Journal of Drug Delivery Science and Technology最新文献

{"title":"Dual-drug-loaded complex hydrogel dressing composed of oxidized hyaluronic acid and modified mesoporous silica for diabetes foot wounds","authors":"Wenrui Zhang ,&nbsp;Hao Zhang ,&nbsp;Jinlin He ,&nbsp;Xingwei Sun ,&nbsp;Mingzu Zhang ,&nbsp;Peihong Ni","doi":"10.1016/j.jddst.2025.107575","DOIUrl":"10.1016/j.jddst.2025.107575","url":null,"abstract":"<div><div>Hyaluronic acid (HA) has good biocompatibility and significant therapeutic effects in wound healing. However, for the treatment of diabetes wounds, enhancing the strength, antibacterial and multifunctional healing properties of hydrogel dressings based on HA to make them easy to use is still the focus of attention. Herein, we report a hybrid hydrogel dressing composed of oxidized hyaluronic acid (OHA), mesoporous silica loaded with tetracycline, and metformin for the repair of diabetic foot ulcers. HA was first oxidized by using the oxidizing agent sodium periodate to yield OHA containing aldehyde groups (-CHO) in the side chain. Next, amino-modified mesoporous silica (MSN-NH₂) was synthesized by a one-step method, and MSN-NH₂ was loaded with tetracycline (TH) to obtain MSN-NH₂-TH nanoparticles. Finally, OHA, branched polyethyleneimine (<em>b</em>PEI, as crosslinking agent), MSN-NH₂-TH, and metformin (Met) were mixed and subjected to a Schiff base reaction to form the dual-drug-loaded complex hydrogel (OP@MSN-TH/Met) containing 35.6% TH in situ. The structures of the synthesized OHA and MSN-NH₂ were characterized by FT-IR spectroscopy. The rheological properties and adhesiveness of the hydrogels with different components were investigated. The results of in vitro drug release, antibacterial, and biocompatibility experiments all demonstrated that the complex hydrogel has good performance. Among them, the result of in vitro drug release indicated that the hydrogel has pH-responsive properties. It rapidly releases most of metformin from cross-linked nanoparticles, while simultaneously achieving sustained and slow release of tetracycline. This dual-release mechanism achieves antibacterial and anti-inflammatory effects, ensuring that the whole process of diabetic wound healing is free from bacterial infection. In addition, the diabetes mouse model experiment showed that the wound-closure rate of mice reached 96.6% on the 12th day, indicating that the hydrogel dressing has a good therapeutic effect.</div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107575"},"PeriodicalIF":4.9,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220039","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":"Hydrogel-integrated biomimetic hydroxyapatite scaffolds with tunable porosity for enhanced curcumin delivery","authors":"Kamrun Nahar Fatema ,&nbsp;Longlong Li ,&nbsp;Khurshid Ahmad ,&nbsp;Jongyun Kim ,&nbsp;Dong-Weon Lee","doi":"10.1016/j.jddst.2025.107572","DOIUrl":"10.1016/j.jddst.2025.107572","url":null,"abstract":"<div><div>Bone disorders affect nearly 50 % of adults over 50, with severe injuries often surpassing natural healing capacity. While hydroxyapatite (HA)-based scaffolds have shown promise in bone tissue engineering, their effectiveness is limited by brittleness, poor mechanical properties, and inconsistent drug release. To overcome these limitations, we developed a porous biomimetic scaffold with over 70 % porosity, integrating a pH-responsive hydrogel composed of polyacrylic acid, sodium alginate, carboxymethyl cellulose, potato starch, and propyl gallate (PSCPP). This scaffold is designed to stably encapsulate curcumin within hydroxyapatite, addressing these challenges. The system delivers curcumin with dual-phase kinetics: a rapid release in acidic inflammatory environments (pH 5.4) and a transition to sustained release at physiological pH (7.4). Experimental results show a release rate of 3 % over 7 days at neutral pH compared to a 90 % cumulative release at acidic pH, confirming its pH-responsive behavior. Key innovations include PG-stabilized curcumin with starch-modulated release, PSCPP hydrogel optimizing pH responsiveness and swelling, and HA-hydrogel hybridization that preserves bioactivity while enhancing mechanical strength. In vitro studies confirm the scaffold's biocompatibility with over 80 % cell viability. This design combines mechanical stability with controlled drug delivery, demonstrating effective features for bone scaffold applications where both structural support and therapeutic release are needed.