Drug Development and Industrial Pharmacy最新文献

{"title":"Estimation of rezdiffra (MGL-3196) by validated RP-HPLC approach in bulk material and pharmaceutical formulation.","authors":"Md Abid Hasan, Raisa Tasnim, Ejaj Sumit, Musfirat Tania, Maria Kibtia Ali","doi":"10.1080/03639045.2026.2656426","DOIUrl":"10.1080/03639045.2026.2656426","url":null,"abstract":"<p><strong>Introduction: </strong>Rezdiffra MGL-3196 is a newly authorized systemic medication for moderate to severe liver fibrosis associated with noncirrhotic nonalcoholic steatohepatitis (NASH).</p><p><strong>Objective: </strong>The objective is to create a high-performance liquid chromatographic method for rezdiffra assessment that is simple, accurate, and validated in compliance with ICH guidelines.</p><p><strong>Material and methods: </strong>Data processing was done using Chromeleon software and Vanquish HPLC. Rezdiffra was effectively separated using a mobile phase containing of 0.05% Trifluoroacetic acid in 80% of Acetonitrile at a wavelength of 220 nm and a flow rate of 1.0 ml/min on an ODS, C18; 4.6 mm × 250 cm; 5 µm, packed USP column. At 3.5 min, the rezdiffra replied. Selectivity, precision, linearity, LOD/LOQ, accuracy, robustness, and solution stability were among the validation metrics whose performance was confirmed.</p><p><strong>Results: </strong>There was no interference, and all the peaks were well separated. Over the range of 5-200 mcg/ml, the correlation coefficient of rezdiffra was 0.9996, indicating that the technique-maintained linearity at varying concentrations. The percentage of the rezdiffra recovered at various concentrations fell between 98.0 and 102.0. The absolute difference of the content at various adjusted circumstances was within 2.0 of the original condition when the column temperature and the flow rate were altered from the real rate. After 24 h at room temperature, autosampler (15 °C to 25 °C), and refrigerator (2-8 °C), the solutions remained stable.</p><p><strong>Conclusion: </strong>The verified HPLC method can be a practical analytical technique for the analysis of Rezdiffra in pharmaceutical products.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-10"},"PeriodicalIF":2.2,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147632832","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":"Systematic review on effectiveness of flavonoids against breast cancer: insights from in-vitro, in-vivo studies and molecular pathway studies.","authors":"Deepika Sharma, Malakapogu Ravindra Babu, Shriyansh Srivastava","doi":"10.1080/03639045.2026.2659917","DOIUrl":"10.1080/03639045.2026.2659917","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;On a global scale, breast cancer is the most prevalent form of cancer that affects women and the leading cause of death. Radiation therapy, chemotherapy, and hormone therapy are the contemporary approaches that are utilized in the treatment of breast cancer. However, these treatments come with a number of downsides, including resistance to medicine, unpleasant side effects, and treatment outcomes that are not satisfying enough to be considered satisfactory. The most important objective of this review was to incorporate the most recent discoveries about flavonoids, which are a category of polyphenolic chemicals that are obtained from plants. The majority of flavonoids can be found in foods, including fruits, vegetables, and plants used for medicinal purposes. A number of studies have shown that flavonoids possess anticancer properties and hence could serve as adjunctive drugs for the treatment of BC.