Drug Delivery and Translational Research最新文献

{"title":"Chitosan-Artesunate nanoparticles: A dual anti-fibrotic and anti-inflammatory strategy for preventing bleb fibrosis post-glaucoma filtration surgery.","authors":"Jingyuan Liu, Shutong Wang, Guangshuang Tan, Boding Tong, Ying Wu, Lusi Zhang, Bing Jiang","doi":"10.1007/s13346-025-01819-7","DOIUrl":"10.1007/s13346-025-01819-7","url":null,"abstract":"<p><p>Glaucoma filtration surgery (GFS) effectively lowers intraocular pressure in glaucoma patients, but postoperative bleb fibrosis often leads to surgical failure. Artesunate (ART) has demonstrated antifibrotic potential; however, its clinical use is limited by poor solubility and rapid degradation. This study aimed to develop chitosan-ART nanoparticles (CS@ART NPs) to improve ART's therapeutic efficacy in preventing bleb fibrosis. CS@ART NPs were synthesized using an ionic gelation method for chitosan encapsulation. Their characterization, including analyses of morphology, hydrodynamic properties, surface charge, encapsulation efficiency, drug release kinetics, stability, chemical structure, and mucoadhesive interactions, was carried out using various techniques such as TEM, DLS, zeta potential analysis, HPLC, FT-IR, ¹H-NMR, and adhesion assays. The antifibrotic effects were evaluated in a rabbit GFS model through subconjunctival injection. Histological analysis as well as immunohistochemistry for fibrosis markers α-SMA and fibronectin were detected. In vitro studies were conducted using human primary ocular fibroblasts stimulated with TGF-β1 to assess anti-inflammatory and anti-proliferative effects, measured by EdU incorporation, Western blot for signaling pathway components, and cytokine expression. CS@ART NPs exhibited a uniform size distribution (135.73 ± 0.90 nm), stable dispersion, high encapsulation efficiency (86.4%), and sustained drug release. In the GFS model, a single subconjunctival injection of CS@ART significantly reduced collagen deposition, as well as α-SMA and fibronectin expression at the surgical site. In vitro, CS@ART demonstrated superior antifibrotic effects with a significantly lower IC50 for inhibiting fibroblast proliferation compared to ART alone. Mechanically, CS@ART suppressed the Cyclin D1-CDK4/6, TGF-β1/SMAD, and PI3K/Akt signaling pathways. Additionally, CS@ART showed marked anti-inflammatory effects, reducing inflammatory cell infiltration and IL-6 expression. CS@ART NPs play a dual role both alleviate bleb fibrosis and inflammation after GFS as a promising therapeutic strategy for improving surgical outcomes in glaucoma patients.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3563-3580"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523024","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":"Application of platelet-rich plasma lysate combined with hyaluronic acid microneedles for the treatment of alopecia.","authors":"Zhengxin Suo, Yingcan Xu, Along Zhang, Ye Cao, Jiaxin Liu, Hong Wang, Rui Zhong","doi":"10.1007/s13346-025-01816-w","DOIUrl":"10.1007/s13346-025-01816-w","url":null,"abstract":"<p><p>Androgenetic alopecia (AGA) continues to pose a significant challenge due to the paucity of effective therapeutic options. Upon lysis, platelet-rich plasma (PRP) releases numerous growth factors (GFs), which facilitate tissue reconstruction and hair regeneration. However, concerns such as infection, bleeding, local erythema, and patient anxiety associated with injections have substantially diminished patient acceptance. To address these issues, we developed a microneedle (MN) system loaded with PRP lysate (PL), termed PL-MN, designed to deliver GFs transdermal to sites of hair loss without inducing significant discomfort. The PL-MN not only exhibits a well-defined needle structure but also demonstrates excellent in vivo penetration and external transdermal efficacy. Upon skin penetration, the needle matrix rapidly dissolves, releasing GFs directly to the target site. In animal tests, the PL-MN shows synergistic effects by orchestrating an upregulation in the expression of Ki67 and CD31, which collectively foster cell proliferation and migration, thereby facilitating the expedited progression of hair follicles (HFs) into the anagen phase and promoting peripheral angiogenesis. Compared with minoxidil, the first-line clinical drug for treating AGA (administered once per day, 20 times in total), the PL-loaded MN could induce hair regeneration in mice with a lower frequency of administration (once every 3 days, 5 times in total). Consequently, such a safe and GFs-releasing MNs patch shows great potential for clinical AGA treatment.