USP Draft Chapter <1062> "Tablet Compression Characterization"

Recommendation

Thursday, 17 February 2022 9 .00 - 16.30 h

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The USP General Chapters—Physical Analysis Expert Committee proposes a new general chapter <1062> to describe the basic principles and practices used in the characterization of tablet compression. The proposal has been published in Pharmacopeial Forum 42(5) [Sept. 2016] and is open for comment until November 30, 2016.

The USP emphasizes that "this chapter is intended to facilitate the standardization of terminology and provide a general description and characterization of key aspects of the tablet compression process. Therefore, this chapter will address the need for practical information and provide a useful resource for the pharmaceutical industry."

Additionally, "responses to a Stimuli article (Proposed New USP General Information Chapter “Tablet Compression Characterization <1062>”) published in Pharmacopeial Forum 40(4) [July–Aug. 2014] have been incorporated into this chapter, which represents a consensus view on the appropriate application of the chapter in pharmaceutical practices."

USP says that "Material in this chapter is neither intended as a prescriptive method nor as a replacement for a given unit manual or standard method. Instead, the chapter provides general theory and information on the use of laboratory tools for characterization of pharmaceutical tablet compression."

The proposed chapter contains the following topics:

1. BACKGROUND  
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   
4. TOOLING  
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  
REFERENCES  

Furthermore, another Stimuli article about this chapter is published in the same issue of PF: "USP Responses to Comments on Stimuli Article "Proposed New USP General Information Chapter: Tablet Compression Characterization <1062>".

The original Stimuli article in PF 40(4) "focused on the standardization of terminology and general description of key aspects of the tablet compression process. The objective was to identify and build up areas of consensus that could be included in the general chapter to address the need for practical information and to provide a useful resource for the pharmaceutical industry." One question addressed was about the identification of a reference material (e.g., an excipient or a powder blend) - would it be useful for powder compression characterization and standardization in the industry?

Five parties submitted their comments following publication of the original Stimuli article. The current Stimuli article responds to these public comments. USP states that "on the basis of comments received and after much discussion, the Expert Committee concluded that the development of a USP Reference Standard will not be conducted at this time."

Following your registration on the USP Pharmacopeial Forum website you can get to the proposal for general chapter <1062> and the complete stimuli articles.