Drug Delivery and Translational Research最新文献

{"title":"Stable self-assembled oral metformin-bridged nanocochleates against hepatocellular carcinoma.","authors":"Mohamed G El-Melegy, Amal H El-Kamel, Radwa A Mehanna, Ahmed Gaballah, Hoda M Eltaher","doi":"10.1007/s13346-024-01724-5","DOIUrl":"10.1007/s13346-024-01724-5","url":null,"abstract":"<p><p>Despite its established anti-diabetic activity, Metformin hydrochloride (MET) has been repurposed for the management of hepatocellular carcinoma (HCC). Owing to MET high aqueous solubility and poor oral permeability, a novel nanoplatform is sought to overcome the current challenges of traditional formulations. In this study, we developed MET-bridged nanocochleates (MET-CO) using a direct bridging method followed by optimization and assessment using various in-vitro and in-vivo pharmacokinetic methods. The optimized nanocochleates MET-CO_DCP 19, containing dicetyl phosphate (DCP), displayed uniform snail-shaped nano-rolls measuring 136.41 ± 2.11 nm with a PDI of 0.241 ± 0.005 and a highly negative ζ-potential of -61.93 ± 2.57 mV. With an impressive MET encochleation efficiency (> 75%), MET-CO_DCP 19 exhibited a controlled biphasic release profile, with minimal initial burst followed by prolonged release for 24 h. Importantly, they showed significant MET permeation in both in-vitro Caco-2 and ex-vivo intestinal models compared to non-DCP containing formula or MET solution. The in-vivo oral bioavailability study demonstrated pronounced improvements in the pharmacokinetic parameters with a 5.5 relative bioavailability compared to MET solution. Notably, a significant reduction in IC₅₀ values in HepG2 cells after 24 h of treatment was observed. Furthermore, the optimized formulation showed a significant downregulation of anti-apoptotic and cancer stemness genes, with 12- and 2-fold lower expression compared to MET solution. These promising results highlight the efficacy of the novel MET-bridged nanocochleates as a stable nanoplatform for enhancing the oral bioavailability of MET and boosting its anticancer potential against HCC.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"2064-2086"},"PeriodicalIF":5.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12037436/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616756","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":"Assessment of leachables and extractables in \"super-swelling\" hydrogel-forming microarray patches.","authors":"Qonita Kurnia Anjani, Peter E McKenna, Eneko Larrañeta, Panagiotis Manesiotis, Yidan Luo, Masoud Adhami, Fabiana Volpe-Zanutto, Gareth Orr, Sabrina Roussel, Ryan F Donnelly","doi":"10.1007/s13346-025-01880-2","DOIUrl":"https://doi.org/10.1007/s13346-025-01880-2","url":null,"abstract":"<p><p>Hydrogel-forming microarray patches (MAPs) offer a minimally invasive platform for transdermal drug delivery, enabling systemic absorption of active pharmaceutical ingredients. Unlike dissolving MAPs, which deposit their entire polymer matrix into the skin, hydrogel-forming MAPs remain intact upon removal, reducing polymer exposure while delivering higher drug doses than dissolving or coated MAPs. Moreover, they have demonstrated excellent biocompatibility and do not cause skin or systemic issues, even with repeated application in humans. This study assessed the leachable and extractable compounds from hydrogel-forming MAPs composed of Gantrez^® S-97, PEG 10,000, and sodium carbonate under various conditions. Under physiological conditions (37°C in water), minimal PEG 10,000 leaching (10.4 ± 2.0%) and negligible Gantrez^® S-97 extraction (< 2%) confirmed the hydrogel matrix's stability and safety. However, stress testing in DMSO at 70°C led to increased PEG 10,000 extraction (up to 32.9 ± 6.1%) and minor Gantrez^® S-97 degradation, likely due to ester hydrolysis. These findings highlight the robustness of hydrogel-forming MAPs, ensuring minimal systemic exposure to unbound polymers while maintaining effective drug delivery. The results support their potential for chronic therapeutic applications requiring repeated dosing. Further clinical studies are needed to validate these findings, facilitating regulatory approval and broader adoption across diverse medical applications.