Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability, and Dosage Form

July 10, 2013

 

Baumann, J.M., D.E. Dobry, R.J. Ray, and D.T. Vodak, “Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability, and Dosage Form,” Drug Dev. Delivery, 13:4(2013)30-36.

 

Given the ever-increasing number of compounds that present oral absorption challenges, efficient and “phaseappropriate” formulation development is crucial for robust optimization of key formulation attributes and successful progression of these compounds. Amorphous dispersions enable progression of low-solubility compounds and open multiple opportunities for optimization and understanding during formulation and process development. Deep understanding of the critical-to-performance attributes of amorphous dispersions as they relate to performance, manufacturability, stability, and downstream manufacture into solid dosage forms makes efficient and robust formulation development possible.   This paper discusses the development and use of amorphous spray-dried dispersions (SDDs) and the testing methodologies used to optimize the formulation and spray-drying process for performance, manufacturability, stability, and incorporation into final dosage forms. Innovative models and tools are used to predict and select the optimum formulation and process early in the development process. Use of guidance maps, process development flowcharts, in vitro tests, and models all enable efficient and successful formulation development. 

 

 

Topics: 
Bioavailability Enhancement