Tablet Scoring Guidance for Pharmaceutical Analysis

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