as are applicability maps that identify the physical-property boundaries of drug molecules where “conventional” SDD technology is applied.