New Data Demonstrates Potential of Using In-Line Measured Coating Thickness to Predict Dissolution Profiles

New Data Demonstrates Potential of Using In-Line Measured Coating Thickness to Predict Dissolution Profiles

Is there a correlation between functional coating thickness and dissolution profiles?
Is Real-time dissolution prediction of a coating process using particle size data a viable control method?
Will prediction data be reliable enough to use to use during process development, optimisation, scale up and transfer?
Is there potential for process control or troubleshooting based on PSD trending?

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.

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.”

To download the entire Application Note complete with experiment plan, materials and equipment used, results, conclusions please click here

Lab, Pilot and Commercial Scale Implementation

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

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.

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.

Tags: excipients formulation

New Data Demonstrates Potential of Using In-Line Measured Coating Thickness to Predict Dissolution Profiles

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