Tablet Formulation

Taking Shape
Designing a tablet requires careful consideration to be given to its By Dale Natoli and
shape, as small adjustments to the size or profile can have a direct Bill Turner at Natoli
Engineering Company
impact on both the production process and customer acceptance –
resulting in success or failure

Tablet shape affects many aspects

of tablet production. We are Figure 1: Tablet bisection
often asked, “Why that tablet
shape?” when submitting design
suggestions after researching
a solution to a tablet or tooling
issue. An improper design can
cost millions in lost production
and potentially lead to disaster.
While most companies complete
their due diligence when
selecting a tablet shape, some
lack understanding of the extent
to which shape can influence
production – particularly the
efficiency of the tableting operation.

Some companies design unique

tablets hoping to reach an clog or produce an unacceptable is not paid to the score design,
acceptable level of consumer level of dust at the bottom of tablets can have edge attrition
recognition, with the objective the bottle. It is for these reasons, and chipping issues when breaking
to maintain customer loyalty; among others, that tablet shape is attempted by the consumer
this effort is generally driven by should be carefully considered (see Figure 1).
marketing. Tablets are also designed and engineered during the initial
to consider the end-user, such as a design phase. Even if the tablet When deciding upon the type
‘break-easy’ bisect design or a three- is to be a particular shape, it is and depth of a score, the tablet
dimensional animal-shaped multi- possible to add features into the diameter, width (if oblong in
vitamin aimed at children. Tablets design that will reduce production shape) and overall thickness
may be designed for a technical issues, and subsequently decrease must be taken into account. It is
application like watch batteries, the overall cost. particularly important to know the
automotive airbags and pre-formed thickness of the tablet to judge
desiccants, while some companies Tablet Scoring how deep the score should be to
desire a tablet shape engineered provide a complete and accurate
to provide easy and unobstructed A recent hot button issue has been break. If a tablet design results in
production, such as a simple uniform tablet splitting as it applies an excessively thick tablet, it may
standard round. to generic products relating to be necessary to
their reference product. When increase the size Keywords
Certain tablet shapes play havoc incorporating a bisect into a tablet slightly to decrease
with tooling and press function design, proper tablet configuration, the thickness. The Uniform tablet splitting
– adding significant costs to the thickness, hardness, and bisect type, ultimate goal is to
Score design
unit dose. The same can be said depth and placement can all receive accurate
Edge attrition
regarding packaging issues, as an affect achieving a uniform dose breaks and uniform
incorrect tablet design can chip, in a split tablet. If careful attention doses after the split. Compression force

Innovations in Pharmaceutical Technology Issue 50 45

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When it comes to generics, consumers accept them more

readily if they closely resemble the original reference tablet.
This increases patient compliance and acceptance of the
medication, and can also reduce errors in dispensing

