Splitting unscored tablets
What are the problems or risks associated with splitting unscored tablets, especially if they are film-coated or modified
Splitting unscored tablets is fraught with unpredictability, regardless of the splitting method engaged. Unscored tablets
are not designed to be subdivided into reliable and consistent partial doses, and often result in splintered parts with significant
loss of mass. Splitting unscored film-coated tablets or modified-release tablets will, in most cases, result not only in an
inaccurate medicine dosage, but could also have other undesirable effects. In the case of film-coated tablets, particularly
if the film coat is functional (e.g., an enteric coat), the tablet contents could be hydrolysed in the stomach, resulting
in profound drug degradation. Similarly with modified-release tablets, fracturing the intact tablet could result in a markedly
faster release profile from the broken segments and the production of unwanted side effects because of the overly rapid absorption
of the tablet contents. In general, unscored, film-coated tablets should be swallowed whole to avoid untoward effects.
The main risks are:
API dosage control. The risk of uneven pieces and fragments with varying dosages is very high compared with scored tablets. Risks are measured
in quality-assurance processes according to the pharmacopoeias.
Modification of timed release characteristics. These characteristics can, in some instances, be totally destroyed when a tablet is broken.
To lower the risks and ensure QbD on multilayer tablets designed especially to be split without score marks, you have to create
tablets that are real production prototypes and browse the behavior in the whole design space using tableting robots like
How different is the tabletting process for scored tablets compared with unscored tablets in terms of the technology and equipments
involved, quality control and quality assurance protocols, and stability testing requirements?
Precision and reliability are even more critical than usual when producing scored tablets. The sensitivity to variance is
increased in upscale process, as well as in tablet production. It is important to take note of the following:
- Before compression, it is crucial to ensure that processes are in place to avoid demixing, segregation, and over-lubrication;
classical issues during processing.
- During compression, there should be tighter regulation control and rejection rules.
- Uniformity of mass and filling are important parameters. Different weight or uneven filling creates different hardness, which
in turn impacts friability and the quality of breaking, as well as uneven filling.
Tooling design is of course crucially important and computer simulation can provide information on stress line inside tablets.
However, only studies of real tablets, opposed to virtual models, on a fully instrumental press like STYLCAM or STYL'One can
provide you with data and results rapidly. To further limit your risk, a 'tableting robot' like a STYL'One can browse the
design space and help you rapidly select the ideal punch design and production parameters.