Splitting tablets can affect safety and efficacy of a product and, with the practice on the rise, the US Food and Drug Administration (FDA) has published draft guidance to help manufacturers.
“Insurance companies and doctors are increasingly recommending that patients split tablets, either to adjust the patients’ dose or as a cost-saving measure”, the FDA writes. Internal FDA research into tablet splitting raised issues related to safety, stability, dissolution and absorption.
In the draft guidance the FDA outlines what criteria must be met to address these concerns. Tablet scoring should be avoided if there is risk of unintended drug exposure, chemotherapeutic for example, and if the product uses a modified release system that may be affected by splitting.
When tablet scoring is used the split tablet, when stored in a pharmacy bottle with a cap but no seal, should meet stability requirements for 90 days at 25°C and 60 per cent relative humidity.
Data should also be provided to the FDA to show the split tablet meets the same finished-product testing requirements as the whole product. The type of data required is different for immediate and modified release solid oral dosage forms.
Manufacturers of generic products must make sure their products follow the same scoring practices as reference drugs. Consistency between generic and reference drugs allows patients to switch between the two and makes sure neither product has an advantage because it is scored.
If the reference product has a patent protecting its scoring configuration the generic manufacturer must contact the Office of Generic Drugs (OGD) for guidance. Manufacturers should also contact the OGD if the scoring configuration was accepted through the suitability petition process.