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3517-3527"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467294","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":"Microemulsion-based formulation of enterocin CC2: a novel antimicrobial solution targeting Streptococcus mutans.","authors":"Zhang Jin Ng, Choon Fu Goh, Ana Masara Ahmad Mokhtar, Rozi Nuraika Binti Ramli, Chee Keong Lee, Joo Shun Tan","doi":"10.1007/s13346-025-01823-x","DOIUrl":"10.1007/s13346-025-01823-x","url":null,"abstract":"<p><p>Dental caries, driven predominantly by Streptococcus mutans, remains a significant global challenge. Conventional treatments often fall short due to antimicrobial resistance and limited efficacy. Enterocin CC2, a potent bacteriocin, offers a promising alternative but is hindered by stability and delivery challenges. This study pioneers the development of a cutting-edge microemulsion designed to enhance the stability, bioavailability, and antimicrobial potency of enterocin CC2 against S. mutans. A comprehensive screening of 124 formulations was conducted, evaluating thermodynamic stability, cytotoxicity, and antioxidant potential. The optimized formulation underwent rigorous analysis for physicochemical properties, antimicrobial activity, and long-term stability under varied storage conditions. The innovative microemulsion formulation, incorporating 0.5 mg/mL enterocin CC2, 0.5% surfactant blend (Tween 80 + PEG 400, 1:1), and 0.5% oil, demonstrated micro-sized droplets (88.50-92.10 nm), exceptional thermodynamic stability, and robust antimicrobial efficacy. Remarkably, it reduced the time to eradicate S. mutans UKMCC 1019 from 8 h (unformulated) to 5 h, outperforming 0.2% w/v chlorhexidine and 0.5 mg/mL nisin. Stability tests confirmed consistent performance in pH, viscosity, and antimicrobial activity for up to six weeks across various temperatures, with no detectable cytotoxicity. This study introduces a groundbreaking microemulsion formulation that redefines antimicrobial therapy for S. mutans. By leveraging the enhanced stability and rapid action of enterocin CC2, this innovation offers a transformative approach to oral health management, paving the way for next-generation antimicrobial solutions.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3607-3625"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585106","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":"Simvastatin loaded surface-decorated 3D-dendritic mesoporous silica nanoparticles for enhanced antihyperlipidemic activity: in vitro and in vivo appraisal.","authors":"Abdulsalam M Kassem, Elsaied H Barakat, Maged K Elsayad, Sherif E Emam, Tarek M Ibrahim, Ayman Salama, Mohammed Elmowafy, Nabil K Alruwaili, Omar Awad Alsaidan, Mohamed A Abdelgawad","doi":"10.1007/s13346-025-01825-9","DOIUrl":"10.1007/s13346-025-01825-9","url":null,"abstract":"<p><p>Simvastatin is a potent statin with antioxidant and anti-inflammatory characteristics, often used to treat hyperlipidemia and related cardiovascular disorders. Nonetheless, its therapeutic advantages are limited by poor water solubility and substantial degradation by CYP3A4 enzymes. This research aimed to improve simvastatin's physicochemical characteristics and therapeutic effectiveness by developing 3D-dendritic mesoporous silica nanoparticles as nanocarriers. Dendritic silica nanoparticles were manufactured using a one-pot biphase stratification process and then surface-modified with aminopropyl groups to enhance drug loading and release characteristics. The optimization of loading parameters, such as solvent type, drug-to-carrier ratio, and loading duration, produced dendritic spherical nanoparticles with a uniform size (< 200 nm), a zeta potential of + 21 mV, and a substantial drug loading capacity (> 20%). Characterization verified the conversion of crystalline simvastatin into an amorphous state, promoting improved saturation solubility and demonstrating sustained release via a Fickian diffusion mechanism. In vivo assessments revealed enhanced antihyperlipidemic, antioxidant properties, and considerable protection against oxidative damage in a poloxamer-407-induced hyperlipidemia model. Histological evaluations of liver and aorta tissues demonstrated almost normal morphology, highlighting the safety and usefulness of the nanoparticles. These results emphasized the potential of aminated dendritic silica nanoparticles as an effective platform for enhancing simvastatin therapeutic efficacy.