Drug Development and Industrial Pharmacy最新文献

{"title":"<i>Arctium minus (Hill) Bernh.</i> extract-loaded polycaprolactone and bilayer polycaprolactone/polyvinyl alcohol electrospun nanofiber scaffolds as bioactive wound dressings.","authors":"Tugba Eren Boncu, Cigdem Yucel, Selen Ilgun, Gökce Seker Karatoprak","doi":"10.1080/03639045.2025.2528062","DOIUrl":"https://doi.org/10.1080/03639045.2025.2528062","url":null,"abstract":"<p><strong>Objective: </strong>It was aimed to formulate blank and <i>Arctium minus</i> extract-loaded Polycaprolactone (PCL) and bilayer Polycaprolactone/Polyvinyl alcohol (PCL/PVA) electrospun herbal nanofiber scaffolds as bioactive wound dressings.</p><p><strong>Methods: </strong>Electrospinning was used to produce nanofiber scaffolds and characterization studies of nanofibers (morphology, diameter) and the scaffolds(release, encapsulation efficiency, cytotoxicity, cell adhesion and proliferation, <i>in-vitro</i> wound healing, antioxidant activity) were carried out. MTT assay was used to determine the cytotoxicity of the fiber scaffolds on L929 mouse fibroblast cell line. Cell adhesion and proliferation were determined by imaging the cells seeded on scaffolds with scanning electron microscopy and fluorescent microscope. Wound healing assay was performed by creating an artificial wound (gap) to simulate the wound in the cell environment. The antioxidant efficacy of the extract produced from the scaffolds was assessed using 1,1-diphenyl-2-picrylhydrazyl (DPPH●) and 2,2-Azino-bis3-ethylbenzothiazoline-6-sulfonic acid(ABTS●+) assays.</p><p><strong>Results: </strong>All nanofibers were smooth and bead-free in the diameter range of 877.9-1257.9 nm, and had favorable encapsulation efficiency (91.9-97.5%), suitable <i>in-vitro</i> release. While the viability was between 71.4-73.6% in blank scaffolds, it increased up to 94.8-99.8% in extract-loaded scaffolds. However, all scaffolds can be used safely. All scaffolds (except blank PCL) provided a suitable environment for cell adhesion and proliferation. Both extract-loaded fiber scaffolds accelerated wound healing by improving cell migration. The amount of extract released was increased through formulation, demonstrating a strong capacity to scavenge DPPH● and ABTS●+ radicals.</p><p><strong>Conclusion: </strong>In conclusion, <i>Arctium minus</i> extract-loaded PCL and PCL/PVA lead to significant enhancement in viability, adhesion, proliferation and <i>in-vitro</i> wound healing, indicating that they can be used as effective and safe wound dressings.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-14"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539513","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":"Molecular dynamics and surfactant study for enhancing the formation and anti-oral cancer efficacy of D-limonene nanoemulsions.","authors":"Yotsanan Weerapol, Suwisit Manmuan, Sontaya Limmatvapirat, Jitnapa Sirirak, Poomipat Tamdee, Apichaya Sukontachard, Sukannika Tubtimsri","doi":"10.1080/03639045.2025.2523524","DOIUrl":"10.1080/03639045.2025.2523524","url":null,"abstract":"<p><strong>Objective: </strong>D-Limonene (D-LMN) is a potential anti-oral cancer agent. The incorporation of D-LMN into a nanoemulsion enhances its potential efficacy against oral cancer cells by improving its aqueous compatibility. This study evaluated the impact of surfactant type and concentration on their properties through experimental and molecular dynamics studies.</p><p><strong>Methods: </strong>D-LMN nanoemulsions were produced using different polyoxyethylene nonionic surfactants. The nanoemulsions were compared on droplet size, size distribution, zeta potential, droplet morphology, stability, interaction among molecules, anticancer activity, and cell death mechanism. Molecular dynamics simulations were also conducted to elucidate the dynamics of the components.</p><p><strong>Results: </strong>Cremophor RH40 and Tween 60 yielded a nanoemulsion with a small droplet size (<100 nm). Cremophor RH40 also produced the nanoemulsion with the narrowest size distribution. Two-dimensional nuclear Overhauser effect spectroscopy-nuclear magnetic resonance and molecular dynamic simulation studies revealed that Cremophor RH40 effectively produced nanoemulsions with small droplets and high stability. The nanoemulsions formulated with Tween 60 exhibited more potent inhibitory effects against oral cancer cells than those with Cremophor RH40. However, surfactant type did not influence the mechanism underlying the apoptotic.</p><p><strong>Conclusions: </strong>This study demonstrated that surfactants with an intermediate hydrophilic-lipophilic balance of approximately 15, particularly those with large polar heads and multiple hydrocarbon chains, were suitable for the production of anti-oral cancer D-LMN nanoemulsions by phase-inversion temperature technique.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-19"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474245","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":"Albumin-based nanoparticles: a potential and emerging oral drug delivery system.","authors":"Yanping Sun, Huijia Song, Shuo Li, Huimin Zhang, Yongjun Sun, Zibin Gao","doi":"10.1080/03639045.2025.2504440","DOIUrl":"10.1080/03639045.2025.2504440","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this review is to elaborate current development and challenges of oral albumin nanoparticles, and realize their clinical application.