Drug Development and Industrial Pharmacy最新文献

{"title":"Patient-centered innovations in ambulatory care: developing a fixed-dose tablet to enhance adherence for patients with chronic diseases.","authors":"Saleh F Alqifari, Hanan Alshareef, Hesham M Tawfeek, Palanisamy Amirthalingam, Sadeem F Alharbi, Rahaf M Alatawi, Hayaa T Alahmari, Khulood A Qasem, Ghareb M Soliman","doi":"10.1080/03639045.2025.2513407","DOIUrl":"10.1080/03639045.2025.2513407","url":null,"abstract":"<p><strong>Objective: </strong>To improve medication adherence in patients with chronic diseases by developing a tablet formulation containing a combination of metformin, atorvastatin, aspirin, and enalapril maleate. Significance: Effectively managing chronic diseases often requires multiple medications, which can result in low patient adherence and suboptimal therapeutic outcomes. Developing a combination tablet is an effective modality to address this issue.</p><p><strong>Methods: </strong>To test the patient perception, an online survey was distributed patients with chronic diseases. Based on the survey results, combination tablets were prepared by direct compression using a multifunctional excipient (PROSOLV^® EASYtab). The compatibility between the drugs and excipients was studied using differential scanning calorimetry (DSC) and Fourier-transform infrared (FT-IR) spectroscopy. The tablets were evaluated for weight uniformity, friability, hardness, thickness, diameter, disintegration time, uniformity of drug content, and <i>in vitro</i> drug release.</p><p><strong>Results: </strong>Most participants reported issues with non-adherence, but expressed a strong positive perception of combination tablets, particularly regarding their effectiveness in improving their condition. DSC and FT-IR studies confirmed the compatibility of the investigated drugs with each other and the used excipient. The tablets fulfilled the European Pharmacopeia 2014 specifications for the tested parameters. The release of all four drugs was fast and a cumulative percent drug release of approximately 50-85% was observed after 15 min.</p><p><strong>Conclusions: </strong>These findings highlight the significant potential of the combination tablets as a single-dose delivery system, allowing the simultaneous administration of multiple medications for patients with chronic diseases, thereby enabling more effective and streamlined management.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"826-835"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172920","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 of semi solid dosage forms for topical application utilizing quality by design (QbD) approach.","authors":"Eni Bushi, Ledjan Malaj, Piera Di Martino, Gentjan Mataj, Brunilda Myftari","doi":"10.1080/03639045.2025.2498521","DOIUrl":"10.1080/03639045.2025.2498521","url":null,"abstract":"<p><strong>Objective: </strong>Over the last few decades, there have been advancements in our comprehension of the design and development of topical semisolid formulations; however, they still follow an empirical development. Our study focuses on building a framework for designing and developing topical semisolid products using 'Quality by Design' (QbD) approach.</p><p><strong>Methods: </strong>A literature review was conducted to identify and list the factors related to the design and development of topical semi-solid dosage forms using Quality by Design approach. The information extracted from the relevant articles was used to build a QbD framework based on four main pillars: Define the Quality Target Product Profile (QTPP); identify Critical Quality Attributes (CQAs); identify Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs); understand how CMAs and CPPs affect CQAs and establish a control strategy.</p><p><strong>Results: </strong>Some typical elements of the QTPP for topical products include dosage form, route of administration, shelf life, critical quality attributes of the final formulation. Critical material attributes such as characteristics of API (molecular weight, lipophilicity, solubility, metamorphosis events, and polymorphism), characteristics of excipients, and critical process parameters (temperature, heating and cooling rates, mixing speed, pumping speed, order of addition) are identified and explained for their impact on CQAs.</p><p><strong>Conclusions: </strong>Proper characterization of the API and drug delivery system will increase the likelihood of developing a stable, pleasing, and tolerable topical formulation and minimize the risk of failure.