</div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107572"},"PeriodicalIF":4.9,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220040","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":"Evaluating the impact of lyophilization process parameters on mRNA encapsulated lipid nanoparticles using machine learning","authors":"Iori Mizogaki ,&nbsp;Takuya Suzuki ,&nbsp;Ryo Ohori ,&nbsp;Syusuke Sano ,&nbsp;Shoki Hara ,&nbsp;Takayuki Miyazaki ,&nbsp;Kenji Kubara ,&nbsp;Yoko Ida ,&nbsp;Keita Kondo ,&nbsp;Yuta Suzuki ,&nbsp;Katsumi Onai ,&nbsp;Yohei Mukai ,&nbsp;Koji Ukai ,&nbsp;Tetsuya Ozeki","doi":"10.1016/j.jddst.2025.107573","DOIUrl":"10.1016/j.jddst.2025.107573","url":null,"abstract":"<div><div>mRNA-encapsulated lipid nanoparticles (mRNA-LNPs) play a pivotal role in the mitigation of COVID-19. However, these vaccines are frequently accompanied by critical challenges such as a relatively short shelf life and the necessity for frozen storage. The development of lyophilized formulations has garnered significant interest in addressing these limitations, in turn enhancing the stability of mRNA-LNPs. Although lyophilization is a commonly employed manufacturing technique, systematic investigations of the relationship between its potential critical process parameters (pCPPs) and critical quality attributes (CQAs) of mRNA-LNPs remain scarce. In this study, we evaluated the effects of selected pCPPs (freezing rate, annealing temperature, and primary drying temperature) on various CQAs, including particle size, polydispersity index, mRNA and lipid content, encapsulation efficiency, RNA integrity, and <em>in vitro</em> activity. Among these attributes, only particle size exhibited a statistically significant variation across the investigated process parameters. Cryo-electron microscopy revealed that this observation was a consequence of bleb-like structures induced by lyophilization. Feature importance analysis based on a gradient boosting model identified freezing rate and annealing temperature as the most influential variables. The model further predicted that particle size was particularly sensitive to a freezing rate of approximately −0.3 °C/min, underscoring the necessity of precise control of freezing conditions to maintain product stability. These findings demonstrate that machine learning-based modelling can facilitate the quantitative evaluation of the effects of pCPPs on CQAs using a minimal number of experiments, thereby enabling a more comprehensive understanding of the mRNA-LNP manufacturing process and supporting the rational design of robust production strategies.</div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107573"},"PeriodicalIF":4.9,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220038","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":"Rectal drug delivery systems (RDDS) in inflammatory bowel disease (IBD) therapy: current status, challenges and emerging strategies","authors":"Prakash Monika ,&nbsp;Maitreyi Darbha ,&nbsp;S. Reneeka ,&nbsp;Kirti Gupta ,&nbsp;H.R. Tejashree ,&nbsp;Mohamed Shabi ,&nbsp;Shwetha Krishnamurthy","doi":"10.1016/j.jddst.2025.107567","DOIUrl":"10.1016/j.jddst.2025.107567","url":null,"abstract":"<div><div>Rectal drug delivery systems (RDDS) are increasingly being explored as a practical and targeted approach for managing inflammatory bowel disease (IBD), particularly in cases of ulcerative colitis (UC) and Crohn's disease (CD). Unlike oral or injectable therapies that often struggle with systemic side effects and poor targeting, RDDS allow medications to act directly at the site of inflammation, improving drug bioavailability and reducing unwanted systemic exposure. Over time, researchers have sought to address the limitations of rectal administration, including discomfort, variable retention, and formulation instability. These challenges are being mitigated through innovative design strategies. Recent advances in drug carriers, such as nanoparticles, mucoadhesive hydrogels, thermosensitive formulations, and microbiome-responsive systems, have facilitated more precise and sustained drug release. In parallel, natural compounds, particularly phytochemicals, are being incorporated into these carriers to impart anti-inflammatory and antioxidant properties while minimizing side effects. However, despite promising laboratory outcomes, clinical translation remains limited. Challenges such as anatomical variability, patient compliance, and long-term formulation stability continue to slow progress. This review explores recent developments in RDDS for IBD, reflecting on both the scientific advances made and the gaps that remain. It also highlights the growing need for patient-centric, interdisciplinary strategies, encompassing advances in nanoparticle-based carriers, polymeric and microbiome-responsive systems along with phytocompound-based formulations to fully realise the therapeutic potential of rectal delivery in IBD care<strong>.