{"title":"Retraction notice to \"Corrigendum to \"Impact of polymer chemistry on critical quality attributes of selective laser sintering 3D printed solid oral dosage forms\" [International Journal of Pharmaceutics:X Volume 6 (2023) 100203] [International Journal of Pharmaceutics: X 9 (2025) 100319].","authors":"Evgenii Tikhomirov, Valerie Levine, Michelle Åhlén, Nicole Di Gallo, Maria Strømme, Thomas Kipping, Julian Quodbach, Jonas Lindh","doi":"10.1016/j.ijpx.2025.100388","DOIUrl":"10.1016/j.ijpx.2025.100388","url":null,"abstract":"<p><p>[This retracts the article DOI: 10.1016/j.ijpx.2025.100319.][This retracts the article DOI: 10.1016/j.ijpx.2023.100203.].</p>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"100388"},"PeriodicalIF":6.4,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12766097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145911572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-19DOI: 10.1016/j.ijpx.2025.100398
Christoph Krauss , Maria Montero Mirabet , Jian-Feng Zhang , Karsten Mäder
This study investigates the potential of VECOLLAN®, a recombinant, novel, non-animal-derived collagen-like protein, for use in electrospinning applications relevant to biomedical and drug delivery sectors. Given the limitations of animal-derived collagens, including immunogenicity and variability, VECOLLAN® offers a promising alternative due to its biotechnological production and non-immunogenic, non-allergenic, and non-inflammatory properties. We optimized the electrospinning parameters for VECOLLAN® and examined the effects of a novel coaxial crosslinking approach on the dissolution and disintegration behaviors of the resultant fibers. Our results demonstrate that VECOLLAN®-based fibers can achieve varying degrees of water insolubility, influenced by crosslinker concentration and type of crosslinker. Additionally, the fibers exhibit distinct swelling behaviors. With the addition of hyaluronic acid, the water absorption capacity could be increased. We investigated the distribution of silver nanoparticles within the fibers, confirming the homogeneity of the coaxial electrospinning process. Mechanical tests revealed that increased crosslinker concentrations lead to greater stability and rigidity, while elastin incorporation improved elongation properties. This study lays the groundwork for developing electrospun fibers made from a non-animal-derived collagen-like protein, highlighting the potential for applications in drug delivery and tissue engineering. Future research should focus on assessing the biocompatibility of these fibers further to explore their utility as drug carriers or cell scaffolds. Overall, our findings underscore the promising properties of VECOLLAN®-based fibers in advancing innovative solutions in the biomedical and drug delivery sectors.
{"title":"Electrospinning of animal-free derived collagen-like protein: Development and characterization of VECOLLAN®- nanofibers for biomedical applications","authors":"Christoph Krauss , Maria Montero Mirabet , Jian-Feng Zhang , Karsten Mäder","doi":"10.1016/j.ijpx.2025.100398","DOIUrl":"10.1016/j.ijpx.2025.100398","url":null,"abstract":"<div><div>This study investigates the potential of VECOLLAN®, a recombinant, novel, non-animal-derived collagen-like protein, for use in electrospinning applications relevant to biomedical and drug delivery sectors. Given the limitations of animal-derived collagens, including immunogenicity and variability, VECOLLAN® offers a promising alternative due to its biotechnological production and non-immunogenic, non-allergenic, and non-inflammatory properties. We optimized the electrospinning parameters for VECOLLAN® and examined the effects of a novel coaxial crosslinking approach on the dissolution and disintegration behaviors of the resultant fibers. Our results demonstrate that VECOLLAN®-based fibers can achieve varying degrees of water insolubility, influenced by crosslinker concentration and type of crosslinker. Additionally, the fibers exhibit distinct swelling behaviors. With the addition of hyaluronic acid, the water absorption capacity could be increased. We investigated the distribution of silver nanoparticles within the fibers, confirming the homogeneity of the coaxial electrospinning process. Mechanical tests revealed that increased crosslinker concentrations lead to greater stability and rigidity, while elastin incorporation improved elongation properties. This study lays the groundwork for developing electrospun fibers made from a non-animal-derived collagen-like protein, highlighting the potential for applications in drug delivery and tissue engineering. Future research should focus on assessing the biocompatibility of these fibers further to explore their utility as drug carriers or cell scaffolds. Overall, our findings underscore the promising properties of VECOLLAN®-based fibers in advancing innovative solutions in the biomedical and drug delivery sectors.</div></div>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"Article 100398"},"PeriodicalIF":6.4,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145154408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-19DOI: 10.1016/j.ijpx.2025.100401
