Drug Development and Industrial Pharmacy最新文献

{"title":"Thermosensitive chitosan hydrogel loaded cetuximab: a novel approach for parenteral controlled delivery.","authors":"Ahmed A H Abdellatif, Abdullah Aljutayli, Ahmed M Mohammed","doi":"10.1080/03639045.2025.2494126","DOIUrl":"10.1080/03639045.2025.2494126","url":null,"abstract":"<p><strong>Objective: </strong>The controlled release method improves the stability of cetuximab (CTX), which is typically impacted by the environmental variables present in regular formulations.</p><p><strong>Significant: </strong>It is possible to preserve the effectiveness of CTX by encapsulating it in a chitosan hydrogel to reach the target site <i>via</i> direct injection easily.</p><p><strong>Method: </strong>CTX was loaded into the thermosensitive polymer-based hydrogel, namely chitosan (CH) with the aid of a crosslinking β-glycerophosphate (β-GP) alone or in combination with Pluronic F127 (<math><mtext>Pl F</mtext><mn>127</mn></math>). The formulated hydrogels were subjected to different types of characterizations, such as stability and rheological studies. Furthermore, they were tested for their antiproliferative activities against HEPG2 (hepatic cancer cell lines).</p><p><strong>Results: </strong>Hydrogels had a homogeneous preparation, were transparent, and showed no signs of aggregation. Moreover, CH/β-GP gel type recorded a lower viscosity in comparison to the other hydrogel type <math><mtext>CH</mtext><mo>/</mo><mi>β</mi><mo>-</mo><mtext>GP</mtext><mo>/</mo><mtext>Pl F</mtext><mn>127</mn></math> system of (110.3 ± 5.2, and 148.4 ± 4.4 Cp, respectively). The conducted pharmacokinetic studies demonstrated a continued increase in rabbits' plasma throughout the first four days (<i>T</i>_max) with <i>C</i>_max of 3.663 μg/mL which also showed a decline below the detected limit after 15 days. Nevertheless, the formulated CH-based hydrogel showed a sustained release with a longer value of MRT of more than 9 days with an estimated AUC_0-t of 41.917 μg/L/day.</p><p><strong>Conclusion: </strong>The medicated CH/β-GP hydrogel formula demonstrated superior targeting-controlled efficiency compared to free CTX.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"597-605"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986352","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 use of nanomedicines in the healthcare systems: a policy brief.","authors":"Somayeh Vandghanooni, Mehdi Jaymand, Morteza Eskandani","doi":"10.1080/03639045.2025.2489594","DOIUrl":"10.1080/03639045.2025.2489594","url":null,"abstract":"<p><strong>Objective: </strong>Nanomedicine is the application of nanotechnology to medicine and, therefore, a potentially transformative approach to healthcare. This new and interdisciplinary field has three main applications in diagnostics, controlled/targeted drug delivery, and regenerative medicine. Nanomedicine has great potential to change human health by advancing diagnosis, prevention and treatment for a wide variety of diseases, including cancer, cardiovascular conditions, and neurological disorders. Despite the overwhelming potential, there are some issues impeding the complete integration of nanomedicines into healthcare systems.</p><p><strong>Significance: </strong>This policy brief addresses such critical issues to inform and guide decision-making on effectively deploying nanomedicine to improve patient outcomes and advance important public health initiatives. In addition, some prospects were also presented for the future. It discusses the current barriers to their wide application, particularly regarding regulatory hurdles and the production of robust clinical evidence.</p><p><strong>Key findings: </strong>These brand-new nanosystems have some serious drawbacks in regard to safety, efficacy, and regulatory compliance, not to mention public acceptance. Nanomaterials can be so complex that their manufacturing processes become complex, which may potentially bring into question long-term effects on human health and the environment.</p><p><strong>Conclusions: </strong>This policy brief identifies key considerations for policymakers and stakeholders, highlighting the requirement for integration among researchers, clinicians, and regulatory bodies. To facilitate the safe and successful integration of nanomedicines into patient care, continued collaboration are imperative. Priority in the future should be given to developing comprehensive regulatory frameworks, raising public awareness, and promoting interdisciplinary research to resolve existing challenges and unlock the potential of nanomedicines in the healthcare sector.