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Publikation Evaluierung von Carbonatpuffer für die Wirkstofffreisetzung aus Tabletten(Hochschule für Life Sciences FHNW, 2024) Loureiro Cunha, Margarida; Lanz, Michael; Imanidis, Georgios11 - Studentische ArbeitPublikation How technical innovations may help to prevent drug shortages in switzerland(Schweizerische Chemische Gesellschaft, 2023) Gygax, Daniel; Eigenmann, Kaspar; Suter, Christian; Hürzeler Müller, Marianne; Mahmoud, Ahmed; Mosbacher, Johannes; Pöllinger, NorbertIn this work, we investigated the technical feasibility of 'on-demand' production of selected drugs to cover their demand for a time window of 90 days. We focused on two sub-processes 'automated chemical synthesis' and 'formulation in micropellets' to enable personalized dosing. The production of drugs 'on-demand' is challenging, important, but also attractive. Switzerland could thus gain access to an additional instrument for increasing resilience for supply-critical drugs. The biggest challenge in the case study presented here is the scalability of automated chemical synthesis and the application range of micropellet formulations.01A - Beitrag in wissenschaftlicher ZeitschriftPublikation Analysis of the physical characteristics of an anhydrous vehicle for compounded pediatric oral liquids(MDPI, 2023) Banov, Daniel; Liu, Yi; Ip, Kendice; Shan, Ashley; Vu, Christine; Zdoryk, Oleksandr; Bassani, August S.; Carvalho, MariaThe paucity of suitable drug formulations for pediatric patients generates a need for customized, compounded medications. This research study was set out to comprehensively analyze the physical properties of the new, proprietary anhydrous oral vehicle SuspendIt® Anhydrous, which was designed for compounding pediatric oral liquids. A wide range of tests was used, including sedimentation volume, viscosity, droplet size after dispersion in simulated gastric fluid, microscopic examination and content uniformity measurements to evaluate the properties of the anhydrous vehicle. The results showed that the vehicle exhibited consistent physical properties under varying conditions and maintained stability over time. This can be attributed to the unique blend of excipients in its formulation, which not only maintain its viscosity but also confer thixotropic behavior. The unique combination of viscous, thixotropic and self-emulsifying properties allows for rapid redispersibility, sedimentation stability, accurate dosing, potential drug solubility, dispersion and promotion of enhanced gastrointestinal distribution and absorption. Furthermore, the vehicle demonstrated long-term sedimentation stability and content uniformity for a list of 13 anhydrous suspensions. These results suggest that the anhydrous oral vehicle could serve as a versatile base for pediatric formulation, potentially filling an important gap in pediatric drug delivery. Future studies can further investigate its compatibility, stability and performance with other drugs and in different clinical scenarios.01A - Beitrag in wissenschaftlicher ZeitschriftPublikation Advancing algorithmic drug product development. Recommendations for machine learning approaches in drug formulation(Elsevier, 2023) Murray, Jack D.; Lange, Justus J.; Bennett-Lenane, Harriet; Holm, René; Kuentz, Martin; O'Dwyer, Patrick J.; Griffin, Brendan T.Artificial intelligence is a rapidly expanding area of research, with the disruptive potential to transform traditional approaches in the pharmaceutical industry, from drug discovery and development to clinical practice. Machine learning, a subfield of artificial intelligence, has fundamentally transformed in silico modelling and has the capacity to streamline clinical translation. This paper reviews data-driven modelling methodologies with a focus on drug formulation development. Despite recent advances, there is limited modelling guidance specific to drug product development and a trend towards suboptimal modelling practices, resulting in models that may not give reliable predictions in practice. There is an overwhelming focus on benchtop experimental outcomes obtained for a specific modelling aim, leaving the capabilities of data scraping or the use of combined modelling approaches yet to be fully explored. Moreover, the preference for high accuracy can lead to a reliance on black box methods over interpretable models. This further limits the widespread adoption of machine learning as black boxes yield models that cannot be easily understood for the purposes of enhancing product performance. In this review, recommendations for conducting machine learning research for drug product development to ensure trustworthiness, transparency, and reliability of the models produced are presented. Finally, possible future directions on how research in this area might develop are discussed to aim for models that provide useful and robust guidance to formulators. © 202301A - Beitrag in wissenschaftlicher ZeitschriftPublikation Co‐current filtrate flow in TFF perfusion processes. Decoupling transmembrane pressure from crossflow to improve product sieving(Wiley, 2023) Romann, Patrick; Giller, Philip; Sibilia, Antony; Herwig, Christoph; Zydney, Andrew L.; Perilleux, Arnaud; Souquet, Jonathan; Bielser, Jean‐Marc; Villiger, ThomasHollow fiber‐based membrane filtration has emerged as the dominant technology for cell retention in perfusion processes yet significant challenges in alleviating filter fouling remain unsolved. In