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Significance of review: &lt;/strong&gt;Flavonoids have been shown to have very promising potential in the treatment of cancer, particularly breast cancer, according to recent study. Flavonoids possess pharmacological properties that differ from those of other compounds. For the purpose of this review, we searched the databases PubMed, Scopus, Embase, and Web of Science for articles that were published between January 2020 and May 2025 and explored the function that flavonoids play against breast cancer. When searching for the most recent publications, we used the phrases 'Flavonoids' and 'Breast Cancer' to discover them. Through the application of PRISMA principles, a total of 3,103 papers were discovered, and forty original research papers were chosen based on inclusion and exclusion criteria. The review technique was documented in the International Prospective Register of Systematic Reviews (PROSPERO) with the registration number CRD420261326368. The included studies investigated breast cancer mechanisms through &lt;i&gt;in vivo&lt;/i&gt; experiments, &lt;i&gt;in vitro&lt;/i&gt; and molecular analyses of apoptosis induction, tumor volume reduction, angiogenesis inhibition, metastasis suppression, drug resistance reversal and breast cancer signaling pathway modulation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Key findings: &lt;/strong&gt;Flavonoids such as naringenin, hesperidin, quercetin, baicalin, chrysin, ononin, scutellarin, and 2'-hydroxychalcone have demonstrated anticancer potential in breast cancer models, primarily &lt;i&gt;in vitro&lt;/i&gt; and preclinical studies. A number of significant signaling pathways, including NF-κB, MAPK, Wnt/β-catenin, AMPK/mTOR, and PI3K/Akt/mTOR, were altered in connection with these effects. Flavonoids have been shown to have the ability to reduce drug resistance and increase the cytotoxic effects of chemotherapy medications such as doxorubicin and docetaxel, according to research that was conducted through several experiments. However, many studies used concentrations that may not be pharmacokinetically achievable &lt;i&gt;in vivo&lt;/i&gt;, and cli","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-19"},"PeriodicalIF":2.2,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147688618","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 dissolution of poorly water-soluble prednisolone <i>via</i> spray-dried arabinoxylan microspheres: a novel arabinoxylan-based drug delivery system.","authors":"Muniyandy Saravanan, Rowena Gan, Chin Jia Rei, Neo Ming Shin, Thenapakiam Sathasivam","doi":"10.1080/03639045.2026.2658200","DOIUrl":"https://doi.org/10.1080/03639045.2026.2658200","url":null,"abstract":"<p><strong>Background: </strong>Prednisolone's poor aqueous solubility limits its oral bioavailability, necessitating the development of innovative formulation strategies.</p><p><strong>Objective: </strong>This study aimed to extract AX from ispaghula husk and develop AX-based spray-dried microspheres to improve prednisolone dissolution.</p><p><strong>Methods: </strong>AX was extracted from ispaghula husk, and its molecular weight was determined using gel permeation chromatography. Prednisolone-loaded AX microspheres (F1-F4) were prepared by spray drying and evaluated for drug loading, entrapment efficiency, and product yield. Structural and physicochemical characterization was performed using NMR, FTIR, SEM, and DSC. <i>In vitro</i> dissolution studies were conducted over 60 min. Initial and relative dissolution rates, along with similarity factor (f₂) analysis, were used to compare formulations.</p><p><strong>Main findings: </strong>Drug loading ranged from 3.7 to 15.63% w/w, with the highest values observed for F3 and F4. Entrapment efficiency increased with drug loading, ranging from 15.85% (F1) to 36.43% (F4), while product yield ranged from 52.4 to 63.1% w/w. NMR confirmed drug stability following spray drying. SEM revealed irregular, rough-surfaced microspheres and reduced drug particle size. FTIR demonstrated drug-polymer compatibility, and DSC indicated drug amorphization. Formulations F3 and F4 achieved >72% dissolution within 60 min, exceeding pure prednisolone (26.8%) and the commercial tablet (49.9%). Similarity factor analysis indicated that F1 was closest to the marketed product, whereas F3 and F4 exhibited superior dissolution rates.</p><p><strong>Conclusion: </strong>Spray-dried AX microspheres significantly enhanced prednisolone dissolution, highlighting AX as a biocompatible, scalable, and promising excipient for poorly water-soluble drugs.