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"523-533"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788126","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":"Stability indicating HPTLC - densitometric method for estimation of vonoprazan fumarate.","authors":"Mitalben S Parmar, Dimal A Shah, Usmangani K Chhalotiya","doi":"10.1080/03639045.2025.2492192","DOIUrl":"10.1080/03639045.2025.2492192","url":null,"abstract":"<p><strong>Objectives: </strong>High performance thin layer chromatography method was developed and validated for analysis of vonoprazan fumarate. An Alkaline forced degradation kinetic study was performed to find out probable rate of degradation of vonoprazan fumarate.</p><p><strong>Material and methods: </strong>Aluminum packed TLC plates precoated with silica gel 60 F 254 were used as stationary phase and Methanol: Toluene: triethylamine (6: 4: 0.1 v/v/v) was used as mobile phase. The detection was carried out at 267 nm wavelength as absorbance mode. HPTLC/MS analysis study was performed to detect alkaline degradant.</p><p><strong>Results: </strong>A compact band (R_f value of 0.43 ± 0.1) was obtained for vonoprazan fumarate. Regression analysis shows a good linear relationship (R² = 0.9996) between peak area and concentration in the range 200-1200 ng/band. The accuracy determined by standard addition method for vonoprazan fumarate and percentage recovery was found to be 99.72% - 101.74%. Forced degradation stability study was performed under different stress conditions including hydrolytic, oxidative, thermal and photolytic. Degradation was observed under alkaline condition and it was found to follow first order degradation kinetic. The possible structure of base degradants was also determined using HPTLC-MS analysis. The method was successfully applied for the estimation of drug in synthetic mixture.</p><p><strong>Conclusion: </strong>A New, Simple, precise and accurate method has been developed and validated for the quantification of vonoprazan fumarate. Forced degradation studies were performed. The method can be used for quality control and stability sample evaluation of vonoprazan fumarate.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"546-554"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991485","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":"Green synthesis and biomedical potential of l-ascorbic acid-stabilized copper sulfide nanoparticles as antibacterial and antioxidant agents.","authors":"Shafiul Haque, Saba Siddiqui, Abdullah Mashraqi, Raju K Mandal, Mohd Wahid, Faraz Ahmad, Bushra Fatima","doi":"10.1080/03639045.2025.2487939","DOIUrl":"10.1080/03639045.2025.2487939","url":null,"abstract":"<p><strong>Background: </strong>Inorganic metal nanoformulations are potential therapeutic agents for a variety of biomedical applications, particularly as antimicrobial and antioxidant agents. The main objective of this study was to synthesize copper sulfide nanoparticles (CuS NPs) and evaluate their efficiency as an antioxidant and antibacterial agent.</p><p><strong>Methods: </strong>CuS NPs were prepared in a single step process using l-ascorbic acid as the stabilizing agent. Systematic structural and morphological characterization was performed using standard techniques of X-ray diffraction (XRD), Fourier-transform infrared (FT-IR) spectroscopy, scanning electron microscopy (SEM), and transmission electron microscopy (TEM). Further, agar well disk-diffusion method was applied for determination of the antibacterial sensitivity and minimum inhibitory concentration (MIC) of CuS NPs against multiple pathogenic bacterial strains. Their antioxidant potential was evaluated as total reduction capability, and nitric oxide (NO) and 2,2-diphenyl-1-picrylhydrazyl (DPPH) free radical scavenging activities at multiple doses, with l-ascorbate as the reference.</p><p><strong>Results: </strong>The results indicated amorphous nature of the CuS NPs with the size range of 8.17-9.63 nm. FT-IR confirmed presence of several bioactive functional groups required for the reduction of copper ions. Additionally, CuS NPs showed robust antibacterial activities against bacterial species such as <i>Escherichia coli</i> and <i>Staphylococcus aureus</i> in the agar well diffusion assays, with zone of inhibition values ranging between 21 and 23 mm. CuS NPs also showed potent dose-dependent antioxidant activity.</p><p><strong>Conclusion: </strong>CuS NPs prepared in this study in a cost- and time-efficient manner have excellent antibacterial and antioxidant properties with the potential to be used for different biomedical applications.