Journal of Pharmaceutical Innovation最新文献

{"title":"Novel Ketoconazole-Loaded Niosomal Gel with Carbamide for Enhanced Topical Delivery and Skin Hydration in Fungal Infections","authors":"Prajitha Biju,&nbsp;Manjunath M. Shenoy,&nbsp;Rouchelle Tellis,&nbsp;Ramesh Bhat,&nbsp;Ranajit Das,&nbsp;Ashwini Prabhu,&nbsp;Mohammed Gulzar Ahmed,&nbsp;Vivek Ghate","doi":"10.1007/s12247-024-09916-9","DOIUrl":"10.1007/s12247-024-09916-9","url":null,"abstract":"<div><h3>Purpose</h3><p>Atopic dermatitis is a condition, wherein the outermost skin layer is disrupted, leading to excessive water loss and cutaneous lesions. This study assesses an antifungal topical formulation utilizing a vesicular system loaded with ketoconazole and a hydrating agent to treat fungal skin infections while preventing resistance and recurrence.</p><h3>Methods</h3><p>The Central Composite Design in Design Expert software was used to optimize ketoconazole-loaded niosomes, with vesicle size and drug entrapment efficiency as dependent variables and surfactant and organic solvent concentrations as independent variables. The optimized formulation was evaluated against predicted values, and compatibility and stability were analyzed via FT-IR and differential scanning calorimetry. Niosome morphology was examined using light microscopy and SEM. Niosomes were incorporated into a hydrogel containing 5% carbamide, a pH stabilizer, and preservative to enhance dermal bioavailability. The gel underwent evaluations for viscosity, antifungal activity, <i>in vitro</i> drug release, <i>ex vivo</i> permeation, skin irritation, TEWL, and histopathology.</p><h3>Results</h3><p>Optimized niosomes had a vesicle size of 275 nm and 98.38% drug entrapment efficiency. The gel was translucent, non-sticky, had a viscosity of 18,200 mPa·s at 20 °C, and exhibited a sustained <i>in vitro</i> drug release. The release kinetics followed zero-order and Baker-Lonsdale models, with R² values of 0.94 and 0.99. Application on mice reduced moisture loss and improved skin barrier function.</p><h3>Conclusion</h3><p>The ketoconazole-loaded niosomal gel is a promising carrier for dermal drug delivery against fungal infections.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143594778","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":"Bioinspired Chitosan-Based Patches Enriched With Lipid-Casein Nanocarriers: An Innovative Approach for Wound Management and Evaluation in a Rat Model","authors":"Madhu Kumari,&nbsp;Monika Dwivedi,&nbsp;K. Jayaram Kumar,&nbsp;Ashok Kumar Pattnaik","doi":"10.1007/s12247-025-09946-x","DOIUrl":"10.1007/s12247-025-09946-x","url":null,"abstract":"<div><h3>Purpose</h3><p>Wounds are physical injuries that disrupt the skin’s structure and function, necessitating a complex healing process to restore integrity and functionality. Ursolic acid (UA), a naturally occurring compound, exhibits remarkable antioxidant, anti-inflammatory, and antimicrobial properties, making it a promising candidate for wound healing applications. However, its therapeutic potential is hindered by challenges such as poor solubility, limited permeability, and low bioavailability, which restrict its effectiveness in clinical settings. Delivering UA through nanocarriers provides a significant advantage in resolving these issues, we designed bioinspired milk protein casein-lipid nanocarriers (UA LCNPs) that were incorporated in a chitosan-based transdermal patch.</p><h3>Method</h3><p>UA LCNPs were prepared using the desolvation method utilizing casein and Phospholipon 90 ^® G. UA LCNPs were characterized by dynamic light scattering (DLS), surface morphology, DSC, and FTIR parameters. The formulated nanoparticles were then incorporated into the chitosan patch using solvent-casting method. The UA LCNPs loaded patches were evaluated for the drug content, surface pH, FESEM, swelling index, hemolysis assay, antioxidant, etc. Furthermore, the developed transdermal patch was characterized and evaluated for in vitro permeation and in vivo wound treatment activity in rats.</p><h3>Results</h3><p>The formulated nanoparticles were spherical, with particle size (PS) 172.9 nm, zeta potential (ZP) -14.5 mV, and a PDI value were 0.336. The prepared patch from the nanoparticles was smooth, homogenous, and flexible having high drug content. The results showed that a transdermal patch can effectively control the UA release from the patch and the accumulation of UA in the skin. The hemolysis data provides insight into safety profile and <i>invivo</i> antioxidant activity showing strong antioxidant properties by inhibiting lipid peroxidation. The results showed that the transdermal patch UA LCNPs (test group) demonstrated effective wound healing compared to the control group and marketed ointment groups.