Formulation Development of Hot Melt Extrudate to Stabilize Amorphous API

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
AIChE Annual Meeting
November 1, 2012 - 9:20am-9:45am
Hot Melt Extrusion:  Identification and optimization of key excipients utilizing high-throughput screening methodology.

By utilizing various tool kits available in the chemical engineering toolbox, a case study would be presented on formulation development in an accelerate timeframe for a marketed drug product.  A new high throughput screening methodology will be presented, to screen various excipients, in order to quickly identify the optimum extrusion composition, using a small scale (1-mL) vials, based on blend uniformity, Tg and heat capacity for the various mixture of interest.  To optimize the throughput requirements for manufacturing scale, an ordinary differential equation would be used to solve the required temperature profile of the extrudate in order to achieve desired properties, such as, swelling of the strand, tackiness to cut, elastic and brittle fracture of the strand.   Also, work on new hot face pelletization technique would be presented for containment issues for a highly potent (OHC-5 category) API, to achieve the desired pellet distribution in order to prepare a uniform blend for tablet development.

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