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USP Proposes New Chapter to Standardise Compaction Simulation for Pharmaceutical Tablets.

The United States Pharmacopeia (USP) has released a proposed new general chapter, <1245> compaction simulation, addressing the growing need for standardised guidance in pharmaceutical compaction simulation.

This chapter aims to fill the regulatory gap in the early-stage development and scale-up of solid oral dosage forms. With tablets being the most common form of drug delivery, the chapter provides essential framework for simulating the compression process using in large-scale manufacturing.

 

Bridging the Lab-to-Production Gap

In pharmaceutical development, early tablet formulations are created on single station presses that do not replicate the dynamics of high-speed rotary presses used in production. This mismatch can lead to inconsistencies in tablet quality when scaling up. Compaction Simulators, which mimic industrial press on a small scale, offer a solution. The USP’s new chapter outlines scientifically sound practices for using such simulators effectively.

Applications Across Development Stages:

The chapter also discusses the wide applicability of compaction simulation in formulation troubleshooting, scale-up assessment, tooling design, and advanced techniques such as multilayer tablet and tablet-in-tablet development. It emphasizes the importance of accurate simulation profiles based on actual production machine geometry and tooling.

At Merlin, we use specialist equipment and the latest scientific techniques to investigate powder compressibility. Our Compaction simulator can be used to mimic the punch movement profile and operating settings of any production press using integrated software. We can offer Heckel testing to calculate the strain rate sensitivity and identify known risks to tablet development for new APIs.  As well as, tabletability assessments to assess the key functional properties of prototype formulations.

Compaction simulators allow you to have access to high-speed compaction data for products on laboratory scale samples. Compaction simulators allow you to speed up the decision-making process with high quality predictive methods. Formulation and manufacturing experience linking science to commercial manufacturing methods. R&D measurements to support latest computer modelling techniques.

 

Looking Ahead

The new <1245> chapter is expected to be finalised and incorporated into the USP compendium in December 2025. Its introduction reflects USP’s commitment to supporting innovation and quality in pharmaceutical manufacturing by offering robust, science-based standards.

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