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Use of a continuous twin screw granulation and drying system during formulation development and process optimization
09 Jun 2023 | Contributor(s):: Vercruysse, J., Peeters, E., Fonteyne, M., Cappuyns, P., Delaet, U., Van Assche, I., De Beer, T., Remon, J. P., Vervaet, C.
Since small scale is key for successful introduction of continuous techniques in the pharmaceutical industry to allow its use during formulation development and process optimization, it is essential to determine whether the product quality is similar when small quantities of materials are...
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Stability and repeatability of a continuous twin screw granulation and drying system
09 Jun 2023 | Contributor(s):: Vercruysse, J., Delaet, U., Van Assche, I., Cappuyns, P., Arata, F., Caporicci, G., De Beer, T., Remon, J. P., Vervaet, C.
The aim of this study was to investigate the process transfer of a commercially available product from the current batch fluid bed granulation and drying production method to an innovative continuously operating from powder to tablet production line using twin screw granulation as an intermediate...
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Simplified end-to-end continuous manufacturing by feeding API suspensions in twin-screw wet granulation
09 Jun 2023 | Contributor(s):: Schmidt, A, de, Waard, HMoll, KP, Kleinebudde, P, Krumme, M
This study focussed on investigating the coupling of continuous manufacturing of drug substance and continuous manufacture of drug product. An important step in such an integrated end-to-end continuous manufacturing was envisioned by dosing the API as suspension into a twin-screw wet granulation...
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Simplified formulations with high drug loads for continuous twin-screw granulation
09 Jun 2023 | Contributor(s):: Meier, R., Thommes, M., Rasenack, N., Krumme, M., Moll, K. -P., Kleinebudde, P.
As different batches of the same excipients will be intermixed during continuous processes, the traceability of batches is complicated. Simplified formulations may help to reduce problems related to batch intermixing and traceability. Twin-screw granulation with subsequent tableting was used to...
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Continuous twin screw granulation: Influence of process variables on granule and tablet quality
09 Jun 2023 | Contributor(s):: Vercruysse, J., Diaz, D. Cordoba, Peeters, E., Fonteyne, M., Delaet, U., Van Assche, I., De Beer, T., Remon, J. P., Veryaet, C.
The aim of the current study was to screen theophylline (125 mg) tablets manufactured via twin screw granulation in order to improve process understanding and knowledge of process variables that determine granule and tablet quality. A premix of theophylline anhydrate, alpha-lactose monohydrate...