Drug Development and Industrial Pharmacy最新文献

{"title":"<i>Terminalia arjuna</i> gum as a novel biopolymer for microbead formulation in pH-sensitive drug delivery.","authors":"Maryam Basharat, Sobia Noreen, Amjid Khan, Farooq Anwar, Bushra Ijaz, Khurram Shahzad Munawar, Mudeera Anwar, M Abdullah","doi":"10.1080/03639045.2025.2531402","DOIUrl":"10.1080/03639045.2025.2531402","url":null,"abstract":"<p><strong>Objective: </strong>Biocompatible drug delivery systems that endure stomach acidity while enabling controlled release in the colon are essential for enhancing bioavailability.</p><p><strong>Significance: </strong>This study presents <i>Terminalia arjuna</i> (<i>T. arjuna</i>) gum, a plant-based substitute for synthetic excipients and a natural, biodegradable polymer for controlled drug delivery. It helps create safer, more efficient oral formulations with more stability of acid-labile drugs.</p><p><strong>Method: </strong><i>T. arjuna</i> gum was utilized to create plain, blended (<i>T. arjuna</i> gum and sodium alginate were used in a blended formulation to increase stability, drug entrapment, and controlled release), and coated (Propylene glycol and gum mixture was used as the coating material) microbeads <i>via</i> the ionic gelation method.</p><p><strong>Result: </strong>Characterization showed that the size of plain microbeads was 645.67 ± 7.74 μm, while the size of coated microbeads was 586.23 ± 7.18 μm. Drug entrapment efficiency ranged from 67.06% to 88.12%. Swelling studies in pH 7.4 buffer revealed that coated microbeads had a higher swelling index (1.47 ± 0.09) than blended microbeads (1.18 ± 0.06). <i>In vitro</i> release studies demonstrated sustained release, as predicted by the Korsmeyer-Peppas model, indicating non-Fickian diffusion. Scanning Electron Microscopy (SEM) results revealed spherical microbeads with varying surface morphologies, including rough, porous, and smooth textures, depending on the formulation. Thermogravimetric Analysis (TGA) and Differential Scanning Calorimetry (DSC) confirm the stability of microbeads. Powder X-ray Diffraction (PXRD) confirmed the amorphous form of P-Na within the microbeads, and Fourier-Transform Infrared Spectroscopy (FTIR) validated successful drug entrapment without significant interactions with the polymer. Acute toxicity studies on Swiss albino mice showed no adverse effects, and <i>in vivo</i> pharmacokinetic studies in rabbits demonstrated a prolonged P-Na half-life, increasing from 1.12 to 2.24 hrs with a C_max of 2264.8 ng/mL.</p><p><strong>Conclusion: </strong>These findings suggest that <i>T. arjuna</i> gum-based microbeads are promising candidates for sustained drug delivery applications. Future research should focus on optimizing these formulations for various drugs, exploring additional therapeutic applications, and investigating the long-term stability of <i>T. arjuna</i> gum-based systems for potential clinical use.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1299-1317"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An insight into molecular targets and nanotherapeutics for diabetic wound healing.","authors":"Shivani Saraf, Poornima Agrawal, Laxmikant Gautam, Priyanka Kumari","doi":"10.1080/03639045.2025.2531408","DOIUrl":"10.1080/03639045.2025.2531408","url":null,"abstract":"<p><strong>Objective: </strong>This article reviewed the recent research findings of diabetic wound healing including molecular targets, signaling pathways, and nanotherapeutics for diabetic wound healing.</p><p><strong>Significance: </strong>The prevalence of diabetes (DI) is rising daily throughout the world, and one of the main issues for diabetic patients is poor wound healing. Therefore, new molecular target identification and advanced drug delivery systems development are necessary for the effective treatment of diabetic wounds.</p><p><strong>Method: </strong>In this review, we briefly discussed the different molecular targets for selective drug delivery to the diabetic wound. This review also elaborated on the recent nanotechnology-based drug delivery systems for the healing of diabetic wounds.</p><p><strong>Results: </strong>The diabetic wound healing (DIWH) process follows the partial or uncoordinated route and delays the acute and chronic wound healing. Therefore, various molecular targets have been explored for the treatment of DIWH such as growth factors, cytokines, neuropeptides, immunomodulators, chemokines, and epigenetic regulators. Several signaling pathways were also investigated as a molecular target for diabetic wound healing like STAT3 pathway, HIF-1 signaling, AMPK signaling, Akt/mTOR pathway, and Notch signaling. Advanced drug delivery systems such as nanofibers, nanoparticulate systems, nanogels, and gene therapy showed promising results in diabetic wound healing.