(233a) Chemical Engineering Principles in Oral Solid Dosage Process Development-Where Are We?

Shi, W., Bristol-Myers Squibb Company
While solid processing is a common engineerâ??s domain across industries, there are still gaps in the pharmaceutical industry in applying basic chemical engineering principles, from API development to drug product development, especially equipment design and process control. General gaps and misconceptions in these areas gathered from field experience will be presented along with case studies. While the barrier to apply equipment modification or to upgrade process control could be complicated and cumbersome in the heavily regulated industry, the benefit of such change cannot be ignored due to the fact that there were (and are) significant amount of development work caused by the lack of basic principles in designing the current system (as simple of sufficient heat transfer). The other element of barrier is rather cultural, i.e., no desire to change as the current system is workable. In summary, opportunities along with challenges in the pharmaceutical process development are waiting for more chemical engineers to explore.