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-12"},"PeriodicalIF":2.2,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147722022","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":"Curcumin-loaded beta-glucan nanoparticles: preparation, physicochemical properties, and molecular modeling.","authors":"Quoc-Hoai Nguyen, An-Khanh Pham, Huu-Manh Nguyen, Hoai-Xuan Ngo, Hoang-Anh Nguyen, Nguyen-Thach Tung","doi":"10.1080/03639045.2026.2654742","DOIUrl":"10.1080/03639045.2026.2654742","url":null,"abstract":"<p><strong>Objectives: </strong>This study introduces the application of wet milling, a well-established top-down technique, as a novel approach for preparing beta-glucan nanoparticles (BG-NPs) as carriers for poorly soluble drugs, using curcumin (CC) as a model compound. This presents one of the first studies illustrating wet milling as a feasible way to produce BG-NPs with enhanced drug delivery capabilities, potentially improving the bioavailability of CC in particular and other poorly soluble drugs in general.</p><p><strong>Methods: </strong>A two-step process was employed: first, optimizing beta-glucan (BG) nanocarrier preparation, followed by CC incorporation. Separating factor (NaOH) and hydrolyzing factor (CH₃COOH) were used to facilitate the size reduction of BG's robust triple-helix structure.</p><p><strong>Results: </strong>Under optimized conditions, BG-NPs with an average size of 408.8 ± 13.1 nm were produced. Curcumin-loaded BG-NPs (CC/BG-NPs) at the optimal drug-to-carrier ratio of 0.4:1 (<i>w/w</i>) achieved a particle size of approximately 300 nm with 98% loading efficiency and 84.3% drug release within 120 min, which is approximately a 4-fold increase compared to raw CC (18.4%). Solid-state analysis, FTIR spectroscopy, molecular docking, and molecular dynamics simulation confirmed the formation of hydrogen bonds between CC's carbonyl and methoxy groups with BG's hydroxyl groups, along with stabilizing hydrophobic interactions.</p><p><strong>Conclusion: </strong>The optimized formulation produced uniform nanoparticles with sizes suitable for efficient cellular uptake and drug delivery. Using CC as a model drug, we demonstrated enhanced dissolution through strong intermolecular interactions between the drug and carrier.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-15"},"PeriodicalIF":2.2,"publicationDate":"2026-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147626998","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 bactericidal potential of coenzyme Q₁₀ through an optimized oral nano-system formulation approach: <i>in-vitro</i> characterization and antimicrobial evaluation.","authors":"Heba Abdel Hafeez Ismail, Doaa Ahmed El-Setouhy, Basant A Habib, Amany M El Nahrawy, Heba Attia, Eman Abdelhakeem","doi":"10.1080/03639045.2026.2653684","DOIUrl":"10.1080/03639045.2026.2653684","url":null,"abstract":"<p><strong>Objective: </strong>Multidrug-resistant bacterial infections demand innovative therapies. Drug repurposing offers a faster, safer alternative to traditional development.</p><p><strong>Significance: </strong>This study investigates Coenzyme Q10, a safe antioxidant, using a novel proliposomal nano-delivery system to overcome its poor solubility and unlock antimicrobial efficacy.</p><p><strong>Methods: </strong>An optimized CoQ10 proliposomal formulation was developed via factorial design and characterized for size, zeta potential, entrapment efficiency, release, TEM, DSC, and FTIR. Antimicrobial activity against A. baumannii and P. aeruginosa was compared to free drug using the Mann-Whitney U test.<b>Results</b>The optimized formulation showed 172.4 nm size, -24.4 mV zeta potential, 72.43% entrapment, and 69.06% release over 24h-an 11.27-fold enhancement over unformulated CoQ10. It transformed the drug into an amorphous state and formed spherical vesicles. It significantly potentiated activity (p<0.05), reducing MIC and MBC against both pathogens.</p><p><strong>Conclusions: </strong>₁₀'s A rationally designed proliposomal system markedly improves CoQ10 dissolution and revives its antimicrobial activity. This first report of nano-encapsulation-augmented efficacy against resistant Gram-negative bacteria offers a promising translatable strategy for clinical investigation.