Journal of Pharmaceutical Innovation最新文献

{"title":"An Innovative Dual-Drug Topical Hydrogel for Synergistic Wound Healing: Formulation and Evaluation","authors":"Neela Bhatia,&nbsp;Smita Kumbhar,&nbsp;Anagha Ajagekar,&nbsp;Rutuja Chougale,&nbsp;Manish Bhatia","doi":"10.1007/s12247-025-10078-5","DOIUrl":"10.1007/s12247-025-10078-5","url":null,"abstract":"<div><h3>Purpose</h3><p>This study aimed to develop and evaluate a dual-drug topical hydrogel incorporating doxycycline and voriconazole to enhance wound healing by addressing polymicrobial infections commonly associated with chronic wounds.</p><h3>Methods</h3><p>The hydrogel was formulated using Poloxamer 407 and sodium alginate as gelling agents, incorporating optimized concentrations of both drugs. Preformulation studies (FTIR, DSC) confirmed drug-excipient compatibility. Physicochemical evaluations included pH (measured directly), spreadability, viscosity, and appearance. Rheological properties were assessed across varying shear rates. In vitro drug release was evaluated using Franz diffusion cells, and release kinetics were modeled using Korsmeyer–Peppas, Higuchi, and first-order models. Antibacterial and antifungal activities were tested against <i>Escherichia coli</i>, <i>Bacillus subtilis</i>, and <i>Rhizopus arrhizus</i>, selected for their clinical relevance. An excision wound model in Wistar rats assessed in vivo healing, supported by histopathology. Stability studies were conducted under accelerated conditions (40 ± 2 °C, 75% RH, 30 days).</p><h3>Results</h3><p>The optimized hydrogel showed ideal pH (6.5 ± 0.2), high spreadability (22.1 ± 1.5 g·cm/sec), and appropriate viscosity (4,100 ± 120 cP). Drug release was sustained over 24 h (doxycycline: 86.2 ± 3.1%; voriconazole: 79.5 ± 2.8%), fitting the Korsmeyer–Peppas model (R² &gt;0.97). The hydrogel exhibited strong antimicrobial activity and achieved 96.5% wound contraction by Day 16, significantly outperforming controls and single-drug treatments (<i>p</i> &lt; 0.01). Histological analysis confirmed improved granulation and collagen deposition.</p><h3>Conclusion</h3><p>The dual-drug hydrogel offers a synergistic, biocompatible, and stable platform for managing chronic polymicrobial wounds, demonstrating promising therapeutic potential.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145170243","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":"Modeling and Prediction of Pharmaceutical Mixing Performance in a Cubic Mixer Equipped with Baffles Using the Artificial Neural Network Model","authors":"Amina Bouhaouche,&nbsp;Kamel Daoud","doi":"10.1007/s12247-025-10070-z","DOIUrl":"10.1007/s12247-025-10070-z","url":null,"abstract":"<div><p>This study aims to model and optimize the mixing performance in a baffled cubic mixer, belonging to the tumbler category of mixers widely used in the pharmaceutical industry, using artificial neural networks (ANN), with a focus on understanding the effects of baffle geometry and operating parameters. Three baffle configurations were investigated to improve mixing homogeneity: (i) four flat baffles located at the midpoints of each wall, (ii) four flat baffles placed at each corner of the mixer, and (iii) a cross-shaped baffle (+) with four axial arms. Additional variables studied include baffle width and powder cohesion strength. Experiments were conducted under varying operational conditions, including rotational speeds ranging from 10 to 20 rpm, fill levels between 35% and 50%, a top-bottom loading profile, and a fixed mixing time of 20 min. A total of 80 experiments were performed to construct the ANN training dataset. The optimal ANN architecture, composed of 15 neurons in the hidden layer, achieved excellent predictive accuracy, with a mean squared error of 3.053 × 10⁻¹¹ and a coefficient of determination (R²) close to 1. Sensitivity analysis using Garson’s algorithm revealed that baffle width is the most influential factor, contributing 32% to the overall effect on mixing performance. This finding highlights the critical role of baffle design in enhancing particle flow and mixing uniformity. Therefore, selecting the optimal width for each baffle shape and position is essential to achieve the desired mixing performance. Notably, the use of baffles led to a reduction in the relative standard deviation (RSD) compared to the unbaffled case, clearly demonstrating the effectiveness of baffle insertion in enhancing mixing homogeneity. The results demonstrate the strong potential of ANN models for accurately capturing complex mixing behavior and guiding the design and optimization of mixing systems.