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"577-586"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763373","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":"Mirtazapine Loaded NLCs‑Based Hydrogel for Topical Delivery in Pruritus: Statistical Optimization, <i>In vitro</i> and Skin Irritation Evaluation.","authors":"Muhammad Akhtar, Aqeedat Javed, Abeer Tariq, Rashna Mirza, Ahmad Abdur Rahman, Hamid Khan, Ahmad Khan","doi":"10.1080/03639045.2025.2495846","DOIUrl":"10.1080/03639045.2025.2495846","url":null,"abstract":"<p><p>Systemic mirtazapine (MRT) delivery for the treatment of pruritus exhibits severe side effects which needs to be addressed. For this purpose, topical nanostructured lipid carriers (NLCs) containing MRT were developed to minimize side effects and enhance therapeutic efficacy. The microemulsion method was utilized for the preparation of MRT loaded NLCs and the final optimized formulation was loaded in the gel for effective topical application. The formulation was optimized in terms of particle size (PS), zeta potential (ZP), polydispersity index (PDI), and percentage entrapment efficiency (% EE) by keeping in view the quantity of drug, tween 80 and lipids ratio. Optimized nano formulation exhibited the PS of 186.3 ± 1.2 nm, with 0.217 ± 0.03 PDI, ZP of -26.0 ± 0.2 mV and %EE of 86.3 ± 0.3%. Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) analysis confirmed the compatibility of components of nano formulation and encapsulation of drug inside lipid matrix, respectively. Further, the gel-based optimized MRT-loaded NLCs dispersion was analyzed for rheology and textural characterization. The prepared hydrogel (MRT-loaded NLCs gel) had a transparent appearance, non-gritty texture, pH, and spreadability of 322.33 ± 0.25%, respectively. MRT loaded NLCs gel exhibited a drug release of 81% in 24 h and followed Korsmeyer-Peppas model. <i>Ex vivo</i> skin permeation depicted only 6.20 µg/cm² drug permeation across the skin after 24 h. Skin irritation study showed no signs of erythema and edema in nano formulation-treated group. MRT-loaded NLCs gel was formulated successfully and may be used as a promising vehicle for topical delivery of pruritus.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"634-646"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143982806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and optimization of venlafaxine niosomes loaded thermosensitive <i>in-situ</i> gel for prolonging intranasal residence in depressive disorder.","authors":"Purushottam Gangane, Mandar Thool, Sachin More, Amol Warokar, Kishor Salunkhe, Pankaj Dangre","doi":"10.1080/03639045.2025.2492193","DOIUrl":"10.1080/03639045.2025.2492193","url":null,"abstract":"<p><strong>Objective: </strong>Venlafaxine (VLF) is the most commonly used drug for the treatment of depressive disorder. The oral bioavailability of VLF is low. Therefore, the present study emphasized the development of niosomes formulation for solubility and permeation improvement.</p><p><strong>Methods: </strong>The niosome-VLF was formulated using a thin film hydration technique employing different molar ratios of Span 40 and cholesterol. The optimization of niosomes was performed using the Box-Behnken screening model, which employs numerical optimization.</p><p><strong>Results: </strong>The optimized niosmoes-VLF showed Particle size: 264.2 ± 2.2 nm; Zeta potential: 49.2 ± 1.3 mV; Polydispersity Index: 0.265 ± 0.15; Entrapment efficiency: 70.25 ± 1.5%. The niosome-VLF (OF) was incorporated into the thermosensitive <i>in situ</i> gel (TISG). The niosome-VLF TISG (OF-A) showed gelling temperature: 37 ± 0.5 °C; gelling time: 23 ± 2.2 s; viscosity: 4526 ± 142 cps; mucoadhesive strength: 3589 ± 65 dyne/cm², drug content: 88 ± 5.4%. The <i>in-vivo</i> pharmacokinetic study revealed a higher concentration of VLF in developed niosome-VLF TISG (OF-A) formulation than VLF suspension. The higher and sustained concentration of VLF in brain and plasma suggested a better therapeutic approach to counteract a chronic depressive disorder. Further, the accelerated stability studies of niosome-VLF TISG (OF-A) indicated good physical and chemical attributes.</p><p><strong>Conclusion: </strong>The intranasal niosome-VLF TISG (OF-A) can be sorted as an alternative approach for targeting the brain for the effective management of CNS conditions like depression.