Hanaa Mabroum , Hamid Ait Said , Hamza Elbaza , Yousra Hamdan , Said Zayane , Rachid Hakkou , Sanae Ben Mkaddem , Rachid El Fatimy , Hicham Ben Youcef , Hassane Oudadesse , Hassan Noukrati , Allal Barroug
This work aims to investigate the effect of the incorporation of additives, including 46S6 bioactive glass (BG) and sodium alginate polymer (Alg), on the adsorption behavior, drug release kinetics, in vitro degradability, antibacterial activity, cytotoxicity, and inflammatory response of ciprofloxacin (Cip)-loaded reference cement (RC). Microstructural analysis revealed that the addition of BG and Alg to the reference cement composition (DCPD-CaCO3) significantly affected its specific surface area, porosity, surface charge, and the pH of the cement pastes, as well as the solubility of ciprofloxacin within the cement matrix. The adsorption and release behaviors of ciprofloxacin were examined in relation to these modified cement properties and the physicochemical characteristics of ciprofloxacin. The results revealed that the adsorption process was mainly governed by a Freundlich-type isotherm, which is characterized by a low affinity between the Cip molecules and the carrier surface. Moreover, the results of the antibiotic release showed that antibiotic release is influenced mainly by the pH and solubility of Cip. Depending on the composition of the cement, the release follows mechanisms driven by Fick's law of diffusion alone or in combination with other mechanisms. The in vitro biodegradation test of the prepared cements in phosphate buffer solution attested that adding BG and alginate improved the degradability of the reference cement. Moreover, the formulated cements exhibited good antibacterial activity against Staphylococcus aureus and Escherichia coli. Finally, the in vitro investigation revealed the non-cytotoxicity and non-inflammatory effects of the ciprofloxacin-loaded cements towards hPBMCs cells, confirming their biocompatibility.
{"title":"Synergistic effects of bioactive glass and sodium alginate on the surface properties and therapeutic release of ciprofloxacin from apatite cements","authors":"Hanaa Mabroum , Hamid Ait Said , Hamza Elbaza , Yousra Hamdan , Said Zayane , Rachid Hakkou , Sanae Ben Mkaddem , Rachid El Fatimy , Hicham Ben Youcef , Hassane Oudadesse , Hassan Noukrati , Allal Barroug","doi":"10.1016/j.ijpx.2025.100401","DOIUrl":"10.1016/j.ijpx.2025.100401","url":null,"abstract":"<div><div>This work aims to investigate the effect of the incorporation of additives, including 46S6 bioactive glass (BG) and sodium alginate polymer (Alg), on the adsorption behavior, drug release kinetics, <em>in vitro</em> degradability, antibacterial activity, cytotoxicity, and inflammatory response of ciprofloxacin (Cip)-loaded reference cement (RC). Microstructural analysis revealed that the addition of BG and Alg to the reference cement composition (DCPD-CaCO<sub>3</sub>) significantly affected its specific surface area, porosity, surface charge, and the pH of the cement pastes, as well as the solubility of ciprofloxacin within the cement matrix. The adsorption and release behaviors of ciprofloxacin were examined in relation to these modified cement properties and the physicochemical characteristics of ciprofloxacin. The results revealed that the adsorption process was mainly governed by a Freundlich-type isotherm, which is characterized by a low affinity between the Cip molecules and the carrier surface. Moreover, the results of the antibiotic release showed that antibiotic release is influenced mainly by the pH and solubility of Cip. Depending on the composition of the cement, the release follows mechanisms driven by Fick's law of diffusion alone or in combination with other mechanisms. The <em>in vitro</em> biodegradation test of the prepared cements in phosphate buffer solution attested that adding BG and alginate improved the degradability of the reference cement. Moreover, the formulated cements exhibited good antibacterial activity against <em>Staphylococcus aureus</em> and <em>Escherichia coli</em>. Finally, the <em>in vitro</em> investigation revealed the non-cytotoxicity and non-inflammatory effects of the ciprofloxacin-loaded cements towards hPBMCs cells, confirming their biocompatibility.</div></div>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"Article 100401"},"PeriodicalIF":6.4,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145154422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-18eCollection Date: 2025-12-01DOI: 10.1016/j.ijpx.2025.100396
A Griveau, C Arib, J Spadavecchia, J Eyer
[This corrects the article DOI: 10.1016/j.ijpx.2022.100129.].
