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      Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion

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          Abstract

          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 context, Twin-Screw-Extrusion (TSE) processes, such as Hot-Melt-Extrusion (HME), are one key aspect of current research. The main benefit of this process technology is the combination of different unit operations. Several of these sub-processes are linked to the Residence Time Distribution (RTD) of the material within the apparatus. In this study a UV/Vis spectrophotometer from ColVisTec was tested regarding the suitability for the inline determination of the RTD of an HME process. Two different measuring positions within a co-rotating Twin-Screw-Extruder were compared to an offline HPLC–UV as reference method. The obtained results were overall in good agreement and therefore the inline UV/Vis spectrophotometer is suitable for the determination of the RTD in TSE. An influence of the measuring position on repeatability was found and has to be taken into consideration for the implementation of PATs. An effect of the required amount of marker on process rheology is not likely due to the low Limit-of-Quantification (LoQ).

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          Most cited references23

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          Melt extrusion: from process to drug delivery technology.

          Starting from the plastic industry, today melt extrusion has found its place in the array of pharmaceutical manufacturing operations. This article reviews the process technology with regard to the set up and specific elements of the extruder as well as its application. Melt extrusion processes are currently applied in the pharmaceutical field for the manufacture of a variety of dosage forms and formulations such as granules, pellets, tablets, suppositories, implants, stents, transdermal systems and ophthalmic inserts. As a specific area the manufacture of solid dispersions, in particular, solid molecular dispersions using the melt extrusion process is reviewed. Melt extrusion is considered to be an efficient technology in this field with particular advantages over solvent processes like co-precipitation. Potential drawbacks like the influence of heat stress and shear forces on the drug active have been overcome in a number of examples with drugs of different chemical structure. Examples of suitable excipients and recent findings like self-emulsifying preparations are presented. The article concludes with a number of published examples of melt extrudates applying the principle of solid molecular dispersions. Improved bioavailability was achieved again demonstrating the value of the technology as a drug delivery tool.
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            Mixing and transport during pharmaceutical twin-screw wet granulation: Experimental analysis via chemical imaging

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              Examining the mechanics of granulation with a hot melt binder in a twin-screw extruder

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                Author and article information

                Journal
                Pharmaceutics
                Pharmaceutics
                pharmaceutics
                Pharmaceutics
                MDPI
                1999-4923
                15 April 2018
                June 2018
                : 10
                : 2
                Affiliations
                [1 ]Institute of Solids Process Engineering, TU Dortmund University, Dortmund 44227, Germany; jens.wesholowski@ 123456tu-dortmund.de
                [2 ]ColVisTec AG, Berlin 12489, Germany; a.berghaus@ 123456colvistec.de
                Author notes
                [* ]Correspondence: markus.thommes@ 123456tu-dortmund.de ; Tel.: +49-231-755-5954
                Article
                pharmaceutics-10-00049
                10.3390/pharmaceutics10020049
                6027324
                29662034
                da178eca-8cfa-4076-8e60-b0b2c3065410
                © 2018 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                Categories
                Article

                uv/vis spectroscopy,residence time distribution,twin screw extrusion,process analytical tool,quality-by-design

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