this work, the benefits of co‐current filtrate flow applied to a tangential flow filtration (TFF) module to reduce or even completely remove Starling recirculation caused by the axial pressure drop within the module was studied by pressure characterization experiments and perfusion cell culture runs. Additionally, a novel concept to achieve alternating Starling flow within unidirectional TFF was investigated. Pressure profiles demonstrated that precise flow control can be achieved with both lab‐scale and manufacturing‐scale filters. TFF systems with co‐current flow showed up to 40% higher product sieving compared to standard TFF. The decoupling of transmembrane pressure from crossflow velocity and filter characteristics in co‐current TFF alleviates common challenges for hollow fiber‐based systems such as limited crossflow rates and relatively short filter module lengths, both of which are currently used to avoid extensive pressure drop along the filtration module. Therefore, co‐current filtrate flow in unidirectional TFF systems represents an interesting and scalable alternative to standard TFF or alternating TFF operation with additional possibilities to control Starling recirculation flow.01A - Beitrag in wissenschaftlicher ZeitschriftPublikation Isolation and characterization of pancreatic lipase inhibitor from rapeseed seeds(Oles Honchar Dnipro National University, 2023) Krusir, Galyna; Pylypenko, Liudmyla; Sevastyanova, Elena; Mazurenko, Kseniia; Moshtakov, Serhii; Shunko, Hanna; Vitiuk, Antonina; Shpyrko, Tetyana; Zdoryk, OleksandrDigestive enzymes and inhibitors of digestive enzymes are effective correctors of digestive processes in the body, the violation of which leads to various diseases (diabetes, hyperlipidemia, cardiovascular diseases, neoplasms and others). The present study identified the most promising plant objects characterized by the highest antilipolytic activity (ALA) in relation to pancreatic lipase. The experimental results indicate that the inhibitory activity (IA) of phenolic compounds of rapeseed is so much high and comparable to ALA "Orlistat", reaching 95.5 % of its activity. This determines the potential possibility of using the phenolic complex of rapeseed as an alternative to anti-lipolytic drugs of synthetic origin. The predominant component of the phenolic complex is low molecular weight phenolic compounds; polyphenolic compounds are almost equally represented by tannins – condensed and hydrolyzable. According to TLC data, the main components of low molecular weight phenols are glucopyranosylsinapate, sinapic acid and sinapin. Among the phenolic compounds of rapeseed seeds, sinapine and hydrolyzable tannins have the highest anti lipolytic activity against lipase. Significant ability to inhibit the action of pancreatic lipase is characterized by both low molecular weight and high molecular weight phenolic compounds of rapeseed.01A - Beitrag in wissenschaftlicher ZeitschriftPublikation Electrospun decellularized extracellular matrix scaffolds promote the regeneration of injured neurons(Elsevier, 09/2023) Mungenast, Lena; Nieminen, Ronya; Gaiser, Carine; Faia-Torres, Ana Bela; Rühe, Jürgen; Suter-Dick, Laura01A - Beitrag in wissenschaftlicher ZeitschriftPublikation Tablet formulation with dual control concept for efficient colonic drug delivery(Elsevier, 25.01.2023) Doggwiler, Viviane; Lanz, Michael; Paredes, Valeria; Lipps, Georg; Imanidis, Georgios01A - Beitrag in wissenschaftlicher ZeitschriftPublikation Efficient colonic drug delivery in domestic pigs employing a tablet formulation with dual control concept(Elsevier, 06/2023) Doggwiler, Viviane; Puorger, Chasper; Paredes, Valeria; Lanz, Michael; Nuss, Katja M.; Lipps, Georg; Imanidis, Georgios01A - Beitrag in wissenschaftlicher ZeitschriftPublikation Indigenous yeasts from rose oil distillation wastewater and their capacity for biotransformation of phenolics(MDPI, 12.01.2023) Rusanova, Mila; Rusanov, Krasimir; Butterweck, Veronika; Atanassov, IvanThe indigenous yeasts associated with the spontaneous fermentation of phenolic-rich rose oil distillation wastewater (RODW) generated after the industrial distillation of rose oil were studied. The ITS-rDNA sequence analysis of the samples collected from RODW fermented at semi-sterile conditions, a waste deposition lagoon and endophytic yeasts isolated from industrially cultivated Rosa damascena suggests that the spontaneous RODW fermentation is caused by yeasts from the genus Cyberlindnera found also as endophytes in the rose flowers. Phylogenetic analysis based on the nucleotide sequences of the translation elongation factor (TEF1α) and 18S- and 26S- rRNA genes further confirmed the taxonomic affiliation of the RODW yeast isolates with the genus Cyberlindnera. The RODW fermentation capacity of a selected set of indigenous yeast isolates was studied and compared with those of common yeast strains. The indigenous yeast isolates demonstrated a superior growth rate, resulting in a nearly double reduction in the phenolic content in the fermented RODW. The indigenous yeasts’ fermentation changed the RODW phenolics’ composition. The levels of some particular phenolic glycosides decreased through the depletion and fermentation of their sugar moiety. Hence, the relative abundance of the corresponding aglycons and other phenolic compounds increased. The capacity for the biotransformation of RODW phenolics by indigenous yeasts is discussed.01A - Beitrag in wissenschaftlicher Zeitschrift