DARU Journal of Pharmaceutical Sciences最新文献

{"title":"Efficacy and safety of different dosages of rituximab for myasthenia gravis: a single-arm meta-analysis.","authors":"Jianchun Li, Di Chen, Fei Zhao, Weihang Cao, Pengfei Jin","doi":"10.1007/s40199-025-00557-y","DOIUrl":"10.1007/s40199-025-00557-y","url":null,"abstract":"<p><strong>Background: </strong>Rituximab (RTX) is one of the treatment options for refractory myasthenia gravis (MG), yet the optimal dosing schedule remains undetermined. Our study aims to explore this issue and offer a valuable reference for clinical dosing.</p><p><strong>Methods: </strong>This is a single-arm meta-analysis. Studies in adults with myasthenia gravis published before 31 December 2023 were searched in PubMed, Web of Science, and other databases. Two primary effectiveness outcomes were analyzed: (1) Proportion of patients achieving minimal manifestation status (MMS) or better, (2) Change in Quantitative MG Score (QMGs) after RTX treatment. Safety outcomes included the incidence and description of serious adverse events (SAEs) and adverse events (AEs). Forest plots were generated to provide an overview and detailed combined effects. Publication bias was evaluated using funnel plots and the Egger test. Conventional dose refers to an RTX regimen similar to that used for the treatment of B-cell lymphoma: 375 mg/m² per week for 4 weeks or 1000 mg for Weeks 1 and 3. Dosing regimens below the conventional dose in a treatment cycle are defined as low dose.</p><p><strong>Results: </strong>A total of 1037 MG patients received RTX treatment. Overall, 59.0% (95% CI: 48.2-69.8%, n = 599) of patients achieved MMS or better, with a mean decrease in QMGs of 6.81 (95% CI, -9.27 to -4.35, n = 222). The low-dose group showed a higher proportion of patients achieving MMS or better (76.6% vs 51.6%) and a more significant decrease in QMGs from baseline (-9.04 vs -3.62) compared to the conventional dose group (P < 0.01). Differences in the incidence of SAEs and AEs between the two groups were not significant (P > 0.05). Univariate meta-regression analyses showed that the dose administered was significantly associated with the proportion of MMS or better and the change in QMGs, whereas the proportion of Musk patients was not significantly associated with any of the outcomes. Stepwise logistic regression analyses showed that non-refractory MG, mild disease severity (MGFA classification), and low-dose were significant predictors for achieving an MMS or better prognosis, whereas for achieving improvement or better, only low dose was an independent predictor.</p><p><strong>Conclusion: </strong>RTX can improve clinical symptoms, reduce QMGs in MG patients and the use of oral glucocorticoids and other immunosuppressants. The efficacy of low-dose RTX in treating MG patients is more effective than conventional-dose RTX and demonstrates a better safety profile. Mild disease severity, non-refractory MG, low dose, and MuSK-MG over AChR-MG predict better efficacy. Large randomized controlled trials are necessary to evaluate the efficacy and safety of RTX in MG patients and its various subtypes.</p>","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"15"},"PeriodicalIF":2.5,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909304/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vancomycin- induced leukocytoclastic vasculitis in a patient with end-stage renal disease: a case report and literature review.","authors":"Maryam S Fakhri B, Ghazal Roostaei, Shila Aghayani, Mohammad Hossein Shojamoradi, Behnoud Vesali, Niloofar Khoshnam Rad","doi":"10.1007/s40199-025-00559-w","DOIUrl":"10.1007/s40199-025-00559-w","url":null,"abstract":"<p><strong>Introduction: </strong>Leukocytoclastic vasculitis (LCV) is a small-vessel inflammatory condition that can rarely occur as an adverse drug reaction (ADR). Vancomycin-induced LCV is an uncommon but potentially serious complication, particularly in patients with pre-existing renal impairment.</p><p><strong>Reason for the report: </strong>This case report describes a patient with end-stage renal disease (ESRD) who developed LCV following vancomycin therapy for a catheter-related infection. The report emphasizes the diagnostic challenges and the importance of prompt and appropriate management of this ADR. A 53-year-old male with ESRD developed skin lesions and systemic symptoms after receiving vancomycin for catheter-related infection. The diagnosis of LCV was confirmed through a skin biopsy. Discontinuation of vancomycin with initiation of mycophenolate mofetil and prednisolone resulted in significant improvement in the patient's condition.