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Page 1
A Review of PAT Strategies in Secondary Solid Oral Dosage Manufacturing of Small Molecules.
Laske S, Paudel A, Scheibelhofer O; Author Team. Laske S, et al. J Pharm Sci. 2017 Mar;106(3):667-712. doi: 10.1016/j.xphs.2016.11.011. Epub 2016 Nov 22. J Pharm Sci. 2017. PMID: 28017464 Review.
To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological, and mathematical) methods for material (e.g., materials, intermediates, products) and process (e.g., temperature, pressure, throughput, …
To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological, and mathe …
Continuous mixing technology: Validation of a DEM model.
Toson P, Doshi P, Matic M, Siegmann E, Blackwood D, Jain A, Brandon J, Lee K, Wilsdon D, Kimber J, Verrier H, Khinast J, Jajcevic D. Toson P, et al. Int J Pharm. 2021 Oct 25;608:121065. doi: 10.1016/j.ijpharm.2021.121065. Epub 2021 Sep 2. Int J Pharm. 2021. PMID: 34481005
After that, the predicted RTDs were compared with the results of tracer spike experiments conducted with two blend material properties at two mass throughputs of 15 kg/h and 30 kg/h. Additionally, three hold-up masses (500, 730 and 850 g) and three impeller speeds (400, 44 …
After that, the predicted RTDs were compared with the results of tracer spike experiments conducted with two blend material properties at tw …
Single-tablet-scale direct-compression: An on-demand manufacturing route for personalized tablets.
Kottlan A, Zirkl A, Geistlinger J, Machado Charry E, Glasser BJ, Khinast JG. Kottlan A, et al. Int J Pharm. 2023 Aug 25;643:123274. doi: 10.1016/j.ijpharm.2023.123274. Epub 2023 Jul 26. Int J Pharm. 2023. PMID: 37507098
Regarding the vibratory mixing process, a dependency of the performance on the applied frequencies and acceleration was observed, with 100 Hz and 90 G performing best, yet still exhibiting varying mixing efficacies depending on the granular system. ...
Regarding the vibratory mixing process, a dependency of the performance on the applied frequencies and acceleration was observed, with 100 H …
A solution for low-dose feeding in continuous pharmaceutical processes.
Sacher S, Heindl N, Afonso Urich JA, Kruisz J, Khinast JG. Sacher S, et al. Int J Pharm. 2020 Dec 15;591:119969. doi: 10.1016/j.ijpharm.2020.119969. Epub 2020 Oct 15. Int J Pharm. 2020. PMID: 33068692
To enable stable processing, low amounts of various agents, e.g., lubricants, can be used. Even more important is the exact dosage of highly potent active pharmaceutical ingredients (APIs), which require feed rates within the range of grams per hour. ...
To enable stable processing, low amounts of various agents, e.g., lubricants, can be used. Even more important is the exact dosage of …
Control oriented modeling of twin-screw granulation in the ConsiGmaTM-25 production plant.
Celikovic S, Poms J, Khinast J, Horn M, Rehrl J. Celikovic S, et al. Int J Pharm. 2023 Jun 25;641:123038. doi: 10.1016/j.ijpharm.2023.123038. Epub 2023 May 12. Int J Pharm. 2023. PMID: 37182794 Free article.
The solutions proposed in this research can be used as a reliable (and necessary) basis for the development of advanced quality-by-design control concepts (e.g., PSD process control). Such concepts would ultimately improve the ConsiGma(TM)-25 process performance in terms o …
The solutions proposed in this research can be used as a reliable (and necessary) basis for the development of advanced quality-by-design co …
Towards a novel continuous HME-Tableting line: Process development and control concept.
Sacher S, Celikovic S, Rehrl J, Poms J, Kirchengast M, Kruisz J, Sipek M, Salar-Behzadi S, Berger H, Stark G, Horn M, Khinast JG. Sacher S, et al. Eur J Pharm Sci. 2020 Jan 15;142:105097. doi: 10.1016/j.ejps.2019.105097. Epub 2019 Oct 21. Eur J Pharm Sci. 2020. PMID: 31648048
Such systems can be used to make complex pharmaceutical formulations, e.g., amorphous solid dispersions of poorly soluble APIs. The pellets are then fed to a direct compaction (DC) line blended with an external phase and tableted continuously. Fully-automated processing re …
Such systems can be used to make complex pharmaceutical formulations, e.g., amorphous solid dispersions of poorly soluble APIs. The p …
Optimized continuous pharmaceutical manufacturing via model-predictive control.
Rehrl J, Kruisz J, Sacher S, Khinast J, Horn M. Rehrl J, et al. Int J Pharm. 2016 Aug 20;510(1):100-15. doi: 10.1016/j.ijpharm.2016.06.024. Epub 2016 Jun 16. Int J Pharm. 2016. PMID: 27317987
Compared to conventional concepts, the proposed approach allows to conveniently consider constraints (e.g. mass hold-up in the blender) and offers a straightforward, easy to tune controller setup. ...In order to realize it on a real system, additional aspects (e.g., …
Compared to conventional concepts, the proposed approach allows to conveniently consider constraints (e.g. mass hold-up in the blende …
Steady-state modeling of a new continuous API dryer: Reduced-order model and investigation of dryer performance.
Salehi MS, Askarishahi M, Jajcevic D, Aigner I, Zettl M, Khinast J. Salehi MS, et al. Int J Pharm. 2023 Mar 25;635:122701. doi: 10.1016/j.ijpharm.2023.122701. Epub 2023 Feb 9. Int J Pharm. 2023. PMID: 36773730
Besides, it was also established that the inlet solid LoD has the most considerable effect on the product quality (e.g., final solid moisture content). The results showed a deviation of less than 10% for the product LoD and the product temperature in most cases....
Besides, it was also established that the inlet solid LoD has the most considerable effect on the product quality (e.g., final solid …
Control of three different continuous pharmaceutical manufacturing processes: Use of soft sensors.
Rehrl J, Karttunen AP, Nicolaï N, Hörmann T, Horn M, Korhonen O, Nopens I, De Beer T, Khinast JG. Rehrl J, et al. Int J Pharm. 2018 May 30;543(1-2):60-72. doi: 10.1016/j.ijpharm.2018.03.027. Epub 2018 Mar 16. Int J Pharm. 2018. PMID: 29555436
The decision on material discharge can be based on the measurement of active pharmaceutical ingredient (API) concentration at specific locations in the production line via process analytic technology (PAT), e.g. near-infrared (NIR) spectrometers. The implementation of the …
The decision on material discharge can be based on the measurement of active pharmaceutical ingredient (API) concentration at specific locat …
Fluidization characterization in the ConSigma 25 dryer via process data - A method of advanced quality assurance in continuous manufacturing.
Rehrl J, Hörmann-Kincses T, Sibanc R, Hsiao WK, Franke M, Khinast J. Rehrl J, et al. Int J Pharm. 2021 Sep 25;607:121041. doi: 10.1016/j.ijpharm.2021.121041. Epub 2021 Aug 26. Int J Pharm. 2021. PMID: 34455056
This paper addresses typical effects and issues associated with the dryer's setup and operation (e.g., unexpected cell temperature profiles, the effects of air flow and temperature on the granule properties, variations in the granule moisture between the dryer cells). ...
This paper addresses typical effects and issues associated with the dryer's setup and operation (e.g., unexpected cell temperature pr …
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