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3642-3663"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603824","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":"Cyclodextrin-mediated enhancement of gastrointestinal drug delivery: unveiling mucoadhesive and mucopenetrating synergy.","authors":"Soheil Haddadzadegan, Ahmad Saleh, Florina Veider, Patrick Knoll, Flavia Laffleur, Gergely Kali, Andreas Bernkop-Schnürch","doi":"10.1007/s13346-025-01832-w","DOIUrl":"10.1007/s13346-025-01832-w","url":null,"abstract":"<p><p>This study evaluates the in vivo mucoadhesive properties of thiolated cyclodextrins (CDs) with varying S-protection using polyethylene glycol (PEG) of different chain lengths. Free thiol groups of thiolated β-CDs (CD-SH) were S-protected with 1 kDa and 2 kDa PEG bearing a terminal thiol group, leading to third-generation of thiolated CDs (CD-SS-PEG). The structure of these thiolated CDs was confirmed and characterized by FT-IR, 1 H NMR, and colorimetric assays. Thiolated and S-protected CDs were evaluated regarding viscosity, cellular uptake and, in vitro and in vivo mucoadhesion. The viscosity of CD-SH, CD-SS-PEG 1 kDa, and CD-SS-PEG 2 kDa mixtures with mucus increased 9-, 7-, and 5.5-fold, respectively, compared to unmodified CD within 3 h. Cellular uptake on Caco-2 cells was 1.75 times higher for highly thiolated CDs than for unmodified CD. In vitro residence time on porcine intestine was prolonged 7-, 8.4-, and 7.9-fold for CD-SH, CD-SS-PEG 1 kDa, and CD-SS-PEG 2 kDa, respectively. In vivo results indicated CD-SS-PEG 1 kDa had the highest potential. Our comprehensive in vitro, ex vivo, and in vivo ffindings demonstrate that CD-SS-PEG 1 kDa is a highly promising candidate for mucoadhesive drug delivery systems.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3753-3767"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397179/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of buspirone hydrochloride-loaded long-acting microneedles for management of anxiety disorders.","authors":"Tanvi Karve, Nisha Shrestha, Thomas Kipping, Ajay K Banga","doi":"10.1007/s13346-025-01803-1","DOIUrl":"10.1007/s13346-025-01803-1","url":null,"abstract":"<p><p>Buspirone hydrochloride (BSP) is an anxiolytic agent approved for the management of anxiety disorders. The current US-FDA approved medications of BSP are administered via the oral route, which is linked to several disadvantages such as low oral bioavailability and low half-life necessitating multiple daily doses. For chronic diseases such as anxiety disorders, where long-term or lifelong management is often required, these factors impact patient compliance and treatment adherence. The present study offers an alternative treatment approach by investigating the feasibility of sustained transdermal delivery of BSP via long-acting microneedles (MNs). Needle-tip-loaded MNs were fabricated via micro-molding technique using various grades of poly-vinyl alcohol (PVA) namely 4-88, 8-88, 18-88, and 26-88. These MNs were compared using characterization techniques such as Parafilm^® insertion testing, scanning electron microscopy (SEM), confocal microscopy, Fourier transform infrared spectroscopy (FTIR), and histological evaluation of MNs-treated human skin. The effect of different grades of PVA on the structural and mechanical properties of the fabricated MNs was evaluated. Further, in vitro release and permeation tests were conducted to assess the drug release patterns and transdermal delivery across dermatomed human skin over 7-day study periods. The highest release (5507.37 ± 456.88 µg/cm²) and delivery (4705.42 ± 634.57 µg/cm²) were observed from PVA 4-88, with significant differences among the PVA grades based on their properties. Notably, all four types of the fabricated PVA MNs crossed the daily and weekly therapeutic targets for the systemic delivery of BSP. Overall, this study established the feasibility of sustained delivery of BSP across the skin using PVA MNs for the management of anxiety disorders.