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-15"},"PeriodicalIF":2.2,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147572480","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":"Intranasal Nanoemulsion-based In-Situ Gel Containing Dexlansoprazole: Formulation Development, <i>In-Vitro</i> and <i>Ex-Vivo</i> Evaluation.","authors":"Gyati Shilakari, U Sai Kumar, Meghamala G, Srilatha B, Abhay Asthana","doi":"10.1080/03639045.2026.2657498","DOIUrl":"https://doi.org/10.1080/03639045.2026.2657498","url":null,"abstract":"<p><strong>Aim: </strong>Dexlansoprazole (DXL) is clinically effective in gastroesophageal reflux and ulcer healing, yet its oral bioavailability is compromised by acid instability, poor aqueous solubility, and extensive first-pass metabolism. To address these limitations, an intranasal nanoemulsion-based in situ gel was developed to bypass gastrointestinal and hepatic metabolism and enable rapid systemic absorption via the highly vascularized nasal mucosa. Owing to the BCS Class II nature of DXL, this approach was designed to enhance solubility, prolong nasal residence time, and provide sustained drug release.</p><p><strong>Methods: </strong>DXL-loaded nanoemulsions (NEs) were prepared using Capmul MCM EP as the oil phase, Cremophor EL as the surfactant, and PEG 300 as the co-surfactant by sonication. The NEs were evaluated for various <i>in vitro</i> parameters, <i>in vitro</i> drug release, and <i>ex vivo</i> permeation.</p><p><strong>Results: </strong>Among all NEs, F3 exhibited optimal characteristics, with a mean droplet size of 40.55 nm, a PDI of 0.374, a zeta potential of -17.70 mV, spherical globules under TEM and the highest cumulative release of 90.02% at 24 h. All NEs displayed significantly enhanced drug release as compared to the drug suspension. Cumulative drug permeation of 90.02 ± 0.565% for F3 and 80.69 ± 0.057% for its in situ gel (F3NEG4) was recorded, with 5.54- and 5.18-fold higher J_ss than the drug suspension, respectively. Additionally, F3 remained physically stable for 3 months at 2-8 °C and 25 ± 5 °C.</p><p><strong>Conclusion: </strong>The developed DXL-loaded NE improved <i>in vitro</i> dissolution, indicating potential enhancement of bioavailability, which requires confirmation through comprehensive <i>in vivo</i> studies.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-25"},"PeriodicalIF":2.2,"publicationDate":"2026-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147662412","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 topical delivery of terbinafine HCl nanomicelles embedded in chitosan gel for improved antifungal activity.","authors":"Gul-E Maryam, Fazli Nasir, Shazma Gohar, Sadia Pervez, Kamran HidayatUllah, Hamza Khalil, Waleed H Almalki, Muzna Ali Khattak, Talaya Hidayatullah, Altaf Ur Rehman, Arbab Tahir Ali, Syeda Rabqa Zainab, Christina Peter, Hilal Zafar","doi":"10.1080/03639045.2026.2654741","DOIUrl":"10.1080/03639045.2026.2654741","url":null,"abstract":"<p><strong>Objectives: </strong>Terbinafine Hydrochloride nanomicelles loaded chitosan gel was prepared with a goal to provide effective and controlled drug deliveryto the skin layers where conventional topical preparations are unable to penetrate.</p><p><strong>Significance: </strong>Terbinafine Hydrochloride is a broad spectrum agent used widely against fungal skin infections. However, the efficacy of conventional topical Terbinafine Hydrochloride formulation is appreciable only when the fungus resides in upper layers of the skin. Terbinafine Hydrochloride nanomicelles provide a good alternative for efficiently eradicating the fungus in deeper skin layers, leading to lower relapse rate.</p><p><strong>Methods: </strong>The nanomicelles were prepared by dissolution method using Soluplus^® polymer and optimized for particle size and encapsulation efficiency. The optimized nanomicelles were characterized for morphology, drug excipients compatibility and EDX analysis, followed by incorporation into chitosan gel and its evaluation for spread ability, <i>ex vivo</i> skin permeation, deposition, distribution and histopathology.