{"title":"Current Status of Development of Oral Formulations Combining Omega-3 Fatty Acids and Statin Ingredients and Prospects for New Formulations","authors":"Ji-Hun Jang, Seung-Hyun Jeong","doi":"10.1007/s12247-025-09959-6","DOIUrl":"10.1007/s12247-025-09959-6","url":null,"abstract":"<div><h3>Background</h3><p>Omega-3 fatty acids (O3FA) and statins effectively reducing the levels of triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C), respectively, and are actively used in clinical practice worldwide for the treatment of hyperlipidemia. Combinations of O3FA and statins have been found effective in managing complex dyslipidemia cases and achieving synergistic therapeutic effects while improving patient compliance.</p><h3>Purpose</h3><p>This study was conducted to examine the current status of the development of combinations of O3FA and statins, which have recently been garnering attention, and to consider future approaches to developing additional formulations.</p><h3>Methods</h3><p>By reviewing published literature and market reports, we summarize the development status of O3FA and statin combinations. We also identified a scope for improvement in such formulations and propose new formulation development approaches.</p><h3>Results</h3><p>Co-administration of direct physical combinations of O3FA and statins is generally considered safe and free of drug interactions, but inherent challenges to drug stability exist. In particular, O3FA oxidation is highly possible, necessitating a spatially separated combination technology without direct contact with statins. An attempt to encapsulate O3FA within soft capsules and statin drugs as powders, granules, or tablets in a hollow capsule was proposed as a new approach that can solve both the stability issues due to potential interactions between ingredients and the content change issues due to ingredient loss during mechanical transport. In addition, a novel combination formulation with fibrate or ezetimibe was proposed to improve TG, cholesterol, and LDL-C levels while maximizing compliance in patients taking multiple medications.</p><h3>Conclusion</h3><p>Attempts to formulate combinations of anti-hyperlipidemic drugs are becoming popular in the management of complex dyslipidemia cases. In this context, this study presents important pharmaceutical perspectives on combining O3FA and statins. The findings presented herein provide useful insights into developing additional improved oral formulations in the future.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143655361","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}
Umair Khan, Prashant Kumar, Sabina Yasmin, Sumit Durgapal, Sumel Ashique, Anurag Verma, Mohammad Yousuf Ansari
{"title":"Preparation and Evaluation of N-Acetyl D-Glucosamine Ethosomal Gel for the Treatment of Hyperpigmentation","authors":"Umair Khan, Prashant Kumar, Sabina Yasmin, Sumit Durgapal, Sumel Ashique, Anurag Verma, Mohammad Yousuf Ansari","doi":"10.1007/s12247-025-09966-7","DOIUrl":"10.1007/s12247-025-09966-7","url":null,"abstract":"<div><p>N-acetyl D-glucosamine (NAG) holds clinical significance in treating hyperpigmentation through its ability to inhibit melanin production, support skin barrier functions, and its favorable treatment profile that makes it suitable for various skin types. This study explores the characterisation of NAG and soya lecithin using Fourier Transform Infrared (FT-IR) spectrophotometry and evaluates ethosomal formulations for drug delivery applications. The zeta potential, pH, extrudability, spreadability, viscosity, and in vitro drug release of many ethosomal formulations were evaluated. An in vivo investigation evaluated hyperpigmentation in rats, and stability tests were conducted at 25 °C and 4 °C. The compatibility of both compounds was confirmed by FTIR, which also showed the presence of distinctive peaks. The diameters of particles varied from 649 to 6463 nm, and their zeta potentials fell between − 8.97 and − 18.63 mV. The range of drug entrapment efficiency was considerable, from 97.23 to 99.43%. Over 45 days, stability studies showed few changes. The pH, extrudability, spreadability, and viscosity of ethosomal gels ranged from 5.89 to 6.38, 45.17 to 63.93 gm/cm², and 6.66 to 10 cm, respectively. Zero-order and Korsmeyer models dominated in vitro drug release, which varied from 8.206 to 25.81%. Significant inflammatory alterations consistent with persistent dermatitis were revealed by histopathological examinations in the in vivo investigation. The findings show potential for treating skin problems by showing that ethosomal formulations of NAG are stable and effective for medication delivery.