[这更正了文章DOI: 10.1016/j.ijpx.2022.100129.]。
{"title":"Corrigendum to 'Biological activity of gold nanoparticles combined with the NFL-TBS.40-63 peptide, or with other cell penetrating peptides, on rat glioblastoma cells' [International Journal of Pharmaceutics: X 4 (2022) 100129].","authors":"A Griveau, C Arib, J Spadavecchia, J Eyer","doi":"10.1016/j.ijpx.2025.100396","DOIUrl":"https://doi.org/10.1016/j.ijpx.2025.100396","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1016/j.ijpx.2022.100129.].</p>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"100396"},"PeriodicalIF":6.4,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12766089/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145911550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-16DOI: 10.1016/j.ijpx.2025.100400
Shuo Xiang , Hui Zhan , Jimin Zhan , Xin Li , Xiaoji Lin , Wenjie Sun
Hypoxia in the tumor microenvironment (TME) is a critical barrier to effective cancer immunotherapy, as it suppresses T cell infiltration and response while fostering immune evasion. Oxygen-supplied nanomaterials (OSNs) have recently emerged as promising tools to alleviate hypoxia, modulate the TME, and enhance the efficacy of immunotherapies. This review explores the synergistic interplay between OSNs and T lymphocytes in overcoming hypoxia-driven immune suppression. We discuss the mechanisms by which hypoxia limits T cell functionality, infiltration, and cytotoxicity, and highlight how nanomaterials restore oxygenation, boost immune activation, and improve chemokine-mediated T cell recruitment. Key advances in nanotechnology, including perfluorocarbon-based systems and catalytic nanoparticles, are evaluated for their ability to improve anti-tumor immunity and synergize with immune checkpoint inhibitors and chimeric antigen receptor-T cell therapies. Finally, we address the challenges of nanomaterial delivery, safety, and clinical translation, emphasizing opportunities for personalized strategies. OSNs offer transformative potential to enhance T cell-mediated anti-tumor responses, advancing immunotherapy's frontier.
{"title":"Breaking hypoxic barrier: Oxygen-supplied nanomaterials for enhanced T cell-mediated tumor immunotherapy","authors":"Shuo Xiang , Hui Zhan , Jimin Zhan , Xin Li , Xiaoji Lin , Wenjie Sun","doi":"10.1016/j.ijpx.2025.100400","DOIUrl":"10.1016/j.ijpx.2025.100400","url":null,"abstract":"<div><div>Hypoxia in the tumor microenvironment (TME) is a critical barrier to effective cancer immunotherapy, as it suppresses T cell infiltration and response while fostering immune evasion. Oxygen-supplied nanomaterials (OSNs) have recently emerged as promising tools to alleviate hypoxia, modulate the TME, and enhance the efficacy of immunotherapies. This review explores the synergistic interplay between OSNs and T lymphocytes in overcoming hypoxia-driven immune suppression. We discuss the mechanisms by which hypoxia limits T cell functionality, infiltration, and cytotoxicity, and highlight how nanomaterials restore oxygenation, boost immune activation, and improve chemokine-mediated T cell recruitment. Key advances in nanotechnology, including perfluorocarbon-based systems and catalytic nanoparticles, are evaluated for their ability to improve anti-tumor immunity and synergize with immune checkpoint inhibitors and chimeric antigen receptor-T cell therapies. Finally, we address the challenges of nanomaterial delivery, safety, and clinical translation, emphasizing opportunities for personalized strategies. OSNs offer transformative potential to enhance T cell-mediated anti-tumor responses, advancing immunotherapy's frontier.</div></div>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"Article 100400"},"PeriodicalIF":6.4,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145117858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-15DOI: 10.1016/j.ijpx.2025.100399
Mohammad Javad Javid-Naderi , Seyed Ali Mousavi Shaegh
Solid lipid nanoparticles (SLNs) represent a promising category of nanocarriers used in medicine and cosmetics, offering enhanced drug protection, controlled release, and targeted delivery for both hydrophilic and lipophilic compounds. Conventional preparation methods, such as high-pressure homogenization and solvent emulsification-evaporation, face several challenges, including increased polydispersity, scaling limitations, and the presence of hazardous residual solvents. Microfluidic technology has emerged as a novel approach for preparing SLNs, addressing issues such as variable particle sizes and residual solvents by facilitating enhanced control over particle dimensions, morphology, and encapsulation efficiency. Microfluidics enables rapid and uniform mixing through micro-scale fluid dynamics, resulting in the production of homogeneous nanoparticles with adjustable characteristics. The review examines key parameters in microfluidic SLN preparation and categorizes various microfluidic chip designs and mixing techniques in detail, illustrating their unique advantages in controlling nanoparticle properties. Furthermore, this article provides a comprehensive overview of microfluidic SLN preparation, emphasizing its advantages over conventional methods, and explores the transformative potential of SLNs for advancing drug delivery systems, cosmetic formulations, and diagnostics. The integration of artificial intelligence (AI) and machine learning to optimize synthesis conditions and enhance reproducibility and scalability for industrial translation are also discussed.
