Journal of Pharmaceutical Innovation最新文献

{"title":"Microemulsion-Based Gel for Skin Delivery of Tacrolimus and Pramoxine Hydrochloride","authors":"Janani Saravanan,&nbsp;K. V. Navyasree,&nbsp;Raiha Hareed,&nbsp;S. Swathi Krishna,&nbsp;Soumya Jagadeesan,&nbsp;Vidya Viswanad","doi":"10.1007/s12247-025-10066-9","DOIUrl":"10.1007/s12247-025-10066-9","url":null,"abstract":"<div>\u0000 \u0000 <span>AbstractSection</span>\u0000 Purpose\u0000 <p>Atopic dermatitis (AD) is a chronic, pruritic skin disorder usually treated with topical tacrolimus and corticosteroids, which are limited by adverse effects such as burning sensations and allergic reactions. We developed a new microemulgel formulation combining tacrolimus with pramoxine hydrochloride, an anesthetic that reduces pruritus by inhibiting voltage-gated sodium channels. This study aimed to optimize the formulation to augment skin retention and permeation of tacrolimus, potentially enhancing therapeutic efficacy and addressing current treatment limitations for AD.</p>\u0000 \u0000 <span>AbstractSection</span>\u0000 Methods\u0000 <p>The microemulgel formulation was optimized using a mixture design. The formulation was evaluated for physicochemical properties, in vitro drug release, ex vivo skin permeation and retention, cell viability (MTT assay), and efficacy in reducing inflammatory mediators (RT-PCR).</p>\u0000 \u0000 <span>AbstractSection</span>\u0000 Results\u0000 <p>The optimized formulation exhibited a favorable release profile, with a rapid initial release of pramoxine hydrochloride for immediate local anesthetic effects, followed by sustained release of tacrolimus for prolonged therapeutic action. Ex vivo permeation studies using porcine skin indicated enhanced permeation and increased drug retention compared to a marketed ointment. Cytotoxicity assays confirmed formulation safety, with cell viability above 90% at therapeutic concentrations. RT-PCR analysis showed a significant reduction in IL-1α expression. Stability studies at various temperatures demonstrated long-term stability and integrity, making the formulation suitable for practical use.</p>\u0000 \u0000 <span>AbstractSection</span>\u0000 Conclusions\u0000 <p>The successfully prepared microemulsion-based gel of tacrolimus and pramoxine hydrochloride demonstrated improved skin permeation and skin retention. This dual drug-loaded microemulgel offers a promising approach for AD treatment, providing immediate relief and sustained therapeutic effect, potentially improving patient complaints and treatment outcomes.</p>\u0000 \u0000 <span>AbstractSection</span>\u0000 Graphical Abstract\u0000 <div><figure><div><div><picture><source><img></source></picture></div></div></figure></div>\u0000 \u0000 </div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144868645","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":"(CR)4-Targeted Liposomal Doxorubicin as Promising Therapeutic Approach for Breast Cancer Therapy","authors":"Sakshi Soni,&nbsp;Ekta Nehra,&nbsp;Puja Panwar Hazari,&nbsp;Anil K. Mishra,&nbsp;Shashank Singh,&nbsp;Sushil K. Kashaw,&nbsp;Vandana Soni","doi":"10.1007/s12247-025-10033-4","DOIUrl":"10.1007/s12247-025-10033-4","url":null,"abstract":"<div><p>One of the main causes of death globally is cancer, hence the present study is based on the designing and formulation of DOX-loaded pegylated liposomal systems. Further, the surfaces of the prepared formulation were modified with the (CR)₄ peptide to improve the efficiency and targeting with reduced systemic side effects. Both LD (DOX-loaded liposomes) and LDM (DOX-loaded surface-modified liposomes) were prepared by remote loading technique and optimized using Box-Behnken design (BBD) within the Response Surface Methodology (RSM). LDM showed spherical shape, vesicle size 118.5 ± 1.28 nm, PDI 0.291 ± 0.006, zeta potential 12.35 ± 0.91 mV, and % entrapment efficiency 67.344 ± 1.27%. In vitro drug release from LDM at pH 6.8 was approximately 66.66 ± 1.98% after 72 h. Using the SRB assessment, in vitro cytotoxicity investigations showed that LDM displayed the most potent cytotoxicity, especially against MCF-7 (breast cancer) with an IC₅₀ of 4.9 ± 0.91 µM, and demonstrated a cytotoxicity hierarchy of HCT-116 &lt; MiaPaca-2 &lt; A549 &lt; MCF-7. Reactive oxygen species production, increased nuclear fragmentation, and variations in the potential of the mitochondrial membrane were all seen in the LDM. LDM exhibited significantly lower hemolysis (4.23 ± 0.17%) compared to the free drug (D) (44.5 ± 0.23%), with no adverse effects on blood coagulation pathways. In vivo, biodistribution, and histopathological studies revealed that LDM exhibited sustained drug release and highest retention in tumor tissue with minimal organ toxicity, as compared to formulations D and LD. So, LDM demonstrates outstanding safety and compatibility for treating breast cancer, exhibiting potent anti-tumor effects while being well-tolerated, making it a potentially effective therapeutic choice.