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Metamorphosis of Twin Screw Extruder-Based Granulation Technology: Applications Focusing on Its Impact on Conventional Granulation Technology
09 Jun 2023 | Contributor(s):: Rao, Rajat Radhakrishna, Pandey, Abhijeet, Hegde, Aswathi R., Kulkarni, Vijay Induvadan, Chincholi, Chetan, Rao, Vinay, Bhushan, Indu, Mutalik, Srinivas
In order to be at pace with the market requirements of solid dosage forms and regulatory standards, a transformation towards systematic processing using continuous manufacturing (CM) and automated model-based control is being thought through for its fundamental advantages over conventional batch...
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Inline UV/Vis spectroscopy as PAT tool for hot-melt extrusion
09 Jun 2023 | Contributor(s):: Wesholowski, Jens, Prill, Sebastian, Berghaus, Andreas, Thommes, Markus
Hot-melt extrusion on co-rotating twin screw extruders is a focused technology for the production of pharmaceuticals in the context of Quality by Design. Since it is a continuous process, the potential for minimizing product quality fluctuation is enhanced. A typical application of hot-melt...
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Inline Determination of Residence Time distributionin Hot-Melt-Extrusion
09 Jun 2023 | Contributor(s):: Wesholowski, Jens, Berghaus, Andreas, Thommes, Markus
In the framework of Quality-by-Design (QbD), the inline determination of process parameters or quality attributes of a product using sufficient process analytical technology (PAT) is a center piece for the establishment of continuous processes as a standard pharmaceutical technology. In this...
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Foam granulation: new developments in pharmaceutical solid oral dosage forms using twin screw extrusion machinery
09 Jun 2023 | Contributor(s):: Thompson, M. R., Weatherley, S., Pukadyil, R. N., Sheskey, P. J.
This paper investigates foam granulation in a twin screw extruder as a new continuous wet granulation technique for pharmaceutical powder drug formulations. Foamed aqueous binder has a reportedly lower soak-to-spread ratio than drop or spray liquid addition in batch granulation. This work...
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Control of Pharmaceutical Cocrystal Polymorphism on Various Scales by Mechanochemistry: Transfer from the Laboratory Batch to the Large-Scale Extrusion Processing
09 Jun 2023 | Contributor(s):: Stolar, T, Lukin, STireli, M, Sovic, I, Karadeniz, B, Kerekovic, I, Matijasic, G, Gretic, M, Katancic, Z, Dejanovic, I, di, Michiel, M, Halasz, I, Uzarevic, K
We demonstrate a controllable mechanochemical synthesis of cocrystal polymorphs of ascorbic acid (vitamin C) and nicotinamide (vitamin B3) on different scales and without using bulk solvents. Next to the previously described polymorph of the 1:1 cocrystal, which is one of the first cocrystals...