For those who need flexible dosing, tablet splitting (for tablets with a functional score-line) can be helpful, but it’s essential to ensure each piece is consistent and effective.
Here’s a quick look at the *key tests and acceptance criteria to assess splitting of scored immediate-release tablets.
To ensure quality and consistency, testing should be conducted on both tablets split manually and those split with a tablet splitter.
1. Tablet Splitability
Procedure: Test 15 tablets (30 halves or 45 thirds) across the hardness range.
Acceptance Criteria:
Loss of Mass: The difference in mass between individual segments and the whole tablet should be less than 3.0%.
Friability: Must comply with USP <1216> Tablet Friability requirements.
2. Dissolution
Procedure: Perform dissolution testing on 12 individual split tablet portions, following the method in the finished product specifications.
Acceptance Criteria: Dissolution data on split tablets should meet the finished product release requirements as established for whole tablets.
3. Uniformity of Dosage Units
Procedure: Test individual split tablet portions in accordance with USP General Chapter <905> Uniformity of Dosage Units.
Acceptance Criteria:
Weight Variation: For split portions containing ≥25 mg of the active drug (or ≥25% of tablet weight), weight variation should be within acceptable limits.
Content Uniformity: For split portions containing <25 mg of the active drug (or <25% of tablet weight), content uniformity requirements must be met.
4. Compliance with Finished Product Specifications
Procedure: Evaluate both manually and mechanically split tablets.
Acceptance Criteria: Split portions should meet the same finished product specifications as whole tablets of equivalent strength.
5. Stability
Procedure: Store split tablet portions in pharmacy dispensing containers (without seal/ desiccant) for 90 days at 25°C ± 2°C / 60% RH ± 5% RH.
Acceptance Criteria: Split portions should comply with the same stability requirements as whole tablets with equivalent strength.
These tests help ensure that split tablets maintain their quality, safety, and effectiveness, providing confidence in dose accuracy and product performance.
Read also:
- Quality Attributes of Tablets Labeled as Having a Functional Score
- Pharmaceutical Tablet Preparation Process
Resource Person: Pearl Pereira Nambiar