(189h) How a Material Property Library Can Promote Rapid Process Development

Pharmaceutical manufacturing is, in essence, the combination of multiple ingredients to create composite products with specific performance (quality) attributes. Ingredient properties interact with the process to generate intermediate blends and finished products that must have specific composition and material properties in order to perform as intended. Moreover, both in batch and in continuous pharmaceutical manufacturing, the properties of ingredients play a dominant role on process performance, and in turn the process often determines the properties of finished products. Understanding the relationship between material properties, process parameters, and product performance is the key technical element needed to model, design, optimize, and control a pharmaceutical manufacturing process.

This presentation will provide information on how one can use the material physical characterization data to predict product performance in the feeding operation, optimizing feeder size and screw design and reducing the time required to optimize the unit operation. In additional to correlating rheological properties to performance, utilizing a material property library for surrogate identification. New API can be scarce or expensive to produce. By utilizing a material library filled with a wide variety of materials and property tests, similarities between different clusters of materials can be identified. Within the cluster a surrogate for the new material can be identified that most closely resembles the API. The results in this work show how a surrogate identified by this method will produce a blend and final product with similar quality attributes, allowing process development to proceed with the surrogate.