Journal of Pharmaceutical Innovation最新文献

{"title":"A Plant Wide Modelling Framework For The Multistage Processes of The Continuous Manufacturing of Pharmaceutical Tablets","authors":"Motaz Deebes,&nbsp;Mahdi Mahfouf,&nbsp;Chalak Omar,&nbsp;Syed Islam,&nbsp;Ben Morgan","doi":"10.1007/s12247-025-10017-4","DOIUrl":"10.1007/s12247-025-10017-4","url":null,"abstract":"<div><p>Continuous manufacturing can be seen as a promising shift in the pharmaceutical industry, offering benefits such as reduced costs and improved product quality. However, the multistage nature of continuous tablet manufacturing demands a deeper understanding of the complex interactions between process parameters, material attributes, and final product quality. This study aims to address this challenge by developing a novel, data-driven modelling framework to predict key critical quality attributes, including particle size distribution, moisture content, and tablet tensile strength across the processing stages of a pilot-scale continuous tablet manufacturing line. A sequential modelling approach was employed, integrating Random Forest and Gradient Boosting Machines to model each processing stage. These models were sequentially trained and interlinked to holistically capture process–material interactions across granulation, drying, milling, and tabletting stages. To manage error propagation between stages, Gaussian Mixture Models were incorporated for error characterisation and uncertainty reduction. The results showed that the proposed framework captured the non-linear interactions between processing parameters and the quality attributes. The incorporation of GMMs was influential in quantifying uncertainty within each process model, resulting in a final estimation of tablet tensile strength with an <span>( R^2 )</span> value of 0.90 using the integrated Random Forest model. This framework demonstrated considerable improvement in the predictive performance of the continuous manufacturing processes modelling through the integration of machine learning models and an uncertainty-aware strategy. The predictive tool is intended to support the Quality by Design (QbD) concept through systematic design space exploration and process understanding of the pharmaceutical continuous manufacturing.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 4","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-10017-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145166097","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":"Predicting Skin Permeability of Compounds with Elasticnet, Ridge and Decision Tree Regression Methods","authors":"Kevin Ita,&nbsp;Pegah Capaul,&nbsp;Pardis Khani","doi":"10.1007/s12247-025-10025-4","DOIUrl":"10.1007/s12247-025-10025-4","url":null,"abstract":"<div><h3>Purpose</h3><p>The aim of this project was to predict the skin permeability of compounds in three modified datasets (Steinmetz et al., Stevens et al. as well as Wilschut et al.).</p><h3>Methods</h3><p>We employed Elasticnet, Ridge and Decision Tree Regression algorithms to forecast the skin permeability values of these compounds.</p><h3>Results</h3><p>When the Ridge regression technique was applied to the modified Wilschut et al dataset, the mean squared error was 0.20, the mean absolute error was 0.33 and the coefficient of determination (R²) was 0.61. The application of the same technique to the modified Stevens et al. dataset resulted in a mean squared error of 1.04, a mean absolute error of 0.5172 and an R-squared value of 0.18. The utilization of the Ridge regression method on the modified Steinmetz et al. dataset resulted in a mean squared error of 0.65, a mean absolute error of 0.67 and an R-squared Score of 0.48. When the Elasticnet regression approach was used on the modified Wilschut et al, the mean squared error was 0.24 and the coefficient of determination (R²) was 0.60. The utilization of the Elasticnet regression technique on the modified Steinmetz et al dataset led to a mean squared error of 0.88 and the coefficient of determination (R²) of 0.30. In comparison, Elasticnet regression technique on the modified Stevens et al dataset led to a mean squared error of 0.32 and the coefficient of determination (R²) of 0.42. The utilization of the Decision Tree(DT) regression on the modified Wilschut et al. dataset, resulted in the mean squared error of 0.28 and the coefficient of determination (R²) of 0.53. Decision Tree regression technique on the modified Stevens et al. dataset yielded a mean squared error: 0.31 and an R-squared Score :of 0.66. When the DT regression method was used on the Steinmetz et al dataset, the mean squared error was 0.89 and the R-squared Score was 0.14.