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Coating Process Control Symposium,10th October 2005.

The meeting was the 5th to be run by the Film Coating Focus
Group since the inaugural meeting back in 2002. It was the
intention to consider how the FDA initiative ‘Pharmaceutical
cGMP’s for the 21st Century – A Risk-Based approach’ was
being addressed by those working in the area of film coating.


Alex Pysik (Pfizer Sandwich) opened up the
morning session by introducing the goals and
definition of the initiative and then by providing
examples of work that was ongoing at Pfizer in the
field of film coating which was attempting to improve
the understanding of their coating processes. He
showed how on-line NIR could be used in a
development scale fluid bed coater to pick up process
related changes. Similarly at line analysis with NIR
could also be used accurately to determine coating
thicknesses. He next covered the use of D.o.E in a
coating process to enable determination of the critical
process parameters and related them to critical quality
attributes such as dissolution. He finished his
presentation by demonstrating the use of N.I.R to
generate a predictive model on the relationship
between coating thickness and dissolution for osmotic
pump tablets.


Tony Moffat (School of Pharmacy, University of
London) and Andrew Parker (Molecular Profiles)
moved the session toward an explanation of what
analytical techniques exist which could be useful to
enable us to understand in more detail both on-line
and at line analysis. They showed the potential of
N.I.R, TOF SIMS, XPS, Confocal Raman
Spectroscopy and X-ray micro C.T as tools to enable
us to understand coated dosage forms as well as
other relevant applications in the field of
pharmaceutical solid dose processes.
The afternoon session was focused around process
control of existing process, be they continuous or
batch as well as highlighting two new technologies
(NRobe and electrostatic deposition) and the process
control challenges they offer.


Wesley Mancoff (Thomas Engineering Inc)
discussed the differences between coating in a batch
coater versus continuous coating. He explained that
the continuous system was best suited to high volume
products. Additionally the continuous coating system
offered potential advantages in terms of uniformity of
coating due to the comparatively higher number of
passes of the tablets through the spray zone. One
paradox Wesley posed to the audience was ‘can a
continuous coater actually be run continuously?’


Kevin Hughes (Colorcon Ltd) covered means of
controlling existing coating processes such as batch
film coating and sugar coating. He highlighted the
large number of coating variables which contribute to
the difficulty in controlling a coating process and also
highlighted the need in particular to be able to control
inlet air humidity, droplet size and tablet bed
temperature, parameters which currently, cannot easily
be monitored using existing coating equipment. In
terms of sugar coating he highlighted the dependence
on operators which traditionally exists but argued that
automation and control was no more difficult and as
relevant here as for film coating processes.
Marshall Whiteman (Phoqus Pharmaceuticals Ltd)
explained Phoqus technology – an alternative means
of achieving film coats onto tablets. The technology
originally based on photocopying has evolved into a
means of accurately depositing films that alter
dissolution profiles as well as offering the potential for
unique colour and logo presentations. The process is
continuous and enables individual tablets to be made.
Thus it lends itself perhaps better than traditional
methods to the use of analytical techniques for in line
process control. One analytical technique Phoqus
have evaluated is Terra Hertz technology which can
non-destructively and accurately measure coating
thickness an essential parameter to control in
controlled release.


The final presentation was delivered by
Graeme Macleod (Magenta) who argued that the
P.A.T initiative currently in vogue should open the door
to think more from first principles about how we
manufacture and coat solid dose forms. He asked
whether or not we actually understand our existing
processes and if we control all the critical variables.
He detailed NRobe technology a novel means of
manufacturing solid dose forms which offers the
possibility of reduced excipient requirement and use
of pre made films which thus ensures lower process
variability. He suggested that equipment and
processes should be designed around products
rather than the existing approach which relies on using
existing equipment and processes to make the best
product possible.

The symposium finished with delegates breaking out
into groups and feeding back their thoughts, opinions
and conclusions from what they had heard throughout
the day in 3 groups covering the topics of new
technologies, existing coating processes and batch
versus continuous coating.

Sponsored by Magenta.


Here is the link if you are registered.
https://www.apsgb.co.uk/Newsletters/Downloads/Autumn_2005.pdf