</p><p><strong>Significance: </strong>Albumin is an emerging protein nanocarrier with a high degree of versatility, safety, stability, modifiability. These characteristics endow albumin nanoparticles with considerable attention and unique roles in drug delivery. However, most albumin nanoparticles are administered intravenously instead of orally, although oral administration is the most popular and common drug delivery route. Oral administration of albumin nanoparticles is their inevitable tendency, but researches referred to this area are still in infancy.</p><p><strong>Methods and results: </strong>Given that, firstly, the basic properties of albumin nanoparticles, like preparation methods, drug loading strategies, targeted drug delivery, and clinical application were simply discussed to provide design guide for their oral administration. Subsequently, the functions and challenges of albumin nanoparticles in oral drug delivery, and strategies to overcome the barriers were highlighted. Finally, aiming to realize their clinical potentials, the possible future trends of orally administrated albumin nanoparticles were also elaborated.</p><p><strong>Conclusions: </strong>In this review, albumin nanoparticles were comprehensively introduced, especially their functions and challenges in oral drug delivery, aiming to guide their design and development.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"679-690"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A comprehensive review of green approaches to drug solubility enhancement.","authors":"B S Mahesha, F R Sheeba, H K Deepak","doi":"10.1080/03639045.2025.2496940","DOIUrl":"10.1080/03639045.2025.2496940","url":null,"abstract":"<p><strong>Objective: </strong>This review explores green approaches to enhance poorly water-soluble drug solubility. Implementing sustainable and green techniques, it provides a comprehensive overview of advancements and applications in drug development.</p><p><strong>Significance of review: </strong>Drug solubility is a key challenge in pharmaceutical research, affecting bioavailability and efficacy. Conventional methods often rely on hazardous solvents and energy-intensive processes, posing environmental and safety concerns. This review emphasizes green chemistry principles as sustainable alternatives to enhance solubility while supporting global sustainability goals.</p><p><strong>Key findings: </strong>Natural and biodegradable polymers in solid dispersions offer effective, eco-friendly solubility enhancement. The application of supercritical CO₂ demonstrates significant potential as a green solvent for solubility enhancement, offering scalability while minimizing environmental impact. Plant-derived and renewable excipients offer a sustainable alternative to synthetic additives.</p><p><strong>Summary of challenges: </strong>Natural polymers face formulation, solubility, and batch variability issues. Deep eutectic solvents and ionic liquids face stability, regulatory hurdles, toxicity risks, and hygroscopicity. Supercritical fluid technology requires costly equipment and precise optimization. Green co-crystallization faces co-former selection, scalability, and stability issues. Further refinement, safety validation, and industrial feasibility studies are needed.</p><p><strong>Potential drawbacks of green approaches: </strong>Green solubility enhancement methods face scalability, regulatory, and cost challenges. Some offer limited solubility gains and stability issues. Ensuring cost-effectiveness, industrial viability, and compliance is key for broader adoption.</p><p><strong>Conclusion: </strong>Green solubility enhancement offers a sustainable solution to drug solubility challenges. Integrating these methods improves efficiency, safety, and environmental impact. This review highlights the need for further research and the adoption of sustainable drug delivery approaches.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"659-669"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969747","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":"Phenyl boronic acid conjugated lipid nanoparticles for targeted delivery of gamma-secretase inhibitor to breast cancer cells.","authors":"Ramakrishna Gummadi, Lakshmi Prasanthi Nori, Sai Kiran S S Pindiprolu","doi":"10.1080/03639045.2025.2511291","DOIUrl":"10.1080/03639045.2025.2511291","url":null,"abstract":"<p><strong>Objective: </strong>The major objective of this study is to develop and evaluate phenyl boronic acid (PBA) conjugated solid lipid nanoparticles (SLNs) (PBA-SUL@SLN) for the targeted delivery of sulindac (SUL) to breast cancer (BC) cells.</p><p><strong>Significance: </strong>Utilizing a dual approach that combines PBA-mediated targeting with Notch-1 pathway inhibition by SUL, the study aims to enhance therapeutic selectivity and efficacy against an aggressive BC subtype, triple negative BC (TNBC), which lacks well-defined molecular targets.</p><p><strong>Methods: </strong>The PBA-SUL@SLN formulation was prepared using emulsification-solvent evaporation method and analyzed for the particle size (PS), zeta potential (ZP), entrapment efficiency (EE), and pH sensitive drug release. Cellular uptake studies were conducted to examine selective internalization in TNBC cells. The therapeutic efficacy was assessed by evaluating Notch-1expression modulation of epithelial-to-mesenchymal transition (EMT), cancer stem cell (CSC) activity, and cytotoxic effects in TNBC cell compared to normal cells.