existing products is often slowed down to study and compare
test methods, handling and other factors. Converting existing
products to automated testing requires confidence that any
potential for increased variability is understood and does not
increase investigations or false rejections.
Replacing chemical testing is further away, but technologies such as FTIR and NIR may be viable for relatively small
tablets currently and possibly a broader range in the future.
Dr. van den Dries: We are now seeing trends in automation in sample preparations that allow you to prepare a
sample and analyze it more efficiently, while also applying
technologies that enable us to fully analyze the tablet without destroying its contents. These trends are becoming
more and more available, and manufacturers are getting
some requests for these technologies. I expect with further
introduction of continuous manufacturing that the demand
to make testing more efficient and automated will increase.
With respect to the precision of on-line testing, on one
hand, off-line testing technologies have a lower variability,
making technologies like HPLC still the preferred resource
for analytical testing. Nevertheless, the biggest advantage
for in-line non-invasive testing, giving it advantages over
conventional testing methods, is the fact that many more
products can be tested in a quicker and non-invasive manner. This provides a much better perspective on the actual
quality and gives more in-depth information on processing.
Are you being asked to test tablets in new and more exact-
ing ways? If so, what are pharmaceutical manufacturers
looking for in tablet testing equipment?
Dr. van den Dries: Not really, the paradigm still exists in
the industry is that we see big pharma companies implementing these technologies, but don’t see many requests
for them at the moment partly because of the higher initial
costs and complexity of implementation. However, we do receive more and more requests to extend in-process testing
and rely less on the release of finished product.
Dr. Gold: Non-invasive and non-destructive methods are becoming more desired as we seek to learn physical properties of
a dosage form. For example, near-infrared spectroscopy may be
used to predict assay and dissolution rates of drug from intact
tablets and capsules. This capability – while requiring an exten-
What are some critical issues facing manufacturers of solid
Charles N. Kettler PhD, Director, Natoli Scientific: The potency of many new APIs is very high and hence the dosage is
low. Maintaining content uniformity of the batch continues to
be a challenge and requires careful quality by design starting
early in the lifetime of a molecule. There are also novel excipients entering the market to enable new release profiles for
new and old drug formulations. Understanding the processing
parameters of these new materials will require careful experimentation in order to exact the proper process understanding
and control. Continuous manufacturing is an option that is receiving a lot of consideration as an alternative to simple batch
processing. The companies that expend resources to utilize
this manufacturing approach will be required to build a critical
mass of process understanding to support their new approach.
Kaspar van den Dries, PhD, Senior Director Formulation
Sciences, Solid Dosage Forms and Softgels, Patheon: The
main challenge manufacturers are facing right now is that
many production processes are batch processes that consist of multiple steps, which by definition are difficult to control. Once a process step is completed, we must move forward to the next process step and cannot go back to make
changes, making it more difficult to manage process variability. Next to that, the blockbuster model leading to large
demands for one specific product is outdated. We are also
seeing much more demand for flexibility in the supply chain,
putting even more emphasis on controlling variability. This
is also the reason that continuous manufacturing is gaining
interest, as it would allow better control of processes.
Is tablet testing becoming more automated? Is at- or
on-line testing of tablets as precise as off-line testing?
Thomas B. “Brad” Gold, Ph.D., Vice President of
Pharmaceutical Development at Metrics Contract Services:
Automated testing of physical characteristics – weight, thickness and hardness – is becoming more common. On-line testing faces many challenges and often has increased variability
related to automated handling of tablets. Asymmetrical tablets
create even more challenges for automated tablet handling
and testing. The advantages for automation for data collec-
■ By Nikita Ernst, Associate Editor
Experts in solid-dosage weigh in on recent trends and share
their views on the future of tablet-testing technology
Keeping Up With
■ 22 OCTOBER 2014 | PHARMACEUTICAL PROCESSING
■ PHARMPRO. COM
■ SOLID DOSAGE
Brad Gold, PhD.
Kaspar van den