Introduction to Unites States Pharmacopeia – USP
United States Pharmacopeia is the set of standards published for the healthcare sector. Divided into various chapters or sections, it addresses issues related to different areas of public health and provides practical solutions for quality operations and effective products. It covers the entire pharma product area, such as processes, methods, equipment, areas, and all the relevant subjects.
Chapter 1062, written as USP <1062>, TABLET COMPRESSION CHARACTERIZATION, provides guidelines for the tablet form of dosages such as equipment, compression process, and associated areas. As discussed above, It also offers some insight into common problems during the compression process and how these can be solved.
USP <1062> Tablet compression characterization
The USP 1062 is divided into fourteen chapters. Each chapter intends to provide guidance related to processes related to compression equipment and associated areas.
Let’s discuss a brief description of each chapter in USP 1062
Chapter 1 – Background
This chapter introduces tablet and tablet compression, tablet properties, and what the USP 1062 includes. It starts by stating that tablet is the widely used dosage form, referencing another USP document, USP <1151>.
It also states that tablet compression is a critical process for manufacturing tablet form and mentions some common problems faced during the tablet compression process. Examples of problems this chapter indicates include capping, lamination, high friability, sticking, and insufficient mechanical strength.
It also mentions ambient conditions, such as temperature and humidity, that play an important role in affecting the tablet’s characteristics.
Some other factors that affect the final tablet product includes
Product particle size
Product particle shape
Surface texture
Moisture content in the raw product particles
Chapter 2 COMPRESSION PHASES
This chapter focuses on aspects of the compression process, such as pressure, strain, and strain rate. It provides information about compression forces and states that there are four stages during tablet compression or formation, as indicated below
Product particle rearrangement
Compression
Decompression
Ejection
Particle rearrangement
In this stage, product particles rearrange themselves to reduce or eliminate pores without deforming individual product particles. Particles undergo slippage, rotation, or translational movement for re-arrangement, and after this process, particles are denser than their initial stage due to the elimination of pores.
Compression
Compression occurs when they are compressed against each other, die walls, and punch. It increases the powder density and reduces the powder volume.
Compression occurs in the die when the powder is compressed against upper and lower punches. For compressing, upper and lower punches move down and up simultaneously in a die.
Decompression
During decompression, punches release pressure on powder by retracting from the die. The upper punch moves upward, while the lower punch moves downward at its initial position.
In this stage, particles undergo controlled elastic recovery. Because uncontrolled elastic recovery could decrease the bonding and mechanical strength. As a result, the tablet will lack the desired physical characteristics, and chances are that the quality department can reject these tablets.
Ejection
This is the final stage, where tablet comes out of lower die in a final finished form.
Chapter 3 Tablet Compression Characterization Equi...
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