Tablet Scoring Guidance in Pharmaceuticals: FDA and USP Considerations

Tablet dosage forms often include one or more scores, which serve a valuable purpose. These scores make it easier to divide the tablet into smaller fractions when a full tablet is not needed for a dose. Ensuring consistent scoring allows the patient to adjust the dosage by splitting the tablet.

When conducting Pharmaceutical Development, there are certain scoring criteria that should be evaluated based on the dosage form. If a new drug product does not meet these criteria, it should not include any scoring feature or reference to scoring in the labeling, including terms like "bisected" or similar language.

Immediate Release Solid Oral Dosage Forms

1. Uniformity of Dosage Units

   Read article on Uniformity of Dosage Units in Pharmaceutical Analysis.

2. Tablet Splitability

   Must be tested for the proposed hardness range using the following criteria

   • Loss of mass must be less than 3.0% between individual segments when compared to the whole tablet. 15 tablets must be tested (30 for bisected tablets, 45 for trisected tablets)

• Split tablet portions must meet USP Friability requirement

3. Dissolution data on split tablet portions should meet finished-product release requirements

Modified Release Solid Oral Dosage Forms (Using Matrix Technology)

1. All above criteria should be met.

2. Dissolution must be demonstrated for the proposed hardness range

3. Dissolution on whole versus split tablet must meet f2 similarity factor criteria

Modified Release Solid Oral Dosage Forms (Using Compressed Film Coated Components)

1. All above criteria should be met

2. Dissolution profile on pre-compressed beads versus post-compressed whole and split tablet portions must meet f2 similarity factor criteria to ascertain the integrity of beads during compression

Reference:

FDA Guidance for Industry: Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation

Tablet Friability Loss of Mass Calculator Preview

Tablet Splitability Loss of Mass Calculator Preview

Frequently Asked Questions

• What is tablet scoring?

  Tablet scoring refers to the groove, break mark, or indentation on a tablet designed to allow the tablet to be split into smaller portions for dose adjustment or easier administration.

• What is tablet splitability?

  Tablet splitability refers to how effectively a tablet can be divided into intended portions while maintaining acceptable mass and dosage uniformity.

• What is loss of mass in tablet scoring studies?

  Loss of mass refers to the percentage of tablet material lost during splitting due to crumbling or fragmentation.

• How many tablets are typically evaluated in scoring studies?

  Common evaluation requirements include:

  • 15 tablets for scored tablet studies 

  • 30 split portions for bisected tablets 

  • 45 split portions for trisected tablets

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