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15 pages, 3795 KB  
Article
Two Drug–Drug Co-Amorphous Systems of Curcumin and Berberine Hydrochloride/Palmatine Hydrochloride with Improved Physicochemical Properties and Multifunctional Activities
by Yanjie Zhang, Quanhu Guo, Ling Liang, Mei Zhang, Rongjian Sa and Benyong Lou
Pharmaceutics 2026, 18(1), 9; https://doi.org/10.3390/pharmaceutics18010009 - 20 Dec 2025
Viewed by 412
Abstract
Background/Objectives: The poor aqueous solubility of curcumin (CUR) limits its pharmaceutical application. Although amorphization can enhance its solubility, the amorphous form often exhibits insufficient physical stability. Co-amorphization, particularly drug–drug co-amorphous (CAM) formation, offers a promising approach to improve solubility, stability, and therapeutic [...] Read more.
Background/Objectives: The poor aqueous solubility of curcumin (CUR) limits its pharmaceutical application. Although amorphization can enhance its solubility, the amorphous form often exhibits insufficient physical stability. Co-amorphization, particularly drug–drug co-amorphous (CAM) formation, offers a promising approach to improve solubility, stability, and therapeutic efficacy. This study aimed to prepare and evaluate two CUR-based CAM systems using isoquinoline alkaloids berberine hydrochloride (BER) and palmatine hydrochloride (PAL) as co-formers to achieve simultaneous stabilization and synergistic bioactivity. Methods: CUR-BER and CUR-PAL CAM systems were prepared via rotary evaporation under vacuum at a 1:1 molar ratio. The solid-state properties were characterized by powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), scanning electron microscope (SEM), and 13C solid-state nuclear magnetic resonance spectroscopy (ssNMR). Dissolution, solubility, and stability studies were conducted, while antioxidant and anticancer activities were assessed by DPPH/ABTS+ radical-scavenging and MTT assays using HT-29 colorectal cancer cells. Results: PXRD and DSC confirmed the formation of single-phase amorphous systems with higher glass transition temperatures, indicating strong intermolecular interactions between CUR and BER/PAL. 13C ssNMR spectroscopy evidenced hydrogen-bond formation between the enolic hydroxyl moiety of CUR and the methoxy oxygen atoms in BER or PAL molecules. Both CAM systems significantly enhanced the solubility and dissolution rate of CUR, with CUR-PAL CAM showing up to a 15.1-fold solubility improvement. The CAM systems also displayed superior thermal stability, photolytic stability, and improved short-term humidity resistance, together with enhanced antioxidant and anticancer activities compared with pure amorphous CUR. Conclusions: Co-amorphization of CUR with isoquinoline alkaloids effectively improved solubility, stability, antioxidant and anticancer activities, representing a promising strategy for the rational design of multifunctional amorphous CUR-based drug formulations. Full article
(This article belongs to the Section Physical Pharmacy and Formulation)
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22 pages, 2446 KB  
Review
Ultrafast Laser-Enabled 3D Glass Microchannel Reactors
by Xiaolong Li, Jinxin Huang, Jian Xu and Ya Cheng
Sensors 2025, 25(23), 7159; https://doi.org/10.3390/s25237159 - 24 Nov 2025
Viewed by 785
Abstract
Microchannel reactors are among the most important tools used for high-performance continuous-flow synthesis. However, most microchannel reactors manufactured with conventional micromachining techniques are limited to two-dimensional (2D) planar geometries, which pose significant challenges for the custom production of three-dimensional (3D) architectures that offer [...] Read more.
