Metabolomics constitutes a promising approach to clinical diagnostics, but its practical implementation in clinical settings is hindered by the requirement for rapid and efficient analytical methods .......
Research into innovative food safety technologies has led to the development of smart packaging with embedded chemical sensors that can monitor food quality throughout the supply chain. Thermochromic ...materials (TM), which are able to dynamically change colour in response to temperature fluctuations, have proven to be reliable indicators of food quality in certain environments. Natural colourants such as curcumin are becoming increasingly popular for smart packaging due to their low toxicity, environmental friendliness and ability to change colour. The innovation in this research lies in the production of a bio-based bilayer membrane specifically designed for irreversible temperature monitoring. Membrane A was prepared by dissolving cellulose acetate and curcumin in acetone at room temperature, with glycerol serving as a plasticiser. At the same time, membrane B was carefully formulated by dissolving cellulose acetate and triethanolamine in acetone, with sorbitol as plasticiser. The preparation of these different membranes revealed a remarkable event: a gradual and irreversible colour transition from an initial yellow to a brick-red hue after 24 hours of storage at 25 °C. The chemical structure and morphological analyses of the membranes were performed using several techniques, including FTIR, DSC and SEM. The membrane labels were adhered to aluminium cans and their colorimetric response was observed over a period of 10 days. Minimal colour variations were observed, confirming the reproducibility and stability of the curcumin-based membranes as temperature sensors.
Research into innovative food safety technologies has led to the development of smart packaging with embedded chemical sensors that can monitor food quality throughout the supply chain.
The goal of the present study was to investigate the link between elementary school teacher burnout and students' perceptions of teacher social–emotional competence (SEC). A total of 676 Grades 4–7 ...students in 35 classrooms rated their classroom teachers' SEC. In addition, teachers self‐reported their current level of experienced burnout at work (i.e., depersonalization and emotional exhaustion). Multilevel analyses revealed significant classroom‐level variability (i.e., 34%) in student‐ratings of teacher SEC. Teacher burnout significantly predicted student‐rated teacher SEC, over and above significant student‐level variables (school self‐concept, sense of autonomy in the classroom) and contextual variables (teacher age, school neighborhood income). Specifically, higher levels of teacher burnout were related to receiving lower SEC ratings by students. Teacher burnout explained a significant portion of the classroom‐level variability in student‐rated teacher SEC. The present study emphasizes the link between teacher burnout and the SEC. Furthermore, given that teacher reports (burnout) were linked to student reports (teacher SEC), these findings also suggest that students notice stress in their classroom teacher.
In recent years, many fast drying techniques such as spray-drying are being explored as alternatives to biopharmaceutical freeze-drying. Thus, it is essential to understand how the processability of ...commonly used excipients will be affected when these new techniques are employed. This study reports a series of observations outlining how the thermally-induced oxidative degradation of polysorbates (PS) evolves in liquid to solid transitions, such as those expected in spray-drying. Firstly, the impact of different evaporation rates on the oxidative degradation of aqueous solutions of two different PS types namely, PS20 and PS80, were screened via evaporative solvent casting. The latter revealed that the evaporation rate could critically impact the rate-limiting steps of PS thermal oxidation. In addition, the potential of saccharides as excipients to mitigate the thermal oxidation of PS80 under slow and fast evaporation conditions was investigated. Five different saccharide excipients were screened, i.e., trehalose dihydrate, maltodextrin, hydroxypropyl-β-cyclodextrin, and Dextran 40. Under slow evaporation conditions, only trehalose dihydrate seemed to be beneficial in avoiding the thermal oxidation of PS80. For fast evaporation conditions, hydroxypropyl-β-cyclodextrin prevented the oxidative degradation of PS80. This implies that distinct strategies to mitigate PS oxidative degradation might be necessary depending on the drying process and rates.
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•Understanding of the interplay among material, formulation properties and processing parameters that are critical for manufacturing DPI products with desired performance.•Model ...informed formulation and process development are emerging as valid tools for DPI products.•Application of advanced PAT technologies to DPI manufacturing holds potential to improve product quality and performance.
Dry powder inhalers (DPI) are well established products for the delivery of actives via the pulmonary route. Various DPI products are marketed or developed for the treatment of local lung diseases such as chronic obstructive pulmonary disease (COPD), asthma or cystic fibrosis as well as systemic diseases targeted through inhaled delivery (i.e. Diabetes Mellitus). One of the key prerequisites of DPI formulations is that the aerodynamic size of the drug particles needs to be below 5 µm to enter deeply into the respiratory tract. These inherently cohesive inhalable size particles are either formulated as adhesive mixture with coarse carrier particles like lactose called carrier-based DPI or are formulated as free-flowing carrier-free particles (e.g. soft agglomerates, large hollow particles). In either case, it is common practice that drug and/or excipient particles of DPI formulations are obtained by processing API and API/excipients. The DPI manufacturing process heavily involves several particle and powder technologies such as micronization of the API, dry blending, powder filling and other particle engineering processes such as spray drying, crystallization etc. In this context, it is essential to thoroughly understand the impact of powder/particle properties and processing on the quality and performance of the DPI formulations. This will enable prediction of the processability of the DPI formulations and controlling the manufacturing process so that meticulously designed formulations are able to be finally developed as the finished DPI dosage form. This article is intended to provide a concise account of various aspects of DPI powder processing, including the process understanding and material properties that are important to achieve the desired DPI product quality. Various endeavors of model informed formulation/process design and development for DPI powder and PAT enabled process monitoring and control are also discussed.
