Guidelines and Codes
Subdividing of Divided Tablets
Published: April 2006
Reviewed: January 2012
- If a tablet is scored or the sponsor indicates that it may be divided, then data must be provided demonstrating that the proposed tablet breaks evenly by showing it conforms to the test for Subdivision of tablets, as described in the General Monograph for Tablets current European pharmacopoeia. The test for subdivision of tablets does not have to be included in the finished product specification.
- If a tablet is unscored, but by virtue of dosing regimen would be
required to be divided then either:
- Data must be provided demonstrating that the tablet breaks evenly through conformance with the test for Subdivision of tablets, as described in the General Monograph for Tablets in the current European Pharmacopoeia; or
- The sponsor includes within the Presentation and Dosage and Administration sections of the product data sheet text: ‘Do not halve tablet. Dose equivalence when the tablet is divided has not been established. This product is not able to deliver all approved dose regimens’.
- It is Medsafe’s expectation that if selected for testing, tablets to which this guideline applies would meet the above test in the European pharmacopoeia.
- All new medicine applications for tablets should include the information required under this guideline. Similar data should be provided when seeking approval for changes that impact on the subdivision of tablets.