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144814372","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":"Mimosa pudica Linn. Root Extract-Mediated Synthesis of Zinc Oxide Nanoparticles: a Study of Glucose Uptake Efficiency on 3T3-L1 Adipocytes","authors":"Chandrasekar Palanichamy,&nbsp;Pavadai Parasuraman,&nbsp;Panneerselvam Theivendren,&nbsp;Murugesan Sankaranarayanan,&nbsp;Madasamy Sundar,&nbsp;Selvaraj Kunjiappan","doi":"10.1007/s12247-025-10064-x","DOIUrl":"10.1007/s12247-025-10064-x","url":null,"abstract":"<div>\u0000 \u0000 <span>AbstractSection</span>\u0000 Purpose\u0000 <p><i>Mimosa pudica</i> is a medicinal plant conventionally used to cure various ailments, including diabetes and is a model for synthesizing new drug derivatives. This work evaluates the glucose utilization potential of Zinc oxide nanoparticles (ZnONPs) derived from the ethanol root extract of <i>M. pudica</i> in 3T3-L1 adipocyte cells.</p>\u0000 \u0000 <span>AbstractSection</span>\u0000 Methods\u0000 <p>Molecular modeling tools were used to predict the potential antidiabetic compounds from <i>M. pudica</i>. ZnONPs were biosynthesized using <i>M. pudica</i> extract, and their physicochemical properties were characterized using UV-visible, FTIR, XRD, DLS, XPS, and FESEM techniques. The in vitro cellular viability of synthesized ZnONPs and glucose utilization efficiency were examined in 3T3-L1 adipocytes.</p>\u0000 \u0000 <span>AbstractSection</span>\u0000 Results\u0000 <p>Using GC-MS and LC-MS analyses, 27 novel bioactive compounds were identified from <i>M. pudica</i> root extract. For the efficient glucose utilization in 3T3-L1 adipocytes, Dipeptidyl-peptidase 4 (DPP-4) inhibition plays a pivotal role, as three of the top binding-scored molecules from <i>M. pudica</i> were identified via molecular docking and dynamics simulation studies. 500 µg of ZnONPs exhibited 73.47 ± 1.59% cellular viability. Further, the in vitro glucose utilization efficiency of ZnONPs was evidenced in 3T3-L1 adipocytes, which displayed concentration-dependent glucose utilization. The effect of ZnONPs (30 µg) on glucose uptake was higher than that of 10 µg of metformin. Bioactive compounds from <i>M. pudica</i> extract might inactivate the DPP-4 enzyme activity and improve insulin release from the pancreas, lowering blood glucose levels via GLUT4 activation.</p>\u0000 \u0000 <span>AbstractSection</span>\u0000 Conclusion\u0000 <p>The findings imply that <i>M. pudica</i>-mediated synthesized ZnONPs might be a plant-based novel oral nanoformulation for managing diabetes mellitus (DM).</p>\u0000 \u0000 <span>AbstractSection</span>\u0000 Graphical Abstract\u0000 <div><figure><div><div><picture><source><img></source></picture></div></div></figure></div>\u0000 \u0000 </div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145142838","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 Effects of a Novel Supplement Containing Probiotics and Vitamin D as an Adjutant Therapy on sNFL and Th Cell Profiles in Patients with Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial","authors":"Alireza Zali,&nbsp;Saba Sadeghi Rashed,&nbsp;Seyedeh Nikan Nejat,&nbsp;Nahid Beladi Moghadam,&nbsp;Javad Arasteh,&nbsp;Saba Taheri,&nbsp;Mehri Salari,&nbsp;Amir M Mortazavian,&nbsp;Mehran Ghaffari,&nbsp;Maryam Tajabadi Ebrahimi","doi":"10.1007/s12247-025-10065-w","DOIUrl":"10.1007/s12247-025-10065-w","url":null,"abstract":"<div><h3>Purpose</h3><p>multiple sclerosis is a chronic autoimmune disease that affects the central nervous system. It damages the myelin sheath that covers nerve fibers, resulting in neurological symptoms, including muscle weakness, vision problems, and difficulty with coordination and balance. Probiotic bacteria have been shown to have a potential role in managing multiple sclerosis by modulating the immune system and reducing inflammation. They modulate the immune system by increasing the production of anti-inflammatory cytokines, including IL-10, TGF-β, and IL-4, and reducing the levels of pro-inflammatory cytokines, such as IFN-γ and IL-17. Probiotics may also improve gut barrier function, which can help prevent the entry of harmful substances into the bloodstream that could trigger an immune response.