</p><h3>Conclusion</h3><p>Our comparison analysis utilizing ElasticNet, Ridge, and Decision Tree regression models to forecast skin permeability across three datasets provides significant insights into the relationship between data quality and model efficacy. This finding is consistent with and enhances the advancing field of computer modeling in cutaneous absorption, specifically in medication development, cosmetic safety, and regulatory science.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145166124","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":"Crosslinked Chitosan-Gellan Gum Nanoparticles for Enhanced Ocular Delivery of Citicoline in Glaucoma Management: Fabrication, Optimization, and Characterization","authors":"Gurpreet Kandav,&nbsp;Tamanna Sharma,&nbsp;Akash Chandel","doi":"10.1007/s12247-025-10019-2","DOIUrl":"10.1007/s12247-025-10019-2","url":null,"abstract":"<div><h3>Purpose</h3><p>To overcome the challenges of conventional ocular formulations, such as poor bioavailability and rapid clearance, this study aims to crosslink chitosan (CS) and gellan gum (GG) polymers to develop and optimize citicoline-loaded chitosan-gellan gum nanoparticles (CT-CS-GG_NPs) for enhanced ocular drug delivery and controlled release, emphasizing glaucoma treatment by protecting neuronal function.</p><h3>Methods</h3><p>CT-CS-GG_NPs were fabricated by crosslinking CS and GG via the ionic gelation method and were optimized using a central composite design with three levels and two factors to assess the influence of chitosan and gellan gum concentration on % entrapment efficiency (%EE), polydispersity index (PDI), zeta potential (ZP) and particle size (PS). The optimized formulation (CT-CS-GG_NPsopt) was further examined by FTIR, TEM, DSC, drug release (In-Vitro) &amp; Ex-Vivo including HET CAM and permeation Studies etc.</p><h3>Results</h3><p>The mean values obtained from 13 batches of CT-CS-GG_NPs for PS, %EE, PDI, and ZP varied within the range of 241.3 to 990.2 nm, 12% to 83.33%, 0.302 to 0.978, and 1.23 to 35.2 mV respectively. CT-CS-GG_NPsopt demonstrated extended in-vitro drug release, reaching 70.6 ± 1.9% over 12 h. Ex-vivo HET-CAM and permeation studies confirmed the non-irritant nature of CT-CS-GG_NPsopt and demonstrated a 2.2-fold higher drug uptake by the goat cornea compared to the drug solution.</p><h3>Conclusion</h3><p>CS and GG were successfully crosslinked to prepare CT-CS-GG_NPs, which exhibit prolonged drug release, potentially enhancing drug absorption and therapeutic effectiveness while showing promise as safe carriers for ocular drug delivery.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145165618","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 Characterization of Leflunomide and Resveratrol Loaded Nanostructured Lipid Carrier Based In-situ Hydrogel System for Effective Management of Rheumatoid Arthritis","authors":"Amit Sahu,&nbsp;Sunny Rathee,&nbsp;Shivani Saraf,&nbsp;Sarjana Raikwar,&nbsp;Pooja Das Bidla,&nbsp;Rajesh Singh Pawar,&nbsp;Sanjay K. Jain","doi":"10.1007/s12247-025-09976-5","DOIUrl":"10.1007/s12247-025-09976-5","url":null,"abstract":"<div><h3>Purpose</h3><p>This study aims to improve the therapeutic effect of leflunomide (LEF), an immune-altering drug, and resveratrol (RSV), a polyphenolic compound distributed locally in the body. LEF and RSV were encapsulated in nanostructured lipid carriers (NLCs).