Microchannel reactors are among the most important tools used for high-performance continuous-flow synthesis. However, most microchannel reactors manufactured with conventional micromachining techniques are limited to two-dimensional (2D) planar geometries, which pose significant challenges for the custom production of three-dimensional (3D) architectures that offer superior microchemical performance. Using unique nonlinear optical effects of ultrafast lasers, hollow microchannel structures with 3D configurations can be flexibly created within transparent glass materials through either direct removal or subsequent chemical etching methods. This review provides an overview of typical fabrication techniques for 3D glass microchannel reactors based on ultrafast laser microfabrication, as well as their state-of-the-art advancements, including large-scale and high-precision manufacture of all-glass microchannels and the facile integration of online monitoring modules. Moreover, the applications of these fabricated microchannel reactors for various continuous-flow microchemical reactions are introduced. Ultrafast laser-enabled 3D glass microchannel reactors hold great potential for developing innovative and industrial-scale continuous-flow manufacturing processes in chemical engineering and pharmaceutical production. Full article
(This article belongs to the Special Issue Feature Review Papers in Optical Sensors)
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31 pages, 924 KB  
Review
Soilless Growing Media for Cannabis Cultivation
by Matěj Malík and Pavel Tlustoš
Agriculture 2025, 15(18), 1955; https://doi.org/10.3390/agriculture15181955 - 16 Sep 2025
Cited by 1 | Viewed by 4131
Abstract
Standardized pharmaceutical-grade cultivation of Cannabis sativa L. increasingly relies on soilless systems for precision, reproducibility, and regulatory compliance. This review examines the role of inert and semi-inert growing media in indoor cannabis production, focusing on their physical properties, agronomic performance, and sustainability. A [...] Read more.
Standardized pharmaceutical-grade cultivation of Cannabis sativa L. increasingly relies on soilless systems for precision, reproducibility, and regulatory compliance. This review examines the role of inert and semi-inert growing media in indoor cannabis production, focusing on their physical properties, agronomic performance, and sustainability. A systematic literature search was conducted using databases such as Scopus, Web of Science, and Google Scholar, emphasizing peer-reviewed original research, experimental trials, and relevant review articles. Evaluated substrates include rockwool, coconut coir, peat-based blends, perlite, vermiculite, expanded clay, foamed glass, phenolic foam, and biochar. Findings show that substrate selection strongly affects vegetative growth, rooting, and flower yield, while cannabinoid concentrations remain primarily genotype-driven under stable environmental and nutritional conditions. Substrate-specific traits such as aeration, water-holding capacity, and nutrient buffering significantly influence biomass production and resource-use efficiency. Rockwool remains the industry standard due to its uniformity and compatibility with fertigation systems, but renewable alternatives like coconut coir and biochar are gaining traction. This review underscores the importance of substrate selection in cannabis cultivation and identifies research gaps in genotype-specific responses and the development of sustainable growing media. Full article
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37 pages, 5459 KB  
Article
Influence of Drug Properties, Formulation Composition, and Processing Parameters on the Stability and Dissolution Performance of Amorphous Solid Dispersions-Based Tablets
by Ioannis Pantazos, Maria Poimenidou, Dimitrios Kouskouridas, Evangelos Tzaferas, Vasiliki Karava, Christos Cholevas, Afroditi Kapourani and Panagiotis Barmpalexis
Polymers 2025, 17(18), 2484; https://doi.org/10.3390/polym17182484 - 14 Sep 2025
Viewed by 3444
Abstract
Polymeric-based amorphous solid dispersions (ASDs) represent a widely employed strategy for enhancing the oral bioavailability of poorly water-soluble drugs, but their successful implementation in solid dosage forms requires careful optimization of both formulation composition and compaction parameters. In this study, the performance of [...] Read more.
