Manufacturing

Small Changes To Tablet Shape

Bring Big Results
Despite being integral to production
success, tablet shape is generally given
the most consideration as new products
are branded by marketing departments,
whereas whole campaigns have been
built around a tablets colour or shape.
However, its important to consider how
small adjustments to tablet shape can
influence everything from production
efficiency to consumer acceptance.
An improper tablet design can cost
millions in lost production and possibly
lead to a disastrous product launch.
While most companies complete their
due diligence when designing a tablet,
unfortunately some dont understand
how greatly tablet shape can influence
production particularly the efficiency of
the tableting operation.
Experienced tooling manufacturers are
often asked to assist in finding a solution
to a tablet or tooling issue. Were often
asked, Why that tablet shape? after
submitting tablet design suggestions that
will greatly improve the tableting process.
Its been our experience that small design
changes that are hardly visible to the
naked eye can have dramatic results.
Why Tablet Design is Important
Usually, the marketing department in
a company drives the tablet design
process. Some companies hope to
maintain consumer loyalty by designing
unique tablets that will encourage a
certain level of consumer recognition.
Tablets are also designed considering
the end user, for example, a breakeasy bisect design offers functionality
and versatility if dosage is adjustable,
and a childs three-dimensional animalshaped
multi-vitamin
encourages
acceptance. However, manufacturing
efficiency is sometimes most important,
with some companies desiring a tablet
shape engineered to provide easy and
unobstructed production - such as a
simple standard round.
All of these issues need to be kept in
mind when designing a tablet, as ease
of production is too often overlooked
during the process. Certain tablet
shapes simply play havoc with tooling
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and press function - adding significant

costs to the unit dose. The same can be
said regarding packaging issues, as an
incorrect tablet design can chip, clog or
produce an unacceptable level of dust at
the bottom of the bottle.
It is for all of these reasons, and more,
that tablet shape should be carefully
considered and engineered during the
initial design phase. Even if the tablet
is desired to be a particular shape, it is
possible to add features into the design
that will reduce production issues
therefore reducing cost.
Consumer Ease of Use
The FDA has issued guidance regarding
tablet shape, size and other attributes that
encourages thoughtful design in regard
to patient acceptance and swallowability.
As certain end users, such as paediatric
and geriatric patients, tend to find it more
difficult to swallow tablets, its important
to consider the medications use and
target demographic. For example, its
been documented that patients find it
difficult to swallow tablets more than
8mm in diameter. Tablets with smaller
cross-sectional areas are easier to
swallow and are less likely to present a
choking hazard than thick, wide or more
spherical designs.
Physical characteristics need to be
considered so as to provide the safest
and most comfortable experience for
the patient, as this will help to facilitate
patient compliance. Certain shapes,
such as ovals, are easier to swallow and
have faster esophageal transit times. The
FDA recommends that drug applicants
design and develop drugs with these
considerations in mind.1
Tablet design also plays an important
role in generic production of reference
listed drugs (RLDs), also known as
branded products. There are many
reasons to consider tablet shape during
brand duplication. Generally, generic
tablets are designed to closely resemble
the RLD. It increases patient compliance
and acceptance of the medication, and
can also reduce errors in dispensing.
However, the FDA has recommended that

when tablet shape can be improved from

the branded product to make it easier
to swallow, then changes to the design
should be made in the generic.
All of these considerations aid in
product success. Other factors such as
friability, tablet weight, transit time,
and dissolution time are also necessary
to consider when designing the tablet.
Once these parameters are established
for the tablet, the tablet production
and packaging departments should be
encouraged to be involved to ensure
that the design can be produced without
encountering issues such as chipping,
picking or sticking. Additionally, the
FDA advises that it has received reports
of tablets being too friable to be pushed
through blister packs. Its important
that any recommendations or concerns
from other departments are addressed
properly. Keeping all departments
involved in the development process will
allow the tablet design to be modified for
success in the marketplace as well as in
production. When a tablet can be easily
produced, it reduces operating cost and
eliminates operators from wasting time
troubleshooting.
Branded or generic, small and
sometimes
imperceptible
design
changes can yield significant results in
improving the patient experience, as
well as providing cost savings to the
manufacturer.
For example, weve worked with
a well-known calcium supplement
manufacturer who was having significant
issues with producing their tablets. The
tablet was originally developed and
marketed to women as an oval shape that
was not intimidating to swallow a good
first step as it meets suggested guidelines.
However, as the tablet moved
into production, the manufacturer
experienced costly issues with its tooling
and tablet presses. The tablet design was
causing excess ejection force, which was
creating excessive punch head wear, and
in turn was causing premature wear on
parts of the press. This chain reaction
was all a result of tablet design. With a
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Manufacturing
redesign that kept the look of the original
shape but took some of the volume out of
the band of the tablet, the manufacturer
was able to reduce all of their efficiency
issues and still present a tablet that was
appealing to consumers.
Clearly, changes to a tablet shape
can reduce costs during production. In
addition to reducing excess ejection force,
adjusting the shape can reduce issues
such as heat and friction during tableting
two things that can cause considerable
problems for a tablet press. Reducing
these issues will significantly reduce parts
wear, tooling and other operating costs
all of which add up quickly.
What Kind of Design Changes can Help
Increase Efficiency?
One of the simple tablet shape changes
that can be made and will bring positive
results is to consider switching from
a bevel edge to a radius edge when
producing uncoated flat bevelled tablets.
This is an improvement that doesnt affect
the overall tablet shape, but can greatly
help to ensure smooth tablet production.
Understandably, companies do what
they can to limit expenditures throughout
the development process. A common
and ill-advised practice is for companies
to attempt to replicate or duplicate an
existing tablet with an inherently weak or
problematic design. This often happens
when companies reproduce designs
already in their portfolio.
One of the oldest tablet designs, the
flat-face (FF) design, has been commonly
used to produce tablets. As commercial
tablet manufacturing took off, the industry
found it needed to rectify edge attrition in
flat-faced tablets. Edge attrition occurred
as the flat-face tool entered into the
compression cycle and pushed powder
to the outside perimeter of the punch tip
and towards the die wall, which in turn
extruded through the punch and die
clearance.
Increase Strength by Increasing Bevel to Flat Radius

