USP General Chapter <1062> Tablet Compression
This USP chapter states that powder compression is a significant and critical process in manufacturing tablets, so chapter 1062 was written to describe the current understanding of tablet compression and outline the experimental methodologies for tablet compression characterisation. This chapter introduces standardised compression test procedures and terminology. The guidance is a useful resource for the pharmaceutical industry. The material in the chapter provides a general theory and information on the laboratory tools for characterisation. Compaction Simulators are ideal tools for generating data to support material understanding.
Compression Testing
Chapter <1062> says that how a powder compresses is impacted by both the powder's properties and the compression process. It is important to understand powder behaviour during the compression process and the ultimate goal is to predict how the power behaviour interacts with the process.
At Merlin, we can provide compressibility testing which allows you to understand the functional properties of your Active Pharmaceutical Ingredient (API). We can assess key properties using only 3-5g of API. These properties are compressibility, compatibility, and true density. The compressibility test will allow us to assess the Strain Rate Sensitivity (%) which gives a sign of the risks of scale-up on the material characteristics of the API.
Chapter 1062 also talks about the importance of tabletability. It helps us understand the causes of poor performance. These include capping and lamination, which are common tableting problems. At Merlin, we can do compactability and tabletability tests at production-like speeds. These tests help you understand the causes of poor performance. We use a compaction simulator to do the tests. It lets us assess compacts across a range of compression conditions. During this test, we measure the punch pressure and the tensile strength. They help us understand the formulation and the factors affecting tabletability. The tabletability profile that is produced from this information will allow you to assess how the tablet blends behave across the whole of its compressibility range. This test can also highlight if physical capping and lamination is anticipated.
Ref: The United States Pharmacopeial Convention (2016). USP40-NF35 The United States Pharmacopeia and National Formulary 2017. pp.8491–8948.