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143638316","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":"Optimization of Risperidone and Quercetin Solid Lipid Nanoparticles Loaded Nasal Insitu Gel by Design Expert and Quality by Design Approach","authors":"Shilpa Pravin Chaudhari, Neha Ganpat Kure, Sarika Ankushrao Nikam","doi":"10.1007/s12247-025-09930-5","DOIUrl":"10.1007/s12247-025-09930-5","url":null,"abstract":"<div><h3>Purpose</h3><p>The objective of the current study is synthesis and optimization of Nasal Insitu Gel loaded with Risperidone (RIS) and Quercetin (QUE) Solid Lipid Nanoparticles (SLN) by Design Expert and Quality by Design (QbD)Approach.</p><h3>Method</h3><p>QTTP (Quality target product profile), critical process parameters (CPP), critical quality attributes (CQAs) were identified. Preliminary screening of factors which affect CPP and CQAs was carried out using Placket Burman design. SLN were prepared by solvent diffusion method. Optimization of SLN was carried by 2<sup>2</sup> (RIS) and 2<sup>3</sup> (QUE) factorial designs. Temperature, Type of co-surfactant, Concentration of surfactant (%) were identified as independent factors and responses were recorded against Particle size, % Entrapment Efficiency. Characterization of prepared SLN were done by analysis of particle size, PDI, Zeta Potential, FTIR, Entrapment Efficiency, TEM etc., synthesized SLN were incorporated into Insitu gel which was evaluated for gelation temperature, viscosity, in-vitro drug diffusion etc.</p><h3>Results</h3><p>RIS SLN and QUE SLN were successfully synthesized. Particle size was found 157.4 ± 2 nm 153 ± 3 nm. Respectively. PDI was observed 0.261 for RIS SLN and 0.240 and QUE SLN. % EE were obtained 91.73 ± 2.6%, 91.73 ± 2.6% respectively indicated successful drug encapsulation. TEM study supported spherical nature. DSC and FTIR study showed successful incorporation of drugs into SLN. SLN were successfully incorporated into 18% concentration of poloxamer for formation of nasal <i>insitu</i> gel. In-vitro diffusion study revealed sustained and controlled drug release.</p><h3>Conclusion</h3><p>The study successfully developed and optimized SLNs loaded with RIS and QUE SLN for nasal administration using the QbD approach. The combination of SLNs and insitu gel provided a stable and effective nasal delivery system. The developed SLNs and <i>insitu</i> gel formulation are promising for nasal administration, offering a viable alternative to oral delivery by effectively bypassing first-pass metabolism and improving drug availability.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143638385","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 Optimization and in Vitro–in Vivo Evaluation of Alpha Lipoic Acid-Loaded Lipid–Polymer Hybrid Nanoparticles Via Design of Experiments","authors":"Özlem Çoban, Hatice Demirtaş, Yesim Kaya-Yasar, Seçkin Engin, Sercan Yıldırım, Mohammed Reza Morsali","doi":"10.1007/s12247-025-09931-4","DOIUrl":"10.1007/s12247-025-09931-4","url":null,"abstract":"<div><h3>Purpose</h3><p>Alpha lipoic acid (ALA) is a natural compound that has recently gained attention for its anti-inflammatory potential. ALA has a low bioavailability and in vitro stability, making its clinical use a challenge. Lipid–polymer hybrid nanoparticles (LPHNPs), a newly discovered core-shell nanostructures, are derived from liposomes and polymeric nanoparticles, and they were commonly used to improve in vivo efficiency and stability of active substances.</p><h3>Methods</h3><p>The current study aimed to prepare ALA-loaded LPHNPs via the design of experiments (DoE) approach to improve oral bioavailability and in vitro stability of ALA. The Plackett-Burman design was used to select independent variables by evaluating the effects of drug amount, stirring rate, polymer amount, lipid/polymer ratio, water/organic solvent (W/Os) ratio, and polyvinyl alcohol (PVA) concentration on formulation properties. Afterward, statistically significant formulation parameters were optimized using the Box-Behnken design (BBD). Finally, the in vitro properties were evaluated, and the <i>in vivo</i> anti-inflammatory effect of the optimized formulation was tested using formalin-induced paw edema in mice.</p><h3>Results</h3><p>The main factors affecting the mean particle size (mPS), polydispersity index (PdI), and ζ potential (ZP) values of ALA-loaded LPHNPs were the stirring rate, W/Os ratio, and PVA concentration; however, the independent variables had no significant effect on encapsulation efficiency (EE). Furthermore, optimized ALA-loaded LPHNPs also significantly reduced paw edema thickness and volume with a prolonged duration of action compared to ALA solution during 6 h after formalin administration.</p><h3>Conclusion</h3><p>The optimized ALA-loaded LPHNPs with core-shell structure had sustained control release up to day 17 and exhibited superior colloidal and chemical stability under various in vitro conditions and prolonged and robust in vivo anti-inflammatory effect.</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 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143622088","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}