</p><h3>Method </h3><p>NLCs were prepared by modified thermal homogenization and melt sonication using compritol ATO 888, oleic acid, Tween 80, and PEG 400. A Box-Behnken design (BBD) was utilized to optimize the formulation. The ideal NLC surface was modified by conjugation with chondroitin sulfate (CHS). Chondroitin sulfate-modified NLCs dispersions (CHS-NLCs) were characterized by particle size, PDI, encapsulation efficiency, and zeta potential. Thermosensitive gel was prepared using Pluronic F-127 (PF-127) and Pluronic F-68 (PF-68). Gels prepared in situ based on CHS-NLCs were characterized by gel time, thermal reversibility, pH, viscosity, injection time, and in vitro release. The effectiveness of the NLC-based in situ hydrogels was tested in an arthritis model.</p><h3>Results </h3><p>The produced CHS-NLCs had a particle size of 188.2 ± 0.85 nm, PDI of 0.396 ± 0.005, zeta potential of -17.16 ± 0.81 mV, LEF and RSV encapsulation efficiency of 92.16 ± 0.41 and 82.82%, respectively. The gel was thermosensitive and released 79.54% and 76.99% of LEF and RSV, respectively, within 144 h. The effectiveness of the proposed method was tested using an arthritis model, and the results showed a reduction in joint pain in mice in 21 days.</p><h3>Conclusion </h3><p>The developed CHS-modified NLC-based in situ hydrogel demonstrated effective, sustained drug release and significant therapeutic benefits in an RA model. This approach holds promise for improved RA management through localized drug delivery.</p><h3>Graphical Abstract</h3><p>Figure: Leflunomide and resveratrol-loaded nanostructured lipid carrier-based in-situ hydrogel system for effective management of Rheumatoid Arthritis</p>\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 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145165294","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":"Unlocking the Therapeutic Potential of Alisertib in Breast Cancer: An In-Depth Exploration of Molecular Targets Using Network Pharmacology and Gene Expression Network","authors":"Suad A. Alghamdi,&nbsp;Mohammed Alissa,&nbsp;Muhammad Suleman","doi":"10.1007/s12247-025-10004-9","DOIUrl":"10.1007/s12247-025-10004-9","url":null,"abstract":"<div><h3>Purpose</h3><p>Breast cancer is a prevalent and serious disease marked by uncontrolled cell growth. Alisertib, a small-molecule inhibitor, shows potential in cancer treatment by blocking cell proliferation. This study uses a network pharmacology approach to identify Alisertib's potential targets in breast cancer.</p><h3>Methods</h3><p>We used network pharmacology, molecular dynamic simulation and binding free energies approaches to identify the potential molecular target of Alisertib in Breast Cancer.</p><h3>Results</h3><p>SwissTarget, SuperPred, and CLCpred identified 100, 721, and 327 potential targets for Alisertib, respectively. From DisGeNet, 6,941 markers associated with breast cancer were identified, among which 29 proteins overlapped as both disease-associated genes and drug targets. Furthermore, the CytoHubba identified 10 hub genes from the PPI network of 29 common targets, with FGFR2, FGFR4, and MAPK7 ranked best based on their degree score. Moreover, the docking analysis revealed a docking scores of -8.854 kcal/mol, -7.373 kcal/mol and -7.262 kcal/mol for FGFR2, FGFR4, and MAPK7-Alisertib complexes respectively. The stable interaction of identified targets and Alisertib was further validated by the 200 ns molecular dynamics simulation. Binding free energy calculations using MM/GBSA yielded values of -61.0977 kcal/mol for the FGFR2-alisertib complex, -52.0032 kcal/mol for FGFR4-alisertib, and -47.9903 kcal/mol for MAPK7-alisertib. These results suggest that Alisertib exhibits stronger binding affinity for FGFR2, FGFR4 and MAPK7 compared to the control.</p><h3>Conclusion</h3><p>These findings suggest that Alisertib has a strong binding affinity and favorable pharmacological interactions with FGFR4, FGFR2, and MAPK7, highlighting its potential as a targeted therapeutic for breast cancer. Consequently, Alisertib warrants further investigation in preclinical and clinical settings to evaluate its efficacy in treating malignant neoplasm of the breast.