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191648","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":"Assessing the integrity and mechanical properties of commercial microneedles: innovation or fad?","authors":"Jing Yi Lee, Shi Hui Dong, Keng Wooi Ng, Choon Fu Goh","doi":"10.1007/s13346-025-01888-8","DOIUrl":"10.1007/s13346-025-01888-8","url":null,"abstract":"<p><p>With the rapid advancements in microneedle technology, the translation of microneedles to end users is now achievable. However, concerns about microneedle product quality persist due to the absence of standard guidelines. This study aims to evaluate the integrity, mechanical properties and skin penetration performance of commercially available polymeric-based cosmetic microneedle patches. The patches were characterised for needle geometry/dimension, mechanical strength and insertion capabilities using in vitro Parafilm^® M and ex vivo porcine skin models. Ten microneedle patches investigated have needle height of ~ 180-500 μm, base width of ~ 100-270 μm and interneedle spacing of ~ 320-686 μm with fracture force up to 14 N. Some microneedles showed deformed needles due to poor packaging protection. Despite most microneedle patches showed good insertion into Parafilm^® M, only 7 patches demonstrated ex vivo porcine skin insertion in OCT analysis. Nevertheless, only 1 microneedle patch demonstrated full skin insertion ratio due to a lower needle density. This study highlights the critical role of needle geometry, mechanical properties and packaging in ensuring microneedle functionality. More importantly, microneedle products are a significant 'innovation' that must prioritise puncture performance and packaging to ensure effectiveness and avoid being dismissed as a mere 'fad'.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191647","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":"A phase I clinical study to evaluate rapid, high-volume, subcutaneous auto-injector tolerability with recombinant human hyaluronidase.","authors":"David W Kang, Robert J Connor, Tara Nekoroski, Jo Ann M Bitsura, Susan K Kindig, Stephen P Knowles, Michael J LaBarre","doi":"10.1007/s13346-025-01883-z","DOIUrl":"https://doi.org/10.1007/s13346-025-01883-z","url":null,"abstract":"<p><p>Until recently, approved handheld auto-injectors (AIs) have been limited to volumes ≤ 2 mL. A prototype rapid high-volume AI (HVAI) that can deliver 10 mL in 30 s was developed to administer therapeutics co-formulated with a proprietary recombinant human hyaluronidase PH20 (rHuPH20). This phase I, open-label study assessed the tolerability of subcutaneous (SC) injections of 10% (100 mg/mL) immunoglobulin G (IgG) solution co-administered with 4000 U/mL rHuPH20, delivered using a syringe pump at a target rate of 5 or 10 mL/30 seconds or the prototype HVAI at a target rate of 10 mL/30 seconds in healthy human subjects. Subjects received 5 mL (Cohort A, n = 12) or 10 mL (Cohort B, n = 12) of test solution via syringe pump (injection visit 1), and 10 mL of test solution via HVAI (Cohorts A & B; injection visit 2). Primary endpoints were tolerability and safety outcomes. Secondary endpoints included HVAI injection duration. All 24 subjects completed visit 1; 23/24 completed visit 2. All injections were tolerated, with no serious adverse events (AEs). Following syringe pump administration, 6/24 subjects (25%) reported eight treatment-emergent AEs (TEAEs); after HVAI administration, 4/23 (17%) reported four TEAEs, all mild in severity. Mean (± SEM) injection duration via HVAI was 27.9 ± 0.8 s. Most subjects (91%, 21/23) experienced no or mild injection-site pain following HVAI administration, and 96% (22/23) said they would be willing to have the HVAI injection again. SC injection of a 10% IgG solution in combination with rHuPH20 was well tolerated at an injection rate of 10 mL/~30 s using the prototype HVAI.