</p><h3>Conclusion</h3><p>This work serves as a platform for the strategic management of wounds through phytomolecules shelled in casein nanocarriers subduing associated solubility and permeability hurdles. Moreover, accommodating them in patches for self-administration at the injury site presents an effective mode of wound management.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div><div><p>Graphical representation of delivery of bioinspired hybrid nanocarriers UA LCNPs through a transdermal patch on excision wound model displaying fast healing</p></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143564415","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":"Good Laboratory Practice in Preclinical Research: Lessons Learned from Warning Letters Issued Between 2019 and 2024 Addressing Violations to the 21 Code of Federal Regulation Part 58","authors":"Isra Dmour","doi":"10.1007/s12247-025-09932-3","DOIUrl":"10.1007/s12247-025-09932-3","url":null,"abstract":"<div><h3>Purpose</h3><p>The study aims to critically review US FDA warning letters (WLs) issued during inspections between 2019 and 2024 for compliance with Good Laboratory Practice in Preclinical research facilities.</p><h3>Methods</h3><p>WLs were downloaded from the US FDA public domain of the WLs and the content of each WL was assessed based on types and frequencies of violations and corrective and preventive actions (CAPA) employed by the testing facility or requested by the FDA investigators. Each WL was evaluated and critically analyzed about the applicable regulation. Violations were correlated with consequences of non-compliance, as addressed by the FDA inspectors.</p><h3>Results</h3><p>Eight WLs letters were analyzed. The incidence of violations concerning the QAU’s failure to meet responsibilities, documentation deficiencies, noncompliance with study protocols, deviations in animal handling, and data capture in the final study report was 12% each. The violations concerning the study director’s failure to fulfil his/her duties and deficient/ noncompliance to pertinent SOPs were 10% each. The incidence of inadequate qualifications among study personnel and the management of specimens/reagents and controls was 9% and 6%, respectively. The minimal variance was linked to specimen/record retention (5%).</p><h3>Conclusion</h3><p>Testing facilities in preclinical research are requested to evaluate personnel responsibilities, improve GLP training programs, and implement adequate standard procedures to comply with GLP standards, reducing the recurrence of these violations and enhancing data integrity and validity that will support a clinical submission.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143564507","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":"Study on Effective Phase Resolution of Xiaoyao Powder and its Anti-Mammary Hyperplasia Effect","authors":"Dai Xiaofang,&nbsp;Zhu Meiwei,&nbsp;Yan Lili,&nbsp;Yang Fangfang,&nbsp;Yang Han,&nbsp;Wang Rui,&nbsp;Guan Qingxia","doi":"10.1007/s12247-025-09937-y","DOIUrl":"10.1007/s12247-025-09937-y","url":null,"abstract":"<div><h3>Purpose</h3><p>Xiaoyao San (XYS) is an ancient clinical dosage form in China. Our previous research discovered that the compound decoction of traditional Chinese medicine presents a mixed-phase system, encompassing nanophase, precipitated phase, suspension phase, and true solution phase. Hence, this study is intended to screen out the effective phases among the four phases of XYS and explore its anti-hyperplasia effect on mammary glands.</p><h3>Methods</h3><p>Four phases of XYS were prepared by centrifugation-dialysis. The preparation process, characterization, determination of chemical composition, and anti-breast hyperplasia effects were investigated.