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"670-678"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981638","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":"Augmented anticancer efficacy of <i>Ailanthus Excelsa</i>-loaded lipidic nanocarriers for breast cancer treatment: <i>in-vitro</i> and <i>in-vivo</i> evaluation.","authors":"Neama Ibrahim, Sarah Yahia, Rabab M El-Sherif, Ibrahim M El-Sherbiny","doi":"10.1080/03639045.2025.2509869","DOIUrl":"10.1080/03639045.2025.2509869","url":null,"abstract":"<p><strong>Background: </strong>One of the most lethal forms of cancer that impacts women worldwide is breast cancer (BC). The treatment results are influenced by multiple factors, such as the phase of diagnosis, hereditary and hormonal influences, medication resistance, and metastases. <i>Ailanthus Excelsa</i> (AE) crude extract is rich in antioxidants and possesses potent anticancer properties, as demonstrated in tests on MCF-7 cells. Additionally, both lavender oil (LO) and tea tree oil (TTO) have potential cytotoxicity against cancer.</p><p><strong>Objectives: </strong>The purpose of this study was to boost the potency and solubility of AE against breast cancer <i>via</i> its loading in lipidic nanocarriers (LNPs) whose structure is based on a mixture of LO and TTO.</p><p><strong>Methods: </strong>The particle size, stability, and zeta potential of AE-loaded LNPs were examined over 6 months, and the measurements confirmed the good stability of the newly developed AE-LNPs.</p><p><strong>Results: </strong>The AE-LNPs have demonstrated a stronger anticancer impact compared to free AE and plain LNPs, where IC₅₀ values were found to be 36.88 ± 3.09, 22.09 ± 2.13, and 7.49 ± 0.67 µg/ml for plain NPs, free AE, and AE-LNPs, respectively. Furthermore, the AE-LNPs exhibited more pronounced anticancer effects in the Ehrlich ascites <i>in-vivo</i> tumor model, accompanied by significant antiproliferative and antioxidant properties. The immunohistochemical analysis of BCL-2 in tumor tissue validated the apoptotic activity of AE-LNPs.</p><p><strong>Conclusion: </strong>This study is the first to examine the formulation of the newly developed AE-loaded LNPs, demonstrating their efficacy in producing anti-proliferative effects and their considerable promise for BC treatment.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"799-810"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119081","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 gliclazide solubility using solid dispersions with carboxymethyl chitosan and polyvinylpyrrolidone K30 as polymeric carriers.","authors":"Berivan Ajeel Ibrahim, Nozad Rashid Hussein, Huner Kamal Omer, Abdelbary Elhissi, Iftikhar Khan","doi":"10.1080/03639045.2025.2506651","DOIUrl":"10.1080/03639045.2025.2506651","url":null,"abstract":"<p><strong>Background: </strong>Gliclazide (Glz) is a second-generation sulfonylurea antidiabetic drug, used to treat type II diabetes mellitus. Glz is a class II drug according to the biopharmaceutic classification system (BCS), indicating that it has high permeability and poor aqueous solubility.</p><p><strong>Objective: </strong>This study aimed to improve the solubility of Glz <i>via</i> the solid dispersion method.</p><p><strong>Methods: </strong>Solid dispersions of the drug were formulated using carboxymethyl chitosan (CMch) and polyvinyl pyrrolidone K30 (PVP K30) in varying drug to carrier ratios (1:1, 1:3, and 1:5 w/w) using kneading and solvent evaporation methods. The solubility of Glz solid dispersions was compared with the pure Glz and co-grounded mixtures of the drug.</p><p><strong>Results: </strong>Both carriers exhibited a noticeable increment in solubility and dissolution rate compared to the drug alone. Glz: CMch (1:5 w/w ratio) formulation made by the kneading method exhibited an increased solubility by approximately nine folds (337.79 ± 4.22 µg/ml) as compared to Glz alone (38.74 ± 4.69 µg/ml). However, the greatest improvement in drug dissolution rate was observed in the dispersion made with 1:5 w/w drug to PVP K30 using the solvent evaporation method, and the percentage drug release reached 100% after 30 min. Solid dispersions characterization manifested the compatibility between the drug and carriers, with alteration in particle morphology, and reduction in drug crystallinity.</p><p><strong>Conclusion: </strong>Overall, solid dispersion using CMch has shown to be an excellent approach for enhancing the solubility and dissolution of the class II drug Glz.