Himanshu Paliwal, Bhupendra G. Prajapati, Akshay Parihar, Mohammad Rashid Khan, Chetan Singh Chauhan
{"title":"Tailoring Drug Release Kinetics in Lipophilic Drug-Loaded Oral Microemulsions: Impact of Surfactant Chain Length","authors":"Himanshu Paliwal, Bhupendra G. Prajapati, Akshay Parihar, Mohammad Rashid Khan, Chetan Singh Chauhan","doi":"10.1007/s12247-025-09952-z","DOIUrl":"10.1007/s12247-025-09952-z","url":null,"abstract":"<div><h3>Purpose</h3><p>The objective is to study the influence of surfactant chain lengths on the solubilization capacity and release pattern from the Rosuvastatin calcium-loaded microemulsion.</p><h3>Methods</h3><p>In the study, rosuvastatin calcium was incorporated into oil-in-water microemulsion formulations using surfactants of varying chain lengths. The developed formulations were then characterized for physicochemical properties, along with stability, release profile and in vitro intestinal permeability. The cytotoxicity assay was performed to assess the safety of microemulsion formulation.</p><h3>Results</h3><p>The stability of microemulsion formulation increases with the increase in carbon chain as indicated with smaller globule size, excellent dispersibility, and reduced dynamic surface tension. Furthermore, the stable rosuvastatin calcium-loaded microemulsion showed relatively higher transmittance value which was observed to be decreased with their dilution over time. The release study showed that the formulations with longer chain length surfactants exhibited higher rate of drug release in both SGF and SIF. The release kinetics of the developed formulation follow zero order equation and release mechanism was identified as supercase-II transport type diffusion. Additionally, the selected microemulsion system did not show any signs of cytotoxic potential on HCT-116 cells.</p><h3>Conclusions</h3><p>It can be concluded that the use of surfactant with longer chain length showed improvement in the transport of the drug through the lipid-rich membrane of intestine. The stable microemulsion allows regulation of epithelial cells and facilitating the paracellular transport of the drug.</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 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143594678","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":"A Review on the Treatment and Diagnosis of Systemic Lupus Erythematosus Using Nanoparticle Systems","authors":"Amin Seddigh, Zahra Salmasi, Fatemeh Kalalinia, Somayeh Marouzi, Maryam Hashemi","doi":"10.1007/s12247-025-09954-x","DOIUrl":"10.1007/s12247-025-09954-x","url":null,"abstract":"<div><p>Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune disease characterized by inflammation due to autoantibodies against nuclear antigens. Current treatments suffer from poor bioavailability, low specificity, and significant side effects. Nanoparticle (NP)-based drug delivery systems offer promising alternatives through enhancing solubility, stability, bioavailability, controlled release and targeted delivery of drugs. Recent studies have demonstrated that NPs with various structures provide a novel approach for treating SLE, potentially reducing side effects while improving efficacy of therapeutic agents. This review aims to present the current status of SLE therapy, along with the potential advantages and challenges of using NPs in diagnosis and treatment of SLE.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143602414","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}
Bhargav E, Gowtham A, Somasekhar Reddy K, Sudheer Akkiraju
{"title":"Enhanced Reepithelization and Dermal Regeneration of a Novel Pongamia Oil Combination Based Chloramphenicol-Coloaded Curcumin Nanoemulsion Fortified with a Chitosan Hydrogel: Statistical Optimization, ex vivo and in vivo Studies","authors":"Bhargav E, Gowtham A, Somasekhar Reddy K, Sudheer Akkiraju","doi":"10.1007/s12247-025-09943-0","DOIUrl":"10.1007/s12247-025-09943-0","url":null,"abstract":"<div><h3>Purpose</h3><p>In the present study, a novel pongamia oil combination-based chloramphenicol (CPL)-coloaded curcumin (CUR) nanoemulsion (NE)-fortified chitosan hydrogel was formulated for effective wound healing.</p><h3>Methods</h3><p>The nanoemulsion was optimized by a central composite design. The factors that exhibited a significant (ANOVA) effect on the responses were studied. FT-IR and DSC studies indicated the compatibility of the drugs with excipients. The selected independent variables were Pongamia oil (PO): Tween 80: propylene glycol (PG), stirring time (ST) and sonication time, and the dependent variables selected were globule size and PDI.