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144186785","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":"Fractional microporation-guided delivery of nanoencapsulated drugs for enhanced cutaneous and follicular absorption: a comparison of ablative laser and radiofrequency microneedling.","authors":"Woan-Ruoh Lee, Ahmed Alalaiwe, Meng-Tsan Tsai, Sindy Hu, Fang-Hsin Chang, Min-Yu Chien, Hsin-Ching Sung, Jia-You Fang","doi":"10.1007/s13346-025-01885-x","DOIUrl":"https://doi.org/10.1007/s13346-025-01885-x","url":null,"abstract":"<p><p>The use of fractional microporation to disrupt superficial skin is an effective approach to enhance drug absorption. This study analyzed and compared the effectiveness of fractional Er:YAG laser and radiofrequency microneedling (RM) in promoting skin penetration and hair follicle (HF) targeting of free or nanoencapsulated minoxidil and minocycline. Porcine skin delivery, with or without laser (3, 6, and 7 mJ) and RM (6.1, 10.2, and 20.4 mJ with a penetration depth of 0.5 or 1.0 mm), was investigated using in vitro permeation test (IVPT). The in vitro and in vivo antibacterial activity of the microporation-assisted minocycline-loaded nanocarriers was also conducted. The skin deposition and flux of free minoxidil were increased by 3- and 56-fold, respectively, with laser treatment at 7 mJ. The laser enhanced the deposition and flux of free minocycline by 25- and 40-fold compared to the untreated control, respectively. RM elevated the drug flux by 5‒18-fold compared to passive absorption. However, this enhancement effect was not observed in skin deposition. Nanostructured lipid carriers (NLC) and liposomes, with sizes of 81 and 76 nm, were produced and entrapped approximately 80% of the drugs, respectively. Microporation increased skin delivery of nanoencapsulated drugs, though this enhancement was less pronounced than that of the free drugs. Biodistribution observed through confocal microscopy showed that microporation increased the penetration depth of lipid-based nanocarriers into the dermis compared to passive diffusion. The nanocarriers were primarily distributed into the microchannels and transported into the surrounding dermal tissue. Minocycline uptake in HF increased from 0.03 to 0.16 and 0.20 nmol/cm² after the nanoencapsulation with NLC and liposomes, respectively. This uptake of NLC was further increased to 1.24 and 1.51 nmol/cm² by laser and RM treatment. The minocycline-loaded nanocarriers inhibited Cutibacterium acnes viability in both planktonic and biofilm forms more effectively than the free drug. The in vivo C. acnes infection model in mice exhibited an efficient bacterial eradication through microporation-mediated nanocarrier delivery. The microchannel closure in laser- and RM-treated skin occurred within 36 and 12 h, respectively, as indicated by transepidermal water loss (TEWL). These findings demonstrate that fractional laser and RM are promising strategies for improving skin- and HF-targeted absorption of nanoencapsulated drugs.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144173059","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":"Ureasil-polyether hybrid polymer-based vaginal ovules for combination therapy in the treatment of vulvovaginal candidiasis.","authors":"Brenda Maria Silva Bezerra, Kaidy G Orellana, Chen Sun, Karina Guimarães Lima, Emmanuel A Ho, João Augusto Oshiro-Junior","doi":"10.1007/s13346-025-01878-w","DOIUrl":"https://doi.org/10.1007/s13346-025-01878-w","url":null,"abstract":"<p><p>The aim of this research was to develop, characterize and evaluate the biocompatibility of ureasil-poly(propylene oxide) (U-PPO400) vaginal ovules for the modified release of a natural polyphenolic compound and an azole agent in the treatment of vulvovaginal candidiasis (VVC) caused by Candida albicans and non-albicans (NAC). The ovules were produced with a hydrophobic and low molecular weight ureasil-polyether through the sol-gel process. ¹H NMR confirmed that the organic-inorganic molecule was obtained. X-ray diffraction (XRD) and scanning electron microscopy (SEM) showed the presence of drug crystals in the ovules. Miconazole (MCZ) and curcumin (CUR) were released by 60.95% and 12.06% in six days, respectively. The synergistic and additive effect of the antifungals was confirmed in NAC strains, with minimum inhibitory concentrations of CUR and MCZ being reduced up to 16 and 8 times. Biocompatibility tests showed that MCZ concentrations higher than 90 µg/mL can negatively affect the vaginal microbiota. U-PPO400 had no impact on the growth of Lactobacillus jensenii. The cytotoxicity of the drugs on VK2/E6E7 vaginal epithelial cells was observed at concentrations equal to or greater than 5.94 µg/mL for MCZ and 256 µg/mL for CUR. No cytotoxic or inflammatory effects were observed after elution of the blank U-PPO400 ovules. This study demonstrated the biocompatibility and potential of the U-PPO400 base to promote controlled release of drugs and to reduce the frequency of use of vaginal ovules. The antifungal efficacy of the CUR/MCZ combination, especially against NAC strains, points to a promising alternative to improve the efficacy of the treatment of VVC.