# Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps
## 4 Tablet Scoring
### Tablet Splitting: Current Practice
In order to mitigate opioid abuse, several steps have been implemented by the FDA to ensure that companies reformulate their painkiller tablets in a way that will make it more difficult to alter the dose [112]. The reformulation known as opioid abuse-deterrent formulations (ADFs), involves adding a blocking agent that will counter the effect of opioids if dissolved and injected [113]. There are a few formulations for oxycodone (e.g., Targiniq ER) and other opioids that have been approved by the FDA that utilize the abuse-deterrent opioid formulation [112]. To mitigate the opioid abuse crisis, these new formulations use specialized excipients that make it difficult to crush the tablets. Another strategy of abuse deterrence involves incorporating aversion properties into the formulation [114; 115]. For example, components that can produce unpleasant effects if the opioid tablets are manipulated [115]. Patients with complex dexterity issues, may have difficulty splitting tablets, either manually or with the use of a tablet splitter and with the use of other non-conventional objects used to partition tablets [94]. A study which focused mainly on issues pertained to the acute geriatric population revealed that more than \(\frac{3}{4}\) of that population were unable to successfully partition tablets. In those cases, the challenges were to ensure that the tablets are evenly partitioned prior to administration [94; 116]. Especially for tablets that are not clearly marked with a score line, and also tablets that lack good physical properties [117]. In some cases, tablets are partitioned unevenly, which can pose some compliance issues and minimize the reliance on the drug [104; 105; 106]. Geometrical configurations of the tablet such as shape, size, thickness and curvature play a crucial role on the performance of the score lines [76]. The depth of the score line can also be a contributing factor [76]. Performance of score lines can be defined by breaking ease, uniformity of mass of subdivided tablets and loss of mass by the subdivision [118]. For breaking ease, an in-vivo reference test and a routinely applicable in-vitro test need to be established. For the uniformity of mass of subdivided tablets, a requirement has recently been set by the European Pharmacopoeia. Loss of mass upon breaking can be limited to not more than 1% [119]. Tablet scoring techniques vary from exerting force to manually breaking the tablets to using tablet sprinters devices that are designed to aide with tablets splitting [120]. Other practices involve the use of non-conventional objects such as kitchen knives [120]. All those practices present accuracy and precision challenges. Various devices available to split tablets are shown in Figure 3.  
Content uniformity of the split tablets was evaluated in studies where various splitting techniques including exerting force to manually break the tablets, using a sharp object (knife) and using a tablet splitter were employed [120; 121; 122; 123; 124]. Tablets split by hand yielded the worst uniformity and exhibited a wider weight variation compared to those that were split using a knife or a tablet splitter. When knives were used to split tablets, a significant variation within the half tablet content uniformity was observed. When tablet splitters were used, the resulted halve tablets revealed a more uniform trend [125]. Among all the tablet splitting techniques that have been implemented, the use of a tablet splitter produced half tablets with significant less weight variation compared to the two other methods [121]. Further data have shown that formulation characteristics and manipulation techniques have great influence on the accuracy of medication modification and should be considered in off-label drug use in vulnerable populations [126; 127; 128]. Figure 3: Various options available to split and crush tablets. Images (**a**) through (**c**) are representations of tablet crushers.