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145169039","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":"Titanium Dioxide in Pharmaceutical Products: A Permissible Daily Exposure Conundrum","authors":"Naseem Charoo","doi":"10.1007/s12247-025-10083-8","DOIUrl":"10.1007/s12247-025-10083-8","url":null,"abstract":"<div><h3>Purpose</h3><p>Titanium dioxide finds widespread application in the pharmaceutical industry as a white pigment in capsule shells, film, and sugar coating compositions. Based on the EFSA (European Food Safety Authority) investigation, the European Commission recently revoked license to use titanium dioxide in food products. Subsequently, major regulatory agencies have reviewed the safety of titanium dioxide in pharmaceutical products and based on well-designed in vitro and in vivo studies, they determined that titanium dioxide poses no safety concern. The practicality of replacing titanium dioxide or omitting it from formulations was determined to have a detrimental influence on the quality, safety, and efficacy of pharmaceutical products. Controlling titanium dioxide levels in formulations to safe levels, on the other hand, could be a realistic strategy of reducing patient exposure to titanium dioxide while maintaining compliance to product critical quality attributes. This article examines the safety of using titanium dioxide in pharmaceutical products while taking into account the worst-case scenario, which is higher daily intake of titanium dioxide via pharmaceutical products.</p><h3>Methods</h3><p>Depending on the NOAEL (no observed adverse effect level) reported in various studies, or the safe threshold advised by regulatory bodies, various scenarios for calculating the PDE (permissible daily exposure) of titanium dioxide in pharmaceutical products are discussed. </p><h3>Results</h3><p>Titanium dioxide does not pose a risk to human health at the current level of use in pharmaceutical products.</p><h3>Conclusion</h3><p>As suggested by the titanium dioxide alternative consortium, a PDE-based control strategy would be desirable.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145168499","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 Multiple Freeze Thaw Cycles on Degradation of Trastuzumab and Rituximab in Different Formulations","authors":"Deepika Sarin,&nbsp;Debasmita Chakraborty,&nbsp;Anurag Rathore","doi":"10.1007/s12247-025-10086-5","DOIUrl":"10.1007/s12247-025-10086-5","url":null,"abstract":"<div><p>Freeze-thaw operations during manufacturing, storage, and distribution are known to significantly impact the physical and chemical stability of mAbs. Most of the investigations thus far have focused on aggregation arising from freeze-thaw, while other possible chemical degradation pathways like oxidation have not been explored much. The present study aims to evaluate the impact of repeated freeze-thaw on the oxidation of two mAbs (trastuzumab and rituximab) in different buffer systems (formulation buffer, phosphate-buffer saline and histidine buffer). The two mAbs were selected as model mAbs in histidine-containing and histidine-free formulations. Aggregation and charge variants were also estimated in this study to understand the trend in agreement with current literature on freeze-thaw stress. The two mAbs were exposed to repeated freezing (-20 ᵒC) and thawing (5 ᵒC) cycles daily (28 days) and weekly (4 weeks). An increase in oxidation up to 3X is observed for trastuzumab samples in the formulation buffer, while the increase is less (1X oxidation) for rituximab samples. Oxidation of the two mAbs in histidine buffer alone was also assessed, and a significant increase of 7X and 8X oxidation was observed in trastuzumab and rituximab, respectively. The presence of oxidized and charged species was also