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How-Tough-Is-Your-Capsule

The document discusses the importance of measuring the strength of hard and soft-shell capsules used in pharmaceuticals and nutraceuticals to ensure they can withstand various forces during production and consumption. It describes testing methods, including tensile and compressive tests, to quantify the mechanical strength and protective capabilities of capsules. The author emphasizes the need for R&D and QC collaboration in establishing and maintaining testing methodologies for consistent capsule performance.

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13 views4 pages

How-Tough-Is-Your-Capsule

The document discusses the importance of measuring the strength of hard and soft-shell capsules used in pharmaceuticals and nutraceuticals to ensure they can withstand various forces during production and consumption. It describes testing methods, including tensile and compressive tests, to quantify the mechanical strength and protective capabilities of capsules. The author emphasizes the need for R&D and QC collaboration in establishing and maintaining testing methodologies for consistent capsule performance.

Uploaded by

fitbaddo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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How Tough Is Your Capsule?

By Bob McGregor, General Manager, Brookfield Engineering

Hard and soft-shell capsules are utilized in large quantities every day in pharmaceutical
and nutraceutical plants around the world. R&D departments engineer the capsule
design to hold up under various forces — from the time that ingredients fill the capsule,
through the packaging process, to the moment when the consumer puts it into their
mouth and either bites down or swallows. Measuring the strength of the capsule is the
key to qualifying whether it will survive the various forces to which it’s subjected.
Performing scientific analysis to correctly characterize the forces is the first step. Using a
proper test method to simulate those forces is the sequel. Physical test instruments are
now equipped with an array of probes and fixtures to make these measurements and
correctly assess the durability of hard and soft shell capsules. The type of general
purpose tester that can perform compression and
tension tests on objects like hard and soft-shell
capsules is shown in Figure 1.

This particular device comes out of the food


industry, where it is referred to as a “texture
analyzer.” Similar general-purpose instruments that
perform compression and tension testing are called
“universal testers.” The bottom line is that they can
deform an object, like a capsule, by compressing it or
pulling it apart.

Testers of this nature utilize a probe or specially


designed fixture moving a defined rate of speed to
deform an object. Therefore, we call this a
controlled-rate measurement. The level of force that
gets measured by the instrument is very much Figure 1: Brookfield CT3 Tester with gelatin
bloom jar
dependent on the rate of deformation. It is important to consider the conditions that
will cause the capsule to deform. These, in turn, suggest the possible rates of
deformation to use in the test.

One established test in the pharmaceutical


industry uses a special fixture to pull a capsule
apart and measure the force required to cause
rupture (see Figure 2). The reason for the test
may seem obvious, but there are design
considerations that affect the strength of the
capsule. When formulating a drug, the
manufacturer must consider whether the drug
substance is compatible with the gelatin shell,
which consists of a mixture of water-soluble
proteins. Drug substances containing reactive
aldehydes can affect the gelatin by cross-linking
Figure 2: Capsule Loop Tensile Test Fixture for
measuring burst strength
with lysine residues within and between the
gelatin strands. The net result is a stiffening of the gelatin structure in the capsule.

The Capsule Loop Tensile Test Fixture uses two pins on separate mounts inserted into
one half of the gelatin capsule to perform the test. The pins move apart from each other
in a uniaxial direction at a rate of 0.5 mm/sec for a programmed distance of up to 15
mm. The tensile force is measured as the pins pull apart, and the resulting data is
captured in a table that plots force vs. separation distance. In general, the deformation
is more gradual at first as the capsule begins to stretch, but then accelerates rapidly as
plastic flow commences. The ultimate purpose of this test is to quantify the mechanical
strength of the capsule shell, thereby enabling manufacturers to identify the effects of
the internal fillings on the strength and stability of the capsule.

A second test uses compressive forces to measure the elasticity and ultimate rupture of
the capsule by penetration. The purpose is to quantify the protective strength of the
capsule wall in compression or puncture. Analysis during the design process for the
capsule identifies the active ingredients therein and the protection that they require to
preserve them from the surrounding environment. The test uses a 2 mm diameter
cylindrical probe, similar to the probe shown in Figure 1, which pushes down on the
capsule at 2.0 mm/sec until failure or up to a distance equal to the diameter of the
capsule. The resulting graph is shown in Figure 3.
How Tough Is Your Capsule? 3

Figure 3: Force vs. distance graph for gelatin capsule in compression test

In both situations, the tension and compression tests measure force levels that are of
similar magnitude. Therefore, the same instrument can be used to perform both tests.

One other test of potential interest relates to the force required to expel capsules from
their packaging. When blister packs are used, a compression test can provide helpful
information on two accounts (see Figure 4). Obviously, it’s important for the capsule to
have proper protection until used. The special blister pack fixture measures the force
required to extract the capsule. This force level must be adequate to provide the
necessary protection, but not so high that the
consumer cannot remove the capsule.

R&D has the responsibility for the initial


groundwork that establishes these compression
and tension test methods. QC becomes the
home for these methods once production
commences and must report back to R&D when
adjustments are needed. The good news is that
today’s instruments are easy to use and quick to
execute the tests. R&D must decide whether the
force vs. distance profile should be captured for
Figure 4: Special fixture for measuring the force to
each test, in which case a PC is needed. More extract capsules from blister packs
How Tough Is Your Capsule? 4

practical and time saving is simply to record the peak force value and ensure that it
meets the minimum force requirement establish during the design process.

Here is a concluding word of advice to the many companies that have yet to implement
this test methodology. The instrumentation is not expensive. Technicians master the
method very quickly. And the results guarantee that your capsules will meet consistent
performance requirements expected by today’s consumer.

About The Author


Robert G. McGregor is the general manager and global marketing manager for
Brookfield's High-End Lab Instrument Sales. He graduated from MIT in Cambridge, MA,
and holds M.S. and B.S. degrees in mechanical engineering.

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