Polymeric-based amorphous solid dispersions (ASDs) represent a widely employed strategy for enhancing the oral bioavailability of poorly water-soluble drugs, but their successful implementation in solid dosage forms requires careful optimization of both formulation composition and compaction parameters. In this study, the performance of polymeric-based ASD tablets were investigated using two model active pharmaceutical ingredients (APIs) with distinct glass-forming abilities (GFAs) and physicochemical characteristics: (1) indomethacin (IND, a good glass former) and (2) carbamazepine (CBZ, a poor glass former). ASDs were prepared at various API-to-polyvinylpyrrolidone (PVP) ratios (10:90, 20:80 and 40:60 w/w) and incorporated into round-shaped tablets at different ASD loadings (20% and 50% w/w). The impact of compaction pressure and dwell time on the mechanical properties, disintegration, and supersaturation performance was assessed, both immediately after preparation and following three months of storage at 25 °C and 60% relative humidity. Solid-state analysis confirmed the amorphous state of the APIs and revealed the development of API–polymer molecular interactions. Supersaturation studies under non-sink conditions demonstrated that dissolution behavior was strongly influenced by drug loading, polymer content, and compaction conditions, with CBZ formulations exhibiting faster release but greater susceptibility to performance loss during storage. The comparative evaluation of IND and CBZ highlights the critical role of API properties in determining the physical stability and dissolution performance of ASD tablets, underscoring the need for API-specific design strategies in ASD-based formulation development. Full article
(This article belongs to the Special Issue Polymers and Their Role in Drug Delivery, 2nd Edition)
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20 pages, 1239 KB  
Article
Monitoring Visual Fatigue with Eye Tracking in a Pharmaceutical Packing Area
by Carlos Albarrán Morillo, John F. Suárez-Pérez, Micaela Demichela, Mónica Andrea Camargo Salinas and Nasli Yuceti Miranda Arandia
Sensors 2025, 25(18), 5702; https://doi.org/10.3390/s25185702 - 12 Sep 2025
Viewed by 2787
Abstract
This study investigates visual fatigue in a real-world pharmaceutical packaging environment, where operators perform repetitive inspection and packing tasks under frequently suboptimal lighting conditions. A human-centered methodology was adopted, combining adapted self-report questionnaires, high-frequency eye-tracking data collected with Tobii Pro Glasses 3, and [...] Read more.
This study investigates visual fatigue in a real-world pharmaceutical packaging environment, where operators perform repetitive inspection and packing tasks under frequently suboptimal lighting conditions. A human-centered methodology was adopted, combining adapted self-report questionnaires, high-frequency eye-tracking data collected with Tobii Pro Glasses 3, and lux-level measurements. Key eye-movement metrics—including fixation duration, visit patterns, and pupil diameter—were analyzed within defined work zones (Areas of Interest). To reduce data complexity and uncover latent patterns of visual behavior, Principal Component Analysis was applied. Results revealed a progressive increase in visual fatigue across the workweek and throughout shifts, particularly during night work, and showed a strong association with inadequate lighting. Tasks involving high physical workload under poor illumination emerged as critical risk scenarios. This integrated approach not only confirmed the presence of visual fatigue but also identified high-risk conditions in the workflow, enabling targeted ergonomic interventions. The findings provide a practical framework for improving operator well-being and inspection performance through sensor-based monitoring and environment-specific design enhancements, in alignment with the goals of Industry 5.0. Full article
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12 pages, 1618 KB  
Article
Fast Quantification of Lithium Concentration in Non-Compliant Materials Using Laser-Induced Breakdown Spectroscopy
by Simona Raneri, Vincenzo Palleschi, Francesco Poggialini, Beatrice Campanella, Giulia Lorenzetti, Pilario Costagliola, Valentina Rimondi, Guia Morelli and Stefano Legnaioli
Appl. Sci. 2025, 15(17), 9583; https://doi.org/10.3390/app15179583 - 30 Aug 2025
Cited by 1 | Viewed by 857
Abstract
Although approximately half of global lithium consumption is used in the rechargeable battery industry, lithium is also in demand for other specialized applications, such as high-temperature lubricants, ceramics, glass, and pharmaceuticals. The growing need for efficient lithium recovery and recycling underscores the importance [...] Read more.