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145165296","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 Evaluation of Raloxifene Hydrochloride Co-Crystals with Bioenhancer – a Potential Approach for Solubility and Bioavailability Enhancement","authors":"Hetal Thakkar,&nbsp;Krishna Modi,&nbsp;Dhvani Shah,&nbsp;Darshana Patel","doi":"10.1007/s12247-025-09998-z","DOIUrl":"10.1007/s12247-025-09998-z","url":null,"abstract":"<div><h3>Purpose</h3><p>The main purpose of the research work was to formulate cocrystals of Raloxifene Hydrochloride(RXL-HCl) in order to increase its solubility and oral bioavailability. The effect of addition of bioenhancer on the oral bioavailability was also examined.</p><h3>Methods</h3><p>Co-crystals of RXL HCl with tartaric acid as a coformer were successfully formulated with salt to coformer stoichiometric ratio of 1:1 by using solvent evaporation method. Characterization was done by FTIR analysis, SEM, DSC, pXRD, solubility, in- vitro dissolution, and in-vivo pharmacokinetic study.</p><h3>Results</h3><p>Optical microscopy and SEM analysis revealed the formation of plate-shaped crystals. The stretching and bending vibration patterns were different in the FTIR spectra of the developed formulation in comparison to the RXL HCl indicating the formation of the co-crystals. DSC analysis showed a melting endotherm at 235ºC which is less than that of RXL HCl indicating the formation of co-crystals. The pXRD pattern of co-crystals was different compared to that of the RXL HCl. The solubility of co-crystals in aqueous media was found to be 14.1 mg/mL which is almost 80 folds higher compared to RXL HCl. The <i>in-vitro</i> dissolution study of co-crystals showed 82.9%, 57%, and 65% drug dissolution after 120 min in water, acidic media, and alkaline media respectively, which is significantly greater compared to the RXL HCl. The <i>in-vivo</i> pharmacokinetic study showed almost 6 folds higher bioavailability compared to the marketed product.</p><h3>Conclusion</h3><p>Administration of cocrystals of Raloxifene Hydrochloride with Naringin as a bioenhancer led to a significant enhancement in oral bioavailability.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145164566","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":"Chronotherapeutic Delivery of Lornoxicam Pellets for Rheumatoid Arthritis: Formulation Development and Optimization Using a Randomized Factorial Design","authors":"Swapnil Jain","doi":"10.1007/s12247-025-10021-8","DOIUrl":"10.1007/s12247-025-10021-8","url":null,"abstract":"<div><p>Rheumatoid arthritis (RA) is a chronic condition marked by joint pain and stiffness, especially in the morning, necessitating medication for management. This study focused on developing, evaluating, and optimizing coated lornoxicam pellets for targeted colon delivery, utilizing carboxymethyl <i>Caesalpinia spinosa</i> gum to address the chronotherapeutic needs of RA. The pellets were prepared using an extrusion-spheronization technique and subsequently coated in a fluidized bed processor with polymers such as Eudragit^® S 100 and RL 100. An 11-run, 2-factor, 3-level randomized full factorial design was employed to assess the influence of varying independent factors on the responses, leading to the identification of an optimized formulation. The drug release profiles of the formulation batches showed that at the 4th hour, release in the upper gastrointestinal (GI) tract ranged from 0 to 16.79%, while at the 10th hour, release at colonic pH ranged from 71.95 to 95.64%. Additionally, the optimized formulation demonstrated enhanced drug release in the presence of rat cecal matter, indicating its potential for targeted colonic delivery. In vivo pharmacokinetic studies of the optimized formulation showed a clearance of 0.022 L/hr and a volume of distribution of 0.319 L, indicating slow elimination and limited tissue distribution. The high area under curve values (44.53 and 96.12 µgh/mL) reflected effective absorption and good systemic exposure. The mean residence time of 21.30 h suggested prolonged residence time, supporting sustained therapeutic levels in the colon. These findings suggest that the optimized lornoxicam-coated pellet formulation holds promise for the chronotherapeutic management of early morning RA symptoms.