</p><p><strong>Conclusion: </strong>This review summarized the pathogenesis, challenges, molecular targets, conventional therapy, and nanotherapeutics for DIWH. Development in the area of new molecular targets and molecular targeting approaches using nanotechnology offer a promising treatment option for diabetic wounds. Further clinical studies are still needed to prove the potential of nanotherapeutics for diabetic wound healing.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1167-1183"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antimycobacterial and autophagic activity of nebulized delamanid microemulsion targeting alveolar macrophage.","authors":"Himanshu Paliwal, Krittawan Tongkanarak, Nattanit Aekwattanaphol, Teerapol Srichana","doi":"10.1080/03639045.2025.2532762","DOIUrl":"10.1080/03639045.2025.2532762","url":null,"abstract":"<p><strong>Objective: </strong>The aerosol delivery of the novel anti-tubercular drug delamanid for pulmonary targeting holds promise for the effective treatment of multi-drug-resistant tuberculosis. Here, we developed a microemulsion formulation of delamanid for nebulization, evaluating its potential bioactivity.</p><p><strong>Methods: </strong>Herein, we attempted to develop microemulsion formulations loaded delamanid for nebulization and their physicochemical characteristics were assessed. The formulation was checked for aerosol characteristics, cytotoxic potential, <i>in vitro</i> antimycobacterial activity, and autophagy.</p><p><strong>Results: </strong>The optimized formulations, nebulized into a next-generation impactor, exhibited a fine particle fraction of 63.12%, ensuring efficient <i>in vitro</i> deposition. <i>In vitro</i> evaluations revealed that formulation did not demonstrate any cytotoxic potential on respiratory cell lines up to 2.5 µg/mL and lack of inflammatory cytokines production and nitric oxide from macrophage NR8383 cells, signified its safety. The flow cytometry analysis revealed that the elimination of <i>Mycobacterium bovis</i> by formulation after day 4, with considerably low minimum bactericidal concentration. The formulation demonstrated adequate macrophage autophagic activity when evaluated using confocal laser scanning microscopy and Western blot.</p><p><strong>Conclusion: </strong>Consequently, the aerosolized microemulsion of delamanid for pulmonary delivery may serve as an effective therapy for MDR-TB, necessitating further <i>in vivo</i> studies.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1347-1362"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of actuation force on the quality assessment of pressurized metered-dose inhalers.","authors":"Yaru Zhou, Bo Yang, Wentao Pan","doi":"10.1080/03639045.2025.2533523","DOIUrl":"10.1080/03639045.2025.2533523","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the influence of varied actuation forces on the quality assessment of pressurized metered-dose inhalers(pMDIs).</p><p><strong>Methods: </strong>Both manual and automatic methods were employed to assess the effects of manual actuation and automatic actuation (with different set actuation forces) on the delivered dose uniformity (DDU), emitted dose per actuation (EDPA), and aerodynamic particle size distribution (APSD) results of pMDIs.</p><p><strong>Results: </strong>When manual actuation was performed, the discrepancies in the DDU were observed, whereas differences in the EDPA and APSD results were not evident. When utilizing automatic actuation, the results for DDU, EDPA, and APSD all exhibited good uniformity. However, it was observed that inadequate actuation force, insufficient to fully open the valve, resulted in lower outcomes for all the aforementioned parameters. And when the actuation speed is excessively low, it results in a decline in the FPF value.</p><p><strong>Conclusions: </strong>The process of routine manual testing for DDU in inhalation aerosols, as well as methodology transfer in this field, necessitates meticulous attention to the standardization of operation techniques and actuation forces among diverse experimenters. Furthermore, using automated actuation can avoid variations due to manual operation and achieve good uniformity of results. However, when employing automatic actuation, it is crucial to select an actuation force that effectively ensures complete valve opening, thereby safeguarding the accuracy and reliability of the inhalation aerosol product. This suggests that attention should be paid to patients with limited hand strength (such as children and the elderly) when using aerosols.