{"title":"Advanced microfluidic techniques for the preparation of solid lipid nanoparticles: Innovations and biomedical applications","authors":"Mohammad Javad Javid-Naderi , Seyed Ali Mousavi Shaegh","doi":"10.1016/j.ijpx.2025.100399","DOIUrl":"10.1016/j.ijpx.2025.100399","url":null,"abstract":"<div><div>Solid lipid nanoparticles (SLNs) represent a promising category of nanocarriers used in medicine and cosmetics, offering enhanced drug protection, controlled release, and targeted delivery for both hydrophilic and lipophilic compounds. Conventional preparation methods, such as high-pressure homogenization and solvent emulsification-evaporation, face several challenges, including increased polydispersity, scaling limitations, and the presence of hazardous residual solvents. Microfluidic technology has emerged as a novel approach for preparing SLNs, addressing issues such as variable particle sizes and residual solvents by facilitating enhanced control over particle dimensions, morphology, and encapsulation efficiency. Microfluidics enables rapid and uniform mixing through micro-scale fluid dynamics, resulting in the production of homogeneous nanoparticles with adjustable characteristics. The review examines key parameters in microfluidic SLN preparation and categorizes various microfluidic chip designs and mixing techniques in detail, illustrating their unique advantages in controlling nanoparticle properties. Furthermore, this article provides a comprehensive overview of microfluidic SLN preparation, emphasizing its advantages over conventional methods, and explores the transformative potential of SLNs for advancing drug delivery systems, cosmetic formulations, and diagnostics. The integration of artificial intelligence (AI) and machine learning to optimize synthesis conditions and enhance reproducibility and scalability for industrial translation are also discussed.</div></div>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"Article 100399"},"PeriodicalIF":6.4,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145117859","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-13DOI: 10.1016/j.ijpx.2025.100397
Junjie Wang , Chenxiao Zhang , Huiru Wu , Guofei Li
Vitiligo is an acquired depigmenting skin disorder that significantly impacts the physical and mental health of patients, primarily characterized by the loss of epidermal melanocytes, leading to white patches on the skin and mucous membranes. The pathogenesis of vitiligo is complex, with oxidative stress, immune imbalance, and the interaction between these two factors playing a key role. Current treatment strategies mainly focus on alleviating oxidative stress to regulate immune responses, thereby inhibiting the excessive immune activation that damages melanocytes, with drug interventions being the primary approach. However, due to the barrier effect of the skin's stratum corneum, the therapeutic outcomes of these treatments remain suboptimal. The introduction of novel nanoparticle drug delivery systems has revolutionized local treatments for vitiligo, enhancing both the efficacy and safety of drugs and offering new possibilities for personalized and precision treatments. In this review, we systematically summarize the latest advances in the understanding of vitiligo's pathogenesis, treatment strategies, and the role of nanoparticle-based therapies, with a focus on lipid-based and polymeric nanoparticle drug delivery systems, nanoemulsions, microemulsions, hydrogels, and microneedles. These studies emphasize improving treatment outcomes for vitiligo by enhancing drug loading efficiency, improving skin penetration, and increasing local drug concentration, providing theoretical support for further research into vitiligo's pathogenesis and the development of novel therapeutic agents.