</p><p><strong>Results: </strong>The PBA-SUL@SLN formulation exhibited an optimal PS of (153.35 nm), a ZP of (22.87 mV), and an EE of 83.06%, with preferential drug release observed in the acidic tumor microenvironment. Increased cellular uptake in MDA-MB-231 cells led to notable downregulation of Notch-1, inhibition of EMT, and potential reduction in CSC activity. Cytotoxicity assays revealed strong and selective efficacy against TNBC cells while causing minimal effects on normal cells.</p><p><strong>Conclusions: </strong>The PBA-SUL@SLN formulation presents a promising targeted therapeutic strategy for TNBC, addressing key limitations of existing treatments.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"811-825"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144136144","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":"Functionalized liposomes for intranasal levodopa delivery to the brain.","authors":"Daria S Gordeeva, Achraf Sym Tameloucht, Irina I Semina, Rouslan I Moustafine","doi":"10.1080/03639045.2025.2509273","DOIUrl":"10.1080/03639045.2025.2509273","url":null,"abstract":"<p><strong>Objective: </strong>The study evaluated functionalized liposomes as potential carriers for intranasal delivery of levodopa.</p><p><strong>Methods: </strong>Lipid film hydration method was used to obtain conventional and functionalized liposomes with polyethylene glycol or maleimide-PEG. The liposome structure was analyzed by dynamic light scattering and ¹H-NMR spectroscopy. Isolated sheep nasal mucosa was used for mucoadhesion and mucous penetration studies. Levodopa release was assessed using a Franz diffusion cell. <i>In vivo</i> experiments were conducted using a method based on the inhibition of dopaminergic transmission.</p><p><strong>Results: </strong>The average liposome diameter was 81-91 ± 1 nm. The Pdi was less than 0.300. The zeta potential was negative. An increase in the molar weight of polyethylene glycol in the liposome structure improved mucosa penetration to 0.4 mm. The presence of maleimide did not affect the mucoadhesive properties. The levodopa release profile corresponded to Fickian diffusion. Intranasal administration of levodopa <i>in vivo</i> caused dopaminergic transmission inhibition in rats after 1 h.</p><p><strong>Conclusion: </strong>According to the received results, functionalized liposomes are promising for further evaluation as intranasal drug carriers.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"758-770"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109843","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":"Combating breast cancer-associated metastasis using paclitaxel and tranilast-loaded human serum albumin nanoparticles.","authors":"Naitik Jain, Syed Shahrukh, Paras Famta, Saurabh Shah, Ganesh Vambhurkar, Dadi A Srinivasarao, Anamika Sharma, Giriraj Pandey, Suraj Wagh, Swapnil Shinde, Anjesh Khan, Prashanth Kumar, Saurabh Srivastava","doi":"10.1080/03639045.2025.2509861","DOIUrl":"10.1080/03639045.2025.2509861","url":null,"abstract":"<p><strong>Objective: </strong>The objective of the current study is to combat breast cancer-associated metastasis using paclitaxel (PTX) and tranilast (TRA)-loaded human serum albumin (HSA) nanoparticles.</p><p><strong>Significance: </strong>This combinatorial therapy uses microtubule stabilizing agent PTX, along with TGFβ inhibitor TRA. TRA may offer an improved therapeutic effect in breast cancer by inhibiting cell proliferation and metastasis.</p><p><strong>Methods: </strong>Inspired by the remarkable anticancer properties of both drugs, they were encapsulated into HSA nanoparticles to enhance tumor site-specific drug accumulation and ensure sustained release over a prolonged period. The HSA nanoparticles were fabricated using the desolvation method and optimized using a Box-Behnken design (BBD) with a three-level, two-factor approach. Further, these nanoparticles were characterized using TEM, FTIR, XRD, and particle size. <i>In vitro</i> experiments were conducted using the MDA-MB-231 cell line, employing cell viability, cellular uptake, nuclear staining, scratch assay, and cell cycle analysis.</p><p><strong>Key findings: </strong><i>In vitro</i> release kinetics reveal sustained PTX and TRA release from HSA nanoparticles. Wound healing assay depicted improved anti-migratory activity of PTX-TRA-NPs (30 nM to 75 µM). Furthermore, the novel combination treatment caused G2/M phase cell cycle arrest, as indicated by cell cycle analysis.</p><p><strong>Conclusion: </strong>HSA nanoparticles enhance the delivery and accumulation of hydrophobic drugs (PTX and TRA) in breast cancer cells, offering improved therapeutic outcomes. This combinatorial strategy permits further preclinical investigation for synergistic breast cancer management.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"786-798"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119088","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":"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":"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}