Spray-drying is an inherently continuous and well-established industrial drying process. It can accelerate manufacturing of biopharmaceuticals and vaccine products, resulting in both an economic and ...health benefit. In this review, we cover a systematic assessment and discuss the spray-drying of diverse protein pharmaceuticals and excipients included therein, solvent systems applicable to these formulations, equipment used and, respective process parameters. Further, key quality aspects of spray-dried protein solids are discussed. Based on the overall trends, we present a concise perspective into the future of protein pharmaceuticals spray-drying.
Objectives
Solid biopharmaceutical products can circumvent lower temperature storage and transport and increase remote access with lower carbon emissions and energy consumption. Saccharides are ...known stabilizers in a solid protein produced via lyophilization and spray drying (SD). Thus, it is essential to understand the interactions between saccharides and proteins and the stabilization mechanism.
Methods
A miniaturized single droplet drying (MD) method was developed to understand how different saccharides stabilize proteins during drying. We applied our MD to different aqueous saccharide-protein systems and transferred our findings to SD.
Results
The poly- and oligosaccharides tend to destabilize the protein during drying. The oligosaccharide, Hydroxypropyl β-cyclodextrin (HPβCD) shows high aggregation at a high saccharide-to-protein molar ratio (S/P ratio) during MD, and the finding is supported by nanoDSF results. The polysaccharide, Dextran (DEX) leads to larger particles, whereas HPBCD leads to smaller particles. Furthermore, DEX is not able to stabilize the protein at higher S/P ratios either. In contrast, the disaccharide Trehalose Dihydrate (TD) does not increase or induce protein aggregation during the drying of the formulation. It can preserve the protein’s secondary structure during drying, already at low concentrations.
Conclusion
During the drying of S/P formulations containing the saccharides TD and DEX, the MD approach could anticipate the in-process (in) stability of protein X at laboratory-scale SD. In contrast, for the systems with HPβCD, the results obtained by SD were contradictory to MD. This underlines that depending on the drying operation, careful consideration needs to be applied to the selection of saccharides and their ratios.
The production of green hydrocarbons in the standard refinery has significant potential to reduce our reliance on oil and shorten the path to sustainability. Second-generation biomass can help to ...achieve this objective yet presents important drawbacks. It is majorly composed of reactive compounds and features low density. These features could be overcome by previously transforming the biomass by ketalization reaction into a bio-crude mainly composed by ketal-sugar derivatives. In this work, a representative compound of the bio-crude class, i.e. 1,2:3,5-di-O-isopropylidene-α-d-xylofuranose (DX) were used in up to 50 wt% mixtures in n-hexane was converted in a laboratory scale fluidized catalytic cracking (FCC) reactor. A commercial and a simplified FCC catalyst were used. Converting a mixture of 30% DX in n-hexane in the presence of a commercial catalyst gave 42.3% aromatics in the liquid product, while pure n-hexane gave merely 8.9%. The use of deactivated catalysts further reduced the coke yield to half of the fresh one. The nature of the coke on the spent catalyst is exclusively composed by carbon and hydrogen, demonstrating that DX is easily deoxygenated. The n-hexane conversion slight reduced in the presence of DX, and did not reduce the stability of the catalyst through micropore blocking. This work demonstrates that adding DX allows to contributes to high gree-aromatic production in FCC and that products distribution is remarkably affected by the type of catalyst used.
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•New approach for personalized manufacturing of unit doses for biologics (<1mg).•Inkjet printing as dispensing method for unit doses.•Drying at ambient temperatures and vacuum drying ...does not induce aggregation.•Polysorbate 80 improves printing – reduction of surface tension and increase in viscosity.•Successful printing of protein solutions.
This study addressed the need for a flexible (personalizable) production of biologics, allowing their stabilization in the solid state and processing of small batch volumes. Therefore, inkjet printing into vials followed by a gentle vacuum drying step at ambient temperature was investigated by screening different formulations with a 22-full factorial design of experiments regarding printability. Human Serum Albumin (HSA) was used as a model protein in a wide range of concentrations (5 to 50 mg/ml), with (10 w/v%) and without the surfactant polysorbate 80 (PS80). PS80 was identified to positively affect the formulations by increasing the Ohnesorge number and stabilizing the printing process. The dispensed volumes with a target dose of 0.5 mg HSA were dried and analyzed concerning their residual moisture (RM) and protein aggregation. All investigated formulations showed an RM < 10 wt% and no significant induced protein aggregation as confirmed by Size Exclusion Chromatography (<2.5%) and Dynamic Light Scattering (Aggregation Index ≤ 2.5). Additionally, long-term printability and the available final dose after reconstitution were investigated for two optimized formulations. A promising formulation providing ∼93% of the targeted dose and a reconstitution time of 30 s was identified.
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