Track: Discovery and Basic Research - Pharmaceutics - Pharmaceutical Polymers
Category: Late Breaking Poster Abstract
Pharmaceutical Excipient Compactions and Evaluation: Entrapped Air
Purpose: A variety of defects during pharmaceutical compactions are observed at both the micro- and macroscale. Entrapped air, lamination, and microscale structural cracking are observed when compaction is performed at sufficiently high-speed. By studying these phenomena, the limitations of modern compaction studies can be discovered for optimizing manufacturing tolerances. Methods: To avoid working with restrictive active pharmaceutical ingredient the observations are performed on excipient compacts. X-ray microtomography and optical microscopy are utilized to observe these defects directly. The usage of finite element analysis is useful in coordinating the compaction parameters with which to isolate viable production paths. By using solely excipient material in these compaction models, the FEM analysis can use ordered identical particle arrangements to examine the mechanical characteristics of both the material studied as well as the mechanics inherent to the processes. Results: Clear qualitative positive recognition of entrapped air and lamination indicated with optical microscopy and x-ray tomography. The contributing factors to the development of such defective characteristics are examined through adapting prior literature to a finite element analysis exploration, yielding a positive correlation between the depth of entrapped air with crack volume. Conclusion: The pharmaceutical compact defects developed in compacted excipient material provide a testbed for extreme manufacturing tolerances without the concern for the inclusion of active pharmaceutical ingredients. The examination of the defective material can be performed using optical microscopy and x-ray microtomography, yielding quantitative results. Further, the nature of the defects can be explored using finite element analysis of a subset of particles.