Although approximately half of global lithium consumption is used in the rechargeable battery industry, lithium is also in demand for other specialized applications, such as high-temperature lubricants, ceramics, glass, and pharmaceuticals. The growing need for efficient lithium recovery and recycling underscores the importance of fast and accurate analytical tools for determining lithium concentrations in non-compliant and waste materials generated by industrial processes. In this paper, we present a machine learning-based procedure utilizing Laser-Induced Breakdown Spectroscopy (LIBS) to accurately quantify lithium concentrations in lithium-rich non-compliant materials derived from the industrial production of enamels used for coating metallic surfaces. This procedure addresses challenges such as strong self-absorption and matrix effects, which limit the effectiveness of conventional univariate calibration methods. By employing a multivariate approach, we developed a single model capable of quantifying lithium content across a wide concentration range. A comparison of the LIBS results with those obtained using conventional laboratory analysis (Inductively Coupled Plasma–Optical Emission Spectrometry, ICP-OES) confirms that LIBS can deliver the speed, precision, and reliability required for potential routine applications in the lithium recovery and recycling industry. Full article
(This article belongs to the Section Chemical and Molecular Sciences)
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18 pages, 2901 KB  
Article
Characterization of Different Copovidone Grades as Carrier Materials in Hot Melt Extrusion of Amorphous Solid Dispersions
by Marvin Daalmann, Vincent Kimmel, Christian Muehlenfeld, Markus Thommes and Judith Winck
Pharmaceutics 2025, 17(9), 1138; https://doi.org/10.3390/pharmaceutics17091138 - 30 Aug 2025
Viewed by 1227
Abstract
Background/Objectives: Copovidone (polyvinylpyrrolidone-vinyl acetate copolymer, PVP/VA) is a widely used pharmaceutical excipient with various applications in drug formulation. In hot melt extrusion (HME), PVP/VA is an approved carrier material for the production of amorphous solid dispersions (ASDs) by embedding drugs on a molecular [...] Read more.
Background/Objectives: Copovidone (polyvinylpyrrolidone-vinyl acetate copolymer, PVP/VA) is a widely used pharmaceutical excipient with various applications in drug formulation. In hot melt extrusion (HME), PVP/VA is an approved carrier material for the production of amorphous solid dispersions (ASDs) by embedding drugs on a molecular level. This study investigates the properties and processability of two copovidone grades—Plasdone™ S-630 (PS-630) and the novel Plasdone™ S-630 Ultra (PS-630U)—to assess their suitability as ASD carrier materials. Methods: The thermal and physicochemical characteristics of both polymers were evaluated, focusing on glass transition temperature and polymer melt rheology. The process performance in HME was investigated on small-scale as well as in production-scale extrusion. The two model drugs itraconazole and griseofulvin were used to examine drug dissolution and degradation during HME via in-line UV-vis spectroscopy. Results: When comparing both polymers, PS-630U offers various advantages due to the improved powder feeding behavior and reduced yellowing of extruded products while maintaining similar melt properties and drug compatibility compared to PS-630. Conclusions: These findings support the use of PS-630U as an optimized copovidone grade for ASD manufacturing, facilitating improved processing characteristics and best product qualities without the requirement of significant formulation adjustments. Full article
(This article belongs to the Section Physical Pharmacy and Formulation)
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22 pages, 1375 KB  
Review
Polymorphic Transformations of Pharmaceutical Materials Induced by Mechanical Milling: A Review
by Mathieu Guerain and Jean-François Willart
Pharmaceutics 2025, 17(7), 946; https://doi.org/10.3390/pharmaceutics17070946 - 21 Jul 2025
Cited by 4 | Viewed by 1262
Abstract
A review of the literature on polymorphic transformations by milling on pharmaceutical materials was carried out. The available information on 18 pharmaceutical materials was compiled. In particular, when data are available, the starting and final crystalline forms, their enantiotropic or monotropic relationship, the [...] Read more.
