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Validation and applications of an expedited tablet friability method
Frederick Osei-Yeboah1, Changquan Calvin Sun1
1Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 9-127B Weaver-Densford Hall, 308 Harvard Street S.E., Minneapolis, MN 55455, United States.
International Journal of Pharmaceutics
|March 1, 2015
Summary
An expedited tablet friability test was developed to overcome the limitations of current pharmacopeia methods. This new method provides statistically similar results, enabling efficient formulation development and tablet design.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Chemical Engineering
Background:
- The harmonized tablet friability test (USP, Pharm. Eur., JP) assesses tablet mechanical strength but is labor and material intensive.
- Current friability testing limitations hinder its application in early-stage formulation development.
Purpose of the Study:
- To develop and validate an expedited tablet friability test method.
- To demonstrate the utility of the expedited method in formulation and tooling design.
Main Methods:
- Utilized existing United States Pharmacopeia (USP) test apparatus for the expedited method.
- Validated the expedited method against the standard pharmacopeia method using microcrystalline cellulose and dibasic calcium phosphate dihydrate.
- Investigated the relationship between tablet friability and mechanical strength.
Main Results:
- The expedited friability test yielded statistically comparable results to the standard pharmacopeia method.
- Established a power law relationship between tablet friability and tablet mechanical strength.
- Demonstrated practical applications in tablet formulation and tooling design.
Conclusions:
- The developed expedited tablet friability test is a valid and efficient alternative to standard methods.
- This expedited method facilitates systematic and efficient tablet formulation and tooling design.
- The findings support broader adoption of expedited friability testing in pharmaceutical development.
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