Brand Duplication This increases patient compliance often reproduced – but ill-advised –
and acceptance of the medication, design is one of the oldest and most
There are many reasons to as well as reducing errors in commonly used configurations: the
consider tablet shape during dispensing. However, the FDA has flat face bevel edge (FFBE).
brand duplication. In addition to recommended that when tablet
consumer acceptance, it is essential shape can be improved from the The FFBE was designed as an
to look at the medication’s physical branded product to make it easier alternative to the more common
characteristics so as to provide the to swallow, then changes to the flat face design. As commercial
best experience when swallowing design should be implemented tablet manufacturing took off,
the tablet. For example, it has in the generic. the industry found it needed to
been documented that patients rectify edge attrition in flat faced
find it difficult to swallow tablets All of these considerations aid in tablets. Edge attrition occurred as
more than 8mm in diameter. product success. Other factors, such the flat face tool entered into the
Certain shapes, such as ovals, are as friability, tablet weight, transit compression cycle and pushed
easier to swallow and have faster time and dissolution time, also powder to the outside perimeter
oesophageal transit times. The FDA come into play when designing of the punch tip and towards the
has issued guidance recommending the tablet. Once these parameters die wall, which in turn extruded
that drug applicants design and are established for the medication, through the punch and die
develop products with these points the production and packaging clearance (see Figure 2). In contrast,
in mind. departments should be involved the FFBE design proved beneficial
to ensure that the design can be for reducing soft edges by guiding
When it comes to generics, produced without encountering the powder back into the tablet.
consumers accept them more issues such as chipping, picking However, this design presented a
readily if they closely resemble or sticking. This will allow the new issue – punch weakness.
the original reference tablet. design to be modified for success A necessary lack of cup depth
in production. When a tablet can causes a limit on compression
be easily manufactured, it reduces force in order to avoid tip bending
Figure 2: Flat faced tablets can result in edge attrition, with powder tooling costs and eliminates and distortion.
being pushed to the outside perimeter of the punch before extruding wasted time that operators spend
through the punch clearance
troubleshooting. Radius Edge
There is an alternative design to
Design Configuration the FFBE: the flat face radius edge
(FFRE). This allows for a significantly
Soft edges associated
Branded or generic, small design higher compression force to be
with extruded powder
changes can yield notable results applied without causing punch
in improving the patient experience tip damage when producing flat
when swallowing tablets, as well faced tablets with a shallow cup
as bringing cost savings to the depth. It should be considered
manufacturer. when producing flat faced tablets
as it provides better uniform tablet
Bevel Edge hardness; the powder has a natural
A common issue when designing flow across the radius, reducing hot
tablets is attempting to duplicate spots and discolouration to the top
an existing tablet that has an of the tablet.
inherently weak or problematic
design. This often happens when By eliminating the bevel edge and
companies copy designs already replacing it with a radius edge,
in their portfolio. An example of an the FFRE design allows maximum

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100 Figure 3: Maximum

safe operating force
(S7 steel), with a
90
7/16-inch diameter

80

70
Tip force (kN)

60

50

40

30

20

10

0
Flat face bevel edge Concave bevel edge Compound cup Flat face radius edge Standard cup

Cup configuration

compression forces – in a number round and shaped tablets to assist supplier as well, they should
of cases – to almost double, in reducing edge attrition during be able to provide the experience
allowing additional pressure the coating process. Similar to in tablet design and guidance
to alleviate conditions such as issues experienced with FFBE, that will help to head off possible
sticking in the corner junction of applying a radius edge to this problems before they occur.
the bevel and the flat. Using this tablet would make a better and Keeping all responsible parties
design clearly has advantages more robust design, allowing an included in the design process
during tablet production and can increase in maximum compression will ensure a successful and
eliminate many headaches when force. In effect, replacing the bevel timely launch.
powder needs high compression with a radius creates a compound
force (see Figure 3). cup design, which is much more
desirable than the original Dale Natoli is President of Natoli
The FFRE design can also improve CCBE design. Engineering Company Inc, and has
product acceptance among over 35 years of global experience
consumers. Tablets produced on Working Together in the tablet compression industry.
tooling with a radius edge design He has published articles for major
have a softer look and better mouth Many considerations should be pharmaceutical publications and
feel, which is highly desirable. taken into account when tablets are authored chapters in three books, including the Tablet
Additionally, the difference between designed. Small adjustments to the Specification Manual sponsored by the American
Pharmaceutical Association. He presents lectures for
the FFBE and FFRE designs is often tablet’s shape can positively impact
universities, pharma associations and tablet manufacturers
visually unnoticeable. As a result, issues that arise from production,
worldwide. Email: sales@natoli.com
FFRE presents enough advantages influencing customer acceptance.
over FFBE for it to be considered To design a tablet with a high degree Bill Turner is the Technical Service
for all new flat face designs applied of success, it is important to get all Manager of Tooling and Tablets at Natoli
to non-coated tablets – this may departments involved in the process. Engineering Company Inc, where he has
someday make the FFBE design also served as Engineering Manager and
obsolete. From marketing through to Tablet and Tool Designer for 25 years.
production and packaging, He educates and trains Natoli sales and
Concave bevel edge tablets (CCBE) everyone has a stake in the service staff and conducts training seminars to the industry
also benefit from the application product’s success and should in tablet design, tool design and troubleshooting, both
in-house and on site. Email: eng@natoli.com
of a radius edge. The CCBE is a be given the opportunity to
design commonly used on both comment. By involving a tooling

Innovations in Pharmaceutical Technology Issue 50 47