Scale-up and implementation
into commercial production
of a technologically
complex drug product
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Description
The project concerned scaling up and implementing the production of an oral film-coated tablet. Technical difficulties resulted primarily from the specific properties of the active substance, which constituted approximately 90% of the tablet composition. The active substance molecule was a cross-linked polymer with elastic properties and a high affinity for water, significantly increasing the volume of the active substance.
This meant a non-standard approach to the tablet compression and film-coating stages was necessary. Thanks to its use, it was possible to determine the optimal process parameters and validate the manufacturing process on an industrial scale.
Key points
Scale-up strategy
Design of experiments
Sampling plan
Technical batches manufacturing
Control strategy over process parameters
Process validation
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.
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We have a broad experience in problem solving pharmaceutical problems for diverse companies.
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