European Journal of Pharmaceutical Sciences最新文献

{"title":"Development and optimization of an LED-based particle image velocimetry methodology for dynamic powder flowability in pharmaceutical manufacturing.","authors":"Sang Min Lee, Ji Yeon Kim, Du Hyung Choi","doi":"10.1016/j.ejps.2026.107543","DOIUrl":"https://doi.org/10.1016/j.ejps.2026.107543","url":null,"abstract":"<p><p>Conventional static flowability tests lack the sensitivity to capture process-relevant powder dynamics. This study developed and optimized an LED-based particle image velocimetry (PIV) system for real-time, non-invasive characterization of powder dynamic flowability during blending. Three PIV parameters, illumination intensity, CLAHE window size, and interrogation window size, were systematically optimized; optimal conditions (65,125 lx; 16 px CLAHE; 32 px) yielded reproducible velocity vector fields. The system was applied to six excipients: three MCC grades (Avicel® PH-102, PH-112, PROSOLV® SMCC 50) and three lactose-based powders (Cellactose® 80, Tablettose® 80, MicroceLac® 100), with complementary FT4 powder rheometer measurements. Multi-parametric analysis encompassing velocity magnitude, vorticity, shear strain rate, stretching deformation rate, and correlation coefficient across spatially defined regions of interest revealed powder-specific flow dynamics. Among MCC grades, PROSOLV® SMCC 50 showed the highest velocity (0.99 px/frame), while Avicel® PH-102 and PH-112 were comparable (0.32 px/frame each) yet differed 6-9-fold in blade-region vorticity and shear strain rate, representing mechanistic differences not discernible by static Carr's index. Among lactose-based powders sharing similar static classifications, PIV revealed distinct velocity profiles: MicroceLac® 100 (0.78), Cellactose® 80 (0.71), and Tablettose® 80 (0.51 px/frame). FT4 cohesion and unconfined yield strength inversely correlated with PIV velocity (r = -0.97), corroborating the PIV-derived flowability rankings, whereas basic flowability energy did not predict blending performance, confirming that confined-condition metrics do not capture process-relevant dynamics. These results establish LED-based PIV as a practical, multi-dimensional flowability characterization tool, complementary to powder rheometry, with direct relevance to excipient selection and process design in pharmaceutical manufacturing.</p>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":" ","pages":"107543"},"PeriodicalIF":4.7,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of a semi-automated hybrid immunocapture liquid chromatography-mass spectrometry method to quantify LALA-mutated biotherapeutics in mouse plasma.","authors":"Vittoria Papa, Ilse De Salve, Francesco Molinaro, Andrea Di Ianni, Stefania Monge, Rita Mastroianni, Alessandra Ariaudo, Patrizia Tavano, Valeria Castagna, Kyra Cowan, Federico Riccardi Sirtori","doi":"10.1016/j.ejps.2026.107540","DOIUrl":"https://doi.org/10.1016/j.ejps.2026.107540","url":null,"abstract":"<p><p>Biotherapeutic antibodies are increasingly being developed and, various strategies have recently been used to maximize their potential therapeutic efficacy. The crystallizable fragment (Fc) region of therapeutic monoclonal antibodies (mAbs) is often engineered to tailor their effector functions and pharmacokinetic (PK) properties by introducing point mutations. Notably, most of these mutations are in the hinge and constant domains of the heavy chain, which may silence antibody effector functions. Several liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods have been published to quantify biotherapeutics with a canonical human Fc portion. This work presents a rapid and sensitive hybrid immunocapture liquid chromatography-tandem mass spectrometry (IC-LC-MS/MS) method for quantifying total antibody concentration, specifically targeting the LALA-mutated peptide (L234A/L235A). The sample preparation process, which includes immunocapture, as well as trypsin and Glu-C digestion, is efficiently completed within two days through automation. The developed method was validated according to the ICH M10 guideline and white papers recommendation, focusing on the following parameters - accuracy, precision, dilution linearity, selectivity, stability, recovery- and using a humanized IgG1 LALA-mutated antibody, teplizumab, as analytical standard. The method demonstrated linearity for total antibody detection in mouse plasma samples, with a dynamic range from 150 