A review of the literature on polymorphic transformations by milling on pharmaceutical materials was carried out. The available information on 18 pharmaceutical materials was compiled. In particular, when data are available, the starting and final crystalline forms, their enantiotropic or monotropic relationship, the glass transition temperature of the compound and its melting temperature, the experimental observation of a transient or partial amorphization of compounds, and the transformation kinetics make it possible to suggest a two-step transformation mechanism. First, an amorphization occurs under milling of the starting polymorphic form. Secondly, a recrystallization of the amorphous form occurs towards the final form. The observed transformation kinetics are due to the fact that the recrystallization of the amorphous material towards the final form depends on the accidental formation of a cluster of this form during milling. Moreover, the observation of the transient amorphous form depends on the relative position of the glass transition temperature of the material with respect to the milling temperature. This mechanism seems to be independent of the enantiotropic or monotropic character of the polymorphic forms involved in the transformation. Full article
(This article belongs to the Collection Feature Papers in Pharmaceutical Technology)
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21 pages, 1014 KB  
Review
Pharmaceutical Packaging Materials and Medication Safety: A Mini-Review
by Yaokang Lv, Nianyu Liu, Chao Chen, Zhiwei Cai and Jianhang Li
Safety 2025, 11(3), 69; https://doi.org/10.3390/safety11030069 - 18 Jul 2025
Cited by 2 | Viewed by 10896
Abstract
Pharmaceutical packaging materials play a crucial role in ensuring the safety and efficacy of medications. This mini-review examines the properties of common packaging materials (glass, plastics, metals, and rubber) and their implications for drug safety. By analyzing 127 research articles from PubMed, Web [...] Read more.
Pharmaceutical packaging materials play a crucial role in ensuring the safety and efficacy of medications. This mini-review examines the properties of common packaging materials (glass, plastics, metals, and rubber) and their implications for drug safety. By analyzing 127 research articles from PubMed, Web of Science, and CNKI databases (2000–2025), we also discuss recent regulatory updates in China and highlight emerging technologies, including nanomaterials, sustainable packaging solutions, and intelligent packaging systems that present new opportunities for the pharmaceutical industry. Key findings include the following: (1) The physicochemical properties of packaging materials and potential microbial contamination risks during production significantly impact drug quality and safety, underscoring the need for enhanced research and regulatory oversight. (2) Each material exhibits distinct advantages and limitations: glass demonstrates superior chemical stability but may leach ions; plastics offer versatility but risk plasticizer migration; metals provide exceptional strength yet have limited applications; rubber ensures effective sealing but may release additives compromising drug quality. (3) The pharmaceutical packaging sector is evolving toward intelligent systems and sustainable solutions to address contemporary healthcare challenges. This review can aid pharmaceutical companies in selecting drug packaging and guide manufacturers in developing innovative packaging solutions. Full article
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25 pages, 7095 KB  
Article
Kinetics of Phase Transitions in Amorphous Carbamazepine: From Sub-Tg Structural Relaxation to High-Temperature Decomposition
by Roman Svoboda and Adéla Pospíšilová
Int. J. Mol. Sci. 2025, 26(13), 6136; https://doi.org/10.3390/ijms26136136 - 26 Jun 2025
Cited by 1 | Viewed by 861
Abstract
Thermokinetic characterization of amorphous carbamazepine was performed utilizing non-isothermal differential scanning calorimetry (DSC) and thermogravimetry (TGA). Structural relaxation of the amorphous matrix was described in terms of the Tool–Narayanaswamy–Moynihan model with the following parameters: Δh* ≈ 200–300 kJ·mol−1, β = [...] Read more.
