Journal of Pharmaceutical Innovation最新文献

{"title":"Development and Evaluation of 5-Flucytosine Solid Lipid Nanoparticle-Loaded Topical Gels for Enhanced Chronic Wound Healing","authors":"Vinay Kumar Chakravarthy Maddikunta,&nbsp;Kumaraswamy Gandla,&nbsp;Rajkumari Thagele","doi":"10.1007/s12247-025-10063-y","DOIUrl":"10.1007/s12247-025-10063-y","url":null,"abstract":"<div><p>This study aimed to develop and evaluate a 5-Flucytosine (5-FC)-loaded solid lipid nanoparticle (SLN) gel optimized for chronic wound healing. SLNs were prepared using stearic acid and poloxamer 407 and optimized via central composite design. The optimized nanoparticles exhibited a particle size of 390.60 nm, entrapment efficiency of 89.60% and PDI of 0.215. SLNs were incorporated into a Carbopol 934 gel base for topical application. The formulation demonstrated a high drug content (94.58 ± 0.73% w/w) and favorable rheological properties. In vitro drug release studies indicated an initial burst followed by sustained release (91.5% at 7 h). FTIR confirmed drug-excipient compatibility. Biocompatibility was verified using an MTT assay in human fibroblasts. In vivo wound healing studies in diabetic mice showed enhanced collagen deposition, immune cell recruitment, and accelerated wound closure. The developed SLN-based gel presents a promising strategy for localized, sustained antimicrobial delivery in chronic wound management.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145161274","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":"Enhancing Skin Penetration of Meloxicam: Liposomal Formulation Development and Optimization","authors":"Aryan YousefiFard,&nbsp;Anayatollah Salimi,&nbsp;Eskandar Moghimipour,&nbsp;Nasim Karami","doi":"10.1007/s12247-025-10060-1","DOIUrl":"10.1007/s12247-025-10060-1","url":null,"abstract":"<div><h3>Background</h3><p>Meloxicam is a potent nonsteroidal anti-inflammatory drug (NSAID) utilized for the treatment of acute pain and inflammatory diseases, including osteoarthritis and rheumatoid arthritis. Despite its therapeutic benefits, meloxicam’s oral use can be associated with significant gastrointestinal risks, such as bleeding, ulcerations, and perforations, which pose challenges to patient safety and treatment adherence. Transdermal drug delivery effectively reduces these limitations, with liposomes providing an appropriate system for this route of administration. The study aimed to develop a liposomal formulation of meloxicam that could pass through skin barriers and facilitate transdermal drug delivery.</p><h3>Materials and Methods</h3><p>The study was based on a full factorial design, and the effect of independent variables, namely lecithin, cholesterol, and sonication time, was investigated to determine the liposomes constructed by the thin film hydration method.</p><h3>Results</h3><p>The particle sizes of liposomes ranged from 146 to 268 nm, with drug loading percentages between 26.24% and 63.13%. Higuchi’s model best matched the drug release profiles. The findings indicated that reducing the amounts of both lecithin and cholesterol resulted in an increased percentage of drug release. Additionally, enhanced sonication time led to higher steady-state fluxes (Jss) and permeability coefficients, as well as a reduction in lag time (Tlag).</p><h3>Conclusion</h3><p>This study showed that the liposomal formulation improved skin penetration by getting around meloxicam’s physicochemical limitations. This suggests a promising way to deliver the drug topically.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div><div><p>Graphical abstract shows increased penetration of meloxicam into the skin by optimizing liposomal formulation </p></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-10060-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145142059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulation and Characterization of Isavuconazole-Loaded Chitosan/Sodium Alginate Nanoparticles for Dermal Delivery: in Vitro and in Vivo Evaluation for Enhanced Antifungal Therapy","authors":"Shahzad Khan,&nbsp;Asif Nawaz,&nbsp;Muhammad Khursheed Alam Shah,&nbsp;Muhammad Shahid Latif,&nbsp;Muhammad Haroon,&nbsp;Abdullah Khan,&nbsp;Tarek Mohamed Ali Elsayed","doi":"10.1007/s12247-025-10052-1","DOIUrl":"10.1007/s12247-025-10052-1","url":null,"abstract":"<div>\u0000 \u0000 <p>The present study aimed to develop isavuconazole-loaded nanoparticles (NPs) using chitosan and sodium alginate polymers via the ionic gelation technique for topical antifungal therapy. Nanoparticles were formulated with various surfactants and extensively characterized for their physicochemical properties. The particle size of the developed NPs ranged from 167 to 475 nm, with a polydispersity index (PDI) between 0.26 ± 0.09 and 0.39 ± 0.23, indicating uniform particle distribution. The zeta potential values confirmed the surface charge variation among formulations: chitosan and chitosan-alginate NPs exhibited a positive charge (33.08 ± 0.86 to 46 ± 2.9 mV), while alginate-only NPs were negatively charged (-30 ± 2.63 mV). Scanning electron microscopy revealed that all nanoparticles were spherical and smooth. The drug content ranged from 81.54 to 90.56%, with a drug loading capacity of 7.4 ± 1.1% to 10.3 ± 1.7%. Entrapment efficiency across formulations F1-F7 varied between 40.21 ± 1.54% and 60.64 ± 1.43%. ATR-FTIR analysis confirmed the compatibility of isavuconazole with chitosan, sodium alginate, and other excipients. The in vitro release profile indicated sustained drug release from the prepared nanoparticles. Kinetic modeling of drug release studies confirmed that the optimized formulation followed the Higuchi model. The skin permeation studies were performed using rat skin and demonstrated gradual and controlled drug transport. The optimized formulation (F4), containing tween 80 as a surfactant and permeation enhancer, showed the highest skin penetration (75.37%) and retention (19.72%). Antifungal activity against <i>Candida albicans</i> was significantly enhanced in the nanoparticle formulation, with F4 exhibiting a zone of inhibition of 17.65 mm compared to the pure drug. In vivo antifungal efficacy using a cutaneous candidiasis model revealed a marked reduction in fungal burden with F4, decreasing to 1.95 log CFU/lesion. Additionally, skin irritation studies indicated no signs of erythema, edema, or inflammation. Therefore, the developed chitosan/sodium alginate nanoparticles could be a promising drug delivery system for the enhancing antifungal efficacy of isavuconazole.</p>\u0000 </div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145160557","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":"Bioanalytical Method Development, Pharmacokinetic Determination, and Time-Dependent Mobility of a Novel Chronosystem of ACE Inhibitor","authors":"Saniya Jawed,&nbsp;Satish CS,&nbsp;Vimal Kumar","doi":"10.1007/s12247-025-10057-w","DOIUrl":"10.1007/s12247-025-10057-w","url":null,"abstract":"<div><h3>Purpose</h3><p>The Pharmacokinetic parameters were determined, and IVIVC has been proved in the current research work of formulated novel chronosystem (ChrDDS) of perindopril erbumine (PER).</p><h3>Methods</h3><p>To assess pure drug in the rabbit plasma, a swift, precise, and highly sensitive HPLC method was built. The time-dependent mobility of the ChrDDS was observed using radiography (X-ray). A Level A IVIVC relationship was established between the fraction of drug released (FDR) and the fraction of drug absorbed (FDA). The stability testing was performed for 180 days following ICH Q1A (R2) guidelines.</p><h3>Results</h3><p>Using a 30:25:45 methanol, acetonitrile, and phosphate buffer mixture having a pH of 2.6, the PER retention time was 4.880 min. The drug was released in a pulsatile manner, up to 24 h in the in vitro dissolution study, with two lag phases. The in-vivo pharmacokinetics revealed that the C_max for PER ChrDDS was 111.41 ± 14.35 ng/ml, with a T_max of 8 h and an MRT of 12.63 ± 1.81 h. The level-A IVIVC was validated by the correlation coefficient of 0.9894.</p><h3>Conclusion</h3><p>There were no discernible alterations in the physical characteristics, cumulative percentage release, or PER content, according to the stability estimation. Meeting all the requirements for hypertension chronotherapy, this study has the potential to be expanded in the future.