</p><p><strong>Outcome: </strong>The presented case underlines the recognition of vancomycin-induced LCV, especially in the vulnerable population of patients with ESRD. It emphasizes the need for a high degree of suspicion of drug-related adverse events and early diagnosis and management to achieve good outcomes.</p><p><strong>Clinical trial number: </strong>Not applicable.</p>","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"13"},"PeriodicalIF":2.5,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11904013/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Development of amphotericin B inclusion complex formulation in dissolvable microarray patches for intravaginal delivery.","authors":"Habiburrahim Burhanuddin, Cindy Kristina Enggi, Frederika Tangdilintin, Rizki Rachmad Saputra, Purnawan Pontana Putra, Sartini Sartini, Aliyah Aliyah, Rina Agustina, Juan Domínguez-Robles, Muhammad Aswad, Andi Dian Permana","doi":"10.1007/s40199-025-00555-0","DOIUrl":"10.1007/s40199-025-00555-0","url":null,"abstract":"","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"12"},"PeriodicalIF":2.5,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11865404/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143499649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the consumption pattern and efficacy of Linezolid in COVID-19 hospitalized patients in a hospital in Tehran-Iran.","authors":"Alireza Tavasoli Rostami, Morteza Izadi, Mohsen Saberi, Mehdi Raei, Mostafa Soodmand, Khadijeh Nasiri, Hossein Mardani Nafchi, Mahdi Bagheri","doi":"10.1007/s40199-024-00554-7","DOIUrl":"10.1007/s40199-024-00554-7","url":null,"abstract":"<p><strong>Background: </strong>The inappropriate use of antibiotics increases the costs of treatment, antibiotic resistance, increased disease length and duration of hospital stay.</p><p><strong>Objectives: </strong>The aim of this study was investigating the pattern of use and effectiveness of the Linezolid in COVID-19 hospitalized patients.</p><p><strong>Methods: </strong>In this retrospective cross-sectional analytical study was carried out from February 2020 (from the beginning of the pandemic in Iran) to the end of September 2020, 32 COVID-19 patients that used Linezolid were included. The data retrieved from medical document's unit and analysis was performed by SPSS statistical software version 20.</p><p><strong>Results: </strong>According to the three elements of the 1- culture of resistant bacteria 2-the correct daily dose and 3-adequate duration of the drug, consumption pattern of Linezolid was irrational in 24 (75%) COVID-19 patients and it was rational only in 8 (25%) patients. Twenty-three (71.9%) patients received sufficient doses of the drug and 9 (28.1%) patients did not receive the required minimum dose. Four (50%) patients who rationally received Linezolid improved and the remaining 4 died. Leukopenia occurred in 1 patient (3.1%), anemia appeared in 24 individuals (75%), and 15 patients (46.9%) developed thrombocytopenia.</p><p><strong>Conclusion: </strong>We suggest that the prescription of Linezolid is in accordance with the standard instructions and the stewardship antibiotic program to reduce the medication costs, drug side effects, and the prevalence of antibiotic resistance.</p>","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"11"},"PeriodicalIF":2.5,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11699184/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142920980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of biosynthesized zinc oxide nanoparticles on gene expression and apoptosis in triple-negative breast cancer cells.","authors":"Hannaneh Zarrinnahad, S Ahmad Dehdast, Ghazaleh Chizari Fard, Mitra Nourbakhsh, Mohammad Kazem Koohi, Ghodratollah Panahi, Amin Karimpour, S Mehdi Rezayat, Mohammad Shabani","doi":"10.1007/s40199-024-00553-8","DOIUrl":"10.1007/s40199-024-00553-8","url":null,"abstract":"<p><strong>Objective(s): </strong>Some forms of breast cancer such as triple-negative phenotype, are serious challenge because of high metastatic cases, high mortality and resistance to conventional therapy motivated the search for alternative treatment approaches. Nanomaterials are promising candidates and suitable alternatives for improving tumor and cancer cell treatments.