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"735-746"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144132174","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":"Modified sodium caseinate-based nanomicelles for enhanced chemotherapeutics against breast cancer via improved cellular uptake and cytotoxicity.","authors":"Farah Rehan, Md Emranul Karim, Nafees Ahemad, Omer Salman Qureshi, Seemal Jelani, Siew Hua Gan, Ezharul Hoque Chowdhury","doi":"10.1080/03639045.2025.2495849","DOIUrl":"10.1080/03639045.2025.2495849","url":null,"abstract":"<p><strong>Objective: </strong>Poor prognosis, drug resistance, and lower drug loading capacity of the delivery systems lead to therapeutic failures of breast cancers. Herein, we functionalized sodium caseinate nanomicelles (NaCNs) with the divalent calcium (Ca²⁺) and the glucose (Glc) to increase the loading capacity of micelles for higher cellular uptake and cytotoxicity against breast cancer cells.</p><p><strong>Methodology: </strong>Modification of casein micelles was confirmed through Fourier transform infrared spectra (FTIR). Triple quadrupole liquid chromatography-mass spectrometry (TQOF-LCMS/MS) was utilized as a simple, rapid, and sensitive method for protein corona quantification around casein through SwissProt.Mus_musculus database and through <i>de novo</i> sequencing. Un-modified and modified casein micelles were further characterized through field emission scanning electron microscope (FESEM), high resolution-transmission electron microscope (HR-TEM), and energy-dispersive X-ray (EDX). Whereas, sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) was used for protein separation and analysis during micelles formation.</p><p><strong>Results: </strong>Calcium divalent modified sodium caseinate nanomicelles (Ca-NaCNs) and glucose-modified sodium caseinate nanomicelles (Glc-NaCNs) were successfully developed, demonstrating a significantly improved micellar stability. Glc-NaCNs-DOX showed a zeta size of 297.13 ± 15.66 nm with an improved zeta potential of -13.73 ± 0.579 with a drug loading efficiency (DLE) of 86% as compared to our previously published casein formulations since the modified versions involved more soluble casein in the protein micelle matrix, Whereas, Ca-NaCNs-DOX also showed an IC₅₀ value of approximately 197.1 nm as compared to IC₅₀ of free DOX (341.8 nm) and when compared to unmodified DOX loaded formulations (<i>p</i> < .001).</p><p><strong>Conclusion: </strong>Modified NaCNs exhibit the potential to be investigated further as a novel delivery system for similar active moieties to maximize their therapeutic effects.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"702-719"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987477","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":"Assessment of Cytotoxic Effects of Quercetin Nanoemulgel on Different Skin Cancer cell lines.","authors":"Joshna Booravilli, Janaki Devi Sirisolla","doi":"10.1080/03639045.2025.2509274","DOIUrl":"10.1080/03639045.2025.2509274","url":null,"abstract":"<p><strong>Objective: </strong>Quercetin, a polyphenolic flavonoid with antioxidant and anticancer effects, has limited use due to poor water solubility. The objective of this study was to improve the therapeutic effectiveness of quercetin by developing a topical quercetin nanoemulgel.</p><p><strong>Method: </strong>By optimizing the oil (clove oil) and smix ratio (Tween 20:propylene glycol), quercetin nanoemulsion was prepared by spontaneous emulsification method and then evaluated. The optimized nanoemulsion was further prepared to form quercetin nanoemulgel.</p><p><strong>Results: </strong>According to evaluation studies, the optimized quercetin nanoemulsion (QUE NE 3) exhibited stability with a negative zeta potential (-38.2 mV), a tiny particle size (98.2 nm), and high entrapment effectiveness (96.36%). The optimized nanoemulsion was formulated into a nanoemulgel (QUE NEG 3). Studies on <i>ex vivo</i> drug release of quercetin nanoemulgel (QUE NEG 3) showed improved permeability, with cumulative drug release of 93.56 ± 1.16% in 8 h, which was greater than standard quercetin gel (QG) and drug free loaded nanoemulgel (DFL NEG). This was proved by CLSM which shows the delivery of QUE NEG 3 into the dermis. Dose-dependent inhibitory effects were found in cytotoxicity assays conducted on skin cancer cell lines (TE 354.T, A431, and A375) by using the MTT assay. The results demonstrated that quercetin nanoemulgel (QUE NEG 3) showed higher cytotoxicity of 66.52% especially against A431 cells. Hence proving its ability to treat squamous cell carcinoma.</p><p><strong>Conclusion: </strong>These findings imply that the quercetin nanoemulgel is a viable drug delivery method for enhancing quercetin's solubility and therapeutic efficacy.