ng/mL (lower limit of quantification, LLOQ) to 15,000 ng/mL (upper limit of quantitation, ULOQ). All validation parameters tested in mouse plasma met the predefined acceptance criteria, demonstrating the method's reliability and robustness. Additionally, the qualified method was successfully used to characterize the pharmacokinetic profile in mice of an antibody-drug conjugate (ADC-1) containing the LALA mutation in its Fc region. This work provides a valuable foundation for the quantification of new biological entities (NBEs) and antibody-drug conjugates (ADCs) in pharmaceutical development, as it enables the measurement of engineered Fc biotherapeutics using a unique and highly selective peptide, irrespective of the type of biological matrix and even in the presence of other biomolecules of similar IgG isotype.</p>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":" ","pages":"107540"},"PeriodicalIF":4.7,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147812669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel indole-based derivatives as promising NLRP3 Inflammasome Inhibitors: Design, Synthesis, Biological Evaluation, and In Silico Studies.","authors":"Simona Di Martino, Maria Rita Giuffrè, Giovanna Li Petri, Maria Rita Gulotta, Chiara Zichittella, Elvira Passalacqua, Giuseppe Barberi, Pietro Amico, Marco Buscetta, Claudia Coronnello, Ugo Perricone, Chiara Cipollina, Maria De Rosa","doi":"10.1016/j.ejps.2026.107533","DOIUrl":"https://doi.org/10.1016/j.ejps.2026.107533","url":null,"abstract":"<p><p>Seeking to identify a new chemotype for the development of NLRP3 inhibitors, inspired by the structure of the tool compound MCC950 (9), we designed and synthesized new derivatives by choosing the indole heterocycle as spacer between the furanyl moiety and the chemically handy sulfonamide chain core. Four compounds (19c, 19e, 19g, and 19j) selectively reduced NLRP3-dependent IL-1β levels with micromolar inhibitory activity in THP-1 cells, and were safe at the same concentrations. Moreover, they inhibited lactate dehydrogenase release, caspase-1 enzymatic activity, and ASC speck formation with a dose-response effect. Indoles 19c and 19g confirmed their biological activity in primary human macrophages, with IC₅₀ of 19 and 15 µM, respectively. Furthermore, no off-target effects were observed as the compounds did not inhibit LPS-induced TNF release. In silico studies helped us rationalize the binding mode and showed that these derivatives can accommodate the NACHT domain and make several interactions with crucial key residues of the protein. Remarkably, the target engagement assay displayed that 19c and 19g can displace MCC950, thus confirming their direct binding to the NACHT domain. These preliminary results suggest the potential for future development of this new class of indoles as NLRP3 inhibitors.</p>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":" ","pages":"107533"},"PeriodicalIF":4.7,"publicationDate":"2026-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147728673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to \"Optimization and aerodynamic performance of nebulizable pirfenidone-loaded human serum albumin nanoparticles for targeted pulmonary delivery\" [European Journal of Pharmaceutical Sciences 220 (2026) 107477].","authors":"Jia-Yu Liu, I-Ling Chen, Meng-Hsuan Cheng, Chu-Chun Chien, Chih-Kuang Chen, Zheng-Ian Lin, Shiou-Lan Chen, Yi-Ping Fang","doi":"10.1016/j.ejps.2026.107522","DOIUrl":"https://doi.org/10.1016/j.ejps.2026.107522","url":null,"abstract":"","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":" ","pages":"107522"},"PeriodicalIF":4.7,"publicationDate":"2026-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147671601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Holistic evaluation of particle formation induced by physical stress in liquid peptide solutions","authors":"Patrick Schlossbauer ,&nbsp;Stefanie Schopf ,&nbsp;Katrin Lindner,&nbsp;Anna Müller,&nbsp;Ingo Presser,&nbsp;Maximilian Wittmann","doi":"10.1016/j.ejps.2026.107455","DOIUrl":"10.1016/j.ejps.2026.107455","url":null,"abstract":"<div><div>Insufficient physical stability remains a major challenge regarding the development of liquid therapeutics as aggregation and degradation of the drug substance can lead to patient safety concerns through increased immunogenicity or reduced potency. During its lifetime, a drug product (DP) containing for example a therapeutically active peptide