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3466-3479"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397187/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Microneedle-mediated intracochlear injection safely achieves higher perilymphatic dexamethasone concentration than intratympanic delivery in guinea pig.","authors":"François Voruz, Sharon J Feng, Eugénie Breil, Michelle Yu, Daniella R Hammer, Aykut Aksit, Fereshteh Zandkarimi, Elizabeth S Olson, Jeffrey W Kysar, Anil K Lalwani","doi":"10.1007/s13346-025-01821-z","DOIUrl":"10.1007/s13346-025-01821-z","url":null,"abstract":"<p><p>Intracochlear injection through the round window membrane (RWM) has been proposed to overcome imprecise drug delivery into the inner ear. Using a novel ultrasharp microneedle, we compared the perilymphatic dexamethasone (DEX) concentration achieved after intratympanic vs. intracochlear injection at two different time points and assessed its safety in guinea pigs. For this purpose, DEX sodium phosphate (10 mg/mL) was administered either in the right middle ear space via continuous intratympanic injection or in the right scala tympani of the cochlea with microneedle-mediated injection (1 µL at 1 µL/min) across the RWM. Both groups were evaluated at 1-hour or 3-hour time points. Perilymph from both cochleae was sampled for liquid chromatography-mass spectrometry, and bilateral cochleae were harvested for immunofluorescence. Eighteen guinea pigs were included. The mean DEX concentration was higher in the intracochlear delivery group than in the intratympanic delivery group at 1-hour time point (mean difference 67,863 ng/mL, 95% CI (8,352-127,374 ng/mL), p = 0.03). No difference was found at 3-hour time point. In every animal on both cochleae, no disruption in hair and supportive cells of the organ of Corti and utricle was observed. Significant middle ear inflammation was observed with the intratympanic delivery method compared to intracochlear. In conclusion, microneedle-mediated intracochlear injection achieves higher perilymphatic DEX concentration than the intratympanic route by a factor of 7 while preserving the cochlear architecture and inducing significantly less middle ear inflammation. In this new era of inner ear therapeutics, the potential for translational application is tangible and promising.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3595-3606"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143499751","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":"Unlocking the potential of remdesivir: innovative approaches to drug delivery.","authors":"Maie S Taha, Alaa Akram, Ghada A Abdelbary","doi":"10.1007/s13346-025-01843-7","DOIUrl":"10.1007/s13346-025-01843-7","url":null,"abstract":"<p><p>Given the recurrent waves of COVID-19 and the emergence of new viral infections, optimizing the potential of remdesivir as an antiviral agent is critical. While several reviews have explored the efficacy of remdesivir, few have comprehensively addressed its challenges, such as the necessity for intravenous infusion, suboptimal lung accumulation, and safety concerns related to its formulation. This review critically examines these challenges while proposing innovative solutions and effective combinations with other antiviral agents and repurposed drugs. By highlighting the role of complex generics, we aim to enhance therapeutic efficacy in ways not previously discussed in existing literature. Furthermore, we address the development of novel drug delivery systems which specifically aim to improve remdesivir's pharmacological profile. By analyzing recent findings, we assess both the successes and limitations of current approaches, providing insights into ongoing challenges and strategies for further optimization. This review uniquely focuses on targeted drug delivery systems and innovative formulations, thereby maximizing remdesivir's therapeutic benefits and broadening its application in combating emerging viral threats. In doing so, we fill a critical gap in literature, offering a comprehensive overview that informs future research and clinical strategies.