confirmed with intact mass and peptide mapping analysis. The results highlight the increased mAb oxidations in histidine-polysorbate 20 buffer compared to the citrate-polysorbate 80 formulation buffer upon repeated freeze-thaw. Maximum formation of high molecular weight species (15.94%) was observed in the phosphate-buffer saline samples of trastuzumab. An increase in acidic (19.54–23.22%) and basic variants (5.23–9.44%) was observed for rituximab, whereas a decrease in acidic variants (32.60–26.63%) was observed for trastuzumab samples. In view of the results, we can surmise that manufacturers need to investigate and accordingly design freeze-thaw procedures for storage of their in-process samples, drug substance, or drug product.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145168631","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 a PH-Responsive Bovine Serum Albumin-Functionalized Layered Double Hydroxide Nanocarrier for Targeted Therapy of Ovarian Cancer","authors":"Mervat Shafik Ibrahim,&nbsp;Nihal Mohamed Elmahdy Elsayyad,&nbsp;Shereen H. Noshi","doi":"10.1007/s12247-025-10104-6","DOIUrl":"10.1007/s12247-025-10104-6","url":null,"abstract":"<div><h3>Purpose</h3><p>Ovarian cancer accounts for 4.7% of cancer-related deaths in women, with paclitaxel (PAC) being an effective treatment option. However, poor water solubility and inefficient release within the tumor microenvironment limit its clinical use. This study aims to optimize a novel PAC pH-sensitive nanocarrier system based on layered double hydroxide (LDH) functionalized with bovine serum albumin (BSA) to enhance its delivery and release.</p><h3>Methods</h3><p>A response surface D-optimal design was utilized to optimize the formulation of BSA-d-LDH-PAC nanoparticles, considering particle size (PS), drug entrapment efficiency (EE%), and zeta potential (ZP). The optimized formulation (F3) was characterized using structural and physicochemical analyses, and in vitro drug release studies were conducted at different pH levels. Additionally, cytotoxicity studies were performed to evaluate the therapeutic potential of the developed system.</p><h3>Results</h3><p>The optimized formulation (F3) incorporated 16 mg/mL BSA, 0.5 mg PAC, and delaminated layered double hydroxide (d-LDH), yielding nanoparticles with a brucite-like structure, a diameter of 95 nm, a ZP of -27 mV, and an EE% of 51%. Molecular modeling and FTIR analysis confirmed the layered LDH structure and successful integration of BSA and PAC via hydrogen bonding, contributing to high drug loading and entrapment efficiency. The less ordered particle arrangement enhanced PAC aqueous solubility and facilitated rapid release, with 90% of the drug released at pH 5.5 within 5 h. Cytotoxicity studies demonstrated the superior anticancer activity of BSA-d-LDH-PAC compared to free PAC suspension.</p><h3>Conclusion</h3><p>BSA-functionalized LDH nanoparticles provide an efficient, pH-responsive delivery system for PAC, improving solubility, controlled release, and cytotoxic efficacy. These findings emphasize the future promise of this nanocarrier system for enhanced ovarian cancer treatment and broader applications in targeted drug delivery.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-10104-6.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145100544","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":"Development and Optimization of ZnO Nanoparticle-Embedded Fe3+-Crosslinked pH-Sensitive Carboxymethyl Cellulose/Poly(Vinyl Alcohol) Nanocomposite Beads: in Vitro Release Properties of an Anti-Cancer Drug","authors":"Emine Bulut,&nbsp;Aytekin Ersöz,&nbsp;İbrahim Hakkı Ciğerci","doi":"10.1007/s12247-025-10128-y","DOIUrl":"10.1007/s12247-025-10128-y","url":null,"abstract":"<div><h3>Purpose</h3><p>This study aims to design and evaluate a carboxymethyl cellulose (CMC)/poly(vinyl alcohol) (PVA) nanocomposite drug delivery system incorporating ZnO nanoparticles for the controlled, pH-responsive release of sunitinib malate (SM). The work focuses on reducing burst release, improving cumulative drug release in the gastrointestinal tract, and examining the effect of ZnO nanoparticle amount on swelling behavior, entrapment efficiency, and drug release kinetics.