{"title":"recent advances in the pathogenesis of vitiligo and the application of novel drug delivery systems in its treatment","authors":"Junjie Wang , Chenxiao Zhang , Huiru Wu , Guofei Li","doi":"10.1016/j.ijpx.2025.100397","DOIUrl":"10.1016/j.ijpx.2025.100397","url":null,"abstract":"<div><div>Vitiligo is an acquired depigmenting skin disorder that significantly impacts the physical and mental health of patients, primarily characterized by the loss of epidermal melanocytes, leading to white patches on the skin and mucous membranes. The pathogenesis of vitiligo is complex, with oxidative stress, immune imbalance, and the interaction between these two factors playing a key role. Current treatment strategies mainly focus on alleviating oxidative stress to regulate immune responses, thereby inhibiting the excessive immune activation that damages melanocytes, with drug interventions being the primary approach. However, due to the barrier effect of the skin's stratum corneum, the therapeutic outcomes of these treatments remain suboptimal. The introduction of novel nanoparticle drug delivery systems has revolutionized local treatments for vitiligo, enhancing both the efficacy and safety of drugs and offering new possibilities for personalized and precision treatments. In this review, we systematically summarize the latest advances in the understanding of vitiligo's pathogenesis, treatment strategies, and the role of nanoparticle-based therapies, with a focus on lipid-based and polymeric nanoparticle drug delivery systems, nanoemulsions, microemulsions, hydrogels, and microneedles. These studies emphasize improving treatment outcomes for vitiligo by enhancing drug loading efficiency, improving skin penetration, and increasing local drug concentration, providing theoretical support for further research into vitiligo's pathogenesis and the development of novel therapeutic agents.</div></div>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"Article 100397"},"PeriodicalIF":6.4,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145094829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-12DOI: 10.1016/j.ijpx.2025.100394
Haixia Ren , Charles A. Laughton , Clive J. Roberts , Kam Loon Fow
Fused deposition modeling (FDM) is a widely investigated 3D printing technology for pharmaceutical applications because of its advantages, including easy access of equipment and cost-effectiveness. Despite its versatility, the FDM 3D printing process is multi-step, time-consuming and resource intensive, and requires a holistic selection of material and formulation design to achieve successful printing. The aim of this work is to develop an efficient approach to streamline FDM 3D tablet-printing processes, as well as to explore the factors that may influence the physical stability of the tablets produced. For this purpose, the polymer Affinisol™ HPMC HME 15LV and the model drug felodipine were selected for printing process evaluation, and the produced drug-polymer tablets were investigated for printing quality and physical stability. The approach began with a material-based rheological study to predict the processing temperature range for the hot melt extrusion process which was used to produce the required filament feedstock for FDM 3D printing. Flory-Huggins (F-H) theory and phase diagram were applied to guide the expected drug-polymer system physical stability with various ratios under different temperatures, suggesting that the system would be unstable when the weight fraction of felodipine is greater than 0.3. Based on these analyses, FDM 3D printed tablets with varying drug loads, printing temperatures, and infill densities were produced, and the long-term physical stability of the printed tablets under different conditions was monitored using XRD, DSC and polarized light microscopy. The results of the extrusion and printing process, as well as the observed long-term physical stability, were consistent with the findings from the predictions from the rheological study and theoretical evaluations. This suggests that an approach which combines rheological studies, theoretical evaluations and phase diagram construction could be applied as a pre-screen and optimization strategy, removing the need for full material characterization prior to FDM 3D printing of medicine. Such an approach significantly minimizes the amount of drug required, accelerates excipient selection, and optimizes the process for pharmaceutical manufacturing using FDM 3D printing. Furthermore, this methodology holds promise for broader application in other material-based FDM printing processes, offering a versatile framework for optimizing printing quality and stability across diverse systems.