</p><h3>Results</h3><p>The globule size of the formulations F15a & F15b was found to be 280.23 ± 0.21 and 276.45 ± 0.29 nm, with PDIs of 0.390 ± 0.02 and 0.593 ± 0.02 and zeta potentials of -65.43 ± 0.39 and -70.73 ± 0.63 mV, which confirmed the uniform globule size distribution and stability of the formulations. Compared with the plain drugs, formulations F15a and F15b presented a greater zone of inhibition against <i>Staphylococcus aureus</i> (38 & 35 mm) and <i>E. coli</i> (32&29 mm). TEM analysis revealed a nearly spherical shape of the globules that was free from coalescence. The <i>invitro</i> drug release data indicated sustained drug release for up to 72 h. The <i>exvivo</i> drug release rates of F15a and F15b were 92.4% and 95%, respectively, for CPL and 87.6% and 94%, respectively, for CUR at 24th h. Contour plots were used to select the desired batch range. The stability studies indicated that the formulations remained stable at 40 ± 2 °C and an RH of 75 ± 5%. Compared with the control (70.00 ± 0.18%) and standard (92.04 ± 0.84%) groups, the optimized NE-CPL-CUR hydrogel F15a & F15b-treated groups exhibited greater wound contraction (94.44 ± 0.56 & 99.08 ± 0.18%) at the end of 21 days. Histopathological studies revealed better and improved reepithelization and epidermal and dermal regeneration.</p><h3>Conclusion</h3><p>The results of the present study demonstrated that the developed NE-CPL-CUR (0.5:1; CPL and CUR) chitosan-based hydrogel provided better wound healing because of the synergistic combination and presence of Pongamia oil in the nanoemulsion.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143594776","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}
Sijun Wu, Guangpu Fang, Guoming Zhou, Xiaoyang Zhang, Fan Li, Zhanrui Zhang, Yongqiang Ma, Hai Liu, Wenlong Li
{"title":"Advanced Machine Vision Technique for Analyzing the Blending Process of Sustained-Release Pellets","authors":"Sijun Wu, Guangpu Fang, Guoming Zhou, Xiaoyang Zhang, Fan Li, Zhanrui Zhang, Yongqiang Ma, Hai Liu, Wenlong Li","doi":"10.1007/s12247-025-09960-z","DOIUrl":"10.1007/s12247-025-09960-z","url":null,"abstract":"<div><h3>Objectives</h3><p>The tablet of multi-unit pellet system (TMUPS) tends to enable diversified therapeutic outcomes, due to the characteristic of containing pellets with different release behaviors. In the development of TMUPS formulations, it is essential to uniformly blend the pellets to ensure that the drug release profile of the formulation meets expectations.</p><h3>Methods</h3><p>In order to achieve the characterization of the blending status of sinomenine hydrochloride pellets and determine the blending endpoint, a method based on the machine vision (MV) technique combined with the independent circle (IC) image analysis algorithm was proposed. Fifteen experimental batches of the blending process with varying conditions were designed for the research. The images of pellets distribution at six different layers were captured using a MV photography platform, and the spatial distribution of the pellets during the blending process was digitally characterized using the IC algorithm.</p><h3>Results</h3><p>Compared to the traditional counting method, the utilization of the MV technique allowed for the accurate and timely determination of the blending endpoints of all batches and enabled the monitoring of changes in the blending status to detect when the demixing phenomenon occurred, based on the proportions, total number, and area occupied by the two types of pellets.</p><h3>Conclusions</h3><p>The MV method established in this paper may serve as a potential strategy for the monitoring of the relatively complex blending process involving multiple types of pellets with similar properties.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143583506","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}
Prajitha Biju, Manjunath M. Shenoy, Rouchelle Tellis, Ramesh Bhat, Ranajit Das, Ashwini Prabhu, Mohammed Gulzar Ahmed, Vivek Ghate