</p><h3>Results</h3><p>The four phases of XYS were successfully separated. The characterization results indicated that the nanophase of XYS had the smallest particle size, polydispersity index (PDI) value, and the largest potential value, with an average particle size of approximately 100 nm. In the content determination, the component content ratios of the four phases were consistent, and the content of the nanophase was much higher than that of the other phases. The pharmacodynamic results demonstrated that all indicators of rats in the XYS whole liquid and nanophase groups were significantly improved compared with those in the model group (<i>p</i> &lt; 0.05). At the same time, there were no significant differences in the indicators of rats in the other phase groups. The grey correlation degree analysis revealed that the common peaks of both XYS whole liquid and nanophase were correlated with the pharmacological effect, and the correlation degrees were all greater than 0.7.</p><h3>Conclusion</h3><p>This research successfully proved from physicochemical characterization and pharmacodynamics perspectives that the nanophase is the effective phase and that multiple components jointly exert the anti-hyperplasia effect of mammary glands.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143564416","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 Optimization of a Self-Nanoemulsifying Drug Delivery System (SNEDDS) for Enhanced Oral Delivery of Dolutegravir","authors":"Raghuveer Pathuri,&nbsp;Lakshmi Devi Gottemukkula","doi":"10.1007/s12247-025-09951-0","DOIUrl":"10.1007/s12247-025-09951-0","url":null,"abstract":"<div><h3>Purpose</h3><p>The aim of this present study is to develop and optimise a self-nano emulsifying drug delivery system (SNEDDS) for the enhanced oral delivery of dolutegravir (DTG), a poorly water-soluble antiretroviral drug.</p><h3>Methods</h3><p>The SNEDDS formulation was developed using Capmul MCM (oil), Kolliphor RH40 (surfactant), and PEG 400 (co-surfactant). Box Behnken design was employed to optimize the composition of the SNEDDS formulation. The prepared formulations were evaluated for droplet size, polydispersity index (PDI), zeta potential, self-emulsification time, and in vitro drug release.</p><h3>Results</h3><p>The optimized SNEDDS formulation (F2) exhibited a droplet size of 79.2 ± 0.9 nm, PDI of 0.105 ± 0.012, zeta potential of -32.1 ± 1.5 mV, and self-emulsification time of 22 ± 2 s. In vitro drug release studies demonstrated a significantly higher cumulative drug release from the optimised SNEDDS formulation (98.9 ± 0.9% in 60 min) than pure DTG (42.5 ± 2.1%). The optimized formulation exhibited excellent thermodynamic stability and robustness under various stress conditions. Ex vivo drug release studies using rat stomach tissue confirmed the enhanced drug release potential of the optimized SNEDDS formulation in the gastric environment.</p><h3>Conclusion</h3><p>The developed SNEDDS formulation offers a promising approach for the enhanced oral delivery of DTG, potentially improving its bioavailability and therapeutic efficacy.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143564414","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":"Artificial Intelligence: Preface, Applications and Future Perspective in Relation to Pharmaceutical Sector","authors":"Supriya Singh,&nbsp;Sanket Kumar,&nbsp;Sheikh Shahnawaz Quadir,&nbsp;Saloni Bhandari,&nbsp;Bhuvanesh Baniya,&nbsp;Garima Joshi,&nbsp;C. P. Jain,&nbsp;Deepak Choudhary","doi":"10.1007/s12247-025-09940-3","DOIUrl":"10.1007/s12247-025-09940-3","url":null,"abstract":"<div><h3>Purpose</h3><p>Artificial intelligence (AI) platforms are among the most prominent digital innovations in the contemporary time. The colossal growth and success of AI has garnered the attention of the scientific community and it is also being accepted in the public domain. The current review aims to provide in depth information about the utilization of AI in the pharmaceutical sector along with the limitations, ethical-legal aspects and future perspective of this technology in uplifting the growth of this sector. </p><h3>Methods</h3><p>The accredited web pages of PubMed, Google Scholar, Scopus and Web of Science were accessed using the terms “artificial intelligence” and “pharmaceutical”. Cross-referencing important articles yielded additional references which were evaluated and utilized for inclusion in writing this review.</p><h3>Result</h3><p>The dexterity of AI tools was explored in numerous domains of pharmaceutical sector like drug discovery, pharmaceutical product development, manufacturing, product management, clinical &amp; diagnostic field, 3D printing technology and community pharmacy. It was found that the augmentation of AI with pharmaceutical sector will lift the growth of this sector by heaps and bounds for the reason that every facet will be reshaped in terms of finances and time.