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145171735","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":"Spectrophotometric Methods for Simultaneous Development and Validation of Anti-diabetic drug Alogliptin and Canagliflozin","authors":"Aniket Bhardwaj,&nbsp;Saurabh Verma,&nbsp;Vikesh Kumar Shukla,&nbsp;Havagiray R. Chitme","doi":"10.1007/s12247-025-10053-0","DOIUrl":"10.1007/s12247-025-10053-0","url":null,"abstract":"<div><h3>Background</h3><p>Alogliptin (ALO) selective inhibitor of dipeptidyl peptidase-4 (DPP-4) and Canagliflozin is the sodium-glucose cotransporter-2 (SGLT-2) inhibitor against type 2 diabetes mellitus.</p><h3>Purpose</h3><p>The study aimed to spectrophotometric simultaneous novel method development and validation of antidiabetic drugs Alogliptin (ALO) and Canagliflozin (CANA).</p><h3>Results</h3><p>A linear response was observed over a concentration range of 10–100 µg/mL for both compounds, achieving high correlation coefficients (R²) of 0.999, indicating excellent analytical reliability. The limits of detection (LOD) for CANA and ALO were determined to be 1.65 µg/mL and 8.8 µg/mL while the limits of quantification (LOQ) for CANA and ALO were 5.0 µg/mL and 26 µg/mL, respectively. The method was rigorously validated as per International Conference on Harmonization (ICH) Q2R1guidelines, assessing key parameters such as linearity, precision, accuracy, sensitivity, and robustness. Intra-day and inter-day precision studies yielded relative standard deviation (RSD) values below 2%, confirming the method’s reproducibility. Recovery studies demonstrated high accuracy, with recovery values for CANA and ALO ranging from 98 to 102%, further validating the method’s effectiveness. The study also evaluated the ruggedness of the method, with results showing acceptable limits and a % RSD value of less than 2% across different analysts and trials.</p><h3>Conclusion</h3><p>The UV spectrophotometric method developed is simple, cost-effective, and timesaving, making it suitable for routine estimation of ALO and CANA in both bulk and dosage forms. This method can be effectively applied for quality control, pharmacokinetic, and stability studies, thereby contributing significantly to the field of pharmaceutical analysis.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145171734","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":"Design and Evaluation of the PLGA Nanoparticles Containing Ketorolac Tromethamine in Glioblastoma Treatment","authors":"Tuğba Çopur,&nbsp;Nihat Kurt,&nbsp;Esra Pezik,&nbsp;Doruk Yalçın,&nbsp;Sibel Bozdağ Pehlivan,&nbsp;Levent Öner","doi":"10.1007/s12247-025-10051-2","DOIUrl":"10.1007/s12247-025-10051-2","url":null,"abstract":"<div><p>The blood–brain barrier (BBB) separates blood from brain tissue, making drug delivery to the brain a significant challenge. This study aims to develop and optimize a novel nanoparticle system that may overcome the BBB and have a potential effect on glioblastoma. Ketorolac tromethamine (KT)-loaded poly(lactic-co-glycolic acid) (PLGA) RG 503-H nanoparticles were prepared using water/oil/water (W/O/W) emulsification solvent evaporation. KT-loaded nanoparticles have a particle size of 155.5 ± 2.08 nm, a zeta potential of -12.9 ± 1.23 mV, a polydispersity index of 0.111 ± 0.035, and an encapsulation efficiency of 53.46%. A significant portion of the drug (&gt; 90%) was released in 6 h and completed within 24 h. When 3% (w/v) mannitol and trehalose were used as cryoprotectants, the nanoparticles remained physically stable. Additionally, it has been discovered that KT solution is cytotoxic at high doses to Rat Brain Glioblastoma (RG2) cells, and KT-loaded nanoparticles are more effective than drug solutions at lower doses.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145170881","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":"Forced Gas Convection for Uniform Freezing of Lyophilization Vials","authors":"Steven J. Burcat,&nbsp;Rohan P. Kadambi,&nbsp;Lorenzo Stratta,&nbsp;Richard D. Braatz,&nbsp;Roberto Pisano,&nbsp;Alexander H. Slocum,&nbsp;Bernhardt L. Trout","doi":"10.1007/s12247-025-10037-0","DOIUrl":"10.1007/s12247-025-10037-0","url":null,"abstract":"<div><h3>Purpose</h3><p>Conventional shelf-freezing in pharmaceutical lyophilization suffers from batch variation and is potentially incompatible with emerging continuous lyophilization systems. This work presents a forced gas convective freezing chamber for suspended vials in cross-flow to improve the quality of the freezing process and meet the continuous lyophilization needs.