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1363-1372"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative study between pH, time and colonic bacterial enzyme triggered polymers for colonic delivery of coated ketoprofen multi-particulates.","authors":"Debaprasad Ghosh, Ashu Mittal, Mandeep Kumar Arora","doi":"10.1080/03639045.2025.2525951","DOIUrl":"10.1080/03639045.2025.2525951","url":null,"abstract":"<p><strong>Background: </strong>In this study, we aimed to prepare, evaluate, and compare drug-loaded pellets of ketoprofen coated with different triggering mechanisms for colonic delivery.</p><p><strong>Objective: </strong>The purpose of this study was to compare Eudragit S100 and Eudragit L100 based pH-dependent, hydroxypropyl cellulose and ethyl cellulose-based time-dependent and high methoxylated pectin and ethyl cellulose-based colonic bacterial enzymatic degradation-dependent coatings over drug-loaded pellets for most efficient colon targeting.</p><p><strong>Methods: </strong>Any possible drug-polymer interactions were analyzed using Fourier-transform infrared spectroscopy and differential scanning calorimetry. Drug-loaded pellets were prepared using powder layering technology. Different batches of coated pellets were prepared for <i>in vitro</i> evaluation, and optimized batches were selected. These optimized batches were investigated for surface topography by scanning electron microscopy and for colon targeting efficiency by <i>in vivo</i> X-ray roentgenography and gamma scintigraphy studies in white New Zealand rabbits.</p><p><strong>Results: </strong>The drug and polymers were found to be compatible. The prepared coated multi-particulates exhibited favorable micrometric properties. In vitro dissolution studies showed that the polysaccharide pectin high methoxylated and ethyl cellulose-coated optimized batch limited drug release to 16.724 ± 1.124% in the upper gastrointestinal tract and released up to 91.556 ± 3.144% in the colon following zero-order Korsmeyer-peppas super case-II transport (mean dissolution time 36.1779 h). Scanning electron microscopy analysis confirmed the surface characteristics of the pellets before and after dissolution. <i>In vivo</i> studies in New Zealand white rabbits using X-ray roentgenography and gamma scintigraphy demonstrated the optimized batch's gastrointestinal transit and colon targeting efficiency.</p><p><strong>Conclusion: </strong>Statistically, the polysaccharide-based formulation showed promising results for targeted drug release in the colon.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1230-1243"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Simple but novel taxifolin@pro-glycymicelles as effective treatment for acetaminophen overdose-induced hepatotoxicity: preparation, in vitro characterizations, and in vivo experimental evaluations.","authors":"Yao Dong, Ling Zhang, Xixi Song, Xiaoli Chen, Yuyan He, Xianggen Wu, Mengshuang Li","doi":"10.1080/03639045.2025.2525968","DOIUrl":"10.1080/03639045.2025.2525968","url":null,"abstract":"<p><strong>Objective: </strong>To develop a simple but novel formulation named TAX@pro-glycymicelles with glycyrrhizin as the nanomaterial encapsulating taxifolin (TAX).</p><p><strong>Significance: </strong>TAX@pro-glycymicelles, simply prepared with two generally recognized as safe phytochemicals, demonstrated excellent characteristics, improved oral bioavailability of TAX, and strong effects against hepatotoxicity.</p><p><strong>Methods: </strong>TAX@pro-glycymicelles were prepared, and its physicochemical properties were determined. Safety assays, oral bioavailability in rats, treatment effects and mechanisms on liver injury in mice were also inflicted on TAX@pro-glycymicelle.</p><p><strong>Results: </strong>TAX@pro-glycymicelles were simply prepared, and the obtained powder demonstrated good storage stability and could be rapidly solubilized into water solutions to be clear nano-glycymicelle solutions. The apparent aqueous solubility of TAX from TAX@pro-glycymicelles was exceptionally improved to higher than 40 mg/ml. The <i>in vitro</i> release of TAX@pro-glycymicelles was also accelerated, and their <i>in vitro</i> antioxidative activity increased. Hemolysis and hen's egg test-chorioallantoic membrane assays showed that TAX@pro-glycymicelles exhibited good safety profiles. Oral bioavailability of TAX@pro-glycymicelles was approximately 32.1% higher than that of bare TAX in rats. TAX@pro-glycymicelles was also found to have a stronger dose-dependent treatment effect on acetaminophen overdose-induced hepatotoxicity in mice than bare TAX, including decreasing liver-to-body and spleen-to-body weight ratios, significantly decreasing alanine aminotransferase and aspartate aminotransferase levels in serum, decreasing inflammation and oxidative stress cytokine levels in livers, and reversing severe histological damage to liver tissues. The mechanisms of inhibiting oxidative stress and blocking high-mobility group box 1 signaling-related proinflammatory cytokines were involved in these strong treatment effects.