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"771-785"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and evaluation of mucoadhesive buccal films for sustained release of glipizide using natural proteins.","authors":"Sheeba Fr, Ashish K Mullani, Avinash Patel T V, Ajay Koushik Ms, Shetty Chethan, Sultan Alshehri, Walaa F Alsanie, Abdulhakeem S Alamri, Majid Alhomrani, Amal F Alshammary, Syed Imam Rabbani, Syed Mohammed Basheeruddin Asdaq","doi":"10.1080/03639045.2025.2518500","DOIUrl":"10.1080/03639045.2025.2518500","url":null,"abstract":"<p><strong>Purpose: </strong>To address the challenges of frequent glipizide dosing, including its variable bioa-vailability and gastrointestinal side effects, this study developed and evaluated mucoadhesive buccal films using natural proteins (albumin, gelatin, casein) combined with HPMC E15 to achieve sustained drug delivery.</p><p><strong>Methods: </strong>Nine formulations (F1-F9) were prepared using solvent casting technique and sys-tematically characterized. Comprehensive evaluations included: (1) drug-polymer compatibil-ity studies (FT-IR, DSC), (2) physicochemical characterization (thickness, weight uniformity, swelling index, moisture content, folding endurance, surface pH), (3) ex-vivo permeation studies through sheep buccal mucosa, and (4) stability assessments to determine film longevi-ty.</p><p><strong>Results: </strong>Compatibility studies utilizing FT-IR and DSC confirmed no significant incompati-bility between glipizide and the excipients. Some of the important physicochemical character-istics recorded for different formulations were surface pH (6.6 - 6.8), folding endurance (72 - 184), moisture content (5.66 - 12.54%), thickness (0.171 - 0.236 mm), weight (0.150 - 0.238 mg), and swelling index (15.8% after 1 hour to 86.6% after 5 hours). Furthermore, neg-ligible variation was observed in these characteristics when stability studies were conducted after 3 months. The ex-vivo permeation studies demonstrated a sustained release of glipizide over 8 hours, with release percentages ranging from 80.94% to 90%. Formulation F6, which achieved an 8-hour release of 89.29%, was identified as optimal. Kinetic analysis revealed zero-order release kinetics for all formulations.</p><p><strong>Conclusion: </strong> The developed mucoadhesive buccal films exhibited excellent sustained-release properties, representing a significant improvement over conventional dosage forms. This in-novative delivery system shows strong potential for enhancing diabetes management through improved bioavailability and patient compliance, while minimizing gastrointestinal side effects.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-13"},"PeriodicalIF":2.4,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246974","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":"Physico-mechanistic studies on effect of spray drying and corrective excipients on direct compressibility of nanosponges by SeDeM analysis.","authors":"Monica Rp Rao, Madhura Patil, Bushra Bagwan, Prerana Patil, Isha Bhaleghare","doi":"10.1080/03639045.2025.2522854","DOIUrl":"10.1080/03639045.2025.2522854","url":null,"abstract":"<p><strong>Objectives: </strong>SeDeM analysis enables rapid screening of powders for direct compression (DC) into tablets. Aim of this work was to investigate plain nanosponges (NS) and spray dried nanosponges (SDNS) for direct compressibility using SeDeMExpert system. Beta-cyclodextrin (β-CD) based NS are widely used for solubility, stability enhancement, and taste masking. Evaluation of their compressibility profile will shorten timelines required for early formulation development studies of tablets excipients.</p><p><strong>Methods: </strong>NS were synthesized by crosslinking β-CD with diphenyl carbonate (DPC) and spray dried. They were evaluated for spectral and particle characteristics and characterized by SeDeManalysis. Primary indices of dimension: compressibility, flowability, lubricity, and stability were calculated by converting the micromeritic properties into 'r' values using factors. Radar diagrams were plotted to map micromeritic properties. Avicel^® and Supertab^® were mixed with NS and SDNS to correct deficiencies.</p><p><strong>Results: </strong>Spectral characterization confirmed formation of NS. SeDeManalysis and radar diagrams conveyed lacunae in powder characteristics. SDNS displayed better micromeritics than NS however compressibility index was deficient in both. Avicel^® and Supertab^® were mixed with NS and SDNS and SeDeM analysis of mixtures revealed superior micromeritic properties providing conclusive proof of direct compressibility. Index of good compressibility (IGC) of mixtures was above limits.</p><p><strong>Conclusions: </strong>SeDeManalysis is promising technique to characterize powders and predict compressibility of powders. It provides pointers to need for particle engineering to facilitate DC.