can be exposed to various types of physical stress. Here, several methods to induce diverse forms of physical stress on liquid solutions were developed using a buffer solution and implemented by testing different therapeutically active peptides in a tool formulation. Methods to investigate the influence of stress induction during stirring, different kinds of shaking, pumping, and freezing and thawing of the peptide solutions were investigated. The establishment with buffer solution allowed fine-tuning of the parameters to not damage materials like glass vials and tubing themselves. Repeated peristaltic pumping at 110 rpm for 2 h led to time-dependent formation of subvisible particles (SVPs) in each peptide-containing sample. More peptide-specific results were achieved with stirring experiments at 600 rpm over three days. Shaking in glass vials on an orbital shaker at 420 rpm for 10 days did in most cases not introduce enough stress to trigger any response. When switching to a shaking motion induced by a microplate shaker at 1200 rpm, the distinguishability of samples could be increased over the same period due to increased interfacial stress. Freezing and thawing in glass vials at - 50°C led to the formation of SVPs already in peptide-free solutions, possibly due to glass delamination. Subsequent evaluation of visual appearance, absorbance at 620 nm, peptide concentration and covalently bound multimers revealed further insights into stress-induced particle formation of peptide drugs in solution.</div></div>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":"219 ","pages":"Article 107455"},"PeriodicalIF":4.7,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146097004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Targeting neuroinflammation in Parkinson's disease: Immunomodulatory effects of a hyaluronic acid-based nanoreinforced hydrogel loaded with GDNF and mesenchymal stem cells","authors":"Rubén del Campo-Montoya ,&nbsp;Xavier Mulet i Piera ,&nbsp;Silvia Romero-Murillo ,&nbsp;Enrique Santamaría ,&nbsp;Elisa Garbayo ,&nbsp;María J. Blanco-Prieto","doi":"10.1016/j.ejps.2025.107368","DOIUrl":"10.1016/j.ejps.2025.107368","url":null,"abstract":"<div><div>Like other neurodegenerative disorders, Parkinson's disease is marked by widespread neuroinflammation, which may contribute to its etiology and is a key component of its progression. Consequently, anti-inflammatory strategies, which can incorporate regenerative and cell therapy components, are promising therapeutic candidates for the management of the disease. To this end, we have developed a supramolecular hydrogel (HG) based on modified hyaluronic acid that combines nanoencapsulated GDNF (NPs GDNF), a potent neurotrophic factor with a less well-studied anti-inflammatory potential, and mesenchymal stem cells (MSCs). We have evaluated the anti-inflammatory effect of the HG by quantifying the NO produced by a murine microglia cell line against LPS. In addition, we have corroborated these functional results by transcriptomic analyses, where we have also been able to delve deeper into the mechanisms by which the HG exerts this anti-inflammatory effect. We have observed that both HG components (GDNF and MSCs) and the combination of all of them (HG-NPs GDNF-MSCs) are able to decrease NO production in microglia insulted with LPS. Furthermore, we have been able to corroborate these results at the transcriptional level, where HG was able to decrease most of the pathways commonly associated with inflammation, such as interferon regulators or the interleukins IL-1 or TNF-α. In conclusion, the developed HG was able to reduce inflammation in a murine microglial cell line, both transcriptionally, with the suppression of pro-inflammatory pathways, and functionally, with a reduction in nitric oxide production.