R.015

FFBE W/.015 BLD RAD

MAX TIP FORCE=30 kN

R.060

R.030

FFBE W/.030 BLD RAD

MAX TIP FORCE=36 kN

FFBE W/.060 BLD RAD

MAX TIP FORCE=41 kN

COLOR KEY

Strength

Weakness

Figure 4

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On an FF punch tip, there was virtually

no cup or cup depth it was simply flat;
so there was no cup limiting compression
force. Pressure limits were determined by
the punch tip size.
To combat this issue, the flat-face
bevel edge, or FFBE, configuration was
developed as an alternative. This design
is one of the oldest and most commonly
reproduced designs yet it presents
many manufacturing challenges.
The FFBE design proved to be
beneficial for reducing soft edges by
guiding the powder back into the tablet;
however the design presented a new
issue - punch weakness. A necessary lack
of cup depth in this design caused a limit
on compression force in order to avoid
tip bending and distortion. So although
the FFBE corrected edge attrition, it
presented new manufacturing issues such
as substantially limiting compression
force and difficulty in achieving desired
hardness when compressing certain
powders.

Detail DWG Forces.

design advantages that improve patient
acceptance.
By eliminating the bevel edge and
replacing it with a radius edge, the FFRE
design allows maximum compression
forces in many cases to almost double,
allowing additional pressure to alleviate
conditions such as sticking in the corner
junction of the bevel and the flat. The

Max Force Chart S7

In order to combat these problems,
another design evolved. This alternative
design, the flat-face radius edge, or FFRE,
is a much more robust design that allows
for a significantly higher compression
force to be applied without causing
punch tip damage when producing flatfaced tablets with a shallow cup depth.
The FFRE design should be considered
when producing flat-faced bevelled
edge tablets because it provides several
manufacturing improvements as well as

radius edge is simply stronger. Increasing

the radius by even a fraction dramatically
increases the strength.
The FFRE produces better uniform
tablet hardness as well, which provides
for a highly desired uniform dissolution
rate as well. In this design, the powder
has a natural flow across the radius,
which will reduce hot spots and or
discolouration to the perimeter of the top
of the tablet. Clearly, the FFRE shape has
advantages during tablet production and
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Manufacturing

can eliminate many headaches when

powder needs high compression force.
Using an FFRE design instead of an
FFBE design is a very simple change that
can bring big results. Weve observed that
companies experiencing a tool breaking
issue can change the radius by even 20
thousandths of an inch and eradicate
certain problems. Reducing downtime
by keeping tablet presses running and
eliminating tool breakage can add up to
significant cost savings.
The FFRE design can also improve product
acceptance among consumers. Tablets
produced on tooling with a radius edge
design can have a softer look and better
mouth feel, which is highly desirable.
Although the difference between the FFBE
and FFRE designs typically is visually
unnoticeable, a more appealing tablet
can cause consumer acceptance and
compliance to skyrocket.
The FFRE tablet design presents
enough advantages over the FFBE design
that it should be considered for all new
flat-face designs applied to non-coated
tablets, which may someday make the
FFBE design obsolete.
Concave bevel edge, or CCBE, tablets
suffer from a similar legacy to the FFBE

design. The CCBE is a design commonly

used on both round and shaped tablets
to assist in reducing edge attrition
during the coating process. This design
would also benefit from the addition
of a radius edge. As with the issues
encountered with the FFBE, applying a
radius edge to this tablet would make
a better and more robust design, which
would generally allow an increase in
maximum compression force. In effect,
replacing the bevel with a radius creates
a compound cup design, which is much
more desirable than the CCBE design.
These often imperceptible changes
can bring tangible results. As mentioned,
small adjustments to the tablets shape
can positively impact issues that arise
during production as well as improve the
consumer experience in using tablets.
Many considerations should be borne
in mind when tablets are designed.
To design a tablet with a high degree
of success, its important to get all
departments involved in the process.
Even if the marketing department drives
the design process, other departments
from production to packaging should
be given the opportunity to comment,
as they too should have a stake in the
products success. Be sure to involve your
tooling supplier as well, as they should

have experience in tablet design and will

be able to provide guidance that will help
to head off possible problems before they
occur. Keeping all responsible parties
included in the design process will ensure
a successful and timely launch.
Its in everyones best interest to
provide a product that succeeds in
the marketplace and provides a great
experience for the consumer.
References
1. Food and Drug Administration. Size,
Shape, and Other Physical Attributes
of Generic Tablets and Capsules.
Draft Guidance. (2013)

Dale Natoli is president of

Natoli Engineering Company,
Inc., and has over 35 years of
worldwide experience in the
tablet compression industry.
He has published articles for
major
pharmaceutical
publications and authored
chapters in three books,
including
the
Tablet
Specification Manual, sponsored by the
American Pharmaceutical Association. He
presents lectures for universities, pharmaceutical
associations
and
tablet
manufacturers
worldwide.
Email: info@natoli.com

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