</p><p><strong>Results: </strong>The optimized formulation with 1:4 (Terbinafine Hydrochloride: Soluplus^®) resulted in the nanomicelles with diameter of 61 nm, poly dispersity index of 0.1 and encapsulation efficiency of 95.2%. TEM analysis confirmed the spherical nature while chemical compatibility of formulation ingredients, drug encapsulation and amorphous nature of the drug was confirmed by FTIR, EDX analysis and DSC respectively. The TbH nanomicelles loaded chitosan gel depicted improved antifungal efficacy and distribution in the skin layers as compared to conventional available formulations.</p><p><strong>Conclusion: </strong>The prepared Terbinafine Hydrochloride loaded chitosan gel is claimed to demonstrate improved antifungal efficacy and skin delivery highlighting its potential for the topical treatment of skin fungal infections.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-16"},"PeriodicalIF":2.2,"publicationDate":"2026-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147627202","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":"Polysaccharide-based suspensions: a novel pediatric-friendly formulation for administering furosemide through nasogastric tubes.","authors":"Luiza Gonçalves Soutier, Carla Suellen Gurski, Felipe Neme Ribeiro, Giovanna Araujo de Morais Trindade, Marcel Henrique Marcondes Sari, Thais Martins Guimarães, Roberto Pontarolo, Luana Mota Ferreira","doi":"10.1080/03639045.2026.2651289","DOIUrl":"10.1080/03639045.2026.2651289","url":null,"abstract":"<p><strong>Objective: </strong>Our study aimed to develop extemporaneous furosemide suspensions using a polysaccharide as the suspensor agent and to evaluate their stability and drug loss during tube administration.</p><p><strong>Significance: </strong>Extemporaneous oral furosemide liquid formulations are often necessary for managing neonatal cardiovascular disorders, as commercial formulations are typically limited to solid preparations. However, the practice involves syrup as the vehicle, and data on the stability of these formulations are missing.</p><p><strong>Methods: </strong>Suspensions were prepared by crushing tablets and using xanthan gum as a thickening agent, without the addition of sugar or preservatives. Samples were stored at room temperature, under refrigeration, and at 40 °C. Physicochemical stability was evaluated on days 0, 3, 5, and 7, assessing pH, density, sedimentation volume, redispersion time, and drug content. Drug quantification was performed using an adapted UV spectrophotometric method. Microbiological stability was evaluated on the same days following standard procedures for nonsterile preparations. <i>In vitro</i> simulations of nasogastric tube administration were conducted to determine potential drug loss.</p><p><strong>Results: </strong>The formulation maintained stable physicochemical properties over 7 days, with no sedimentation and a density of 1.2 g/mL. Drug content remained near 100%, and pH was around 6.0, with non-Newtonian behavior. Microbiological assessments confirmed conformity with microbial count limits and the absence of pathogens for seven days under refrigeration, at room temperature, and at 40 °C. After nasogastric tube administration, the losses were 13% and 14%.</p><p><strong>Conclusions: </strong>Oral furosemide suspensions prepared with xanthan gum exhibited satisfactory physicochemical and microbiological stability. These neonatal formulations show potential for the safe management of pediatric cardiovascular disorders.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-14"},"PeriodicalIF":2.2,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147510518","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":"AQbD-based UHPLC approach for quantification of everolimus residues in cleaning validation processes.","authors":"Jagdish Gohel, Ajay Patel, Rajendra Kotadiya","doi":"10.1080/03639045.2026.2654748","DOIUrl":"10.1080/03639045.2026.2654748","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to develop and validate a robust reverse-phase ultra-performance liquid chromatography (UHPLC) method for the quantification of everolimus residues on pharmaceutical manufacturing equipment surfaces, ensuring effective cleaning validation.