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3390-3413"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397135/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improvement of coronary microcirculation in acute myocardial ischemia rats using a nanoscale carrier SiO₂@PEG loaded with Nicorandil.","authors":"Rui Wang, Yujing Mo, Yingcong Liang, Yuanhui Liu, Zhongchan Sun, Wenting Shang, Ling Xue","doi":"10.1007/s13346-025-01820-0","DOIUrl":"10.1007/s13346-025-01820-0","url":null,"abstract":"<p><p>Coronary microcirculatory dysfunction, affecting over half of acute myocardial infarction (AMI) patients, correlates significantly with AMI prognosis. Nicorandil is an effective drug that markedly improves coronary microcirculation, but current clinical formulations of Nicorandil exhibit a relatively short half-life and lack cardiac selectivity. We formulated and synthesized a variety of mesoporous silica nanoparticles (MSNs) as a drug carrier for loading and delivering Nicorandil. We performed PEG modification on MSNs to enhance their biocompatibility. The SiO₂@PEG showed good serum stability, maintained a uniform spherical structure with a particle size distribution centered within 200 nm and exhibits good dispersibility. SiO₂@PEG-Nicorandil showed no significant impact on AC 16 cells' viability at concentrations up to 50 µg/mL. SiO₂@PEG-Nicorandil significantly enhanced the viability of AC16 cells under oxidative stress conditions, while concurrently reducing intracellular levels of reactive oxygen species (ROS) and Ca²⁺. For the rat coronary microvascular dysfunction model, the SiO₂@PEG-Nicorandil group demonstrated a greater decrease in thrombus formation and the expression of inflammatory cytokines, outperforming the Nicorandil group. In vivo imaging revealed that within one hour post-injection of SiO₂@PEG-Nicorandil-CY7, a notable increase in CY7 fluorescence intensity was observed in the cardiac region compared to surrounding tissues. Drug concentration measurements demonstrated that Nicorandil maintained a stable concentration in cardiac blood at 48 h in the SiO₂@PEG-Nicorandil group. Taken together, SiO₂@PEG-Nicorandil had exhibited superior cardiac-targeting capabilities and sustained-release properties. Within a specific concentration range, it demonstrated enhanced therapeutic effects in the treatment of coronary microcirculation disorders in rats when compared to conventional Nicorandil formulations.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3581-3594"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572518","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":"The translational journey of cancer nanomedicines: biological and entrepreneurial lessons learned.","authors":"Cristianne Johanna Ferdinand Rijcken","doi":"10.1007/s13346-025-01867-z","DOIUrl":"10.1007/s13346-025-01867-z","url":null,"abstract":"<p><p>Despite exhaustive investments, the breakthrough potential of nanomedicines (NM) is not yet realized. Whilst Doxil and covid-19 vaccines demonstrated certain benefits, many NM failed in clinical development. Lies the true reason for this limited success in inappropriate assumptions, incorrect approaches, or other omissions? This note describes the translational journey of CPC634 (docetaxel entrapping core-crosslinked polymeric micelles) and illustrates lessons learned in drug product development. Scientific elements are to understand the pathophysiology of the diseased tissue, the journey of NM upon administration and resulting drug release and the induced pharmacodynamic effects over time, particularly in actual patients. Industrial elements comprise market-product fit, target product profile, competitive benchmarking, while development efficiency focuses to generate a positive business case. A goal-oriented product design which is validated by external experts increases chances of development success and assures investor-readiness. NM development will progress by aligning fundamental biological insights with industrial product requirements, driving therapeutic breakthroughs.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3351-3362"},"PeriodicalIF":5.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984963","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}