Thomas Dürig, Vivian Bi and Fengyuan Yang
Ashland Specialty Ingredients Inc., 500 Hercules Rd, Wilmington DE, 19808

Compaction simulators have been widely used at different stages of pharmaceutical solid formulation development. We at Ashland have a long history of using compaction simulators as tools to increase the efficiency of R&D activities. In this presentation, a variety of case studies will be used to illustrate the broad application of compaction simulators in the development and characterization of polymers, formulation and process development, or trouble-shooting.

Development of a new grade of excipient:

Ideas for new excipients or new grades of existing excipients often originate from unmet customer needs. For example, in the process of assisting a customer with formulation development, a compactability issue arose. The polymer of interest, with different degrees of substitution and viscosity, was compressed using a compaction simulator, and pressure-punch distance curves were plotted to obtain axial recovery. A correlation between material properties and axial recovery was established, and a new grade of excipient with superior compactability has been developed and launched accordingly.

Predicting scale up in unusual situations:

             In one case study, tablet sticking and picking issues occurred, only at production scale. New formulations were developed as a mitigation measure; however, evaluating the new formulations at production scale was cost prohibitive. A novel method using a compaction simulator was developed to predict the occurrence of that sticking and picking issue, and the method was proven both effective and efficient for identification of improved formulation and tooling design (Figure 1). In another case, compaction simulator was used to determine commercial compaction conditions to optimize survival of probiotic live cultures.

Figure 1. Comparison of two formulations: compression force, compression thickness, compression energy, plastic energy, ejection force and ejection energy as functions of compression cycle.

In addition to these case studies, other applications of compaction simulators in oral solid dosage form design will be presented and discussed.

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Thomas Dürig,

Dr. Tom Dürig is a Senior R&D Director and global head leads R&D and technical services for Pharmaceutical and Health and Wellness Specialities. These groups, located in North America, Europe, Middle East, Latin America, and Asia provide technical service and are focused on research and development of highly functional materials that enable overcoming drug delivery challenges such as bioavailability enhancement, drug stabilization and controlled drug delivery as well as process technologies to achieve advanced drug delivery and continuous manufacturing.