</p><h3>Methods</h3><p>Zinc oxide (ZnO) nanoparticles were synthesized via the precipitation method. Subsequently, CMC/PVA nanocomposite beads incorporating ZnO nanoparticles and SM were fabricated using a gelation method with Fe³⁺ ions. XRD, FTIR, SEM-EDX, DSC, and TGA analyses confirmed the successful incorporation of ZnO nanoparticles into the beads and provided structural, morphological, and thermal characterization of both the nanocomposite beads and ZnO. The entrapment efficiency of SM, bead yield, and drug release behavior were evaluated as functions of polymer ratio, SM loading percentage, FeCl₃ concentration, and ZnO content. In addition, cytotoxicity was evaluated using the MTT assay for SM, SM-loaded CMC/PVA-ZnO nanocomposite beads, empty CMC/PVA-ZnO beads, and empty CMC/PVA beads without ZnO.</p><h3>Results</h3><p>The average bead size ranged from 1443.1 ± 145.8 to 1717.2 ± 61.5 μm. The maximum entrapment efficiency (40.14%) was achieved in beads containing 5% ZnO, compared to 33.91% in beads without ZnO. Incorporation of ZnO nanoparticles into the polymer matrix enhanced drug release. At pH 1.2 and pH 7.4, beads containing 25% ZnO exhibited the higher SM release, reaching 67.63% and 85.64%, respectively, compared to beads with 5% and 15% ZnO. The release kinetics of the nanocomposite beads were analyzed using five different drug release models. Cytotoxicity testing of SM-loaded nanocomposite beads via MTT assay confirmed their biocompatibility. Among the prepared formulations, beads with a CMC/PVA ratio of 5/1, FeCl₃ concentration of 0.2 M, SM amount of 10%, and ZnO content of 5% (B₅) demonstrated the most favorable characteristics, including the highest entrapment efficiency, controlled drug release profile, and optimal bead size.</p><h3>Conclusion</h3><p>According to the results, the prepared pH-sensitive nanocomposite beads, incorporating of ZnO nanoparticles with excellent properties, can be a promising candidate drug carrier for further research to release SM, which is used as a chemotherapy drug to treat various cancers.</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 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145090419","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":"Toxicity Assessment of Oral Liquid Formulations of Novel Ciprofloxacin-Dicarboxylic Acid Salts in Female Albino Rats: Haematological, Biochemical, and Histopathological Parameters","authors":"Sadat Abdulla Aziz,&nbsp;Twana Mohammed M. Ways,&nbsp;Thomas Hibbard,&nbsp;Mohammed Tofiq Salih,&nbsp;Goran Mohammed Raouf,&nbsp;Kenneth Shankland,&nbsp;Hisham Al-Obaidi","doi":"10.1007/s12247-025-10079-4","DOIUrl":"10.1007/s12247-025-10079-4","url":null,"abstract":"<div><h3>Purpose</h3><p>This study aimed to evaluate and compare the systemic toxicity profiles of novel ciprofloxacin salts synthesised using dicarboxylic acid counterions. To our knowledge, this represents the first in vivo comparative toxicity assessment of these specific crystalline ciprofloxacin–dicarboxylic acid salts. These salts represent previously unreported solid forms of ciprofloxacin with enhanced solubility and potential for improved oral bioavailability. Albino rats were administered oral liquid formulations, and systemic effects were assessed through haematological, biochemical, and histopathological evaluations.</p><h3>Methods</h3><p>Aqueous Liquid dispersions of ciprofloxacin salts with succinic, glutaric, adipic, and pimelic acids were prepared and orally administered to female albino rats at doses equivalent to 20 mg/kg (low dose) and 60 mg/kg (high dose) of ciprofloxacin for 14 consecutive days. Haematological, biochemical, and histopathological assessments were conducted to determine systemic toxicity. A composite toxicity score was calculated based on percentage deviations from control values in key biochemical markers, and a Z-score heatmap was generated to visualize overall trends.