Bioavailability Enhancement Webinar Series: Amorphous Solid Dispersion Formulations Using the Spray Dry Process

November 21, 2013 - 8:00am

The 2nd part in the bioavailability enhancement webinar series aired November 21, 2013 and focuses on Amorphous Solid Dispersion Formulations Using the Spray Dry Process.

Current estimates show that more than 30% of new chemical entities require solubilization technology to achieve efficacious plasma exposure. Amorphous solid dispersion technology is a preferred formulation option to improve solubility and dissolution rate of these insoluble compounds. It is evident that when amorphous compounds are delivered orally, their solubility advantage could translate into enhanced bioavailability, especially under conditions where the dissolution in the gastrointestinal tract is the rate-limiting step for absorption. Amorphous solid dispersions are commonly prepared by two manufacturing processes including hot-melt extrusion and spray drying.

The spray drying process can be an advantageous process due to its broad applicability to drug candidates and relatively easy scalable nature—scaling from tens of milligrams to metric tons. This webinar discusses the application of amorphous solid dispersions via spray drying process in preclinical formulation identification, including stability and performance considerations. Spray dry process development and scale-up through clinical supply manufacture are also covered. In addition, considerations in development of immediate-release dosage forms from amorphous spray-dried dispersions are discussed.

Presenters: David Vodak, Ph.D., Dana Settel and Brett Caldwell, Ph.D.

Bioavailability Enhancement