New USP Chapter <1245> Compaction Simulation published

The new Chapter <1245> Compaction Simulation in the USP is a newly added chapter that describes procedures for simulating tableting. It was first published with USP 47 - NF 42, First Supplement and, like all USP chapters with a number > 999, is considered informative.

Chapter <1245> describes standardised procedures for simulating tableting (compaction simulation) in order to characterise critical material attributes in the development of solid oral dosage forms (OSDs). The main application here is in early formulation and process development.

The new chapter explains how single-punch tablet press systems can be used to collect data to determine material properties such as compactability. This helps, for example, in assessing suitability for direct compression. Potential process or scale-up problems can be identified early and avoided if necessary. This is also useful when optimising formulations for high-speed rotary presses. Chapter <1245> is aimed in particular at formulation and process developers and provides support through early evaluation of the compressibility of formulations.

The new USP chapter <1245> Compaction Simulation is divided into the following sections:

1 Introduction - Introduction to the scope of application of compaction simulation.
2 Scope - Definition of the scope of application: powders or granules for the manufacture of solid oral dosage forms.
3 Terminology - Definition of important terms such as 'tabletability', "compressibility" and 'compactability'.
4 Equipment - Description of typical single-punch press systems with force and displacement measurement and software for data evaluation.
5 Methodology - Instructions for performing compaction simulations, including systematic variation of the compression force.
6 Data Analysis - Description of the evaluation, divided into:
" 6.1. Tabletability - Relationship between compression force and tablet breakage resistance.
" 6.2. Compressibility - Relationship between compression force and volume reduction or density.
" 6.3. Compactability - Relationship between density and tablet breakage resistance.

7 Applications - Application examples for the characterisation of materials, the selection of formulations, comparison of raw materials and support with troubleshooting.

References - Bibliography.