</p><h3>Methods</h3><p>First, computational fluid dynamics simulations were performed to determine key process parameters. Then, physical chambers were built to meet these requirements. Sets of twenty 10R vials containing 3 mL of aqueous solution were frozen to characterize the per-vial heat transfer. Additionally, a novel nucleation technique was investigated where conditioned vials were exposed to an impulse of <span>(&lt;)</span> <span>(-)</span>30<span>(^circ )</span>C gas. Finally, frozen vials were completely dried in 12 h in an attached vacuum chamber.</p><h3>Results</h3><p>The chambers conditioned vials from 25<span>(^circ )</span>C to −1<span>(^circ )</span>C in under 20 min, with final vial temperatures varying by less than 0.5<span>(^circ )</span>C. The impulse technique induced nucleation in all vials within 30 s without significantly cooling them. After nucleation, the system accessed slow (0.05 g/min) and rapid (1.0 g/min) solidification rates, as well as post-solidification procedures including typical ramp and hold protocols. Dried vials had residual moisture below 2.5 wt% and showed no signs of collapse.</p><h3>Conclusions</h3><p>This freezing chamber was demonstrated to track gas temperature setpoints as low as −50<span>(^circ )</span>C within ±1<span>(^circ )</span>C and induce nucleation in all vials virtually simultaneously, enabling excellent control of the freezing process. The chamber’s cooling via forced convection and its available front and back faces make it compatible with integration into a continuous lyophilization system.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-10037-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145171386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Evolution of Turbocharged Cancer Therapeutics - How Regulatory Flexibility has Driven Accelerated Cancer Biologics Approvals in the United States (1993–2023)","authors":"Fathima Musthafa,&nbsp;Simran Simran,&nbsp;Vishal Sachin Gangawane,&nbsp;Vaishnavi Milind Kalokhe,&nbsp;Aftab Ahmad,&nbsp;Saurabh Srivastava","doi":"10.1007/s12247-025-10059-8","DOIUrl":"10.1007/s12247-025-10059-8","url":null,"abstract":"<div><h3>Background</h3><p>The United States Food and Drug Administration’s (USFDA) accelerated approval process enables the rapid introduction of biologics based on surrogate endpoints for unmet medical needs, particularly in cancer treatment. Biologics play a vital role in precision medicine by enhancing the immune system’s ability to fight cancer or targeting malignancies directly. Since its inception in 1992, the program has significantly increased the approval of cancer biologics.</p><h3>Method</h3><p>This study analysed the regulatory status of accelerated biologics approved for cancer over 30 years, based on the USFDA “Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint” report (as of September 30, 2024). The time to full approval, withdrawal trends, and the submission of Biologics License Application (BLA) and supplements were evaluated.</p><h3>Results</h3><p>Out of the 106 Biologics License Applications (BLAs), 97 (91.50%) were for cancer and 9 (8.49%) for non-oncology indications. Among 37 original BLAs, 22 (59.45%) achieved full approval, 11 (29.72%) were not converted, and 4 (10.81%) were withdrawn. For 60 supplements, 38 (63.33%) gained full approval, 14 (23.33%) were not converted, and 8 (13.33%) were withdrawn. Accelerated approval of BLAs for cancer took an average of 4.44 years to reach full approval, while supplements required 3.10 years. Withdrawals averaged 3.64 years for BLAs and 4.14 years for supplements.</p><h3>Conclusion</h3><p>The study highlights the dominance of BLA supplements over original BLAs, their faster conversion to full approval, and greater time for withdrawal. These findings underscore the significance of supplement applications in enhancing the regulatory and clinical value of previously approved biologics.