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144173062","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":"First-in-line subcutaneous injectable for reversible, non-hormonal male contraception.","authors":"Sarah Anne Howard, James K Tsuruta, Andres Prieto Trujillo, Roopali Shrivastava, Ava Cohen, Rani S Sellers, Katherine G Hamil, Michael G O'Rand, S Rahima Benhabbour","doi":"10.1007/s13346-025-01871-3","DOIUrl":"https://doi.org/10.1007/s13346-025-01871-3","url":null,"abstract":"<p><p>Contraceptive options for men are limited to either condom use or surgical vasectomy. Ongoing scientific efforts seek to expand existing male contraceptive options to include reversible options with high efficacy and reliability. Herein, we formulated EP055, a novel non-hormonal compound with reversible contraceptive effect, into an in-situ forming implant (ISFI) to demonstrate potential of male contraception with a long-acting injectable. Over a dozen ISFI formulations were studied, though release durations were limited due to the hydrophilic nature of EP055. An optimized EP055-ISFI formulation (F.04) elicited sustained release in vitro over 35 days and was further investigated in vivo for safety, pharmacokinetics (PK), and efficacy in male BALB/c mice. Plasma EP055 concentrations elicited high burst release in the first 24 h followed by first order-like release kinetics up to day 14 and sustained release between day 14-28. EP055 ISFI removal resulted in a rapid decline of EP055 plasma concentration, which fell below the limit of quantification. A reduction in sperm motility and an increase in premature acrosomal membrane degradation were observed with sperm samples collected at day 3 post EP055-ISFI administration, indicating contraceptive efficacy. Furthermore, EP055 was well-tolerated with no signs of systemic inflammation. Collectively, these results support future development of EPPIN-targeting molecules and in-situ forming implants for male contraception.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144157469","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":"Xinshuaining preparation ameliorates doxorubicin-induced cardiac injury in heart failure rats by regulating gut microbiota.","authors":"Qian Nie, Jue Zhao, Sattar Haseeb, Siwei Deng, Xin Zhang, Rui Wang, Xu Luo, Wen Xie","doi":"10.1007/s13346-025-01879-9","DOIUrl":"https://doi.org/10.1007/s13346-025-01879-9","url":null,"abstract":"<p><p>Heart failure (HF) has a serious impact on patients' lives and health. Gut microbiota plays an important role in the development of HF. Xinshuaining (XSN) preparation has a therapeutic effect on the HF. However, the mechanism of action of XSN in HF is still unclear. Our study aimed to explore the possible function and mechanism of XSN on HF induced by doxorubicin (DOX) in rats. DOX-induced HF rat models were prepared, grouped and treated. The ultrasound indexes of rat heart were measured before sampling, and the indexes of cardiac pathology, fibrosis degree, gut microbiota and metabolites were detected by ELISA, HE staining, Masson staining, immunohistochemistry, 16SrDNA sequencing, liquid chromatography-mass spectrometry (LC/MS) after sampling. XSN can significantly improve the cardiac function of HF rats, including increasing LVEF, LVFS, decreasing LVESD, LVESV, LVEDV levels, and at the same time, XSN can also reduce the heart weight index, reduce the cardiac histopathological damage and fibrosis. In addition, XSN can regulate the abundance and function of gut microbiota, inhibit the level of TMAO, and regulate plasma metabolites in HF rats. In conclusions, XSN improves cardiac function and delays the process of cardiac fibrosis in HF rats, and its mechanism may be related to the regulation of gut microbiota and metabolites.