Tablet Scoring or Splitability Test or Breakability Test:

Scope:

  • Tablet Scoring or Splitability Test or Breakability Test guidance provides references to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored.
  • This feature is useful since the score can be used to split the tablet into fractions when a dose is required that is less than a whole tablet.
  • Applicable for IR product. Modified release (MR) split may affect the release of product.

Guidelines and Criteria:

  1. The dosage amount intended to be obtained after splitting the tablet should not be below the minimum therapeutic dose indicated on the approved labeling of drug product.
  2. The split tablet should be safe to handle and should not expose the user to unexpected medication.
  3. Modified release (MR) products for which the control of drug release can be compromised or being uneffective by tablet splitting should not have a scoring feature.
  4. The split tablet, when stored in pharmacy dispensing containers (no seal/no desiccant), should demonstrate adequate stability for a period of 90 days at 25ºC± 2º C/60 ± 5 % Relative Humidity (RH).
  5. The split tablet portions should meet the same finished-product (FP) testing requirements as for a whole-tablet product with equivalent strength. To support the tests and criteria for the product with the suggested functional scoring, a risk assessment should be given. The data gathered should be sent to the Agency for review.
  6. The assessment should be undertaken on both tablets that are split nonmechanically (by hand/Manually) and tablets that are split mechanically (with a tablet splitter). Any suggested dissolution test data must be produced on a minimum of 12 individual split tablet portions.

Immediate Release (IR) Solid Oral Dosage Forms

  1. USP General Chapter Uniformity of Dosage Units (UOD) – Split tablet portions containing 25 mg or more of a drug substance that accounts for 25% or more (by weight) of the split tablet portion are allowed to be tested for Weight Variation (WV). If not, the Content Uniformity (CU) test should be performed.
  • Tablet splitability at both ends of the proposed hardness range should be demonstrated by:
  • Testing 15 tablets to confirm a loss of mass of less than 3.0 % between the individual segments (30 for bisected tablets, 45 for trisected tablets, etc.) when compared to the whole tablet. The data collected for each tablet should be sent to the Agency for review.
  • The split tablet should be safe to handle and should not expose the user to unexpected medication.
  • Dissolution data on split tablet portions should meet the criteria of finished-product (FP) release requirements.

Modified Release (MR) Solid Oral Dosage Forms (Using Matrix Technology)

  • All above criteria under Immediate Release (IR) Solid Oral Dosage Forms should be met.
  • Dissolution should be established at both ends of the hardness range.
  • Dissolution on the whole tablet vs split tablet portions should meet the similarity factor (f2) criteria.

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

  • All above criteria under Immediate Release Solid Oral Dosage Forms & Modified Release Solid Oral Dosage Forms (Using Matrix Technology) should be met.
  • Dissolution profile: To determine the integrity of beads during compression, the dissolution profile on pre-compressed beads against post-compressed entire and split tablet parts should match similarity factor (f2) criteria.

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