Thermokinetic characterization of amorphous carbamazepine was performed utilizing non-isothermal differential scanning calorimetry (DSC) and thermogravimetry (TGA). Structural relaxation of the amorphous matrix was described in terms of the Tool–Narayanaswamy–Moynihan model with the following parameters: Δh* ≈ 200–300 kJ·mol−1, β = 0.57, x = 0.44. The crystallization of the amorphous phase was modeled using complex Šesták–Berggren kinetics, which incorporates temperature-dependent activation energy and degree of autocatalysis. The activation energy of the crystal growth was determined to be >320 kJ·mol−1 at the glass transition temperature (Tg). Owing to such a high value, the amorphous carbamazepine is stable at Tg, allowing for extensive processing of the amorphous phase (e.g., self-healing of the quench-induced mechanical defects or internal stress). A discussion was conducted regarding the converse relation between the activation energies of relaxation and crystal growth, which is possibly responsible for the absence of sub-Tg crystal growth modes. The high-temperature thermal decomposition of carbamazepine proceeds via multistep kinetics, identically in both an inert and an oxidizing atmosphere. A complex reaction mechanism, consisting of a series of consecutive and competing reactions, was proposed to explain the second decomposition step, which exhibited a temporary mass increase. Whereas a negligible degree of carbamazepine degradation was predicted for the temperature characteristic of the pharmaceutical hot-melt extrusion (~150 °C), the degradation risk during the pharmaceutical 3D printing was calculated to be considerably higher (1–2% mass loss at temperatures 190–200 °C). Full article
(This article belongs to the Section Physical Chemistry and Chemical Physics)
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15 pages, 3887 KB  
Article
Cold Consolidation of Waste Glass by Alkali Activation and Curing by Traditional and Microwave Heating
by Francesco Carollo, Emanuele De Rienzo, Antonio D’Angelo, Paolo Sgarbossa, Luisa Barbieri, Cristina Leonelli, Isabella Lancellotti, Michelina Catauro and Enrico Bernardo
Materials 2025, 18(11), 2628; https://doi.org/10.3390/ma18112628 - 4 Jun 2025
Cited by 3 | Viewed by 1361
Abstract
Despite efforts to recycle, boro-alumino-silicate pharmaceutical glass (BASG) results in a significant portion of glass cullet currently landfilled. Highly contaminated fractions of BASG cullet are largely unemployed because of the presence of metals in their composition that prevents recycling. This waste glass can [...] Read more.
Despite efforts to recycle, boro-alumino-silicate pharmaceutical glass (BASG) results in a significant portion of glass cullet currently landfilled. Highly contaminated fractions of BASG cullet are largely unemployed because of the presence of metals in their composition that prevents recycling. This waste glass can be eligible to produce sustainable alkali-activated materials (AAMs) reducing at the same time consumption of raw materials and CO2 emissions. The ‘weak’ alkaline attack (NaOH < 3 M) determines the gelation of glass suspensions. Condensation reactions occur in hydrated surface layers, leading to strong bonds (Si-O-Si, Al-O-Si, etc.) between individual glass particles. Alkali are mostly expelled from the gel due to the formation of water-soluble hydrated carbonates. Microwave treatment has been implemented on samples after precuring at 40 °C, saving time and energy and achieving better mechanical properties. To improve the stability and reduce the release of glass components into solution, the consolidated monoliths were subjected to boiling/drying cycles. The chemical stability, cytotoxicity and antibacterial behavior of the final products have been investigated with the purpose of obtaining new competitive and sustainable materials. For further stabilization and for finding new applications, the activated and boiled samples can be fired at low temperature (700 °C) to obtain, respectively, a homogeneous foam or a compact material with glass-like density and microstructure. Full article
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18 pages, 1196 KB  
Article
Diazepam Photocatalytic Degradation in Laboratory- vs. Pilot-Scale Systems: Differences in Degradation Products and Reaction Kinetics
by Kristina Tolić Čop, Mia Gotovuša, Dragana Mutavdžić Pavlović, Dario Dabić and Ivana Grčić
Nanomaterials 2025, 15(11), 827; https://doi.org/10.3390/nano15110827 - 29 May 2025
Cited by 1 | Viewed by 1350
Abstract
Industrial growth led to the expansion of existing environmental problems, where different kinds of pollutants can enter the environment by many known routes, particularly through wastewater. Among other contaminants, pharmaceuticals, such as diazepam, once released, pose a significant challenge related to their removal [...] Read more.
