New Data Demonstrates Potential of Using In-Line Measured Coating Thickness to Predict Dissolution
Profiles
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- Is there a correlation between functional
coating thickness and dissolution profiles?
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Is Real-time dissolution prediction of a
coating process using particle size data a viable
control method?
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Will prediction data be reliable enough to use
to use during process development, optimisation, scale
up and transfer?
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Is there potential for process control or
troubleshooting based on PSD trending?
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New data is now available from a series of experiments
conducted recently by industry leaders Glatt, Colorcon and
Innopharma. Colorcon Suglets® were coated with a
Surelease® and Opadry®EC functional coating solution in a Glatt
GPCG2® lab-scale fluid bed system. In-Line particle
size measurement was then performed using an Innopharma
Eyecon2™particle analyser.
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Chris O’Callaghan. Senior
Product Manager, Innopharma Technology said “The Eyecon2™ data demonstrates clearly not only that a
strong correlation exists between functional coating thickness,determined by particle size increase and dissolution
profile but also that real-time dissolution prediction of a coating process using particle size data and a
formulation-based model is a viable control method.”
Christian Knopf, a Glatt PAT
Expert, explains: “Hardware interface solutions for Eyecon2 and Glatt process equipment are available
for lab, scale up and larger machines and the ethernet connectivity and the
Eyecon2’s
OPC UA protocol allow complete integration into the GlattView Eco, Mega or Conti interface, making an additional
Laptop unnecessary for operators who prefer to use the machine control system to control and access the
data.”
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To download the entire
Application Note complete with experiment plan, materials and equipment used, results, conclusions please
click here
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Lab, Pilot and Commercial Scale Implementation
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Innopharma Technology and Glatt have collaborated to develop
Eyecon2
hardware interface and control
system integration solutions for the most popular Glatt
machines from the GPGC2 at lab scale to scale up and production
machines. This facilitates rapid set up to generate real time
in-line PSD data for deeper process understanding during
QbD/DoE development and scale up activities and for process
control during manufacture where required.
For more information please click
here
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Innopharma Technology is a division of Innopharma,
specialised in the development of efficient, reliable and rapid
direct measurement PAT analysers that support research,
development and investigational experiments resulting in
greater knowledge and more robust manufacturing processes.
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The Glatt Group has specialized in the manufacturing,
handling and processing of powdery solids for the
pharmaceutical, fine-chemical and food processing industries
for more than 60 years. the core technology is the
fluidized-bed method for granulation and drying, pelletization
and coating of solids. The Glatt Group also offer laboratory,
pilot and production equipment for the batch or continuous
processes, product and process development and product handling
for contract manufacturing.
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Colorcon® is a world leader in the development, supply and
support of formulated products for the pharmaceutical
industry. Colorcon® provides a wide range of
pharmaceutical film coatings and pharmaceutical formulation
development assistance. Fully formulated, complete
film coating systems, modified release technologies, and
excipients assist all pharmaceutical and nutritional
supplement companies in the development of cost-effective,
high quality products with superior performance and
appearance.
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