Over the past several years increasingly more poorly soluble drug compounds are being formulated from amorphous solid dispersions into oral solid dosage forms.  Due to often larges differences in solubility of the crystalline drug form and formulated amorphous form, development of dissolution methods which are sensitive to drug form is possible but can be challenging. Based on several case studies, strategies and challenges for developing form-sensitive dissolution methods for solid-dispersion formulations are discussed in the framework of method robustness and suitability of such methods during drug development and in a quality control environment.

Dissolution method development for amorphous solid dispersions: Strategies and challenges

248th National Meeting (2014)

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