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145169575","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":"Fabrication of Sustainable Modified Fenugreek Gum Block Copolymer in Oral Controlled Drug Delivery System: Synthesis, Toxicity, in Vitro and in Vivo Pharmacokinetics","authors":"Baburao N. Chandakavathe,&nbsp;Raghavendra Kulkarni,&nbsp;Ashwin Mali,&nbsp;Amol Muthal,&nbsp;Vaibhav Shinde,&nbsp;Ravindra Kulkarni","doi":"10.1007/s12247-025-10048-x","DOIUrl":"10.1007/s12247-025-10048-x","url":null,"abstract":"<div><h3>Background</h3><p>Grafting of small molecules over carbohydrate polymeric chain afford new chemically modified substances which possess modified properties which are essential for drug release studies. Fenugreek seeds contain carbohydrate gum polymer as one of the constituent which was isolated and grafted with acryl amide. Such grafted polymer was explored for drug release studies here.</p><h3>Methods</h3><p>The objective of present invention was to develop acrylamide (Aam) grafted fenugreek gum (FG) based polymer in the presence of ceric ammonium nitrate under microwave conditions. The developed copolymer was characterized for the confirmation of grafting using elemental analysis, DSC, FTIR, NMR, Mass spectrometry data and toxicity studies along with surface morphology. The potential of grafted polymer was assessed by formulating nifedipine tables including pure gum, grafted copolymer and HPMC K100M.</p><h3>Results</h3><p>In vitro drug release studies of the F1-F5 batches reflected 92.24 to 94.72% release within 5 h, while, F6-F10 extended the release up to 12 h. The release was retarded with increase in concentration of grafted copolymer which was anticipated. The optimized batch F8, demonstrated 94.19% drug release in 12 h and this batch was further extended to in vivo study. The pharmacokinetics studies of optimized formulation in rabbits showed an area under the curve of 6050.45 (ng/mL)×h as compared with marketed nifedipine tablet (6723.88 (ng/mL)×h) which signified the release modulating property of the polymer.</p><h3>Conclusion</h3><p>The acrylamide grafted copolymer successfully retarded the drug release and hence can be explored for the extended-release formulations and can be further explored as high performing material.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145170407","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":"Immunostimulatory Activity without Pathological Effects of Fish Protein Hydrolysate from Clarias Catfish","authors":"Endar Marraskuranto,&nbsp;Fajar Shodiq Permata,&nbsp;Ekowati Chasanah,&nbsp;Pujoyuwono Martosuyono,&nbsp;Farida Ariyani","doi":"10.1007/s12247-025-10049-w","DOIUrl":"10.1007/s12247-025-10049-w","url":null,"abstract":"<div><h3>Introduction</h3><p>Fish protein hydrolysate (FPH), in particular, contains small, crucial peptides that offer beneficial health effects. However, research on its immunological effects remains limited. This study investigates the impact of fish hydrolysate on immune-related tissues (blood and spleen) and visceral organs (liver and kidneys) in rats.</p><h3>Methods</h3><p>FPH was produced from the hydrolysis of Clarias catfish-minced meat using Alcalase. In vivo evaluation was conducted using freeze-dried FPH<b>.</b> Thirty male Wistar rats (150–200 g) were divided into five groups: placebo, three FPH doses (0.125, 0.250, and 0.500 mg/g BW), and one commercial product (0.125 mg/g BW). Treatments were given orally by gavage, diluted in 1 mL of distilled water, once daily for 14 days. On day 15, rats were euthanized, and blood, spleen, liver, and kidneys were collected. Blood parameters were analyzed using an automatic hematology analyzer. Organ weight and size were measured morphometrically. White pulp area, glomerular width, and liver sinusoid size were measured using a microruler in ImageJ. Splenic IgM expression was assessed via immunohistochemical (IHC) staining and quantified using the ImmunoRatio plugin in ImageJ. A docking study was conducted between two peptides with the Mas receptor and Toll-like receptor 4 (TLR4).</p><h3>Results</h3><p>Studies confirmed that catfish-derived FPH does not cause pathological changes in the spleen, liver, or kidneys, aside from liver sinusoid dilation. Additionally, it significantly increases (p &lt; 0.05) circulating leukocytes, differential leukocyte counts, and IgM expression in the spleen. Two peptides from catfish-derived FPH showed good affinity for the Mas receptor and TLR4.</p><h3>Conclusion</h3><p>These findings indicate that catfish-derived FPH can improve immune function without causing damage to organs.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145170405","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}