Development of Amorphous Solid Dispersions using the Spray-drying Process: Early Development through Clinical Manufacture

December 13, 2012 - 9:30am

This webinar will cover (1) Identification of amorphous formulation with a focus on performance and stability, (2) Process development and scale-up from 100-mg scale through >1Kg, (3) Considerations in preclinical through clinical manufacture of spray dried amorphous dispersions, and (4) Incorporation of intermediate amorphous formulations into immediate release final dosage forms.

David Vodak, Ph.D. will be presenting this webinar through the AAPS Physical Pharmacy and Biopharmaceutics Section.  Ping Gao, Ph.D. of Abbott will be the moderator.

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 will discuss 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 will also be covered. In addition, considerations in development of immediate-release dosage forms from amorphous spray-dried dispersions will be discussed.

Bioavailability Enhancement