Industrial growth led to the expansion of existing environmental problems, where different kinds of pollutants can enter the environment by many known routes, particularly through wastewater. Among other contaminants, pharmaceuticals, such as diazepam, once released, pose a significant challenge related to their removal from complex environmental matrices due to their persistence and potential toxicity. For this reason, it is a great challenge to find suitable methods for the treatment of wastewater. The aim of this paper was to investigate the stability of diazepam, subjecting it to various degradation processes (hydrolysis and photolysis), focusing on photocatalysis, an advanced oxidation process commonly used for the purification of industrial wastewater. The photocatalytic system consisted of UV-A and simulated solar irradiation with titanium dioxide (TiO2) immobilized on a glass mesh as a photocatalyst, with an additional reaction performed in the presence of an oxidizing agent, i.e., hydrogen peroxide, to improve diazepam removal from water matrices. The kinetic rate of diazepam degradation was monitored with a high-performance liquid chromatograph coupled with a photodiode array detector (HPLC-PDA). The target compound was characterized as a hydrolytically and photolytically stable compound with t1/2 = 25 h. The presence of an immobilized TiO2 catalyst contributed significantly to the degradation of diazepam under the influence of UV-A and simulated solar radiation, with t1/2 in the range of 1.61–2.56 h. Five degradation products of diazepam were identified at the laboratory scale by MS analysis (m/z = 267, m/z = 273, m/z = 301, m/z = 271, and m/z = 303), while the toxicity assessment revealed that diazepam exhibited developmental toxicity and a low bioaccumulation factor. The pilot-scale process resulted in significant improvements in diazepam degradation with the fastest degradation kinetics (0.6888 h−1). These results obtained at the pilot scale highlight the potential for industrial-scale implementation, offering a promising and innovative solution for pharmaceutical removal from wastewater. Full article
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22 pages, 2478 KB  
Article
Optimized Spirulina Fermentation with Lacticaseibacillus rhamnosus: Bioactive Properties and Pilot-Scale Validation
by Akif Emre Kavak, Didem Balkanlı, Osman Sagdıc, Akın Özdemir and Enes Dertli
Fermentation 2025, 11(5), 248; https://doi.org/10.3390/fermentation11050248 - 1 May 2025
Cited by 1 | Viewed by 2571
Abstract
Sustainable bio-based products derived from fermentation are gaining increasing interest. The present study was designed to determine the interaction of Lacticaseibacillus rhamnosus 23.2 bacteria with spirulina in a 3 L glass bioreactor and the effect of aeration and agitation speed on the final [...] Read more.
Sustainable bio-based products derived from fermentation are gaining increasing interest. The present study was designed to determine the interaction of Lacticaseibacillus rhamnosus 23.2 bacteria with spirulina in a 3 L glass bioreactor and the effect of aeration and agitation speed on the final product biomass and antioxidant capacity. The fermentation medium contained only glucose, an inorganic salt mixture, and spirulina powder. The estimated biomass and antioxidant activity were found to be 3.74 g/L and 84.72%, respectively, from the results of the optimization model. Scale-up was performed with the obtained optimization data, and three pilot-scale fermentations were carried out in a 30 L stainless steel bioreactor. As a result of pilot production, the obtained bioactive products were freeze-dried, and their antibacterial, antioxidant, total phenolic properties, and cytotoxic activity were investigated. The pilot production results showed that the increase in bacterial cell number was around 3–4 log after 24 h of fermentation. An inhibitory effect against pathogenic bacteria was observed. A strong radical scavenging effect was found in antioxidant analyses. Total phenolic substance content was 26.5 mg gallic acid equivalent (GAE) g−1, which was the highest level in this study. Cytotoxic activity showed that bioactive products had a cytotoxic effect against Caco-2 adenocarcinoma cells. This study emphasizes the potential of Arthrospira platensis biomass as a substrate for the production of lactic acid bacteria (LAB)-based bioproducts. It is thought that the results obtained from this study may position potential innovative strategies in the food, pharmaceutical, agriculture, and cosmetic industries. Full article
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13 pages, 1428 KB  
Review
Scientifically Supported Best Practices in Leachable Screening Studies for Pharmaceutical and Parenteral Drug Products
by Arvind Singh Gusain, Subhash Chandra, Isaac Moura Araújo, João Paulo Martins de Lima and Henrique Douglas Melo Coutinho
Future Pharmacol. 2025, 5(2), 18; https://doi.org/10.3390/futurepharmacol5020018 - 12 Apr 2025
Cited by 2 | Viewed by 4085
Abstract
Purpose: Pharmaceutical parenteral drug products (PDPs) and orally inhaled nasal drug products (OINDPs) are critical medications for patient care, for which the route of administration is intravenous or oral/nasal inhalation, and the drug products directly infuse into the bloodstream or lungs, but they [...] Read more.
