10/11 March 2020
On August 26, 2016 the United States Pharmacopeia (USP) Expert Committee General Chapters - Dosage Forms announced a major revision of general chapter Tablet Breaking Force <1217>. Comments can be submitted until October 15, 2016.
During tablet formulation and manufacturing it is important to routinely test the tablet breaking force. These tests insure a constant level of high quality results during tablet production. Therefore, standardized test procedures as described in general chapter <1217> are required. The USP general chapter <1217> Tablet Breaking Force was proposed as a new general chapter in 2005 and has been part of USP official text since 2007 (USP30 - NF 25, First Supplement). The USP General Chapters - Dosage Forms Expert Committee is planning a major revision of this general chapter, as part of the cycle of reviews.
Tablet breaking force test apparatus manufacturers and tablet press manufacturers are the suggested audience for the proposed revision. The proposal is expected to be published in PF 43(2) [Mar.–May 2017].
The USP points out that "The General Chapters - Dosage Forms Expert Committee is interested in enhancing the information available on apparatus description, including designs in which constant loading rate or constant platen movement is employed, typical ranges of movement or loading rate, sensitivity for breaking force, methods of calibration, and sample size."
Additionally, the USP emphasizes that "the General Chapters - Dosage Forms Expert Committee is contacting manufacturers of tablet breaking force test apparatus to request the following information:
Responses received by USP until October 15, 2016 will be provided to the subcommittee for consideration.
For further information please read the General Chapter Prospectus: Tablet Breaking Force <1217> on the USP website.