</strong></div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107567"},"PeriodicalIF":4.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220037","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":"Advancements in alginate-derived biomaterials for tissue engineering and regenerative medicine: Emerging innovations and translational outlooks","authors":"Suraj Kumar ,&nbsp;Rishabha Malviya ,&nbsp;Saurabh Srivastava ,&nbsp;Ching Siang Tan ,&nbsp;Mohammad Y. Alshahrani","doi":"10.1016/j.jddst.2025.107569","DOIUrl":"10.1016/j.jddst.2025.107569","url":null,"abstract":"<div><div>Alginate, a polysaccharide obtained from brown seaweed, is increasingly recognized as a valuable biomaterial for Tissue Engineering and Regenerative Medicine (TE-RM). Recent studies show that alginate hydrogels not only provide structural support but also actively influence cell–matrix interactions, vascular growth, and scaffold remodeling. This review highlights these mechanistic insights and explains how alginate modifications such as chemical functionalization, biocompatibility crosslinking, and incorporation into composites are helping to overcome common challenges like immune activation, fibrotic encapsulation, and limited mechanical stability. Recent progress in clinical trials, regulatory pathways, and intellectual property development demonstrates alginate's translational potential in TE-RM. By focusing on both biological mechanisms and clinical progress, collectively, the evidence establishes alginate as a promising platform for next-generation advances in TE-RM.</div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107569"},"PeriodicalIF":4.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145154549","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":"Selectively activated plasma protein, DNA and cancer-cells by CB-Cu/Ag NPs","authors":"Sanjay Kumar Sahu ,&nbsp;Aditya Moktan Tamang ,&nbsp;S. Austin Richard ,&nbsp;Manickam Selvaraj ,&nbsp;Arun Karnwal ,&nbsp;Tanmay Kumar Ghorai","doi":"10.1016/j.jddst.2025.107568","DOIUrl":"10.1016/j.jddst.2025.107568","url":null,"abstract":"<div><div>Here, we reported the sustainable synthesis of metal nanoparticles (M = Cu and Ag) via eco-friendly, co-precipitation process using an aqueous extract of cinchona bark (CB) loaded with 0.005M CuCl₂.2H₂O and 0.01M AgNO₃. Synthesize nanoparticles were characterized by different spectroscopic techniques. Their small particle sizes and distinct morphologies contribute to enhanced cellular uptake and improved interaction with biological targets, making them promising candidates for cancer treatment. The main objectives of this work are that the resulting nanoparticles were designed for passive targeted drug delivery through plasma protein (BSA/HSA) and CT-DNA binding. CB-CuONPs exhibited protein binding constants of 0.225 × 10¹¹M⁻¹ for BSA and 0.266 × 10¹¹M⁻¹ for HSA. Whereas CB-AgNPs showed higher affinity at 0.541 × 10¹¹M⁻¹ for BSA and 0.513 × 10¹¹M⁻¹ for HSA, and strongly interacted with CT-DNA (3.0669 × 10¹¹M⁻¹). Cytotoxicity studies revealed that CB-CuONPs showed potent cytotoxic activity, with IC₅₀ concentrations of 65.8 μg for KB3 oral cancer KB3 cell line and 26.2 μg for AGS Colon cancer cell line, compared to CB-AgNPs (70.6 μg for KB3 and 54.6 μg for AGS cell lines). Combined cytotoxicity and biocompatibility findings suggest that CB-CuONPs may be more promising anticancer candidates than CB-AgNPs when used with proper dosage control. Additionally, molecular docking confirmed strong binding interactions of cinchona phytochemicals with BSA and CT-DNA, supporting their potential for passive targeted cancer therapy with minimal side effects toward eukaryotic cells.</div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107568"},"PeriodicalIF":4.