BRIEFING

 〈1245〉 Compaction Simulation. Because USP does not have standards regarding compaction simulation, the General Chapters—Physical Analysis Expert Committee proposes the following chapter to address this need.

 Compaction simulation is used in the adequate design and execution of the compression process for pharmaceutical tablets. This chapter provides guidance regarding scientifically sound practices for the use of compaction simulation in the design, process development, and manufacturing of pharmaceutical tablet dosage forms. It includes discussion of the following:

1. Compaction physics

2. Instruments and systems used for compaction simulation

3. Benefits and limitations of compaction simulation

4. Applications of compaction simulation

 (GCPA: E. Biba)

 Case ID—SUB-84