Purpose: Pharmaceutical parenteral drug products (PDPs) and orally inhaled nasal drug products (OINDPs) are critical medications for patient care, for which the route of administration is intravenous or oral/nasal inhalation, and the drug products directly infuse into the bloodstream or lungs, but they are categorized as high-risk for leachables. Method: These external foreign chemical substances (leachables) may adversely affect and alter patient safety. Results: These primary container closure systems and manufacturing process equipment mainly comprise rubber elastomers, polypropylene, resin, ink, adhesives, glass, or plastic material. To establish the ID of detected compounds and their quantity in the finished parenteral drug formulation and then to assess the formulation for toxicological safety, broad-scope non-specific analytical screening methods are required that are capable of screening out and quantifying the predicted/unpredicted leachable compounds at the levels that pose anticipated toxicological concerns for human patients. Before the selection of the final primary packaging system for the parenteral drug product, their extractable screening profile/knowledge is required to minimize leachable compounds in the finished drug product formulation and to develop and manufacture a safe product for human patients. The adverse effect or toxicity of leachables proportionally increases with an increase in the dose of the drug product or the duration of therapy because the volume of the drug product administered to a patient in a larger quantity is directly proportional to the concentration of the detected leachable. Conclusion: This document outlines the detailed process/scientific approach for conducting an organic leachable screening profile for parenteral drug products with respect to the chemical nature of leachables, i.e., polarity, propensity, volatility, and techniques. Full article
(This article belongs to the Special Issue Feature Papers in Future Pharmacology 2025)
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17 pages, 2770 KB  
Article
Analysis of Pharmaceutical Active Compounds in Complex Water Samples: Sample Filtration as an Option
by Sofia Silva, João Rodrigues, Vitor V. Cardoso, Rui N. Carneiro and Cristina M. M. Almeida
Molecules 2025, 30(7), 1609; https://doi.org/10.3390/molecules30071609 - 3 Apr 2025
Viewed by 1366
Abstract
Sample pretreatment is one of the most important steps in guaranteeing the success of a chromatographic analysis. The selected methodology must ensure simultaneously that a sample is “clean” enough for analysis and that the target analytes are not removed in the process. This [...] Read more.
Sample pretreatment is one of the most important steps in guaranteeing the success of a chromatographic analysis. The selected methodology must ensure simultaneously that a sample is “clean” enough for analysis and that the target analytes are not removed in the process. This can be especially difficult when working with complex matrices such as natural waters and wastewater. For pharmaceutical active compounds (PhACs) analysis by solid-phase extraction (SPE) followed by ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS), and due to the high level of organic matter in wastewater, the water samples are filtered consecutively through three filters, a paper filter, a glass microfiber filter of 1 µm, and a Nylon filter of 0.45 µm. This filtration allows the sample’s passage through the SPE cartridge to be faster, and there is no cartridge clogging, allowing for greater efficiency in the adsorption process. The big question is whether the PhACs are eliminated during filtration, since they may be adsorbed to organic matter. This work aimed to determine if the best approach for quantifying PhACs in wastewater and surface waters would be to filter them prior or to perform SPE directly. Both approaches analyzed a total of 26 PhACs. Turbidity (TUR) and permanganate index (PI) were determined, and their values were high for samples with a high organic matter content. A statistical analysis was performed to determine the best approach to treat these water samples and whether any correlation existed between PhAC concentrations, PI, and TUR. The PhAC quantification shows a positive correlation with TUR and a negative correlation with PI for most of the target PhACs. However, there are not significantly different results for filtered and not-filtered wastewater samples. Full article
(This article belongs to the Special Issue Exclusive Feature Papers in Analytical Chemistry)
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