New FDA Requirements regarding Tablet Splitting

In August, the CDER published the Guidance for Industry "Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation" which provides new recommendations for authorisation applications (NDAs and ANDAs) of tablets that have been scored.

The FDA considers tablet scoring as an issue when determining whether a generic drug product is the same as the original one, the so-called reference listed drug (RLD). Tablets may be manufactured with one or several scores. The score can be used to facilitate the splitting of the tablet into fractions when less than a full tablet is desired for a dose. For this reason, the Agency emphasizes the need for scoring of tablets to be standardised for both generic products and their RLD.

The FDA considers the growing recommendation of doctors or health insurers that tablets should be split by the patients either to adjust the dose or as a cost-saving measure. In this context, the safety of medicinal products can be questioned for example regarding variations in the tablet content, weight, disintegration, dissolution, and stability issues.

The European Pharmacopeia (EP) already provides appropriate provisions to this topic while the United States Pharmacopeia (USP) only published a Stimuli article in 2009.

The new FDA Guideline will now provide consistent and significant criteria for scored tablets. Here are some examples:

  • The API amount after splitting the tablet should not be below the minimum therapeutic dose
  • Modified release products for which the control of drug release can be compromised by tablet splitting (e.g., exterior film coat) should not have a scoring feature.
  • The split tablet should be stable for a period of 90 days!
  • The split tablet portions should meet the same requirements as for the finished-product
  • Any recommended dissolution test data must be generated on a minimum of 12 individual split tablet portions.

The scored tablets should also be tested by the indicated patient group to ensure patients can split these tablets correctly.

Read the Draft Guideline

 to find out more about the further requirements.

Dr Günter Brendelberger
CONCEPT HEIDELBER (a service provider entrusted by the ECA Foundation)

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