</p><p><strong>Materials and methods: </strong>Biosynthesis of ZnO NPs by help of Berberis integerrima fruit extract, has been done. Analysis of Zinc Oxide NPs using DLS, FTIR, SEM, and EDS techniques have been performed. Moreover, biological activities of ZnO NPs evaluated through MTT method, Flow cytometry, and real time PCR methods. Biocatalytic and apoptotic activity of ZnO NPs on healthy HFF (human fibroblast cell line), MDA-MB 231, and MDA-MB 468 (triple negative breast cancer cell lines, (TNBC)) evaluated. Furthermore, Bax, Bcl-2 and caspase-3 apoptotic genes expression changes in cancer cells assessed in compare to GAPDH as a house keeping gene.</p><p><strong>Results: </strong>Physico-chemical investigation demonstrated ZnO NPs were confirmed by Berberis integerrima fruit extract for the first time. The MTT assay and Flow cytometry results indicated biocompatibility of the ZnO NPs in normal cell line and high anticancer potential against TNBC MDA-MB-231 and MDA-MB-468 cell lines. The IC50 of ZnO NPs were 104.4 and 44.86, 20.96 after 24 hours for HFF, MDA-MB-231 and MDA-MB-468 cells, respectively.</p><p><strong>Conclusion: </strong>The current research showed a fast, cost effective and ecofriendly method for ZnO NPs nanoparticle synthesis. Furthermore, In vitro data analysis demonstrated biocompatibility and highly anticancer effects of biosynthesized ZnO NPs against TNBC cancerous cells.</p>","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"10"},"PeriodicalIF":2.5,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11682029/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In-vivo and in-vitro assessment of curcumin loaded bile salt stabilized nanovesicles for oral delivery.","authors":"Fahima M Hashem, Dalia Elkhateeb, Marwa M Ali, Rania S Abdel-Rashid","doi":"10.1007/s40199-024-00544-9","DOIUrl":"10.1007/s40199-024-00544-9","url":null,"abstract":"<p><strong>Background: </strong>Bile salts enriched nanovesicles (bilosomes) have been attention worthy in the past few years due to their distinctive effect on the enhancement of drug delivery through various physiological administration routes. Oral delivery of multifunctioning phytochemical curcumin has faced a lot of difficulties due to its scarce solubility and poor oral bioavailability.</p><p><strong>Objective: </strong>The current investigation aimed to develop curcumin loaded bilosomes for improvement of oral curcumin bioavailability with maximum efficiency and safety.</p><p><strong>Methods: </strong>The effect of formulation variables (type of span, SDC % to total lipid content Span/Cholesterol molar ratio) on physicochemical characterization and in vitro drug release in simulated intestinal fluid was investigated. Furthermore, in-vivo protective effect of bilosomes on hepatic and renal functions was also studied.</p><p><strong>Results: </strong>and conclusion. The results revealed that the best curcumin loaded bilosomal formulation showed spherical nanovesicular morphology with particle size 145.1 ± 19.42 nm with highly reasonable %EE (93%), Zeta potential (≥ -30mv), prominent controlled in-vitro release reaching 55.18 ± 1.10 after 96 h. The formulation also showed good storage stability with negligible differences in physical features and content. The IC50 values of bilosomal, niosomal, and free curcumin were 216.50, 211.44, and 121.63 mmol/ml, respectively revealing that the unencapsulated curcumin displayed high toxicity on Caco2 cell line (nearly 2 folds). Additionally, the prepared bilosomes showed significant in-vivo hepatic and renal protection in liver cirrhosis induced rats with conservation to all liver and renal markers and histopathological morphology. The study assumes the effectiveness and safety of oral delivery of curcumin loaded bile salts stabilized nanovesicles and its powerful commandment for further investigations.</p>","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"9"},"PeriodicalIF":2.5,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11666894/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-performance liquid chromatography method for measuring Captopril: an empirical study on hydrogel film permeability test.","authors":"Siti Fatriyah, Noverra Mardhatillah Nizardo, Delly Ramadon","doi":"10.1007/s40199-024-00552-9","DOIUrl":"10.1007/s40199-024-00552-9","url":null,"abstract":"<p><strong>Background: </strong>High-performance liquid chromatography (HPLC) has emerged as a highly sensitive and versatile analytical technique for quantifying antihypertensive drugs, such as Captopril (CAP). This study focused on the optimization and validation of an HPLC method for quantifying CAP in an in vitro hydrogel permeability test.