USP announced Major Revision of General Chapter <1217> "Tablet Breaking Force"

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:

  • Non-proprietary developments in the design and change in use of equipment relative to the information contained in the current official chapter.
  • Chapter <1217> speaks to two design approaches for tablet breaking force testers; constant loading rate and constant platen movement. Manufacturers of Tablet Hardness/Tensile Strength/Breaking Force are encouraged to provide information on the approach taken with their equipment as well as the designed range of loading rate or platen velocity. Information provided will help the Committee revise the chapter so that the text represents the current test apparatus.
  • The subcommittee is interested in expanding the section on calibration. Recommendations on calibration equipment, the period between calibration activities, calibration procedures, and calibration best practices are welcomed.
  • Lastly the subcommittee is reviewing the references that support the General Chapter. Recommendations on recent publications that support the General Chapter or publications that support any information provided in response to this request are also welcomed."

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.

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