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"587-596"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986002","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":"Enhanced Tacrolimus efficacy in psoriasis with innovative transethosomes: a promising preclinical study on Wistar rats.","authors":"Vishwanath Jadhav, Kishori P Sutar, Sankalp S Sammasagi, Siddarth Usulkar, Vinayak Patil","doi":"10.1080/03639045.2025.2482664","DOIUrl":"10.1080/03639045.2025.2482664","url":null,"abstract":"<p><strong>Aim: </strong>This study focuses on the formulation and evaluation of Tacrolimus-loaded transethosomes, which are then incorporated into a gel for topical application. The goal is to achieve deeper transdermal penetration, enhancing the treatment regimen.</p><p><strong>Methods: </strong>Transethosomes were formulated using the cold method and optimized using 3² factorial design (DESIGN EXPERT^® Software) using different concentrations of lipid and ethanol. They were characterized for vesicle size, entrapment efficiency, zeta potential, and polydispersity index. The optimized batch was incorporated into the carbopol 940 gel base. <i>In vitro</i> and <i>ex vivo</i> permeation studies were carried out to determine the diffusion and release pattern. Skin irritancy and <i>in vivo</i> imiquimoid-induced anti-psoriatic activity were carried out on Wistar rats.</p><p><strong>Results: </strong>The F1 batch, characterized by a low concentration of ethanol and lipids, demonstrated a vesicle size of 168 nm, an entrapment efficiency of 85%, a zeta potential of -36 mV, and a polydispersity index of 0.12. <i>In vitro</i> release studies indicated an 85.32% drug release and a 76.34% drug permeation after 24 h. The drug release adhered to zero-order kinetics, with the Korsmeyer-Peppas model suggesting a non-Fickian diffusion mechanism. <i>In vivo</i> studies of Tacrolimus-loaded transethosomal gel in an imiquimod-induced psoriasis-like rat model demonstrated significant therapeutic effects within seven days. Histopathological analysis showed reduced hyperkeratosis, epidermal hyperplasia, and inflammation, with fewer inflammatory cells in the dermis. Stability tests confirmed the formulation's integrity at 4 and 25 °C over 90 days.</p><p><strong>Conclusion: </strong>The study's outcome revealed that tacrolimus-loaded transethosomes could effectively manage psoriasis.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"454-466"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718313","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 of etoricoxib-loaded mesoporous silica nanoparticles laden gel as vehicle for transdermal delivery: optimization, <i>ex vivo</i> permeation, histopathology, and <i>in vivo</i> anti-inflammatory study.","authors":"Dibya Lochan Mohanty, Noota Divya, Ameeduzzafar Zafar, Musarrat Husain Warsi, Gnyana Ranjan Parida, Priyanka Padhi, Mohammad Khalid, Mohd Yasir, Md Ali Mujtaba","doi":"10.1080/03639045.2025.2490287","DOIUrl":"10.1080/03639045.2025.2490287","url":null,"abstract":"<p><strong>Objective: </strong>Etoricoxib (ETB) is a nonsteroidal anti-inflammatory therapeutic agent. It is poorly soluble and has various gastrointestinal side effects such as bleeding and ulcers after oral administration. The present research aimed to develop an ETB-loaded mesoporous silica nanoparticle-laden gel (ETB-MSNPs) for transdermal delivery to improve therapeutic efficacy.</p><p><strong>Methods: </strong>The ETB-MSNPs were synthesized using a precipitation and solvent evaporation technique and their optimization was performed using a Box-Behnken design. The optimized ETB-MSNPs were incorporated into a carbopol-chitosan gel and evaluated for <i>in vitro</i>, <i>ex vivo</i>, and <i>in vivo</i> anti-inflammatory activity.</p><p><strong>Results: </strong>The ETB-MSNPs displayed nanosize of particles with nanosize distribution and high entrapment efficiency of ETB. The Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) studies showed that ETB was encapsulated in MSNPs. The optimized ETB-MSNPs were successfully integrated into the carbopol and chitosan gel, which exhibited excellent viscosity and spreadability. The optimized ETB-MSNPs gel exhibited a significantly higher and more sustained release of ETB compared to pure ETB gel. Optimized ETB-MSNPs gel exhibited a considerably higher anti-inflammatory effect with a significant reduction in IL-1β and TNF-α levels compared to pure ETB gel. The histopathological examination confirmed that optimized ETB-MSNPs gel did not exhibit any toxicity on the skin.</p><p><strong>Conclusion: </strong>Based on the findings, the results suggest that the MSNPs gel has the potential as a carrier for enhancing the therapeutic efficacy of ETB through topical delivery, although further studies are needed to fully confirm its effectiveness.