</p><p><strong>Conclusions: </strong>TAX@pro-glycymicelles were found to be promising nano-formulations for treating acetaminophen overdose-induced hepatotoxicity.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1269-1284"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrating the design thinking approach into pharmaceutical product development: emphasizing nanomedicine innovation.","authors":"Aliasgar Shahiwala","doi":"10.1080/03639045.2025.2563633","DOIUrl":"10.1080/03639045.2025.2563633","url":null,"abstract":"<p><strong>Objective: </strong>To perform a narrative review that critically examines the application of design thinking (DT) in pharmaceutical product development, with emphasis on its role in advancing nanomedicine innovation and patient-centric drug design.</p><p><strong>Significance of review: </strong>DT offers a human-centered, iterative alternative to the traditional linear R&D model. Its integration into pharmaceutical development addresses challenges such as high attrition rates, limited patient input, regulatory complexity, and scalability, thereby improving translational success. This review adopts a conceptual and narrative approach, analyzing the five stages of DT, Empathize, Define, Ideate, Prototype, and Test, within the context of pharmaceutical development.</p><p><strong>Key findings: </strong>The application of DT fosters tangible benefits in pharmaceutical innovation, including empathy-driven product design, targeted problem framing, and iterative prototyping aligned with user and regulatory needs. Case studies such as Doxil^®, ABRAXANE^®, and mRNA-based COVID-19 vaccines illustrate established successes, while emerging examples, including CRISPR-based therapeutics and extracellular vesicle (EV) nanocarriers, underscore the forward-looking potential of this methodology. Together, these examples highlight how DT accelerates development timelines, mitigates risk, and enhances patient and regulatory alignment.</p><p><strong>Conclusions: </strong>Integrating DT into pharmaceutical product development enhances innovation by fostering interdisciplinary collaboration, reducing costs, and increasing the likelihood of successful translation to market. Its strategic application in nanomedicine provides a transformative pathway for next-generation therapies that are safer, more effective, and aligned with patient expectations and evolving regulatory frameworks.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-11"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and <i>in-vitro</i> optimization of telmisartan-curcumin solid dispersion nanoparticles for the management of diabetic nephropathy using DoE approach.","authors":"Aruna Rawat, Samrat Chauhan, Rahul Pratap Singh, Monika, Sumeet Gupta, Vikas Jhawat","doi":"10.1080/03639045.2025.2525952","DOIUrl":"10.1080/03639045.2025.2525952","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to develop and optimize telmisartan (TLS)-curcumin (Cur) solid dispersion nanoparticles (SDNs) to improve the management of diabetic nephropathy (DN) by enhancing TLS's solubility and release rate.</p><p><strong>Methods: </strong>A Box-Behnken design (BBD) was used to optimize the formulation with critical excipients PVP VA S630 and Poloxamer 407. Pre-formulation studies assessed TLS's solubility and lipophilic nature. The optimized formulation (TLS-15) was evaluated for solubility, drug release, particle size, zeta potential, and <i>in vitro</i> release. A comparison was made with a formulation without Cur (TLS-15 WC). TEM imaging and release kinetics analysis were conducted.</p><p><strong>Results: </strong>The optimized formulation (TLS-15) demonstrated significantly improved solubility (4.801 μg/mL) and drug release (99.68%) with an appropriate particle size (303.5 nm) and zeta potential (-12.17 mV). TLS-15 WC exhibited lower values for solubility (4.74 μg/mL), drug release (98.3%), particle size (291.2 nm), and zeta potential (-25.4 mV). TEM revealed uniformly distributed spherical nanoparticles (NPs). TLS-15 showed a 99.54% release after 6 h, compared to 98.3% for TLS-15 WC, following first-order release kinetics (<i>R</i>² = 0.9934).</p><p><strong>Conclusions: </strong>The study successfully developed and optimized TLS-Cur SDNs, enhancing TLS's solubility and release. Cur played a critical role in boosting the therapeutic potential of the formulation. While challenges remain with stability and manufacturing, the formulation shows promise for improving bioavailability and efficacy in DN treatment. However, additional studies are needed to validate its effectiveness.