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145164875","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":"Hydroxypropyl-β-Cyclodextrin-Enhanced Azelaic Acid Hydrogel for Acne Treatment: Evaluation of Antimicrobial, Anti-inflammatory, and Skin Penetration Properties","authors":"Muhammet Davut Arpa,&nbsp;Sevde Nur Biltekin Kaleli,&nbsp;Nilay Doğan","doi":"10.1007/s12247-025-10020-9","DOIUrl":"10.1007/s12247-025-10020-9","url":null,"abstract":"<div><h3>Purpose</h3><p>Azelaic acid (AZE) is a widely used agent in acne treatment, but its poor water solubility limits its therapeutic potential. In this study, the effectiveness of azelaic acid (AZE)—a compound with limited therapeutic efficacy due to its poor water solubility—was investigated in HPMC-based hydrogel formulations, in which solubility was enhanced through complexation with hydroxypropyl-<i>β</i>-cyclodextrin (HβCD).</p><h3>Methods</h3><p>The developed AZE-HβCD hydrogel (F1) was evaluated in comparison with a conventional AZE hydrogel (G1) and a commercial cream formulation. In vitro antiacne activity was tested by the disk diffusion method. COX-1 and COX-2 enzyme inhibition and quantification of TNF-α levels were determined to evaluate the anti-inflammatory effectiveness. On the other hand, cytotoxicity, irritation, ex vivo penetration, and short-term stability studies were carried out.</p><h3>Results</h3><p>The F1 formulation exhibited significant antimicrobial activity, particularly against <i>Cutibacterium acnes</i> and <i>Staphylococcus aureus</i> compared to the control groups (at least <i>p</i> &lt; 0.01). The In vitro COX-2 inhibition rate and the 4.7-fold reduction in TNF-α levels in LPS-stimulated RAW 264.7 macrophages demonstrated the notable anti-inflammatory properties of F1. Cytotoxicity assays revealed that F1 was highly biocompatible in both human keratinocyte (HaCaT) and HEK293 cells. In ex vivo studies using Franz diffusion cells, F1 showed significantly higher AZE accumulation and skin penetration compared to the commercial product (<i>p</i> &lt; 0.05).</p><h3>Conclusion</h3><p>These findings suggest that HPMC-based hydrogel formulations containing AZE-HβCD may serve as promising alternatives for acne treatment by enhancing anti-inflammatory and antimicrobial efficacy as well as skin penetration.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-025-10020-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145164213","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":"Evaluation of Antimicrobial Efficacy and Cell Viability of Qbd Optimized Formulation of Curcumin-Loaded Nano-Emulgel","authors":"Varsha Tiwari,&nbsp;Abhishek Tiwari,&nbsp;Deepak Jain,&nbsp;Narahari N. Palei,&nbsp;Ajay Sharma,&nbsp;Arya Lakshmi Marisetti,&nbsp;Disha Dutta","doi":"10.1007/s12247-025-10008-5","DOIUrl":"10.1007/s12247-025-10008-5","url":null,"abstract":"<div><p>The objective of this study was to develop and optimize curcumin-loaded nanoemulgel (NEG) using linseed oil, vitamin E and carbapol 934 and to evaluate antimicrobial, antifungal, and cytotoxicity activity, along with the possible gene-gene interactions of curcumin using network pharmacology. Eight different formulations were developed by using linseed oil and vitamin E and optimized based on particle size and entrapment efficiency using Design Expert software prior to formulation. The Differential Scanning Calorimetry (DSC) plot for Carbopol displayed distinct peak at 83.33 °C, curcumin at 133.93 °C and tween 80 at 102.17 °C. The DSC of F₁, F₂, and F₃ formulations does not showed any sharp peak. The results indicated that all formulations-maintained pH values within the range of 6.2 to 6.8, aligning with the requirements for topical applications. The spreadability values, ranging from 11.25 to 15.85, demonstrated that the formulations could be easily applied to the skin or target surfaces. Viscosity of all formulations was found to be within the range of 1145.62 to 2258.47 cps, show ed the best formulations F₃. Among the eight formulations, F3 emerged as the most efficient, exhibiting