Melt extrusion is a well characterized industrial manufacturing technology that has been in use for over a century for a range of applications. First applied to commercial pharmaceutical products in the early 1980's, this technology has emerged as a first line choice for the production of amorphous solid dispersions, controlled release products, melt granulations and shaped delivery systems. Consisting of six major steps (feeding, conveying, melt compounding, devolatilization, pumping and shaping) extrusion provides unique flexibility to match process specification to desired product attributes. The continuous, solvent free nature of the process and ability to implement in-line monitoring make extrusion one of the preferred platforms for the production of high volume amorphous solid dispersions. This presentation describes the fundamental aspects of melt extrusion for pharmaceutical applications, with a focus on the production of amorphous solid dispersions for oral bioavailability enhancement.

Hot-melt extrusion for drug delivery

244th National Meeting (2012)

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