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220551","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":"Topical nanoparticles for the treatment of skin cancer: Present concerns and challenges","authors":"Pritipragatika Nayak ,&nbsp;Surya Kanta Swain ,&nbsp;Itishree Jogamaya Das ,&nbsp;Sushree Sambita Swain ,&nbsp;Bikash Ranjan Jena ,&nbsp;Himansu Bhusan Samal","doi":"10.1016/j.jddst.2025.107566","DOIUrl":"10.1016/j.jddst.2025.107566","url":null,"abstract":"<div><div>Skin cancer (SC), commonly known as melanoma, has become a predominant malignancy among humans. The skin is a widely utilized pathway for administering both local and systemic drugs, presenting the potential for nanoparticle-based delivery. SC treatment varies based on the disease stage. Many techniques, including radiotherapy, Surgery, and chemotherapy, are now being used to diagnose SC. However, the limitation of the current treatment approach is that researchers are searching for an improved delivery system to achieve better outcomes. Various pharmaceutical approaches, from nanotechnology to physical enhancement techniques, are presently being developed to improve medication delivery systems for specific targeted tumors. The topical method of drug delivery is the most well-known strategy for delivering nanoparticles to the dermal layer. The stratum corneum, which forms the uppermost layer, represents a significant barrier to the skin. To overcome these problems, nanotechnology has sparked a growing interest in its application in treating SC by offering efficient drug delivery at lower toxicity levels. Topical delivery of drugs offers effective administration due to their numerous benefits, including avoiding fast-pass hepatic metabolism, reducing systemic side effects, and non-invasiveness. This comprehensive review highlights the latest developments in various nanoparticle technologies for treating skin cancer both systemically and topically, as well as provides a summary of relevant patents and clinical trial outcomes.</div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107566"},"PeriodicalIF":4.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220036","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":"Biosynthesized lincomycin loaded copper oxide nanoparticles using cichorium intybus based thin film spray for enhanced antibacterial and wound healing","authors":"Sajid Ali ,&nbsp;Rashna Mirza ,&nbsp;Zubariya Amjad ,&nbsp;Muhammad Ilyas ,&nbsp;Salman Khan ,&nbsp;Shefaat Ullah Shah ,&nbsp;Saqib Jahan ,&nbsp;Abdullah R. Alanzi ,&nbsp;Moneerah J. Alqahtani ,&nbsp;Jawaher H. Alqahtani ,&nbsp;Stephane Gibaud ,&nbsp;Kifayat Ullah Shah","doi":"10.1016/j.jddst.2025.107570","DOIUrl":"10.1016/j.jddst.2025.107570","url":null,"abstract":"<div><div>Wound infections remain a persistent and significant concern in clinical practice, driving the need for more efficient and targeted therapeutic solutions. This study focuses on the development and evaluation of lincomycin-loaded copper oxide nanoparticle-based film-forming spray (LIN-CuO NPs-FFS) designed to accelerate wound healing. Copper oxide nanoparticles (CuO NPs) were synthesized via a green methodology employing <em>Cichorium intybus</em> extract and optimized using Design Expert® software. These optimized nanoparticles were then incorporated into a film-forming spray formulation. Comprehensive <em>in vitro</em>, <em>ex vivo</em>, <em>in vivo</em>, and stability analyses were conducted on both the LIN-CuO nanoparticles and LIN-CuO NPs-FFS. Physicochemical characterization indicated that the CuO nanoparticles possessed an average particle size of 253.1±1.2 nm, a zeta potential of −29.9±0.7 mV, and a PDI of 0.2205 ± 0.098. Upon lincomycin loading, the particle size increased to 294±1.8 nm, with a zeta potential of −30.8±0.7 mV, a PDI of 0.394±0.01, and an encapsulation efficiency of 87 ± 0.2 %. The formulation's structural and chemical integrity was verified through UV spectroscopy, XRD, and FTIR analyses. Drug release and permeation studies demonstrated a sustained release pattern and superior skin penetration compared to lincomycin film-forming sprays. Antimicrobial studies confirmed potent antibacterial activity, while <em>in vivo</em> results highlighted enhanced wound closure, reduced bacterial burden, and improved epithelial regeneration. Furthermore, the formulation remained stable over a six-month storage period. These findings highlight the therapeutic potential of LIN-CuO NPs-FFS, indicating its effectiveness for the topical management of MRSA-infected wounds.</div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107570"},"PeriodicalIF":4.