{"title":"Development of an efficient approach to boost fused deposition modeling (FDM) printing of felodipine-HPMC tablets for enhanced physical stability","authors":"Haixia Ren , Charles A. Laughton , Clive J. Roberts , Kam Loon Fow","doi":"10.1016/j.ijpx.2025.100394","DOIUrl":"10.1016/j.ijpx.2025.100394","url":null,"abstract":"<div><div>Fused deposition modeling (FDM) is a widely investigated 3D printing technology for pharmaceutical applications because of its advantages, including easy access of equipment and cost-effectiveness. Despite its versatility, the FDM 3D printing process is multi-step, time-consuming and resource intensive, and requires a holistic selection of material and formulation design to achieve successful printing. The aim of this work is to develop an efficient approach to streamline FDM 3D tablet-printing processes, as well as to explore the factors that may influence the physical stability of the tablets produced. For this purpose, the polymer Affinisol™ HPMC HME 15LV and the model drug felodipine were selected for printing process evaluation, and the produced drug-polymer tablets were investigated for printing quality and physical stability. The approach began with a material-based rheological study to predict the processing temperature range for the hot melt extrusion process which was used to produce the required filament feedstock for FDM 3D printing. Flory-Huggins (F-H) theory and phase diagram were applied to guide the expected drug-polymer system physical stability with various ratios under different temperatures, suggesting that the system would be unstable when the weight fraction of felodipine is greater than 0.3. Based on these analyses, FDM 3D printed tablets with varying drug loads, printing temperatures, and infill densities were produced, and the long-term physical stability of the printed tablets under different conditions was monitored using XRD, DSC and polarized light microscopy. The results of the extrusion and printing process, as well as the observed long-term physical stability, were consistent with the findings from the predictions from the rheological study and theoretical evaluations. This suggests that an approach which combines rheological studies, theoretical evaluations and phase diagram construction could be applied as a pre-screen and optimization strategy, removing the need for full material characterization prior to FDM 3D printing of medicine. Such an approach significantly minimizes the amount of drug required, accelerates excipient selection, and optimizes the process for pharmaceutical manufacturing using FDM 3D printing. Furthermore, this methodology holds promise for broader application in other material-based FDM printing processes, offering a versatile framework for optimizing printing quality and stability across diverse systems.</div></div>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"Article 100394"},"PeriodicalIF":6.4,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145265805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-12DOI: 10.1016/j.ijpx.2025.100395
Flora Bouchier , Astrid Boje , Gavin Reynolds
Pharmaceutical drug products in the form of tablets are produced via a series of manufacturing steps, transforming powder blends to compacted granules with carefully selected properties such as tensile strength and dissolution time. Typical oral solid dosage form (OSD) manufacturing processes include direct compression (DC), roller compaction (RC), high shear granulation (HSG) and continuous direct compression (CDC). Design of each process step is required to achieve end-product quality for the specific material properties and available equipment, although design decisions are typically made without a quantitative understanding of the impact on product environmental footprint. Using a ‘cradle-to-gate’ life cycle assessment (LCA) methodology, a quantitative sustainability comparison has been made between standard OSD manufacturing platforms across different production scales. The results demonstrate that for small batch sizes, DC produces tablets with the lowest carbon footprint, however at larger batch sizes, CDC is the most carbon efficient manufacturing platform. Due to the high carbon footprint of the active pharmaceutical ingredient (API), formulation process yields had the greatest impact on overall carbon footprint, although emissions from equipment energy, cleaning and facility overheads were also analysed. Data from these LCA models has been combined with systems models of the CDC manufacturing processes. These combined models are used to demonstrate the optimisation of processes to meet robust product quality attribute targets whilst identifying opportunities to minimise the drug product carbon footprint.