</p><h3>Methods</h3><p>The presented double-blind, placebo-control clinical trial was conducted to investigate the effect of a novel supplement containing probiotics and vitamin D, so IL-10, TGF-b, IL-4, IL-17, and IFN-gamma cytokines, and neurofilament light chain biomarker were measured by ELISA. Also, we determined the EDSS score and quality of life for patients.</p><h3>Results</h3><p>the results revealed that consuming the supplement for twelve weeks can significantly reduce the concentration of NFL biomarker compared to the control group. For the first time, these valuable results demonstrate the effect of probiotic bacteria on reducing this biomarker. Also, the results showed a significant decrease in IL-17 and IFN-γ and modulatory effects on IL-4 and TGF-β. On the other hand, a considerable rise is demonstrated in the IL-10 level.</p><h3>Conclusion</h3><p>These findings could provide the supplement as a novel co-therapeutic strategy for multiple sclerosis.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145142397","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":"Microneedle-Mediated Delivery of Amikacin-Liposomes: A Minimally Invasive Strategy against Bacterial Septicemia","authors":"Amala Maxwell,&nbsp;Suman Pahal,&nbsp;Pinal Chaudhari,&nbsp;Bhim Bahadur Chaudhari,&nbsp;Sameera Peri,&nbsp;Sudheer Moorkoth,&nbsp;Vivek Ghate,&nbsp;Praveen Kumar Vemula,&nbsp;Shaila Lewis","doi":"10.1007/s12247-025-10056-x","DOIUrl":"10.1007/s12247-025-10056-x","url":null,"abstract":"<div><h3>Purpose</h3><p>Sepsis is a severe systemic infection with a high mortality rate worldwide. Majorly, sepsis is treated by administering antibiotics including amikacin. Nevertheless, the present course of therapy necessitates frequent bolus doses of amikacin, leading to patient non-adherence, prolonged hospital stays, and regular therapeutic monitoring. Administration of amikacin by the intravenous or intramuscular routes requires precise dosage calculations, and appropriate disposal of sharp wastes. Amikacin’s shorter half-life makes it more challenging to administer intravenously and achieve adequate systemic concentrations. An innovative formulation and delivery approach to combat infection, particularly in a low-resource healthcare setting can be lifesaving to many, by reducing errors due to inappropriate needle disposal and expanding access to outpatient antibiotic treatment.</p><h3>Methods</h3><p>In response to the challenge, novel delivery systems were fabricated, including microneedle (MN) patches containing amikacin (Ak-MN) and amikacin-loaded liposomes (Ak-lip-MN). These systems were designed to offer sustained and extended delivery, to improve the treatment of infections. The Ak-MN and Ak-lip-MN were prepared using the PDMS micro-molding technique and evaluated for their piercing strength, in vivo skin insertion, pharmacokinetics, and stability.</p><h3>Results</h3><p>The higher TEWL value of 375.6 g/m²/h and the histological studies showed good MN skin insertion. The developed MN patches demonstrated a prolonged release profile lasting as long as 96 h, with maximum plasma concentrations (C_max) of 450 ng/mL for Ak-MN and 250 ng/mL for Ak-lip-MN. This can lower continual dosage administration and enhance the antibacterial efficacy at reduced doses, making way for effective treatment approaches for the management of sepsis.</p><h3>Conclusion</h3><p>The study overcomes the drawbacks of traditional intravenous injections, by developing dissolving microneedles with improved therapeutic efficacy.</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":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145142610","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":"Phytochemical Profiling of Citrus Maxima (Brum.) Merr. Essential Oil, its Antibacterial Evaluation and Computational Studies","authors":"Vijayalakshmi P,&nbsp;Malarkodi Velraj","doi":"10.1007/s12247-025-10055-y","DOIUrl":"10.1007/s12247-025-10055-y","url":null,"abstract":"<div><h3>Background</h3><p><i>Citrus maxima</i> (Burm). Merr. (<i>C. maxima</i>) is traditionally used in Ayurveda as sedative and for the treatment of cough, fever, asthma, diarrhoea, ulcers and diabetes. <i>C.maxima</i> peel oil is traditionally used to relieve stress. It ‘s antimicrobial, cardioprotective, hepatoprotective and anti-inflammatory properties make it a versatile remedy. <i>C. maxima</i> hold immense potential for modern therapeutic applications.