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144149657","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":"Evaluation of proinsulin(F25D) as a targeting ligand for insulin-binding B cells in autoimmune diabetes.","authors":"Kyle D Apley, Lindsay E Bass, Jaylyn King, Grant Downes, Kristen Wang, Mason V Forchetti, Daniel J Moore, Peggy Kendall, Rachel H Bonami, Cory J Berkland","doi":"10.1007/s13346-025-01869-x","DOIUrl":"https://doi.org/10.1007/s13346-025-01869-x","url":null,"abstract":"<p><p>Insulin-binding B cells are implicated in Type 1 Diabetes (T1D) pathology. Antigen-specific immunotherapy (ASIT) holds promise in T1D. However, ASIT-targeted suppression of insulin-binding B cells is hampered by insulin's hormonal activity and the resulting binding and endocytosis of insulin by insulin receptors (INSR). To evaluate ASIT strategies that target insulin-binding B cells in vivo, non-hormonally active insulin variants are needed. In this work, we aimed to improve upon prior non-hormonal insulin variants by making mutations to the insulin precursor, proinsulin, and including a c-terminal sortase (SrtA) tag (LPETGGHG) to enable facile site-selective bioconjugation to scaffolds or payloads. Of the insulin variants investigated that retained low-nM binding to the murine-derived insulin autoantibody mAb 125, proinsulin(F25D)-SrtA had the lowest INSR binding and activity and the greatest fibrillation resistance. Compared to desoctapeptide insulin, a previously proposed non-hormonal insulin variant, proinsulin(F25D)-SrtA demonstrated 50-fold lower INSR binding and 100-fold greater fibrillation lag time. However, insulin(F25D)-SrtA bound to the anti-insulin antibody 12M4 isolated from a presymptomatic T1D individual, whereas proinsulin(F25D)-SrtA and desoctapeptide insulin did not, highlighting the potential for anti-insulin B cells to develop in human T1D that would escape this ASIT moiety. The characteristics of proinsulin(F25D)-SrtA make it a well-suited non-hormonal insulin variant for insulin-binding B cell targeting and warrants additional study with other anti-insulin B cell specificities derived from T1D individuals.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119173","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":"A patented portable multifunctional nebulizer for enhanced respiratory drug delivery: an experimental study.","authors":"Hao Chen, Yanman Chen, Deep K Vaishnani, Jiajia Zhang","doi":"10.1007/s13346-025-01882-0","DOIUrl":"https://doi.org/10.1007/s13346-025-01882-0","url":null,"abstract":"<p><p>This study aimed to design and evaluate the clinical efficacy of a new patented portable multifunctional medical nebulizer. The portable multifunctional nebulizer, constructed using medical-grade PVC, incorporates four main systems: a nebulization system, a particle size adjustment mechanism, a heating unit, and a power storage system. This study employed a comparative experimental design. A conventional medical nebulizer, commonly used in a tertiary hospital, was selected as the control group, while the newly developed portable multifunctional nebulizer served as the experimental group. Each group underwent 30 experimental runs, with controlled variables across all tests. Key parameters assessed included initial mist emission time, nebulization rate, particle size distribution, medication splash loss, residual drug volume, and noise levels. The particle size distribution was measured using dynamic light scattering (DLS) technology, while medication loss was calculated by capturing mist spillover and measuring residual drug volume. Noise levels during stable nebulization were recorded using a sound level meter. The experimental group demonstrated the production of smaller, more uniform nebulized particles, reduced medication splash loss, decreased residual drug volume, and lower noise emissions. Statistically significant differences (P < 0.05) were observed across all parameters when compared to the control group. The multifunctional medical nebulizer consistently generates particles within a size range of 120-160 nm, improving drug delivery to target organs, minimizing medication loss, and reducing operational noise. This innovative design represents a significant advancement in the clinical application of respiratory therapy.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119027","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}