Type of Posting: General Chapter Prospectus
Posting Date: 26–Aug–2016
Expert Committee: General Chapters—Dosage Forms
Input Deadline: October 15, 2016
Suggested audience: Tablet breaking force test apparatus manufacturers, tablet press manufacturers
Estimated proposal PF: 43(2) [Mar.–May 2017]
Background and objective(s): <1217> Tablet Breaking Force was proposed as a new General Chapter in 2005 and has been part of USP official text since 2007. The General Chapters—Dosage Forms Expert Committee is planning a major revision of this General Chapter, as part of the cycle of reviews.
Description of scope and application: 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.
Anticipated implementation timing: The General Chapters—Dosage Forms Expert Committee intends to publish this revision in Pharmacopeial Forum 43(2) [Mar.–May 2017].
Other information: 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.
- <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.
Contact Information: Responses received by William Brown web@usp.org on October 15, 2016 will be provided to the subcommittee for consideration.