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"506-521"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794743","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":"Gliclazide loaded spanlastic nanovesicles: empowering bioavailability and antidiabetic efficacy.","authors":"Shimaa Mazyed, Soha M El-Masry, Haidy Abbas, Mohammad M Abd-Alhaseeb, Heba M Elbedaiwy","doi":"10.1080/03639045.2025.2480183","DOIUrl":"10.1080/03639045.2025.2480183","url":null,"abstract":"<p><strong>Objective: </strong>This work aimed to prepare spanlastics nanovesicles (SNVs) loaded with gliclazide (GCZ) to increase the drug's oral bioavailability and anti-diabetic effects.</p><p><strong>Methods: </strong>Two types of edge activators (tween 80 and/or brij35) and two types of spans (span 60 and span 80) were used to prepare SNVs using the ethanol injection method,2³ factorial design was used to investigate the effects of various span types, edge activator types, and the ratio of span to edge activator.</p><p><strong>Results: </strong>The optimum formulation (F6) was selected and its <i>in-vitro</i> drug release, <i>in-vivo</i> pharmacokinetics, and pharmacodynamics were evaluated. A transition electron microscope (TEM) showed spherical particles with smooth surfaces, (F6) drug release was (Q₁₂ 97.05 ± 4.85) while GCZ powder was (97.89 ± 4.56 after 4 h) also showed better entrapment efficiency (EE% 95.1 ± 3.8). <i>In- vivo</i> pharmacokinetic study showed an increase in C_max and t_max (12.93 ± 1.34, 3.2 ± 0.83) compared to unprocessed GCZ powder (2.88 ± 1.59, 1.8 ± 0.74). <i>In-vivo</i> pharmacodynamics study of diabetic rats demonstrated that GCZ-loaded SNVs has a higher % maximum decrease in blood glucose levels (MR) 58.31 ± 5.70 compared to 38.33 ± 8.18 for free drug and % total drop in blood glucose levels (TD) 25.78 ± 5.31% for GCZ-SNVs compared to 20.26 ± 6.05% for free drug. Histopathological examination revealed no cytotoxic signs in any of the examined samples.</p><p><strong>Conclusion: </strong>Results revealed a significant rise in relative bioavailability, sustained and prolonged drug release when compared to the unprocessed GCZ powder.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"440-453"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647552","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":"Formation of self-assembled polyelectrolyte complex derived from BSA and nanogels: a study to optimize processing parameters and preserve protein integrity.","authors":"Jahanzeb Mudassir, Aamir Jalil, Khizar Abbas, Yusrida Darwis","doi":"10.1080/03639045.2025.2479758","DOIUrl":"10.1080/03639045.2025.2479758","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this work was to identify, optimize, and use nondestructive process to develop nano-formulation using polyelectrolyte complexation (PEC) between polymeric nanocarrier and bovine serum albumin.</p><p><strong>Significance: </strong>Proteins are mostly degraded during preparation and loading into nano-carriers which hinders success in protein delivery.</p><p><strong>Method: </strong>Herein, novel PEC consisting of model protein BSA and nanogels (NGs), were prepared to form self-assembled polyelectrolyte nanocomplexes <b>(</b>BSA/NGs-PEC). The BSA/NGs-PEC were obtained by mixing BSA and nanogels at various weight ratios (1:2, 1:4, 1:5, 1:6, 1:8, 1:10), pH values of solution (1.2, 4.0, 6.0), incubation time (2, 4, 6, 8 h), and stirring rate (without, 100, 200 rpm). The prepared PEC were evaluated for particle size (PS), polydispersity index (PDI), zeta potential (ZP), and percentage of complexation efficiency (%CE). To study insights into structural integrity and biological activity, the SDS-PAGE and esterase activity assay was performed on BSA released from final optimized formulation.</p><p><strong>Results: </strong>The optimized parameters were BSA/nanogels mixing ratios at 1:8, pH of complex-forming medium at 4.0, incubation time of 6 h, and stirring rate at 100 rpm. The SDS-PAGE and esterase activity assay revealed that the primary structure and bioactivity, respectively, of BSA was still intact.</p><p><strong>Conclusion: </strong>The results suggest that current scheme for optimization has considerable potential for creating protein-based delivery system by using PEC <i>via</i> electrostatic interaction.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"430-439"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656401","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}