1273 NORTH CHURCH STREET,
MOORESTOWN NEW
JERSEY, U.S.A. SUITE 106, 08057-1194
TEL. 1 856 234 3626 FAX
1 856 234 8657
Pharmaceutical
Solid Oral Dosage Product Printing
The
F.D.A. has dictated that orally ingested solid dosage forms of ethical and
O.T.C products be identified in a manner that makes them discernible from
similar shape, color, etc., products.
This ruling has been instituted to reduce, and hopefully eliminate,
mistaken ingestion.
Acceptable
identification has traditionally been achieved by debossing, and embossing
which utilizes a tablet press, or by printing / branding with a liquid ink
using a printing machine. In addition,
blister packaging, (where the unmarked product form could be dispensed individually
from clearly marked packaging for immediate ingestion,) was once common and
acceptable.
Debossed
product, prior to the advanced coating techniques incorporated today, were
difficult for many to swallow, often tasted unpleasant, and were susceptible to
moisture, contamination and odor absorption, yet were clearly identifiable when
lighting could shadow the image making it more visible. This of course presented a problem in low
light conditions.
The
advent of modern coating techniques, made these types of products easier to
swallow and less distasteful. On the
other hand, these coatings have a tendency to fill up debossed or embossed
areas, often rendering them at times unidentifiable, especially by the elderly,
and those with less than perfect eyesight.
Blister packaging is an
option, but produces a human error factor.
The product is clearly identifiable within the package, but essentially
becomes unidentifiable, when unmarked, when separated from its package, especially
if it is not ingested within a short period of time. The F. D. A. now mandates the identification of the product
within the blisters.
This
brings us to the printing / branding method of identification. Today's pharmaceutical grade, F.D.A.
approved inks should be designed specifically for the type of product
they are intended for, and also for the particular design of the printing press
which will carry out the products' identification.
There
are various types of product surfaces, such as;
Gelatin hard shell and soft shell capsules
Gelatin dipped or enrobed,
compressed tablets and caplets
Enteric or aqueous coated
tablets and caplets, some waxed usually with bees' or carnuba wax, or
combinations of both. Some are not
waxed at all, and some have had dry coatings applied such as magnesium stearate
or talc, for increased slip and lubricity.
Sugar shell coated compressed
tablets and caplets, some are waxed, some are not.
Some coatings are new
technologies incorporating copolymers,
cellulose, or other, often proprietary compositions.
It is
imperative
that during the process of product development that the ink supplier is made
aware of all information regarding the products surface characteristics. They will need to formulate and supply the
printing ink best suited for the application, and the printing machine model
which best suits the particular product.
Inks
contain ingredients to suit certain surface and environmental conditions. Basic ingredients are;
The color selected,
usually composed of FD&C or D&C lakes or dyes or synthetic iron oxide
pigments.
Shellac or hydroxypropyl
methyl cellulose which are the binders that
allows the color to adhere to the product surface.
Solvents to: maintain the
ink's viscosity; dissolve the shellac and keep it liquid; control and maintain
the drying time of the ink, and allow
the inks to penetrate or "bite" into certain surfaces, especially
waxes.
It is
extremely important that your printing ink contains (even in small amounts) all
of every available ingredient that could possibly be required to adjust the ink
to suit changing conditions. Once
submissions are made to the F. D. A., it can be time consuming to re-submit
because of something overlooked in the early stages of product development.
Identification
via printing machinery provides unique advantages to the pharmaceutical and
Confectionary manufacturer. In today's
competitive markets, advertising is generally everything. Marketing persons design their packaging to
be attractive and enticing, and at the same time can present the product inside
their package with the privilege of providing its' own expression. Implementing unique and attractive
identifications can set a company's product apart from its competition,
virtually eliminate counterfeiting, and clearly state a products identity, thus
avoiding the possibility of accidental drug reaction or even poisoning, because
the product is properly identified.
Printing
can be accomplished on one side or two sides of the product. It can incorporate letters or numbers,
company or specialty logos, or combinations of all. Hard shell, two color gelatin capsules can be oriented and
printed in two colors, either in line on the surface, or wrapped around the
diameters allowing the printing of a large amount of information, such as,
name, strength, dosage and other pertinent information. What can be imprinted on a product, is only
limited by a designer's imagination and the available printing area, and nearly
every color imaginable is available.
A
products' physical appearance is usually described as being
"dimensional". A sphere being
one dimension, a flattened sphere becomes a tablet which has two dimensions, an
elongated tablet now becomes a caplet which is three dimensions, and so
on. The more dimensions a product
contains requires more manipulation to orient or position it to perform the
printing and packaging task.
Compressed
products all have straight sides due to the compressing of the granulation or
compound within a set of punches and a die.
These straight sides are normally referred to as the "belly
band". The size of the "belly
band" is determined by the thickness of the compressed product, and the
shape of the top and bottom surfaces after compression. The wider this band becomes, the more
difficult it becomes to determine if the product wants to lie down, or stand on
its' edge. It is to the designer's
advantage to design the tooling so as to minimize the possibility of the
product standing on its edge, to eliminate "side printing", which is
not desirable. If minimizing this band
width cannot be implemented, it is strongly advised that there be an
absolute minimum of .100" inches (2.54mm) difference between the
width and thickness of the compressed product.
(The width should be larger than the thickness.) This will give the product an identity. The greater the width to thickness ratio,
and the smaller the "belly band", the greater the success rate of
proper product positioning.
The
next factor to consider is the surface finish and lubricity of the
product. The amount of lubricant on the
products' surface should be discussed with the ink manufacturer prior to
finalization, to determine adhesion qualities.
It should be made aware that the finer and slipperier the surface is,
the easier it will be to move and manipulate the product. This is a benefit throughout the whole
process, from emptying coating pans, to final packaging.
It has
been our intention to inform Project Managers of the parameters to be explored
during the start of new product development. Starting off new projects should be undertaken carefully to ensure
"painless" operation later on.
It has
been ourexperience that Managers and Project Heads who are well informed before
finalizing a project, enjoy a greater sense of accomplishment when looking
back on a successful venture which ended up productive beyond expectation.