</div></div>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":"219 ","pages":"Article 107368"},"PeriodicalIF":4.7,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145476936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ROS-responsive diselenide exosomes restore mitophagy to resolve sterile inflammation in liver IRI","authors":"Tao Zhou ,&nbsp;Zhiwei Jiang ,&nbsp;Qingluan Hu ,&nbsp;Siqi Qiu ,&nbsp;Junda Gao ,&nbsp;Jianjun Zhang ,&nbsp;Feng Xue ,&nbsp;Lin Lu ,&nbsp;Ling Chang","doi":"10.1016/j.ejps.2026.107457","DOIUrl":"10.1016/j.ejps.2026.107457","url":null,"abstract":"<div><div>Liver ischemia–reperfusion injury (IRI) drives graft dysfunction and postsurgical morbidity. We show that hepatocellular MST1 is markedly upregulated in IRI and exacerbates damage by blocking PINK1-dependent mitophagy. Defective mitochondrial clearance causes mtDNA leakage, which activates macrophage cGAS–STING signaling and fuels inflammatory injury. Curcumin inhibits this MST1–PINK1 axis, restoring mitophagy and limiting mtDNA release. To translate these insights, we engineered Curcumin@EV@Se—stem-cell–derived extracellular vesicles surface-modified with diselenide-PEG for ROS-responsive, “stealth” delivery. In oxygen–glucose deprivation/reoxygenation models, Curcumin@EV@Se improved hepatocyte viability, preserved mitochondrial potential, reduced ROS and inflammatory cytokines, and promoted reparative/angiogenic programs. In a murine hepatic IRI model, systemic Curcumin@EV@Se decreased necrosis and TUNEL positivity and improved serum transaminases and histology, indicating enhanced liver function and regeneration. These data identify MST1-mediated mitophagy blockade with secondary cGAS–STING activation as a central pathogenic axis in IRI and present Curcumin@EV@Se as a mechanism-guided therapy that restores mitochondrial quality control and dampens innate immune activation, with translational promise for liver transplantation and acute hepatic injury.</div></div>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":"219 ","pages":"Article 107457"},"PeriodicalIF":4.7,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146118256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identification of pyrrolo[2,3-d]pyrimidine-based dual MERTK and FLT3 inhibitor: Hit-to-lead, machine learning, modeling, synthesis, and biological evaluation","authors":"Abdellah Yamani ,&nbsp;Paweł Maliszewski ,&nbsp;Natalia Piórkowska ,&nbsp;Patrycja Olejkowska-Podgórska ,&nbsp;Wojciech Pietruś ,&nbsp;Mario Luigi Naitana ,&nbsp;Agata Mitkowska ,&nbsp;Artur Łaszek ,&nbsp;Delfina Popiel ,&nbsp;Agata Mikołajczyk ,&nbsp;Tomasz Kornatowski ,&nbsp;Kinga Jastrzębska ,&nbsp;Filip Mituła ,&nbsp;Jakub Dominowski ,&nbsp;Artur Janusz ,&nbsp;Michał Górka ,&nbsp;Joanna Hucz-Kalitowska ,&nbsp;Małgorzata Teska-Kamińska ,&nbsp;Aleksandra Stańczak ,&nbsp;Monika Delis ,&nbsp;Maciej Wieczorek","doi":"10.1016/j.ejps.2025.107421","DOIUrl":"10.1016/j.ejps.2025.107421","url":null,"abstract":"<div><div>Overexpression of MERTK and FLT3 plays a crucial role in activating signal transduction pathways in various human hematological malignancies. These signaling pathways have been extensively studied and have shown significant potential as a promising therapeutic target for the treatment of acute myeloid leukemia (AML). In this study, we employed a modern medicinal chemistry approach, hybridizing machine learning (ML) with a bioisosterism strategy, to design and synthesize a new series of pyrrolo[2,3-<em>d</em>] pyridine derivatives as potent dual inhibitors of MERTK and FLT3. Through successive structure-activity relationship (SAR) studies, we successfully identified the lead compound 31l as a highly potent and selective MERTK/FLT3 dual inhibitor. Compound 31l exhibited remarkable kinase inhibitory activity against MERTK and FLT3 with IC₅₀ values of 2.58 and 0.86 nM, respectively, and potential anti-proliferative activity against MOLM-13 cell lines (IC₅₀ value of 7.50 nM). Furthermore, compound 31l displayed a favorable metabolic stability profile in both human and mouse liver microsome screens and an oral bioavailability of 56%. This finding suggests that lead compound 31l is a promising tool for further optimization and development as a potential MERTK/FLT3 dual inhibitor anti-AML drug candidate.</div></div>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":"219 ","pages":"Article 107421"},"PeriodicalIF":4.7,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146096970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term clinical outcomes of 0.015 % tacrolimus HPβCD eye drops in ocular surface inflammatory disorders","authors":"María Puente-Iglesias ,&nbsp;Andrea Cuartero-Martínez ,&nbsp;Rosario Touriño-Peralba ,&nbsp;María Teresa Rodríguez-Ares ,&nbsp;María Jesús Giráldez ,&nbsp;Eva Yebra-Pimentel ,&nbsp;Eva Torres-Sangiao ,&nbsp;Miguel González-Barcia ,&nbsp;Irene Zarra-Ferro ,&nbsp;Francisco J Otero-Espinar ,&nbsp;Anxo Fernández-Ferreiro ,&nbsp;Ana Castro-Balado","doi":"10.1016/j.ejps.2026.107459","DOIUrl":"10.1016/j.ejps.2026.107459","url":null,"abstract":"<div><h3>Background</h3><div>Topical tacrolimus offers potent anti-inflammatory effects across a spectrum of ocular surface diseases, but its ophthalmic use has been limited by formulation challenges. This study evaluated 0.015 % tacrolimus/hydroxypropyl-β-cyclodextrin eye drops (TCD) long-term performance.