</p><p><strong>Objectives: </strong>The main objective of this study was to develop and validate an HPLC method for quantifying CAP in an in vitro hydrogel permeability test.</p><p><strong>Methods: </strong>The HPLC method employed a C18 column (Waters, Sunfire, 5 μm; 250 × 4.6 mm) and a mobile phase consisting of methanol-water (85% v/v orthophosphoric acid) in a 55:45 (v/v) ratio at a flow rate of 0.5 mL/min. The UV-Vis detector was configured to detect CAP at a wavelength of 220 nm. The hydrogel film used in the permeability test was prepared using poly (vinyl alcohol)/poly (vinyl caprolactam) (PVA/PNVCL) with citric acid as a crosslinking agent.</p><p><strong>Results: </strong>All results met the validation parameters according to ICH Guideline. The HPLC method showed consistent retention time (4.7-4.9 min), linearity (1-50 µg/mL; r = 0.9995), accuracy (98.11-101.78%), precision (RSD ≤ 2%), and LoD/LoQ (0.19/0.62 µg/mL). The developed HPLC method was successfully applied to an in vitro permeability test using horizontal diffusion cells. The results demonstrated that CAP permeated through the swollen hydrogel film, with a cumulative drug permeation exceeding 30%.</p><p><strong>Conclusion: </strong>This highlighted the method's utility in assessing drug transport properties through hydrogels. The validated HPLC method demonstrates robustness and reliability for quantifying CAP in the hydrogel permeability test.</p>","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"8"},"PeriodicalIF":2.5,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11662129/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Electroceuticals: Unlocking the promise of therapies.","authors":"Isha Mishra, Kajal Chaudhary, Vikram Sharma, Gaurav Krishna, Raghav Mishra","doi":"10.1007/s40199-024-00549-4","DOIUrl":"10.1007/s40199-024-00549-4","url":null,"abstract":"<p><strong>Objectives: </strong>Electroceuticals refers to the constantly growing disciplines of bioelectric and bioelectronic medication. These include a broad variety of devices that have been invented and are now being utilized in medical implants, wearable medical electronics, and bioelectronics. The primary aim of this study is to encompass several facets of electroceuticals, their applications, and recent advancements in the field of medical challenges.</p><p><strong>Evidence acquisitions: </strong>A complete literature study was conducted, which included a comprehensive review of globally recognized scientific research databases.</p><p><strong>Results: </strong>The progressive refinement and diminution of technology, in conjunction with swift advancements in comprehending the role of electrical pathways in the human body, have rendered it progressively viable to manipulate these pathways for therapeutic purposes.</p><p><strong>Discussion and conclusion: </strong>Electrical stimulation impacts and modifies biological functioning and pathological processes in the body. In the contemporary era of medicine, health care practitioners from a variety of fields utilize electricity to cure disease or injury or to assess and diagnose using a variety of electrically driven medical tools.</p>","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"7"},"PeriodicalIF":2.5,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11655896/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends analysis and future study of the pharmaceutical industry field: a scoping review.","authors":"Manuchehr Bashirynejad, Fatemeh Soleymani, Shekoufeh Nikfar, Abbas Kebriaeezadeh, Reza Majdzadeh, Behzad Fatemi, Ali Zackery, Nafiseh Zare","doi":"10.1007/s40199-024-00550-x","DOIUrl":"10.1007/s40199-024-00550-x","url":null,"abstract":"<p><strong>Objective: </strong>The main aim of this study was to explore and understand the emerging developments, changes, and patterns shaping the future of the pharmaceutical industry. The pharmaceutical industry is evolving rapidly due to scientific breakthroughs, societal changes, and technological advancements. Companies can adapt, and innovate to stay competitive and advance healthcare objectives by understanding the changes and patterns shaping the future.</p><p><strong>Methods: </strong>We conducted a thorough Scoping Review across PubMed, Embase, Web of Science, and Scopus, focusing on future trends in the pharmaceutical industry. Studies were carefully selected based on predefined criteria, ensuring a comprehensive and relevant collection.