Downstream Processing Considerations

Successful development of a drug product containing the drug in the amorphous form would not be feasible without a deeper understanding of all parameters having an influence on the critical quality attributes of the final dosage form. For amorphous systems in particular, the desired degree of supersaturation and the physical and chemical stability need to be ensured when formulating the amorphous solid dispersion. Based on the quality target product profile (QTPP), several aspects need to be taken into consideration, such as the desired release profile of the drug and the size of capsule or tablet acceptable from a patient’s perspective.