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Transfer from High-Shear Batch to Continuous Twin Screw Wet Granulation: A Case Study in Understanding the Relationship Between Process Parameters and Product Quality Attributes
Contributor(s):: Beer, Paul, Wilson, David, Huang, Zhenyu, De Matas, Marcel
A twin screw to high-shear batch granulation technology switch was evaluated for a pharmaceutical development project. Differences in granule (particle size distribution and porosity) and tablet (dissolution) quality attributes were analysed for both continuous and batch technologies. Liquid to...
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Process design applied to optimise a directly compressible powder produced via a continuous manufacturing process
Contributor(s):: Gonnissen, Y., Goncalves, S. I. V., De Geest, B. G., Remon, J. P., Vervaet, C.
Manufacturing of 'ready-to-compress' powder mixtures for direct compression was performed by spray drying, without granulation, milling and/or blending steps in between spray drying and compaction. Powder mixtures containing acetaminophen, mannitol, erythritol, maltodextrin, crospovidone,...
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New approach to optimizing risk management of the sticking problem using scale-independent critical material attributes and the quantitative process parameter
Contributor(s):: Ando, Hirotaka, Hara, Yuko, Sato, Kazunari, Dohi, Masafumi, Hakomori, Tadashi, Yonemochi, Etsuo
In pharmaceutical manufacturing of solid formulations, blending with a lubricant is a key process in preventing sticking during compression. Sticking not only results in tablets with a disfigured appearance but also brings about the interruption of continuous operations. The aim of our study was...
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Development of directly compressible powders via co-spray drying
Contributor(s):: Gonnissen, Y., Remon, J. P., Vervaet, C.
Continuous production of directly compressible powders was achieved by coprocessing acetaminophen and carbohydrates via spray drying. Binary and ternary powder mixtures containing drug substance and carbohydrates were prepared by co-spray drying and evaluated on spray drying processibility,...
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Continuous manufacturing: the future in pharmaceutical solid dosage form manufacturing
Contributor(s):: Desai, Parind Mahendrakumar, Van Vaerenbergh, Griet, Holman, Jim, Liew, Celine Valeria, Heng, Paul Wan Sia
As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and...
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Application of multivariate methods to compression behavior evaluation of directly compressible materials
Contributor(s):: Haware, Rahul V., Tho, Ingunn, Bauer-Brandl, Annette
The present study is an approach to describe and predict compaction and tablet properties by a combination of a set of commonly used mathematical descriptors and multivariate methods based on continuous compression profiles. Effects of formulation and process parameters (e.g. composition, powder...