</p><h3>Results</h3><p>Haematological analysis revealed no significant changes in RBC and WBC counts or platelet levels. Biochemical evaluations showed only mild alterations in liver and kidney function markers, lipid profiles, and hormonal levels, largely comparable to the control group. Notably, the GAH and AAH groups exhibited significantly elevated AST and ALT levels compared to the control group (<i>P</i> &lt; 0.05). AST levels in the GAH, AAH, and control groups were 459.00 ± 52.37, 467.33 ± 159.75, and 113.33 ± 32.25 U/L, and ALT levels were 62.33 ± 13.65, 65.00 ± 11.36, and 33.67 ± 11.93 U/L, respectively. The composite toxicity score identified the glutaric acid (GAH) and adipic acid (AAH) salts at high doses as having the most systemic impact (72.4% and 71.95%, respectively), while the pimelic acid salt at high dose (PAH, 21.27%) and adipic acid salt at low dose (AAL, 15.78%) were among the safest. Z-score heatmap analysis supported these findings. Histopathological examination revealed no significant pathological changes in the spleen, kidney, or heart, though minor liver changes were observed.</p><h3>Conclusion</h3><p>The novel ciprofloxacin dicarboxylic acid salts demonstrated a favorable safety profile in rats, with minimal systemic toxicity and only mild histological liver alterations at higher doses. These findings provide important foundational preclinical safety data, supporting further development of these novel salt forms as potentially safer and more bioavailable ciprofloxacin formulations.</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 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145078815","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":"Evaluating the Impact of Adding Herbal Medicine into Standard Treatment for Patients with Primary Hypertension in Comparison to a Placebo: A Triple-Blinded Randomized Controlled Trial","authors":"Maliheh Motavasselian,&nbsp;Arash Gholoobi,&nbsp;Hasan Rakhshandeh,&nbsp;Majid Khadem-Rezaiyan,&nbsp;Amir Hosein Bahrami,&nbsp;Siamak Mokhtari,&nbsp;Abbas Bahrami,&nbsp;Batul Jalal Kamali","doi":"10.1007/s12247-025-10073-w","DOIUrl":"10.1007/s12247-025-10073-w","url":null,"abstract":"<div><h3>Purpuse</h3><p>This research was conducted to assess the impact of Gaznab syrup (aqueous extract of <i>Urtica dioica</i> and <i>Ziziphus jujube</i>) on systolic and diastolic blood pressure levels in patients diagnosed with hypertension (stage I).</p><h3>Methods</h3><p>We executed a triple-blinded, randomized controlled trial involving 36 participants <b>(</b>ages 30–65 years) who were administered either Gaznab syrup (intervention group, 5 cc, <i>n</i> = 18) or a placebo (control group, 5 cc, <i>n</i> = 18) twice daily as supplementary treatment over an 8-week duration. Systolic and diastolic blood pressures were measured initially at baseline and subsequently at weeks 4 and 8. Furthermore, laboratory analyses and side effects were conducted.</p><h3>Results</h3><p>The mean systolic blood pressure (MSBP) at baseline in the Intervention and Control groups was 146. 63 ± 4. 56 mmHg and 147. 00 ± 4. 00 mmHg, respectively (<i>p</i> = 0.814). By the conclusion of the study, MSBP and standard deviation in the intervention and control groups were recorded at 134. 94 ± 8. 17 mmHg and 147. 63 ± 5. 04 mmHg, respectively (<i>p</i> = 0.001). The mean diastolic blood pressure (MDBP) at baseline <b>for</b> the intervention and control groups was 91. 97 ± 2. 45 mmHg and 92. 77 ± 2. 06 mmHg, respectively (<i>p</i> = 0.294); at the end of the study, MDBP in the Intervention and Control groups was found to be 85. 25 ± 4. 04 mmHg and 92. 75 ± 2. 34 mmHg, respectively (<i>p</i> &lt; 0.000).</p><h3>Conclusion</h3><p>According to the findings, Gaznab syrup can markedly lower both systolic and diastolic blood pressure levels <b>in</b> individuals suffering from essential hypertension.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145073921","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 Doxorubicin Efficacy with a Novel Lipid-Polymer Nanosystem Containing Melatonin: Formulation, Characterization and in Vitro Study","authors":"Somayeh Marouzi,&nbsp;Zahra Boroghani,&nbsp;Ghasem Anbiaee,&nbsp;Vahid Fattahi Moghaddam,&nbsp;Zahra Salmasi,&nbsp;Fatemeh Kalalinia,&nbsp;Maryam Hashemi","doi":"10.1007/s12247-025-10095-4","DOIUrl":"10.1007/s12247-025-10095-4","url":null,"abstract":"<div><h3>Objective(s)</h3><p>Recently, combination therapy for cancer has been shown to be more effective than monotherapy, resulting in reduced side effects and increased treatment efficacy. Melatonin, a naturally produced hormone, exhibits anticancer properties by inducing apoptosis and modulating the immune system; however, its short half-life and variable bioavailability limit its effectiveness. The current research examines how melatonin-chitosan-phosphatidylcholine nanoparticles (Cht-Pc/MLT NPs), as a novel lipid-polymer nanosystem, could enhance the anticancer properties of doxorubicin (DOX) against colorectal cancer cell lines (C26).