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1244-1256"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A novel data-driven approach to assess the chewability and grittiness of the chewable tablets using a texture analysis.","authors":"Yu Zhang, Hongyue Liu, Jitong Wang, Fan Zhao, Jinru Hu, Zhidan Liu, Ruixiang Li, Minchen Liu, Jia Zeng, Li Qin, Ruofei Du","doi":"10.1080/03639045.2025.2523547","DOIUrl":"10.1080/03639045.2025.2523547","url":null,"abstract":"<p><strong>Context: </strong>Chewable tablet palatability significantly impacts patient compliance, but current pharmacopeias have no standardized evaluation methods. This requires developing an objective system for assessing the palatability of chewable dosage forms, which will aid in setting quality control standards.</p><p><strong>Objective: </strong>Using a texture analyzer, this study aimed to develop an objective, data-driven approach to evaluate chewability and grittiness in chewable tablets.</p><p><strong>Methods: </strong>10 commercially available chewable tablet formulations were assessed, with subjective sensory evaluations supplemented by texture analysis-based measurements to quantify attributes of chewability and grittiness. To evaluate chewability, measurements of axial compression force, work, and adhesion were conducted, establishing optimal conditions of 400 N, 3 mm, and 50% strain to simulate oral chewing. For grittiness, a correlation between particle size and linear distance value was demonstrated, with Calcium carbonate used as a reference material to establish a standardized evaluation scale.</p><p><strong>Results: </strong>Results indicated a strong correlation between tablet formulations and their sensory and texture analysis scores, with stickiness largely influenced by formulation ingredients such as milk powder and cacao powder. And the particle size of the insoluble material in the tablets largely influences the grit sensation.</p><p><strong>Conclusion: </strong>We developed a novel data-driven approach that offers a standardized assessment system to evaluate palatability characteristics in chewable tablets, facilitating more consistent formulation comparisons and potential optimization for consumer acceptability. This approach highlights the utility of texture analysis in transitioning empirical palatability assessments to objective, quantifiable methods, which may extend to other oral dosage forms.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1203-1217"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144607802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigation on the protective effect of Ganoderma Lucidum spore oil on pustular acne based on molecular dynamics simulation and experimental validation.","authors":"Chunyu Wang, Hanxiao You, Yuting Yan, Yue Zhou, Xinxin Liu","doi":"10.1080/03639045.2025.2531403","DOIUrl":"10.1080/03639045.2025.2531403","url":null,"abstract":"<p><p>Ganoderma lucidum spore oil (GLSO), a bioactive natural product, demonstrates notable antioxidant, anti-inflammatory, and immunomodulatory properties, suggesting therapeutic potential. Pustular acne, characterized by intrafollicular pus accumulation, is primarily mediated by oxidative stress. This study investigated the antioxidative and therapeutic effects of GLSO on pustular acne through integrated computational and experimental approaches. Network pharmacological analysis revealed eight core targets associated with pustular acne pathogenesis. Molecular docking and dynamics simulations demonstrated stable binding of lucidone A and Cerevisterol to key targets (PTPN6/KDR), suggesting their role in modulating oxidative signaling pathways. <i>In vitro</i> experiments demonstrated that GLSO (25-100 mg/L) significantly improved the viability of H₂O₂-treated human keratinocytes and attenuated intracellular ROS levels, achieving efficacy comparable to that of vitamin C (positive control). Western blot and RT-PCR analyses confirmed that GLSO upregulates mRNA and protein expression of PTPN6 and KDR. Additionally, GLSO exhibited potent total antioxidant capacity (ABTS: 2.88 mmol/g; FRAP: 0.126 mmol/g). These findings suggest that GLSO alleviates pustular acne by targeting oxidative stress <i>via</i> active components such as lucidone A and Cerevisterol, which modulate PTPN6 and KDR signaling. This study provides mechanistic insights and preclinical evidence to support further clinical development of Ganoderma-derived therapeutics.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1318-1330"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}