</div></div><div><h3>Methods</h3><div>In a prospective, open-label, sequential design, 56 patients treated ≥6 months with 0.03 % tacrolimus ethanol-based formulation (TE) were switched to TCD and followed for 12 months. Assessments of efficacy and safety at baseline (TE) and month 12 (TCD) included concomitant corticosteroid use, distance best-corrected visual acuity, slit-lamp grading of conjunctival and corneal signs, Oxford staining, tear meniscus height (TMH), non-invasive break-up time, ocular redness, intraocular pressure, NEI VFQ-25 (National Eye Institute Visual Function Questionnaire) scores, symptom visual analog scales and adherence. In addition, a comparative evaluation of microbiological stability in use was performed for both eye drops.</div></div><div><h3>Results</h3><div>Concomitant corticosteroids declined from 21.4 % to 5 %; two-thirds of eyes maintained or improved visual acuity; ≥80 % showed stable or improved (TMH p&lt;0.0001) corneal/conjunctival. TMH increased significantly (median 0.25 to 0.29 mm; p&lt;0.0001), while break-up time and intraocular pressure remained stable. VFQ-25 total score rose from 82.8 to 87.8 (p&lt;0.001); burning, photophobia and foreign-body sensation decreased (p&lt;0.05), thereby promoting adherence to treatment. Both tacrolimus formulations were similarly contaminated due to improper manipulation by the patients.</div></div><div><h3>Conclusions</h3><div>The 0.015 % tacrolimus/HPβCD formulation proves efficacy, and safety over 12 months for the treatment of diverse ocular inflammatory conditions, delivering sustained clinical stability and patient-reported benefits with reduced steroid reliance.</div></div>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":"219 ","pages":"Article 107459"},"PeriodicalIF":4.7,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulation and evaluation of semi-solid extrusion (SSE) 3D-printed drug preparations using poloxamers and polyethylene oxide as co-printed carrier polymers","authors":"Kristiine Roostar ,&nbsp;Oleh Koshovyi ,&nbsp;Ivo Laidmäe ,&nbsp;Jaan Aruväli ,&nbsp;Urve Paaver ,&nbsp;Jyrki Heinämäki","doi":"10.1016/j.ejps.2026.107458","DOIUrl":"10.1016/j.ejps.2026.107458","url":null,"abstract":"<div><div>Semi-solid extrusion (SSE) 3D printing offers a versatile platform for preparing personalised pharmaceutical dosage forms. We investigated the applicability of the three different grades of poloxamers combined with polyethylene oxide (PEO) in pharmaceutical SSE 3D printing. The binary mixtures of poloxamers (F68, F87, and F108) and PEO at a ratio of 55:45 (w/w) were used in preparing the aqueous gels for SSE 3D printing. Acetylsalicylic acid (ASA) was used as a model drug in the concentrations 5%, 7%, and 9% (w/w). The physicochemical properties, printability, geometric accuracy, structural fidelity, and in-vitro drug-release behaviour of SSE 3D-printed 4 × 4 grids and axially perforated tablets were studied. We found that poloxamer F108 as a co-printed carrier polymer (with PEO) formed high-viscosity gels, which were feasible for SSE 3D-printing. The poloxamer F68- and F87-based gel formulations in turn showed reduced print fidelity. FTIR spectroscopy analysis confirmed compatibility between ASA, PEO, and all three poloxamers studied. The SSE 3D-printed grid preparations exhibited immediate-release behaviour with an initial burst release of the drug (ASA), followed by a diffusion- and erosion-controlled drug release in vitro. The release rates decreased in order of poloxamer grade: F87 &gt; F68 &gt; F108. Overall, poloxamer grade F108 was the most feasible carrier polymer to be combined with PEO for the SSE 3D printing of ASA-loaded dosage forms. The present poloxamer and PEO co-printed formulations provide an alternative printing platform for aqueous-based SSE 3D printing of immediate-release oral drug preparations applicable in personalized medicine or compounding settings.</div></div>","PeriodicalId":12018,"journal":{"name":"European Journal of Pharmaceutical Sciences","volume":"219 ","pages":"Article 107458"},"PeriodicalIF":4.7,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146187080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}