</p><p><strong>Results: </strong>We identified and selected 24 studies that met our predefined criteria from a pool of 3617 studies. These studies served as the foundation for a detailed exploration of trends within the pharmaceutical industry. This compilation offers a profound understanding of the diverse forces propelling change, including technological advancements, regulatory shifts, evolving market dynamics, and regional nuances.</p><p><strong>Conclusions: </strong>This research highlights transformative trends such as artificial intelligence, 3D printing, blockchain technology, and digital integration revolutionizing drug discovery, development, manufacturing, and delivery. However, successful implementation hinges on addressing challenges through practical strategies, interdisciplinary collaborations, and region-specific considerations. Future research should explore implementation approaches, facilitating the effective translation of these innovations into tangible healthcare benefits. This forward-looking analysis empowers the pharmaceutical industry to strategically position itself for long-term success in addressing evolving global needs.</p>","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"6"},"PeriodicalIF":2.5,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11652559/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of amphotericin B inclusion complex formulation in dissolvable microarray patches for intravaginal delivery.","authors":"Habiburrahim Burhanuddin, Cindy Kristina Enggi, Frederika Tangdilintin, Rizki Rachmad Saputra, Purnawan Pontana Putra, Sartini Sartini, Aliyah Aliyah, Rina Agustina, Juan Domínguez-Robles, Muhammad Aswad, Andi Dian Permana","doi":"10.1007/s40199-024-00546-7","DOIUrl":"10.1007/s40199-024-00546-7","url":null,"abstract":"<p><strong>Background: </strong>Amphotericin B (AMB) is a drug used to treat vulvovaginal candidiasis (VVC), which is a fungal infection affecting the vagina and vulva. Nevertheless, the substance's limited capacity to dissolve in water leads to poor absorption when taken orally, hence diminishing its therapeutic efficacy. In order to address this limitation, β-cyclodextrin (βCD) was used to create AMB in the form of an inclusion complex.</p><p><strong>Objective: </strong>This study aims to enhance the solubility and bioavailability of AMB by formulating it into an inclusion complex with βCD. Subsequently, we developed dissolvable microarray patches (DMP) as a novel drug delivery system, optimizing the formulation for improved retention, penetration, and controlled release of AMB.</p><p><strong>Methods: </strong>The stability of the AMB-βCD inclusion complx (IC) structure has been confirmed by employing molecular docking studies. The formulation of DMP involved the incorporation of IC with polyvinyl alcohol (PVA) and polyvinylpyrrolidone (PVP). The mechanical strength, ability to be inserted, and propensity to irritate Amphotericin B-Inclusion Complex-Dissolvable Microarray Patches (IC-DMP) were evaluated by laboratory experiments utilizing the porcine vaginal mucosal layer. Further investigations, such as Differential Scanning Calorimetry (DSC), were performed to assess the physicochemical characteristics of the IC.</p><p><strong>Results: </strong>The solubility of the pure medication was greatly enhanced up to fourfold by the inclusion complex. The assessment of IC-DMP exhibited exceptional mechanical robustness and insertion abilities, with no indications of discomfort. Among the formulas tested in ex vivo vaginal kinetic experiments, Formula F3 had the most effective retention in the porcine vaginal mucosal layer. It had an AUC value of 208.02 ± 0.33 h.µg/cm³ and the highest C_max value of 20.05 ± 0.06 µg/cm³. Therefore, Formula F3 was the most efficient formula in terms of vaginal drug delivery.</p><p><strong>Conclusion: </strong>The integration of IC into the DMP system significantly enhances the solubility and bioavailability of AMB, facilitating its absorption in the circulatory system when applied intravaginally for vulvovaginal candidiasis treatment. These promising initial findings support further clinical evaluation of this novel drug delivery system.</p>","PeriodicalId":10888,"journal":{"name":"DARU Journal of Pharmaceutical Sciences","volume":"33 1","pages":"5"},"PeriodicalIF":2.5,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635085/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}