Breaker Lines - Good or Bad?Print
The use of scoring on tablets has long been implemented by the manufacturing industry mainly to prevent stress fractures but later on for more considerations that are primarily aesthetic. Bisects are different as they present a challenge to manufacturers as they can affect the tablet's:
(a) band thickness, (b) cup depth and (c) intended hardness. As tablet size changes, bisects placed may also change.
A score is useful for consumers that would like to change from branded to generic tablets but may need to half the tablets to ensure consistent dosage needs. This situation is becoming more frequent as doctors and even insurance providers recommend patients split the tablet for correct dosage and even for cost savings.
It is important as a manufacturer to use the correct type of design of your tablets. A score or breaker line can be added to a pills design simply by adapting the punch dies (tooling) in the tablet press.
Scoring is also a controversial issue when it comes to the dosages that generic drugs carry and if it is the correct or has the equivalent drug dosage as that of the branded or reference drug. That said, whether a tablet is scored or not can play a significant role in the competition area. A branded or reference drug may have a well-defined score and a generic one would have one for aesthetic purposes and as such, the question of the drug equivalency is put into question.
One consultant commented that the scoring opens up patient’s non-compliance. The FDA conducted its own research, which revealed that scoring might lead in fact to inconsistencies in the content, weight, dissolution and disintegration of the tablet.
The FDA established a guideline to provide consistent criteria where scored tablets should be evaluated.
- Provide harmonized approach to the chemical and manufacturing process
- Ensure consistency
- Provide information through product label
Guidelines and Criteria:
- The drug dosage should not be below the indicated dose in the approved labelling.
- Tablets should be safe to handle and not pose risk of unintended drug exposure.
- Drugs that are for modified release should not have a scoring features.
- Split tablet bottles and caps should meet the stability requirements for 90-day period at 25C or minus 2C/60 percent RH +/- 5% RH.
- Split tablet portion should be equivalent to the whole tablet with equivalent strength. A risk assessment should be conducted to justify the score and criteria for the product.
- Scored tablets should be tested using patient population to ensure that the patients can split the tablet as indicated in the label.
- Scoring configuration of generic tablet should be the same as that of the reference tablet.
- New study on the splitability should be provided before any product change.
What are the latest improvement in tablet scoring or bisecting?
Recent improvements to the bisect design or what is called as “pressure sensitive” bisect help reduce edge attrition and chipping. The new design needs a radius or facet that eliminates the sharp edge of the tablet at bisect and at the start of the punch cup. The design is more common with the European industry as they have adopted the European Pharmacopeia standards earlier, which pertains to the uniform dose of split tablet that was presented in 2002.
What are the key features that manufacturers should adopt for good splitability?
To ensure good splitability it is a good practice to establish communication with one’s tooling vendor in terms of the requirements and compression needs. If the split tablet requires equal drug dose, it is important to consider the design of the tablet. For uniform dose, it is necessary to consider (a) tablet configuration, (b) thickness, (c) hardness, and (d) bisect type. Modern designs allow companies to create a 3D model of the tablet including bisect details in relation to the thickness of the tablet as well. This would help manufacturers and should be taken advantage of when one is thinking of redesigning an existing tablet.
Monitoring and quality control of scored tablets
In my point of view, there are no advances as to equipment or protocol issued to make sure that the split tablet has uniform dose. That said, recent interviews with R & D and other QA professionals, uniformity of dose for split tablets has gained attention and compliance to the EU Phamacopeia and FDA guidelines are observed.
There has been recent news concerning Accu-Break Pharmaceutical patented process where tablet design consisted of two layers. The first later or the bottom is the non-drug part and is compressed flat and primarily used as a base for the second layer which contains the drug formulation. The top layer is compressed using upper punch with a bisect design. The bisect divides the second layer and then compresses it until bisect penetrates the first layer for a uniform and precise dose.
Thoughts about “Scoring is just a door to patient’s non-compliance?”
There is no question that intake of whole tablet is better than split tablet when it comes to accurate dose of the prescribed medicine. One would feel more comfortable knowing that one is taking the right dosage. That said, bisect or split tablets maybe here for a long time. It is the responsibility of the providers to ensure that the split tablet would ensure that the dose is the right amount of medication needed by the patient.
If you are interested in adding a breaker line to your range of tablets, please visit our tablet press punch dies