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

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.

People in the Pharmaceutical Industry interested in learning more about the benefits of spray-dried dispersions

Ms. Settell is the Director of Engineering at Bend Research and has been with the company since 1999. She is the former Director of Operations at the company’s current Good Manufacturing Practice (cGMP) facility, where she assisted with the installation, commissioning, start-up, maintenance, validation, and operation of a PSD-2/FSD-4 spray dryer. In addition, she oversaw all aspects of production at the facility, which manufactures drug products that met cGMP standards.

Ms. Settell has extensive experience with scaling up drug production from development through commercial production. She was instrumental in technology development, technology transfer, and startup of a $90 million commercial plant in Ireland to manufacture our spray-dried dispersion (SDD) technology at the metric ton scale.

Ms. Settell holds a bachelor’s degree in chemical engineering from the University of Colorado. She holds two patents and is a member of the American Institute of Chemical Engineers.

Corey Bloom, Director, Formulation Science, Bend Research Inc. 

Before being named Director of Formulation Science, Dr. Bloom held the positions of group leader and senior research chemist. He holds a bachelor’s degree in chemistry from Gustavus Adolphus College in St. Peter, Minnesota, and earned his PhD in analytical/materials chemistry from Colorado State University.

For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies. The firm’s innovative drug-delivery solutions grow from a solid base of scientific and engineering fundamental understanding.

Bend Research provides formulation and dosage-form support, assists in process development and optimization, manufactures clinical-trial quantities of drug candidates in its cGMP facilities, and advances promising drug candidates from conception through commercialization. Bend Research is a leader in novel drug formulations, including those based on solubilization technologies such as spray-dried dispersions, hot-melt extrusion, and inhaled, controlled-release, and biotherapeutic technologies.

Bend Research has more than 200 employees based in four state-of-the-art facilities in Bend, Oregon, USA. For more information about Bend Research, please contact Phoenix Ivers by email at Phoenix.Ivers@BendResearch.com or phone 541-382-4100.