</p><h3>Objectives</h3><p>The current study aims to perform phytochemical profiling, <i>in-vitro</i> anti-bacterial evaluation and <i>in-silico</i> analysis of oil extracted from the peels of <i>Citrus maxima (Brum.) Merr.</i></p><h3>Methods</h3><p>The essential oil from the peel of <i>Citrus maxima (C.maxima)</i> was extracted, and chemical profiling was conducted using Gas Chromatography-Mass Spectrometry (GC–MS). In vitro antioxidant and antibacterial assays were performed to evaluate the potential benefits of <i>Citrus maxima</i> peel oil in combating <i>Escherichia coli (E.coli), Staphylococcus aureus (S.aureus),</i> and <i>Streptococcus agalactiae (S.alginate)</i>. In silico antibacterial docking was carried out with AutoDock (version 4.2) 1N67 for the bacterial receptor Clumping Factor A.</p><h3>Results</h3><p>The findings confirmed the presence of total phenolic and total flavonoid contents. <i>Citrus maxima</i> peel oil was also found to exhibit potential <i>in-vitro</i> antioxidant and antibacterial activity against <i>Staphylococcus aureus, Streptococcus agalactiae, and Escherichia coli</i>. The docking results indicate that alpha-pinene exhibited the strongest binding affinity (-8.33 kcal/mol) and the lowest inhibition constant (101.34 nM).</p><h3>Conclusion</h3><p>The findings highlight the pharmacological potential of <i>Citrus maxima</i> peel oil as a natural antioxidant and antimicrobial agent. Its promising bioactive properties make it a valuable source for pharmaceutical applications.</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 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145142681","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":"USFDA Warning Letters: An Analysis of Compliance in Over-the-Counter Drug Products (2020–2024)","authors":"Pujita Konda,&nbsp;Sravani yerram,&nbsp;Mohammad Nuwaid Khader,&nbsp;Ramesh Joga,&nbsp;Muhammad NIZAM V P,&nbsp;Mahesh Girhe,&nbsp;Ajmal C S,&nbsp;Saurabh Srivastava","doi":"10.1007/s12247-025-10061-0","DOIUrl":"10.1007/s12247-025-10061-0","url":null,"abstract":"<div>\u0000 \u0000 <p>Over-the-counter (OTC) drug products are a critical component of the U.S. healthcare system, requiring stringent regulatory oversight to ensure their safety, quality, and efficacy. Despite the U.S. Food and Drug Administration’s (USFDA) continuous surveillance, persistent non-compliance issues necessitate enforcement actions such as Warning Letters (WLs). This study aims to identify recurring compliance challenges and regulatory trends affecting OTC products by analyzing WLs issued by the Center for Drug Evaluation and Research (CDER) between January 2020 and September 2024. A total of 3041 WLs were reviewed, of which 573 were issued by CDER for drug products, and 202 specifically targeted OTC manufacturers. These WLs were categorized based on the nature of violations to detect enforcement patterns. Labeling deficiencies emerged as the most frequent violation, followed by cGMP non-compliance and product adulteration. Furthermore, there were notable concerns regarding the adulterated products and compliance with cGMP standards, pointing to gaps in manufacturing processes and oversight. The annual WL count for OTC products ranged from 36 to 48 in the mentioned time period, indicating ongoing systemic concerns rather than isolated incidents. This study also emphasises the major violation case studies highlighting post-WL corrective and preventive actions (CAPA), providing valuable industry insights into regulatory expectations and remediation pathways. In summary, the study demonstrates regulatory challenges within the OTC industry, including inadequacies in Labeling, adulteration, and cGMP non-compliance. These challenges emphasize the necessity of enforcement, transparent compliance mechanisms, and uniform standards to ensure the integrity of OTC products in an evolving market.</p>\u0000 </div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145142354","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 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}