Evaluating Tablet Splitability by Calculating Loss of Mass (+ Excel calculator)

Tablets may be manufactured with one or more scores, serving a useful purpose in facilitating the splitting of the tablet into smaller portions when a full tablet is not required for a dose. Consistent scoring ensures that patients can conveniently adjust the dosage as needed.

One criterion that new products with scores must adhere to is tablet splitability, which is measured at both ends of the proposed hardness range. To accomplish this, it is necessary to test 15 tablets to ensure that the loss of mass between the individual segments, when compared to the whole tablet, is less than 3.0 percent.

Download our loss of mass calculator below to easily evaluate tablet splitability.

Loss of Mass Calculator Preview

To use this, just enter the weights of the whole and split tablets in the respective columns as shown in the preview below. The template automatically calculates the loss of mass for each tablet and flags any value that exceeds the recommended 3.0%.

This template saves you valuable time by automating calculations. Additionally, it provides a convenient way to identify any tablets that did not pass the test. The resulting table can also be utilized for generating reports and creating presentations.

Related article: Tablet Scoring Guidance in Pharmaceuticals: FDA and USP Considerations

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Tablet Splitability Test for Tablet Scoring Preview

Frequently Asked Questions

• What is tablet splitability?

  Tablet splitability refers to how effectively a tablet can be divided into smaller portions while maintaining acceptable weight, dose uniformity, and physical integrity.

• What is “loss of mass” in tablet splitting?

  Loss of mass refers to the amount of tablet material lost during splitting due to:

  • Crumbling 

  • Chipping 

  • Powder formation 

  • Fragmentation 

  It is usually expressed as a percentage of the original tablet weight.

• Why is loss of mass measured?

  Loss of mass is measured to evaluate whether splitting a tablet significantly affects dose accuracy and product quality.

• What factors affect tablet splitability?

  Factors include:

  • Tablet hardness 

  • Tablet shape 

  • Presence and depth of score line 

  • Formulation composition 

  • Splitting technique 

  • Moisture content

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