optimal characteristics with a particle size of 1121 nm and zeta potential of -29.2 mV. This formulation was selected for further evaluation against antimicrobial activity against <i>Salmonella</i> and <i>Staphylococcus aureus</i> using the plate count agar technique, and cell viability assay has been performed through MTT assay. The F₃ formulation demonstrated significantly strong antimicrobial effect, which was further enhanced by increasing the dose of both F3 and pure curcumin. MTT assay of F₃ formulation revealed cell viability of 25.64%, with compared to 39.67% for pure curcumin, suggesting minimal cytotoxicity. The antimicrobial activity was performed for its effectiveness against model microorganisms like <i>Staphylococcus aureus</i>, <i>E. coli</i>, and <i>Candida albicans</i>, while curcumin alone showed limited antifungal activity, the F₃ formulation exhibited promising antifungal effects against <i>Aspergillus oryzae (A. oryzae)</i> and <i>Aspergillus niger (A. niger).</i> The antifungal potency of F₃ was dose-dependent, with higher doses showing increased efficacy. Network pharmacology analysis suggested that F₃ may exert its therapeutic effects by inhibiting tubulin proteins, modulating RNA translation, and affecting cell signalling pathways. Therefore, the F₃ formulation was established as cost-effective, efficient antimicrobial formulation with minimal cytotoxicity, making it a promising candidate for further development in both antimicrobial and antifungal therapies with minimum toxicity.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145163812","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":"Transdermal Co-Delivery of Sumatriptan Succinate and Naproxen Sodium via Dissolving Microneedle Patch","authors":"Azka Yousaf,&nbsp;Zulcaif Ahmad,&nbsp;Asif Mahmood,&nbsp;Muhammad Imran Khan,&nbsp;Muhammad Furqan Akhtar","doi":"10.1007/s12247-025-10007-6","DOIUrl":"10.1007/s12247-025-10007-6","url":null,"abstract":"<div><h3>Purpose</h3><p>Current migraine therapies face challenges such as poor patient compliance and delayed onset of action, necessitating novel delivery strategies. The development of transdermal drug delivery systems, particularly microneedle patches, offered a viable substitute for enhancing patient compliance and avoiding the first-pass effect.</p><h3>Method</h3><p>This research focused on the fabrication and characterization of a microneedle patch to deliver the combination of sumatriptan succinate and naproxen sodium. Microneedles were fabricated using Polyvinyl alcohol and Hydroxy propyl methyl cellulose via solvent casting technique. The prepared microneedle patches were characterized for their morphological and mechanical properties, drug release kinetics, drug content determination, and ability of the microneedles to penetrate.</p><h3>Result</h3><p>SEM analysis confirmed the uniformity in the height of the microneedles with an average height of 500 µm and a base diameter of 200 µm. The microneedle patches showed adequate mechanical strength to pierce the stratum corneum without breaking, and an average insertion force of about 5.28 ± 0.1 N was needed. <i>In-vitro</i> insertion and irritation study verified the successful insertion of needles without any notable deformation and no irritation to the skin was observed. XRD study confirms the crystalline structure of both API individually and the amorphous state in the formulation. <i>In-vitro</i> release experiments revealed a regulated release profile over 24 h i.e. 86.8% ± 0.3% (Sumatriptan succinate) and 86.34% ± 0.7% (Naproxen sodium). The drug loading efficiency of both drugs i.e. Sumatriptan succinate and Naproxen sodium was observed as 100% and 99.7% respectively.</p><h3>Conclusion</h3><p>This innovative approach could improve patient compliance and outcomes compared to conventional therapies. More animal studies should be done to ascertain the effectiveness and safety of the system on a commercial scale.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 3","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145164544","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}