{"title":"Life cycle assessment of pharmaceutical tablet manufacturing: A comparative analysis and systems model integration framework","authors":"Flora Bouchier , Astrid Boje , Gavin Reynolds","doi":"10.1016/j.ijpx.2025.100395","DOIUrl":"10.1016/j.ijpx.2025.100395","url":null,"abstract":"<div><div>Pharmaceutical drug products in the form of tablets are produced via a series of manufacturing steps, transforming powder blends to compacted granules with carefully selected properties such as tensile strength and dissolution time. Typical oral solid dosage form (OSD) manufacturing processes include direct compression (DC), roller compaction (RC), high shear granulation (HSG) and continuous direct compression (CDC). Design of each process step is required to achieve end-product quality for the specific material properties and available equipment, although design decisions are typically made without a quantitative understanding of the impact on product environmental footprint. Using a ‘cradle-to-gate’ life cycle assessment (LCA) methodology, a quantitative sustainability comparison has been made between standard OSD manufacturing platforms across different production scales. The results demonstrate that for small batch sizes, DC produces tablets with the lowest carbon footprint, however at larger batch sizes, CDC is the most carbon efficient manufacturing platform. Due to the high carbon footprint of the active pharmaceutical ingredient (API), formulation process yields had the greatest impact on overall carbon footprint, although emissions from equipment energy, cleaning and facility overheads were also analysed. Data from these LCA models has been combined with systems models of the CDC manufacturing processes. These combined models are used to demonstrate the optimisation of processes to meet robust product quality attribute targets whilst identifying opportunities to minimise the drug product carbon footprint.</div></div>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"Article 100395"},"PeriodicalIF":6.4,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145154409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The development of efficient liposomal encapsulations of proteins for pharmaceutical applications is limited by several factors: their high molecular weight, interactions with surrounding substances, or the generally lower stability compared to small molecules. In this work, various liposomal formulations were prepared using the thin-film hydration method followed by extrusion, to investigate their suitability for the encapsulation of the plant-derived antitumoral mistletoe lectin-1 (ML-1). This can be significantly optimized by exploiting its preferential binding to galactose-containing structures, such as modified lipids integrated into the liposomal bilayer. Incorporation of the galactosylated lipid DSPE-PEG2k-Gal into the membrane significantly enhanced the overall recovery rate and encapsulation efficiency of ML-1, attributed to its affinity for the functionalized component. Compared to non-functionalized liposomes, a 2-fold to 4-fold increase in percentage encapsulation efficiency was observed. The galactosylated lipid optimized the ratio of encapsulated to surface-adsorbed ML-1 and facilitated its preferential localization within the core of the liposomes. A strong correlation was identified between the number of entrapped ML-1 molecules per liposome and the degree of galactosylation. The formulations demonstrated high in vitro cytotoxicity, as exemplified with murine colon-26 carcinoma cells, with the galactose-functionalized liposomes achieving an IC50 value comparable to free ML-1. This strategy presents significant potential for developing more efficient and targeted liposomal formulations of pharmaceutical proteins with specific affinities to tailored lipid components, advancing drug delivery technologies, and improving therapeutic options for cancer treatment.
{"title":"Galactosylated liposomes for targeted encapsulation and enhanced cytotoxicity of Mistletoe Lectin, an antitumoral type 2 ribosome-inactivating protein","authors":"Josanna Kaufmann , Eray Cetin , Tiana Kraus , Harden Rieger , Gero Leneweit","doi":"10.1016/j.ijpx.2025.100392","DOIUrl":"10.1016/j.ijpx.2025.100392","url":null,"abstract":"<div><div>The development of efficient liposomal encapsulations of proteins for pharmaceutical applications is limited by several factors: their high molecular weight, interactions with surrounding substances, or the generally lower stability compared to small molecules. In this work, various liposomal formulations were prepared using the thin-film hydration method followed by extrusion, to investigate their suitability for the encapsulation of the plant-derived antitumoral mistletoe lectin-1 (ML-1). This can be significantly optimized by exploiting its preferential binding to galactose-containing structures, such as modified lipids integrated into the liposomal bilayer. Incorporation of the galactosylated lipid DSPE-PEG2k-Gal into the membrane significantly enhanced the overall recovery rate and encapsulation efficiency of ML-1, attributed to its affinity for the functionalized component. Compared to non-functionalized liposomes, a 2-fold to 4-fold increase in percentage encapsulation efficiency was observed. The galactosylated lipid optimized the ratio of encapsulated to surface-adsorbed ML-1 and facilitated its preferential localization within the core of the liposomes. A strong correlation was identified between the number of entrapped ML-1 molecules per liposome and the degree of galactosylation. The formulations demonstrated high in vitro cytotoxicity, as exemplified with murine colon-26 carcinoma cells, with the galactose-functionalized liposomes achieving an IC<sub>50</sub> value comparable to free ML-1. This strategy presents significant potential for developing more efficient and targeted liposomal formulations of pharmaceutical proteins with specific affinities to tailored lipid components, advancing drug delivery technologies, and improving therapeutic options for cancer treatment.</div></div>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"10 ","pages":"Article 100392"},"PeriodicalIF":6.4,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145094860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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