</p><p><strong>Significance: </strong>Cleaning validation is a critical requirement in pharmaceutical manufacturing to prevent cross-contamination and ensure product integrity. The application of the Analytical Quality by Design (AQbD) framework enhances method robustness, reliability, and regulatory compliance while aligning with principles of sustainable and green analytical chemistry.</p><p><strong>Methods: </strong>Risk assessment tools and a central composite design were used to identify and control critical method parameters. Chromatographic separation was achieved using an Acquity UPLC BEH C18 column (50 mm × 2.1 mm; 1.7 μm) with a mobile phase consisting of acetonitrile and water (65:35% v/v) at a flow rate of 0.4 mL/min. The method was validated according to ICH Q2 (R2) guidelines.</p><p><strong>Results: </strong>The developed method demonstrated a rapid retention time of 1.57 min and excellent linearity over the concentration range of 0.4 to 3.0 μg/mL, with a correlation coefficient (R²) of 0.999. The limits of detection and quantification were found to be 0.100 μg/mL and 0.392 μg/mL, respectively. The method showed high specificity, precision (%RSD within acceptable limits), and recovery accuracy ranging from 91% to 100%.</p><p><strong>Conclusions: </strong>The developed method provides a sensitive, precise, and eco-friendly solution for the quantification of everolimus residues in cleaning validation processes. It fulfils regulatory expectations and is suitable for routine use in pharmaceutical quality control settings, reinforcing product safety and operational efficiency.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-17"},"PeriodicalIF":2.2,"publicationDate":"2026-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147622102","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":"Albendazole-loaded chitosan nanoparticle conjugated with hyaluronic acid for the treatment of psoriasis.","authors":"Shrikanth Nair, Prabha Singh","doi":"10.1080/03639045.2026.2651296","DOIUrl":"10.1080/03639045.2026.2651296","url":null,"abstract":"<p><strong>Objective: </strong>To design and develop hyaluronic acid (HA) conjugated Albendazole (ABZ) loaded chitosan nanoparticles (HA-ABZ-CSNP) loaded hydrogel for the treatment of psoriasis.</p><p><strong>Significance: </strong>Albendazole (ABZ), a commonly used anti-parasitic drug, has garnered a lot of attention lately including anticancer and anti-psoriasis properties. Chitosan nanoparticle followed by conjugation with HA was formulated in hydrogel base making it an excellent strategy for targeting overexpressed CD44 receptor on psoriatic skin as well as alleviating the problems, such as dryness, itchiness associated with psoriasis.</p><p><strong>Methods: </strong>ABZ-CSNP was formulated by ionic gelation technique followed by conjugation with hyaluronic acid (HA) and was evaluated for particle size, zeta potential, entrapment efficiency, respectively. Developed HA-ABZ-CSNP were incorporated into hydrogel base and were evaluated for <i>in-vitro</i> drug release. <i>Ex-vivo</i> studies were performed. <i>In-vivo</i> studies were performed on Balb/c mice and tests, such as Psoriasis Area Severity Index (PASI), Spleen weight assessment, and histopathological studies were conducted.</p><p><strong>Results: </strong>Optimized HA-ABZ-CSNP showed a particle size of 170.1 ± 76.38 nm, zeta potential of 31.6 mV, and entrapment efficiency of 98.89%, respectively. Developed HA-ABZ-CSNP hydrogel showed a Korsemeyer and Peppas release model and an <i>in-vitro</i> release of 93.90 ± 32.50 % in around 24 h. <i>Ex-vivo</i> studies were conducted which showed 30.74 ± 13.65% in 24 h. <i>In-vivo</i> studies conducted on Balb/c mice showed reduced PASI, Spleen weight as well as reduced keratinocyte proliferation in histopathological studies.</p><p><strong>Conclusions: </strong>In conclusion, developed novel formulation of ABZ reduced keratinocyte proliferation making it a possible effective strategy in the management of psoriasis.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-15"},"PeriodicalIF":2.2,"publicationDate":"2026-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147527573","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}