</p><h3>Methods</h3><p>The Cht-Pc/MLT NPs were synthesized using the self-assembly method. The formulations’ physicochemical characterizations, including particle size, stability, and release profile, were investigated. The cytotoxicity evaluation was conducted independently and with free DOX on the C26 cell line using the MTT and sub-G1 assays.</p><h3>Results</h3><p>The optimal formulation displayed a size of 173 ± 18.17 nm, a surface charge of 16.28 mV, encapsulation efficiency and loading capacity of 63.148% and 30.861%, respectively. It was observed that the release of MLT from the NPs in simulated gastric fluid (SGF, pH 1.2) was minimal during the initial 4 h, making it suitable for oral administration. On the other hand, in intestinal fluid (SIF, pH 6.8), about 30% of MLT was released within the first 4 h, and at the end of 48 h, the release reached 45%. The observed changes in particle size after three months of storage at 4 °C were negligible obtained. Our research demonstrated that the combined delivery of DOX and Cht-Pc/MLT NPs significantly enhanced the cytotoxicity of colorectal cancer cells (C26) compared to other groups.</p><h3>Conclusion</h3><p>The results indicate that this designed combination treatment system may be applicable in chemotherapy protocols.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145073917","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":"Optimized Transfersomal Hyaluronic Acid/Carboxymethyl Chitosan Hydrogel for Enhanced Ocular Delivery of Fluconazole in Fungal Keratitis","authors":"Biswarup Das,&nbsp;Amit Kumar Nayak,&nbsp;Subrata Mallick","doi":"10.1007/s12247-025-10091-8","DOIUrl":"10.1007/s12247-025-10091-8","url":null,"abstract":"<div><p>The current research presents the development of transfersomal hydrogel-based formulation for effective ocular administration of fluconazole, where the hydrogel-base was prepared using hyaluronic acid (HA) and carboxymethyl chitosan (CMCH). Transfersomes loaded with fluconazole were formulated by thin-film hydration and the formulation optimization was performed by a 2³ factorial design-based approach. The optimized formulation (FTD) exhibited 68.55 nm vesicle size, 0.250 polydispersity index, – 13.7 mV zeta potential, 71.66 ± 2.15% entrapment efficiency, and 1.009 deformability index. The transmission electron microscopy image exhibited the vesicular morphology of FTD. Afterward, FTD formulation was incorporated within HA/CMCH hydrogel-base to prepare transfersomal hydrogel formulation (FTH), which exhibited 93.18 ± 3.11% drug content, 6.4 ± 0.7 pH, 4.68 × 10³ cPs viscosity (at 10 rpm), 36.25 ± 1.25 mm spreadability, and 3.85 × 10³ dyne/cm² ex vivo corneal mucoadhesive force. FTH formulation exhibited a spherical to elliptical morphology with smooth surface in Field emission-scanning electron microscopy image. The drug-excipient compatibility within FTH formulation was indicated by Fourier transform-infrared spectroscopy. The results of ex vivo ocular drug permeation exhibited a sustained drug release profile from FTH formulation over 24 h. The developed FTH formulation showed significant antifungal activity against <i>Candida albicans</i>. In addition, it was found both stable and non-irritant. Therefore, the findings showed a new approach to improve the ocular fluconazole permeation through HA/CMCH-based transfersomal hydrogel system for effective topical delivery of fluconazole in fungal keratitis management.</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 5","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145073650","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}