</p><h3>Conclusion</h3><p>Significant developments in AI offers a revolutionary chance for drug discovery, formulation, clinical and diagnostic applications, 3D printing and plentiful applications in the pharmaceutical industry. However, AI presents risk factors and ethical concerns that must be handled before society, health systems, and individuals can fully benefit from it. Pharmaceutical developers should ensure that the AI tools and procedures comply with all ethical and regulatory standards enforced by the regulatory agencies.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143564489","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":"Formulation and Development of Resveratrol-Loaded Sulfobutylether β-Cyclodextrin and PVP K90-Based Nanofiber Mat Via Electrospinning for the Breast Cancer Therapy","authors":"Priyanka Shinde,&nbsp;Amol Shete,&nbsp;Vishwajeet Ghorpade,&nbsp;Namdev Harale,&nbsp;Swapnali Patil,&nbsp;Namrata Desai,&nbsp;Snehal Patil","doi":"10.1007/s12247-025-09956-9","DOIUrl":"10.1007/s12247-025-09956-9","url":null,"abstract":"<div><h3>Purpose</h3><p>Breast cancer (BC) remains the leading cause of cancer-related mortality among women. This study aimed to improve the solubility, stability, and therapeutic efficacy of Resveratrol (RES) by developing an electrospun nanofiber mat for targeted drug delivery to breast tissue.</p><h3>Methods</h3><p>RES was incorporated into an inclusion complex with sulfobutylether β-cyclodextrin (SBE-β-Cyd) and polyvinylpyrrolidone (PVP K90). Polymer selection was guided by molecular docking and solution-state stability studies. The nanofibers were characterized using FTIR, DSC, XRD, and SEM, and evaluated for entrapment efficiency, moisture content, contact angle, and tensile strength. In vitro and ex vivo studies assessed drug release in phosphate buffer (pH 7.4) and biocompatibility using the HET-CAM assay. Antioxidant activity was analyzed via the DPPH assay, while anticancer potential was tested against MCF-7 breast cancer cells.</p><h3>Results</h3><p>The nanofibers demonstrated sustained RES release, enhanced solubility, and improved skin permeation. Biocompatibility studies confirmed their non-irritant nature and antioxidant assays showed maintained activity. Cytotoxicity assays indicated that RES-loaded nanofibers exhibited significant anticancer effects against MCF-7 cells, surpassing pure RES.</p><h3>Conclusion</h3><p>The developed RES-loaded nanofiber mat presents a promising localized treatment for breast cancer by overcoming RES’s solubility and stability limitations. The formulation enables sustained drug release and enhanced therapeutic efficacy, warranting further in vivo investigations to validate its clinical potential.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143564490","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":"Colloidal Copper Nanoparticles Loaded with Vanillic Acid as Liquid Dressings: Development, Characterisation and Evaluation","authors":"Mohini Yadav,&nbsp;Neelam Datt,&nbsp;Priyanka Maurya,&nbsp;Vishwambhar Mishra,&nbsp;Shailendra K. Saraf","doi":"10.1007/s12247-025-09948-9","DOIUrl":"10.1007/s12247-025-09948-9","url":null,"abstract":"<div><h3>Purpose</h3><p>The study aimed to develop liquid dressings containing copper nanoparticles infused with vanillic acid to enhance their antibacterial properties.</p><h3>Method</h3><p>PEG 6000 served as a stabilising agent in the chemical reduction process. The Box-Behnken design was employed to optimise the synthesised nanoparticles. Vanillic acid, obtained from Vanilla planifolia, possesses medicinal qualities, promoting wound healing and antioxidant properties. The nanoparticles were integrated into an optimised batch of in-situ film (liquid dressing) and assessed using DSC, FESEM, cytotoxicity analysis, and in-vivo testing.</p><h3>Result</h3><p>The optimised batch exhibited an entrapment effectiveness of 90.9%, an in-vitro drug release of 89.6%, a particle size of 97.9 nm, a zeta potential of -31 mV, and a polydispersity index of 0.316.</p><h3>Conclusion</h3><p>The liquid dressing exhibited superior wound healing capabilities compared to the pure Vanillic acid solution.