{"title":"Novel Ketoconazole-Loaded Niosomal Gel with Carbamide for Enhanced Topical Delivery and Skin Hydration in Fungal Infections","authors":"Prajitha Biju, Manjunath M. Shenoy, Rouchelle Tellis, Ramesh Bhat, Ranajit Das, Ashwini Prabhu, Mohammed Gulzar Ahmed, Vivek Ghate","doi":"10.1007/s12247-024-09916-9","DOIUrl":"10.1007/s12247-024-09916-9","url":null,"abstract":"<div><h3>Purpose</h3><p>Atopic dermatitis is a condition, wherein the outermost skin layer is disrupted, leading to excessive water loss and cutaneous lesions. This study assesses an antifungal topical formulation utilizing a vesicular system loaded with ketoconazole and a hydrating agent to treat fungal skin infections while preventing resistance and recurrence.</p><h3>Methods</h3><p>The Central Composite Design in Design Expert software was used to optimize ketoconazole-loaded niosomes, with vesicle size and drug entrapment efficiency as dependent variables and surfactant and organic solvent concentrations as independent variables. The optimized formulation was evaluated against predicted values, and compatibility and stability were analyzed via FT-IR and differential scanning calorimetry. Niosome morphology was examined using light microscopy and SEM. Niosomes were incorporated into a hydrogel containing 5% carbamide, a pH stabilizer, and preservative to enhance dermal bioavailability. The gel underwent evaluations for viscosity, antifungal activity, <i>in vitro</i> drug release, <i>ex vivo</i> permeation, skin irritation, TEWL, and histopathology.</p><h3>Results</h3><p>Optimized niosomes had a vesicle size of 275 nm and 98.38% drug entrapment efficiency. The gel was translucent, non-sticky, had a viscosity of 18,200 mPa·s at 20 °C, and exhibited a sustained <i>in vitro</i> drug release. The release kinetics followed zero-order and Baker-Lonsdale models, with R<sup>2</sup> values of 0.94 and 0.99. Application on mice reduced moisture loss and improved skin barrier function.</p><h3>Conclusion</h3><p>The ketoconazole-loaded niosomal gel is a promising carrier for dermal drug delivery against fungal infections.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143594778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Madhu Kumari, Monika Dwivedi, K. Jayaram Kumar, Ashok Kumar Pattnaik
{"title":"Bioinspired Chitosan-Based Patches Enriched With Lipid-Casein Nanocarriers: An Innovative Approach for Wound Management and Evaluation in a Rat Model","authors":"Madhu Kumari, Monika Dwivedi, K. Jayaram Kumar, Ashok Kumar Pattnaik","doi":"10.1007/s12247-025-09946-x","DOIUrl":"10.1007/s12247-025-09946-x","url":null,"abstract":"<div><h3>Purpose</h3><p>Wounds are physical injuries that disrupt the skin’s structure and function, necessitating a complex healing process to restore integrity and functionality. Ursolic acid (UA), a naturally occurring compound, exhibits remarkable antioxidant, anti-inflammatory, and antimicrobial properties, making it a promising candidate for wound healing applications. However, its therapeutic potential is hindered by challenges such as poor solubility, limited permeability, and low bioavailability, which restrict its effectiveness in clinical settings. Delivering UA through nanocarriers provides a significant advantage in resolving these issues, we designed bioinspired milk protein casein-lipid nanocarriers (UA LCNPs) that were incorporated in a chitosan-based transdermal patch.</p><h3>Method</h3><p>UA LCNPs were prepared using the desolvation method utilizing casein and Phospholipon 90 <sup>®</sup> G. UA LCNPs were characterized by dynamic light scattering (DLS), surface morphology, DSC, and FTIR parameters. The formulated nanoparticles were then incorporated into the chitosan patch using solvent-casting method. The UA LCNPs loaded patches were evaluated for the drug content, surface pH, FESEM, swelling index, hemolysis assay, antioxidant, etc. Furthermore, the developed transdermal patch was characterized and evaluated for in vitro permeation and in vivo wound treatment activity in rats.</p><h3>Results</h3><p>The formulated nanoparticles were spherical, with particle size (PS) 172.9 nm, zeta potential (ZP) -14.5 mV, and a PDI value were 0.336. The prepared patch from the nanoparticles was smooth, homogenous, and flexible having high drug content. The results showed that a transdermal patch can effectively control the UA release from the patch and the accumulation of UA in the skin. The hemolysis data provides insight into safety profile and <i>invivo</i> antioxidant activity showing strong antioxidant properties by inhibiting lipid peroxidation. The results showed that the transdermal patch UA LCNPs (test group) demonstrated effective wound healing compared to the control group and marketed ointment groups.</p><h3>Conclusion</h3><p>This work serves as a platform for the strategic management of wounds through phytomolecules shelled in casein nanocarriers subduing associated solubility and permeability hurdles. Moreover, accommodating them in patches for self-administration at the injury site presents an effective mode of wound management.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div><div><p>Graphical representation of delivery of bioinspired hybrid nanocarriers UA LCNPs through a transdermal patch on excision wound model displaying fast healing</p></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 2","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143564415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}