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220553","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":"3D-printed biopolymer matrices for the vehiculization and controlled release of octenidine in wound antibiotic therapy","authors":"Ignacio Rivero Berti ,&nbsp;Manuel Horue ,&nbsp;Tugce Boztepe ,&nbsp;Marcelo Calderón ,&nbsp;Luciano Mengatto ,&nbsp;Stephan Gehring ,&nbsp;Sergio Katz ,&nbsp;Germán Islan ,&nbsp;Federico Karp","doi":"10.1016/j.jddst.2025.107558","DOIUrl":"10.1016/j.jddst.2025.107558","url":null,"abstract":"<div><div>Chronic and acute wounds are important health system problems due to re-hospitalization rates and treatment engagement. Antibiotic-controlled release systems can be a relevant solution for generating long-term therapies without patient intervention. The present work investigated pH-sensitive biopolymeric systems obtained by extrusion-based 3D printing. Alginate and carboxymethyl chitosan were used as matrix polymers for ink production, while octenidine was the vehiculized antibiotic. Different polymer proportions were explored to evaluate the release mechanism in response to different pH environments. Physicochemical characterization was performed using infrared spectrometry (FTIR) and thermogravimetric analysis (TGA). Detailed photography was used to determine 3D-printing fidelity. SEM images were used for the morphological characterization. Swelling and octenidine release profiles were evaluated in different non-chelating buffers. After the print's crosslinking bath, the obtained encapsulation efficiency was 100 %. The printing fidelity was in the order of 0.9–1.8. Swelling studies showed that some formulations lost weight, whereas others increased by 400 %. After 7 days, the drug released was 20–85 %, depending on the polymer composition and buffer/pH environment. All the prints presented antimicrobial capacity against <em>Staphylococcus aureus</em>. The present work demonstrates the potential of biopolymeric 3D-printed systems as advanced wound dressings, combining pH-responsive antibiotic release and antimicrobial activity with the adaptive design capabilities of 3D printing, offering a versatile platform for personalized wound-healing therapies.</div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107558"},"PeriodicalIF":4.9,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145154547","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":"Stabilisation of a monoclonal antibody formulation in the presence of poloxamer 188 and related PEG/PPG systems","authors":"Lukas Bollenbach ,&nbsp;Torsten Schultz-Fademrecht ,&nbsp;Karsten Mäder ,&nbsp;Patrick Garidel","doi":"10.1016/j.jddst.2025.107562","DOIUrl":"10.1016/j.jddst.2025.107562","url":null,"abstract":"<div><div>Surfactants like poloxamer 188 are commonly used to stabilise antibody and other protein drug products. This study investigated the impact of poloxamer 188 on the stability of an antibody model protein in an aqueous buffered solution in comparison to mixtures composed of both polyethylene glycol and polypropylene glycol block polymers. The separate consideration of the block polymer units is important to understand the stabilising characteristics of poloxamer 188 and its degradation products. Therefore, interfacial stress was applied using a 48-hour shaking test to evaluate the stabilisation properties of the surfactants for an antibody. The effect of shaking was investigated by visual inspection, nephelometric turbidity measurement, size exclusion chromatography, and sub-visible particle formationvia backgrounded membrane imaging. Surface tension measurements revealed the impact of polyethylene glycol and polypropylene glycol on the air-water interface and showed that high surface activity is not the only decisive factor for protein stabilisation. It was determined that all excipients have the capacity to protect the antibody from protein particle formation to a certain extent. Polypropylene glycol performed better than polyethylene glycol due to a higher tendency to interact with the air-water interface. Surprisingly, mixtures of polyethylene glycol and polypropylene glycol, similar to their molecular weight ratio in poloxamer 188, led to comparable stabilisation properties to those of the triblock polymer poloxamer. This study indicates different stabilisation mechanisms for polyethylene glycol and polypropylene glycol combined in the poloxamer 188 molecule.</div></div>","PeriodicalId":15600,"journal":{"name":"Journal of Drug Delivery Science and Technology","volume":"114 ","pages":"Article 107562"},"PeriodicalIF":4.9,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145220044","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}