The new USP general Chapter <1062> Tablet Compression Characterization has been approved and published in USP40-NF35 , second supplement, June 1, 2017. The chapter will become official on December 1, 2017.
The draft chapter <1062> has been previously published in Pharmacopeial Forum 42(5) [Sept. 2016] and was open for comment until November 30, 2016.
According to the USP, "the tablet is currently the most widely used dosage form for oral drug delivery. The advantages of the tablet include economy of manufacture, patient convenience, and compliance. Tablets may also offer additional advantages over other dosage forms, such as superior physical or chemical stability."
In this context, "powder compression is a critical process in manufacturing the tablet dosage form. Although this process has been used routinely for over a century, problems related to powder compression in pharmaceutical formulation development and manufacturing persist. Common problems include tablet failures, such as capping and lamination, high friability, powder sticking to punch surfaces or the die wall, and insufficient mechanical strength to withstand stress in downstream processing. Some formulations may exhibit acceptable compression characteristics during early development where production volumes are usually low but become problematic during scale-up."
USP says that "this new chapter describes the current understanding of this specialized area and outlines experimental methodologies for characterization of tablet compression to provide guidance for standardized compression test procedures and use of terminology. Although the fundamental concepts described here are also applicable to other processes, such as plug formation during encapsulation and roller compaction, the focus of this article is on tableting."
The new general chapter <1062> is structered as following:
2. COMPRESSION PHASES,
3. TABLET COMPRESSION CHARACTERIZATION EQUIPMENT,
3.1 Hydraulic Press
3.2 Instrumented Research Tablet Press
3.3 Tablet Press Emulator
3.4 Compaction Simulator
3.5 Instrumented Production Tablet Press
5. PUNCH DISPLACEMENT-TIME PROFILES,
6. TABLET MECHANICAL STRENGTH,
7. TABLET POROSITY AND SOLID FRACTION,
8. MANUFACTURABILITY PROFILE,
9. TABLETABILITY PROFILE,
10. COMPRESSIBILITY PROFILE,
11. COMPACTIBILITY PROFILE,
12. TABLET COMPRESSION PROFILE,
13. MACHINE SPEED SENSITIVITY,
14. CONCLUSIONS AND RECOMMENDATIONS,
GLOSSARY (defines terms with the International System of Units (SI), commonly used in pharmaceutical tablet compression),
For more Information please visit the USP-NF Homepage.