Spray Dried Dispersions: Robust Formulation and Science of Scale from Preclinical to Launch

September 29, 2011 - 8:00am

Speakers: Dana Settell and Corey Bloom

 

Spray-dried dispersions (SDDs) are an increasingly popular formulation choice in all stages of development for the oral delivery of poorly soluble drugs.  This webinar will address scientific and practical aspects of formulation selection and process design relative to early- and late-stage pharmaceutical development. 

 

Specific topics that will be discussed include

  • the selection and optimization of robust formulations;
  • key SDD quality attributes: performance, manufacturability, and stability
  • spray-drying scale-up using a Quality-by-Design (QbD) framework.

 

Case studies will be presented to illustrate issues that may arise during product progression based on the presenters’ years of experience in developing and manufacturing SDD formulations.  Over the past 18 years, Bend Research has successfully developed and applied SDD technology to more than 400 compounds, including hundreds of compounds in in vivo tests and dozens of compounds in clinical trials.  A unique process flowchart methodology has been developed that allows rapid and efficient feasibility assessment and scale-up of formulations, minimizing time, cost, and the consumption of valuable active pharmaceutical ingredient.