Processing of Amorphous Solid Dispersions for Poorly Soluble Drugs
An estimated 60 percent of compounds in early development have poor solubility due to low solubility and dissolution rates (DCS IIa and IIb). Hot-melt extrusion (HME) of amorphous solid dispersions is one approach Bend Research, a division of Capsugel Dosage Form Solutions, uses to address APIs with limited bioavailability. By using small scale screening techniques and an integrated process and formulation approach, Bend Research is able to rapidly develop a progressable drug intermediate and dosage form for preclinical and clinical manufacture. These approaches balance the target absorption profile, manufacturability, physical and chemical stability, and API availability.
In this webinar, scientists from Bend Research will provide insight into HME fundamentals, including solid dispersion formulation selection. Strategies and case studies for solid dispersion formulation selection and definition of a HME process operating space will be reviewed.
Presented by
Charlie McLaughlin,
Engineering Technical Group Lead
Charlie McLaughlin is an engineering technical group lead at Bend Research, a division of Capsugel Dosage Form Solutions, where he leads a team of scientist and engineers to develop and manufacture novel pharmaceutical formulations. His primary areas of expertise include process development, scale-up, and de-risking of solid dispersions and immediate release tablets. He has thorough experience in designing and executing experiments for solid dispersion based immediate release dosage forms, spray-drying technologies, providing spray-drying expertise for customer product testing and experimentation and developing spray-drying models and tests for pharmaceutical- and biotechnology-based engineering problems.
Mr. McLaughlin joined Bend Research in 2010. He holds a B.S. in chemical and biological engineering from Montana State University.
Scott Bone,
Chemistry Technical Group Lead
Scott Bone is a chemistry technical group lead at Bend Research, a division of Capsugel Dosage Form Solutions, where he designs and coordinates execution of project work plans, including analytical support for the development of novel pharmaceutical formulation. Focus areas include formulation development for spray-dried dispersions (SDDs) and hot melt extrusions (HMEs) for bioavailability enhancement and formulation development for immediate release solid dosage forms. His expertise includes polymers and coatings.
Mr. Bone joined Bend Research in 2009. He holds a M.S. in chemistry, University of Oregon and a B.S. in chemistry from Southern Oregon University. He has authored 2 publications and contributed to 1 patent.