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Tablet Designs – Should you stop making round tablets?

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22 May 2016 No comments

Tablet design requires careful research and understanding especially on its shape as even tiny adjustments can have a direct impact not only on the production but also with patient’s acceptance, which can result to either success or failure.

The tablet’s design can affect the production and often we ask why the shape of the tablet when one is submitting the designs after the research on a particular issue. An unsuitable design can cost millions and lead to problems. Although most companies do due diligence when selecting the size and shape of the tablet, lack of understanding can affect the efficiency of the operation.

Some organizations design their tablet in a unique way in hopes of achieving customer recognition and loyalty; this is driven primarily by marketing. Tablets that are designed for end-users such as the ‘break-easy’ bisect design or 3-dimensional multivitamins aimed for younger patients. Tablets can be designed for technical applications such as airbags, watch batteries, dessicants while some organizations want a tablet shape-engineered in order to provide a simple and unhindered production example of which are simple customary rounds.

Certain designs can damage tools and press functions, which can result to significant expenses to the production unit. The same can also be said about packaging as an error in the design can cause chipping, clogging or dust to accumulate at the bottle’s bottom. It is for this reason that the tablet shape should be considered carefully not only in the initial phase but also during the next few processes. Even if the tablet is designed in a different way, it is possible for manufacturers to add extra features that would decrease production issues and overall expense.

Tablet Scoring

This is a recent issue concerning uniform tablet splitting which applies to generic products relating to the reference item. In adding bisect in the tablets design, it is important to configure the thickness, bisect type, hardness, placement and depth as this affects the uniform dose in a split tablet. Concentrated attention is required with score design as it can cause the tablet to chip or its edges to weaken when patients try to break the tablet.

In deciding the depth and type score, one should take into consideration the width, diameter and overall thickness. It is particularly crucial to know the tablet’s thickness to judge how deep the score should be in order to make an accurate break. If the tablet is excessively thick, it is important to increase the size of the tablet to decrease its thickness. The objective would be to achieve accurate breaks and uniform doses when the tablet is split.

When it comes to the generics, manufacturers must produce a tablet that closely resembles the original reference tablet, as patients are more compliant and accepting of the medication and errors are also reduced during dispensing.

Duplication

There is a variety of reasons why the shape of the tablet should be considered during brand duplication. Aside from easy acceptance by the public, it is also important to take into consideration the physical characteristics of the tablet to ensure that patients would be able to take the tablet comfortably. An example would be when, in a documented case, patients find it hard to swallow 8mm diameter tablets. Ovals and other shapes are easier to swallow and have faster transit times. The FDA has already issued guidelines that manufacturers should follow in developing their products.

Generic tablets are more acceptable for patients as they closely resemble the original tablet. This results to the patient readily complying and accepting the medication and helps in reducing problems when it comes to dispensing the tablets. The FDA suggests that should there be a way to improve and make it easier for patients to take the drugs, then modification is implemented.

These considerations help make the product a success. Other factors that should be considered include the weight, friability, and dissolution as well as the transit time. Once these parameters are considered, the other departments such as the production and packaging team would then be involved to ensure that the package design would not cause sticking, chipping or sticking of the tablet. The modification would ensure a success production. When a product is easy to develop, it helps lower the cost and becomes a time saver as operators can concentrate on the production rather than troubleshoot problems.

Configuration

Whether the tablet is branded or generic, simple designs can result to excellent patient experience as well as bring cost savings to the company.

  1. Bevel edge – one of the common problems when it comes to duplicating is when one is trying to duplicate a weak design. This usually occurs when the company will try to copy the designs that are already in their portfolio. One example is the flat faced bevel edge or FFBE. This design was developed as a substitute to the more common flat face design. As production for tablet increases, companies find out that it needs to modify the edge attrition that occurs on flat face tablets. Edge attrition happens when the tool enters the compression cycle and pushes the powder to the outside area of the punch tip and towards the die wall, which would cause it to be extruded through the punch and die.

The FFBE design however provides beneficial effects as it reduces the soft edges of the tablet by guiding the powder back to the tablet. This design however has a flaw as well – punch weakness. The lack of cup depth causes a limitation to the compression force in order to prevent the tip from bending and distorting.

  1. Radius Edge – another alternative to the FFBE is the FFRE or the flat face radius edge. The FFRE allows a substantial compression force to be applied without causing damage to the punch die when producing flat face tablets. The FFRE should be used when producing flat face tablets as it provides a uniform hardness, reduces spots and discoloration of the tablet’s top as well as causes the powder to have a natural flow across the radius.

In replacing the bevel edge with the radius edge, it allows for the maximum compression force to almost double and alleviate certain conditions such as sticking. The design’s advantage helps eliminate problems especially when high compression force is needed.

The FFRE can also improve customers’ acceptance. Tablets that are manufactured using this tool has a more softer look to it as well as a better and more improved feel to it which is highly desirable. The difference between the FFBE and FFRE is subtle and quite unnoticeable. As a result, it would eventually be used for all new flat face designs of non-coated tablets and may make the FFBE obsolete in the near future.

  1. Concave bevel edge – the Concave bevel edge or CCBE also benefits from the application of the radius edge. The CCBE is often used for round shaped tablets as it helps with lessening edge attrition during coating. Applying the FFRE would help make the tablet design better and allow maximum compression force. By replacing the bevel with a radius, it creates a compound cup design, which is much more desired than the original design.

Many considerations should be taken into account when tablets are being designed. Small changes can have a huge impact especially when it comes to production as well as patient’s acceptance. In order to develop and create a successful design, it is crucial that all departments work together. From the marketing people to production to packaging, every key personnel has a stake in the success and as such should be given the opportunity for their opinions to be heard. Asking tooling suppliers to join can positively influence and improve the design experience and ensure a successful launch of the product.