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-13"},"PeriodicalIF":2.4,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474246","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":"<i>Coreopsis Tinctoria</i> flavonoids phospholipid complex: molecular dynamics simulation, preparation, characterization, and <i>in vitro</i> release.","authors":"Kaixuan Wang, Xinmei Chen","doi":"10.1080/03639045.2025.2519975","DOIUrl":"10.1080/03639045.2025.2519975","url":null,"abstract":"<p><strong>Objective: </strong>To prepare the <i>Coreopsis tinctoria</i> flavonoids phospholipid complex(CTF-PC) and evaluate its physical characterization and release profile.</p><p><strong>Significance: </strong><i>Coreopsis Tinctoria</i> flavonoids (CTF) have excellent antioxidant and liver-protective activity. However, CTF exhibits low solubility and permeability, restricting its <i>in vivo</i> absorption and effectiveness. The phospholipid is a nontoxic amphiphilic substance with excellent biocompatibility. It can complex drugs to promote absorption and is expected to be a potentially effective drug delivery system.</p><p><strong>Methods: </strong>In this study, the following components were utilized as indicator components in CTF: Quercetagitrin, Marein, and Luteolin. The molecular docking and molecular dynamics simulation were used to predict the binding forms and affinity of the phospholipid to CTF. CTF-PC was prepared based on the solvent evaporation method. The structure of CTF-PC was characterized by ultraviolet spectroscopy (UV), infrared spectroscopy (IR), X-ray diffraction (XRD), and differential scanning calorimetry (DSC). Equilibrium solubility and oil-water partition coefficients of CTF components in extract and phospholipid complex were determined. Furthermore, <i>in vitro</i> release assays were designed to assess the release characteristics of CTF-PC.</p><p><strong>Results: </strong>CTF was mainly bound to the phosphate groups of phospholipid through hydrogen bonding with strong affinity. CTF-PC could significantly improve the lipid solubility of CTF. Besides, the CTF-PC exhibited a slow-release effect. Its release characteristic in the gastrointestinal tract conformed with the first-class model.</p><p><strong>Conclusions: </strong>CTF-PC improved the lipid solubility and slow release of CTF. It potentially promoted the absorption of CTF in the stomach, duodenum, and jejunum. It holds promise for improving the absorption and therapeutic efficacy of CTF.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-12"},"PeriodicalIF":2.4,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316166","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":"HPLC-based quantitative assessment of antiviral agents in artificial saliva.","authors":"Aysun Dinçel, Feyyaz Onur","doi":"10.1080/03639045.2025.2519977","DOIUrl":"10.1080/03639045.2025.2519977","url":null,"abstract":"<p><strong>Background: </strong>The efficient analytical method for antiviral drug quantification is crucial in pharmaceutical and biomedical research, particularly for ensuring accurate dosage and monitoring therapeutic efficacy. Accurate quantification of these compounds in artificial saliva is essential for pharmacokinetic studies, as saliva-based drug monitoring offers a noninvasive alternative to traditional blood sampling.</p><p><strong>Objective: </strong>A novel high-performance liquid chromatographic (HPLC) method for simultaneous analysis of three selected antivirals: Tenofovir Disoproxil Fumarate (TDF), Favipiravir (FAV), Ritonavir (RIT) and internal standard as another antiviral (emtricitabine) in artificial saliva was optimized and validated, including sample preparation using new extraction procedure.</p><p><strong>Methods: </strong>The chromatographic separation was achieved with XTerra, C18 (250 × 4.6 mm, 3.5 µm) analytical column (20 °C) at a wavelength of 215 nm, and the mobile phase was composed of 0.1% phosphoric acid, methanol, and an acetonitrile mixture; 32:60:8 (v/v) at a flow rate of 0.8 mL/min. The method was linear over the range of 0.1-1.0 µg/mL.</p><p><strong>Results: </strong>The method has been found according to ICH guidelines specific, accurate (recovery, 93.003%-103.357%), sensitive (LOD and LOQ were values found as 0.03 and 0.1 µg/mL, respectively), and precise (RSD; 0.412%-3.175%).</p><p><strong>Conclusion: </strong>A validated HPLC method was developed for the precise determination of different antiviral agents in artificial saliva.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-8"},"PeriodicalIF":2.4,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274444","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}