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143564488","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":"The Effect of Rheum turkestanicum Janisch in the Treatment of Bacterial Vaginosis Recurrence: A triple-Blinded Randomized Clinical Trial","authors":"Sedigheh Mousaei,&nbsp;Zahra Esmaeili,&nbsp;Leila Mohtashami,&nbsp;Shokouh Sadat Hamedi,&nbsp;Fatemeh Mahjoub,&nbsp;Lida Jarahi,&nbsp;Kiarash Ghazvini,&nbsp;Malihe Afiat,&nbsp;Mahnaz Boroumand Rezazadeh,&nbsp;Seyed Kazem Farahmand,&nbsp;Siamak Mokhtari,&nbsp;Maliheh Motavasselian","doi":"10.1007/s12247-025-09945-y","DOIUrl":"10.1007/s12247-025-09945-y","url":null,"abstract":"<div><h3>Objectives</h3><p>Bacterial vaginosis (BV) is a common condition among women of reproductive age. Short-term antibiotic treatments are often clinically effective, but recurrence after treatment is frequent. The high recurrence rate and increasing antibiotic resistance highlight the need for new treatment methods. This study aimed to evaluate the effectiveness of a vaginal gel containing <i>Rheum turkestanicum Janisch</i> in comparison to metronidazole for the treatment and prevention of BV recurrence.</p><h3>Study Design</h3><p>This study was a randomized, triple-blinded, controlled trial involving 30 women. Married women aged 18 to 50 years who had been diagnosed with BV and did not meet any exclusion criteria were randomly allocated to the intervention or control groups. The intervention group received <i>R. turkestanicum</i> vaginal gel and <i>R. turkestanicum</i> capsules, while the control group received metronidazole vaginal gel and placebo capsules. Both groups underwent treatment for 7 days.</p><h3>Main Outcome Measures</h3><p>Variables such as demographic data, bacterial vaginosis patients’ signs and symptoms, Amsel’s criteria, and Nugent score were compared and examined before and after treatment with rhubarb and metronidazole in the patients.</p><h3>Results</h3><p>The initial assessment, conducted 10 days after treatment, showed significant improvement in each control and treatment group, but there was no significant difference between the two groups. However, the evaluation of recurrence status 30 days later indicated that the intervention group (using <i>R. turkestanicum</i> vaginal gel and <i>R. turkestanicum</i> capsules) was significant to metronidazole in treating recurrence.</p><h3>Conclusion</h3><p><i>Rheum turkestanicum</i> has the potential to be offered as a novel treatment for BV.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143553814","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 of Colon-Targeted Naringin-Loaded Microbeads in Acetic Acid-Induced Colitis Model in Rats for the Management of Inflammatory Bowel Disease","authors":"Sonia Chauhan,&nbsp;Ranjit K. Harwansh,&nbsp;Rupa Mazumder","doi":"10.1007/s12247-025-09947-w","DOIUrl":"10.1007/s12247-025-09947-w","url":null,"abstract":"<div><h3>Purpose</h3><p>The study aimed to develop naringin (NAR)-loaded microbeads coated with Eudragit-S100 polymer for colon-targeted drug delivery, focusing on effectively treating inflammatory bowel disease (IBD).</p><h3>Methods</h3><p>NAR-loaded microbeads were formulated by ionic gelation technique. The formulation variables (concentration of chitosan, sodium alginate and sodium tripolyphosphate) were optimized by using Box-Behnken's Design (BBB). Morphological and characterization of the microbeads were performed. Additionally, the therapeutic potential of the microbeads was evaluated in the acetic-acid-induced colitis model by assessing colitis severity, inflammatory markers and histological examination of colonic tissue.</p><h3>Results</h3><p>The optimized formulation exhibited a particle size (PS) (258.42 ± 2.98 µm), drug entrapment efficacy (DEE) (87.04 ± 1.67%), % yield (88.45 ± 2.87%), swelling index (SI) (1.21 ± 0.08) in pH 7.4, and zeta potential (-26.24 ± 0.21 mV). Maximum drug release (93.07 ± 3.67%) was achieved in simulated colonic fluid at pH 7.4 over 24 h, following a <i>non-Fickian mechanism</i> involving diffusion, matrix erosion, and bacterial degradation. The results demonstrated that optimized formulation significantly alleviated colitis symptoms by reducing oxidative stress and inflammatory cytokines in colon tissue.</p><h3>Conclusion</h3><p>NAR-loaded microbeads, optimized by Box–Behnken design, showed strong therapeutic potential in an acetic acid (AA)-induced colitis model. They reduced tissue necrosis factor-α and myeloperoxidase while improving antioxidant levels such as catalase and superoxide dismutase, offering a promising targeted therapy for IBD.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143553768","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}